Geron
Annual Report 2015

Plain-text annual report

Use these links to rapidly review the documentTABLE OF CONTENTS ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATEDSTOCKHOLDER MATTERSTable of ContentsUNITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington, D.C. 20549FORM 10-KCommission File Number: 0-20859GERON CORPORATION(Exact name of registrant as specified in its charter)Delaware(State or other jurisdiction ofincorporation or organization) 75-2287752(I.R.S. EmployerIdentification No.)149 Commonwealth Drive, Suite 2070, Menlo Park,CA(Address of principal executive offices) 94025(Zip Code)Registrant's telephone number, including area code: (650) 473-7700 Securities registered pursuant to Section 12(b) of the Act:Title of each class Name of each exchange on whichregisteredCommon Stock, $0.001 par value The Nasdaq Stock Market LLC Securities registered pursuant to Section 12(g) of the Act: None Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes o No ý Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes o No ý Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filingrequirements for the past 90 days. Yes ý No o Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Website, if any, every Interactive Data Filerequired to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorterperiod that the registrant was required to submit and post such files). Yes ý No o Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405 of this chapter) is not contained herein, andwill not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-(Mark One) ý ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the Fiscal Year Ended December 31, 2015oro TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the transition period from to .K or any amendment to this Form 10-K. ý Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. Seethe definitions of "large accelerated filer", "accelerated filer" and "smaller reporting company" in Rule 12b-2 of the Exchange Act. Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes o No ý The aggregate market value of voting and non-voting common equity held by non-affiliates of the registrant was approximately $673,346,000 basedupon the closing price of the registrant's common stock on June 30, 2015 on the Nasdaq Global Select Market. The calculation of the aggregate market valueof voting and non-voting common equity held by non-affiliates of the registrant excludes shares of common stock held by each officer, director andstockholder that the registrant concluded were affiliates on that date. This determination of affiliate status is not necessarily a conclusive determination forother purposes. As of March 3, 2016, there were 158,916,775 shares of common stock outstanding.DOCUMENTS INCORPORATED BY REFERENCE: Large accelerated filer o Accelerated filer ý Non-accelerated filer o(Do not check if asmaller reporting company) Smaller reporting company oDocument Form 10-KPartsPortions of the Registrant's definitive proxy statement for the 2016 annual meeting of stockholders to be filed pursuant to Regulation 14A within120 days of the Registrant's fiscal year ended December 31, 2015 IIITable of Contents TABLE OF CONTENTS In this report, unless otherwise indicated or the context otherwise requires, "Geron," "the registrant," "we," "us," and "our" refer to Geron Corporation, aDelaware corporation.2 Page PART I Item 1. Business 3 Item 1A. Risk Factors 29 Item 1B. Unresolved Staff Comments 66 Item 2. Properties 66 Item 3. Legal Proceedings 66 Item 4. Mine Safety Disclosures 67 PART II Item 5. Market for the Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases ofEquity Securities 68 Item 6. Selected Financial Data 70 Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations 72 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 87 Item 8. Financial Statements and Supplementary Data 88 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 125 Item 9A. Controls and Procedures 125 Item 9B. Other Information 127 PART III Item 10. Directors, Executive Officers and Corporate Governance 128 Item 11. Executive Compensation 128 Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 129 Item 13. Certain Relationships and Related Transactions, and Director Independence 129 Item 14. Principal Accounting Fees and Services 129 PART IV Item 15. Exhibits, Financial Statement Schedules 129 SIGNATURES 130 Table of ContentsForward-Looking Statements This annual report on Form 10-K, including "Business" in Part I, Item 1 and "Management's Discussion and Analysis of Financial Condition and Resultsof Operations" in Part II, Item 7, contains forward-looking statements that involve risks and uncertainties, as well as assumptions that, if they nevermaterialize or prove incorrect, could cause the results of Geron Corporation, or Geron or the Company, to differ materially from those expressed or implied bysuch forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Insome cases, forward-looking statements can be identified by the use of terminology such as "may," "expects," "plans," "intends," "will," "should," "projects,""believes," "predicts," "anticipates," "estimates," "potential," or "continue" or the negative thereof or other comparable terminology. The risks anduncertainties referred to above include, without limitation, risks related to our dependence on Janssen Biotech, Inc. for the development, regulatory approval,manufacture and commercialization of imetelstat, uncertainty of clinical trial results or regulatory approvals or clearances, the future development ofimetelstat, including any future efficacy or safety results that cause the benefit-risk profile of imetelstat to become unacceptable, our ability to identify andacquire and/or in-license other oncology products, product candidates, programs or companies to grow and diversify our business, our need for additionalcapital to support the development and commercialization of imetelstat in collaboration with Janssen and to otherwise grow our business, enforcement of ourpatent and proprietary rights, potential competition and other risks that are described herein and that are otherwise described from time to time in ourSecurities and Exchange Commission reports including, but not limited to, the factors described in Part I, Item 1A, "Risk Factors," of this annual report onForm 10-K. Geron assumes no obligation for and except as required by law, disclaims any obligation to update these forward-looking statements to reflectfuture information, events or circumstances.Calculation of Aggregate Market Value of Non-Affiliate Shares For purposes of calculating the aggregate market value of shares of our common stock held by non-affiliates as set forth on the cover page of this annualreport on Form 10-K, we have assumed that all outstanding shares are held by non-affiliates, except for shares held by each of our executive officers, directorsand 5% or greater stockholders. In the case of 5% or greater stockholders, we have not deemed such stockholders to be affiliates unless there are facts andcircumstances which would indicate that such stockholders exercise any control over our company. These assumptions should not be deemed to constitute anadmission that all executive officers, directors and 5% or greater stockholders are, in fact, affiliates of our company, or that there are no other persons whomay be deemed to be affiliates of our company. Further information concerning shareholdings of our executive officers, directors and principal stockholdersis incorporated by reference in Part III, Item 12 of this annual report on Form 10-K. PART I ITEM 1. BUSINESS Company Overview We are a biopharmaceutical company that currently supports the clinical stage development of a telomerase inhibitor, imetelstat, in hematologicmyeloid malignancies, by Janssen Biotech, Inc., or Janssen. Early clinical data, including molecular responses in essential thrombocythemia, or ET, andremission responses, including reversal of bone marrow fibrosis, in myelofibrosis, or MF, suggest imetelstat may have disease-modifying activity byinhibiting the progenitor cells of the malignant clones for the underlying diseases.3Table of Contents On November 13, 2014, we entered into a collaboration and license agreement, or the Collaboration Agreement, pursuant to which we granted Janssenthe exclusive rights to develop and commercialize imetelstat worldwide for all indications in oncology, including hematologic myeloid malignancies, andall other human therapeutic uses. The Collaboration Agreement became effective on December 15, 2014, and we received $35 million from Janssen as anupfront payment. Additional consideration under the Collaboration Agreement includes payments up to a potential total of $900 million for the achievementof development, regulatory and commercial milestones, as well as royalties on worldwide net sales. Under the Collaboration Agreement, Janssen is wholly responsible for the development, manufacturing and commercialization of, and seekingregulatory approval for imetelstat worldwide. To that end, Janssen is currently proceeding with the development of imetelstat with two clinical trials: aPhase 2 trial in MF, referred to as IMbark™, and a Phase 2/3 trial in myelodysplastic syndromes, or MDS, referred to as IMerge™. In July 2015, IMbark™opened to patient enrollment, and the first patient was dosed in September 2015. In December 2015, IMerge™ opened to patient enrollment, and the firstpatient was dosed in January 2016. We are contributing 50% of the development costs for these clinical trials, which Janssen is solely conducting. Janssenmay consider initiating additional clinical trials, such as possible registration studies in MF and MDS, and possible exploratory Phase 2 and potential followon Phase 3 studies in acute myelogenous leukemia, or AML. The costs for such studies will be borne 100% by Janssen, unless and until Janssen elects tomaintain its license rights and continues to advance the development of imetelstat in any indication, and we subsequently elect certain opt-in rights to sharefurther U.S. development and promotion costs in exchange for higher tiered royalty rates and higher future development and regulatory milestone paymentsif imetelstat is successfully developed and approved (as described in the section below entitled "Future Development of Imetelstat in Collaboration withJanssen"). We expect Janssen to perform a data cut for IMbark™ in the second half of 2017, and for Janssen to thereafter initiate the protocol-specified primaryanalysis; however, the timing may vary based on numerous factors, including the pace of patient enrollment in the clinical trial. Following completion of theprotocol-specified primary analysis of IMbark™ by Janssen or a certain time period after the initiation of the first Phase 3 MF study, if any, Janssen mustnotify us of their decision, or a Continuation Decision, as to whether they elect to maintain the license rights granted to them under the CollaborationAgreement and continue to advance the development of imetelstat in any indication. In the event that IMbark™ has been terminated early or suspended,Janssen must instead notify us of their Continuation Decision by the date that is the later of 24 months after the initiation of IMerge™ or 24 months after thetermination of IMbark™ or commencement of the suspension period, as applicable. With projected reduced operational demands as a result of the Collaboration Agreement with Janssen, on March 3, 2015, we announced anorganizational resizing to reduce our workforce from 39 to 21 positions, which was complete as of December 31, 2015. We had approximately $146.7 million in cash and investments as of December 31, 2015. We believe our current operational and financial resources mayenable us to acquire one or more oncology products, product candidates, programs or companies to diversify our business.Telomeres and Telomerase in Normal Development In the human body, normal growth and maintenance of tissues occurs by cell division. However, most cells are only able to divide a limited number oftimes, and this number of divisions is regulated by telomere length. Telomeres are repetitions of a deoxyribonucleic acid, or DNA, sequence located at theends of chromosomes. They act as protective caps to maintain stability and integrity of the chromosomes, which contain the cell's genetic material. Normally,every time a cell divides, the4Table of Contentstelomeres shorten. Eventually, they shrink to a critically short length, and as a result, the cell either dies by apoptosis or stops dividing and senesces. Telomerase is a naturally occurring enzyme that maintains telomeres and prevents them from shortening during cell division in cells, such as stem cellsthat must remain immortalized to support normal health. Telomerase consists of at least two essential components: a ribonucleic acid, or RNA, template(hTR), which binds to the telomere, and a catalytic subunit (hTERT) with reverse transcriptase activity, which adds a specific DNA sequence to thechromosome ends. The 2009 Nobel Prize for Physiology and Medicine was awarded to Drs. Elizabeth H. Blackburn, Carol W. Greider and Jack Szostak,former Geron collaborators, for the discovery of how chromosomes are protected by both telomeres and telomerase. Telomerase is active during embryonic development, enabling the rapid cell division that supports normal growth. During the latter stages of humanfetal development and in adulthood, telomerase is repressed in most cells, and telomere length gradually decreases during a lifetime. In tissues that have ahigh turnover throughout life, such as blood and gut, telomerase can be transiently upregulated in progenitor cells to enable controlled, self-limitedproliferation to replace cells lost through natural cell aging processes. In proliferating progenitor cells, relatively long telomeres are maintained byupregulated telomerase. As the progeny of progenitor cells mature, telomerase is downregulated and telomeres shorten with cell division, preventinguncontrolled proliferation.Telomeres and Telomerase in Cancer Telomerase is upregulated in many tumor progenitor cells, which enables the continued and uncontrolled proliferation of the malignant cells that drivetumor growth and progression. Telomerase expression has been found to be present in approximately 90% of biopsies taken from a broad range of humancancers. Our nonclinical studies, in which the telomerase gene was artificially introduced and expressed in normal cells grown in culture, have suggested thattelomerase does not itself cause a normal cell to become malignant. Instead, the sustained upregulation of telomerase enables tumor cells to maintaintelomere length, providing them with the capacity for limitless proliferation. We believe that the sustained upregulation of telomerase is critical for tumorprogression as it enables malignant progenitor cells to acquire cellular immortality and avoid apoptosis, or cell death.Telomerase Inhibition: Inducing Cancer Cell Death We believe that inhibiting telomerase may be an attractive approach to treating cancer because it may limit the proliferative capacity of malignant cells.We and others have observed in various in vitro and rodent tumor models that inhibiting telomerase results in telomere shortening and arrests uncontrolledmalignant cell proliferation and tumor growth. In vitro studies have suggested that tumor cells with short telomeres may be especially sensitive to the anti-proliferative effects of inhibiting telomerase. Our nonclinical data also suggest that inhibiting telomerase is particularly effective at limiting the proliferationof malignant progenitor cells, which have high levels of telomerase and are believed to be important drivers of tumor growth and progression. Many hematologic malignancies, such as ET, MF, and polycythemia vera, or PV, are known to arise from malignant progenitor cells in the bone marrowthat express higher telomerase activity and have shorter telomeres when compared to normal healthy cells.Imetelstat: The First Telomerase Inhibitor to Advance to Clinical Development Imetelstat is a lipid conjugated 13-mer oligonucleotide that we designed to be complementary to and bind with high affinity to the RNA template oftelomerase, thereby directly inhibiting telomerase activity. The compound has a proprietary thio-phosphoramidate backbone, which is designed to provideresistance to the effect of cellular nucleases, thus conferring improved stability in plasma and tissues, as5Table of Contentswell as improved binding affinity to its target. To improve the ability of imetelstat to penetrate cellular membranes, we conjugated the oligonucleotide to alipid group. Imetelstat's IC50, or half maximal inhibitory concentration, is 0.5-10 nM in cell free assays. The tissue half-life of imetelstat, or the time it takesfor the concentration or amount of imetelstat to be reduced by half, in bone marrow, spleen, liver and tumor has been estimated to be 41 hours in humans,based on data from our animal studies and clinical trial data. The tissue half-life indicates how long a drug will remain present in the tissues, and a longertissue half-life may enable a drug to remain at effective doses for a longer period of time. Imetelstat also has been shown in nonclinical studies to exhibitrelatively preferential inhibition of the clonal proliferation of malignant progenitor cells compared to normal progenitors. For these reasons, imetelstat hasbeen studied as a treatment for malignant diseases. Imetelstat is the first telomerase inhibitor to advance to clinical development. The Phase 1 trials that we completed evaluated the safety, tolerability,pharmacokinetics and pharmacodynamic effects of imetelstat. We established doses and dosing schedules that were tolerable and achieved target exposuresin patients that were consistent with those required for efficacy in animal models. We believe adverse events were generally manageable and reversible. Thedose-limiting toxicities were thrombocytopenia, or reduced platelet count, and neutropenia, or reduced neutrophil count. Following intravenousadministration of imetelstat using tolerable dosing regimens, clinically relevant and significant inhibition of telomerase activity was observed in varioustypes of tissue in which telomerase activity is measurable, including normal bone marrow hematopoietic cells, malignant plasma cells, hair follicle cells andperipheral blood mononuclear cells.Developing Imetelstat to Treat Hematologic Myeloid MalignanciesProof-of-Concept in Essential Thrombocythemia Myeloproliferative neoplasms, or MPNs, are hematologic myeloid malignancies that arise from malignant hematopoietic myeloid progenitor cells in thebone marrow, such as the precursor cells of red blood cells, platelets and granulocytes. Proliferation of malignant progenitor cells leads to an overproductionof any combination of myeloid white cells, red blood cells and/or platelets, depending on the disease. These overproduced cells may also be abnormal,leading to additional clinical complications. MPN diseases include PV, ET and MF. ET is an MPN characterized by a high platelet count, often accompaniedby a high white cell count, and an increased risk of thrombosis, or bleeding, in higher risk patients. In January 2011, we initiated a Phase 2 clinical trial of imetelstat in patients with ET. The Phase 2 ET trial was a multi-center, single arm, and open labeltrial that we designed to provide proof-of-concept for the potential use of imetelstat as a treatment for hematologic myeloid malignancies, such as MF, MDSor AML. The trial leveraged clinical observations from Phase 1 trials suggesting that imetelstat reduces platelet counts, as well as nonclinical observationsthat imetelstat distributes well to bone marrow in rodent models and selectively inhibits the proliferation of malignant progenitors ex vivo from patients withET. Hematologic responses were measured by reductions in platelet counts, and molecular responses were measured by reductions in the JAK2 V617F mutantallele burden in circulating granulocytes as assessed by a reduction in the proportion of the abnormal Janus kinase 2, or JAK2, gene compared to the normal,or wild type JAK2 gene. Reductions in calreticulin, or CALR, and myeloproliferative leukemia protein, or MPL, mutant allele burdens were measuredsimilarly. We believe that the observed reductions in JAK2, CALR and MPL allele burdens are consistent with selective inhibition of the malignantprogenitor cells responsible for the disease, and suggest that imetelstat may exhibit disease-modifying activity.6Table of Contents The primary efficacy analysis of the Phase 2 ET trial was conducted in October 2013 and the data were published in the September 3, 2015 issue of TheNew England Journal of Medicine:Patient Demographics:•A total of 18 ET patients were enrolled in the study, and all had received one or more previous treatments. •The median baseline platelet count was 787,500 per cubic millimeter (range: 521,000 to 1,359,000). •The JAK2 V617F gene mutation was detected in eight patients, the CALR gene mutation was detected in five patients and MPL genemutations were detected in two patients at baseline.Efficacy Data:•Imetelstat induced platelet count reductions in all 18 patients in the trial (a 100.0% hematologic response rate) and normalizations in 16 out of18 patients (an 88.9% complete response rate). •The median time on therapy was 17.1 months (range: 6.9 months to 2.7 years). •Seven out of the eight (87.5%) patients with a JAK2 V617F gene mutation achieved 72% to 96% reductions in JAK2 V617F allele burden thatqualified as partial molecular responses. The median JAK2 V617F mutant allele burden was reduced by 71% at month 3 after the initiation oftreatment and remained reduced by 59% at month 12 despite less frequent maintenance dosing. •MPL and CALR mutant allele burdens were also reduced by 15% to 66%. Data from further mutational analyses of patient samples from the Phase 2 ET trial were presented in an oral session at the 57th American Society ofHematology (ASH) Annual Meeting and Exposition in December 2015, and showed that imetelstat treatment suppressed allele burdens of multiple additionalmutations. Collectively, these data suggest that imetelstat inhibits the progenitor cells of the malignant clone or clones believed to be responsible for theunderlying disease in a relatively selective manner.Safety Data: The nature of adverse events reported in the Phase 2 ET trial have been similar to the adverse events reported in other imetelstat clinical trials, withfatigue, gastrointestinal symptoms and cytopenias being the most frequently observed adverse events. Additional observations from the Phase 2 ET trialinclude:•One patient experienced Grade 3 hepatic cirrhosis, which was initially assessed by the investigator to be related to imetelstat. The patient laterexperienced hepatic encephalopathy and died of bleeding esophageal varices after the primary analysis in October 2013. Both of thesesubsequent events were assessed after the patient's death by the investigator to be unrelated to imetelstat. •Two patients experienced reversible Grade 3 alanine transaminase, which was assessed by the investigator to be possibly attributable toimetelstat. •At least one abnormal liver function test, or LFT, was observed in laboratory findings in all patients in the trial, with some patientsexperiencing persistent low-grade LFT abnormalities with longer dosing. With longer dosing, Grade 1 increases in alkaline phosphatase wereobserved, associated with mostly Grade 1 to some Grade 2 unconjugated hyperbilirubinemia. The clinical significance and long-termconsequences of such persistent low-grade LFT abnormalities is currently undetermined.7Table of Contents On March 11, 2014, the United States Food and Drug Administration, or FDA, issued a full clinical hold on our Investigational New Drug application, orIND, for imetelstat, citing a lack of evidence of reversibility of hepatotoxicity, concern regarding a risk of chronic liver injury, and a lack of adequate follow-up in patients who had hepatotoxic effects. All the patients who were still receiving imetelstat discontinued active treatment and were observed for safety.Follow-up safety data from those patients and the patients who had already discontinued prior to the clinical hold showed that LFT abnormalities resolved tonormal or baseline during or after withdrawal of imetelstat treatment in most patients. We submitted a complete response to the FDA with follow-upinformation regarding reversibility of hepatotoxicity for all patients who received imetelstat in the ET and multiple myeloma studies, and the FDA lifted theclinical hold on October 31, 2014.Clinical Development in Myelofibrosis MF is a myeloproliferative neoplasm among related diseases, such as ET, and is characterized by clonal proliferation of malignant hematopoieticprogenitor cells in the bone marrow that causes bone marrow fibrosis, increased bone density, known as osteosclerosis, and abnormal rapid proliferation ofblood vessels, known as pathological angiogenesis. MF patients may exhibit abnormally low red blood cells/hemoglobin, known as progressive anemia,abnormally low white blood cells, known as leukopenia, abnormally high white blood cells, known as leukocytosis, abnormally low platelets, known asthrombocytopenia, abnormally high platelets, known as thrombocytosis, an abnormally high proportion of immature blood cells in the blood, known asperipheral blood leukoerythroblastosis, and abnormally high precursor white cells in the blood, known as excess circulating blasts. In addition, impairedblood production from the bone marrow causes blood production to shift to other organs such as the spleen and liver, known as extramedullaryhematopoiesis, which leads to an enlarged spleen, known as splenomegaly, or an enlarged liver, known as hepatomegaly. MF patients can also suffer fromdebilitating constitutional symptoms, such as drenching night sweats, fatigue, severe itching, known as pruritus, fever and bone pain. The estimatedprevalence of MF in the United States, or U.S., is approximately 13,000 patients, with an annual incidence of approximately 3,000 patients. Approximately70% of MF patients are classified as having intermediate-2 or high risk disease, as defined by the Dynamic International Prognostic Scoring System Plus, orDIPSS Plus, described in a 2011 Journal of Clinical Oncology article. These patients have a median survival of approximately one to three years,representing a significant unmet medical need. Allogeneic hematopoietic cell transplantation, or allo-HCT, is the only current treatment approach for MF that can lead to complete remission of thedisease with normalization of peripheral blood counts, regression of bone marrow fibrosis, disappearance of cytogenetic abnormalities, normalization ofspleen size and resolution of constitutional symptoms. However, use of allo-HCT is limited to a very small number of eligible patients due to the lack ofsuitable donors, older age and/or comorbid conditions. In addition, graft vs. host disease and life-threatening infections are other limitations of allo-HCTtreatment.Pilot Study in Myelofibrosis (MF Pilot Study) Based on the data from the Phase 2 ET trial, in November 2012, Dr. Ayalew Tefferi, or the investigator, at Mayo Clinic, initiated a clinical trialevaluating imetelstat in patients with MF. This trial, known as the MF Pilot Study, was designed to assess the effect of imetelstat in patients with MF. The MFPilot Study is an open label trial in patients with primary MF, post-ET MF, or post-PV MF who are classified as intermediate-2 or high risk as defined byDIPSS Plus. In the MF Pilot Study, imetelstat is administered as a single agent over a two hour intravenous infusion to patients in multiple patient cohorts. Inthe first cohort, Cohort A, imetelstat is given once every three weeks. In the second cohort, Cohort B, imetelstat is given weekly for four weeks, followed byone dose every three weeks. The starting dose of imetelstat in Cohorts A and B was 9.4 mg/kg, with dose reductions and dose holds8Table of Contentsallowed for toxicity. The primary endpoint in the MF Pilot Study is overall response rate, which is defined by the proportion of patients who are classified asresponders, which means that they have achieved either a clinical improvement, or CI, partial remission, or PR, or complete remission, or CR, consistent withthe criteria of the 2013 International Working Group for Myeloproliferative Neoplasms Research and Treatment, or IWG-MRT criteria, described in a 2013Blood article. Secondary endpoints include reduction of spleen size by palpation, improvement in anemia or inducement of red blood cell transfusionindependence, safety and tolerability. In January 2014, Mayo Clinic closed the MF Pilot Study to new patient enrollment. Following is a summary of the efficacy and safety data from Cohorts A and B (n=33) of the MF Pilot Study, using a December 2014 data cut-off date, aspublished in the September 3, 2015 issue of The New England Journal of Medicine.Patient Demographics:•The patients enrolled were classified as having either intermediate-2 or high risk disease by DIPSS Plus. 16 patients were classified asintermediate-2 and 17 patients were classified as high risk. •Of the 33 patients, 18 (54.5%) had primary MF, 10 (30.3%) had post-PV MF, and five (15.2%) had post-ET MF. •26 of 33 (78.8%) patients had received prior treatments, including sixteen patients (48.5%) with JAK inhibitors. •13 of 33 (39.4%) patients were dependent on red-cell transfusions, defined as requiring six units of packed red blood cells during the 12 weekperiod prior to enrollment, including at least two units of red-cell transfusions in the last four weeks prior to study entry, for a hemoglobinlevel of less than 8.5 grams per deciliter. •23 of 33 (69.7%) patients had palpable splenomegaly (median: 15 centimeters below the left costal margin; range: five to 33 centimeters).Efficacy Data:•Seven of 33 (21.2%) patients achieved remissions as defined by the IWG-MRT criteria, including a complete remission, or CR, in four patientsand a partial remission, or PR, in three patients. •The four patients with a CR had documented reversal of bone marrow fibrosis, and three of them also had molecular remissions. •For the patients who achieved remissions, median duration was 18 months (range: 13 months to 20+ months) for CRs and 10 months (range:7 months to 10+ months) for PRs. •Eight of 23 (34.8%) patients with splenomegaly achieved spleen responses by palpation, which is defined as either greater than or equal to50% decrease if the baseline is greater than or equal to 10 centimeters or becoming non palpable if baseline is five to less than 10 centimeters.Four of the eight patients who achieved a spleen response also achieved a remission. •Four of 13 (30.8%) patients who were transfusion dependent at baseline became transfusion independent, which is defined as an absence ofany packed red blood cell transfusions during any consecutive three month interval with a hemoglobin level of at least 8.5 grams per deciliter.Three of the four patients who became transfusion independent also achieved a remission and sustained a hemoglobin level of more than 10grams per deciliter during imetelstat therapy. At the data-cutoff date, these three patients were still transfusion-independent.9Table of Contents•17 of 21 (81.0%) patients with at least 1% circulating blasts, or immature white cells, at baseline achieved either complete resolution (n=14,66.7%) or partial resolution (n=3, 14.3%), defined as 50% reduction from baseline. •22 of 27 (81.5%) patients with leukoerythroblastosis achieved either complete resolution (n=13, 48.1%) or partial resolution (n=9, 33.3%),defined as 50% reduction from baseline. •Eight of 10 (80.0%) patients with marked leukocytosis achieved either complete resolution (n=3, 30.0%) or partial resolution (n=5, 50.0%),defined as 50% reduction from baseline. •11 of 11 (100.0%) patients with thrombocytosis achieved either complete resolution (n=10, 90.9%) or partial resolution (n=1, 9.1%), definedas 50% reduction from baseline. We believe that these efficacy data from the MF Pilot Study suggest that imetelstat may have disease-modifying activity in MF. Furthermore, we believethat the remissions reported as of the cut-off date may be characterized as durable.Safety Data: The nature of adverse events reported in the MF Pilot Study have been similar in nature to the adverse events reported in the Phase 2 ET trial, withfatigue, gastrointestinal symptoms and cytopenias being the most frequently observed adverse events. Additional observations from the MF Pilot Studyinclude:•The dose-limiting and most clinically significant side effects were cytopenias (decreases in the counts of certain types of circulating bloodcells), primarily thrombocytopenia (low level of platelets) and neutropenia (low level of neutrophils), which were the principal reason for theprotocol-mandated dose reductions that occurred in 22 out of 33 patients (66.7%) in the study. One patient died due to intracranialhemorrhage that was attributed by the treating physician to drug-induced grade 4 thrombocytopenia after weekly dosing. •To mitigate the risk of severe, persistent cytopenias, the protocol for the MF Pilot Study was amended to raise the hematologic threshold forretreatment and include more stringent monitoring and dose adjustment criteria. Since then, no further episodes of significant bleeding eventsassociated with thrombocytopenia, or infections associated with neutropenia, or episodes of febrile neutropenia have been reported to us bythe investigator or Janssen. As a result, we believe that the myelosuppressive effect of the drug may be manageable through dose hold rulesand dose modifications. •Low grade LFT abnormalities were observed in patients in the study. None of the LFT abnormalities were linked to clinically significantadverse events, and the LFT abnormalities reversed to baseline values in the majority of patients upon withdrawal of imetelstat treatment. In March 2014, we were informed by Mayo Clinic that the investigator's IND for the MF Pilot Study was placed on partial clinical hold by the FDA dueto a safety signal of hepatotoxicity that was identified in Geron's Phase 2 clinical trials of imetelstat and that it was unknown if this hepatotoxicity wasreversible. The investigator submitted a complete response to the FDA with follow-up information regarding reversibility of hepatotoxicity for all patientswho received imetelstat in the MF Pilot Study, and the partial hold was removed by the FDA in June 2014.10 Table of ContentsStatus of the Study In March 2015, we transferred our investigational new drug application, or IND, for imetelstat to Janssen, as well as the IND that we received inSeptember 2014 from Mayo Clinic for the MF Pilot Study. Upon transfer of the IND for the MF Pilot Study to Janssen, Janssen assumed responsibility as trialsponsor for the MF Pilot Study. The MF Pilot Study remains closed to new patient enrollment, but remaining enrolled patients continue to receive imetelstattreatment. Janssen continues to collect data and information principally related to safety from those patients who remain enrolled in the MF Pilot Study. Inthis regard, additional and updated safety data generated from the MF Pilot Study may be materially different from the data discussed above. Accordingly,the data discussed above should be considered carefully and with caution. Please refer to the risk factor entitled "Risks Related to Clinical andCommercialization Activities—Success in early clinical trials may not be indicative of results in potential future clinical trials. Likewise, preliminary datafrom clinical trials we have reported should be considered with caution since the final data may be materially different from the preliminary data, particularlyas more patient data becomes available" under Part I, Item 1A, "Risk Factors," of this annual report on Form 10-K.Clinical Development in Myelodysplastic Syndromes Myelodysplastic syndromes, or MDS, are a group of blood disorders that arise from the proliferation of malignant progenitor cell clones in the bonemarrow, resulting in disordered and ineffective production of the myeloid lineage, which includes red blood cells, white blood cells and platelets. In MDS,bone marrow and peripheral blood cells may have abnormal, or dysplastic, cell morphology. MDS is frequently characterized clinically by severe anemia, orlow red cell counts and low hemoglobin. In addition, other peripheral cytopenias, or low numbers of white blood cells and platelets, may cause life-threatening infections and bleeding. Transformation to AML occurs in up to 30% of MDS cases and results in poorer overall survival. MDS is the most common of the myeloid malignancies. There are approximately 12,000 reported new cases of MDS in the United States every year andapproximately 60,000 people living with the disease. MDS is primarily a disease of the elderly, with median age at diagnosis around 70 years. The majorityof patients, approximately 70%, fall into what are considered to be the lower risk groups at diagnosis, according to the IPSS, or International PrognosticScoring System, that takes into account the presence of a number of disease factors, such as cytopenias and cytogenetics to assign relative risk of progressionto AML and overall survival. When initially diagnosed with MDS, approximately 80% of patients have anemia. Chronic anemia is the predominant clinical problem in lower riskdisease. Many of these patients become dependent on red blood cell transfusions, which can lead to elevated levels of iron in the blood and other tissues thatthe body has no normal way to eliminate. Iron overload is a potentially dangerous condition. Studies in patients with MDS have shown that iron overloadresulting from regular red blood cell transfusions is associated with a poorer overall survival and a higher risk of developing AML.Pilot Study Cohort in MDS Based on his preliminary observations in patients with MF, the investigator in the MF Pilot Study enrolled a cohort of nine patients with a form of MDSknown as refractory anemia with ring sideroblasts, or RARS, in the MF Pilot Study. In this cohort, or the MDS-RARS Cohort, imetelstat is given once everyfour weeks, at a starting dose of 7.5 mg/kg, with dose reductions and dose holds allowed for toxicity. Under the protocol, patients may receive an increaseddose after the first two cycles of treatment if certain safety and response criteria are met. Efficacy assessments in the MDS-RARS Cohort were according to the2006 International Working Group criteria for MDS, described in a 2006 Blood article, and included the proportion of patients achieving red blood cell11Table of Contentstransfusion independence. The effect on spleen size by palpation, and on thrombocytosis and leukocytosis, as well as safety and tolerability were alsoassessed. Following is a summary of the efficacy and safety data from the MDS-RARS Cohort that were presented by the investigator in an oral session at the57th ASH Annual Meeting and Exposition in December 2015.Patient Demographics:•The patients enrolled were classified as having either intermediate-1 or intermediate-2 risk disease by IPSS. Seven patients were classified asintermediate-1 and two patients were classified as intermediate-2. •Seven of nine patients had received prior treatments, including six with erythropoiesis stimulating agents, or ESAs. •All patients enrolled were anemic, defined as having hemoglobin levels less than 10 grams per deciliter. •Eight of nine patients were dependent on red blood cell transfusions, defined as requiring four units of packed red blood cells during the eightweek period prior to study entry.Efficacy Data:•Three of the eight (37.5%) patients who were transfusion dependent at study entry became transfusion independent, defined as not requiringtransfusions for at least eight weeks. •The median duration of transfusion independence was 28 weeks (range: nine weeks to 37 weeks). •One patient had a >50% decrease in palpable spleen size from 16 centimeters below the left costal margin at baseline and a decrease in redblood cell transfusion rate. •In two patients, neutrophil and platelet counts normalized. •One patient achieved an erythroid hematologic improvement, defined as an increase in hemoglobin levels by 1.5 grams per deciliter.Safety Data: The nature of adverse events presented by the investigator in the MDS-RARS Cohort have been similar to the adverse events reported in the MF PilotStudy, with fatigue, gastrointestinal symptoms and cytopenias among the most frequently observed adverse events. Additional observations presented by theinvestigator in the MDS-RARS Cohort include:•One patient with pre-existing cardiovascular disease history died of cardiac arrest, which was assessed by the investigator to be unrelated toimetelstat. •No prolonged (defined as lasting four weeks or longer) Grade 3 hematological toxicities were observed. •Low grade LFT abnormalities were observed in this cohort of patients. These LFT abnormalities reversed to baseline values in the majority ofpatients in the MDS-RARS Cohort upon withdrawal of imetelstat treatment. No patients in the MDS-RARS Cohort discontinued due to LFTabnormalities, and none of the LFT abnormalities were linked to clinically significant adverse events.12Table of Contents We believe that these data suggest that imetelstat may have clinically meaningful activity in some patients with MDS-RARS that warrants further studiesin patients with MDS.Future Development of Imetelstat in Collaboration with Janssen On November 13, 2014, we entered into the Collaboration Agreement, which gave Janssen the exclusive rights to develop and commercialize imetelstatworldwide for all indications in oncology, including hematologic myeloid malignancies, and all other human therapeutic uses. The Collaboration Agreementbecame effective on December 15, 2014, and we received $35 million from Janssen as an upfront payment. Additional consideration under the CollaborationAgreement includes payments up to a potential total of $900 million for the achievement of development, regulatory and commercial milestones, as well asroyalties on worldwide net sales. Under the Collaboration Agreement, Janssen is wholly responsible for the development, manufacturing and commercialization of, and seekingregulatory approval for imetelstat worldwide. To that end, Janssen is currently proceeding with the development of imetelstat with two clinical trials:IMbark™ and IMerge™. In July 2015, IMbark™ opened to patient enrollment, and the first patient was dosed in September 2015. In December 2015,IMerge™ opened to patient enrollment, and the first patient was dosed in January 2016. We are contributing 50% of the development costs for these clinicaltrials, which Janssen is solely conducting. Janssen may consider initiating additional clinical trials, such as possible registration studies in MF and MDS, andpossible exploratory Phase 2 and potential follow on Phase 3 studies in AML. The costs for such studies will be borne 100% by Janssen, unless and until theymake an affirmative Continuation Decision and we elect our U.S. Opt-In Rights (as defined and described in further detail below). We expect Janssen to perform a data cut for IMbark™ in the second half of 2017, and for Janssen to thereafter initiate the protocol-specified primaryanalysis; however, the timing depends on numerous factors, including the pace of patient enrollment in IMbark™. Following the protocol-specified primaryanalysis of IMbark™ or a certain time period after the initiation of the first Phase 3 MF study, if any, Janssen must notify us of their Continuation Decision. Inthe event that IMbark™ is terminated early or suspended, Janssen must instead notify us of their Continuation Decision by the date that is the later of24 months after the initiation of IMerge™ or 24 months after the termination of IMbark™ or commencement of the suspension period, as applicable. In the event that Janssen notifies us of an affirmative Continuation Decision, we will then have an option to share further U.S. development andpromotion costs, or the U.S. Opt-In Rights, in exchange for higher tiered royalty rates and higher future potential milestone payments if imetelstat issuccessfully developed and approved. If we exercise the U.S. Opt-In Rights, then we and Janssen will share U.S. development and promotion costs beyondIMbark™ and IMerge™ on a 20/80 basis (Geron 20%, Janssen 80%), we will receive a $65 million milestone payment at the time of the ContinuationDecision, and will be eligible to receive additional potential payments of up to $470 million in development and regulatory milestones, up to $350 millionin sales milestones, and tiered royalties ranging from a mid-teens up to a low twenties percentage rate on worldwide net sales of imetelstat in any countrieswhere regulatory exclusivity exists or there are valid claims under the patent rights exclusively licensed to Janssen. In addition, if we exercise the U.S. Opt-InRights, we will also have a separate co-promotion option, or the U.S. Co-Promotion Option, to provide 20% of the U.S. selling effort with our sales forcepersonnel, in lieu of funding 20% of U.S. promotion costs, upon regulatory approval and commercial launch of imetelstat in the United States. Such co-promotion would be conducted under a Janssen prepared promotion plan, and in accordance with a co-promotion agreement to be agreed by us and Janssenat the time of our exercise of the U.S. Co-Promotion Option. We would be responsible for all costs associated with establishing and maintaining our salesforce in any conduct of such co-promotion. All product sales would be booked by Janssen. If we do not exercise the U.S. Opt-In Rights upon an affirmativeContinuation Decision by Janssen, then all further13Table of Contentsdevelopment and promotion costs beyond IMbark™ or IMerge™ will be borne by Janssen, we will receive a $65 million milestone payment at the time ofthe Continuation Decision plus a $70 million milestone payment for Janssen's retention of full U.S. rights, and will be eligible to receive additional potentialpayments of up to $415 million in development and regulatory milestones, up to $350 million in sales milestones, and tiered royalties ranging from adouble-digit up to a mid-teens percentage rate on worldwide net sales in any countries where regulatory exclusivity exists or there are valid claims under thepatent rights exclusively licensed to Janssen. Under the terms of the Collaboration Agreement, we and Janssen have created a joint governance structure, including joint development and steeringcommittees and working groups, to oversee and manage worldwide regulatory, development and manufacturing work under the joint clinical developmentplan and promotional activities (assuming we exercise the U.S. Opt-In Rights) for imetelstat, with Janssen responsible for the operational execution of thoseactivities. In addition, both we and Janssen may propose to the joint development committee imetelstat development for any new indications not thenprovided for in the joint clinical development plan and if we and Janssen agree such development should be conducted outside of the joint clinicaldevelopment plan, both we and Janssen would be entitled to independently undertake such development at the developing party's own cost, subject to theother party's obligation to provide reimbursement for its specified portion of the development costs plus a premium following marketing approval ofimetelstat in such newly proposed indication as a result of such independent development. In the event that we do not exercise the U.S. Opt-In Rightsfollowing Janssen's positive Continuation Decision, the joint governance structure under the Collaboration Agreement would be dissolved, a joint oversightcommittee would monitor the progress of the collaboration, and we would have no further rights to conduct any independent imetelstat development. After an affirmative Continuation Decision by Janssen, the Collaboration Agreement would remain in effect until the expiration of the last-to-expirepatent or the royalty obligations on sales of imetelstat cease, unless terminated earlier. If Janssen does not effect an affirmative Continuation Decision, thenthe Collaboration Agreement would terminate and all rights to the imetelstat program would revert to us. Janssen may terminate the Collaboration Agreementat any time for convenience or due to a safety-related concern. If a notice of termination from Janssen occurs, we would be entitled to certain continuedoperational support from Janssen and cost-sharing under various circumstances and all rights to the imetelstat program would revert to us.14Table of ContentsClinical Trials Initiated Under the Collaboration with JanssenIMbark™ IMbark™ is designed to assess the efficacy, safety and tolerability of two dose levels of single-agent imetelstat in patients with MF. The trial is designedto enroll approximately 200 patients, including approximately 100 patients per dosing arm, with DIPSS intermediate-2 or high risk MF who have relapsedafter or are refractory to JAK inhibitor treatment. At the time of enrollment, patients must have measurable splenomegaly and symptoms of MF. Patients willbe assigned randomly on a blinded basis on a 1:1 ratio to one of two dosing arms—9.4 mg/kg every three weeks or 4.7 mg/kg every three weeks. Dosereductions for adverse events are allowed and will follow protocol-specified algorithms. Multiple medical centers across North America, Europe and Asia are planned to participate in IMbark™. Study design information for IMbark™,including patient eligibility criteria, is posted on clinicaltrials.gov, and the list of participating clinical trial sites is expected to be updated on an ongoingbasis. The co-primary efficacy endpoints for the trial are spleen response rate and symptom response rate. Spleen response rate is defined as the percentage ofpatients who achieve 35% reduction in spleen volume from baseline at the Week 24 visit, as measured by imaging scans and assessed at a central imagingfacility and by an Independent Review Committee. Symptom response rate is defined as the percentage of patients who have 50% reduction in TotalSymptom Scores from baseline at the15 Study Name IMbark™ IMerge™ Indication Myelofibrosis Myelodysplastic Syndromes Patient Population DIPSS intermediate-2 or high risk MF patientswho have relapsed after or are refractory to JAKinhibitor treatment Transfusion dependent patients with IPSS lowor intermediate-1 risk MDS who have relapsedafter or are refractory to prior ESA treatment Design Phase 2, open-label, randomized to two dosingarms, single-blinded Phase 2/3: Part 1 is Phase 2, open-label, single-arm; Part 2 is Phase 3 double-blind,randomized, placebo-controlled Primary Endpoint Spleen response rate and symptom responserate (co-primary endpoints) Red blood cell transfusion-independence(RBC-TI) rate 8 weeks Selected Secondary Endpoints CR or PR rate, CI rate, anemia, spleen andsymptom responses, and safety RBC-TI rate 24 weeks, time to and durationof RBC-TI, hematologic improvement rate, CRor PR rate, RBC transfusion requirement,myeloid growth factor use, patients' quality oflife, overall survival assessment and time toprogression to AML Estimated Enrollment Up to 200 (approximately 100 in each dosingarm) Up to 200 (approximately 30 in Part 1 and 170in Part 2) Table of ContentsWeek 24 visit, based on patient-reported outcomes on a modified Myelofibrosis Symptom Assessment Form version 2.0 electronic diary. The protocol-specified primary analysis of the co-primary endpoints will occur after all enrolled and treated patients have been followed for at least 24 weeks. We expectJanssen to perform a data cut for IMbark™ in the second half of 2017, and for Janssen to thereafter initiate the protocol-specified primary analysis; however,the timing may vary depending on numerous factors, including the pace of patient enrollment in IMbark™. Secondary efficacy endpoints include the numberof patients achieving CR or PR, CI, and anemia, spleen and symptom responses as assessed using the modified 2013 IWG-MRT criteria. These secondaryendpoints will be assessed at the time of the primary efficacy analysis. Exploratory endpoints include cytogenetic and molecular responses, as well asleukemia-free survival. Safety outcomes will be monitored throughout the trial and will include enhanced data collection and reporting for adverse events of interest, includinghepatobiliary-associated laboratory findings and hepatic adverse events. We expect Janssen to conduct an internal review of data for safety and efficacy from IMbark™ after 40 patients (20 patients per dosing arm) have beenenrolled and treated for at least 12 weeks. We expect that this review, if conducted, would assess the adequacy of one or both of the initial dosing regimens.We expect IMbark™ enrollment to continue at the time of internal review. As a result of this internal review, one or both dosing arms could continue asplanned, be stopped or modified, or alternative doses could be selected. It is also possible that Janssen would elect to not continue the study, and, potentially,to terminate the Collaboration Agreement. Depending on numerous factors, including the pace of patient enrollment in IMbark™, we expect Janssen toconduct this internal data review in the second half of 2016. We expect full clinical data from IMbark™ to be presented at a medical conference to bedetermined in the future.IMerge™ IMerge™ is designed to evaluate imetelstat in transfusion dependent patients with IPSS low or intermediate-1 risk MDS who have relapsed after or arerefractory to prior treatment with an erythropoiesis-stimulating agent. As designed, IMerge™ consists of two parts and a total of approximately 200 patients are expected to be enrolled. Part 1 of the trial is planned as aPhase 2, open-label, single-arm design to assess the efficacy and safety of imetelstat. Up to 30 patients are expected to be enrolled in Part 1, who will allreceive imetelstat and be followed for safety, hematologic improvement and reduction in transfusion requirement. Before proceeding to Part 2, the data fromPart 1 must support a positive assessment of the benefit-risk profile of imetelstat in these patients. Based on numerous factors, including the pace of patientenrollment in Part 1 of the trial, we expect Janssen to conduct an internal review of the data from Part 1 in the second half of 2016. During this internalreview, no new patients will be enrolled into the study. Part 2 of the trial is planned as a Phase 3 double-blind, randomized, placebo-controlled design tocompare the efficacy of imetelstat against placebo. Approximately 170 patients are expected to be enrolled in Part 2, and such patients will be assignedrandomly, in a 2:1 ratio, to receive either imetelstat or placebo. The inclusion criteria for both parts of the trial require that at the time of enrollment eachpatient must be red blood cell transfusion-dependent. Imetelstat in Parts 1 and 2, or placebo in Part 2, will be administered as an intravenous infusion. Theplanned starting dose of imetelstat will be 7.5 mg/kg every four weeks and may be escalated according to certain protocol-specified conditions. Dosereductions for adverse events may follow protocol-specified algorithms. All patients may receive supportive care, including transfusions or myeloid growthfactors, as needed per investigator discretion and according to local standard practices. The primary efficacy endpoint is designed to be the rate of red blood cell transfusion-independence lasting at least eight weeks, defined as the proportionof patients without any red blood16Table of Contentscell transfusion during any consecutive eight weeks since entry to the trial. A primary efficacy analysis is planned to occur 12 months after the last patient isenrolled. We expect full clinical data from IMerge™ to be presented at a medical conference to be determined in the future. Secondary efficacy endpoints include the proportion of patients achieving red blood cell transfusion-independence lasting at least 24 weeks, the time toand duration of red blood cell transfusion-independence, the proportion of patients achieving hematologic improvement, the proportion of patientsachieving CR or PR according to the 2006 International Working Group, or IWG, criteria for MDS, the proportion of patients requiring red blood celltransfusions and the amount, the proportion of patients requiring the use of myeloid growth factors and the dose, as well as assessments of the change in thepatients' quality of life using several different validated instruments. Patients are also planned to be followed for an assessment of overall survival and time toprogression to AML. These secondary endpoints are expected to be assessed at the time of the primary efficacy analysis. Safety outcomes will be monitored throughout the trial and will include enhanced data collection and reporting for adverse events of interest, includinghepatobiliary-associated laboratory findings and hepatic adverse events. Multiple medical centers across North and South America, Europe and Asia are planned to participate in the trial. Study design information for IMerge™,including patient eligibility criteria, is posted on clinicaltrials.gov, and the list of participating clinical trial sites is expected to be updated on an ongoingbasis.Research and Development Our research and development costs were $17.8 million, $20.7 million and $23.2 million for the years ended December 31, 2015, 2014 and 2013,respectively. See Item 7, "Management's Discussion and Analysis of Financial Condition and Results of Operations—Research and Development Expenses"for additional detail regarding our research and development activities.Intellectual Property Intellectual property, including patent protection, is very important to our business. We file patent applications in the United States and otherjurisdictions, and we also rely on trade secret protection and contractual arrangements to protect aspects of our business. An enforceable patent withappropriate claim coverage can provide an advantage over competitors who may seek to employ similar approaches to develop therapeutics, and so the futurecommercial success of imetelstat, and therefore our future success, will be in part dependent on our intellectual property strategy. The information providedin this section should be reviewed in the context of the section entitled "Risks Related to Protecting Our Intellectual Property" under Item 1A, "Risk Factors". The development of biotechnology products, including imetelstat, typically includes the early development of a technology, followed by rounds ofincreasingly focused innovation around a product opportunity, including identification and definition of a specific product candidate and uses thereof,manufacturing processes, product formulation and administration methods. The result of this process is that biotechnology products are often protected byseveral families of patent filings that are filed at different times during product development and cover different aspects of the product. Consequently, earlierfiled, broad technology patents will usually expire ahead of patents covering later developments such as product formulations, so that patent expirations on aproduct may span several years. Patent coverage may also vary from country to country based on the scope of available patent protection. There are alsoopportunities to obtain an extension of patent coverage for a product in certain countries, which adds further complexity to the determination of patent life.17Table of Contents We endeavor to monitor worldwide patent filings by third parties that are relevant to our business. Based on this monitoring, we may determine that anaction is appropriate to protect our business interests. Such actions may include negotiating patent licenses where appropriate, filing oppositions against apatent, filing a request for post grant review against a patent or filing a request for the declaration of an interference with a patent application or issued patent.Imetelstat We have issued patents in the United States, Europe and other countries related to imetelstat. Composition of matter patents generally provide the mostmaterial coverage, and therefore may convey competitive advantages. Because imetelstat is still under development, subsequent innovation and associatedpatent filings may provide additional patent coverage with later expiration dates. Examination of overseas patent applications typically lags behind U.S.examination particularly where cases are filed first in the United States. It may be possible to obtain patent term extensions of some patents in some countriesfor claims covering imetelstat which could further extend the patent term. Our patent rights relating to imetelstat include those covering a method of inhibiting telomerase using the nucleic acid sequence complementary to hTR,(the RNA component of telomerase against which the oligonucleotide component of imetelstat is targeted); composition claims to the drug molecule andrelated nucleic acid telomerase inhibiting molecules; the amidate nucleic acid chemistry used in the oligonucleotide; as well as manufacturing processes forthe drug, and method of treatment and kit claims, certain of which are co-owned by us. These patents have been exclusively licensed to Janssen for imetelstatand related products whose mechanism of action is telomerase inhibition, for all human disorders or medical conditions. In addition, certain of our patentrights for measuring the expression of telomerase activity or the length of telomeres in cells have been non-exclusively licensed to Janssen and othercompanies. Under the terms of the Collaboration Agreement with Janssen, we remain responsible for prosecuting, at Janssen's direction, the patents exclusivelylicensed to Janssen, with costs shared between us and Janssen on a 50/50 basis. For intellectual property developed under the Collaboration Agreement, theparty having sole ownership interest in such intellectual property will be responsible for prosecuting any such patents, with Janssen bearing all of the patentcosts for such intellectual property solely owned by Janssen and with patent costs for such intellectual property either jointly owned or solely owned by usshared between the parties on a 50/50 basis.Telomerase Our patent rights relating to telomerase that cover the cloned genes that encode the catalytic protein component (hTERT) of human telomerase and cellsthat are immortalized by expression of recombinant hTERT are co-owned with and in-licensed exclusively from the University of Colorado. Certain patentsfor identifying telomerase modulators or diagnosing cancer by measuring the expression of telomerase activity are co-owned and in-licensed from theUniversity of Texas Southwestern Medical Center and the University of California.18Product Candidate U.S. Patent Status /Expiration Date Europe Patent Status /Expiration Date Japan Patent Status /Expiration DateImetelstat (composition of matter) Issued / 2025 Issued / 2020* Issued / 2024*An additional composition of matter patent application for imetelstat has been filed that, if issued, would provide European patentprotection until 2024. In addition, we have received patent coverage in Europe until 2029 for the use of imetelstat for the treatment ofcancer utilizing certain dosing regimens.Table of ContentsLicensing In addition to the Collaboration Agreement with Janssen, we have also granted licenses to a number of other organizations in the ordinary course of ourbusiness to utilize aspects of our technologies to develop and commercialize products outside of the imetelstat program. These include:•licenses to several biotechnology and pharmaceutical companies to use or commercialize telomerase immortalized cells in drug discoveryresearch; •licenses to several companies to sell antibodies specific to telomerase for research purposes; •licenses to several companies to develop and commercialize reagent kits, or to provide services, for the measurement of telomere length ortelomerase activity for research purposes; •a license to a company to develop and commercialize a particular telomerase-based technology for cancer detection; and •a license to a company for the development of cancer immunotherapies for veterinary applications.For the years ended December 31, 2015, 2014 and 2013, we recognized revenues from license fees and royalties under various license agreements of$1.4 million, $1.2 million and $1.3 million, respectively. See Item 7, "Management's Discussion and Analysis of Financial Condition and Results ofOperations—Revenues" for additional detail regarding these revenues.Competition The pharmaceutical and biotechnology industries are intensely competitive. Other pharmaceutical and biotechnology companies and researchorganizations currently engage in or have in the past engaged in efforts related to the biological mechanisms related to imetelstat, including the study oftelomeres, telomerase, our proprietary oligonucleotide chemistry, and the research and development of therapies for the treatment of hematologic myeloidmalignancies. In addition, other products and therapies that could directly compete with imetelstat currently exist or are being developed by pharmaceuticaland biopharmaceutical companies and by academic institutions, government agencies and other public and private research organizations. Many companies are developing alternative therapies to treat hematologic myeloid malignancies. For example, if approved for commercial sale for thetreatment of MF, imetelstat would compete against Incyte Corporation's ruxolitinib, or Jakafi®, which is orally administered. In clinical trials, Jakafi®reduced spleen size, abdominal discomfort, early satiety, bone pain, night sweats and itching in MF patients. Recently, there have also been reports of overallsurvival benefit as well as improvement in bone marrow fibrosis from Jakafi® treatment. Other treatment modalities for MF include hydroxyurea for themanagement of splenomegaly, leukocytosis, thrombocytosis and constitutional symptoms; splenectomy and splenic irradiation for the management ofsplenomegaly and co-existing cytopenias, or low blood cell counts; chemotherapy and pegylated interferon. Drugs for the treatment of MF-associated anemiainclude erythropoiesis-stimulating agents, androgens, danazol, corticosteroids, thalidomide and lenalidomide. There are other investigational treatments forMF further along in development than imetelstat, such as pacritinib by CTI Biopharma Corporation, or CTI Biopharma, in collaboration with BaxaltaIncorporated, or Baxalta, and momelotinib by Gilead Sciences, Inc., or Gilead, which is currently in a Phase 3 clinical trial, and other inhibitors of the JAK-STAT pathway, as well as several investigational treatments in early phase testing such as histone deacetylase inhibitors, inhibitors of heat shock protein 90,hypomethylating agents, PI3 Kinase and mTOR inhibitors, anti-fibrosis antibodies, hedgehog inhibitors, anti-LOX2 inhibitors, recombinant pentraxin 2protein, KIP-1 activators, TGF-beta inhibitors, FLT inhibitors, and other tyrosine kinase inhibitors.19Table of Contents If approved for commercial sale for the treatment of MDS, imetelstat would compete against a number of treatment options, including erythropoiesisstimulating agents and other hematopoietic growth factors; immunomodulators such as lenalidomide by Celgene Corporation, or Celgene; hypomethylatingagents, such as azacitidine by Celgene and decitabine by Janssen; in addition to investigational treatments that may be further along in development thanimetelstat, such as oral versions of azacitidine; histone deacetylase inhibitors; activin type IIA receptor inhibitors, such as sotatercept by AcceleronPharma, Inc., or Acceleron; TGF-beta superfamily inhibitors, such as luspatercept by Acceleron in collaboration with Celgene; thrombopoietin receptoragonists, such as eltrombopag by Novartis, PI3 Kinase inhibitors, such as rigosertib by Onconova Therapeutics, Inc., or Onconova; Flt-3 inhibitors, such asquizartinib by Ambit Biosciences Corporation, or Ambit Biosciences; and JAK-STAT pathway inhibitors. Independently, Janssen is developing therapies for hematologic malignancies, including AML, MDS, multiple myeloma and ABC-subtype diffuse largeB-cell lymphoma. Molecular and cellular pathways of interest include:•cell surface targets for immune-directed therapy; •immune checkpoint inhibition; •leukemia stem cells; •pathway addiction (genetic alterations, cell-type specific pathways); •conditional sensitivity (stress, protein-producing tumors); •targeting of T-cells and natural killer "NK" cells to tumors; •identification of novel tumor-specific antigens; and •progression from early MDS to AML and cancer interception.Success by Janssen in any of these approaches may compete with imetelstat or render imetelstat obsolete or noncompetitive, which could lead to a decisionby Janssen to discontinue the imetelstat program and terminate the Collaboration Agreement, which would materially and adversely affect our business andbusiness prospects and might cause us to cease operations. Smaller companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.We anticipate increased competition in the future as new companies explore treatments for hematologic myeloid malignancies, which may significantlyimpact the commercial viability of imetelstat. Academic institutions, government agencies and other public and private research organizations may alsoconduct research, seek patent protection and establish collaborative arrangements for research, clinical development and marketing of products similar toimetelstat. These companies and institutions compete with us in recruiting and retaining qualified development and management personnel as well as inacquiring technologies complementary to the imetelstat program. In addition to the above factors, imetelstat will face competition based on:•product efficacy and safety; •convenience of product administration; •cost of manufacturing; •the timing and scope of regulatory consents; •status of reimbursement coverage; •price; and20Table of Contents•patent position, including potentially dominant patent positions of others. As a result of the foregoing, competitors may develop more commercially desirable or affordable products than imetelstat, or achieve earlier patentprotection or product commercialization than us or Janssen. Competitors have developed, or are in the process of developing, technologies that are, or in thefuture may be, competitive to imetelstat. Some of these products may have an entirely different approach or means of accomplishing therapeutic effectssimilar or superior to those that may be demonstrated by imetelstat. Competitors may develop products that are safer, more effective, or less costly thanimetelstat, or more convenient to administer to patients and, therefore, present a serious competitive threat to imetelstat. In addition, competitors may pricetheir products below what Janssen may determine to be an acceptable price for imetelstat, may receive better third-party payor coverage and/orreimbursement, or may be more cost-effective than imetelstat. Such competitive products or activities by competitors may render imetelstat obsolete, whichmay cause Janssen to terminate the Collaboration Agreement, which would severely and adversely affect our business prospects and might cause us to ceaseoperations.Government Regulation Regulation by governmental authorities in the United States and other countries is a significant factor in the development, manufacture and marketing ofimetelstat, which is being developed in collaboration with Janssen. We anticipate that imetelstat will require regulatory approval by governmental agenciesprior to commercialization. In particular, potential human therapeutic products, such as imetelstat, are subject to rigorous preclinical and clinical testing andother approval procedures of the FDA and similar regulatory authorities in European and other countries. Various governmental statutes and regulations alsogovern or influence testing, manufacturing, safety, labeling, storage, import, export, distribution and recordkeeping related to such products and theirmarketing. In collaboration with Janssen, the process of obtaining these approvals and the subsequent compliance with appropriate statutes and regulationsrequire the expenditure of substantial time and money, and there can be no guarantee that approvals will be granted. The information provided in this sectionshould be reviewed in the context of the section entitled "Risks Related to Clinical and Commercialization Activities" under Item 1A, "Risk Factors".United States Food and Drug Administration Regulatory Approval Process Prior to commencement of clinical trials involving humans, preclinical testing of new pharmaceutical products is generally conducted on animals in thelaboratory to evaluate the potential efficacy and safety of a product candidate. The results of these trials are submitted to the FDA as part of an INDapplication, which must become effective before clinical testing in humans can begin. The FDA can place an IND on clinical hold at any time, whichprevents the conduct of clinical trials under the IND until safety concerns are addressed by the IND sponsor to the FDA's satisfaction. Typically, clinicalevaluation involves a time consuming and costly three phase trial process. In Phase 1, clinical trials are conducted with a small number of healthy volunteersor patients afflicted with a specific disease to assess safety and to evaluate the pattern of drug distribution and metabolism within the body. In Phase 2,clinical trials are conducted with groups of patients afflicted with a specific disease in order to determine preliminary efficacy, optimal dosages and expandedevidence of safety. The Phase 2 trials can be conducted comparing the investigational treatment to a comparator arm, or not. If used, a comparator usuallyincludes standard of care therapy. Safety and efficacy data from Phase 2 clinical trials, even if favorable, may not provide sufficient rationale for proceedingto a Phase 3 clinical trial. In Phase 3, large scale, multi-center, comparative trials are conducted with patients afflicted with a target disease to providesufficient data to demonstrate the efficacy and safety required by the FDA. The FDA closely monitors the progress of each of the three phases of clinicaltesting and may, at its discretion, re-evaluate, alter, suspend, or terminate the trials. Human clinical trials must be conducted21Table of Contentsin compliance with Good Clinical Practice regulations and applicable laws, with the oversight of Institutional Review Boards for the protection of humansubjects. The manufacture of drug product candidates is subject to requirements that drugs be manufactured, packaged and labeled in conformity with currentGood Manufacturing Practices and applicable laws. The results of the preclinical and clinical testing of drugs and complete manufacturing information are submitted to the FDA in the form of a New DrugApplication, or NDA, for review and for approval prior to commencement of commercial sales. Submission of an NDA requires the payment of a substantialuser fee to the FDA, which may be waived in certain cases. In responding to an NDA submission, the FDA may approve the drug for commercialization,impose limitations on its indications for use and labeling, including in the form of Risk Evaluation and Mitigation Strategies or may issue a completeresponse letter. Even if an NDA is approved, its sponsor is subject to ongoing and pervasive regulatory compliance requirements.European and Other Regulatory Approval Process Prior to initiating clinical trials in a region outside of the United States, a clinical trial application must be submitted and reviewed by the appropriateregulatory authority regulating the country in which the trial will be conducted. Whether or not FDA clearance or approval has been obtained, approval of aproduct by comparable regulatory authorities in Europe and other countries is necessary prior to commencement of marketing the product in such countries.The regulatory authorities in each country may impose their own requirements and may refuse to grant an approval, or may require additional data beforegranting it, even though the relevant product has been cleared or approved by the FDA or another authority. As with the FDA, the regulatory authorities inthe European Union, or EU, and other developed countries have lengthy approval processes for pharmaceutical products. The process for gaining approval inparticular countries varies, but generally follows a similar sequence to that described for FDA approval. In Europe, the European Medicine Agency, or EMA,and the European Committee for Proprietary Medicinal Products, or CPMP, provide a mechanism for EU member states to exchange information on allaspects of product licensing. The EU has established the EMA for the evaluation of medical products, with both a centralized procedure with which themarketing authorization is recognized in all EU member states and a decentralized procedure, the latter being based on the principle of licensing within onemember country followed by mutual recognition by the other member countries.Orphan Drug Designation For a drug to qualify for orphan drug designation by the FDA, both the drug and the disease or condition must meet certain criteria specified in theOrphan Drug Act, or ODA, and FDA's implementing regulations. Orphan drug designation is granted by the FDA's Office of Orphan Drug Products in order tosupport development of medicines for underserved or rare diseases and patient populations that affect fewer than 200,000 people in the United States or, ifthe disease or condition affects more than 200,000 individuals annually in the United States, if there is no reasonable expectation that the cost of developingand making the drug would be recovered from sales in the United States. Orphan drug designation qualifies the sponsor of the drug for various developmentincentives of the ODA, including, if regulatory approval is received, the potential for seven years of market exclusivity with certain limited exceptions andcertain tax credits for qualified clinical testing. A marketing application for a prescription drug product that has received orphan drug designation is notsubject to a prescription drug user fee unless the application includes an indication for a disease or condition other than the rare disease or condition forwhich the drug was granted orphan drug designation. The granting of orphan drug designation does not alter the standard regulatory requirements andprocess for obtaining marketing approval. The safety and effectiveness of a drug must be established through adequate and well-controlled studies. Orphandrug exclusivity does not prevent22Table of Contentsthe FDA from approving a different drug for the same disease or condition, or the same drug for a different disease or condition. On June 11, 2015 and December 23, 2015, the FDA granted orphan drug designation to imetelstat for the treatment of MF and MDS, respectively. Orphan drug designation by the European Commission provides regulatory and financial incentives for companies to develop and market therapies thattreat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the EU, and where no satisfactory treatment isavailable. In the EU, orphan drug designation also entitles a party to financial incentives such as reduction of fees or fee waivers, as well as protocolassistance from the EMA during the product development phase, and direct access to the centralized authorization procedure. In addition, ten years of marketexclusivity is granted following drug product approval, meaning that another application for marketing authorization of a later similar medicinal product forthe same therapeutic indication will generally not be approved in the EU. This period may be reduced to six years if the orphan drug designation criteria areno longer met, including where it is shown that the product is sufficiently profitable to not justify maintenance of market exclusivity. On November 15, 2015, the EMA granted orphan drug designation to imetelstat for the treatment of MF.Fraud and Abuse, Data Privacy and Security, and Transparency Laws and Regulations We may also be subject to additional healthcare regulation and enforcement by the federal government and by authorities in the states and foreignjurisdictions in which we conduct our business. Such laws include, without limitation, state and federal anti-kickback, fraud and abuse, false claims, privacyand security, and physician payment sunshine laws. The federal Anti-Kickback Statute makes it illegal for any person or entity, including a prescription drug manufacturer (or a party acting on its behalf) toknowingly and willfully, directly or indirectly, solicit, receive, offer, or pay any remuneration that is intended to induce the referral of business, including thepurchase, order, lease of any good, facility, item or service for which payment may be made under a federal healthcare program, such as Medicare orMedicaid. The term "remuneration" has been broadly interpreted to include anything of value. Several courts have interpreted the statute's intent requirementto mean that if any one purpose of an arrangement involving remuneration is to induce referrals of federal healthcare covered business, the Anti-KickbackStatute has been violated. Federal false claims and false statement laws, including the federal civil False Claims Act, prohibit, among other things, any person or entity fromknowingly presenting, or causing to be presented, for payment to, or approval by, federal programs, including Medicare and Medicaid, claims for items orservices, including drugs, that are false or fraudulent or not provided as claimed. Entities can be held liable under these laws if they are deemed to "cause" thesubmission of false or fraudulent claims by, for example, providing inaccurate billing or coding information to customers, promoting a product off-label, orfor providing medically unnecessary services or items. The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, created additional federal criminal statutes that prohibit amongother actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-partypayors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcareoffense, and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement inconnection with the delivery of or payment for healthcare benefits, items or services.23 Table of Contents HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and their implementing regulations,require certain types of individuals and entities to protect the privacy, security, and electronic exchange of certain patient data. The federal Physician Payments Sunshine Act requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment isavailable under Medicare, Medicaid or the Children's Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare &Medicaid Services, or CMS, information related to payments or other transfers of value made to physicians and teaching hospitals, and applicablemanufacturers and applicable group purchasing organizations to report annually to CMS ownership and investment interests held by the physicians and theirimmediate family members. Analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements andclaims involving healthcare items or services reimbursed by non-governmental third party payors, including private insurers. Additionally, we may besubject to state laws that require pharmaceutical companies to comply with the pharmaceutical industry's voluntary compliance guidelines and the relevantcompliance guidance promulgated by the federal government. Further, we may be subject to state laws that require drug manufacturers to report informationrelated to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures, as well as state and foreign lawsgoverning the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are notpreempted by HIPAA, thus complicating compliance efforts. If our operations are found to be in violation of any of these federal, state or foreign laws orregulations, we may be subject to penalties, including without limitation, administrative or civil penalties, imprisonment, damages, fines, disgorgement,exclusion from participation in government healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, or thecurtailment or restructuring of our operations.Reimbursement and Health Reform Significant uncertainty exists as to the coverage and reimbursement status of any product candidate that receives regulatory approval. In the UnitedStates and markets in other countries, sales of imetelstat, if approved for commercial sale, will depend, in part, on the extent to which third-party payorsprovide coverage and establish adequate reimbursement levels for imetelstat. In the United States, third-party payors include federal and state healthcare programs, government authorities, private managed care providers, privatehealth insurers and other organizations. There has been increasing legislative and enforcement interest in the United States with respect to specialty drugpricing practices. Specifically, there have been several recent U.S. Congressional inquiries and proposed bills designed to, among other things, bring moretransparency to drug pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursementmethodologies for drugs. Further, third-party payors are increasingly challenging the price, examining the medical necessity and reviewing the cost-effectiveness of medical drug products and medical services, in addition to questioning their safety and efficacy. Such payors may limit coverage to specificdrug products on an approved list, also known as a formulary, which might not include all of the FDA-approved drugs for a particular indication. Janssen mayneed to conduct expensive pharmaco-economic studies in order to demonstrate the medical necessity and cost-effectiveness of imetelstat, in addition to thecosts required to obtain the FDA approvals. Nonetheless, imetelstat may not be considered medically necessary or cost-effective. Moreover, the process for determining whether a third-party payor will provide coverage for a drug product may be separate from the process for settingthe price of a drug product or for establishing the reimbursement rate that such a payor will pay for the drug product. A payor's decision24Table of Contentsto provide coverage for a drug product does not imply that an adequate reimbursement rate will be approved. Further, one payor's determination to providecoverage for a drug product does not assure that other payors will also provide coverage for the drug product. Adequate third-party reimbursement may not beavailable to enable Janssen to maintain price levels sufficient to realize an appropriate return on Janssen's and our investment in imetelstat. The United States and some foreign jurisdictions are considering or have enacted legislative and regulatory proposals to contain healthcare costs, as wellas to improve quality and expand access. For example, in March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care andEducation Reconciliation Act, collectively known as the Affordable Care Act, or ACA, was signed into law. Among the provisions of the ACA of importanceto the biopharmaceutical industry are:•an annual, nondeductible fee on any entity that manufactures or imports specified branded prescription drugs and biologic agents; •an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program to 23.1% and 13.0% of theaverage manufacturer price for branded and generic drugs, respectively; •a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that areinhaled, infused, instilled, implanted or injected; •extension of a manufacturer's Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed careorganizations; •expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to certainindividuals with income at or below 133% of the federal poverty level; •a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiatedprices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for a manufacturer's outpatient drugsto be covered under Medicare Part D; and •a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research,along with funding for such research. We expect that the ACA, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria andlower reimbursement, and in additional downward pressure on the price that may be charged for imetelstat. We cannot predict the entire impact of the ACA.There have been judicial and Congressional challenges to certain aspects thereof, and we expect that there will be additional challenges and amendments inthe future. In addition, other legislative changes have been proposed and adopted since the ACA was enacted. For example, in August 2011, the President signedinto law the Budget Control Act of 2011, which, among other things, created the Joint Select Committee on Deficit Reduction to recommend to Congressproposals in spending reductions. The Joint Select Committee on Deficit Reduction did not achieve a targeted deficit reduction of at least $1.2 trillion forfiscal years 2012 through 2021, triggering the legislation's automatic reduction to several government programs. This includes aggregate reductions toMedicare payments to providers of up to 2% per fiscal year, which went into effect beginning on April 1, 2013 and, following passage of the BipartisanBudget Act of 2015, will stay in effect through 2025 unless additional Congressional action is taken. Additionally, in January 2013, the American TaxpayerRelief Act of 2012 was signed into law, which, among other things, reduced Medicare payments to several providers, including hospitals and imagingcenters.25Table of ContentsManufacturing A typical sequence of steps in the manufacture of imetelstat drug product includes the following key components:•starting materials, which are well-defined raw materials that are used to make bulk drug substance; •bulk drug substance, which is the active pharmaceutical ingredient in a drug product that provides pharmacological activity or other directeffect in the treatment of disease; and •final drug product, which is the finished dosage form that contains the drug substance that is shipped to the clinic for patient treatment. In accordance with the Collaboration Agreement, Janssen is now responsible for the manufacture and management of the supply of imetelstat on a globalbasis for clinical trials and, after any regulatory approval, all commercial activities. Consequently, we are, and expect to remain, dependent on Janssen toappropriately supply imetelstat and other clinical trial materials. Currently, third-party contractors perform certain process development and other technicaland scientific work with respect to imetelstat, as well as supply starting materials and manufacturing drug substance and drug product. Janssen does not havedirect control over third-party personnel or operations. These third-party contractors, and/or any other contractors that Janssen may rely upon for themanufacture and/or supply of imetelstat, typically complete their services on a proposal by proposal basis under master supply agreements and may need tomake substantial investments to enable sufficient capacity increases and cost reductions, and to implement those regulatory and compliance standardsnecessary for successful Phase 3 clinical trials and commercial production. These third-party contractors, and/or any other contractors that Janssen may relyupon for the manufacture and/or supply of imetelstat, may not be able to achieve such capacity increases, cost reductions, or regulatory and compliancestandards, and even if they do, such achievements may not be at a commercially reasonable cost. Neither we nor Janssen have any long-term commitments orcommercial supply agreements with any of the third-party contractors for imetelstat. The information provided in this section should be reviewed in thecontext of the section entitled "Risks Related to Our Business" under Item 1A, "Risk Factors".Concentration of Revenues In 2015, we recognized revenue from the $35 million upfront payment we received from Janssen in December 2014 upon delivery of the imetelstatlicense rights and completion of our performance of the technology transfer-related activities to Janssen as outlined under the Collaboration Agreement. Theupfront payment from Janssen represented 96% of our 2015 revenues. In 2014 and 2013, the majority of our revenues were from license fees and royaltiesunder licenses granted to several biotechnology and pharmaceutical companies to use telomerase immortalized cells in drug discovery research and for drugdiscovery applications. Two customers accounted for approximately 31% and 42% of our 2014 and 2013 revenues, respectively. We operate in one operatingsegment and have operations solely in the United States. All of our long-lived assets are maintained in the United States. Information regarding totalrevenues, net loss and total assets is set forth in our financial statements included in Item 8 of this annual report on Form 10-K.Consultants We have consulting agreements with a number of leading academic scientists, clinicians and regulatory experts. These individuals serve as keyconsultants or expert witnesses with respect to the imetelstat program or in legal proceedings. They also serve as important contacts for us throughout thebroader scientific and clinical communities. They are distinguished individuals with expertise in26Table of Contentsnumerous fields, including telomere and telomerase biology, cellular biology, molecular biology, oncology and drug regulations. We retain each consultant according to the terms of a consulting agreement. Under such agreements, we pay them a consulting fee and reimburse themfor out-of-pocket expenses incurred in performing their services for us. In addition, some consultants hold options to purchase our common stock, subject tothe vesting requirements contained in the consulting agreements. Our consultants may be employed by other entities and therefore may have commitments totheir employer, or may have other consulting or advisory agreements that may limit their availability to us.Executive Officers of the Company The following table sets forth certain information with respect to our executive officers as of January 31, 2016: John A. Scarlett, M.D., has served as our Chief Executive Officer and a director since joining Geron in September 2011 and President since January2012. Dr. Scarlett has served as a director for Chiasma, Inc., a biopharmaceutical company focused on transforming injectable drugs into oral medications,since February 2015. Prior to joining Geron, Dr. Scarlett served as President, Chief Executive Officer and a member of the board of directors of Proteolix, Inc.,a privately held, oncology-oriented biopharmaceutical company, from February 2009 until its acquisition by Onyx Pharmaceuticals, Inc., an oncology-oriented biopharmaceutical company, in November 2009. From February 2002 until its acquisition by Ipsen, S.A. in October 2008, Dr. Scarlett served as theChief Executive Officer and a member of the board of directors of Tercica, Inc., an endocrinology-oriented biopharmaceutical company, and also as itsPresident from February 2002 through February 2007. From March 1993 to May 2001, Dr. Scarlett served as President and Chief Executive Officer of SensusDrug Development Corporation. In 1995, he co-founded Covance Biotechnology Services, Inc., a contract biopharmaceutical manufacturing operation, andserved as a member of its board of directors from inception to 2000. From 1991 to 1993, Dr. Scarlett headed the North American Clinical Development Centerand served as Senior Vice President of Medical and Scientific Affairs at Novo Nordisk Pharmaceuticals, Inc., a wholly owned subsidiary of Novo Nordisk A/S.Dr. Scarlett received his B.A. degree in chemistry from Earlham College and his M.D. from the University of Chicago, Pritzker School of Medicine. Olivia K. Bloom has served as our Executive Vice President, Finance since February 2014, Chief Financial Officer since December 2012 and Treasurersince February 2011. Ms. Bloom previously served as our Senior Vice President, Finance from December 2012 to February 2014, Chief Accounting Officerfrom September 2010 to December 2012 and Vice President, Finance from January 2007 to December 2012. Ms. Bloom joined the Company in 1994 as aSenior Financial Analyst and from 1996 to 2011 served as our Controller. Prior to Geron, Ms. Bloom started her career in public accounting at27Name Age PositionJohn A. Scarlett, M.D. 64 President and Chief Executive OfficerOlivia K. Bloom 47 Executive Vice President, Finance, Chief FinancialOfficer and TreasurerMelissa A. Kelly Behrs 52 Executive Vice President, Business Development andPortfolio & Alliance ManagementAndrew J. Grethlein, Ph.D. 51 Executive Vice President, Development and TechnicalOperationsStephen N. Rosenfield, J.D. 66 Executive Vice President, General Counsel andCorporate SecretaryTable of ContentsKPMG Peat Marwick and became a Certified Public Accountant in 1994. Ms. Bloom graduated Phi Beta Kappa with a B.S. in Business Administration fromthe University of California at Berkeley. Melissa A. Kelly Behrs has served as our Executive Vice President, Business Development and Portfolio & Alliance Management, since July 2014. Priorto that she was our Executive Vice President, Portfolio and Alliance Management, since February 2014 and she was our Senior Vice President, Portfolio andAlliance Management, from September 2012 to February 2014. Ms. Behrs joined Geron in November 1998 as Director of Corporate Development. Since then,she has served in various managerial positions, including General Manager, R&D Technologies; Vice President, Corporate Development; Senior VicePresident, Therapeutic Development, Oncology; and Senior Vice President, Strategic Portfolio Management. From 1990 to 1998, Ms. Behrs worked atGenetics Institute, Inc., a biotechnology research and development company, serving initially as Assistant Treasurer and then as Associate Director ofPreclinical Operations where she was responsible for all business development, regulatory, and project management activities for the PreclinicalDevelopment function. Ms. Behrs received a B.S. from Boston College and an M.B.A. from Babson College. Andrew J. Grethlein, Ph.D., has served as our Executive Vice President, Development and Technical Operations, since July 2014. Prior to that, he servedas our Executive Vice President, Technical Operations since joining Geron in September 2012. From January 2010 to September 2012, Dr. Grethlein wasExecutive Vice President and Chief Operating Officer for Inspiration Biopharmaceuticals, a biopharmaceutical company. From October 2008 until January2010, Dr. Grethlein was Senior Vice President of Biotechnology and Portfolio Management Team Leader for Hematology at Ipsen S.A., a global specialtypharmaceutical company. His responsibilities at Ipsen included planning and execution of worldwide strategy for product and portfolio development in thehematologic therapeutic area. From 2003 to 2008, Dr. Grethlein served as Senior Vice President of Pharmaceutical Operations at Tercica, Inc., anendocrinology-oriented biopharmaceutical company. In this role, he was a member of the senior executive team that governed corporate strategy, businessplanning and company operations, and had responsibility for all manufacturing and quality functions. Before joining Tercica, Dr. Grethlein served in variouspositions at Elan Corporation, a biotechnology company, from 1997 to 2003, including as Senior Director, South San Francisco Pharmaceutical Operations,where he had responsibility as site head for commercial manufacturing operations. From 1995 to 1997, Dr. Grethlein served as Manager, BiologicsDevelopment and Manufacturing, for Athena Neurosciences, Inc., a pharmaceutical company. Prior to this, he served in various engineering positions for theMichigan Biotechnology Institute, a nonprofit technology research and business development corporation. Dr. Grethlein received his A.A. degree in liberalarts from Simon's Rock Early College, his B.S. in biology from Bates College, and his M.S. and Ph.D. in chemical engineering from Michigan StateUniversity. Stephen N. Rosenfield, J.D., has served as our Executive Vice President, General Counsel and Corporate Secretary since February 2012, General Counseland Secretary since January 2012 and Secretary since joining Geron in October 2011. Since July 2009, Mr. Rosenfield has been a consultant to a privatecompany. From October 2008 until June 2009, Mr. Rosenfield was the General Counsel and Secretary of Tercica, Inc., a U.S. subsidiary of Ipsen, S.A., aglobal specialty pharmaceutical company. From June 2004 until October 2008, Mr. Rosenfield was the General Counsel and Secretary of Tercica, Inc., anendocrinology-oriented biopharmaceutical company, from January 2006 until October 2008, he was also the Executive Vice President of Legal Affairs, andfrom June 2004 until January 2006, Mr. Rosenfield was the Senior Vice President of Legal Affairs. Prior to joining Tercica, Mr. Rosenfield served as theExecutive Vice President of Legal Affairs, General Counsel and Secretary of InterMune, Inc., a biotechnology company focused in pulmonology and fibroticdiseases. Prior to joining InterMune, Mr. Rosenfield was an attorney at Cooley LLP, an international law firm, where he served as outside counsel forbiotechnology and technology clients. Mr. Rosenfield received a B.S. from Hofstra University and a J.D. from Northeastern University School of Law.28Table of ContentsEmployees As of December 31, 2015, we had 17 full-time and three part-time employees. Three of our employees hold Ph.D. degrees and eight hold other advanceddegrees. Of this current total workforce, four employees were engaged in, or directly supported, our research and development activities, and 16 employeeswere engaged in business development, legal, finance and administration. None of our employees are covered by a collective bargaining agreement; nor havewe experienced work stoppages. We consider relations with our employees to be good.Corporate Information Geron Corporation was incorporated in the State of Delaware on November 28, 1990.Available Information Our internet address is www.geron.com. Information included on our website is not part of this annual report on Form 10-K. We make available free ofcharge on our website our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and all amendments to those reports assoon as reasonably practicable after such material is electronically filed with or furnished to the United States Securities and Exchange Commission, or theSEC. In addition, copies of our annual reports are available free of charge upon written request. The SEC also maintains an Internet site that contains reports,proxy and information statements, and other information regarding issuers that file electronically with the SEC. The address of that site is www.sec.gov. ITEM 1A. RISK FACTORS Our business is subject to various risks and uncertainties that may have a material adverse effect on our business, financial condition or results ofoperations. You should carefully consider the risks and uncertainties described below, together with all of the other information included in this annualreport on Form 10-K. Our business faces significant risks and uncertainties, and those described below may not be the only risks and uncertainties we face.Additional risks and uncertainties not presently known to us or that we currently believe are immaterial may also significantly impair our business,financial condition or results of operations. If any of these risks or uncertainties occur, our business, results of operations or financial condition couldsuffer, the market price of our common stock could decline and you could lose all or part of your investment in our common stock. RISKS RELATED TO OUR BUSINESS We have exclusively outlicensed imetelstat, which was our sole product candidate, to Janssen. We are wholly dependent upon our collaborativerelationship with Janssen to further develop, manufacture and commercialize imetelstat. If Janssen fails to perform as required by the CollaborationAgreement or abandons the imetelstat program, the potential for us to generate future revenues from milestone payments and royalties from imetelstatwould be significantly reduced, the development and/or commercialization of imetelstat could be terminated or substantially delayed, and our businesswould be severely harmed. Under the terms of the Collaboration Agreement, we and Janssen have created a joint governance structure, including joint committees and workinggroups, to oversee and manage worldwide regulatory, development, manufacturing and commercialization activities for imetelstat; however, Janssen is solelyresponsible for the operational execution of those activities. Accordingly, the timely and successful completion by Janssen of those activities willsignificantly affect the timing and amount of any revenues from milestone payments and royalties we may receive under the Collaboration Agreement, andthese activities will be influenced by, among other things, the efforts and allocation of resources by Janssen, none of which we control. If Janssen does notperform in the manner we expect or fulfill its responsibilities in a timely manner, or at all, the clinical development, manufacturing, regulatory29Table of Contentsapproval and/or commercialization of imetelstat could be delayed or terminated, and it could become necessary for us to assume the responsibilities for theclinical development, manufacturing, regulatory approval and/or commercialization of imetelstat at our own expense. Accordingly, there can be no assurancethat any of the development, regulatory or sales milestones under the Collaboration Agreement will be achieved or that we will receive any future milestoneor royalty payments under the Collaboration Agreement. In addition, because Janssen is solely responsible for the operational execution of worldwide regulatory, development, manufacturing andcommercialization activities related to imetelstat, we are solely dependent on Janssen to provide us with timely and accurate information concerning theseactivities. If we do not receive accurate information from Janssen in a timely manner, or at all, regarding these activities, including, for example, plans for, andenrollment of, and efficacy and safety results from, clinical trials of imetelstat, then the timeliness and accuracy of our public disclosures, as well as ourgovernance-related decision-making regarding these activities, may be adversely affected. Our collaboration with Janssen may be unsuccessful due to other factors, including the following:•Janssen may choose to terminate the Collaboration Agreement for convenience; •Janssen may provide a negative Continuation Decision and halt its development of imetelstat, in which case we would receive no furtherpayments from Janssen under the Collaboration Agreement; •the results of IMbark™ and/or IMerge™ may be negative or inconclusive, or Janssen may observe safety issues in either of these studies,which may result in a negative Continuation Decision by Janssen; •Janssen may choose not to develop and commercialize imetelstat in certain, or any, markets or for one or more indications, if at all; •Janssen may take considerably more time advancing imetelstat through the clinical and regulatory process than we currently anticipate, whichcould materially delay the achievement of milestones and, consequently the receipt of milestone payments from Janssen, and ultimately, anyroyalties we might receive on worldwide net sales of imetelstat; •in the event of a dispute between us and Janssen regarding Janssen's performance under the Collaboration Agreement, it may be difficult for usto prove that Janssen breached its obligation to use "commercially reasonable efforts" with regard to the development, regulatory approval,manufacture and commercialization of imetelstat under the Collaboration Agreement; •Janssen may not dedicate the resources necessary to carry imetelstat through clinical development or may not obtain the necessary regulatoryapprovals for imetelstat, and this would delay the achievement of development, regulatory or sales milestones; •Janssen's ability to achieve development and manufacturing objectives or milestones may be delayed or substantially impacted if we areunable to provide to Janssen in a timely manner, or at all, further information related to imetelstat that has been or may be requested byJanssen; •subject to our election of the U.S. Co-Promotion Option, Janssen will be responsible for all aspects of the commercialization of imetelstatworldwide, including pricing decisions which would affect the royalties on worldwide net sales we could receive; •Janssen may change the focus of its commercialization efforts or prioritize other programs more highly and, accordingly, reduce the efforts andresources allocated to imetelstat, which would have the direct effect of reducing our royalties or share of potential co-promotion activitiessince the extent of our U.S. Co-Promotion Option is limited to a percentage of overall promotion activities under the CollaborationAgreement;30Table of Contents•Janssen may fail to manufacture or supply sufficient quantities of imetelstat or other clinical trial materials for use in planned clinical trials,which could delay, suspend or stop any imetelstat clinical activities; •Janssen may fail to develop a commercially viable formulation or manufacturing process for imetelstat, and may fail to manufacture or supplysufficient quantities of imetelstat for commercial use, if approved, which would result in lost sales revenue and reduced royalties for us; •Janssen may not comply with all applicable regulatory requirements or may fail to report safety data from clinical trials of imetelstat inaccordance with all applicable regulatory requirements, which could delay, suspend or stop clinical activities of imetelstat being performed byJanssen or by us; and •if Janssen is acquired by a third party during the term of our collaboration with Janssen, the acquirer may have different strategic priorities thatcould cause it to terminate the Collaboration Agreement or reduce its commitment to our collaboration.If our collaboration with Janssen is unsuccessful as a result of any of the above factors, or any other factors, then Janssen may terminate the CollaborationAgreement, and we would not be eligible for any further payments from Janssen under the Collaboration Agreement, which would severely and adverselyaffect our business and business prospects.Clinical development involves a lengthy and expensive process with uncertain outcomes. Current clinical trials of imetelstat being conducted by Janssen,including IMbark™, IMerge™ and the MF Pilot Study, and potential future clinical trials of imetelstat, may fail to adequately demonstrate the safety andefficacy of imetelstat, which would prevent or delay regulatory approval and commercialization and negatively affect our ability to earn revenues frommilestone payments or royalties under the Collaboration Agreement with Janssen. Before regulatory approvals for the commercial sale of imetelstat can be obtained, clinical testing must be conducted to show that imetelstat is both safeand effective for use in each target indication. Such clinical testing is expensive, can take many years to complete, and its outcome is inherently uncertain.Failure can occur at any time during clinical testing. Most product candidates that commence clinical trials are never approved as commercial products. The clinical development of imetelstat will be influenced by results from current clinical trials, including IMbark™, IMerge™ and the MF Pilot Studybeing conducted by Janssen, and potential future clinical trials of imetelstat. The advancement of current clinical trials of imetelstat and commencement ofpotential future clinical trials of imetelstat could be delayed or abandoned for a variety of reasons, including as a result of failures or delays by Janssen in:•obtaining or maintaining regulatory clearance to commence, conduct or continue current or potential future clinical trials of imetelstat,including IMbark™, IMerge™ and the MF Pilot Study, in a timely manner, or at all, in the United States or other countries; •maintaining the INDs for imetelstat that we have transferred to Janssen, without such INDs being placed on full or partial clinical hold by theFDA; •properly designing, enrolling, conducting or completing IMbark™, IMerge™ and potential future clinical trials, and promptly or adequatelyreporting data from such trials; •demonstrating sufficient safety and efficacy of imetelstat in IMbark™, IMerge™ and potential future clinical trials without safety issues, sideeffects or dose-limiting toxicities, including any additional or more severe safety issues in addition to those that have been observed to date in31Table of Contentsprevious or ongoing clinical trials related to imetelstat, whether or not in the same indications or therapeutic areas;•properly conducting and/or completing the MF Pilot Study and promptly or adequately reporting data from such trial; •obtaining or accessing necessary clinical data in accordance with appropriate clinical or quality practices to ensure complete data sets; •responding to safety or futility findings by the data review committees of clinical trials, including IMbark™, IMerge™ and potential futureclinical trials, based on emerging data occurring during such clinical trials; •manufacturing sufficient quantities of imetelstat or other clinical trial materials in a manner that meets the quality standards of the FDA andother regulatory authorities, and responding to any disruptions to drug supply, clinical trial materials or quality issues that may arise; •ensuring the ability to manufacture imetelstat at acceptable costs for Phase 3 clinical trials and commercialization; •obtaining sufficient quantities of any study-related treatments, materials (including comparator therapy) or ancillary supplies; •obtaining acceptance by regulatory authorities of manufacturing changes or clinical trial protocol amendments, as well as subsequentlyimplementing such manufacturing changes and/or clinical trial protocol amendments successfully; •complying with current and future regulatory requirements, policies or guidelines, including domestic and international laws and regulationspertaining to fraud and abuse, transparency, and the privacy and security of health information; •reaching agreement on acceptable terms and on a timely basis, if at all, with collaborators and vendors located in the United States or foreignjurisdictions, including contract research organizations, laboratory service providers and clinical trial sites, on all aspects of clinicaldevelopment; and •obtaining institutional review board or ethics committee approval of clinical trial protocols or protocol amendments to conduct clinical trialsat prospective clinical trial sites.Failures or delays with respect to any of these events could adversely affect Janssen's ability to maintain or successfully complete any current clinical trials ofimetelstat or to initiate potential future clinical trials of imetelstat, which could increase development costs, impair our ability to earn revenues frommilestone payments or royalties under the Collaboration Agreement or cause Janssen to terminate the Collaboration Agreement, any of which couldadversely impact our financial results, would have severe adverse effects on our business and business prospects, and might cause us to cease operations.If Janssen encounters difficulties enrolling or retaining patients in current and potential future clinical trials of imetelstat, clinical development andcommercialization activities could be delayed or otherwise adversely affected, which could cause Janssen to terminate the Collaboration Agreement, andour business would be severely harmed. The timely completion of a clinical trial in accordance with its protocol depends, among other things, on the ability to enroll a sufficient number ofpatients who remain in the study until its conclusion. Janssen may experience difficulties in patient enrollment in IMbark™ and IMerge™, or32Table of Contentspotential future clinical trials of imetelstat for a variety of reasons. The enrollment and retention of patients depends on many factors, including:•the patient eligibility criteria in the protocol; •the size of the patient population required for analysis of the trial's primary endpoint; •the proximity of patients to study sites; •the design of the trial; •Janssen's ability to recruit clinical trial investigators with the appropriate competencies and experience; •clinicians' and patients' perceptions as to the potential advantages of imetelstat in relation to other available therapies, including any newdrugs that may be approved for the indications being investigated; •the ability to obtain and maintain patient consents; and •the risk that patients enrolled in the clinical trial will drop out of the trial before completion due to lack of efficacy, side effects or personalissues. In addition, IMbark™ and IMerge™, or potential future clinical trials of imetelstat, will compete with other clinical trials for product candidates that arein the same therapeutic areas with imetelstat, and this competition will reduce the number and type of patients available to enroll in the imetelstat clinicaltrials. Since the number of qualified clinical investigators is limited, we expect IMbark™ and IMerge™, or potential future clinical trials of imetelstat, to beconducted at the same clinical trial sites that competitors use, which will reduce the number of patients who are available for the imetelstat clinical trials atsuch clinical trial site. Moreover, because imetelstat represents a departure from more commonly used methods for cancer treatment, potential patients andtheir doctors may be inclined to use conventional therapies, rather than enroll patients in the imetelstat clinical trials. Delays in patient enrollment or the inability to retain or treat patients could result in increased costs, lead to incomplete data sets or adversely affect thetiming or outcome of IMbark™ and IMerge™, or potential future clinical trials of imetelstat, which could prevent completion of these trials and adverselyaffect the clinical development and commercialization of imetelstat, either of which would delay the timing of the Continuation Decision from Janssen orcould cause Janssen to terminate the Collaboration Agreement. Such occurrences would severely and adversely affect the future of imetelstat and ourbusiness prospects and might cause us to cease operations.Imetelstat may cause, or have attributed to it, undesirable or unintended side effects or other characteristics that delay or prevent the commencementand/or completion of clinical trials for imetelstat, delay or prevent its regulatory approval, or limit its commercial potential, which in each case couldcause Janssen to terminate the Collaboration Agreement and which in turn would severely and adversely affect our business prospects and might cause usto cease operations. Imetelstat may cause, or have attributed to it, undesirable or unintended side effects or other characteristics adversely affecting its safety or efficacy thatcould delay or prevent the commencement and/or completion of clinical trials for imetelstat. In our Phase 1 clinical trials of imetelstat, we observed dose-limiting toxicities, including thrombocytopenia when imetelstat was used as a single agent, and neutropenia when imetelstat was used in combination withpaclitaxel, as well as a low incidence of severe infusion reactions. In our Phase 2 clinical trials of imetelstat in ET, multiple myeloma, or MM, and solidtumors, we observed hematologic toxicities as well as gastrointestinal events, infections, muscular and joint pain, fatigue and infusion reactions. In addition,in our Phase 2 clinical trials of imetelstat, we observed LFT abnormalities, the clinical significance and long-term33Table of Contentsconsequences of which are currently undetermined. If patients in current or potential future clinical trials of imetelstat experience similar or more severehepatotoxicity, including LFT abnormalities, severe hepatic or other severe adverse events, the IND for imetelstat may again be placed on clinical hold, andJanssen may be delayed or precluded from further developing imetelstat. In the ET Trial, one patient died of bleeding esophageal varices, a complication ofchronic liver disease, for which imetelstat initially could not be excluded as a causative agent but which was later determined by the investigator to beunrelated to imetelstat. In the MF Pilot Study, cytopenias have been the primary dose-limiting toxicity reported to date, consistent with our observations inprevious Geron-sponsored imetelstat studies. However, during the MF Pilot Study, more persistent and profound cytopenias, particularly thrombocytopenia,were observed with imetelstat administered on a weekly basis. This included one case of febrile neutropenia after prolonged myelosuppression withintracranial hemorrhage resulting in patient death, which was assessed as possibly related to imetelstat by the investigator. Serious adverse events observed in clinical trials could delay or prevent any regulatory approvals of imetelstat or could hinder or prevent marketacceptance of imetelstat, which could cause Janssen to terminate the Collaboration Agreement or cause Janssen to limit its commercialization of imetelstat tocertain indications. Such occurrences would adversely impact our financial results, have severe adverse effects on our business and business prospects, andmight cause us to cease operations.If Janssen does not elect to continue the development of imetelstat in a timely manner, or at all, our business and business prospects would be severelyharmed. Under the terms of the Collaboration Agreement, Janssen is not obligated to make any additional payments to us until it makes an affirmativeContinuation Decision following the results of IMbark™, or, if IMbark™ is terminated early or suspended for an extended period of time, within a certaintime period thereafter as set forth in the Collaboration Agreement. The timing of Janssen's Continuation Decision also affects the timing and our opportunityto make our decision regarding our U.S. Opt-In Rights, as well as our election, if we exercise our U.S. Opt-In Rights, of our U.S. Co-Promotion Option. IfIMbark™ is terminated early, suspended for an extended period of time, or is otherwise unsuccessful, Janssen may provide a negative Continuation Decision,in which case, the Collaboration Agreement would terminate, we would not be eligible for any further payments from Janssen under the CollaborationAgreement and our business and business prospects would be severely and adversely affected, which might cause us to cease operations. In addition, Janssen may terminate the Collaboration Agreement at any time for convenience. If Janssen terminates the Collaboration Agreement, then,depending on the timing of such event:•we would no longer have the right to receive any milestone payments or royalties under the Collaboration Agreement; •the development of imetelstat would likely be terminated or significantly delayed; •we would bear all of the risks and costs related to the further clinical development, manufacturing, regulatory approval and commercializationof imetelstat; •we would need to raise additional capital if we were to choose to pursue imetelstat development on our own, or we would need to establishalternative collaborations with third parties, which might not be possible in a timely manner, or at all, or might not be possible on termsacceptable to us, in which case it would likely be necessary for us to limit the size or scope of the imetelstat development program or to seekadditional funding by other means to accommodate the increased expenditures; and •we would need to hire additional employees to support the development and commercialization of imetelstat, which would increase our needfor additional funding.34Table of ContentsAny termination of the Collaboration Agreement by Janssen at any time would have a material adverse effect on our results of operations, financial condition,business prospects and the future of imetelstat, any of which would have severe adverse effects on our business and business prospects, and might cause us tocease operations.If Janssen fails to manufacture or provide clinical and commercial quantities of imetelstat, on a timely basis, or at all, this could result in a delay ofclinical trials or regulatory approvals, or lost sales. In accordance with the Collaboration Agreement, Janssen is now responsible for the manufacture and management of the supply of imetelstat on a globalbasis for all clinical trials and commercial activities. Consequently, we are, and expect to remain, dependent on Janssen to appropriately supply imetelstatand other clinical trial materials. The process of manufacturing imetelstat is complex and subject to several risks, including:•scaling-up and attaining sufficient production yields with appropriate quality control and quality assurance; •reliance on third-party manufacturers and suppliers; •supply chain issues, including the timely availability and shelf life requirements of raw materials and other supplies; •shortage of qualified personnel; and •compliance with regulatory requirements, which are less well-defined for oligonucleotide products than for small molecule drugs, that vary ineach country where imetelstat might be sold.As a result of these risks, Janssen may not perform as agreed or may default in its obligations to supply imetelstat or other clinical trial materials for clinicaltrials and/or commercial activities. Janssen also may fail to deliver the required quantities of imetelstat or other clinical trial materials on a timely basis, or atrequired or applicable quality standards. Any such failure by Janssen could delay current and/or potential future clinical trials and any applications forregulatory approval and therefore delay the payment of potential milestone payments to us, or, if approved for commercial sale, could impair Janssen's abilityto meet the market demand for imetelstat and therefore result in decreased sales and reduced royalties for us.Our decision to exercise our U.S. Opt-In Rights under the Collaboration Agreement with Janssen for imetelstat must be made within a limited time afterJanssen makes an affirmative Continuation Decision and, as a result, we may be required to invest substantial capital based on limited clinical data. We must elect to exercise our U.S. Opt-In Rights within a short timeframe following Janssen's affirmative Continuation Decision. Although we expect toreceive information from Janssen regarding data from IMbark™ and IMerge™, proposed future clinical development plans and costs, estimates in timing forcommercializing imetelstat and related promotional activities, and calculation of our share of development costs incurred to date by Janssen that we will berequired to reimburse if we exercise our U.S. Opt-In Rights, we will be required to rapidly decide whether to make a substantial capital investment inimetelstat prior to the conclusion of any Phase 3 registration-enabling clinical trial. Accordingly, if imetelstat were to become unsuccessful in any Phase 3registration-enabling clinical trial or were to fail to receive regulatory approval, we would not receive any financial return on this substantial capitalinvestment. Such an occurrence would negatively impact our financial condition and results of operations, and might cause us to cease operations.35Table of ContentsWe may not be able to successfully identify and acquire and/or in-license other oncology products, product candidates, programs or companies to growand diversify our business, and, even if we are able to do so, we may not be able to successfully manage the risks associated with integrating any suchproducts, product candidates, programs or companies into our business or we may otherwise fail to realize the anticipated benefits of these acquisitions. We have exclusively outlicensed imetelstat, which was our sole product candidate, to Janssen. Accordingly, we are relying exclusively upon ourcollaborative relationship with Janssen to further develop, manufacture and commercialize imetelstat. To grow and diversify our business, we plan tocontinue our business development efforts to identify and seek to acquire and/or in-license other oncology products, product candidates, programs orcompanies. Such efforts have not yet resulted in any transaction, and may never result in a transaction. Future growth through acquisition or in-licensing willdepend upon the availability of suitable products, product candidates, programs or companies for acquisition or in-licensing on acceptable prices, terms andconditions. Even if appropriate opportunities are available, we may not be able to obtain them; and may not have the ability to develop, obtain regulatoryapproval for and commercialize them or the financial resources necessary to pursue them. The competition to acquire or in-license rights to promisingproducts, product candidates, programs and companies is fierce, and many of our competitors are large, multinational pharmaceutical and biotechnologycompanies with considerably more financial, development and commercialization resources and experience than we have. In order to compete successfully inthe current business climate, we may have to pay higher prices for assets than may have been paid historically, which may make it more difficult for us torealize an adequate return on any acquisition. Thus, even if we succeed in identifying promising products, product candidates or programs, we may not beable to acquire rights to them on acceptable terms, or at all. Even if we are able to successfully identify and acquire or in-license new products, product candidates, programs or companies, we cannot assure youthat we will be able to successfully manage the risks associated with integrating any products, product candidates, programs or companies into our businessor the risks arising from anticipated and unanticipated problems in connection with an acquisition or in-licensing. In any event, we may not be able to realizethe anticipated benefits of any acquisition or in-licensing for a variety of reasons, including the possibility that a product candidate proves not to be safe oreffective in clinical trials, a product fails to reach its forecasted commercial potential or the integration of a product, product candidate, program or companygives rise to unforeseen difficulties and expenditures. Any failure in identifying and managing these risks and uncertainties effectively would have a materialadverse effect on our business. In addition, acquisitions create other uncertainties and risks, particularly when the acquisition takes the form of a merger or other business consolidation.We may encounter unexpected difficulties, or incur unexpected costs, in connection with transition activities and integration efforts, which include:•high acquisition costs; •the need to incur substantial debt or engage in dilutive issuances of equity securities to pay for acquisitions; •the potential disruption of our historical business and our activities under the Collaboration Agreement; •the strain on, and need to continue to expand, our existing operational, technical, financial and administrative infrastructure; •our lack of experience in commercializing any products; •the difficulties in assimilating employees and corporate cultures; •the failure to retain key managers and other personnel;36Table of Contents•the challenges in controlling additional costs and expenses in connection with and as a result of the acquisition; •the need to write down assets or recognize impairment charges; •the diversion of our management's attention to integration of operations and corporate and administrative infrastructures; and •any unanticipated liabilities for activities of or related to the acquired business or its operations, products or product candidates. If we fail to integrate or otherwise manage an acquired business successfully and in a timely manner, resulting operating inefficiencies could increasecosts and expenses more than we planned, could negatively impact the market price of our common stock and could otherwise distract us from execution ofour strategy. Failure to maintain effective financial controls and reporting systems and procedures could also impact our ability to produce timely andaccurate financial statements. In addition, the Collaboration Agreement with Janssen prohibits us from commercializing, under the intellectual property we have licensed exclusivelyto Janssen, any substance whose identified or known mechanism of action is telomerase inhibition. Further, if we exercise our U.S. Co-Promotion Optionunder the Collaboration Agreement, we will be required to certify at the time of exercising our U.S. Co-Promotion Option that we are not marketing orpromoting, and have no right to market or promote, any such products for any oncology indication. Our right to co-promote in the U.S. may be terminated byJanssen if we develop or commercialize a product for treating an oncology indication that acts through the same mechanism of action as imetelstat or that issubstitutable for imetelstat. Accordingly, our Collaboration Agreement with Janssen could adversely affect our ability to acquire or in-license, or to research,develop or market, promising products, product candidates or programs.We may be unable to successfully retain key personnel to support our collaboration with Janssen or to manage any future growth. Under the terms of the Collaboration Agreement, we and Janssen have created a joint governance structure, including joint committees and workinggroups, to manage worldwide regulatory, development, manufacturing and commercialization activities for imetelstat, and we will have ongoingresponsibilities to oversee and participate in the collaboration with Janssen. In addition, we remain responsible for prosecuting, at Janssen's direction, thepatents we exclusively licensed to Janssen, and have sole responsibility for those patents that were non-exclusively licensed to Janssen. If we are unable tosuccessfully retain, motivate and incentivize our personnel, our ability to support the Collaboration Agreement with Janssen could be impaired, and ourbusiness and the price of our common stock would be adversely impacted. In addition, our future growth and success depend to a significant extent on the skills, experience and efforts of our executive officers and key membersof our staff. We face intense competition for qualified individuals from numerous pharmaceutical, biopharmaceutical and biotechnology companies, as wellas academic and other research institutions. The previous restructurings we implemented and our March 2015 organizational resizing, as well as ourcollaboration with Janssen and uncertainties regarding our ability to diversify our business after exclusively outlicensing imetelstat, which was our soleproduct candidate, to Janssen, could have an adverse impact on our ability to retain and recruit qualified personnel or we may incur unanticipatedinefficiencies caused by our reduced personnel resources. We may be unable to retain our current personnel or attract or assimilate other highly qualifiedmanagement and development personnel in the future on acceptable terms. The loss of any or all of these individuals could harm our business and couldimpair our ability to support our collaboration with Janssen or to support future growth.37Table of ContentsWe and certain of our officers have been named as defendants in three securities lawsuits, two of which are purportedly class action lawsuits, and certainof our officers and/or directors have been named as defendants in four derivative lawsuits. These, and potential similar or related lawsuits, could result insubstantial damages, divert management's time and attention from our business, and have a material adverse effect on our results of operations. Theselawsuits and any other lawsuits will be costly to defend or pursue and are uncertain in their outcome. Securities-related class action lawsuits and derivative litigation has often been brought against companies which experience volatility in the marketprice of their securities. This risk is especially relevant for us because biotechnology and biopharmaceutical companies often experience significant stockprice volatility in connection with their product development programs. On March 14, 2014, a purported class action securities lawsuit was commenced in the United States District Court for the Northern District of California,or the California District Court, naming as defendants us and certain of our officers. The lawsuit alleges violations of the Securities Exchange Act of 1934 inconnection with allegedly false and misleading statements made by us related to our Phase 2 trial of imetelstat in patients with ET or PV. The plaintiffalleges, among other things, that we failed to disclose facts related to the occurrence of persistent low-grade LFT abnormalities observed in our Phase 2 trialof imetelstat in ET or PV patients and the potential risk of chronic liver injury following long-term exposure to imetelstat. The plaintiff seeks damages and anaward of reasonable costs and expenses, including attorneys' fees. On March 28, 2014, a second purported class action securities lawsuit was commenced in the California District Court, naming as defendants us andcertain of our officers. This lawsuit, which is based on the same factual background as the purported class action securities lawsuit that commenced onMarch 14, 2014, also alleges violations of the Securities Exchange Act of 1934 and seeks damages and an award of reasonable costs and expenses, includingattorneys' fees. On June 30, 2014, both of the foregoing lawsuits, or the Class Action Lawsuits, were consolidated for all purposes, and a lead plaintiff and lead counselwere appointed by the California District Court. On July 21, 2014, the California District Court ordered the lead plaintiff to file its consolidated amendedcomplaint in the Class Action Lawsuits, which was filed on September 19, 2014. We filed our motion to dismiss the consolidated amended complaint onNovember 18, 2014. On April 10, 2015, the California District Court granted our motion to dismiss with respect to some of the allegedly false and misleadingstatements made by us and denied our motion to dismiss with respect to other allegedly false and misleading statements made by us. On May 22, 2015, wefiled our answer to the consolidated amended complaint in the Class Action Lawsuits. On June 6, 2014, a securities lawsuit, not styled as a class action, was commenced in the United States District Court for the Southern District ofMississippi, or the Mississippi District Court, naming as defendants us and certain of our officers. This lawsuit, which is based on the same factualbackground as the Class Action Lawsuits, also alleges violations of the Securities Exchange Act of 1934 and seeks damages and an award of reasonable costsand expenses, including attorneys' fees. On August 11, 2014, we filed a motion to transfer the securities lawsuit filed in the Mississippi District Court to theCalifornia District Court so it could be consolidated with the Class Action Lawsuits. On November 4, 2014, the Mississippi District Court granted our motionand transferred the case to the California District Court, and the transferred case has been consolidated by the California District Court with the Class ActionLawsuits filed in the California District Court. On April 21, 2014, a stockholder purporting to act on our behalf filed a derivative lawsuit in the Superior Court of California for the County of SanMateo, or the San Mateo County Court, against certain of our officers and directors. The lawsuit alleges breaches of fiduciary duties by the defendants andother violations of law. In general, the lawsuit alleges that the defendants caused or allowed the dissemination of allegedly false and misleading statementsrelated to our Phase 2 trial of imetelstat in38Table of Contentspatients with ET or PV. On June 26, 2015 and June 29, 2015, respectively, two additional derivative lawsuits naming certain of our officers and directors asdefendants were filed in the California District Court by stockholders purporting to act on our behalf. The two derivative cases filed in the California DistrictCourt were consolidated on August 13, 2015. On August 25, 2015, an additional derivative lawsuit naming certain of our officers and directors as defendantswas filed in the San Mateo County Court. The two derivative cases filed in the San Mateo County Court were consolidated on September 5, 2015. Theselawsuits, each of which is based on the same factual background as the derivative lawsuit filed on April 21, 2014 in the San Mateo County Court, also allegebreaches of fiduciary duties by the defendants and other violations of law. The plaintiffs in each of the foregoing derivative lawsuits are seeking unspecifiedmonetary damages and other relief, including reforms and improvements to our corporate governance and internal procedures. Proceedings in the derivativelawsuits have been stayed. It is possible that additional suits will be filed, or allegations received from stockholders, with respect to these same or other matters, including, forexample, the duration and nature of follow-up conducted by Janssen or us of patients enrolled in current and potential future clinical trials of imetelstat, andalso naming us and/or our officers and directors as defendants. These lawsuits and any other lawsuits are subject to inherent uncertainties, and the actualdefense and disposition costs will depend upon many unknown factors. The outcome of these lawsuits is necessarily uncertain. We could be forced to expendsignificant resources in the defense against these lawsuits and we may not prevail. In addition, we may incur substantial legal fees and costs in connectionwith these lawsuits. We currently are not able to estimate the possible cost to us from these matters, as these lawsuits are currently at an early stage, and wecannot be certain how long it may take to resolve these matters or the possible amount of any damages that we may be required to pay. We have notestablished any reserve for any potential liability relating to these lawsuits. It is possible that we could, in the future, incur judgments or enter intosettlements of claims for monetary damages. A decision adverse to our interests on these actions could result in the payment of substantial damages, orpossibly fines, and could have a material adverse effect on our cash flow, results of operations and financial position.We may also be subject to litigation arising from completed strategic transactions or if the results of our business and collaboration activities are notsuccessful. On October 1, 2013, we closed the transaction to divest our human embryonic stem cell assets and our autologous cellular immunotherapy programpursuant to the terms of an asset contribution agreement, or the Contribution Agreement, that we entered into in January 2013 with BioTime, Inc., orBioTime, and Asterias Biotherapeutics, Inc., or Asterias. On November 13, 2014, we announced that we had entered into the Collaboration Agreement withJanssen to develop and commercialize imetelstat worldwide. We may face litigation arising from or related to the value received by our stockholders, if any,from our distribution of the Asterias Series A common stock we received under the Contribution Agreement and/or the warrants to purchase BioTimecommon stock, or the BioTime Warrants, distributed by Asterias under the Contribution Agreement, or our role as a named underwriter with respect to ourdistribution of the Asterias Series A common stock, including the delays we experienced with respect to completing our distribution of the Asterias Series Acommon stock, or we may face litigation based on other matters related to the Contribution Agreement and the Collaboration Agreement or the transactionscontemplated thereby, including if we are unable to generate substantial value under the Collaboration Agreement with Janssen or such collaboration isotherwise unsuccessful. For example, these strategic transactions could result in litigation arising out of any claims that our stockholders suffered financial losses due to thetransactions, the approval of our stockholders was required under applicable law or otherwise should have been obtained prior to the completion of either orboth of these transactions, or that our officers and directors breached their fiduciary duties in39Table of Contentsconnection with the approval and completion of these transactions. Although we believe that stockholder approval was not required under applicable law inorder to complete either or both of these transactions and therefore we neither sought nor intend to seek such stockholder approval, it is possible that personswho were stockholders at the time of the applicable transaction may claim that their approval was required, in which case litigation could follow, whichcould result in substantial damages to us and/or could negatively affect our rights and obligations under either of these agreements or, in the case of theCollaboration Agreement, could result in the termination of that agreement. Likewise, our stockholders may believe that the financial and other terms of the Collaboration Agreement are not favorable to either us or ourstockholders, including any belief that the potential payments we may receive under the Collaboration Agreement are inadequate. Litigation brought by ourstockholders challenging the validity of, or financial losses resulting from, these transactions could also result in claims against us by Asterias and/or Janssen,and each of the Contribution Agreement and the Collaboration Agreement provide for indemnification by us of BioTime and Janssen, respectively, againstall losses and expenses relating to breaches of our representations, warranties and covenants in the applicable agreement, which could expose us to furtherfinancial obligations and damages. The occurrence of any one or more of the above could have a significant adverse impact on our business and financialcondition. In addition, if the results of our business and collaboration activities are not successful, including without limitation, if:•we or Janssen are otherwise unable to continue development of imetelstat due to actions by regulatory authorities, such as the previous fullclinical hold that was placed by the FDA in March 2014 on the IND for imetelstat; •we, Janssen or any investigators ascertain that the use of imetelstat results in significant systemic or organ toxicities, including hepatotoxicity,or other safety issues resulting in an unacceptable benefit-risk profile; •the conduct of current clinical trials, such as IMbark™, IMerge™ and the MF Pilot Study, including the MDS-RARS Cohort, being conductedby Janssen, and potential future clinical trials, results in patient injury or death, or any failure to meet regulatory and/or compliancerequirements; •the final or any preliminary results from IMbark™, IMerge™ or the MF Pilot Study, including the MDS-RARS Cohort, or any potential futureclinical trial of imetelstat, are deemed not to be successful; •we or Janssen are unable to obtain regulatory clearance to commercialize imetelstat for sale in the United States and other countries, in atimely manner, or at all, or such regulatory clearance is revoked or put on hold by governmental or regulatory authorities in any jurisdiction; •Janssen discontinues the further development of imetelstat and terminates the Collaboration Agreement for any reason; or •Asterias is unable to develop our stem cell assets, and we are not able to receive any royalties from the sale of any potential stem cell productsby Asterias,our stock price would likely decline, and future litigation may result. A decision adverse to our interests in any such lawsuits could result in the payment ofsubstantial damages by us, and could have a material adverse effect on our cash flow, results of operations and financial position or could otherwise severelyharm our business.40Table of Contents Our business may also bring us into conflict with our licensees, licensors, or others with whom we have contractual or other business relationships, orwith our competitors or others whose interests differ from ours. If we are unable to resolve those conflicts on terms that are satisfactory to all parties, we maybecome involved in litigation brought by or against us. For example, we are subject to the risk of possible disagreements with Janssen, including thoseregarding the development and/or commercialization of imetelstat, interpretation of the Collaboration Agreement and ownership of proprietary rights. Inaddition, in certain circumstances we may believe that a particular milestone under the Collaboration Agreement has been achieved, and Janssen maydisagree with our belief. In that case, receipt of that milestone payment may be delayed or may never be received, which would adversely affect our financialcondition and may require us to adjust our operating plans. While the Collaboration Agreement provides for a joint governance structure to oversee andmanage worldwide regulatory, development, manufacturing and commercialization activities for imetelstat, Janssen generally will, subject to limitedexceptions, have the deciding vote in the event of any disagreement. In any event, the joint governance structure contemplated by the CollaborationAgreement will be dissolved in the event that we do not exercise our U.S. Opt-In Rights, which would preclude our ability to participate in any furtherdecision-making for imetelstat. Reliance on a joint governance structure also subjects us to the risk that changes in key management personnel that aremembers of the various joint committees may materially and adversely affect the functioning of these committees, which could significantly delay orpreclude imetelstat development and/or commercialization. As a result of possible disagreements with Janssen, we also may become involved in litigation orarbitration, which would be time-consuming and expensive. Monitoring, initiating and defending against legal actions, including our currently-pending securities-related lawsuits and derivative litigations, aretime-consuming for our management, likely to be expensive and may detract from our ability to fully focus our internal resources on our business activities.The outcome of litigation is always uncertain, and in some cases could include judgments against us that require us to pay damages, enjoin us from certainactivities, or otherwise negatively affect our legal or contractual rights, which could have a significant adverse effect on our business. In addition, theinherent uncertainty of such litigation, including our currently-pending securities-related lawsuits and derivative litigations, could lead to increasedvolatility in our stock price and a decrease in the value of our stockholders' investment in our common stock. RISKS RELATED TO CLINICAL AND COMMERCIALIZATION ACTIVITIES The research and development of imetelstat is subject to numerous risks and uncertainties. The science and technology of telomere biology, telomerase and our proprietary oligonucleotide chemistry are relatively new. There is no precedent forthe successful commercialization of a therapeutic product candidate based on these technologies. Significant research and development activities will benecessary to further develop imetelstat, which was our sole product candidate that we have exclusively outlicensed to Janssen, which may take years toaccomplish, if at all. Because of the significant scientific, regulatory and commercial challenges that must be overcome to successfully research, develop and commercializeimetelstat, the development of imetelstat in hematologic myeloid malignancies, including MF and MDS, or any other indications, may be delayed orabandoned, even after significant resources have been expended on it. Our decisions to discontinue our Phase 2 clinical trial of imetelstat in metastatic breastcancer in September 2012, and to discontinue our development of imetelstat in solid tumors with short telomeres in April 2013, are examples of this. Anydelay or abandonment of the development of imetelstat in hematologic myeloid malignancies would have a material adverse effect on our collaboration withJanssen, which could result in the termination of the Collaboration Agreement. Any of these events would have severe adverse effects on our business andbusiness prospects and likely result in the failure of our business.41Table of ContentsSuccess in early clinical trials may not be indicative of results in potential future clinical trials. Likewise, preliminary data from clinical trials we havereported should be considered with caution since the final data may be materially different from the preliminary data, particularly as more patient databecomes available. A number of new drugs and biologics have shown promising results in preclinical studies and initial clinical trials, but subsequently failed to establishsufficient safety and efficacy data to obtain necessary regulatory approvals. There is typically an extremely high rate of attrition from the failure of productcandidates proceeding through clinical trials. Data obtained from preclinical and clinical activities are subject to varying interpretations, which may delay,limit or prevent regulatory approval. Product candidates in later stages of clinical trials may fail to show the desired benefit-risk profile despite havingprogressed through preclinical studies and initial clinical trials. Most product candidates that commence clinical trials are never approved as products. Data from our preclinical studies and Phase 1 and Phase 2 clinical trials of imetelstat, as well as preliminary, additional or updated data from the MF PilotStudy, including the MDS-RARS Cohort, should not be relied upon as evidence that subsequent or larger-scale clinical trials of imetelstat will succeed. Theresults we obtained from the ET Trial may not predict the future therapeutic benefit of imetelstat, if any, in other hematologic myeloid malignancies,including MF. In addition, the known LFT abnormalities and dose-limiting toxicities associated with imetelstat, such as profound thrombocytopenia andneutropenia and other safety issues, including death, that have been observed in both previous and ongoing clinical trials, including the MF Pilot Study andMDS-RARS Cohort, could cause complexities in treating patients with MF or MDS and could result in the discontinuation of the MF Pilot Study, includingthe MDS-RARS Cohort, IMbark™ or IMerge™. Also, the criteria used to assess efficacy in the MF Pilot Study have not been validated for clinical use andmay not be considered by the FDA or other regulatory authorities to be accurate predictors of efficacy for different endpoints that may be required by the FDAor other regulatory authorities for Phase 3 clinical trials. The preliminary results of the MF Pilot Study presented by the investigator at the American Society of Hematology, or ASH, annual meeting inDecember 2013, as updated by the investigator at ASH in December 2014, will need to be confirmed in one or more larger Phase 2 and Phase 3 trials in MF atmultiple treating centers. The results reported by us, Janssen or by the investigator in the MF Pilot Study, including in the MDS-RARS Cohort, may not bereproduced in IMbark™, IMerge™ or in any potential imetelstat trials conducted in the future, or by any other investigator or group of investigators, or inany trial enrolling a larger number of patients or conducted at multiple treating centers, and thus should not be relied upon as indicative of future clinicalresults of imetelstat in MF, MDS or in any other hematologic myeloid malignancy. In addition, from time-to-time, we or Janssen may report or announce preliminary data from current or potential future clinical trials, such as the ongoingMF Pilot Study, IMbark™ and IMerge™. For example, the investigator for the MF Pilot Study reported preliminary data from the trial in December 2013,which the investigator updated in December 2014, and reported preliminary data from the MDS-RARS Cohort in December 2015. Since those data werepreliminary, the final data from the MF Pilot Study, including the MDS-RARS Cohort, may be materially different than the preliminary data reported by theinvestigator. Since remaining patients previously enrolled in the MF Pilot Study, including the MDS-RARS Cohort, continue to receive imetelstat,principally safety data continue to be generated, and additional and updated data may materially change the overall conclusions from the preliminary datareported for the MF Pilot Study, including the MDS-RARS Cohort. Therefore, such preliminary data should be considered carefully and with caution.Material adverse changes in the final data from the MF Pilot Study, including the MDS-RARS Cohort, could jeopardize our Collaboration Agreement withJanssen and if Janssen were to terminate the Collaboration Agreement, our business prospects would be severely and adversely affected, and we might ceaseoperations. Even if final safety data from the MF Pilot Study, including the MDS-RARS Cohort, are positive, significant additional clinical testing will benecessary for the future development of imetelstat in MF or MDS. Any safety42Table of Contentsand efficacy data from the MF Pilot Study, including the MDS-RARS Cohort, may not be reproducible in IMbark™, IMerge™ or in any potential imetelstattrials conducted in the future.Clinical trials of imetelstat may not uncover all possible adverse effects that patients may experience from imetelstat treatment. Clinical trials by their nature examine the effect of a potential therapy in a sample of the potential future patient population. As such, clinical trialsconducted with imetelstat, to date and in the future, may not uncover all possible adverse events that patients treated with imetelstat may experience.Because previously enrolled patients who remain on study continue to receive imetelstat in the MF Pilot Study, additional or more severe toxicities or safetyissues in the MF Pilot Study, including additional serious adverse events and clinically significant LFT abnormalities, may be observed as patient treatmentcontinues and more data become available. Likewise, additional or more severe toxicities or safety issues, including additional serious adverse events andclinically significant LFT abnormalities, may be observed in IMbark™ and IMerge™, particularly given the larger target patient enrollment in those studies.Since IMbark™, IMerge™ and the MF Pilot Study are ongoing studies in which additional data is being generated, the benefit-risk profile of imetelstat willcontinue to be assessed, including the risk of hepatotoxicity, severe cytopenias and any other severe adverse effects that may be associated with life-threatening clinical outcomes. If such toxicities or other safety issues in any clinical trial of imetelstat result in an unacceptable benefit-risk profile, then:•the commencement and/or completion of any current or potential future clinical trials, including the MF Pilot Study, IMbark™ and IMerge™,would likely be delayed, for example by being placed on a clinical hold, halted or prohibited; or •additional, unexpected clinical trials or preclinical studies may be required to be conducted.The occurrence of any of these events could cause Janssen to abandon their development of imetelstat entirely and terminate the Collaboration Agreement.Any termination of the Collaboration Agreement by Janssen would have a severe adverse effect on our results of operations, financial condition, businessprospects and the future of imetelstat, any of which might cause us to cease operations.Obtaining regulatory clearances and approvals to develop and market imetelstat in the United States and other countries is a costly and lengthy process,and we cannot predict whether or when regulatory authorities will permit additional imetelstat development or approve imetelstat for commercial sale. Federal, state and local governments in the United States and governments in other countries have significant regulations in place that govern drugresearch and development and may prevent us, in collaboration with Janssen, from successfully conducting development efforts or from commercializingimetelstat. Imetelstat must receive all relevant regulatory approvals before it may be marketed in the United States or other countries. Obtaining regulatoryapproval is a lengthy, expensive and uncertain process. Because imetelstat involves the application of new technologies and a new therapeutic approach, itmay be subject to substantial additional review by various government regulatory authorities, and, as a result, the process of obtaining regulatory approvalsfor imetelstat may proceed more slowly than for product candidates based upon more conventional technologies, and any approval that may be receivedcould limit the use of imetelstat. Prior to initiating potential future clinical trials of imetelstat, clinical trial protocols must be submitted to the FDA or regulatory authorities in othercountries. Questions or comments from these agencies that must be addressed would likely delay further clinical development of imetelstat and potentiallythe timing of any Continuation Decision by Janssen or could cause Janssen to terminate the Collaboration Agreement, which would severely and adverselyaffect the future of imetelstat and our business prospects.43Table of Contents Before Janssen can seek to obtain regulatory approval for the commercial sale of imetelstat, multiple clinical trials, including larger-scale Phase 3clinical trials, will need to be conducted to demonstrate that imetelstat is safe and effective for use in a diverse population. If imetelstat cannot be developedin potential future clinical trials, including Phase 3 clinical trials, our Collaboration Agreement with Janssen will be negatively impacted and likely beterminated altogether, which would have severe adverse effects on our business and business prospects, and might result in the failure of our business. If the interpretation by us or Janssen of safety and efficacy data obtained from preclinical and clinical studies varies from interpretations by the FDA orregulatory authorities in other countries, this would likely delay, limit or prevent further development and approval of imetelstat which may cause Janssen toterminate the Collaboration Agreement. For example, the FDA and regulatory authorities in other countries may require more or different data than what hasbeen generated from our preclinical studies and previous or ongoing clinical trials, such as the MF Pilot Study, IMbark™ or IMerge™. In addition, delays orrejections of regulatory approvals, or limitations in marketing authorizations, may be encountered as a result of changes in the regulatory environment orregulatory agency policy during the period of product development and/or the period of review of any application for regulatory agency approval forimetelstat. We do not expect imetelstat to be approved for commercial sale for many years, if at all. The benefit-risk profile of imetelstat will also affect the assessment by the FDA and regulatory authorities in other countries of the drug's cost-effectiveness and/or marketability, which assessment could prevent or limit its approval for marketing and successful commercial use. If regulatorysubmissions requesting approval to market imetelstat are submitted, the FDA and regulatory authorities in other countries may conclude that the overallbenefit-risk profile of imetelstat treatment does not merit approval of imetelstat for marketing or further development for any indication. Any of these eventscould cause Janssen to terminate the Collaboration Agreement, which would severely harm our business and prospects, and might cause us to ceaseoperations. Delays in obtaining regulatory agency clearances and approvals or limitations in the scope of such clearances or approvals could:•significantly harm the commercial potential of imetelstat; •impose costly procedures upon future development activities; •diminish any competitive advantages that may have been available; or •adversely limit the amount of, or affect our ability to receive, any milestone payments or royalties under the Collaboration Agreement withJanssen. Even if the necessary time and resources are committed by us and Janssen, the required regulatory agency clearances and approvals may not be obtainedfor imetelstat. Further, if regulatory agency clearances and approvals are obtained to commence commercial sales of imetelstat, they may impose significantlimitations on the indicated uses or other aspects of the product label for which imetelstat can be marketed. Further, an approval might be contingent on theperformance of costly additional post-marketing clinical trials that would be required after approval. The occurrence of any of these events could limit thepotential commercial use of imetelstat, and therefore delay the payment of potential milestone payments to us, or, if approved for commercial sale, couldreduce the market demand for imetelstat and therefore result in decreased sales and reduced royalties for us under the Collaboration Agreement. Occurrence ofany of these events could negatively impact our collaboration with Janssen or cause Janssen to terminate the Collaboration Agreement, which would severelyand adversely affect our business and business prospects.44Table of ContentsAlthough orphan drug designation has been granted to imetelstat for the treatment of MF and MDS, these designations may not be maintained, whichwould eliminate the benefits associated with orphan drug designation, including the potential for market exclusivity, which would likely result in potentialsales revenue for imetelstat, if any, to be reduced, and would likely harm our business and business prospects. Although the FDA granted orphan drug designation to imetelstat in June 2015 for the treatment of MF and for the treatment of MDS in December 2015,and the EMA granted it in November 2015 for the treatment of MF, Janssen may not be the first to obtain marketing approval of a product candidate for theorphan-designated indication due to the uncertainties associated with developing pharmaceutical products. In addition, exclusive marketing rights in theUnited States or the EU, if granted, may be limited if Janssen seeks approval for an indication broader than the orphan-designated indication or suchmarketing exclusivity may be lost if the FDA or the EMA later determines that the request for orphan drug designation was materially defective, or if Janssenis unable to ensure and provide sufficient quantities of imetelstat to meet the needs of patients with the rare disease or condition. Further, even if Janssenobtains orphan drug exclusivity for imetelstat, that exclusivity may not effectively protect imetelstat from competition because different drugs with differentactive moieties can be approved for the same condition. Even after an orphan drug product is approved, the FDA or EMA can subsequently approve adifferent drug with the same active moiety for the same condition if the FDA or EMA concludes that the later drug is safer, more effective, or makes a majorcontribution to patient care. Occurrence of any of these events could result in decreased sales and reduced royalties for us, and may harm our business andbusiness prospects. In addition, orphan drug designation will neither shorten the development time nor regulatory review time for imetelstat, and does notgive imetelstat any advantage in the regulatory review or approval process.Failure to achieve continued compliance with government regulation could delay or halt commercialization of imetelstat, which we have exclusivelyoutlicensed to Janssen. Approved products and their manufacturers are subject to continual review, and discovery of previously unknown problems with a product or itsmanufacturer may result in restrictions on the product or manufacturer, including import restrictions, seizure and withdrawal of the product from the market. Ifapproved for commercial sale, future sales of imetelstat will be subject to government regulation related to numerous matters, including the processes of:•manufacturing; •advertising and promoting; •selling and marketing; •labeling; and •distribution.If, and to the extent that, we are or Janssen is unable to comply with these regulations, our ability to earn potential milestone payments and royalties fromworldwide net sales of imetelstat would be materially and adversely impacted. Failure to comply with regulatory requirements can result in severe civil and criminal penalties, including but not limited to:•recall or seizure of products; •injunctions against the import, manufacture, distribution, sales and/or marketing of products; and •criminal prosecution.45Table of ContentsThe imposition of any of these penalties or other commercial limitations could negatively impact our collaboration with Janssen or cause Janssen toterminate the Collaboration Agreement, either of which would severely and adversely affect our business and business prospects and might cause us to ceaseoperations.Any development activities conducted by Janssen under a Janssen Independent Development Plan, or IDP, may create significant reimbursementobligations for us, which could result in reduced cash inflow from future milestone payments and royalties until we have fully paid our reimbursementobligations under the Collaboration Agreement. Under the Collaboration Agreement, Janssen may conduct certain development activities for imetelstat under a Janssen IDP if we and Janssen agree thatsuch activities should be performed outside of the mutually agreed global clinical development plan. Although Janssen would bear all of the costs for suchJanssen IDP, if we exercised our U.S. Opt-In Rights and if any data from a Janssen IDP supports approval by a regulatory agency in the United States or othercountries, then we would be required to reimburse Janssen for our share of the costs of that Janssen IDP plus a premium pursuant to the terms of theCollaboration Agreement. This cost reimbursement is payable as a lump sum up to a certain threshold upon receipt of regulatory approval for the Janssen IDP.Any remaining amounts in excess of the threshold are payable in installments by offsetting milestone payments or royalties received by us over a certainperiod of time, at which time any remaining reimbursement amount would be payable in a lump sum. This payment mechanism could result in reduced cashinflow from future milestone payments and royalties, which would adversely affect our results of operations and financial condition.Under the Collaboration Agreement, if we develop imetelstat independently under our own IDP, the success of that IDP may depend on our ability toprovide adequate financial and technical resources, and failure to successfully conduct or fund our own IDP activities may adversely affect our business. Under the Collaboration Agreement, we may conduct certain development activities for imetelstat under a Geron IDP if we and Janssen agree that suchactivities should be performed outside of the mutually agreed global clinical development plan. In the event we conduct any clinical activities under a GeronIDP, we will be responsible for paying all of the development costs for the Geron IDP. Because the outcome of any clinical activities and/or regulatoryapproval process is highly uncertain, we cannot reasonably estimate whether any Geron IDP activities we may undertake will succeed. Since we are onlyeligible for reimbursement from Janssen for their share of the Geron IDP costs plus a premium if any data from a Geron IDP supports approval by a regulatoryagency in the United States or other countries, we may not recoup our investment in any Geron IDP, which could adversely affect our financial condition. Inaddition, we may need additional capital to support any Geron IDP activities and we cannot assure you that our existing capital resources, future interestincome, potential milestone payments and royalties under the Collaboration Agreement and potential future sales of our common stock will be sufficient tofund these future activities. If sufficient capital is not available, we may be unable to pursue activities under a Geron IDP, which could adversely affect ourbusiness. To execute activities under a Geron IDP, we likely would be required to collaborate with contract research organizations, investigators, academicinstitutions, vendors, clinical trial sites, scientific consultants and others. We would be dependent upon the ability of these parties to perform theirresponsibilities reliably. In addition, we would have limited control over the activities of these organizations, investigators, scientific consultants andvendors. Except as otherwise required by our agreements with them, we could expect only limited amounts of their time to be dedicated to our activities. Ifany of these third parties were unable or refuse to contribute to projects on which we needed their help, our ability to conduct activities under a Geron IDPcould be significantly harmed. Also, if the performance of these services is not of the highest quality, does not achieve necessary46Table of Contentsregulatory compliance standards, or if such organization or vendor stops or delays its performance for any reason, it would impair and delay our ability toreport data from clinical activities under a Geron IDP which would, in turn, hinder our ability to make the necessary representations or provide the necessaryinformation to regulatory authorities, if at all. As a result, we may not obtain regulatory approval and receive any reimbursement from Janssen for their shareof the costs for the Geron IDP, which could adversely affect our business and financial condition.If third parties that manufacture imetelstat fail to perform as needed, then the clinical and commercial supply of imetelstat will be limited. Currently, third-party contractors perform certain process development or other technical and scientific work with respect to imetelstat, as well assupplying starting materials and manufacturing drug substance and drug product. Janssen, which is responsible for the manufacture and management of thesupply of imetelstat on a global basis for clinical trials and, after any regulatory approval, all commercial activities, currently relies on these third-partycontractors to produce and deliver sufficient quantities of imetelstat and other clinical trial materials to support clinical trials on a timely basis and to complywith applicable regulatory requirements. Janssen does not have direct control over these third-party personnel or operations. Reliance on these third-partymanufacturers is subject to several risks, including:•being unable to identify suitable third-party manufacturers, because the number of potential manufacturers is limited and regulatoryauthorities may require significant activities to validate and qualify any replacement manufacturer, which could involve new testing andcompliance inspections; •being unable to contract with third-party manufacturers on acceptable terms, or at all; •the inability of third-party manufacturers to timely formulate and manufacture imetelstat or to produce imetelstat in the quantities or of thequality required to meet clinical and commercial needs; •decisions by third-party manufacturers to exit the contract manufacturing business during the time required to supply clinical trials or tosuccessfully produce, store and distribute products; •compliance by third-party manufacturers with cGMP standards mandated by the FDA and state agencies and other government regulationscorresponding to foreign regulatory authorities; •breach or termination of manufacturing contracts; •capacity limitation and scheduling imetelstat as a priority in contracted facilities; and •natural disasters that affect contracted facilities.Each of these risks could lead to delays in drug supply, or the inability to manufacture drug supply necessary for preclinical and clinical activities, andcommercialization. In addition, any decision by Janssen to self-manufacture imetelstat, change third-party contractor manufacturers or make changes tomanufacturing processes, product vial size or packaging, or formulations for imetelstat, could result in manufacturing delays. Manufacturing delays couldadversely impact the completion of current clinical trials, such as IMbark™ and IMerge™, or the initiation of potential future clinical trials, which may causeJanssen to terminate the Collaboration Agreement or delay the timing of any Continuation Decision that Janssen could provide to us, either of which wouldseverely and adversely affect our business prospects and might cause us to cease operations. In addition, current third-party contractors and/or any other contractors utilized by Janssen may need to make substantial investments to enablesufficient capacity increases and cost reductions, and to implement those regulatory and compliance standards necessary for successful Phase 3 clinical trials47Table of Contentsand commercial production of imetelstat. These third-party contractors may not be able to achieve such capacity increases, cost reductions, or regulatory andcompliance standards, and even if they do, such achievements may not be at commercially reasonable costs. Janssen currently does not have any long-termcommitments or commercial supply agreements with any of the third-party contractors for imetelstat, and changing manufacturers may be prolonged anddifficult due to inherent technical complexities and because the number of potential manufacturers is limited. It may be difficult or impossible for Janssen tofind a replacement manufacturer on acceptable terms, or at all.It may not be possible to manufacture imetelstat at costs or scales necessary to conduct clinical trials or potential future commercialization activities. Oligonucleotides are relatively large molecules produced using complex chemistry, and the cost of manufacturing an oligonucleotide like imetelstat isgreater than the cost of making typical small-molecule drugs. Therefore, imetelstat for clinical use is more expensive to manufacture than most othertreatments currently available today or that may be available in the future. Similarly, the cost of manufacturing imetelstat for commercial use will need to besignificantly lower than current costs in order for imetelstat to become a commercially successful product. Janssen may not be able to achieve sufficient scaleincreases or cost reductions necessary for successful commercial production of imetelstat, which could result in decreased sales and reduced royalties for us.We have not yet negotiated our agreement with Janssen specifying all of the terms for our co-promotion of imetelstat should we exercise our U.S. Co-Promotion Option. In addition, we do not have a sales force and may not develop an effective one, if at all. Pursuant to the Collaboration Agreement with Janssen, we have a U.S. Co-Promotion Option if we exercise our U.S. Opt-In Rights. Assuming we exercisethe U.S. Co-Promotion Option, we can elect to provide 20% of the U.S. imetelstat selling effort with Geron sales force personnel, in lieu of funding 20% ofU.S. promotion costs upon regulatory approval and commercial launch of imetelstat in the United States. While the Collaboration Agreement includes thematerial terms of our U.S. Co-Promotion Option, we and Janssen mutually agreed to negotiate a separate agreement specifying detailed activities andresponsibilities with respect to the marketing and co-promotion of imetelstat following our election to exercise our U.S. Co-Promotion Option. We will needto negotiate this separate agreement with Janssen and, as a result, Janssen may impose restrictions or additional obligations on us, including financialobligations. Any restrictions or additional obligations may restrict our co-promotion activities or involve more significant financial or other obligations thanwe currently anticipate. In addition, we have no sales experience as a company, and there are risks involved with establishing our own sales force capabilities,including:•incurring substantial expenditures to develop a sales force and function; •exposure to unforeseen costs and expenses; and •being unable to effectively recruit, train or retain sales personnel.Accordingly, we may be unable to establish our own sales force, which would delay or preclude us from participating in co-promoting imetelstat in theUnited States. In addition, because of our current lack of expertise in sales operations, any sales force we establish may not be effective, or may be lesseffective than any sales force that Janssen utilizes to promote imetelstat. In such event, the commercialization of imetelstat may be adversely affected, sincewe would be wholly reliant on Janssen's sales efforts, and this could materially and adversely affect any sales milestone or royalties we may receive under theCollaboration Agreement.48Table of ContentsThe Collaboration Agreement limits our ability to transfer our U.S. Co-Promotion Option to a potential acquirer. Although the Collaboration Agreement permits us to be acquired by any company, our right to transfer our U.S. Co-Promotion Option in the case of anacquisition, merger, consolidation, share exchange, business combination, recapitalization, sale of a majority of assets or similar transaction is limited, andsubject to Janssen's sole discretion under certain circumstances. If we are acquired outside of such limited circumstances, then we may not be able to transferthe U.S. Co-Promotion Option to such acquirer as part of the acquisition. This limiting provision may discourage potential acquisition bids for us or lowerour value, thus preventing holders of our common stock from benefiting from what they may believe are the positive aspects of an acquisition, including thepotential realization of a higher rate of return on their investment from this type of transaction.We may not be able to obtain or maintain sufficient insurance on commercially reasonable terms or with adequate coverage against potential liabilities inorder to protect ourselves against product liability claims. Our business exposes us to potential product liability risks that are inherent in the testing, manufacturing and marketing of human therapeutic anddiagnostic products. We may become subject to product liability claims if the use of imetelstat is alleged to have injured patients, including any injuriesalleged to arise from any hepatotoxicity from imetelstat. We currently have limited clinical trial liability insurance, and we may not be able to maintain thistype of insurance for any clinical trials, including clinical trials that we may conduct under a Geron IDP or in collaboration with Janssen under theCollaboration Agreement. In addition, product liability insurance is becoming increasingly expensive. Being unable to obtain or maintain product liabilityinsurance in the future on acceptable terms or with adequate coverage against potential liabilities could have a material adverse effect on our business. RISKS RELATED TO PROTECTING OUR INTELLECTUAL PROPERTY We remain responsible for prosecuting, at Janssen's direction, the patents we have exclusively licensed to Janssen. The success of our collaboration withJanssen will depend on our ability to protect our technologies and imetelstat through patents and other intellectual property rights. Protection of our proprietary technology is critically important to our business, especially with respect to our collaboration with Janssen. Our successwill depend in part on our ability to obtain, enforce and extend our patents and maintain trade secrets, both in the United States and in other countries. If weare unsuccessful in any of these regards, the value of our technologies and imetelstat will be adversely affected, and we and/or Janssen may be unable tocontinue development of imetelstat. Further, our patents may be challenged, invalidated or circumvented, and our patent rights may not provide proprietaryprotection or competitive advantages to us or Janssen. In the event that we are unsuccessful in obtaining and enforcing our patents and other intellectualproperty rights, we or Janssen may not be able to further develop or commercialize imetelstat, any of which might delay or halt ongoing or potential futureclinical trials of imetelstat and any applications for regulatory approval and therefore delay or halt the payment of potential milestone payments to us, or, ifimetelstat is approved for commercial sale, could impair Janssen's ability to sell imetelstat and therefore result in decreased sales and reduced royalties for us.Occurrence of any of these events could negatively impact our collaboration with Janssen or cause Janssen to terminate the Collaboration Agreement, whichwould materially and adversely affect our business, and might cause us to cease operations. The patent positions of pharmaceutical and biopharmaceutical companies, including ours, are highly uncertain and involve complex legal and technicalquestions. In particular, legal principles for biotechnology and pharmaceutical patents in the United States and in other countries are evolving, and the extentto which we will be able to obtain patent coverage to protect our technologies and49Table of Contentsimetelstat, or enforce issued patents, is uncertain. If we or Janssen infringe the patents of others, we or Janssen may be blocked from continuing developmentwork with respect to imetelstat or be required to obtain licenses on terms that may impact the value of imetelstat or cause it to be commercially impracticable. A number of significant changes to U.S. patent law occurred when the Leahy-Smith America Invents Act, or the AIA, was signed into law onSeptember 16, 2011. These include provisions that affect the way patent applications are prosecuted and may affect patent litigation. Many of the substantivechanges to patent law associated with the AIA, and in particular, the first to file provisions, became effective on March 16, 2013. For example, under the AIA,patent rights are awarded to the first inventor to file a patent application with respect to a particular invention. Since the publication of discoveries inscientific or patent literature tends to lag behind actual discoveries by at least several months and sometimes several years, the persons or entities that wename as inventors in our patents and patent applications may not have been the first to invent the inventions disclosed in the patent applications or patents,or the first to file patent applications for these inventions. As a result, we may not be able to obtain patents for discoveries that we otherwise would considerpatentable and that we consider to be extremely significant to the future success of imetelstat. Thus, our ability to protect our patentable intellectual propertydepends, in part, on our ability to be the first to file patent applications with respect to our inventions or any joint inventions that we may develop withJanssen. Delay in the filing of a patent application for any purpose, including further development or refinement of an invention, may result in the risk of lossof patent rights. The AIA and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and theenforcement or defense of our issued patents. Significant impairment of our imetelstat patent rights would have a material adverse effect on our business andcould cause Janssen to terminate the Collaboration Agreement, which might cause us to cease operations. Among some of the other changes introduced by the AIA are changes that limit where a patentee may file a patent infringement suit and changesproviding opportunities for third parties to challenge any issued patent in the Patent Office. This applies to all of our U.S. patents, even those issued beforeMarch 16, 2013. Because of a lower evidentiary standard necessary to invalidate a patent claim in Patent Office proceedings compared to the evidentiarystandard in United States federal court, a third party could potentially provide evidence in a Patent Office proceeding sufficient for the Patent Office to hold aclaim invalid even though the same evidence would be insufficient to invalidate the claim if first presented in a district court action. Accordingly, a thirdparty could attempt to use the Patent Office procedures to invalidate patent claims that would not have been invalidated if first challenged by the third partyas a defendant in a district court action. Recent court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certainsituations. For example, on June 13, 2013, the U.S. Supreme Court, or the Court, issued a decision in Association for Molecular Pathology v. MyriadGenetics, Inc. holding that claims to isolated genomic DNA were not patentable subject matter, but claims to complementary DNA, or cDNA, molecules werepatentable subject matter. On March 20, 2012, in Mayo Collaborative Services, DBA Mayo Medical Laboratories, et al. v. Prometheus Laboratories, Inc., theCourt held that several claims drawn to measuring drug metabolite levels from patient samples and correlating them to drug doses were not patentable subjectmatter. In addition, recent court rulings in cases such as BRCA1- & BRCA2-Based Hereditary Cancer Test Patent Litig. and Promega Corp. v. LifeTechnologies Corp. have also narrowed the scope of patent protection available in certain circumstances. In addition to increasing uncertainty with regard toour ability to obtain patents in the future, this combination of events may have created uncertainty with respect to the value of certain patents we havepreviously obtained or in-licensed. Depending on decisions by the U.S. federal courts and the Patent Office, the interpretation of laws and regulations governing patents could change inunpredictable ways that would weaken our ability to50Table of Contentsobtain new patents or to enforce our existing patents. Occurrence of these events could significantly impair our imetelstat patent rights which would have amaterial adverse effect on our business and could cause Janssen to terminate the Collaboration Agreement, which might cause us to cease operations.Challenges to our patent rights would result in costly and time-consuming legal proceedings that could prevent or limit development of imetelstat. Our patents may be challenged through administrative or judicial proceedings. Such proceedings are typically lengthy and complex, and an adversedecision can result in the loss of important patent rights. For example, where more than one party seeks U.S. patent protection for the same technology, thePatent Office may declare an interference proceeding in order to ascertain the party to which the patent should be issued. Patent interferences are typicallycomplex, highly contested legal proceedings, subject to appeal. They are usually expensive and prolonged, and can cause significant delay in the issuance ofpatents. Our pending patent applications, or our issued patents, may be drawn into interference proceedings or be challenged through post-grant reviewprocedures, which could delay or prevent the issuance of patents, or result in the loss of issued patent rights. Under the AIA, interference proceedings between patent applications filed on or after March 16, 2013 have been replaced with other types ofproceedings, including derivation proceedings. The AIA also includes post-grant review procedures subjecting U.S. patents to post-grant review proceduressimilar to European oppositions, such as inter partes review, or IPR, covered business method post-grant reviews and other post-grant reviews. U.S. patentsowned or licensed by us may therefore be subject to post-grant review procedures, as well as other forms of review and re-examination. In addition, the IPRprocess under the AIA permits any person, whether they are accused of infringing the patent at issue or not, to challenge the validity of certain patents. As aresult, entities associated with hedge funds have challenged valuable pharmaceutical patents through the IPR process. A decision in such proceedingsadverse to our interests could result in the loss of valuable patent rights which would have a material adverse effect on our business and could cause Janssento terminate the Collaboration Agreement, which might cause us to cease operations. Certain jurisdictions, such as Europe, New Zealand and Australia, permit oppositions to be filed against granted patents or patents proposed to begranted. Under the Collaboration Agreement, Janssen could commercialize imetelstat internationally if approved by regulatory authorities for commercialsale. Therefore, securing both proprietary protection and freedom to operate outside of the United States is important to the Collaboration Agreement withJanssen and our business. Opposition proceedings require significant time and costs, and if we are unable to commit these types of resources to protect ourimetelstat patent rights, we and/or Janssen could be prevented or limited in the development and commercialization of imetelstat. Occurrence of any of theseevents would severely and adversely affect our business prospects and could negatively impact our collaboration with Janssen or cause Janssen to terminatethe Collaboration Agreement, which might cause us to cease operations. As more groups become engaged in scientific research and product development in the areas of telomerase biology, the risk of our patents, or patents thatwe have in-licensed, being challenged through patent interferences, derivation proceedings, post-grant proceedings, oppositions, re-examinations, litigationor other means will likely increase. Challenges to our patents through these procedures would be extremely expensive and time-consuming, even if theoutcome was favorable to us. An adverse outcome in a patent dispute could severely harm our collaboration with Janssen or cause Janssen to terminate theCollaboration Agreement, or could otherwise have a material adverse effect on our business, and might cause us to cease operations, by:•causing us to lose patent rights in the relevant jurisdiction(s); •subjecting us to litigation, or otherwise preventing Janssen or us from commercializing imetelstat in the relevant jurisdiction(s);51Table of Contents•requiring Janssen or us to obtain licenses to the disputed patents; •forcing Janssen or us to cease using the disputed technology; or •requiring Janssen or us to develop or obtain alternative technologies.We or Janssen may be subject to infringement claims that are costly to defend, and as to which we may be obligated to indemnify Janssen or obtainunblocking licenses, and such claims may limit our or Janssen's ability to use disputed technologies and prevent us or Janssen from pursuing research anddevelopment or commercialization of imetelstat. The commercial success of imetelstat will depend upon our and Janssen's ability to develop, manufacture, market and sell imetelstat without infringingor otherwise violating the intellectual property and other proprietary rights of third parties. There is considerable intellectual property litigation in thebiotechnology and pharmaceutical industries, and many pharmaceutical companies, including potential competitors, have substantial patent portfolios. Inthe event our technologies infringe the rights of others or require the use of discoveries and technologies controlled by third parties, we or Janssen may beprevented from pursuing research, development, manufacturing or commercialization of imetelstat, or may be required to obtain licenses to those patents orother proprietary rights or develop or obtain alternative technologies. For example, we are aware that certain third parties have or may be prosecuting patentsand patent estates that may relate to imetelstat, and while we believe these patents will expire before imetelstat is commercialized and/or that these patentsare invalid and/or would not be infringed by the manufacture, use or sale of imetelstat, it is possible that the owner(s) of these patents will assert claimsagainst us and/or Janssen in the future. Under the Collaboration Agreement, we are obligated under certain circumstances to indemnify Janssen from anyclaim of infringement of the patent rights of third parties in Janssen's development, manufacture or commercialization of imetelstat, or to obtain unblockinglicenses from such third parties, at our cost. Since we cannot be aware of all intellectual property rights potentially relating to imetelstat and its uses, we do not know with certainty that imetelstat,or the intended commercialization thereof, does not and will not infringe or otherwise violate any third party's intellectual property. Any infringement claimsagainst us or Janssen would likely be expensive to resolve, and the cost of any indemnification of Janssen or unblocking license that we could be required toobtain under the Collaboration Agreement is unpredictable and could be significant. If we or Janssen are unable to resolve an infringement claimsuccessfully, we or Janssen could be subject to an injunction which would prevent us or Janssen from commercializing imetelstat, and could also require us orJanssen to pay substantial damages. In addition to infringement claims, in the future we or Janssen may also be subject to other claims relating to intellectualproperty, such as claims that we or Janssen have misappropriated the trade secrets of third parties. We expect that as imetelstat continues to progress indevelopment, we will see more efforts by others to obtain patents that are positioned to cover imetelstat. Our success therefore depends significantly on ourand Janssen's ability to operate without infringing patents and the proprietary rights of others. We or Janssen may become aware of discoveries and technologies controlled by third parties that are advantageous to developing or manufacturingimetelstat. Under such circumstances, we or Janssen may initiate negotiations for licenses to other technologies as the need or opportunity arises. We orJanssen may not be able to obtain a license to a technology required for the research, development, manufacture or commercialization of imetelstat oncommercially favorable terms, or at all, or such licenses may be terminated on certain grounds, including as a result of our or Janssen's failure to comply withthe obligations under such licenses. If we or Janssen do not obtain a necessary license or if such a license is terminated, we or Janssen may need to redesignsuch technologies or obtain rights to alternative technologies, which may not be possible, and even if possible, could cause delays in the development effortsfor imetelstat. In cases where we or Janssen are unable to license necessary52Table of Contentstechnologies, we and/or Janssen could be subject to litigation and prevented from researching, developing, manufacturing or commercializing imetelstat, andin certain circumstances we may be required to indemnify Janssen for infringement claims arising from Janssen's research, development, manufacture orcommercialization of imetelstat, which could materially and adversely impact our business. Failure by us or Janssen to obtain rights to alternativetechnologies or a license to any technology that may be required to research, develop, manufacture or commercialize imetelstat would delay potential futureclinical trials of imetelstat and any applications for regulatory approval and therefore delay the payment of potential milestone payments to us, or, ifimetelstat is approved for commercial sale, could impair Janssen's ability to sell imetelstat and therefore result in decreased sales and reduced royalties for us.Occurrence of any of these events could negatively impact our collaboration with Janssen or cause Janssen to terminate the Collaboration Agreement, whichwould materially and adversely affect our business, and might cause us to cease operations.We may become involved in disputes with Janssen or any past or future collaborator(s) over intellectual property inventorship or ownership, andpublications by us or Janssen, or by investigators, scientific consultants and research collaborators, could impair our ability to obtain patent protection orprotect our proprietary information, which, in either case, could have a significant impact on our business. Inventions discovered under research, material transfer or other such collaborative agreements, including our Collaboration Agreement with Janssen,may become jointly owned by us and the other party to such agreements in some cases and the exclusive property of either party in other cases. Under somecircumstances, it may be difficult to determine who invents and owns a particular invention, or whether it is jointly owned, and disputes can arise regardinginventorship and ownership of those inventions. These disputes could be costly and time consuming and an unfavorable outcome could have a significantadverse effect on our business if we were not able to protect or license rights to these inventions. In addition, clinical trial investigators, scientific consultantsand research collaborators generally have contractual rights to publish data and other proprietary information, subject to review by us and/or Janssen.Publications by us or Janssen, or by investigators, scientific consultants and research collaborators containing such information, either with permission or incontravention of the terms of their agreements, may impair the ability to obtain patent protection or protect proprietary information which would have amaterial adverse effect on our business and could cause Janssen to terminate the Collaboration Agreement, which might cause us to cease operations.Much of the information and know-how that is critical to our business is not patentable, and we may not be able to prevent others from obtaining thisinformation and establishing competitive enterprises. We sometimes rely on trade secrets to protect our proprietary technology, especially in circumstances in which we believe patent protection is notappropriate or available. We attempt to protect our proprietary technology in part by confidentiality agreements with our employees, consultants,collaborators and contractors. We cannot provide assurance that these agreements will not be breached, that we would have adequate remedies for any breach,or that our trade secrets will not otherwise become known or be independently discovered by competitors, any of which would harm our businesssignificantly.Significant disruptions of information technology systems, including cloud-based systems, or breaches of data security could adversely affect our business. Our business is increasingly dependent on critical, complex and interdependent information technology systems, including cloud-based systems, tosupport business processes as well as internal and external communications. Our computer systems are potentially vulnerable to breakdown, maliciousintrusion and computer viruses that may result in the impairment of key business processes.53Table of Contents In addition, our data security and information technology systems are potentially vulnerable to data security breaches—whether by employees or others—that may expose sensitive data to unauthorized persons. Such data security breaches could lead to the loss of trade secrets or other intellectual property, orcould lead to the public disclosure of sensitive clinical or commercial data, and the exposure of personally identifiable information (including sensitivepersonal information) of our employees, collaborators, clinical trial patients, and others. A data security breach or privacy violation that leads to disclosure ormodification of or prevents access to patient information, including personally identifiable information or protected health information, could harm ourreputation, compel us to comply with federal and/or state breach notification laws, subject us to mandatory corrective action, require us to verify thecorrectness of database contents and otherwise subject us to liability under laws and regulations that protect personal data, resulting in increased costs or lossof revenue. If we are unable to prevent such data security breaches or privacy violations or implement satisfactory remedial measures, our operations could bedisrupted, and we may suffer loss of reputation, financial loss and other regulatory penalties because of lost or misappropriated information, includingsensitive patient data. In addition, these breaches and other inappropriate access can be difficult to detect, and any delay in identifying them may lead toincreased harm of the type described above. Moreover, the prevalent use of mobile devices that access confidential information increases the risk of datasecurity breaches, which could lead to the loss of confidential information, trade secrets or other intellectual property. While we have implemented securitymeasures to protect our data security and information technology systems, such measures may not prevent such events. Such disruptions and breaches of security could have a material adverse effect on our business, financial condition and results of operations. RISKS RELATED TO OUR FINANCIAL POSITION AND NEED FOR ADDITIONAL FINANCING Although we reported a small profit for the year ending December 31, 2015, we have a history of losses and anticipate continued future losses, and ourcontinued losses could impair our ability to sustain operations. Until 2015, we had never been profitable and we have incurred operating losses every year since our operations began in 1990. While we were profitablein 2015 due to the recognition of revenue in connection with an upfront payment from Janssen under the Collaboration Agreement, we expect to incuradditional operating losses and, as clinical development activities for imetelstat continue under our Collaboration Agreement with Janssen, our operatinglosses may increase in size. As of December 31, 2015, our accumulated deficit was approximately $928.4 million. Losses have resulted principally from costsincurred in connection with our research and development activities and from general and administrative costs associated with our operations. Substantially all of our revenues to date have been research support payments under collaborative agreements and milestones, royalties and otherrevenues from our licensing arrangements. Any revenues generated from our licensing arrangements or ongoing collaborative agreements, including theCollaboration Agreement with Janssen, may not be sufficient alone to sustain our operations. In addition, there can be no assurance that we will receive anymilestone payments or royalties from Janssen in the future. We may be unsuccessful in entering into any new corporate collaboration, partnership or licenseagreements that result in revenues, or existing collaborative agreements or license arrangements, such as the Collaboration Agreement with Janssen, may beterminated or expire. We also expect to experience negative cash flow for the foreseeable future as we fund our operations and capital expenditures. This will result indecreases in our working capital, total assets and stockholders' equity, which may not be offset by milestone payments or royalties from Janssen or by futurefinancings. We will need to generate significant revenues to achieve consistent future profitability. We may not be able to generate these revenues under theCollaboration Agreement with Janssen through milestone payments or royalties, and we may never achieve consistent future54Table of Contentsprofitability. Even if we do become profitable in the future, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failureto achieve consistent future profitability could negatively impact the market price of our common stock and our ability to sustain operations.We may require additional capital to support development and commercialization of imetelstat in collaboration with Janssen and to otherwise grow ourbusiness, and our ability to obtain the necessary funding is uncertain. We may need additional capital to support development and commercialization of imetelstat, especially if we elect to exercise our U.S. Opt-In Rightsand U.S. Co-Promotion Option under the Collaboration Agreement and potentially independently pursue imetelstat development under our own IDP, and tootherwise support the future growth of our business through the acquisition and/or in-licensing of other oncology products, product candidates, programs orcompanies. We cannot assure you that our existing capital resources, future interest income, potential milestone payments and royalties under theCollaboration Agreement with Janssen and potential future sales of our common stock, including pursuant to our At Market Issuance Sales Agreement, or2015 Sales Agreement, with MLV & Co. LLC, or MLV, will be sufficient to fund future planned activities. The timing and degree of any future capitalrequirements will depend on many factors, including:•the accuracy of the assumptions underlying our estimates for our capital needs; •in the event that Janssen provides an affirmative Continuation Decision to us, whether we then elect our U.S. Opt-In Rights to share furtherU.S. development and promotion costs for imetelstat beyond IMbarkTM or IMergeTM under the Collaboration Agreement; •to the extent permitted under the Collaboration Agreement, whether we independently pursue imetelstat development under our own IDP; •our potential reimbursement obligations to Janssen if any data from a Janssen IDP support approval by a regulatory agency in the UnitedStates or other countries; •the achievement of development, regulatory and commercial milestones resulting in the payment to us from Janssen under the CollaborationAgreement and the timing of receipt of such payments, if any; •changes or delays in Janssen's development plans for imetelstat, including changes which may result from any future clinical holds on anyINDs for imetelstat; •Janssen's ability to meaningfully reduce manufacturing costs of imetelstat; •the progress, timing, magnitude, scope and costs of clinical development, manufacturing and commercialization of imetelstat, including thenumber of indications being pursued, subject to permission from the FDA and other regulatory authorities; •the time and costs involved in obtaining regulatory clearances and approvals in the United States and in other countries; •Janssen's ability to successfully market and sell imetelstat, upon regulatory approval or clearance, in the United States and other countries; •if we exercise our U.S. Opt-In Rights, our decision to also exercise our U.S. Co-Promotion Option, including the costs and timing of building aU.S. sales force; •the timing, receipt and amount of royalties under the Collaboration Agreement on worldwide net sales of imetelstat, upon regulatory approvalor clearance, if any; •the cost of acquiring and/or in-licensing other oncology products, product candidates, programs or companies, if any;55Table of Contents•the timing, receipt and amount of royalties on sales of any stem cell products by Asterias, upon development, regulatory approval or clearance,if any; •the sales price and availability of adequate third-party reimbursement for imetelstat; •expenses associated with the pending and potential additional related purported class action securities lawsuits and derivative lawsuits, aswell as any other litigation; and •the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims. In addition, changes in our business may occur that would consume available capital resources sooner than we expect. If our existing capital resources,future interest income, and potential milestone payments and royalties under the Collaboration Agreement with Janssen are insufficient to meet future capitalrequirements, we will need to raise additional capital to fund our operations. Further, if the Collaboration Agreement is terminated, including as a result ofJanssen's failure to provide an affirmative Continuation Decision to us, we would not receive any milestone payments or royalties under the CollaborationAgreement, and we would be required to fund all clinical development, manufacturing and commercial activities for imetelstat ourselves, which wouldrequire us to raise additional capital or establish alternative collaborations with third-party collaboration partners, which may not be possible. Additionalfinancing through public or private equity financings, including pursuant to our 2015 Sales Agreement with MLV, capital lease transactions or otherfinancing sources may not be available on acceptable terms, or at all. We may raise equity capital at a stock price or on other terms that could result insubstantial dilution of ownership for our stockholders. The receptivity of the public and private equity markets to proposed financings is substantiallyaffected by the general economic, market and political climate and by other factors which are unpredictable and over which we have no control. Our ability to raise additional funds will be severely impaired in the event of:•any future clinical holds on any IND for imetelstat; •a failure to show adequate safety or efficacy of imetelstat in current or potential future clinical trials; or •a termination of the Collaboration Agreement or if our collaboration with Janssen is otherwise unsuccessful. If sufficient capital is not available, we may be unable to fulfill our funding obligations under the Collaboration Agreement with Janssen, resulting in ourbreach of the Collaboration Agreement, which could lead to Janssen paying lower milestone payments and lower royalties to us under a reduced royalty tier.This would have a material adverse effect on our results of operations and financial condition. Moreover, to grow and diversify our business, we plan to continue our business development efforts to identify and seek to acquire and/or in-licenseother oncology products, product candidates, programs or companies. Acquisition or in-licensing opportunities that we may pursue could materially affectour liquidity and capital resources and may require us to incur indebtedness, seek equity capital or both. In addition, there can be no assurance that sufficientadditional capital would be available to us in order to pursue any of these opportunities.Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited. Under Section 382 of the Internal Revenue Code of 1986, as amended, or the Code, if a corporation undergoes an "ownership change," generally definedas a greater than 50% change (by value) in its equity ownership over a three-year period, the corporation's ability to use its pre-change56Table of Contentsnet operating loss carryforwards and other pre-change tax attributes (such as research tax credits) to offset its post-change taxable income or taxes may belimited. Changes in our stock ownership, some of which are outside of our control, may have resulted or could in the future result in an ownership change. If alimitation were to apply, utilization of a portion of our domestic net operating loss and tax credit carryforwards could be limited in future periods. Inaddition, a portion of the carryforwards may expire before being available to reduce future income tax liabilities. RISKS RELATED TO OUR COMMON STOCK AND FINANCIAL REPORTING Historically, our stock price has been extremely volatile. Historically, our stock price has been extremely volatile. Between January 1, 2006 and December 31, 2015, our stock has traded as high as $10.00 pershare and as low as $0.91 per share. Between January 1, 2013 and December 31, 2015, the price has ranged between a high of $7.79 per share and a low of$0.98 per share. The significant market price fluctuations of our common stock have been due to and may in the future be influenced by a variety of factors,including:•not receiving timely regulatory clearances or approvals in any jurisdiction, whether within or outside of the United States, including, if we,Janssen or future investigators do not obtain regulatory clearance to commence or conduct studies of imetelstat in MF, MDS or any additionalhematologic myeloid malignancies in a timely manner or at all, including IMbarkTM and IMergeTM; •developments in our collaboration with Janssen, including the termination or modification of the Collaboration Agreement or disputesregarding the collaboration; •announcements regarding the research and development of imetelstat, including results of or delays in any clinical trials of imetelstat, andinvestor perceptions thereof; •announcements regarding the safety of imetelstat, including announcements similar to our March 2014 announcements that the FDA hadplaced a full clinical hold on our IND for imetelstat and a partial clinical hold on the investigator's IND for the MF Pilot Study due to safetyconcerns; •announcements regarding plans to discontinue imetelstat clinical trials; •perception by our stockholders about the adequacy of the consideration received for the divestiture of our stem cell assets to Asterias or theadequacy of potential payments we may receive under the Collaboration Agreement; •the demand in the market for our common stock; •the experimental nature of imetelstat; •fluctuations in our operating results; •our declining cash balance as a result of operating losses; •general market conditions or market conditions relating to the biopharmaceutical and pharmaceutical industries; •announcements of technological innovations, new commercial products, or clinical progress or lack thereof by us, our collaborators, licensees,partners or our competitors; •announcements concerning imetelstat regulatory developments and proprietary rights; •comments by securities analysts; •large stockholders exiting their position in our common stock; •announcements of or developments concerning pending and/or potential future litigation;57Table of Contents•the issuance of common stock to partners, vendors or investors to raise additional capital or to acquire other oncology products, productcandidates, programs or companies; and •the occurrence of any other risks and uncertainties discussed under the heading "Risk Factors." Stock prices and trading volumes for many biopharmaceutical companies fluctuate widely for a number of reasons, including factors which may beunrelated to their businesses or results of operations, such as media coverage, legislative and regulatory measures and the activities of various interest groupsor organizations. In addition to other risk factors described in this section, overall market volatility, as well as general domestic or international economic,market and political conditions, could materially and adversely affect the market price of our common stock and the return on your investment.If we fail to continue to meet the listing standards of NASDAQ, our common stock may be delisted, which could have a material adverse effect on theliquidity of our common stock. Our common stock is currently traded on the Nasdaq Global Select Market. The NASDAQ Stock Market LLC has requirements that a company must meetin order to remain listed on NASDAQ. In particular, NASDAQ rules require us to maintain a minimum bid price of $1.00 per share of our common stock. If theclosing bid price of our common stock were to fall below $1.00 per share for 30 consecutive trading days or we do not meet other listing requirements, wewould fail to be in compliance with NASDAQ's listing standards. There can be no assurance that we will continue to meet the minimum bid price requirement,or any other requirement in the future. If we fail to meet the minimum bid price requirement, The NASDAQ Stock Market LLC may initiate the delistingprocess with a notification letter. If we were to receive such a notification, we would be afforded a grace period of 180 calendar days to regain compliancewith the minimum bid price requirement. In order to regain compliance, shares of our common stock would need to maintain a minimum closing bid price ofat least $1.00 per share for a minimum of 10 consecutive trading days. In addition, we may be unable to meet other applicable NASDAQ listing requirements,including maintaining minimum levels of stockholders' equity or market values of our common stock in which case, our common stock could be delisted. Ifour common stock were to be delisted, the liquidity of our common stock would be adversely affected and the market price of our common stock coulddecrease.The sale of a substantial number of shares may adversely affect the market price of our common stock. The sale of a substantial number of shares of our common stock in the public market, or the perception that such sales could occur, could significantlyand negatively affect the market price of our common stock. As of December 31, 2015, we had 300,000,000 shares of common stock authorized for issuanceand 158,781,359 shares of common stock outstanding. In addition, we had reserved 30,740,857 shares of our common stock for future issuance pursuant toour option and equity incentive plans and outstanding warrants as of December 31, 2015. Issuing additional shares could negatively affect the market priceof our common stock and the return on your investment. Future sales of our common stock, including pursuant to our 2015 Sales Agreement with MLV, or the issuance of common stock to satisfy our current orfuture cash payment obligations or to acquire technology, property, or other businesses, could cause immediate dilution and adversely affect the market priceof our common stock. In addition, under the universal shelf registration statement filed by us in August 2015 and declared effective by the SEC in September2015, we may sell any combination of common stock, preferred stock, debt securities and warrants in one or more offerings, up to a cumulative value of$250 million. The sale or issuance of our securities, as well as the existence of outstanding options and shares of common stock reserved for issuance underour option and equity incentive plans and outstanding warrants, also may adversely affect the terms upon which we are able58Table of Contentsto obtain additional capital through the sale of equity securities, which could negatively affect the market price of our common stock and the return on yourinvestment.Our undesignated preferred stock may inhibit potential acquisition bids; this may adversely affect the market price of our common stock and the votingrights of holders of our common stock. Our certificate of incorporation provides our board of directors with the authority to issue up to 3,000,000 shares of undesignated preferred stock and todetermine or alter the rights, preferences, privileges and restrictions granted to or imported upon these shares without further vote or action by ourstockholders. The issuance of shares of preferred stock may delay or prevent a change in control transaction without further action by our stockholders. As aresult, the market price of our common stock may be adversely affected. In addition, if in the future, we issue preferred stock that has preference over our common stock with respect to the payment of dividends or upon ourliquidation, dissolution or winding up, or if we issue preferred stock with voting rights that dilute the voting power of our common stock, the rights ofholders of our common stock or the market price of our common stock could be adversely affected.Provisions in our charter, bylaws and Delaware law may inhibit potential acquisition bids for us, which may prevent holders of our common stock frombenefiting from what they believe may be the positive aspects of acquisitions and takeovers. Provisions of our charter documents and bylaws may make it substantially more difficult for a third party to acquire control of us and may preventchanges in our management, including provisions that:•prevent stockholders from taking actions by written consent; •divide the board of directors into separate classes with terms of office that are structured to prevent all of the directors from being elected inany one year; and •set forth procedures for nominating directors and submitting proposals for consideration at stockholders' meetings. Provisions of Delaware law may also inhibit potential acquisition bids for us or prevent us from engaging in business combinations. In addition, we haveseverance agreements with several employees and a company-wide severance plan, either of which could require a potential acquirer to pay a higher price.Either collectively or individually, these provisions may prevent holders of our common stock from benefiting from what they may believe are the positiveaspects of acquisitions and takeovers, including the potential realization of a higher rate of return on their investment from these types of transactions.We do not intend to pay cash dividends on our common stock in the foreseeable future. We do not anticipate paying cash dividends on our common stock in the foreseeable future. Any payment of cash dividends will depend upon ourfinancial condition, results of operations, capital requirements and other factors and will be at the discretion of our board of directors.Failure to achieve and maintain effective internal controls in accordance with Section 404 of the Sarbanes-Oxley Act of 2002 could have a materialadverse effect on our business and stock price. Section 404 of the Sarbanes-Oxley Act of 2002, or Section 404, requires that we establish and maintain an adequate internal control structure andprocedures for financial reporting. Our annual reports on Form 10-K must contain an annual assessment by management of the effectiveness of our internalcontrol over financial reporting and must include disclosure of any material weaknesses in internal control over financial reporting that we have identified. Inaddition, our independent registered59Table of Contentspublic accounting firm must annually provide an opinion on the effectiveness of our internal control over financial reporting. The requirements of Section 404 are ongoing and also apply to future years. We expect that our internal control over financial reporting will continue toevolve as our business develops. Although we are committed to continue to improve our internal control processes and we will continue to diligently andvigorously review our internal control over financial reporting in order to ensure compliance with Section 404 requirements, any control system, regardless ofhow well designed, operated and evaluated, can provide only reasonable, not absolute, assurance that its objectives will be met. Therefore, we cannot becertain that in the future material weaknesses or significant deficiencies will not exist or otherwise be discovered. If material weaknesses or other significantdeficiencies occur, these weaknesses or deficiencies could result in misstatements of our results of operations, restatements of our financial statements, adecline in our stock price, or other material adverse effects on our business, reputation, results of operations, financial condition or liquidity. RISKS RELATED TO COMPETITIVE FACTORS Competitors may develop technologies that are superior to or more cost-effective than ours, which may significantly impact the commercial viability ofimetelstat, which could cause Janssen to terminate the Collaboration Agreement and damage our ability to sustain operations. The pharmaceutical and biotechnology industries are intensely competitive. Other pharmaceutical and biotechnology companies and researchorganizations currently engage in or have in the past engaged in efforts related to the biological mechanisms related to imetelstat, including the study oftelomeres, telomerase, our proprietary oligonucleotide chemistry, and the research and development of therapies for the treatment of hematologic myeloidmalignancies. In addition, other products and therapies that could directly compete with imetelstat currently exist or are being developed by pharmaceuticaland biopharmaceutical companies and by academic institutions, government agencies and other public and private research organizations. Many companies are developing alternative therapies to treat hematologic myeloid malignancies. For example, if approved for commercial sale for thetreatment of MF, imetelstat would compete against Incyte Corporation's ruxolitinib, or Jakafi®, which is orally administered. In clinical trials, Jakafi®reduced spleen size, abdominal discomfort, early satiety, bone pain, night sweats and itching in MF patients. Recently, there have also been reports of overallsurvival benefit as well as improvement in bone marrow fibrosis from Jakafi® treatment. Other treatment modalities for MF include hydroxyurea for themanagement of splenomegaly, leukocytosis, thrombocytosis and constitutional symptoms; splenectomy and splenic irradiation for the management ofsplenomegaly and co-existing cytopenias, or low blood cell counts; chemotherapy and pegylated interferon. Drugs for the treatment of MF-associated anemiainclude erythropoiesis-stimulating agents, androgens, danazol, corticosteroids, thalidomide and lenalidomide. There are other investigational treatments forMF further along in development than imetelstat, such as pacritinib by CTI Biopharma in collaboration with Baxalta and momelotinib by Gilead which iscurrently in a Phase 3 clinical trial, and other inhibitors of the JAK-STAT pathway, as well as several investigational treatments in early phase testing such ashistone deacetylase inhibitors, inhibitors of heat shock protein 90, hypomethylating agents, PI3 Kinase and mTOR inhibitors, anti-fibrosis antibodies,hedgehog inhibitors, anti-LOX2 inhibitors, recombinant pentraxin 2 protein, KIP-1 activators, TGF-beta inhibitors, FLT inhibitors, and other tyrosine kinaseinhibitors. If approved for commercial sale for the treatment of MDS, imetelstat would compete against a number of treatment options, including erythropoiesisstimulating agents and other hematopoietic growth factors; immunomodulators such as lenalidomide by Celgene; hypomethylating agents, such asazacitidine by Celgene and decitabine by Janssen; in addition to investigational treatments that may be60Table of Contentsfurther along in development than imetelstat, such as oral versions of azacitidine; histone deacetylase inhibitors; activin type IIA receptor inhibitors, such assotatercept by Acceleron; TGF-beta superfamily inhibitors, such as luspatercept by Acceleron in collaboration with Celgene; thrombopoietin receptoragonists, such as eltrombopag by Novartis, PI3 Kinase inhibitors, such as rigosertib by Onconova; Flt-3 inhibitors, such as quizartinib by Ambit Biosciences;and JAK-STAT pathway inhibitors. Independently, Janssen is developing therapies for hematologic malignancies, including AML, MDS, multiple myeloma and ABC-subtype diffuse largeB-cell lymphoma. Molecular and cellular pathways of interest include:•cell surface targets for immune-directed therapy; •immune checkpoint inhibition; •leukemia stem cells; •pathway addiction (genetic alterations, cell-type specific pathways); •conditional sensitivity (stress, protein-producing tumors); •targeting of T-cells and natural killer "NK" cells to tumors; •identification of novel tumor-specific antigens; and •progression from early MDS to AML and cancer interception.Success by Janssen in any of these approaches may compete with imetelstat or render imetelstat obsolete or noncompetitive, which could lead to a decisionby Janssen to discontinue the imetelstat program and terminate the Collaboration Agreement, which would materially and adversely affect our business andbusiness prospects and might cause us to cease operations. Smaller companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.We anticipate increased competition in the future as new companies explore treatments for hematologic myeloid malignancies, which may significantlyimpact the commercial viability of imetelstat. Academic institutions, government agencies and other public and private research organizations may alsoconduct research, seek patent protection and establish collaborative arrangements for research, clinical development and marketing of products similar toimetelstat. These companies and institutions compete with us in recruiting and retaining qualified development and management personnel as well as inacquiring technologies complementary to the imetelstat program. In addition to the above factors, imetelstat will face competition based on:•product efficacy and safety; •convenience of product administration; •cost of manufacturing; •the timing and scope of regulatory consents; •status of reimbursement coverage; •price; and •patent position, including potentially dominant patent positions of others.61Table of Contents As a result of the foregoing, competitors may develop more commercially desirable or affordable products than imetelstat, or achieve earlier patentprotection or product commercialization than us or Janssen. Competitors have developed, or are in the process of developing, technologies that are, or in thefuture may be, competitive to imetelstat. Some of these products may have an entirely different approach or means of accomplishing therapeutic effectssimilar or superior to those that may be demonstrated by imetelstat. Competitors may develop products that are safer, more effective or less costly thanimetelstat, or more convenient to administer to patients and, therefore, present a serious competitive threat to imetelstat. In addition, competitors may pricetheir products below what Janssen may determine to be an acceptable price for imetelstat, may receive better third-party payor coverage and/orreimbursement, or may be more cost-effective than imetelstat. Such competitive products or activities by competitors may render imetelstat obsolete, whichmay cause Janssen to terminate the Collaboration Agreement, which would severely and adversely affect our business prospects and might cause us to ceaseoperations.To be successful, imetelstat must be accepted by the health care community, which can be very slow to adopt or unreceptive to new technologies andproducts. If approved for marketing, imetelstat may not achieve market acceptance since hospitals, physicians, patients or the medical community in general maydecide not to accept and utilize imetelstat. If approved for commercial sale, imetelstat will compete with a number of conventional and widely accepted drugsand therapies manufactured and marketed by major pharmaceutical companies. The degree of market acceptance of imetelstat will depend on a number offactors, including:•the clinical indications for which imetelstat is approved; •the establishment and demonstration to the medical community of the clinical efficacy and safety of imetelstat; •the ability to demonstrate that imetelstat is superior to alternatives currently on the market; •the ability to establish in the medical community the potential advantage of imetelstat over alternative treatment methods, including withrespect to cost and route of administration; •the label and promotional claims allowed by the FDA or other regulatory authorities for imetelstat, if any; •the timing of market introduction of imetelstat as well as competitive products; •the effectiveness of sales, marketing and distribution support for imetelstat; •the availability of adequate coverage, reimbursement and pricing by government and third-party payors; and •the willingness of patients to pay out-of-pocket in the absence of coverage by third-party payors, including governmental authorities. The established use of conventional products competitive with imetelstat may limit or preclude the potential for imetelstat to receive market acceptanceupon any commercialization. Janssen may be unable to demonstrate any pharmacoeconomic advantage for imetelstat compared to established or standard-of-care therapies, or newly developed therapies, for hematologic myeloid malignancies. Third-party payors may decide that any potential improvement thatimetelstat may provide to clinical outcomes in hematologic myeloid malignancies is not adequate to justify the costs of treatment with imetelstat. If third-party payors do not view imetelstat as offering a better balance between clinical benefit and treatment cost compared to standard-of-care therapies or othertreatment modalities currently in development, imetelstat may not be commercially viable. If the health care community does not accept imetelstat for any ofthe foregoing reasons, or for any other reason, our ability to earn62Table of Contentspotential milestone payments and royalties under the Collaboration Agreement with Janssen would be negatively impacted and our business prospects wouldbe severely and adversely affected.If we fail to comply with federal and state healthcare laws, including fraud and abuse, transparency, and health information privacy and security laws, wecould face substantial penalties and our business, results of operations, financial condition and prospects could be adversely affected. Our business operations and current and future arrangements with investigators, healthcare professionals, consultants, third-party payors and customers,may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations. These laws may constrain the business or financialarrangements and relationships through which we conduct our operations, including how we research, market, sell and distribute any product of ours forwhich marketing approval is obtained. Such laws include:•the federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering,receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of anindividual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under a federal healthcareprogram such as Medicare and Medicaid; •the federal false claims and civil monetary penalties laws, including the civil False Claims Act, which impose criminal and civil penaltiesagainst individuals or entities for, among other things, knowingly presenting, or causing to be presented, to the federal government, claims forpayment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federalgovernment; •the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which imposes criminal and civil liability for, among otherthings, executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; •HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and its implementingregulations, which imposes obligations, including mandatory contractual terms, on certain types of individuals and entities with respect tosafeguarding the privacy, security and transmission of individually identifiable health information; •the federal Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, biologics and medical supplies for whichpayment is available under Medicare, Medicaid or the Children's Health Insurance Program, with specific exceptions, to report annually to theCenters for Medicare & Medicaid Services, or CMS, information related to payments or other transfers of value made to physicians andteaching hospitals, and applicable manufacturers and applicable group purchasing organizations to report annually to CMS ownership andinvestment interests held by the physicians and their immediate family members; and •analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketingarrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including privateinsurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry's voluntary compliance guidelines andthe relevant compliance guidance promulgated by the federal government; state laws that require drug manufacturers to report informationrelated to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state and foreignlaws governing the privacy and security of health information in some circumstances, many of which differ from each other in significant waysand often are not preempted by HIPAA, thus complicating compliance efforts.63Table of Contents Efforts to ensure that our current and future business arrangements with third parties will comply with applicable healthcare laws and regulations willinvolve substantial costs. It is possible that governmental authorities will conclude that our business practices do not comply with current or future statutes,regulations, agency guidance or case law involving applicable healthcare laws. If our operations are found to be in violation of any of these or any otherhealth regulatory laws that may apply to us, we may be subject to significant penalties, including the imposition of significant civil, criminal andadministrative penalties, damages, monetary fines, disgorgement, individual imprisonment, possible exclusion from participation in Medicare, Medicaid andother federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations, any ofwhich could adversely affect our ability to operate our business and our results of operations. Defending against any such actions can be costly, time-consuming and may require significant financial and personnel resources. Therefore, even if we are successful in defending against any such actions that maybe brought against us, our business may be impaired.If acceptable prices or adequate reimbursement for imetelstat is not obtained, the use of imetelstat could be severely limited. The ability to successfully commercialize imetelstat will depend significantly on obtaining acceptable prices and the availability of coverage andadequate reimbursement to the patient from third-party payors. Government authorities and other third-party payors, such as private health insurers andhealth maintenance organizations, determine which medications they will cover and establish reimbursement levels. Assuming Janssen obtains coverage forimetelstat by a third-party payor, the resulting reimbursement payment rates may not be adequate or may require co-payments that patients find unacceptablyhigh. If approved for commercial sale, patients are unlikely to use imetelstat unless coverage is provided and reimbursement is adequate to cover all or asignificant portion of the cost of imetelstat. Therefore, coverage and adequate reimbursement is critical to new product acceptance. Government authorities and other third-party payors are developing increasingly sophisticated methods of controlling healthcare costs, such as bylimiting coverage and the amount of reimbursement for particular medications. Increasingly, third-party payors are requiring that drug companies providethem with predetermined discounts from list prices as a condition of coverage, are using restrictive formularies and preferred drug lists to leverage greaterdiscounts in competitive classes, and are challenging the prices charged for medical products. Further, no uniform policy requirement for coverage andreimbursement for drug products exists among third-party payors in the United States. Therefore, coverage and reimbursement for drug products can differsignificantly from payor to payor. As a result, the coverage determination process is often a time-consuming and costly process that will require Janssen toprovide scientific and clinical support for the use of imetelstat to each payor separately, with no assurance that coverage and adequate reimbursement will beapplied consistently or obtained in the first instance. We cannot be sure that coverage and reimbursement will be available for imetelstat, if approved for commercial sale, and, if reimbursement is available,what the level of reimbursement will be. Coverage and reimbursement may impact the demand for, or the price of, any product candidate for which marketingapproval is obtained. If coverage and reimbursement are not available or reimbursement is available only to limited levels, Janssen may not successfullycommercialize imetelstat, even if marketing approval is obtained. There may also be significant delays in obtaining coverage and reimbursement for newly approved drugs, and coverage may be more limited than thepurposes for which the drug is approved by the FDA or comparable foreign regulatory authorities. In March 2010, the ACA became law and substantially changed the way healthcare will be financed by both governmental and private insurers, andsignificantly impacted the pharmaceutical64Table of Contentsindustry. The ACA contains a number of provisions that may have a significant impact on our business, including provisions that:•expand eligibility criteria for Medicaid programs; •increase the minimum level of Medicaid rebates payable by manufacturers of brand-name drugs from 15.1% to 23.1%; •require collection of rebates for drugs paid by Medicaid managed care organizations; •impose a new methodology by which rebates owed under the Medicaid Drug Rebate Program are calculated for certain drugs; •create a new Patient-Centered Outcomes Research Institute to oversee clinical effectiveness research; •require manufacturers to participate in a coverage gap discount program, under which they must agree to offer 50% point-of-sale discounts offnegotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer'soutpatient drugs to be covered under Medicare Part D, beginning January 2011; and •impose a non-deductible annual fee on pharmaceutical manufacturers or importers who sell "branded prescription drugs" to specified federalgovernment programs.While the U.S. Supreme Court upheld the constitutionality of most elements of the ACA in June 2012 and upheld the ACA against challenges to nationwidetax subsidies in July 2015, other judicial and Congressional challenges against the ACA are likely to be brought in the future. In addition, the United StatesCongress has also proposed a number of legislative initiatives, including possible repeal of the ACA, and recently enacted the Consolidated AppropriationsAct, 2016, which among other things suspended or delayed the implementation of several taxes that were intended to be used to fund ACA programs. At thistime, it remains unclear whether there will be any additional changes made to the ACA, whether to certain provisions or its entirety. We cannot assure that theACA, as currently enacted or as amended in the future, will not adversely affect our business and financial results and we cannot predict how future federal orstate legislative or administrative changes relating to healthcare reform will affect our business. In addition, other legislative changes have been proposed and adopted since the ACA was enacted. For example, in August 2011, the President signedinto law the Budget Control Act of 2011, which, among other things, created the Joint Select Committee on Deficit Reduction to recommend to Congressproposals in spending reductions. The Joint Select Committee on Deficit Reduction did not achieve a targeted deficit reduction of at least $1.2 trillion forfiscal years 2012 through 2021, triggering the legislation's automatic reduction to several government programs. This includes aggregate reductions toMedicare payments to providers of up to 2% per fiscal year, which went into effect beginning on April 1, 2013 and, following passage of the BipartisanBudget Act of 2015, will stay in effect through 2025 unless additional Congressional action is taken. Further, the American Taxpayer Relief Act of 2012,signed into law in January 2013, among other things, also reduced Medicare payments to certain providers, including hospitals, imaging centers and cancertreatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. In the future, there may continue to be additional proposals relating to the reform of the United States healthcare system, some of which could furtherlimit the prices, or the amounts of reimbursement available for imetelstat. There has been increasing legislative and enforcement interest in the United Stateswith respect to specialty drug pricing practices. Specifically, there have been several recent U.S. Congressional inquiries and proposed bills designed to,among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient65Table of Contentsprograms, and reform government program reimbursement methodologies for drugs. If future legislation were to impose direct governmental price controlsand access restrictions, it could have a significant adverse impact on our business and financial results. Managed care organizations, as well as Medicaid andother government agencies, continue to seek price discounts. Some states have implemented, and other states are considering, price controls or patient accessconstraints under the Medicaid program, and some states are considering price-control regimes that would apply to broader segments of their populations thatare not Medicaid-eligible. Due to the volatility in the current economic and market dynamics, we are unable to predict the impact of any unforeseen orunknown legislative, regulatory, payor or policy actions, which may include cost containment and healthcare reform measures. Such policy actions couldhave a material adverse impact on the potential royalties under the Collaboration Agreement with Janssen on sales of imetelstat, if approved. While the ACA has likely increased the number of patients who have insurance coverage for imetelstat, it is uncertain whether its cost containmentmeasures will adversely affect reimbursement for imetelstat. Cost control initiatives could decrease the price that Janssen may receive for imetelstat in thefuture. If imetelstat is not considered cost-effective or adequate third-party reimbursement for the users of imetelstat cannot be obtained, then Janssen may beunable to maintain price levels sufficient to realize an appropriate return on the investment in imetelstat, which could impair our ability to earn potentialmilestone payments and royalties under the Collaboration Agreement with Janssen and our financial condition, operating results and business prospectswould be severely and adversely affected. ITEM 1B. UNRESOLVED STAFF COMMENTS None. ITEM 2. PROPERTIES In September 2015, we amended the lease agreement for our premises at 149 Commonwealth Drive, Menlo Park, California to extend the lease termthrough January 2018 and reduce the space leased by us to approximately 14,500 square feet of office space effective February 2016. Our amended lease at149 Commonwealth Drive includes an option to extend the lease for one additional period of two years. We believe that our facilities are adequate to meetour requirements for the near term. ITEM 3. LEGAL PROCEEDINGS On March 14, 2014, a purported class action securities lawsuit was commenced in the United States District Court for the Northern District of California,or the California District Court, naming as defendants us and certain of our officers. The lawsuit alleges violations of the Securities Exchange Act of 1934 inconnection with allegedly false and misleading statements made by us related to our Phase 2 trial of imetelstat in patients with ET or PV. The plaintiffalleges, among other things, that we failed to disclose facts related to the occurrence of persistent low-grade LFT abnormalities observed in our Phase 2 trialof imetelstat in ET or PV patients and the potential risk of chronic liver injury following long-term exposure to imetelstat. The plaintiff seeks damages and anaward of reasonable costs and expenses, including attorneys' fees. On March 28, 2014, a second purported class action securities lawsuit was commenced inthe California District Court, and on June 6, 2014, a third securities lawsuit, not styled as a class action, was commenced in the United States District Courtfor the Southern District of Mississippi, or the Mississippi District Court, naming as defendants us and certain of our officers. These lawsuits, which are basedon the same factual background as the purported class action securities lawsuit that commenced on March 14, 2014, also allege violations of the SecuritiesExchange Act of 1934 and seek damages and an award of reasonable costs and expenses, including attorneys' fees. On June 30, 2014, the California DistrictCourt consolidated both of the purported class action securities lawsuits filed in the California District Court, or the Class Action Lawsuits, and appointed alead plaintiff and lead counsel to represent the purported class. On July 21, 2014, the California66Table of ContentsDistrict Court ordered the lead plaintiff to file its consolidated amended complaint in the Class Action Lawsuits, which was filed on September 19, 2014. OnAugust 11, 2014, we filed a motion to transfer the securities lawsuit filed in the Mississippi District Court to the California District Court. On November 4,2014, the Mississippi District Court granted our motion and transferred the case to the California District Court, which was thereafter consolidated with theClass Action Lawsuits. We filed our motion to dismiss the consolidated amended complaint on November 18, 2014. On April 10, 2015, the California DistrictCourt granted our motion to dismiss with respect to some of the allegedly false and misleading statements made by us and denied our motion to dismiss withrespect to other allegedly false and misleading statements made by us. On May 22, 2015, we filed our answer to the consolidated amended complaint in theClass Action Lawsuits. It is possible that additional suits will be filed, or allegations made by stockholders, with respect to these same or other matters andalso naming us and/or our officers and directors as defendants. We believe that we have meritorious defenses and intend to defend against these lawsuitsvigorously. On April 21, 2014, a stockholder purporting to act on our behalf filed a derivative lawsuit in the Superior Court of California for the County of SanMateo, or the San Mateo County Court, against certain of our officers and directors. The lawsuit alleges breaches of fiduciary duties by the defendants andother violations of law. In general, the lawsuit alleges that the defendants caused or allowed the dissemination of allegedly false and misleading statementsrelated to our Phase 2 trial of imetelstat in patients with ET or PV. The plaintiff is seeking unspecified monetary damages and other relief, including reformsand improvements to our corporate governance and internal procedures. On June 26, 2015 and June 29, 2015, respectively, two additional derivative lawsuitsnaming certain of our officers and directors as defendants were filed in the California District Court by stockholders purporting to act on our behalf. The twoderivative cases filed in the California District Court were consolidated on August 13, 2015. On August 25, 2015, an additional derivative lawsuit namingcertain of our officers and directors as defendants was filed in the San Mateo County Court. The two derivative cases filed in the San Mateo County Courtwere consolidated on September 5, 2015. These lawsuits, each of which is based on the same factual background as the derivative lawsuit filed on April 21,2014 in the San Mateo County Court, also allege breaches of fiduciary duties by the defendants and other violations of law. The plaintiffs in each of theforegoing derivative lawsuits are seeking unspecified monetary damages and other relief, including reforms and improvements to our corporate governanceand internal procedures. It is possible that additional derivative lawsuits will be filed with respect to these same or other matters and also naming our officersand directors as defendants. Proceedings in the derivative lawsuits have been stayed. We intend to vigorously defend against the claims alleged and to seekdismissal of these lawsuits. These lawsuits and any other related lawsuits are subject to inherent uncertainties, and the actual defense and disposition costs will depend upon manyunknown factors. The outcome of these lawsuits is necessarily uncertain. We could be forced to expend significant resources in the defense against these andany other related lawsuits and we may not prevail. We currently are not able to estimate the possible cost to us from these lawsuits, as they are currently at anearly stage, and such amounts could be material to our financial statements even if we prevail in the defense against these lawsuits. We cannot be certain howlong it may take to resolve these lawsuits or the possible amount of any damages that we may be required to pay. ITEM 4. MINE SAFETY DISCLOSURES Not applicable.67Table of Contents PART II ITEM 5. MARKET FOR THE REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OFEQUITY SECURITIES Market Information Our common stock is quoted on the Nasdaq Global Select Market under the symbol GERN. The high and low intraday sales prices as reported by theNasdaq Global Select Market of our common stock for each of the quarters in the years ended December 31, 2015 and 2014 were as follows: As of March 3, 2016, there were approximately 618 stockholders of record of our common stock. This number does not include "street name" orbeneficial holders, whose shares are held of record by banks, brokers and other financial institutions. We are engaged in a highly dynamic industry, whichoften results in significant volatility of our common stock price. On March 3, 2016, the closing sales price for our common stock was $2.82 per share.Dividend Policy We have never paid cash dividends on our capital stock and do not anticipate paying cash dividends in the foreseeable future, but intend to retain ourcapital resources for reinvestment in our business. Any future determination to pay cash dividends will be at the discretion of the board of directors and willbe dependent upon our financial condition, results of operations, capital requirements and other factors our board of directors deems relevant.Performance Measurement Comparison(1) The following graph compares total stockholder returns of Geron Corporation for the last five fiscal years beginning December 31, 2010 to two indices:the Nasdaq CRSP Total Return Index for the Nasdaq Stock Market-U.S. Companies, or the Nasdaq-US, and the Nasdaq Pharmaceutical Index, or the Nasdaq-Pharmaceutical. The total return for our stock and for each index assumes the reinvestment of dividends, although we have never declared cash dividends onGeron stock, and is based on the returns of the component companies weighted according to their capitalizations as of the end of each quarterly period. TheNasdaq-US tracks the aggregate price performance of equity securities of U.S. companies traded on the Nasdaq Global Select Market, or NGSM. The Nasdaq-Pharmaceutical, which is calculated and supplied by Nasdaq, represents pharmaceutical companies, including biotechnology companies, trading on Nasdaqunder the Standard Industrial Classification (SIC) Code No. 283 Drugs main category (2833—Medicinals & Botanicals, 2834—Pharmaceutical Preparations,2835—Diagnostic Substances, 2836—Biological Products). Geron common stock trades on the NGSM and is a component of both the Nasdaq-US and theNasdaq-Pharmaceutical. The stockholder return shown in the graph below is not necessarily indicative of future performance, and we do not make or endorseany predictions as to future stockholder returns.68 High Low Year ended December 31, 2015 First quarter $4.49 $2.70 Second quarter $4.47 $3.52 Third quarter $4.67 $2.60 Fourth quarter $5.30 $2.60 Year ended December 31, 2014 First quarter $5.92 $1.39 Second quarter $3.47 $1.69 Third quarter $3.30 $1.98 Fourth quarter $3.96 $1.76 Table of Contents Comparison of Five Year Cumulative Total Return on Investment AmongGeron Corporation, the Nasdaq-US Index and the Nasdaq-Pharmaceutical Index(2) (1)This Section is not "soliciting material," is not deemed "filed" with the SEC and is not to be incorporated by reference in any filing of GeronCorporation under the Securities Act of 1933, as amended, or the Exchange Act of 1934, as amended, whether made before or after the date hereof andirrespective of any general incorporation language in any such filing. (2)Shows the cumulative total return on investment assuming an investment of $100 in each of Geron, the Nasdaq-US and the Nasdaq- Pharmaceuticalon December 31, 2010. The cumulative total return on Geron stock has been computed based on a price of $5.19 per share, the price at which Geroncommon stock closed on December 31, 2010.Recent Sales of Unregistered Securities Except as previously reported in our quarterly reports on Form 10-Q and current reports on Form 8-K filed with the Securities and Exchange Commission,or SEC, during the year ended December 31, 2015, there were no unregistered sales of equity securities by us during the year ended December 31, 2015.69Table of Contents ITEM 6. SELECTED FINANCIAL DATA The following selected consolidated financial data should be read together with our audited financial statements and accompanying notes and"Management's Discussion and Analysis of Financial Condition and Results of Operations" appearing elsewhere in this annual report on Form 10-K. Theselected consolidated financial data in this section is not intended to replace our financial statements and the accompanying notes. Our historical results arenot necessarily indicative of our future results.70 Year Ended December 31, 2015 2014 2013 2012 2011 (In thousands, except share and per share data) Consolidated Statements ofOperations Data: Revenues: Collaboration revenue(1) $35,000 $— $— $— $300 License fees and royalties 1,371 1,153 1,283 2,709 2,138 Total revenues 36,371 1,153 1,283 2,709 2,438 Operating expenses: Research and development 17,831 20,707 23,155 51,368 69,316 Restructuring charges(2) 1,306 — 1,462 2,702 5,449 General and administrative 17,793 16,758 15,624 20,397 23,789 Total operating expenses 36,930 37,465 40,241 74,467 98,554 Loss from operations (559) (36,312) (38,958) (71,758) (96,116)Unrealized gain (loss) on derivatives 16 351 (316) 13 643 Interest and other income 677 373 951 3,097 1,024 Losses recognized under equitymethod investment — — — — (503)Losses recognized from debtextinguishment(3) — — — — (1,664)Interest and other expense (88) (82) (56) (233) (237)Net income (loss) $46 $(35,670)$(38,379)$(68,881)$(96,853)Net income (loss) per share: Basic $0.00 $(0.23)$(0.30)$(0.54)$(0.78)Diluted $0.00 $(0.23)$(0.30)$(0.54)$(0.78)Shares used in computing net income(loss) per share: Basic 158,036,162 153,540,341 128,380,800 126,941,024 124,506,763 Diluted 162,663,894 153,540,341 128,380,800 126,941,024 124,506,763 (1)In November 2014, we entered into a collaboration and license agreement, or the Collaboration Agreement, which gave JanssenBiotech Inc., or Janssen, the exclusive rights to develop and commercialize imetelstat worldwide for all indications in oncology,including hematologic myeloid malignancies, and all other human therapeutic uses. The Collaboration Agreement became effectivein December 2014 and we received $35 million from Janssen as an upfront payment, which was classified as deferred revenue on ourbalance sheet as of December 31, 2014. Upon delivery of the imetelstat license rights and completion of our performance of thetechnology transfer-related activities to Janssen as outlined under the Collaboration Agreement, we fully recognized the $35 millionupfront payment as collaboration revenue in the third quarter of 2015.Table of Contents71(2)In March 2015, in connection with projected reduced operational demands as a result of the Collaboration Agreement with Janssen,we announced an organizational resizing to reduce our workforce from 39 to 21 positions, representing approximately 46% of ourworkforce at that time. In connection with this restructuring, we incurred aggregate restructuring charges of approximately$1.3 million in 2015. All actions associated with this restructuring were completed in 2015, and we do not anticipate incurring anyfurther charges in connection with this restructuring. See Note 6 on Restructurings in Notes to Financial Statements of this annualreport on Form 10-K. In April 2013, we announced the decision to discontinue our discovery research programs and companion diagnostics program basedon telomere length and close our research laboratory facility located at 200 Constitution Drive, Menlo Park, California. With thisdecision, a total of 20 positions were eliminated, representing approximately 31% of our workforce at that time. In connection withthis restructuring, we incurred aggregate restructuring charges of approximately $1.4 million in 2013. All actions associated with thisrestructuring were completed in 2013, and we do not anticipate incurring any further charges in connection with this restructuring. In December 2012, we announced the decision to discontinue development of GRN1005, a product candidate that we previouslyexclusively in-licensed. With this decision, a total of 43 positions were eliminated, representing a reduction of approximately 40% ofour workforce at that time. In connection with the restructuring, we incurred aggregate restructuring charges of approximately$2.8 million, of which $2.7 million was recorded in 2012 and $92,000 was recorded in 2013. All actions associated with thisrestructuring were completed in 2013, and we do not anticipate incurring any further charges in connection with this restructuring. In November 2011, we discontinued further development of our stem cell programs. With this decision, a total of 66 positions wereeliminated, representing a reduction of approximately 38% of our workforce at that time. In connection with the restructuring, werecorded aggregate restructuring charges of approximately $5.4 million in 2011. All actions associated with this restructuring werecompleted in 2012, and we do not anticipate incurring any further charges in connection with this restructuring. (3)In November 2011, we repaid the outstanding principal balance, including accrued interest, or Loan Balance, to the CaliforniaInstitute for Regenerative Medicine, or CIRM, representing our entire Loan Balance under our loan agreement with CIRM. Inaddition, we relinquished our right to future disbursements from CIRM under the loan agreement and gave notice of termination. Withthe repayment of the entire outstanding Loan Balance, we have no further amounts owed to CIRM. In connection with the earlytermination of the loan agreement with CIRM, we recognized a debt extinguishment charge of approximately $1.7 million for theunamortized debt discount associated with the loan. December 31, (In thousands) 2015 2014 2013 2012 2011 Consolidated Balance Sheets Data: Cash, restricted cash, cash equivalents and marketablesecurities $146,700 $170,639 $66,019 $96,329 $154,239 Working capital 109,258 111,607 59,470 84,269 112,181 Total assets 148,760 172,511 67,344 99,801 160,047 Accumulated deficit (928,387) (928,433) (892,763) (854,384) (785,503)Total stockholders' equity 142,126 130,712 59,757 85,653 146,603 Table of Contents ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS Overview The following discussion should be read in conjunction with the audited financial statements and notes thereto included in Part II, Item 8 of this annualreport on Form 10-K. We are a biopharmaceutical company that currently supports the clinical stage development of a telomerase inhibitor, imetelstat, in hematologicmyeloid malignancies, by Janssen Biotech, Inc., or Janssen. Telomerase is an enzyme that enables cancer cells, including malignant progenitor cells, tomaintain telomere length, which provides them with the capacity for limitless, uncontrolled proliferation. Using our proprietary nucleic acid chemistry, wedesigned imetelstat to be an oligonucleotide that targets and binds with high affinity to the active site of telomerase, thereby directly inhibiting telomeraseactivity and impeding malignant cell proliferation. Early clinical data, including molecular responses in essential thrombocythemia, or ET, and remissionresponses, including reversal of bone marrow fibrosis, in myelofibrosis, or MF, suggest imetelstat may have disease-modifying activity by inhibiting theprogenitor cells of the malignant clones for the underlying diseases. In November 2014, we entered into a collaboration and license agreement, or the Collaboration Agreement, pursuant to which we granted Janssen theexclusive rights to develop and commercialize imetelstat worldwide for all indications in oncology, including hematologic myeloid malignancies, and allother human therapeutic uses. The Collaboration Agreement became effective in December 2014 and we received $35 million from Janssen as an upfrontpayment, which was classified as deferred revenue on our balance sheet as of December 31, 2014. Upon delivery of the imetelstat license rights andcompletion of our performance of the technology transfer-related activities to Janssen as outlined under the Collaboration Agreement, we fully recognizedthe $35 million upfront payment as collaboration revenue in the third quarter of 2015. Additional consideration that we may receive under the CollaborationAgreement includes payments up to a potential total of $900 million for the achievement of development, regulatory and commercial milestones, as well asroyalties on worldwide net sales of imetelstat. Under the Collaboration Agreement, Janssen is wholly responsible for the development, manufacturing and commercialization of, and seekingregulatory approval for imetelstat worldwide. To that end, Janssen currently is proceeding with the development of imetelstat with two clinical trials: aPhase 2 trial in MF, referred to as IMbark™, and a Phase 2/3 trial in myelodysplastic syndromes, or MDS, referred to as IMerge™. In July 2015, IMbark™opened to patient enrollment, and the first patient was dosed in September 2015. In December 2015, IMerge™ opened to patient enrollment, and the firstpatient was dosed in January 2016. We are contributing 50% of the development costs for IMbark™ and IMerge™ which Janssen is solely conducting.Janssen may consider initiating additional clinical trials, such as possible registration studies in MF and MDS, and possible exploratory Phase 2 andpotential follow on Phase 3 studies in acute myelogenous leukemia, or AML. The costs for such studies will be borne 100% by Janssen, unless and untilJanssen elects to maintain its license rights and continue to advance the development of imetelstat in any indication and we subsequently elect certain opt-inrights to share further U.S. development and promotion costs in exchange for higher tiered royalty rates and higher future development and regulatorymilestone payments if imetelstat is successfully developed and approved, as further described in Note 4 on Collaboration and License Agreement in Notes toFinancial Statements of this annual report on Form 10-K. We expect Janssen to perform a data cut for IMbark™ in the second half of 2017, and for Janssen to thereafter initiate the protocol-specified primaryanalysis; however, the timing may vary based on numerous factors, including the pace of patient enrollment in the clinical trial. Following completion of theprotocol-specified primary analysis of IMbark™ by Janssen or a certain time period after the initiation of the first Phase 3 MF study, if any, Janssen mustnotify us of their decision, or a Continuation Decision, as to whether they elect to maintain the license rights granted to them under72Table of Contentsthe Collaboration Agreement and continue to advance the development of imetelstat in any indication. In the event that IMbark™ has been terminated earlyor suspended, Janssen must instead notify us of their Continuation Decision by the date that is the later of 24 months after the initiation of IMerge™ or24 months after the termination of IMbark™ or commencement of the suspension period, as applicable. For a further discussion regarding the CollaborationAgreement, see Note 4 on Collaboration and License Agreement in Notes to Financial Statements of this annual report on Form 10-K. On June 11, 2015 and December 23, 2015, the United States Food and Drug Administration, or FDA, granted orphan drug designation to imetelstat forthe treatment of MF and MDS, respectively. For a drug to qualify for orphan drug designation by the FDA, both the drug and the disease or condition mustmeet certain criteria specified in the Orphan Drug Act, or ODA, and FDA's implementing regulations. Orphan drug designation is granted by the FDA's Officeof Orphan Drug Products in order to support development of medicines for underserved or rare diseases and patient populations that affect fewer than 200,000people in the United States or, if the disease or condition affects more than 200,000 individuals annually in the United States, if there is no reasonableexpectation that the cost of developing and making the drug would be recovered from sales in the United States. Orphan drug designation qualifies thesponsor of the drug for various development incentives of the ODA, including, if regulatory approval is received, the potential for seven years of marketexclusivity with certain limited exceptions and certain tax credits for qualified clinical testing. A marketing application for a prescription drug product thathas received orphan drug designation is not subject to a prescription drug user fee unless the application includes an indication for a disease or conditionother than the rare disease or condition for which the drug was granted orphan drug designation. The granting of orphan drug designation does not alter thestandard regulatory requirements and process for obtaining marketing approval. The safety and effectiveness of a drug must be established through adequateand well-controlled studies. Orphan drug exclusivity does not prevent the FDA from approving a different drug for the same disease or condition, or the samedrug for a different disease or condition. On November 15, 2015, the European Medicine Agency, or EMA, granted orphan drug designation to imetelstat for the treatment of MF. Orphan drugdesignation by the European Commission provides regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union, or EU, and where no satisfactorytreatment is available. In the EU, orphan drug designation also entitles a party to financial incentives such as reduction of fees or fee waivers, as well asprotocol assistance from the EMA during the product development phase, and direct access to the centralized authorization procedure. In addition, ten yearsof market exclusivity is granted following drug product approval, meaning that another application for marketing authorization of a later similar medicinalproduct for the same therapeutic indication will generally not be approved in the EU. This period may be reduced to six years if the orphan drug designationcriteria are no longer met, including where it is shown that the product is sufficiently profitable to not justify maintenance of market exclusivity. With projected reduced operational demands as a result of the Collaboration Agreement with Janssen, on March 3, 2015, we announced anorganizational resizing to reduce our workforce from 39 to 21 positions, representing a reduction of approximately 46% of our workforce at that time. Thisrestructuring was complete as of December 31, 2015. For a further discussion regarding the organizational resizing, see Note 6 on Restructurings in Notes toFinancial Statements of this Form 10-K. As of December 31, 2015, we had cash, restricted cash, cash equivalents and marketable securities of $146.7 million compared to $170.6 million atDecember 31, 2014 and $66.0 million at December 31, 2013. We estimate that our existing capital resources and future interest income will be sufficient tofund our current level of operations through at least the next 12 months. However, we may use our73Table of Contentsavailable capital resources sooner than we anticipate. In addition, to grow and diversify our business, we plan to continue our business development efforts toidentify and seek to acquire and/or in-license other oncology products, product candidates, programs or companies. Acquisition or in-licensing opportunitiesthat we may pursue could materially affect our liquidity and capital resources and may require us to incur indebtedness, seek equity capital or both. Inaddition, there can be no assurance that sufficient additional capital would be available to us in order to pursue any of these opportunities. For the year ended December 31, 2015, we had net income of $46,000, or $0.00 per share. For the years ended December 31, 2014 and 2013, we incurrednet losses of $35.7 million, or $0.23 per share, and $38.4 million, or $0.30 per share, respectively. Until 2015 we had never been profitable, and we haveincurred significant net losses since our inception in 1990, resulting principally from costs incurred in connection with our research and developmentactivities and from general and administrative costs associated with our operations. As of December 31, 2015, we had an accumulated deficit of$928.4 million. The significance of future losses will depend on whether Janssen continues to develop and advance imetelstat and the clinical andcommercial success of imetelstat, which would result in potential future revenues to us in the form of milestone payments and royalties under theCollaboration Agreement as described above, and whether we in-license or acquire other oncology products, product candidates, programs or companies todiversify our business. We expect to experience negative cash flow and to incur significant and increasing operating expenses for the foreseeable future as thedevelopment of imetelstat progresses in collaboration with Janssen. There can be no assurance that we will receive any milestone payments or royalties fromJanssen in the future, or at all. Imetelstat will require significant additional clinical testing prior to possible regulatory approval in the United States and othercountries, and we do not expect imetelstat to be commercially available for many years, if at all. Substantially all of our revenues to date have been research support payments under collaborative agreements, and milestones, royalties and otherrevenues from our licensing arrangements. We currently have no source of product revenue. Our revenues for 2015 primarily consisted of collaborationrevenue from Janssen, and future revenues are substantially dependent on Janssen's ability to successfully develop and commercialize imetelstat inaccordance with the Collaboration Agreement. Since our inception, we have primarily financed our operations through the sale of equity securities, interestincome on our marketable securities and payments we received under our collaborative and licensing arrangements.Critical Accounting Policies and Estimates Our financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America. Thepreparation of these financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities,revenues and expenses. Note 1 of Notes to Financial Statements describes the significant accounting policies used in the preparation of the financialstatements. Certain of these significant accounting policies are considered to be critical accounting policies, as defined below. A critical accounting policy is defined as one that is both material to the presentation of our financial statements and requires management to makedifficult, subjective or complex judgments that could have a material effect on our financial condition and results of operations. Specifically, criticalaccounting estimates have the following attributes: (i) we are required to make assumptions about matters that are highly uncertain at the time of theestimate; and (ii) different estimates we could reasonably have used, or changes in the estimate that are reasonably likely to occur, would have a materialeffect on our financial condition or results of operations. Estimates and assumptions about future events and their effects cannot be determined with certainty. We base our estimates on historical experience andon various other assumptions believed to be applicable and reasonable under the circumstances. These estimates may change as new events74Table of Contentsoccur, as additional information is obtained and as our operating environment changes. These changes historically have been minor and have been includedin the financial statements as soon as they became known. Based on a critical assessment of our accounting policies and the underlying judgments anduncertainties affecting the application of those policies, management believes that our financial statements are stated fairly in accordance with accountingprinciples generally accepted in the United States, and meaningfully present our financial condition and results of operations. We believe the following critical accounting policies reflect our more significant estimates and assumptions used in the preparation of our financialstatements:Fair Value of Financial Instruments We categorize financial instruments recorded at fair value on our balance sheets based upon the level of judgment associated with inputs used to measuretheir fair value. The categories are as follows:Level 1—Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date. An active market for theasset or liability is a market in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing informationon an ongoing basis.Level 2—Inputs (other than quoted market prices included in Level 1) are either directly or indirectly observable for the asset or liability throughcorrelation with market data at the measurement date and for the duration of the instrument's anticipated life.Level 3—Inputs reflect management's best estimate of what market participants would use in pricing the asset or liability at the measurement date.Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model. A financial instrument's categorization within the valuation hierarchy is based upon the lowest level of input that is significant to the fair valuemeasurement. Following is a description of the valuation methodologies used for instruments measured at fair value on our balance sheets, including thecategory for such instruments. Instruments classified as Level 1 include money market funds, representing 3% of our total financial instruments classified as assets measured at fairvalue as of December 31, 2015. Instruments classified as Level 2 include U.S. government-sponsored enterprise securities, commercial paper and corporatenotes, representing 97% of our total financial instruments classified as assets measured at fair value as of December 31, 2015. The price for each security atthe measurement date is derived from various sources. Periodically, we assess the reasonableness of these sourced prices by comparing them to the pricesprovided by our portfolio managers from broker quotes as well as reviewing the pricing methodologies used by our portfolio managers. Historically, we havenot experienced significant deviation between the sourced prices and our portfolio manager's prices. Non-employee options are normally traded less actively, have trade activity that is one way, and/or are traded in less-developed markets and are thereforevalued based upon models with significant unobservable market parameters, resulting in Level 3 categorization. The fair value for these instruments iscalculated using the Black Scholes option-pricing model. The model's inputs reflect assumptions that market participants would use in pricing the instrumentin a current period transaction. Use of this model requires us to make assumptions regarding stock volatility, dividend yields, expected term of the non-employee options and risk-free interest rates. Changes to the model's inputs are not changes to valuation methodologies, but instead reflect direct or indirectimpacts from changes in market conditions. Accordingly, results from the valuation model in one period may not be indicative of future periodmeasurements. Expected volatilities are based on historical volatilities of our stock. The expected term of non-employee options represents the remainingcontractual term of the instruments. The risk-free interest rate is based on the U.S. Zero Coupon Treasury Strip Yields for the remaining term of the instrument.Options held by non-employees whose performance obligations are75Table of Contentscomplete are classified as derivative liabilities on our balance sheets. For non-employee options classified as liabilities, the fair value of these instruments isrecorded on the balance sheet at inception and adjusted to fair value at each financial reporting date. The change in fair value of the non-employee options isrecorded in the statements of operations as unrealized gain (loss) on derivatives. The non-employee options continue to be reported as a liability until suchtime as the instruments are exercised or expire or are otherwise modified to remove the provisions which require this treatment, at which time theseinstruments are marked to fair value and reclassified from liabilities to stockholders' equity. As of March 31, 2015, all non-employee options classified asliabilities expired unexercised. For a further discussion regarding fair value measurements, see Note 2 on Fair Value Measurements in Notes to Financial Statements of this annual reporton Form 10-K.Revenue Recognition In general, we recognize revenue for each unit of accounting when all of the following criteria have been met: (a) persuasive evidence of an arrangementexists, (b) delivery has occurred or services have been rendered, (c) the seller's price to the buyer is fixed or determinable, and (d) collectability is reasonablyassured. Amounts received prior to satisfying these revenue recognition criteria are recorded as deferred revenue. Amounts expected to be recognized asrevenue within the 12 months following the balance sheet date are classified as current deferred revenue. Amounts not expected to be recognized as revenuewithin the 12 months following the balance sheet date are classified as noncurrent deferred revenue. Since our inception, substantially all of our revenues have been generated from collaboration agreements and licensing arrangements. Economic terms inthese agreements may include non-refundable license payments in cash or equity securities, option payments in cash or equity securities, costreimbursements, cost-sharing arrangements, milestone payments, royalties on future sales of products, or any combination of these items. In applying theappropriate revenue recognition guidance related to these agreements, we first assess whether the arrangement contains multiple elements. In this evaluation,we consider: (i) the deliverables included in the arrangement and (ii) whether the individual deliverables represent separate units of accounting or whetherthey must be accounted for as a combined unit of accounting. This evaluation involves subjective determinations and requires us to make judgments aboutthe individual deliverables and whether such deliverables are separable from the other aspects of the contractual relationship. Deliverables are consideredseparate units of accounting provided that: (i) the delivered item(s) has value to the customer on a standalone basis, and (ii) if the arrangement includes ageneral right of return relative to the delivered item(s), delivery or performance of the undelivered item(s) is considered probable and substantially in ourcontrol. In assessing whether an item has standalone value, we consider factors such as the research, manufacturing and commercialization capabilities of thecollaboration partner and the availability of the associated expertise in the general marketplace. In addition, we consider whether the collaboration partnercan use the other deliverable(s) for their intended purpose without the receipt of the remaining element(s), whether the value of the deliverable is dependenton the undelivered item(s) and whether there are other vendors that can provide the undelivered element(s). Arrangement consideration that is fixed or determinable is allocated among the separate units of accounting using the relative selling price method. Wethen apply the applicable revenue recognition criteria noted above to each of the separate units of accounting in determining the appropriate period andpattern of recognition. We determine how to allocate arrangement consideration to identified units of accounting based on the selling price hierarchyprovided under relevant accounting guidance. The estimated fair value of deliverables under the arrangement may be derived using a best estimate of sellingprice if vendor-specific-objective evidence and third-party evidence are not available.76 Table of Contents Upfront non-refundable signing, license or non-exclusive option fees are recognized as revenue: (i) when rights to use the intellectual property, related toa license that has standalone value from the other deliverables to be provided under the agreement, have been delivered or (ii) over the term of the agreementif we have continuing performance obligations, as the arrangement would be accounted for as a single unit of accounting. When payments are received inequity securities, we do not recognize any revenue unless such securities are determined to be realizable in cash. At the inception of an arrangement that includes milestone payments, we assess whether each milestone is substantive and at risk to both parties on thebasis of the contingent nature of the milestone. This evaluation includes an assessment of whether: (i) the consideration is commensurate with either theperformance to achieve the milestone or the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the performanceto achieve the milestone, (ii) the consideration relates solely to past performance and (iii) the consideration is reasonable relative to all of the deliverablesand payment terms within the arrangement. We consider various factors such as the scientific, clinical, regulatory, commercial and other risks that must beovercome to achieve the respective milestone and the level of effort and investment required to achieve the respective milestone in making this assessment.There is considerable judgment involved in determining whether a milestone satisfies all of the criteria required to conclude that a milestone is substantive.Milestone payments for milestones that are considered substantive would be recognized as revenue in their entirety upon successful accomplishment of themilestone, assuming all other revenue recognition criteria are met. Milestone payments for milestones that are not considered substantive would berecognized as revenue over the remaining period of performance, assuming all other revenue recognition criteria are met. Royalties are recognized as earned in accordance with contract terms when royalties from licensees can be reasonably estimated and collectability isreasonably assured. If royalties cannot be reasonably estimated or collectability of a royalty amount is not reasonably assured, royalties are recognized asrevenue when the cash is received. Revenue from commercial milestone payments is accounted for as royalties and recorded as revenue upon achievement ofthe milestone, assuming all other revenue recognition criteria are met. Cost-sharing expenses are recorded as earned or owed based on the performance requirements by both parties under the respective contracts. Forarrangements in which we and our collaboration partner in the agreement are exposed to significant risks and rewards depending on the commercial successof the activity, we recognize payments between the parties on a net basis and record such amounts as a reduction or addition to research and developmentexpense. For arrangements in which we have agreed to perform certain research and development services for our collaboration partner and are not exposed tosignificant risks and rewards depending on the commercial success of the activity, we recognize the respective cost reimbursements as revenue under thecollaborative agreement as the related research and development services are rendered. Revenue recognition for licenses and collaboration agreements requires significant judgment. We estimate the projected future term of licenseagreements over which we recognize revenue. We evaluate the deliverables under an arrangement and estimate the fair value of those deliverables. We alsoassess the substantive nature of milestones. Our assessments and estimates are based on contractual terms, historical experience and general industry practice.Revisions in these values or estimations have the effect of increasing or decreasing license fee or collaboration revenue in the period of revision. As ofDecember 31, 2015, we have not made any revisions to revenue recognition estimates and we do not expect revisions to currently active agreements in thefuture.Clinical Trial Accruals Prior to our collaboration with Janssen for imetelstat, substantial portions of our preclinical studies and all of our clinical trials were performed by third-party contract research organizations, or CROs,77Table of Contentsand other vendors. We accrued expenses for these activities based upon the estimated amount of work completed on each study. For our clinical trialexpenses, the significant factors used in estimating accruals included the number of patients enrolled, the number of active clinical sites and the duration forwhich the patients had been enrolled in the study. For the clinical development activities being conducted by Janssen, we monitor patient enrollment levelsand related activities to the extent possible through discussions with Janssen personnel and base our estimates on the best information available at the time.However, additional information may become available to us which would allow us to make a more accurate estimate in future periods. In this event, we maybe required to record adjustments to research and development expenses in future periods when the actual level of activity becomes more certain.Valuation of Stock-Based Compensation We measure and recognize compensation expense for all stock-based awards to our employees and directors, including stock options, restricted stockawards and employee stock purchases related to our Employee Stock Purchase Plan, or ESPP, based on estimated fair values. The fair value of stock options,restricted stock awards and employee stock purchases is amortized over the vesting period of the awards using a straight-line method. Further, the estimatedforfeiture rate impacts the amount of aggregate stock-based compensation expense recognized during the period. We use the Black Scholes option-pricingmodel to estimate the grant-date fair value of our stock options and employee stock purchases. Option-pricing valuation model assumptions such as expected volatility, expected term and risk-free interest rate impact the fair value estimate.Expected volatilities are based on historical volatilities of our stock since traded options on Geron common stock do not correspond to option terms andtrading volume of options is limited. The expected term of options represents the period of time that options granted are expected to be outstanding. Inderiving this assumption, we review actual historical exercise and cancellation data and the remaining outstanding options not yet exercised or cancelled.The expected term of employees' purchase rights under our ESPP is equal to the purchase period. The risk-free interest rate is based on the U.S. Zero CouponTreasury Strip Yields for the expected term in effect on the date of grant. Forfeiture rates are estimated based on historical data and are adjusted, if necessary,over the requisite service period based on the extent to which actual forfeitures differ, or are expected to differ, from their estimate. Prior to 2012, we granted restricted stock awards to employees and non-employee directors with service-based vesting schedules that generally vestedannually over four years. The fair value for service-based restricted stock awards was determined using the fair value of our common stock on the date ofgrant. The fair value was amortized as stock-based compensation expense over the requisite service period of the award, which was generally the vestingperiod, on a straight-line basis and was reduced for estimated forfeitures, as applicable. We evaluate the assumptions used in estimating fair values of our stock-based awards by reviewing current trends in comparison to historical data on anannual basis. We have not revised the methods by which we derive assumptions in order to estimate fair values of our stock-based awards. If factors changeand we employ different assumptions in future periods, the stock-based compensation expense that we record for awards to employees and directors maydiffer significantly from what we have recorded in the current period. Compensation expense recognized for stock-based awards to employees and directors was $8.4 million, $7.7 million and $4.4 million for the years endedDecember 31, 2015, 2014 and 2013, respectively. As of December 31, 2015, total compensation cost related to unvested stock-based awards not yetrecognized, net of estimated forfeitures, was $13.3 million, which is expected to be recognized over the next 25 months on a weighted-average basis.78Table of Contents For our non-employee stock-based awards, the measurement date on which the fair value of the stock-based award is calculated is equal to the earlier of:(i) the date at which a commitment for performance by the counterparty to earn the equity instrument is reached or (ii) the date at which the counterparty'sperformance is complete. We recognized stock-based compensation expense of $311,000, $94,000 and $92,000 for the vested portion of the fair value ofnon-employee options and restricted stock awards in our statements of operations for the years ended December 31, 2015, 2014 and 2013, respectively.Results of Operations Our results of operations have fluctuated from period to period and may continue to fluctuate in the future, based upon the progress of research anddevelopment efforts in collaboration with Janssen and whether we are able to acquire and/or in-license other oncology products, product candidates,programs or companies to grow and diversify our business. Results of operations for any period may be unrelated to results of operations for any other period.For example, in 2015 we reported net income for the first time due to recognition of revenue in the third quarter of 2015 in connection with an upfrontpayment from Janssen under the Collaboration Agreement. While we were profitable in 2015 due to the recognition of revenue in connection with theupfront payment from Janssen under the Collaboration Agreement, we expect to incur additional operating losses and, as clinical development activities forimetelstat continue under our Collaboration Agreement with Janssen, our operating losses may increase in size. In addition, historical results should not beviewed as indicative of future operating results. We are subject to risks common to companies in our industry and at our stage of development, including, butnot limited to, risks inherent in research and development efforts, our dependence on Janssen for the development, regulatory approval, manufacture andcommercialization of imetelstat, uncertainty of preclinical and clinical trial results or regulatory approvals or clearances, need for future capital, enforcementof our patent and proprietary rights, reliance upon our collaborators, investigators and other third parties, and potential competition. In order for imetelstat tobe commercialized, we are wholly dependent on Janssen to conduct preclinical tests and clinical trials to demonstrate the safety and efficacy of imetelstat,obtain regulatory approvals or clearances and enter into manufacturing, distribution and marketing arrangements, as well as obtain market acceptance. We donot expect to receive royalties based on sales of imetelstat for many years, if at all.RevenuesCollaboration Revenue Upon the effectiveness of the Collaboration Agreement with Janssen, we received $35 million as an upfront payment, which we classified as deferredrevenue on our balance sheet as of December 31, 2014. We determined delivery of the imetelstat license rights granted by us to Janssen, together with ourperformance of the technology transfer-related activities outlined in the Collaboration Agreement, represented the sole non-contingent deliverable associatedwith the upfront payment. Therefore, we accounted for our delivery of the imetelstat license rights and our performance of the technology transfer-relatedactivities as a single unit of accounting. During the third quarter of 2015, we completed performance of the technology transfer-related activities to Janssen asoutlined under the Collaboration Agreement. Combining this performance with the delivery of the imetelstat license rights, we fully recognized the$35 million upfront payment from Janssen as collaboration revenue on our statements of operations in the third quarter of 2015. Any future collaboration revenue is substantially dependent on Janssen's ability to successfully develop and commercialize imetelstat in accordancewith the Collaboration Agreement. See further discussion of the terms for potential milestones and royalties under the Collaboration Agreement in Note 4 onCollaboration and License Agreement in Notes to Financial Statements of this annual report on Form 10-K.79Table of ContentsLicense Fees and Royalties In addition to the Collaboration Agreement with Janssen, we have entered into several license or collaboration agreements with companies involvedwith oncology, diagnostics, research tools and biologics production. In each of these agreements, we have granted certain rights to our technologies. Inconnection with the agreements, we are eligible to receive license fees, option fees, milestone payments and royalties on future sales of products, or anycombination thereof. We recognized license fee revenues of $722,000, $738,000 and $933,000 in 2015, 2014 and 2013, respectively, related to our variousagreements. The decrease in license fee revenues in 2015 compared to 2014 primarily reflects the receipt of higher license payments in 2014 for researchlicenses related to our hTERT technology. The decrease in license fee revenues in 2014 compared to 2013 primarily reflects the full recognition of a non-refundable up-front license payment in 2013 for an exclusive commercial license using our telomerase promoter technology for oncology-related in vitroassays. We recognized royalty revenues of $649,000, $415,000 and $350,000 in 2015, 2014 and 2013, respectively, on product sales of telomerase detectionand telomere measurement kits to the research-use-only market, cell-based research products and nutritional products. The increase in royalty revenues in2015 compared to 2014 primarily reflects higher product sales by our licensees. The increase in royalty revenues in 2014 compared to 2013 primarily reflectsthe receipt of a milestone fee in 2014 in connection with the achievement of a net sales milestone by a licensee of our hTERT technology. Future license feeand royalty revenues are dependent on additional agreements being signed and current agreements being maintained. Current revenues may not be predictiveof future revenues.Research and Development Expenses For each of our current and prior research and development programs, we incur direct external, personnel related and other research and developmentcosts. Direct external expenses primarily consist of costs paid to outside parties to perform laboratory studies, develop manufacturing processes andmanufacture raw materials and clinical trial drug materials, conduct and manage clinical trials, and provide advice and consultation for scientific and clinicalstrategies. For the year ended December 31, 2015, direct external expenses also included our proportionate share of research and development costs incurredby Janssen under the imetelstat collaboration. Personnel related expenses primarily consist of salaries and wages, stock-based compensation, payroll taxesand benefits for Geron employees involved with ongoing research and development efforts. Other research and development expenses primarily consist oflaboratory supplies, research related overhead associated with leasing, operating and maintaining our facilities and equipment depreciation and maintenance.All of these costs apply to current and historical clinical programs and historical preclinical programs and discovery research efforts. A product candidate isdesignated a clinical candidate once an investigational new drug application has been filed with the FDA, or a similar filing with regulatory agencies outsidethe United States, for the purpose of commencing clinical trials in humans. Preclinical programs included product candidates undergoing toxicology,pharmacology, metabolism and efficacy studies and manufacturing process development required before testing in humans can commence. Research and development expenses were $17.8 million, $20.7 million and $23.2 million for the years ended December 31, 2015, 2014 and 2013,respectively. As shown in the table below, the decrease in research and development expenses in 2015 compared to 2014 primarily reflects the net result oflower personnel related expenses as a result of the restructuring announced in March 2015 and lower direct external expenses for the manufacturing ofimetelstat drug product, partially offset by higher direct external expenses for the development of imetelstat in collaboration with Janssen. The decrease inresearch and development expenses in 2014 compared to 2013 primarily reflects the net result of lower direct external costs due to the wind-down of ourGRN1005 trials in patients with brain metastases and imetelstat trials in solid tumors, reduced personnel related costs resulting from previous80Table of Contentsrestructurings and lower costs for scientific supplies and services and other research-related overhead costs due to the discontinuation of our discoveryresearch programs in April 2013. The decrease in research and development expenses in 2014 compared to 2013 was partially offset by an increase in directexternal costs for the manufacturing of imetelstat drug product. Overall, in 2016 we expect direct external research and development expenses to increase asthe development of imetelstat progresses in collaboration with Janssen. This projected increase is expected to be partially offset by lower personnel relatedresearch and development expenses as a result of the March 2015 restructuring which was complete as of December 31, 2015. During the years ended December 31, 2015 and 2014, imetelstat was our sole research and development program. Research and development expensesfor the years ended December 31, 2015, 2014 and 2013 were as follows: At this time, we cannot provide reliable estimates of how much time or investment will be necessary to commercialize imetelstat. For a more completediscussion of the risks and uncertainties associated with the development of imetelstat, see the sub-sections entitled "Risks Related to Our Business" and"Risks Related to Clinical and Commercialization Activities" in Part I, Item 1A entitled "Risk Factors" and elsewhere in this annual report on Form 10-K.Restructuring Charges In March 2015, in connection with projected reduced operational demands as a result of the Collaboration Agreement with Janssen, we announced anorganizational resizing to reduce our workforce from 39 to 21 positions. In connection with this restructuring, we incurred aggregate restructuring charges ofapproximately $1.3 million in 2015 related to one-time termination benefits, including $307,000 of non-cash stock-based compensation expense relating tothe extension of the post-termination exercise period for certain stock options previously granted to employees affected by the restructuring from 90 days toone year from their respective termination dates. All actions associated with this restructuring were completed in 2015, and we do not anticipate incurringany81 Year Ended December 31, (In thousands) 2015 2014 2013 Direct external research and development expenses: Clinical program: Imetelstat $9,574 $8,901 $7,665 Clinical program: GRN1005(1) — — 1,039 Clinical program: GRNOPC1(2) — — 202 Preclinical programs(3) — — 228 Personnel related expenses 6,478 9,674 10,753 All other research and development expenses 1,779 2,132 3,268 Total $17,831 $20,707 $23,155 (1)In December 2012, we discontinued the GRN1005 program and returned the asset to Angiochem, Inc. in May 2013. (2)In October 2013, we closed the transaction to divest our human embryonic stem cell assets and our autologous cellularimmunotherapy program to Asterias. Asterias assumed all post-closing liabilities with respect to all of the assets contributed by us,including any liabilities related to the GRNOPC1 and autologous cellular immunotherapy clinical trials. (3)In April 2013, we announced the decision to discontinue our discovery research programs and companion diagnostics program basedon telomere length and close our research laboratory facility.Table of Contentsfurther charges in connection with this restructuring. We expect the organizational resizing will reduce our personnel related costs by approximately$5.0 million on an annualized basis. See Note 6 on Restructurings in Notes to Financial Statements of this annual report on Form 10-K for further discussionof the restructuring charges. In April 2013, we announced the decision to discontinue our discovery research programs and companion diagnostics program based on telomere lengthand close our research laboratory facility located at 200 Constitution Drive, Menlo Park, California. With this decision, a total of 20 positions wereeliminated. In connection with this restructuring, we incurred aggregate restructuring charges of approximately $1.4 million in 2013, of which $624,000related to one-time termination benefits, including $28,000 of non-cash stock-based compensation expense relating to the extension of the post-terminationexercise period through the end of December 2013 for certain stock options previously granted to terminated employees, $200,000 related to non-cashcharges for write-downs of excess equipment and leasehold improvements and $546,000 related to costs associated with the closure of our research laboratoryfacility. In connection with the decision to close our research laboratory facility, we entered into an amendment to the lease agreement for the 200Constitution Drive facility under which the lease terminated effective December 31, 2013. As consideration for the early termination of the lease, we paid thelandlord the remaining rents due under the original term of the lease as well as certain facility maintenance costs, all of which have been included inrestructuring charges. In 2013, we received proceeds of approximately $1.1 million from the sale of excess laboratory equipment in connection with theclosure of our research laboratory facility. All actions associated with this restructuring were completed in 2013, and we do not anticipate incurring anyfurther charges in connection with this restructuring.General and Administrative Expenses General and administrative expenses were $17.8 million, $16.8 million and $15.6 million for the years ended December 31, 2015, 2014 and 2013,respectively. The increase in general and administrative expenses in 2015 compared to 2014 is primarily the result of higher non-cash stock-basedcompensation expense. The increase in general and administrative expenses in 2014 compared to 2013 primarily reflects the net result of higher non-cashstock-based compensation expense, increased legal fees associated with the purported class action securities lawsuits and the derivative lawsuit filed againstus and/or certain of our officers and directors and transaction costs associated with the Collaboration Agreement we entered into with Janssen in November2014, partially offset by reduced patent costs and transaction fees associated with the stem cell divestiture which closed in October 2013. We expect generaland administrative expenses to remain consistent in 2016.Unrealized Gain (Loss) on Derivatives Unrealized gain (loss) on derivatives reflects a non-cash adjustment for changes in fair value of options held by non-employees that are classified ascurrent liabilities. Derivatives classified as liabilities are marked to fair value at each financial reporting date with any resulting unrealized gain (loss)recorded in the statements of operations. The derivatives continue to be reported as a liability until such time as the instruments are exercised or expire or areotherwise modified to remove the provisions which require them to be recorded as liabilities, at which time these instruments are marked to fair value andreclassified from liabilities to stockholders' equity. We incurred unrealized gains on derivatives of $16,000 and $351,000 for the years ended December 31,2015 and 2014, respectively, compared to an unrealized loss on derivatives of $316,000 for the year ended December 31, 2013. The unrealized gains andlosses on derivatives primarily reflect the change in fair values of derivative liabilities as a result of fluctuations in the market value of our stock and changesin other inputs factored into the estimate of their fair value such as the volatility of our stock and expected term of the derivative instruments. As of March 31,2015, all non-employee options classified as liabilities expired unexercised. See Note 2 on Fair Value Measurements in Notes to Financial Statements of thisannual report on Form 10-K for further discussion of the fair value of derivatives.82Table of ContentsInterest and Other Income Interest income was $677,000, $373,000 and $219,000 for the years ended December 31, 2015, 2014 and 2013, respectively. The increase in interestincome in 2015 compared to 2014 primarily reflects the increase in our marketable securities portfolio as a result of the receipt of $35 million from Janssen asan upfront payment in December 2014 upon the effectiveness of the Collaboration Agreement and higher yields on our marketable securities portfolio. Theincrease in interest income in 2014 compared to 2013 primarily reflects an increase in our cash and investment balances in connection with the receipt of thenet cash proceeds from the underwritten public offering of shares of our common stock that we completed in February 2014. Interest earned in future periodswill depend on the size of our marketable securities portfolio and prevailing interest rates. Other income was $732,000 for the year ended December 31, 2013 and reflects a net gain on the sale of excess laboratory equipment in connection withthe closure of our research laboratory facility. No other income was recognized for the years ended December 31, 2015 and 2014.Interest and Other Expense Interest and other expense was $88,000, $82,000 and $56,000 for the years ended December 31, 2015, 2014 and 2013, respectively. Interest and otherexpense primarily reflects bank charges related to our cash operating accounts and marketable securities portfolio.Liquidity and Capital Resources Although we had net income for the year ended December 31, 2015 due to the recognition of collaboration revenue in the third quarter of 2015 for the$35 million upfront payment from Janssen upon our delivery of the imetelstat license rights and completion of the technology transfer-related activitiesunder the Collaboration Agreement with Janssen, we expect to experience negative cash flow and incur significant and increasing operating expenses for theforeseeable future as the development of imetelstat continues in collaboration with Janssen. Cash, restricted cash, cash equivalents and marketable securities at December 31, 2015 were $146.7 million, compared to $170.6 million at December 31,2014 and $66.0 million at December 31, 2013. We estimate that our existing capital resources and future interest income will be sufficient to fund our currentlevel of operations through at least the next 12 months. We have an investment policy to invest these funds in liquid, investment grade securities, such asinterest-bearing money market funds, certificates of deposit, municipal securities, U.S. government and agency securities, corporate notes and commercialpaper. Our investment portfolio does not contain securities with exposure to sub-prime mortgages, collateralized debt obligations, asset-backed securities orauction rate securities and, to date, we have not recognized any other-than-temporary impairment charges on our marketable securities or any significantchanges in aggregate fair value that would impact our cash resources or liquidity. To date, we have not experienced lack of access to our invested cash andcash equivalents; however, access to our invested cash and cash equivalents may be impacted by adverse conditions in the financial and credit markets. Thedecrease in cash, restricted cash, cash equivalents and marketable securities in 2015 was the result of cash being used for operations. In August 2015, we entered into an At Market Issuance Sales Agreement, or 2015 Sales Agreement, with MLV & Co. LLC, or MLV, which provides that,upon the terms and subject to the conditions and limitations set forth in the 2015 Sales Agreement, we may elect to issue and sell shares of our common stockhaving an aggregate offering price of up to $50.0 million from time to time through MLV as our sales agent. We are not obligated to make any sales ofcommon stock under the 2015 Sales Agreement. To date, we have not sold any common stock pursuant to the 2015 Sales Agreement. The 2015 SalesAgreement will expire in August 2018 unless extended by the parties.83Table of Contents In connection with the execution of the 2015 Sales Agreement with MLV, we and MLV terminated the At-The-Market Issuance Sales Agreement datedOctober 8, 2012, or 2012 Sales Agreement, which would otherwise have expired in October 2015. We did not sell any common stock under the 2012 SalesAgreement. We may need additional capital resources in order to support development and commercialization of imetelstat, especially if we elect to exercise certainoptions under the Collaboration Agreement and potentially independently pursue imetelstat development under our own independent development planunder the Collaboration Agreement, and to otherwise support the future growth of our business through the acquisition and/or in-licensing of other oncologyproducts, product candidates, programs or companies. We cannot assure you that our existing capital resources, future interest income, potential milestonepayments and royalties under the Collaboration Agreement with Janssen and potential future sales of our common stock, including pursuant to our 2015Sales Agreement with MLV, will be sufficient to fund future planned activities. The timing and degree of any future capital requirements will depend onmany factors, including:•the accuracy of the assumptions underlying our estimates for our capital needs; •in the event that Janssen provides an affirmative Continuation Decision to us, whether we then elect our U.S. Opt-In Rights to share furtherU.S. development and promotion costs for imetelstat beyond IMbark™ or IMerge™ under the Collaboration Agreement; •to the extent permitted under the Collaboration Agreement, whether we independently pursue imetelstat development under our own IDP; •our potential reimbursement obligations to Janssen if any data from a Janssen IDP support approval by a regulatory agency in the UnitedStates or other countries; •the achievement of development, regulatory and commercial milestones resulting in the payment to us from Janssen under the CollaborationAgreement and the timing of receipt of such payments, if any; •changes or delays in Janssen's development plans for imetelstat, including changes which may result from any future clinical holds on anyINDs for imetelstat; •Janssen's ability to meaningfully reduce manufacturing costs of imetelstat; •the progress, timing, magnitude, scope and costs of clinical development, manufacturing and commercialization of imetelstat, including thenumber of indications being pursued, subject to permission from the FDA and other regulatory authorities; •the time and costs involved in obtaining regulatory clearances and approvals in the United States and in other countries; •Janssen's ability to successfully market and sell imetelstat, upon regulatory approval or clearance, in the United States and other countries; •if we exercise our U.S. Opt-In Rights, our decision to also exercise our U.S. Co-Promotion Option, including the costs and timing of building aU.S. sales force; •the timing, receipt and amount of royalties under the Collaboration Agreement on worldwide net sales of imetelstat, upon regulatory approvalor clearance, if any; •the cost of acquiring and/or in-licensing other oncology products, product candidates, programs or companies, if any; •the timing, receipt and amount of royalties on sales of any stem cell products by Asterias upon development, regulatory approval or clearance,if any;84Table of Contents•the sales price and availability of adequate third-party reimbursement for imetelstat; •expenses associated with the pending and potential additional related purported class action securities lawsuits and derivative lawsuits, aswell as any other litigation; and •the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims. In addition, changes in our business may occur that would consume available capital resources sooner than we expect. If our existing capital resources,future interest income, and potential milestone payments and royalties under the Collaboration Agreement with Janssen are insufficient to meet future capitalrequirements, we will need to raise additional capital to fund our operations. Further, if the Collaboration Agreement is terminated, including as a result ofJanssen's failure to provide an affirmative Continuation Decision to us, we would not receive any milestone payments or royalties under the CollaborationAgreement, and we would be required to fund all clinical development, manufacturing and commercial activities for imetelstat ourselves, which wouldrequire us to raise additional capital or establish alternative collaborations with third-party collaboration partners, which may not be possible. Additionalfinancing through public or private equity financings, including pursuant to our 2015 Sales Agreement with MLV, capital lease transactions or otherfinancing sources may not be available on acceptable terms, or at all. We may raise equity capital at a stock price or on other terms that could result insubstantial dilution of ownership for our stockholders. The receptivity of the public and private equity markets to proposed financings is substantiallyaffected by the general economic, market and political climate and by other factors which are unpredictable and over which we have no control. Our ability to raise additional funds will be severely impaired in the event of:•any future clinical holds on any IND for imetelstat; •a failure to show adequate safety or efficacy of imetelstat in current or potential future clinical trials; or •a termination of the Collaboration Agreement or if our collaboration with Janssen is otherwise unsuccessful. If sufficient capital is not available, we may be unable to fulfill our funding obligations under the Collaboration Agreement with Janssen, resulting in ourbreach of the Collaboration Agreement, which could lead to Janssen paying lower milestone payments and lower royalties to us under a reduced royalty tier.This would have a material adverse effect on our results of operations and financial condition. Moreover, to grow and diversify our business, we plan to continue our business development efforts to identify and seek to acquire and/or in-licenseother oncology products, product candidates, programs or companies. Acquisition or in-licensing opportunities that we may pursue could materially affectour liquidity and capital resources and may require us to incur indebtedness, seek equity capital or both. In addition, there can be no assurance that sufficientadditional capital would be available to us in order to pursue any of these opportunities.Cash Flows from Operating Activities Net cash used in operations was $24.2 million and $36.7 million in 2015 and 2013, respectively. Net cash provided by operations was $9.4 million in2014. The increase in net cash used in operations in 2015 compared to 2014 and the decrease in net cash used in operations in 2014 compared to 2013primarily reflects the receipt of $35 million from Janssen as an upfront payment in December 2014 upon the effectiveness of the Collaboration Agreement.Additionally, the decrease in net cash used in operations in 2014 compared to 2013 reflects reduced operating expenses due to previous restructurings85Table of Contentsand the wind-down of our GRN1005 trials in patients with brain metastases and imetelstat trials in solid tumors.Cash Flows from Investing Activities Net cash provided by investing activities was $73,000 and $21.1 million in 2015 and 2013, respectively. Net cash used in investing activities was$77.9 million in 2014. The decrease in net cash used in investing activities in 2015 compared to 2014 primarily reflects increased proceeds from maturities ofmarketable securities. The decrease in net cash provided by investing activities in 2014 compared to 2013 primarily reflects higher purchases of marketablesecurities with the net cash proceeds received from an underwritten public offering of shares of our common stock that we completed in February 2014. For the three years ended December 31, 2015, we have purchased approximately $224,000 in property and equipment, none of which was financedthrough equipment financing arrangements.Cash Flows from Financing Activities Net cash provided by financing activities in 2015, 2014 and 2013 was $2.6 million, $98.4 million and $6.6 million, respectively. Net cash provided byfinancing activities in 2015 reflects the receipt of cash proceeds from the issuance of common stock under our employee equity plans and exercise of warrantsto purchase our common stock. Net cash provided by financing activities in 2014 primarily reflects the receipt of net cash proceeds of approximately$96.8 million, after deducting the underwriting discount and offering expenses payable by us, from the underwritten public offering of 25,875,000 shares ofour common stock at a public offering price of $4.00 per share that we completed in February 2014. Net cash provided by financing activities in 2013 reflectsthe receipt of cash proceeds from the issuance of common stock under our employee equity plans.Significant Cash and Contractual Obligations As of December 31, 2015, our contractual obligations for the next five years and thereafter were as follows:86 Payments Due by Period Contractual Obligations(1) Total Less Than1 Year 1 - 3 Years 4 - 5 Years After5 Years (In thousands) Equipment lease $10 $10 $— $— $— Operating lease(2) 1,386 670 716 — — License fees(3) 330 60 120 75 75 Total contractual cash obligations $1,726 $740 $836 $75 $75 (1)This table does not include payments under our severance plan if there were a change in control of Geron or severance payments toemployees in the event of an involuntary termination. In addition, this table does not include any royalty obligations under ourlicense agreements as the timing and likelihood of such payments are not known. (2)In September 2015, we amended the lease agreement for our premises at 149 Commonwealth Drive, Menlo Park, California to extendthe lease term through January 2018. Our amended lease at 149 Commonwealth Drive includes an option to extend the lease for oneadditional period of two years. Operating lease obligations in the table above do not assume the exercise by us of the option to extendthe lease or any right of termination.Table of ContentsOff-Balance Sheet Arrangements We have not engaged in any off-balance sheet arrangements, including the use of structured finance, special purpose entities or variable interest entities. ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK The following discussion about our market risk disclosures contains forward-looking statements. Actual results could differ materially from thoseprojected in the forward-looking statements. We are exposed to credit risk and interest rate risk. We do not use derivative financial instruments forspeculative or trading purposes. Credit Risk. We currently place our cash, restricted cash, cash equivalents and marketable securities with four financial institutions in the United States.Deposits with banks may exceed the amount of insurance provided on such deposits. While we monitor the cash balances in our operating accounts andadjust the cash balances as appropriate, these cash balances could be impacted if the underlying financial institutions fail or could be subject to other adverseconditions in the financial markets. Financial instruments that potentially subject us to concentrations of credit risk consist primarily of cash equivalents andmarketable securities. Cash equivalents and marketable securities currently consist of money market funds, U.S. government-sponsored enterprise securities,commercial paper and corporate notes. Our investment policy, approved by the audit committee of our board of directors, limits the amount we may invest inany one type of investment issuer, thereby reducing credit risk concentrations. We limit our credit and liquidity risks through our investment policy andthrough regular reviews of our portfolio against our policy. To date, we have not experienced any loss or lack of access to cash in our operating accounts or toour cash equivalents and marketable securities in our investment portfolio. The effect of a hypothetical decrease of 10% in the average yield earned on ourcash equivalents and marketable securities would have resulted in an immaterial decrease in our interest income for the year ended December 31, 2015. Interest Rate Risk. The primary objective of our investment activities is to manage our marketable securities portfolio to preserve principal andliquidity while maximizing the return on the investment portfolio through the full investment of available funds without significantly increasing risk. Toachieve this objective, we primarily invest in widely diversified investments with fixed interest rates, which carry a degree of interest rate risk. Fixed ratesecurities may have their fair value adversely impacted due to a rise in interest rates. Due in part to these factors, our future interest income may fall short ofexpectations due to changes in market conditions and in interest rates or we may suffer losses in principal if forced to sell securities which may have declinedin fair value due to changes in interest rates. The fair value of our cash equivalents and marketable securities at December 31, 2015 was $144.4 million. These investments include $19.2 million ofcash equivalents which are due in less than 90 days, $92.5 million of short-term investments which are due in less than one year and $32.7 million of long-term investments which are due in one to two years. We primarily invest our marketable securities portfolio in securities with at least an investment graderating to minimize interest rate and credit risk as well as to provide for an immediate source of funds. Although changes in interest rates may affect the fairvalue of the marketable securities portfolio and cause unrealized gains or losses, such gains or losses would not be realized unless the investments are sold.Due to the nature of our investments, which are primarily money market funds, U.S. government-sponsored enterprise securities, commercial paper andcorporate notes, we have concluded that there is no material interest rate risk exposure and a hypothetical movement of 1% in market interest rates would nothave a significant impact on the total realized value of our portfolio.87(3)License fees are comprised of minimum annual license payments under our existing license agreements with several universities andcompanies for the right to use intellectual property related to technologies that we have in-licensed.Table of Contents ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA The following financial statements and the related notes thereto, of Geron Corporation and the Report of Independent Registered Public AccountingFirm, Ernst & Young LLP, are filed as a part of this annual report on Form 10-K.88 Page Report of Independent Registered Public Accounting Firm 89 Balance Sheets 90 Statements of Operations 91 Statements of Comprehensive Loss 92 Statements of Stockholders' Equity 93 Statements of Cash Flows 94 Notes to Financial Statements 95 Supplemental Data: Selected Quarterly Financial Information (Unaudited) 124 Table of Contents REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM The Board of Directors and Stockholders of Geron Corporation We have audited the accompanying balance sheets of Geron Corporation as of December 31, 2015 and 2014, and the related statements of operations,comprehensive loss, stockholders' equity and cash flows for each of the three years in the period ended December 31, 2015. These financial statements are theresponsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards requirethat we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includesexamining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accountingprinciples used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our auditsprovide a reasonable basis for our opinion. In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of Geron Corporation atDecember 31, 2015 and 2014, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2015, inconformity with U.S. generally accepted accounting principles. We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), Geron Corporation'sinternal control over financial reporting as of December 31, 2015, based on criteria established in Internal Control—Integrated Framework issued by theCommittee of Sponsoring Organizations of the Treadway Commission (2013 framework) and our report dated March 10, 2016 expressed an unqualifiedopinion thereon./s/ Ernst & Young LLPRedwood City, CaliforniaMarch 10, 201689Table of Contents GERON CORPORATION BALANCE SHEETS See accompanying notes.90 December 31, 2015 2014 (In thousands, except shareand per share data) ASSETS Current assets: Cash and cash equivalents $21,248 $42,796 Restricted cash 267 266 Marketable securities 92,524 108,645 Interest and other receivables 1,206 963 Prepaid assets 647 736 Total current assets 115,892 153,406 Noncurrent marketable securities 32,661 18,932 Property and equipment, net 207 173 $148,760 $172,511 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $160 $1,033 Accrued compensation and benefits 2,974 4,213 Accrued collaboration charges 2,328 — Accrued restructuring charges 52 — Accrued liabilities 1,120 1,537 Deferred revenue — 35,000 Fair value of derivatives — 16 Total current liabilities 6,634 41,799 Commitments and contingencies Stockholders' equity: Preferred stock, $0.001 par value; 3,000,000 shares authorized; no shares issued andoutstanding at December 31, 2015 and 2014 — — Common stock, $0.001 par value; 300,000,000 shares authorized; 158,781,359 and157,429,871 shares issued and outstanding at December 31, 2015 and 2014, respectively 159 157 Additional paid-in capital 1,070,567 1,059,072 Accumulated deficit (928,387) (928,433)Accumulated other comprehensive loss (213) (84)Total stockholders' equity 142,126 130,712 $148,760 $172,511 Table of Contents GERON CORPORATION STATEMENTS OF OPERATIONS See accompanying notes.91 Year Ended December 31, 2015 2014 2013 (In thousands, except share and per share data) Revenues: Collaboration revenue $35,000 $— $— License fees and royalties 1,371 1,153 1,283 Total revenues 36,371 1,153 1,283 Operating expenses: Research and development 17,831 20,707 23,155 Restructuring charges 1,306 — 1,462 General and administrative 17,793 16,758 15,624 Total operating expenses 36,930 37,465 40,241 Loss from operations (559) (36,312) (38,958)Unrealized gain (loss) on derivatives 16 351 (316)Interest and other income 677 373 951 Interest and other expense (88) (82) (56)Net income (loss) $46 $(35,670)$(38,379)Net income (loss) per share: Basic $0.00 $(0.23)$(0.30)Diluted $0.00 $(0.23)$(0.30)Shares used in computing net income (loss) per share: Basic 158,036,162 153,540,341 128,380,800 Diluted 162,663,894 153,540,341 128,380,800 Table of Contents GERON CORPORATION STATEMENTS OF COMPREHENSIVE LOSS See accompanying notes.92 Year Ended December 31, 2015 2014 2013 (In thousands) Net income (loss) $46 $(35,670)$(38,379)Net unrealized loss on marketable securities (129) (70) (54)Comprehensive loss $(83)$(35,740)$(38,433)Table of Contents GERON CORPORATION STATEMENTS OF STOCKHOLDERS' EQUITY See accompanying notes.93 Common Stock AccumulatedOtherComprehensiveIncome (Loss) AdditionalPaid-InCapital AccumulatedDeficit TotalStockholders'Equity Shares Amount (In thousands, except share data) Balances at December 31, 2012 130,242,695 $130 $939,867 $(854,384)$40 $85,653 Net loss — — — (38,379) — (38,379)Other comprehensive loss — — — — (54) (54)Stock-based compensation relatedto issuance of common stock andoptions in exchange for services 66,853 — 252 — — 252 Cancellations of non-vestedrestricted stock under equityplans, net of issuances of commonstock (388,056) — 6,553 — — 6,553 Stock-based compensation forequity-based awards toemployees and directors — — 4,435 — — 4,435 401(k) contribution 756,457 1 1,296 — — 1,297 Balances at December 31, 2013 130,677,949 131 952,403 (892,763) (14) 59,757 Net loss — — — (35,670) — (35,670)Other comprehensive loss — — — — (70) (70)Issuance of common stock inconnection with public offering,net of issuance costs of $6,695 25,875,000 26 96,779 — — 96,805 Stock-based compensation relatedto issuance of common stock andoptions in exchange for services 71,239 — 253 — — 253 Issuance of common stock upon netexercise of warrants 168,039 — — — — — Issuances of common stock underequity plans, net of cancellationsof non-vested restricted stock 564,950 — 1,555 — — 1,555 Stock-based compensation forequity-based awards toemployees and directors — — 7,658 — — 7,658 401(k) contribution 72,694 — 424 — — 424 Balances at December 31, 2014 157,429,871 157 1,059,072 (928,433) (84) 130,712 Net income — — — 46 — 46 Other comprehensive loss — — — — (129) (129)Stock-based compensation relatedto issuance of common stock andoptions in exchange for services 18,077 — 364 — — 364 Issuance of common stock uponexercise of warrants 235,000 1 880 — — 881 Issuances of common stock underequity plans, net of cancellationsof non-vested restricted stock 1,098,411 1 1,693 — — 1,694 Stock-based compensation forequity-based awards toemployees and directors — — 8,397 — — 8,397 401(k) contribution — — 161 — — 161 Balances at December 31, 2015 158,781,359 $159 $1,070,567 $(928,387)$(213)$142,126 Table of Contents GERON CORPORATION STATEMENTS OF CASH FLOWS Year Ended December 31, 2015 2014 2013 (In thousands) Cash flows from operating activities: Net income (loss) $46 $(35,670)$(38,379)Adjustments to reconcile net income (loss) to net cash (used in) provided by operatingactivities: Depreciation and amortization 56 47 320 Accretion and amortization on investments, net 2,098 2,889 1,322 Loss (gain) on retirement/sales of property and equipment, net — 3 (831)Loss on write-downs of property and equipment — — 200 Loss on sales of marketable securities 1 — — Stock-based compensation for services by non-employees 364 253 252 Stock-based compensation for employees and directors 8,397 7,658 4,435 Amortization related to 401(k) contributions 161 111 458 Unrealized (gain) loss on derivatives (16) (351) 316 Changes in assets and liabilities: Interest and other receivables (243) (399) 188 Prepaid assets 89 (72) 1,081 Deposits and other assets — 5 (4)Accounts payable (873) (364) (2,032)Accrued compensation and benefits (1,239) 580 (431)Accrued collaboration charges 2,328 — — Accrued restructuring charges 52 (94) (1,878)Accrued liabilities (417) (246) (1,697)Deferred revenue (35,000) 35,000 — Net cash (used in) provided by operating activities (24,196) 9,350 (36,680)Cash flows from investing activities: Restricted cash transfer (1) 529 (1)Purchases of property and equipment (90) (131) (3)Proceeds from sales of property and equipment — — 1,196 Purchases of marketable securities (206,459) (190,263) (88,977)Proceeds from sales/calls of marketable securities 4,242 10,549 — Proceeds from maturities of marketable securities 202,381 101,412 108,839 Net cash provided by (used in) investing activities 73 (77,904) 21,054 Cash flows from financing activities: Proceeds from issuance of common stock, net of issuance costs 2,575 98,360 6,553 Net cash provided by financing activities 2,575 98,360 6,553 Net (decrease) increase in cash and cash equivalents (21,548) 29,806 (9,073)Cash and cash equivalents, at beginning of year 42,796 12,990 22,063 Cash and cash equivalents, at end of year $21,248 $42,796 $12,990 See accompanying notes.94Table of Contents GERON CORPORATION NOTES TO FINANCIAL STATEMENTS 1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIESOrganization Geron Corporation, or we or Geron, was incorporated in the State of Delaware on November 28, 1990. We are a biopharmaceutical company thatcurrently supports the clinical stage development of a telomerase inhibitor, imetelstat, in hematologic myeloid malignancies, by Janssen Biotech, Inc., orJanssen. Principal activities to date have included obtaining financing, securing operating facilities and conducting research and development. In November2014, we entered into an exclusive collaboration and license agreement, or the Collaboration Agreement, with Janssen to develop and commercializeimetelstat worldwide for all indications in oncology, including hematologic myeloid malignancies, and all other human therapeutic uses. Under theCollaboration Agreement, Janssen is wholly responsible for the development, manufacturing and commercialization of, and seeking regulatory approval forimetelstat worldwide.Net Income (Loss) Per Share Basic net income (loss) per share is calculated by dividing net income (loss) by the weighted-average number of shares of common stock outstandingduring the periods presented, without consideration of common stock equivalents. Diluted net income per share is calculated by adjusting the weighted-average number of shares of common stock outstanding for the dilutive effect of common stock equivalents outstanding for the periods presented, asdetermined using the treasury-stock method. Potential dilutive securities primarily consist of outstanding stock options, restricted stock awards, and warrantsto purchase our common stock. For periods in which we have incurred a net loss, common stock equivalents outstanding for the periods presented, asdetermined using the treasury-stock method, are excluded, as their effect would be anti-dilutive, resulting in the same number of shares being used for thecalculation of basic and diluted net loss per share. For all periods presented in the accompanying statements of operations, the net income (loss) applicable tocommon stockholders is equal to the reported net income (loss). Because we were in a net loss position for 2014 and 2013, 3,072,340 and 532,120 common stock equivalents, respectively, related to outstanding stockoptions, restricted stock awards and warrants (as determined using the treasury-stock method at the estimated average market value) were excluded from thediluted net loss per share calculation as their effect would have been anti-dilutive. In addition for 2015, 2014 and 2013, 9,375,851, 9,113,088 and17,580,121 potentially dilutive securities, respectively,95 Year Ended December 31, (In thousands, except share and per share data) 2015 2014 2013 Net income (loss) $46 $(35,670)$(38,379)Weighted-average shares: Basic 158,036,162 153,540,341 128,380,800 Effect of dilutive securities: Stock options and restricted stock awards 4,627,732 — — Diluted 162,663,894 153,540,341 128,380,800 Net income (loss) per share: Basic $0.00 $(0.23)$(0.30)Diluted $0.00 $(0.23)$(0.30)Table of ContentsGERON CORPORATIONNOTES TO FINANCIAL STATEMENTS (Continued)1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)were excluded from the treasury-stock method and calculation of diluted net income (loss) per share as their effect would have been anti-dilutive.Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires us to make estimatesand assumptions that affect the amounts reported in the financial statements and accompanying notes. On a regular basis, management evaluates theseestimates and assumptions. Actual results could differ from those estimates.Fair Value of Financial InstrumentsCash Equivalents and Marketable Securities We consider all highly liquid investments with an original maturity of three months or less to be cash equivalents. We are subject to credit risk related toour cash equivalents and marketable securities. We place our cash and cash equivalents in money market funds and cash operating accounts. Our marketablesecurities include U.S. government-sponsored enterprise securities, commercial paper and corporate notes with original maturities ranging from four to24 months. We classify our marketable securities as available-for-sale. We record available-for-sale securities at fair value with unrealized gains and losses reportedin accumulated other comprehensive income (loss) in stockholders' equity. Realized gains and losses are included in interest and other income and arederived using the specific identification method for determining the cost of securities sold and have been insignificant to date. Dividend and interest incomeare recognized when earned and included in interest and other income in our statements of operations. We recognize a charge when the declines in the fairvalues below the amortized cost basis of our available-for-sale securities are judged to be other-than-temporary. We consider various factors in determiningwhether to recognize an other-than-temporary charge, including whether we intend to sell the security or whether it is more likely than not that we would berequired to sell the security before recovery of the amortized cost basis. Declines in market value associated with credit losses judged as other-than-temporaryresult in a charge to interest and other income. Other-than-temporary charges not related to credit losses are included in accumulated other comprehensiveincome (loss) in stockholders' equity. We have not recorded any other-than-temporary impairment charges for our available-for-sale securities for the yearsended December 31, 2015, 2014 and 2013. See Note 2 on Fair Value Measurements.Fair Value of Derivatives For non-employee options classified as liabilities, the fair value of these instruments is recorded on the balance sheet at inception and adjusted to fairvalue at each financial reporting date. The change in fair value of the non-employee options is recorded in the statements of operations as unrealized gain(loss) on derivatives. Fair value of non-employee options is estimated using the Black Scholes option-pricing model. The non-employee options continue tobe reported as a liability until such time as the instruments are exercised or expire or are otherwise modified to remove the provisions which require thistreatment, at which time these instruments are marked to fair value and reclassified from liabilities to stockholders' equity. As of March 31, 2015, all non-employee options classified as liabilities expired unexercised. For non-employee options classified as permanent equity, the fair value of the96Table of ContentsGERON CORPORATIONNOTES TO FINANCIAL STATEMENTS (Continued)1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)non-employee options is recorded in stockholders' equity as of their respective vesting dates and no further adjustments are made. See Note 2 on Fair ValueMeasurements.Revenue Recognition In general, we recognize revenue for each unit of accounting when all of the following criteria have been met: (a) persuasive evidence of an arrangementexists, (b) delivery has occurred or services have been rendered, (c) the seller's price to the buyer is fixed or determinable, and (d) collectability is reasonablyassured. Amounts received prior to satisfying these revenue recognition criteria are recorded as deferred revenue. Amounts expected to be recognized asrevenue within the 12 months following the balance sheet date are classified as current deferred revenue. Amounts not expected to be recognized as revenuewithin the 12 months following the balance sheet date are classified as noncurrent deferred revenue.License and/or Collaboration Agreements In addition to the Collaboration Agreement (which is more fully described in Note 4 on Collaboration and License Agreement), we have entered intoseveral license or collaboration agreements with various oncology, diagnostics, research tools and biologics production companies. Economic terms in theseagreements may include non-refundable license payments in cash or equity securities, option payments in cash or equity securities, cost reimbursements,cost-sharing arrangements, milestone payments, royalties on future sales of products, or any combination of these items. In applying the appropriate revenuerecognition guidance related to these agreements, we first assess whether the arrangement contains multiple elements. In this evaluation, we consider: (i) thedeliverables included in the arrangement and (ii) whether the individual deliverables represent separate units of accounting or whether they must beaccounted for as a combined unit of accounting. This evaluation involves subjective determinations and requires us to make judgments about the individualdeliverables and whether such deliverables are separable from the other aspects of the contractual relationship. Deliverables are considered separate units ofaccounting provided that: (i) the delivered item(s) has value to the customer on a standalone basis, and (ii) if the arrangement includes a general right ofreturn relative to the delivered item(s), delivery or performance of the undelivered item(s) is considered probable and substantially in our control. In assessingwhether an item has standalone value, we consider factors such as the research, manufacturing and commercialization capabilities of the collaboration partnerand the availability of the associated expertise in the general marketplace. In addition, we consider whether the collaboration partner can use the otherdeliverable(s) for their intended purpose without the receipt of the remaining element(s), whether the value of the deliverable is dependent on the undelivereditem(s) and whether there are other vendors that can provide the undelivered element(s). Arrangement consideration that is fixed or determinable is allocated among the separate units of accounting using the relative selling price method. Wethen apply the applicable revenue recognition criteria noted above to each of the separate units of accounting in determining the appropriate period andpattern of recognition. We determine how to allocate arrangement consideration to identified units of accounting based on the selling price hierarchyprovided under relevant accounting guidance. The estimated fair value of deliverables under the arrangement may be derived using a best estimate of sellingprice if vendor-specific-objective evidence and third-party evidence are not available.97Table of ContentsGERON CORPORATIONNOTES TO FINANCIAL STATEMENTS (Continued)1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued) Upfront non-refundable signing, license or non-exclusive option fees are recognized as revenue: (i) when rights to use the intellectual property, related toa license that has standalone value from the other deliverables to be provided under the agreement, have been delivered or (ii) over the term of the agreementif we have continuing performance obligations, as the arrangement would be accounted for as a single unit of accounting. When payments are received inequity securities, we do not recognize any revenue unless such securities are determined to be realizable in cash. At the inception of an arrangement that includes milestone payments, we assess whether each milestone is substantive and at risk to both parties on thebasis of the contingent nature of the milestone. This evaluation includes an assessment of whether: (i) the consideration is commensurate with either theperformance to achieve the milestone or the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the performanceto achieve the milestone, (ii) the consideration relates solely to past performance and (iii) the consideration is reasonable relative to all of the deliverablesand payment terms within the arrangement. We consider various factors such as the scientific, clinical, regulatory, commercial and other risks that must beovercome to achieve the respective milestone and the level of effort and investment required to achieve the respective milestone in making this assessment.There is considerable judgment involved in determining whether a milestone satisfies all of the criteria required to conclude that a milestone is substantive.Milestone payments for milestones that are considered substantive would be recognized as revenue in their entirety upon successful accomplishment of themilestone, assuming all other revenue recognition criteria are met. Milestone payments for milestones that are not considered substantive would berecognized as revenue over the remaining period of performance, assuming all other revenue recognition criteria are met. Royalties are recognized as earned in accordance with contract terms when royalties from licensees can be reasonably estimated and collectability isreasonably assured. If royalties cannot be reasonably estimated or collectability of a royalty amount is not reasonably assured, royalties are recognized asrevenue when the cash is received. Revenue from commercial milestone payments is accounted for as royalties and recorded as revenue upon achievement ofthe milestone, assuming all other revenue recognition criteria are met. Cost-sharing expenses are recorded as earned or owed based on the performance requirements by both parties under the respective contracts. Forarrangements in which we and our collaboration partner in the agreement are exposed to significant risks and rewards depending on the commercial successof the activity, we recognize payments between the parties on a net basis and record such amounts as a reduction or addition to research and developmentexpense. For arrangements in which we have agreed to perform certain research and development services for our collaboration partner and are not exposed tosignificant risks and rewards depending on the commercial success of the activity, we recognize the respective cost reimbursements as revenue under thecollaborative agreement as the related research and development services are rendered.Restricted Cash Restricted cash consists of funds maintained in a separate certificate of deposit account for credit card purchases.98Table of ContentsGERON CORPORATIONNOTES TO FINANCIAL STATEMENTS (Continued)1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)Research and Development Expenses Research and development expenses consist of expenses incurred in identifying, developing and testing product candidates resulting from ourindependent efforts as well as efforts associated with collaborations. These expenses include, but are not limited to, in-process research and developmentacquired in an asset acquisition and deemed to have no alternative future use, payroll and personnel expense, lab supplies, preclinical studies, clinical trials,including support for investigator-sponsored clinical trials, raw materials to manufacture clinical trial drugs, manufacturing costs for research and clinicaltrial materials, sponsored research at other labs, consulting, costs to maintain technology licenses, our proportionate share of research and development costsunder cost-sharing arrangements with collaboration partners and research-related overhead. Research and development costs are expensed as incurred,including payments made under our collaboration and/or license agreements.Clinical Trial Costs Prior to our collaboration with Janssen for imetelstat, substantial portions of our preclinical studies and all of our clinical trials were performed by third-party contract research organizations, or CROs, and other vendors. We accrued expenses for these activities based upon the estimated amount of workcompleted on each study. For our clinical trial expenses, the significant factors used in estimating accruals included the number of patients enrolled, thenumber of active clinical sites and the duration for which the patients had been enrolled in the study. For the clinical development activities being conductedby Janssen, we monitor patient enrollment levels and related activities to the extent possible through discussions with Janssen personnel and base ourestimates on the best information available at the time. However, additional information may become available to us which would allow us to make a moreaccurate estimate in future periods. In this event, we may be required to record adjustments to research and development expenses in future periods when theactual level of activity becomes more certain.Depreciation and Amortization We record property and equipment at cost and calculate depreciation using the straight-line method over the estimated useful lives of the assets,generally four years. Leasehold improvements are amortized over the shorter of the estimated useful life or remaining term of the lease.Stock-Based Compensation We maintain various stock incentive plans under which stock options and restricted stock awards are granted to employees, directors and consultants.We also have an employee stock purchase plan for all eligible employees. We recognize stock-based compensation expense on a straight-line basis over therequisite service period, which is generally the vesting period. For additional information, see Note 8 on Stockholders' Equity.Stock Options and Employee Stock Purchase Plan We grant service-based stock options under our equity plans to employees, directors and consultants. The vesting period for employee options isgenerally four years. We use the Black Scholes option-pricing model to estimate the grant-date fair value of our stock options and employee stock planpurchases. The determination of fair value for these stock-based awards on the date of grant using the99Table of ContentsGERON CORPORATIONNOTES TO FINANCIAL STATEMENTS (Continued)1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)Black Scholes option-pricing model is affected by our stock price as well as assumptions regarding a number of complex and subjective variables. Foradditional information, see Note 8 on Stockholders' Equity.Restricted Stock Awards Prior to 2012, we granted restricted stock awards to employees and non-employee directors with service-based vesting schedules that generally vestedannually over four years. The fair value for service-based restricted stock awards was determined using the fair value of our common stock on the date ofgrant. The fair value was amortized as stock-based compensation expense over the requisite service period of the award, which was generally the vestingperiod, on a straight-line basis and was reduced for estimated forfeitures, as applicable.Non-Employee Stock-Based Awards For our non-employee stock-based awards, the measurement date on which the fair value of the stock-based award is calculated is equal to the earlier of:(i) the date at which a commitment for performance by the counterparty to earn the equity instrument is reached or (ii) the date at which the counterparty'sperformance is complete. We recognize stock-based compensation expense for the fair value of the vested portion of non-employee awards in our statementsof operations.Accumulated Other Comprehensive Loss Accumulated other comprehensive loss includes certain changes in stockholders' equity which are excluded from net income (loss). Accumulated othercomprehensive loss on our balance sheets as of December 31, 2015 and 2014 is solely comprised of net unrealized losses on marketable securities.Income Taxes We maintain deferred tax assets and liabilities that reflect the net tax effects of temporary differences between the carrying amounts of assets andliabilities for financial reporting purposes and the amounts used for income tax purposes and are subject to tests of recoverability. Our deferred tax assetsinclude net operating loss carryforwards, research credits and capitalized research and development. Deferred tax assets and liabilities are measured usingenacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. Our netdeferred tax asset has been fully offset by a valuation allowance because of our history of losses. Any potential accrued interest and penalties related tounrecognized tax benefits would be recorded as income tax expense.Concentrations of Customers and Suppliers The majority of our revenues was earned in the United States. Janssen accounted for approximately 96% of our 2015 revenues. Additionally, twocustomers accounted for approximately 31% and 42% of our 2014 and 2013 revenues, respectively. Janssen contracts third-party manufacturers to produce GMP-grade drugs for preclinical and clinical studies. Janssen also contracts for starting materialsto supply those manufacturers and for its own use. Certain development and clinical activities may be delayed if Janssen is unable to obtain100Table of ContentsGERON CORPORATIONNOTES TO FINANCIAL STATEMENTS (Continued)1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)sufficient quantities of starting materials or GMP-grade drugs from current third-party suppliers or other third-party sources.Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update No. 2014-09, or ASU 2014-09, which createsAccounting Standards Codification Topic 606, Revenue from Contracts with Customers, or Topic 606, and supersedes the revenue recognition requirementsin Accounting Standards Codification Topic 605, Revenue Recognition, including most industry-specific revenue recognition guidance throughout theIndustry Topics of the Codification. In summary, the core principle of Topic 606 is to recognize revenue when promised goods or services are transferred tocustomers in an amount that reflects the consideration that is expected to be received for those goods or services. Companies are allowed to select betweentwo transition methods: (1) a full retrospective transition method with the application of the new guidance to each prior reporting period presented, or (2) aretrospective transition method that recognizes the cumulative effect on prior periods at the date of adoption together with additional footnote disclosures.The amendments in ASU 2014-09 are effective for annual reporting periods beginning after December 15, 2017, including interim periods within thatreporting period, and early application is not permitted. We are currently evaluating the impact that the adoption of ASU 2014-09 will have on our financialstatements and related disclosures and have not made any decision on the method of adoption. In November 2015, the FASB issued Accounting Standards Update No. 2015-17, Income Taxes (Topic 740): Balance Sheet Classification of DeferredTaxes, or ASU 2015-17. Current generally accepted accounting principles requires an entity to separate deferred income tax liabilities and assets into currentand noncurrent amounts in a classified statement of financial position. To simplify the presentation of deferred income taxes, ASU 2015-17 requires thatdeferred tax liabilities and assets be classified as noncurrent in a classified statement of financial position. The current requirement that deferred tax liabilitiesand assets of a tax-paying component of an entity be offset and presented as a single amount is not affected by the amendments in this update. Theamendments in this update are effective for financial statements issued for annual periods beginning after December 15, 2016, and interim periods withinthose annual periods. Earlier application is permitted for all entities as of the beginning of an interim or annual reporting period. We are currently evaluatingthe impact that the adoption of ASU 2015-17 will have on our financial statements and related disclosures and have not made any decision regarding thetiming of adoption. With the exception of the standards discussed above, there have been no new accounting pronouncements not yet effective that have significance, orpotential significance, to our financial statements.101 Table of ContentsGERON CORPORATIONNOTES TO FINANCIAL STATEMENTS (Continued)2. FAIR VALUE MEASUREMENTS We categorize financial instruments recorded at fair value on our balance sheets based upon the level of judgment associated with inputs used to measuretheir fair value. The categories are as follows: A financial instrument's categorization within the valuation hierarchy is based upon the lowest level of input that is significant to the fair valuemeasurement. Below is a description of the valuation methodologies used for financial instruments measured at fair value on our balance sheets, includingthe category for such financial instruments.Cash Equivalents and Marketable Securities Available-for-Sale Certificates of deposit and money market funds are categorized as Level 1 within the fair value hierarchy as their fair values are based on quoted pricesavailable in active markets. U.S. government-sponsored enterprise securities, commercial paper and corporate notes are categorized as Level 2 within the fairvalue hierarchy as their fair values are estimated by using pricing models, quoted prices of securities with similar characteristics or discounted cash flows.102 Level 1—Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date. An active market for the assetor liability is a market in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing informationon an ongoing basis. Level 2—Inputs (other than quoted market prices included in Level 1) are either directly or indirectly observable for the asset or liability throughcorrelation with market data at the measurement date and for the duration of the instrument's anticipated life. Level 3—Inputs reflect management's best estimate of what market participants would use in pricing the asset or liability at the measurement date.Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model.Table of ContentsGERON CORPORATIONNOTES TO FINANCIAL STATEMENTS (Continued)2. FAIR VALUE MEASUREMENTS (Continued) Cash equivalents, restricted cash and marketable securities by security type at December 31, 2015 were as follows: Cash equivalents, restricted cash and marketable securities by security type at December 31, 2014 were as follows:103(In thousands) AmortizedCost GrossUnrealizedGains GrossUnrealizedLosses EstimatedFair Value Included in cash and cash equivalents: Money market funds $4,577 $— $— $4,577 Government-sponsored enterprise securities 1,999 — — 1,999 Commercial paper 7,599 — — 7,599 Corporate notes 5,002 — (1) 5,001 $19,177 $— $(1)$19,176 Restricted cash: Certificate of deposit $267 $— $— $267 Marketable securities: Government-sponsored enterprise securities (due in 1 to 2 years) $10,007 $— $(57)$9,950 Commercial paper (due in less than 1 year) 27,661 49 (2) 27,708 Corporate notes (due in less than 1 year) 64,892 1 (77) 64,816 Corporate notes (due in 1 to 2 years) 22,837 — (126) 22,711 $125,397 $50 $(262)$125,185 (In thousands) AmortizedCost GrossUnrealizedGains GrossUnrealizedLosses EstimatedFair Value Included in cash and cash equivalents: Money market funds $40,342 $— $— $40,342 Restricted cash: Certificate of deposit $266 $— $— $266 Marketable securities: Government-sponsored enterprise securities (due in less than 1 year) $401 $— $(1)$400 Government-sponsored enterprise securities (due in 1 to 2 years) 6,556 — (7) 6,549 Commercial paper (due in less than 1 year) 10,985 14 — 10,999 Corporate notes (due in less than 1 year) 97,307 2 (63) 97,246 Corporate notes (due in 1 to 2 years) 12,412 — (29) 12,383 $127,661 $16 $(100)$127,577 Table of ContentsGERON CORPORATIONNOTES TO FINANCIAL STATEMENTS (Continued)2. FAIR VALUE MEASUREMENTS (Continued) Cash equivalents and marketable securities with unrealized losses at December 31, 2015 and 2014 were as follows: The gross unrealized losses related to government-sponsored enterprise securities, commercial paper and corporate notes as of December 31, 2015 and2014 were due to changes in interest rates. We determined that the gross unrealized losses on our cash equivalents and marketable securities as ofDecember 31, 2015 and 2014 were temporary in nature. We review our investments quarterly to identify and evaluate whether any investments haveindications of possible impairment. Factors considered in determining whether a loss is temporary include the length of time and extent to which the fairvalue has been less than the cost basis and whether we intend to sell the security or whether it is more likely than not that we would be required to sell thesecurity before recovery of the amortized cost basis. We currently do not intend to sell these securities before recovery of their amortized cost basis.Derivatives Non-employee options are normally traded less actively, have trade activity that is one way, and/or are traded in less-developed markets and are thereforevalued based upon models with significant unobservable market parameters, resulting in Level 3 categorization. Options held by non-employees whose performance obligations are complete are classified as derivative liabilities on our balance sheets. These optionsare marked to fair value at each reporting period, and upon the exercise of these options, the instruments are marked to fair value and104 Less Than 12 Months 12 Months or Greater Total (In thousands) EstimatedFair Value GrossUnrealizedLosses EstimatedFair Value GrossUnrealizedLosses EstimatedFair Value GrossUnrealizedLosses As of December 31, 2015: Government-sponsored enterprise securities(due in 1 to 2 years) $9,950 $(57)$— $— $9,950 $(57)Commercial paper (due in less than 1 year) 7,834 (2) — — 7,834 (2)Corporate notes (due in less than 1 year) 61,006 (71) 6,301 (7) 67,307 (78)Corporate notes (due in 1 to 2 years) 22,711 (126) — — 22,711 (126) $101,501 $(256)$6,301 $(7)$107,802 $(263)As of December 31, 2014: Government-sponsored enterprise securities(due in less than 1 year) $400 $(1)$— $— $400 $(1)Government-sponsored enterprise securities(due in 1 to 2 years) 5,549 (7) — — 5,549 (7)Corporate notes (due in less than 1 year) 92,989 (63) — — 92,989 (63)Corporate notes (due in 1 to 2 years) 12,383 (29) — — 12,383 (29) $111,321 $(100)$— $— $111,321 $(100)Table of ContentsGERON CORPORATIONNOTES TO FINANCIAL STATEMENTS (Continued)2. FAIR VALUE MEASUREMENTS (Continued)reclassified from derivative liabilities to stockholders' equity. As of December 31, 2014, non-employee options to purchase 284,600 shares of our commonstock at an exercise price of $6.39 per share with a fair value of $16,000 were outstanding and classified as derivative liabilities. The fair value of these non-employee options as of December 31, 2014 was calculated using the Black Scholes option-pricing model with a dividend yield of zero percent, expectedvolatility of 89.50%, risk-free interest rate of 0.04% and expected term of three months. On March 31, 2015, these non-employee options expiredunexercised. Accordingly, we have not reclassified any derivative liabilities to stockholders' equity for any non-employee option exercises during 2015.Fair Value on a Recurring Basis The following table presents information about our financial instruments that are measured at fair value on a recurring basis as of December 31, 2015 andindicates the fair value category assigned. The following table presents information about our financial instruments that are measured at fair value on a recurring basis as of December 31, 2014 andindicates the fair value category assigned.105 Fair Value Measurements at Reporting Date Using Quoted Prices inActive Markets forIdentical Assets SignificantOtherObservableInputs SignificantUnobservableInputs (In thousands) Level 1 Level 2 Level 3 Total Assets Money market funds(1) $4,577 $— $— $4,577 Government-sponsored enterprise securities(1)(3) — 11,949 — 11,949 Commercial paper(1)(2) — 35,307 — 35,307 Corporate notes(1)(2)(3) — 92,528 — 92,528 Total $4,577 $139,784 $— $144,361 Fair Value Measurements at Reporting Date Using Quoted Prices inActive Markets forIdentical Assets /Liabilities SignificantOtherObservableInputs SignificantUnobservableInputs (In thousands) Level 1 Level 2 Level 3 Total Assets Money market funds(1) $40,342 $— $— $40,342 Government-sponsored enterprise securities(2)(3) — 6,949 — 6,949 Commercial paper(2) — 10,999 — 10,999 Corporate notes(2)(3) — 109,629 — 109,629 Total $40,342 $127,577 $— $167,919 Liabilities Derivatives(4) $— $— $16 $16 (1)Included in cash and cash equivalents on our balance sheets. (2)Included in current portion of marketable securities on our balance sheets.Table of ContentsGERON CORPORATIONNOTES TO FINANCIAL STATEMENTS (Continued)2. FAIR VALUE MEASUREMENTS (Continued)Changes in Level 3 Recurring Fair Value Measurements The table below includes a rollforward of the balance sheet amounts for the year ended December 31, 2015, including the change in fair value, forfinancial instruments in the Level 3 category. When a determination is made to classify a financial instrument within Level 3, the determination is basedupon the significance of the unobservable parameters to the overall fair value measurement. However, Level 3 financial instruments typically include, inaddition to the unobservable components, observable components (that is, components that are actively quoted and can be validated to external sources).Accordingly, the gain in the table below includes changes in fair value due in part to observable factors that are part of the methodology. As of March 31,2015, all non-employee options classified as derivative liabilities within the Level 3 fair value category expired unexercised.Credit Risk We currently place our cash, restricted cash, cash equivalents and marketable securities with four financial institutions in the United States. Generally,these deposits may be redeemed upon demand and therefore, bear minimal risk. Deposits with banks may exceed the amount of insurance provided on suchdeposits. Financial instruments that potentially subject us to concentrations of credit risk consist primarily of cash equivalents and marketable securities.Cash equivalents and marketable securities currently consist of money market funds, U.S. government-sponsored enterprise securities, commercial paper andcorporate notes. Our investment policy, approved by the audit committee of our board of directors, limits the amount we may invest in any one type ofinvestment issuer, thereby reducing credit risk concentrations.106(3)Included in noncurrent portion of marketable securities on our balance sheets. (4)Included in fair value of derivatives on our balance sheets. Fair Value Measurements Using Significant Unobservable Inputs (Level 3)Year Ended December 31, 2015 (In thousands) Fair Value atDecember 31,2014 TotalUnrealizedGainIncluded inEarnings(1) Purchases,Sales,Issuances,Settlements TransfersIn and/orOut ofLevel 3 Fair Value atDecember 31,2015 Change inUnrealized GainRelated toFinancialInstrumentsHeld atDecember 31,2015 Derivative liabilities $16 $(16)$— $— $— $— (1)Reported as unrealized gain on derivatives on our statements of operations.Table of ContentsGERON CORPORATIONNOTES TO FINANCIAL STATEMENTS (Continued)3. PROPERTY AND EQUIPMENT Property and equipment, stated at cost, is comprised of the following:4. COLLABORATION AND LICENSE AGREEMENT In November 2014, we and Janssen entered into the Collaboration Agreement, under which we granted to Janssen exclusive worldwide rights to developand commercialize imetelstat for all human therapeutic uses, including hematologic myeloid malignancies. Upon the early termination of the waiting periodsunder the Hart-Scott-Rodino Antitrust Improvements Act of 1976, the Collaboration Agreement became effective on December 15, 2014. Upon theeffectiveness of the Collaboration Agreement, we received $35,000,000 from Janssen as an upfront payment, which was classified as deferred revenue on ourbalance sheet as of December 31, 2014. Under the Collaboration Agreement, Janssen is wholly responsible for the development, manufacturing and commercialization of, and seekingregulatory approval for imetelstat worldwide. To that end, Janssen is currently proceeding with the development of imetelstat with two clinical trials: aPhase 2 trial in MF, referred to as IMbark™, and a Phase 2/3 trial in MDS, referred to as IMerge™. Development costs for IMbark™ and IMerge™ are beingshared between us and Janssen on a 50/50 basis. Additionally, under the terms of the Collaboration Agreement, we remain responsible for prosecuting, atJanssen's direction, the patents licensed to Janssen at the time we entered into the Collaboration Agreement, with costs shared between us and Janssen on a50/50 basis. The cost-sharing arrangement with Janssen began in 2015. As of December 31, 2015, accrued collaboration charges of $2,328,000 on ourbalance sheet represent the net amount owed to Janssen for our proportionate share of research and development costs incurred by them under the imetelstatcollaboration for the three months ended December 31, 2015. Following completion of the protocol-specified primary analysis of IMbark™ or after a certain time period after the initiation of the first Phase 3myelofibrosis study, if any, Janssen must notify us whether it elects to maintain its license rights and continue to advance the development of imetelstat inany indication. In the event that IMbark™ has been terminated early or suspended, Janssen must instead notify us of its decision by the date that is the laterof 24 months from the initiation of IMerge™ or 24 months from the termination of IMbark™ or commencement of the suspension period, as applicable. In the event that Janssen elects to continue to maintain its license rights and advance the development of imetelstat in any indication within theapplicable timeframe set forth in the Collaboration Agreement (such decision, the Continuation Decision), we then would have an option, or the U.S. Opt-InRights, to share further U.S. development and promotion costs in exchange for higher tiered royalty rates and higher future development and regulatorymilestone payments if imetelstat is107 December 31, (In thousands) 2015 2014 Furniture and computer equipment $1,224 $1,158 Lab equipment 130 130 Leasehold improvements 98 74 1,452 1,362 Less accumulated depreciation and amortization (1,245) (1,189) $207 $173 Table of ContentsGERON CORPORATIONNOTES TO FINANCIAL STATEMENTS (Continued)4. COLLABORATION AND LICENSE AGREEMENT (Continued)successfully developed and approved. If we exercise the U.S. Opt-In Rights, then we and Janssen would share U.S. development and promotion costs beyondIMbark™ or IMerge™ on a 20/80 basis (Geron 20%, Janssen 80%), we would receive a $65,000,000 milestone payment, or the Continuation Fee, at the timeof an affirmative Continuation Decision, and would be eligible to receive additional potential payments of up to $470,000,000 in development andregulatory milestones, up to $350,000,000 in sales milestones, and tiered royalties ranging from a mid-teens up to low twenties percentage rate on worldwidenet sales of imetelstat in any countries where regulatory exclusivity exists or there are valid claims under the patent rights exclusively licensed to Janssen. Inaddition, if we exercise the U.S. Opt-In Rights, we then would also have a separate option, or the Co-Promotion Option, to provide 20% of the U.S. sellingeffort with sales force personnel, in lieu of funding 20% of U.S. promotion costs, upon regulatory approval and commercial launch of imetelstat in the UnitedStates. Such co-promotion would be conducted under a Janssen prepared promotion plan, and in accordance with a co-promotion agreement to be agreed bythe parties at the time of our exercise of the Co-Promotion Option. We would be responsible for all costs associated with establishing and maintaining a salesforce in any conduct of such co-promotion. All product sales would be booked by Janssen. If we do not exercise the U.S. Opt-In Rights, then all furtherdevelopment and promotion costs beyond IMbark™ or IMerge™ would be borne by Janssen, we would receive the $65,000,000 Continuation Fee at thetime of an affirmative Continuation Decision plus a $70,000,000 payment, or the Full U.S. Rights Fee, for Janssen's retention of full U.S. rights to imetelstat,and would be eligible to receive additional potential payments of up to $415,000,000 in development and regulatory milestones, up to $350,000,000 insales milestones, and tiered royalties ranging from a double-digit up to mid-teens percentage rate on worldwide net sales of imetelstat in any countries whereregulatory exclusivity exists or there are valid claims under the patent rights exclusively licensed to Janssen. Under the terms of the Collaboration Agreement, we and Janssen created a joint governance structure, including joint committees and working groups, tooversee and manage worldwide regulatory, development and manufacturing work under the joint clinical development plan and promotional activities(assuming we exercise the U.S. Opt-In Rights) for imetelstat, with Janssen responsible for the operational implementation of those activities. In addition,either of the parties may propose to the joint committees imetelstat development for any new indications not then provided for in the joint clinicaldevelopment plan and if the parties agree such development should be conducted outside of the joint clinical development plan, each of Geron and Janssenwould be entitled to independently undertake such development at its own cost, subject to the other party's obligation to provide reimbursement for itsspecified portion of the costs plus a premium for such independent development following marketing approval of imetelstat in such newly proposedindication as a result of such independent development. In the event that we do not exercise the U.S. Opt-In Rights following Janssen's affirmativeContinuation Decision, the joint governance structure under the Collaboration Agreement would be dissolved, a joint oversight committee would monitorthe progress of the collaboration, and we would have no further rights to conduct any independent imetelstat development. After an affirmative Continuation Decision by Janssen, the Collaboration Agreement would remain in effect until the expiration of the last-to-expirepatent or the royalty obligations on sales of imetelstat cease, unless terminated earlier. If Janssen does not effect an affirmative Continuation Decision, thenthe Collaboration Agreement would terminate and all rights to the imetelstat program would revert to us. Janssen may terminate the Collaboration Agreementat any time for convenience or due to a safety-related concern. If a notice of termination from Janssen occurs, we would be entitled to certain108Table of ContentsGERON CORPORATIONNOTES TO FINANCIAL STATEMENTS (Continued)4. COLLABORATION AND LICENSE AGREEMENT (Continued)continued operational support and cost-sharing under various circumstances and all rights to the imetelstat program would revert to us. The terms of the Collaboration Agreement contain multiple deliverables, which include at inception: (i) exclusive worldwide rights to develop andcommercialize imetelstat for all indications, (ii) transfer of know-how and intellectual property, including our obligation to procure supply for manufacturingimetelstat for up to nine months after the effective date of the Collaboration Agreement, (iii) participation on the joint committees and working groups and(iv) potential participation in promoting imetelstat in the United States, if approved for commercial sale. We concluded the license for exclusive worldwiderights to develop and commercialize imetelstat has standalone value to Janssen based on the technical and financial resources of Janssen, including Janssen'sdrug development experience, sizeable employee base with specific experience in hematologic malignancies, and sufficient capital to independentlydevelop imetelstat on a global basis. Since Janssen has final decision-making authority in the event a unanimous decision cannot be reached by the jointcommittees, we determined our participation on the joint committees does not represent a non-contingent deliverable under the Collaboration Agreement. Inaddition, we determined our potential participation in promoting imetelstat in the United States does not represent a non-contingent deliverable becausesuch participation is uncertain and dependent on imetelstat being approved for commercial sale, which is not within our control. Accordingly, we determineddelivery of the license rights granted by us to Janssen, together with our performance of certain technology transfer-related activities under the CollaborationAgreement, represents the sole non-contingent deliverable under the Collaboration Agreement associated with the upfront payment. Therefore, we accountedfor our delivery of the imetelstat license rights and our performance of the technology transfer-related activities as a single unit of accounting. During thethird quarter of 2015, we completed performance of the technology transfer-related activities to Janssen as outlined under the Collaboration Agreement.Combining this performance with the delivery of the imetelstat license rights, we fully recognized the $35,000,000 upfront payment from Janssen ascollaboration revenue on our statements of operations in the third quarter of 2015. We have determined that each of the additional potential milestone payments to us under the Collaboration Agreement, including: (i) the ContinuationFee at the time of an affirmative Continuation Decision, (ii) the Full U.S. Rights Fee if we do not exercise the U.S. Opt-In Rights and (iii) payments based onthe achievement of certain development, regulatory or commercial milestones, represent substantive milestones. Consequently, we will recognize revenue forthese payments in their entirety upon successful accomplishment of the respective milestone. Royalties on future product sales of imetelstat, if successfullycommercialized under the Collaboration Agreement, will be recognized as revenue when earned.109 Table of ContentsGERON CORPORATIONNOTES TO FINANCIAL STATEMENTS (Continued)5. ACCRUED LIABILITIES Accrued liabilities consisted of the following:6. RESTRUCTURINGSMarch 2015 Restructuring With projected reduced operational demands as a result of the Collaboration Agreement with Janssen, on March 3, 2015, we announced anorganizational resizing to reduce our workforce from 39 to 21 positions. In connection with this restructuring, we recorded net restructuring charges ofapproximately $1,306,000 related to one-time termination benefits which were recognized on a pro-rata basis commencing from the date of announcement ofthe resizing over the specified remaining service periods of the employees affected by the restructuring. For the year ended December 31, 2015, werecognized $1,395,000 in restructuring charges for the one-time termination benefits, which included $307,000 of non-cash stock-based compensationexpense relating to the extension of the post-termination exercise period for certain stock options previously granted to employees affected by therestructuring from 90 days to one year from their respective termination dates. Restructuring charges for the year ended December 31, 2015 were reduced bynon-cash adjustments of $89,000 for unused termination benefits. We expect this restructuring to result in aggregate cash expenditures of approximately$999,000, of which $947,000 has been paid as of December 31, 2015. All actions associated with this restructuring were completed in 2015, and we do notanticipate incurring any further charges in connection with this restructuring. The components relating to the March 2015 restructuring, including the outstanding restructuring liability which is included in accrued restructuringcharges on our balance sheet as of December 31, 2015, are summarized in the following table:April 2013 Restructuring On April 25, 2013, we announced the decision to discontinue our discovery research programs and companion diagnostics program based on telomerelength and close our research laboratory facility110 December 31, (In thousands) 2015 2014 Professional legal and accounting fees $481 $431 Clinical trial costs 375 513 Service provider obligations 24 408 Other 240 185 $1,120 $1,537 (In thousands) EmployeeSeverance andOther Benefits Beginning accrual balance as of December 31, 2014 $— Restructuring charges 1,395 Cash payments (947)Non-cash stock-based compensation expense (307)Adjustments or non-cash credits (89)Ending accrual balance as of December 31, 2015 $52 Table of ContentsGERON CORPORATIONNOTES TO FINANCIAL STATEMENTS (Continued)6. RESTRUCTURINGS (Continued)located at 200 Constitution Drive, Menlo Park, California. With this decision, a total of 20 positions were eliminated. In connection with this restructuring,we incurred aggregate restructuring charges of $1,370,000 for the year ended December 31, 2013, of which $624,000 related to one-time termination benefits,including $28,000 of non-cash stock-based compensation expense relating to the extension of the post-termination exercise period through the end ofDecember 2013 for certain stock options previously granted to terminated employees, $200,000 related to non-cash charges for write-downs of excessequipment and leasehold improvements and $546,000 related to costs associated with the closure of our research laboratory facility. In connection with thedecision to close our research laboratory facility, we entered into an amendment to the lease agreement for the 200 Constitution Drive facility under whichthe lease terminated effective December 31, 2013. As consideration for the early termination of the lease, we paid the landlord the remaining rents due underthe original term of the lease as well as certain facility maintenance costs, all of which have been included in restructuring charges for the year endedDecember 31, 2013. The restructuring resulted in aggregate cash expenditures of $1,085,000 after adjustments and non-cash credits. In 2013, we receivedproceeds of $1,080,000 from the sale of excess laboratory equipment in connection with the closure of our research laboratory facility. All actions associatedwith this restructuring were completed in 2013, and we do not anticipate incurring any further charges in connection with this restructuring.7. COMMITMENTS AND CONTINGENCIESSecurities and Derivative Lawsuits On March 14, 2014, a purported class action securities lawsuit was commenced in the United States District Court for the Northern District of California,or the California District Court, naming as defendants us and certain of our officers. The lawsuit alleges violations of the Securities Exchange Act of 1934 inconnection with allegedly false and misleading statements made by us related to our Phase 2 trial of imetelstat in patients with essential thrombocythemia, orET, or polycythemia vera, or PV. The plaintiff alleges, among other things, that we failed to disclose facts related to the occurrence of persistent low-gradeliver function test, or LFT, abnormalities observed in our Phase 2 trial of imetelstat in ET or PV patients and the potential risk of chronic liver injuryfollowing long-term exposure to imetelstat. The plaintiff seeks damages and an award of reasonable costs and expenses, including attorneys' fees. OnMarch 28, 2014, a second purported class action securities lawsuit was commenced in the California District Court, and on June 6, 2014, a third securitieslawsuit, not styled as a class action, was commenced in the United States District Court for the Southern District of Mississippi, or the Mississippi DistrictCourt, naming as defendants us and certain of our officers. These lawsuits, which are based on the same factual background as the purported class actionsecurities lawsuit that commenced on March 14, 2014, also allege violations of the Securities Exchange Act of 1934 and seek damages and an award ofreasonable costs and expenses, including attorneys' fees. On June 30, 2014, the California District Court consolidated both of the purported class actionsecurities lawsuits filed in the California District Court, or the Class Action Lawsuits, and appointed a lead plaintiff and lead counsel to represent thepurported class. On July 21, 2014, the California District Court ordered the lead plaintiff to file its consolidated amended complaint in the Class ActionLawsuits, which was filed on September 19, 2014. On August 11, 2014, we filed a motion to transfer the securities lawsuit filed in the Mississippi DistrictCourt to the California District Court. On November 4, 2014, the Mississippi District Court granted our motion and transferred the case to the CaliforniaDistrict Court, which was thereafter consolidated with the Class Action Lawsuits. We filed our motion to dismiss the consolidated amended complaint onNovember 18, 2014. On April 10, 2015,111Table of ContentsGERON CORPORATIONNOTES TO FINANCIAL STATEMENTS (Continued)7. COMMITMENTS AND CONTINGENCIES (Continued)the California District Court granted our motion to dismiss with respect to some of the allegedly false and misleading statements made by us and denied ourmotion to dismiss with respect to other allegedly false and misleading statements made by us. On May 22, 2015, we filed our answer to the consolidatedamended complaint in the Class Action Lawsuits. It is possible that additional suits will be filed, or allegations made by stockholders, with respect to thesesame or other matters and also naming us and/or our officers and directors as defendants. We believe we have meritorious defenses and intend to defendagainst these lawsuits vigorously. On April 21, 2014, a stockholder purporting to act on our behalf filed a derivative lawsuit in the Superior Court of California for the County of SanMateo, or the San Mateo County Court, against certain of our officers and directors. The lawsuit alleges breaches of fiduciary duties by the defendants andother violations of law. In general, the lawsuit alleges that the defendants caused or allowed the dissemination of allegedly false and misleading statementsrelated to our Phase 2 trial of imetelstat in patients with ET or PV. The plaintiff is seeking unspecified monetary damages and other relief, including reformsand improvements to our corporate governance and internal procedures. On June 26, 2015 and June 29, 2015, respectively, two additional derivative lawsuitsnaming certain of our officers and directors as defendants were filed in the California District Court by stockholders purporting to act on our behalf. The twoderivative cases filed in the California District Court were consolidated on August 13, 2015. On August 25, 2015, an additional derivative lawsuit namingcertain of our officers and directors as defendants was filed in the San Mateo County Court. The two derivative cases filed in the San Mateo County Courtwere consolidated on September 5, 2015. These lawsuits, each of which is based on the same factual background as the derivative lawsuit filed on April 21,2014 in the San Mateo County Court, also allege breaches of fiduciary duties by the defendants and other violations of law. The plaintiffs in each of theforegoing derivative lawsuits are seeking unspecified monetary damages and other relief, including reforms and improvements to our corporate governanceand internal procedures. It is possible that additional derivative lawsuits will be filed with respect to these same or other matters and also naming our officersand directors as defendants. Proceedings in the derivative lawsuits have been stayed. We intend to vigorously defend against the claims alleged and to seekdismissal of these lawsuits. These lawsuits and any other related lawsuits are subject to inherent uncertainties, and the actual defense and disposition costs will depend upon manyunknown factors. The outcome of these lawsuits is necessarily uncertain. We could be forced to expend significant resources in the defense against these andany other related lawsuits and we may not prevail. We currently are not able to estimate the possible cost to us from these lawsuits, as they are currently at anearly stage, and we cannot be certain how long it may take to resolve these lawsuits or the possible amount of any damages that we may be required to pay.Such amounts could be material to our financial statements even if we prevail in the defense against these lawsuits. We have not established any reserves forany potential liability relating to these lawsuits. It is possible that we could, in the future, incur judgments or enter into settlements of claims for monetarydamages.Indemnifications to Officers and Directors Our corporate bylaws require that we indemnify our officers and directors, as well as those who act as directors and officers of other entities at our request,against expenses, judgments, fines, settlements and other amounts actually and reasonably incurred in connection with any proceedings arising out of theirservices to Geron. In addition, we have entered into separate indemnification agreements with each of our directors and officers which provide forindemnification of these directors112Table of ContentsGERON CORPORATIONNOTES TO FINANCIAL STATEMENTS (Continued)7. COMMITMENTS AND CONTINGENCIES (Continued)and officers under similar circumstances and under additional circumstances. The indemnification obligations are more fully described in our bylaws and theindemnification agreements. We purchase standard insurance to cover claims or a portion of the claims made against our directors and officers. Since amaximum obligation is not explicitly stated in our bylaws or in our indemnification agreements and will depend on the facts and circumstances that arise outof any future claims, the overall maximum amount of the obligations cannot be reasonably estimated. We have no such obligations on our balance sheets asof December 31, 2015 and 2014.Operating Lease Commitment On September 15, 2015, we amended the lease agreement for our premises at 149 Commonwealth Drive, Menlo Park, California, to extend the lease termfrom February 2016 through January 2018. As of December 31, 2015, operating lease obligations under the amended lease agreement include aggregatefuture minimum payments of approximately $1,386,000. Rent expense under our operating leases was approximately $878,000, $936,000 and $1,422,000for the years ended December 31, 2015, 2014 and 2013, respectively.Severance Plan We have an Amended and Restated Severance Plan, or Severance Plan, that applies to all employees that are not subject to performance improvementplans, and most significantly provides for, among other benefits: (i) a severance payment upon a Change of Control Triggering Event and Separation fromService (as defined in the Severance Plan) and (ii) a severance payment for each non-executive employee upon a Non-Change of Control Triggering Eventand Separation from Service (as defined in the Severance Plan). A Change of Control Triggering Event and Separation from Service is defined as an eventwhere: (i) an employee is terminated by us without cause in connection with a change of control or within 12 months following a change of control provided,however, that if an employee is terminated by us in connection with a change of control but immediately accepts employment with our successor or acquirer,the employee will not be eligible for the benefits outlined in the Severance Plan, (ii) an employee resigns because in connection with a change of control, theoffered terms of employment (new or continuing) by us or our successor or acquirer within 30 days after the change of control results in a material change inthe terms of employment, or (iii) after accepting (or continuing) employment with us after a change of control, an employee resigns within 12 monthsfollowing a change of control due to a material change in the terms of employment. A Non-Change of Control Triggering Event and Separation from Serviceis defined as an event where a non-executive employee is terminated by us without cause. Severance payments range from two to 18 months of base salary,depending on the employee's position with us, payable in a lump sum payment. The Severance Plan also provides that the provisions of employmentagreements entered into between us and executive or non-executive employees supersede the provisions of the Severance Plan. As of December 31, 2015, allour executive officers have employment agreements with provisions that may provide greater severance benefits than those in the Severance Plan.8. STOCKHOLDERS' EQUITYSales Agreement On August 28, 2015, we entered into an At Market Issuance Sales Agreement, or the 2015 Sales Agreement, with MLV & Co. LLC, or MLV, pursuant towhich we may elect to issue and sell shares of our common stock having an aggregate offering price of up to $50,000,000 from time to time into the113Table of ContentsGERON CORPORATIONNOTES TO FINANCIAL STATEMENTS (Continued)8. STOCKHOLDERS' EQUITY (Continued)open market at prevailing prices through MLV as our sales agent. We will pay MLV an aggregate commission rate equal to up to 3.0% of the gross proceedsof the sales price per share for common stock sold through MLV under the 2015 Sales Agreement. Pursuant to the 2015 Sales Agreement, sales of commonstock will be made in such quantities and on such minimum price terms as we may set from time to time. We are not obligated to make any sales of commonstock under the 2015 Sales Agreement. As of December 31, 2015, we had not sold any common stock pursuant to the 2015 Sales Agreement. The 2015 SalesAgreement will expire in August 2018 unless extended by the parties. In connection with the execution of the 2015 Sales Agreement with MLV, we and MLV terminated the At-The-Market Issuance Sales Agreement datedOctober 8, 2012, or the 2012 Sales Agreement, which would otherwise have expired in October 2015. We did not sell any common stock under the 2012Sales Agreement.Public Offering On February 4, 2014, we completed an underwritten public offering of 25,875,000 shares of our common stock at a public offering price of $4.00 pershare, resulting in net cash proceeds of approximately $96,805,000 after deducting the underwriting discount and offering expenses payable by us.Warrants In connection with each disbursement under the loan agreement with the California Institute for Regenerative Medicine, or CIRM, we were obligated toissue to CIRM a warrant to purchase Geron common stock. Such warrants and the underlying common stock were unregistered. We have no furtherobligations to issue any additional warrants to CIRM. As of December 31, 2015, a warrant to purchase 537,893 shares of our common stock remainedoutstanding. The warrant was issued to CIRM in August 2011 at an exercise price of $3.98 per share and expires in August 2021. In December 2014, CIRM exercised a warrant to purchase 461,382 shares of our common stock utilizing the net exercise provision in the warrantresulting in the issuance of 168,039 shares of our common stock. On March 31, 2015, a warrant to purchase 235,000 shares of our common stock wasexercised at an exercise price of $3.75 per share. We received cash proceeds of approximately $881,000 from the exercise of this warrant.Equity Plans2002 Equity Incentive Plan The 2002 Equity Incentive Plan, or 2002 Plan, expired in May 2012. Upon the adoption of the 2011 Incentive Award Plan in May 2011 (see below), nofurther grants of options or stock purchase rights were made from the 2002 Plan. Options granted under the 2002 Plan expire no later than ten years from thedate of grant. Option exercise prices were equal to 100% of the fair market value of the underlying common stock on the date of grant. Service-based stockoptions under the 2002 Plan generally vested over a period of four years from the date of the option grant. Other stock awards (restricted stock awards andrestricted stock units) had variable vesting schedules which were determined by our board of directors on the date of grant.114Table of ContentsGERON CORPORATIONNOTES TO FINANCIAL STATEMENTS (Continued)8. STOCKHOLDERS' EQUITY (Continued)2011 Incentive Award Plan In May 2011, our stockholders approved the adoption of the 2011 Incentive Award Plan, or 2011 Plan. Our board of directors administers the 2011 Plan.The 2011 Plan provides for grants to employees (including officers and employee directors) of either incentive stock or nonstatutory stock options and stockpurchase rights to employees (including officers and employee directors) and consultants (including non-employee directors). As of December 31, 2015, anaggregate of 12,054,916 shares of our common stock were available for future grants of equity awards under the 2011 Plan. Pursuant to the terms of the 2011Plan, any shares subject to outstanding stock options originally granted under the 2002 Plan or 1996 Directors' Stock Option Plan, or outstanding unvestedrestricted stock awards originally granted under the 2002 Plan, that expire or terminate for any reason prior to exercise or settlement or are forfeited becauseof the failure to meet a contingency or condition required to vest such shares shall become available for issuance under the 2011 Plan. Options granted underthe 2011 Plan expire no later than ten years from the date of grant. Option exercise prices shall be equal to 100% of the fair market value of the underlyingcommon stock on the date of grant. If, at the time we grant an option, the optionee directly or by attribution owns stock possessing more than 10% of the totalcombined voting power of all classes of our stock, the option price shall be at least 110% of the fair market value of the underlying common stock and shallnot be exercisable more than five years after the date of grant. We grant service-based stock options to employees under our 2011 Plan that generally vest over a period of four years from the date of the option grant.Other stock awards (restricted stock awards and restricted stock units) have variable vesting schedules as determined by our board of directors on the date ofgrant. Under certain circumstances, options may be exercised prior to vesting, subject to our right to repurchase shares subject to such option at the exerciseprice paid per share. Our repurchase rights would generally terminate on a vesting schedule identical to the vesting schedule of the exercised option. During2015, we have not repurchased any shares under the 2011 Plan. As of December 31, 2015, we have no shares outstanding subject to repurchase. As of December 31, 2015, our Non-Employee Director Compensation Policy adopted by our board of directors in March 2014 provides for the automaticgrant to non-employee directors of the following types of equity awards under the 2011 Plan: First Director Option. Each person who becomes a non-employee director, whether by election by our stockholders or by appointment by our board ofdirectors to fill a vacancy, will automatically be granted an option to purchase 70,000 shares of common stock on the date such person first becomes a non-employee director, or First Director Option. The First Director Option shall vest annually over three years upon each anniversary date of appointment to ourboard of directors. Subsequent Director Option. Each non-employee director (other than any director receiving a First Director Option on the date of the annual meeting)will automatically be granted a subsequent option to purchase 35,000 shares of common stock, a Subsequent Director Option, on the date of the annualmeeting of stockholders in each year during such director's service on our board of directors. The Subsequent Director Option vests in full on the earlier of: (i)the date of the next annual meeting of our stockholders or (ii) the first anniversary of the date of grant.115 Table of ContentsGERON CORPORATIONNOTES TO FINANCIAL STATEMENTS (Continued)8. STOCKHOLDERS' EQUITY (Continued)1996 Directors' Stock Option Plan The 1996 Directors' Stock Option Plan, or 1996 Directors Plan, expired in July 2006 upon which no further option grants were made from the 1996Directors Plan. The options granted to non-employee directors under the 1996 Directors Plan were nonstatutory stock options and expire no later than tenyears from the date of grant. The option exercise price was equal to the fair market value of the underlying common stock on the date of grant. Options topurchase shares of common stock generally were 100% vested upon grant, except for options granted upon first appointment to the board of directors. Theseinitial options vested annually over three years upon each anniversary date of appointment to the board of directors.2006 Directors' Stock Option Plan The 2006 Directors' Stock Option Plan, or 2006 Directors Plan, was terminated by our board of directors and replaced by the 2011 Plan in March 2014.No further grants of options were made from the 2006 Directors Plan upon the 2006 Directors Plan's termination. All outstanding awards granted under the2006 Directors Plan remain subject to the terms of the 2006 Directors Plan and the individual grants made thereunder. The options granted to non-employee directors under the 2006 Directors Plan were nonstatutory stock options, and they expire no later than ten yearsfrom the date of grant. The option exercise price was equal to the fair market value of the underlying common stock on the date of grant. The First DirectorOption granted to non-employee members of the board of directors under the 2006 Directors Plan vested annually over three years upon each anniversarydate of appointment to the board of directors. The Subsequent Director Option granted to non-employee members of the board of directors on the date of theannual meeting of stockholders in each year during such director's service on our board of directors under the 2006 Directors Plan vested one year from thedate of grant.116Table of ContentsGERON CORPORATIONNOTES TO FINANCIAL STATEMENTS (Continued)8. STOCKHOLDERS' EQUITY (Continued) Aggregate option and award activity for the 2002 Plan, 2011 Plan, 1996 Directors Plan and 2006 Directors Plan is as follows: The aggregate intrinsic value in the preceding table represents the total intrinsic value, based on Geron's closing stock price of $4.84 per share as ofDecember 31, 2015, which would have been received by the option holders had all the option holders exercised their options as of that date. We have not granted any options with an exercise price below or greater than fair market value of our common stock on the date of grant in 2015, 2014or 2013. As of December 31, 2015, 2014 and 2013, there were 11,356,232, 9,129,576 and 8,144,040 exercisable options outstanding at weighted averageexercise prices per share of $2.98, $3.12 and $4.26, respectively. The total pretax intrinsic value of stock options exercised during 2015, 2014 and 2013 was $2,398,000, $989,000 and $2,787,000, respectively. Cashreceived from the exercise of options in 2015, 2014 and 2013 totaled approximately $2,205,000, $1,286,000 and $6,567,000, respectively. Information about stock options outstanding as of December 31, 2015 is as follows:117 Outstanding Options SharesAvailableFor Grant Number ofShares Weighted AverageExercise PricePer Share Weighted AverageRemainingContractual Life(In years) AggregateIntrinsicValue(In thousands)Balance at December 31, 2014 13,384,883 16,958,944 $3.16 $16,038Options granted (2,875,000) 2,875,000 $4.29 Awards granted (14,015) — $ — Options exercised — (1,069,838)$2.06 Options cancelled/forfeited 1,558,423 (1,558,423)$4.65 Awards cancelled/forfeited 625 — $ — Balance at December 31, 2015 12,054,916 17,205,683 $3.29 6.89 $29,267Options exercisable at December 31, 2015 11,356,232 $2.98 6.18 $23,234Options fully vested and expected to vest atDecember 31, 2015 16,703,236 $3.26 6.84 $28,932 Options OutstandingExercise Price Range Number ofShares Weighted AverageExercise PricePer Share Weighted AverageRemainingContractual Life(In years)$1.10 - $1.51 6,003,210 $1.45 6.58$1.55 - $4.34 5,412,577 $3.21 7.63$4.42 - $5.09 4,744,005 $4.99 7.41$5.14 - $9.32 1,045,891 $6.47 2.45$1.10 - $9.32 17,205,683 $3.29 6.89Table of ContentsGERON CORPORATIONNOTES TO FINANCIAL STATEMENTS (Continued)8. STOCKHOLDERS' EQUITY (Continued) Aggregate restricted stock activity for the 2002 Plan, 2011 Plan and 2006 Directors Plan is as follows: The weighted average grant date fair value of restricted stock granted during the years ended December 31, 2015, 2014 and 2013 was $3.75, $2.67 and$2.41 per share, respectively. The total fair value of restricted stock that vested during 2015, 2014 and 2013 was $275,000, $782,000 and $252,000,respectively.Employee Stock Purchase Plan In March 2014, our board of directors adopted the 2014 Employee Stock Purchase Plan, or 2014 Purchase Plan. The 2014 Purchase Plan was approved byour stockholders in May 2014. The 2014 Purchase Plan replaced the 1996 Employee Stock Purchase Plan, or 1996 Purchase Plan, which was terminatedeffective as of the date the 2014 Purchase Plan was approved by our stockholders. Under the 2014 Purchase Plan, we are authorized to sell to eligibleemployees up to an aggregate of 1,000,000 shares of Geron common stock. As of December 31, 2015, an aggregate of 57,635 shares of our common stockhave been issued under the 2014 Purchase Plan since its adoption. The 2014 Purchase Plan is comprised of a series of offering periods, each with a maximum duration (not to exceed 12 months) with new offering periodscommencing on January 1st and July 1st of each year. The date an employee enters the offering period will be designated as the entry date for purposes ofthat offering period. An employee may only participate in one offering period at a time. Each offering period consists of two consecutive purchase periods ofsix months' duration, with the last day of such period designated a purchase date. Under the terms of the 2014 Purchase Plan, employees can choose to have up to 10% of their annual salary withheld to purchase our common stock. Anemployee may not make additional payments into such account or increase the withholding percentage during the offering period. The purchase price per share at which common stock is purchased by the employee on each purchase date within the offering period is equal to 85% ofthe lower of (i) the fair market value per share of Geron's common stock on the employee's entry date into that offering period or (ii) the fair market value pershare of Geron's common stock on the purchase date. If the fair market value of Geron's common stock on the purchase date is less than the fair market valueat the beginning of the offering period, a new 12 month offering period will automatically begin on the first business day following the purchase date with anew fair market value.118 Number ofShares WeightedAverageGrant DateFair ValuePer Share Weighted AverageRemainingContractual Term(In years)Non-vested restricted stock at December 31, 2014 60,970 $4.73 0.37Granted 14,015 $3.75 Vested (73,860)$4.54 Cancelled/forfeited (625)$4.65 ​Non-vested restricted stock at December 31, 2015 500 $4.65 0.10​​​Table of ContentsGERON CORPORATIONNOTES TO FINANCIAL STATEMENTS (Continued)8. STOCKHOLDERS' EQUITY (Continued)Stock-Based Compensation for Employees and Directors We measure and recognize compensation expense for all share-based payment awards made to employees and directors, including employee stockoptions, restricted stock awards and employee stock purchases, based on grant-date fair values for these instruments. We use the Black Scholes option-pricingmodel to estimate the grant-date fair value of our stock options and employee stock purchases. The fair value for service-based restricted stock awards isdetermined using the fair value of our common stock on the date of grant. As stock-based compensation expense recognized in the statements of operations for the years ended December 31, 2015, 2014 and 2013 is based onawards ultimately expected to vest, it has been reduced for estimated forfeitures but at a minimum, reflects the grant-date fair value of those awards thatactually vested in the period. Forfeitures have been estimated at the time of grant based on historical data and revised, if necessary, in subsequent periods ifactual forfeitures differ from those estimates. We recognize stock-based compensation expense on a straight-line basis over the requisite service period, which is generally the vesting period. Thefollowing table summarizes the stock-based compensation expense related to stock options, restricted stock awards and employee stock purchases for theyears ended December 31, 2015, 2014 and 2013 which was allocated as follows: Stock-based compensation expense has been recognized for the modification of the post-termination exercise period for certain stock options previouslygranted to employees affected by the March 2015 and April 2013 restructurings, which has been included in restructuring charges in our statements ofoperations. See Note 6 on Restructurings for further discussion of the restructurings. In addition, modifications to the post-termination exercise period ofoutstanding options held by certain members of our executive management team resulted in additional stock-based compensation expense of $205,000 forthe year ended December 31, 2013 and have been reflected in the above table. The fair value of stock options granted in 2015, 2014 and 2013 has been estimated at the date of grant using the Black Scholes option-pricing modelwith the following assumptions:119 Year Ended December 31, (In thousands) 2015 2014 2013 Research and development $2,139 $2,545 $1,741 Restructuring charges 307 — 28 General and administrative 5,951 5,113 2,666 Stock-based compensation expense included in operating expenses $8,397 $7,658 $4,435 2015 2014 2013Dividend yield 0% 0% 0%Expected volatility range 0.874 to 0.884 0.898 to 0.922 0.742 to 0.792Risk-free interest rate range 1.68% to 1.71% 1.64% to 1.92% 0.80% to 1.97%Expected term 5.5 yrs 5.5 yrs 6 yrsTable of ContentsGERON CORPORATIONNOTES TO FINANCIAL STATEMENTS (Continued)8. STOCKHOLDERS' EQUITY (Continued) The fair value of employee stock purchases in 2015, 2014 and 2013 has been estimated using the Black Scholes option-pricing model with the followingassumptions: Dividend yield is based on historical cash dividend payments and Geron has paid no cash dividends to date. The expected volatility range is based onhistorical volatilities of our stock since traded options on Geron stock do not correspond to option terms and the trading volume of options is limited. Therisk-free interest rate range is based on the U.S. Zero Coupon Treasury Strip Yields for the expected term in effect on the date of grant for an award. Theexpected term of options is derived from actual historical exercise and post-vesting cancellation data and represents the period of time that options grantedare expected to be outstanding. The expected term of employees' purchase rights is equal to the purchase period. Based on the Black Scholes option-pricing model, the weighted average estimated fair value of employee stock options granted during the years endedDecember 31, 2015, 2014 and 2013 was $3.06, $3.57 and $1.03 per share, respectively. The weighted average estimated fair value of employees' purchaserights for the years ended December 31, 2015, 2014 and 2013 was $1.64, $2.10 and $0.75 per share, respectively. As of December 31, 2015, totalcompensation cost related to unvested share-based payment awards not yet recognized, net of estimated forfeitures, was $13,321,000, which is expected to berecognized over the next 25 months on a weighted-average basis.Stock-Based Compensation to Service Providers We grant stock options and restricted stock awards to consultants from time to time in exchange for services performed for us. In general, the stockoptions and restricted stock awards vest over the contractual period of the consulting arrangement. We granted stock options to purchase 75,000 and 80,000shares of our common stock to consultants in 2014 and 2013, respectively. The fair value of stock options and restricted stock awards held by consultants isrecorded as operating expenses over the vesting term of the respective equity awards. In addition, we will record any increase in the fair value of the stockoptions and restricted stock awards as the respective equity award vests. We recorded stock-based compensation expense of $311,000, $94,000 and $92,000for the vested portion of the fair value of stock options and restricted stock awards held by consultants in 2015, 2014 and 2013, respectively. We have also issued common stock to consultants and vendors in exchange for services either performed or to be performed for us. For these stockissuances, we record a prepaid asset equal to the fair market value of the shares on the date of issuance and amortize the fair value of the shares to ouroperating expenses on a pro-rata basis as services are performed or goods are received. In 2015, 2014 and 2013, we issued 18,077, 71,239 and 66,853 sharesof common stock, respectively, in exchange for goods or services. In 2015, 2014 and 2013, we recognized approximately $53,000, $158,000 and $202,000,respectively, of expense in connection with stock grants to consultants and vendors. As of120 2015 2014 2013Dividend yield 0% 0% 0%Expected volatility range 0.654 to 1.392 0.835 to 1.666 0.506 to 1.391Risk-free interest rate range 0.11% to 0.28% 0.06% to 0.15% 0.09% to 0.21%Expected term range 6 mos to 12 mos 6 mos to 12 mos 6 mos to 12 mosTable of ContentsGERON CORPORATIONNOTES TO FINANCIAL STATEMENTS (Continued)8. STOCKHOLDERS' EQUITY (Continued)December 31, 2015, we have recognized operating expenses for the fair value of all stock issuances to consultants and vendors.Common Stock Reserved for Future Issuance Common stock reserved for future issuance as of December 31, 2015 is as follows:401(k) Plan We sponsor a defined-contribution savings plan under Section 401(k) of the Internal Revenue Code covering all full-time U.S. employees, or the Geron401K Plan. Participating employees may contribute up to the annual Internal Revenue Service contribution limit. The Geron 401K Plan also permits us toprovide discretionary matching and profit sharing contributions. The Geron 401K Plan is intended to qualify under Section 401 of the Internal RevenueCode so that contributions by employees or by us, and income earned on the contributions, are not taxable to employees until withdrawn from the Geron401K Plan. Our contributions, if any, will be deductible by us when made. Prior to 2014, our board of directors approved matching contributions for the Geron 401K Plan in our common stock which vested ratably over four yearsfor each year of service completed by the employee, commencing from the date of hire, until they are fully vested when the employee has completed fouryears of service. Due to the number of positions eliminated in the March 2015 and April 2013 restructurings, partial plan terminations were triggered in 2015and 2013. We accelerated the vesting of unvested prior employer matches for employees affected by the respective restructurings, which resulted in $53,000and $266,000 of operating expenses in 2015 and 2013, respectively. As of December 31, 2015, approximately $111,000 remained unvested for the 2013 and2012 matches which will be amortized to operating expenses as the corresponding years of service are completed by the employees.121Outstanding stock options 17,205,683 Options and awards available for grant 12,054,916 Employee stock purchase plan 942,365 Warrants outstanding 537,893 Total 30,740,857  Table of ContentsGERON CORPORATIONNOTES TO FINANCIAL STATEMENTS (Continued)9. INCOME TAXES Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reportingpurposes and the amounts used for income tax purposes. Significant components of our deferred tax assets are as follows: We record net deferred tax assets to the extent we believe these assets will more likely than not be realized. In making such determination, we considerall available positive and negative evidence, including scheduled reversals of deferred tax liabilities, projected future taxable income, tax planning strategiesand recent financial performance. Forming a conclusion that a valuation allowance is not required is difficult when there is negative evidence such ascumulative losses in recent years. Because of our history of losses, the net deferred tax assets have been fully offset by a valuation allowance. The valuationallowance decreased by $2,300,000, $3,300,000 and $5,500,000 during the years ended December 31, 2015, 2014 and 2013, respectively. Approximately$4,900,000 of the valuation allowance for deferred tax assets relates to benefits of stock option deductions which, when recognized, will be allocated directlyto contributed capital. No income tax benefit was realized from stock options exercised in 2015. As of December 31, 2015, we had domestic federal net operating loss carryforwards of approximately $763,000,000 expiring at various dates beginningin 2018 through 2034, and state net operating loss carryforwards of approximately $404,000,000 expiring at various dates beginning in 2015 through 2035,if not utilized. We also had federal research and development tax credit carryforwards of approximately $16,300,000 expiring at various dates beginning in2018 through 2035, if not utilized. Our state research and development tax credit carryforwards of approximately $13,200,000 carry forward indefinitely. Due to the change of ownership provisions of the Tax Reform Act of 1986, utilization of a portion of our domestic net operating loss and tax creditcarryforwards may be limited in future periods. Further, a portion of the carryforwards may expire before being applied to reduce future income tax liabilities. We adopted the provision of the standard for accounting for uncertainties in income taxes on January 1, 2007. Upon adoption, we recognized no materialadjustment in the liability for unrecognized tax benefits. At December 31, 2015, we had approximately $20,100,000 of unrecognized tax benefits, none ofwhich would currently affect our effective tax rate if recognized due to our deferred tax assets being fully offset by a valuation allowance.122 December 31, 2015 2014 (In thousands) Net operating loss carryforwards $276,100 $281,300 Research credits 25,000 23,400 Capitalized research and development 1,400 2,100 License fees 300 500 Other—net 9,800 7,600 Total deferred tax assets 312,600 314,900 Valuation allowance for deferred tax assets (312,600) (314,900)Net deferred tax assets $— $— Table of ContentsGERON CORPORATIONNOTES TO FINANCIAL STATEMENTS (Continued)9. INCOME TAXES (Continued) A reconciliation of the beginning and ending amounts of unrecognized tax benefits is as follows (in thousands): If applicable, we would classify interest and penalties related to uncertain tax positions in income tax expense. Through December 31, 2015, there hasbeen no interest expense or penalties related to unrecognized tax benefits. We do not currently expect any significant changes to unrecognized tax benefits during the fiscal year ended December 31, 2016. In certain cases, ouruncertain tax positions are related to tax years that remain subject to examination by the relevant tax authorities. Tax years for which we have carryforwardnet operating loss and credit attributes remain subject to examination by federal and most state tax authorities. In significant foreign jurisdictions, primarilyScotland and Hong Kong, the 2004 through 2015 tax years generally remain subject to examination by their respective tax authorities.10. SEGMENT INFORMATION Our executive management team represents our chief decision maker. We view our operations as one segment, the discovery and development oftherapeutic products for oncology. As a result, the financial information disclosed herein materially represents all of the financial information related to ourprincipal operating segment.11. STATEMENTS OF CASH FLOWS DATA We have not made any cash payments for taxes or interest for the years ended December 31, 2015, 2014 and 2013.123Balance as of December 31, 2014 $17,100 Increase related to prior year tax positions 2,300 Increase related to current year tax positions 700 Settlements — Reductions due to lapse of applicable statute of limitations — Balance as of December 31, 2015 $20,100 Year Ended December 31, 2015 2014 2013 (In thousands) Supplemental operating activities: Issuance of common stock for 401(k) matching contributions $— $313 $839 Reclassification between deposits and other current assets $— $190 $219 Supplemental investing activities: Net unrealized loss on marketable securities $(129)$(70)$(54)Table of ContentsGERON CORPORATIONNOTES TO FINANCIAL STATEMENTS (Continued)12. SELECTED QUARTERLY FINANCIAL INFORMATION (UNAUDITED) Basic and diluted net income (loss) per share are computed independently for each of the quarters presented. Therefore, the sum of the quarters may notbe equal to the full year net income (loss) per share amounts.124 FirstQuarter SecondQuarter ThirdQuarter FourthQuarter (In thousands, except per share amounts) Year Ended December 31, 2015: Revenues(1) $537 $251 $35,363 $220 Operating expenses 9,993 9,730 8,343 8,864 Net (loss) income (9,315) (9,356) 27,185 (8,468)Basic and diluted net (loss) income per share $(0.06)$(0.06)$0.17 $(0.05)Year Ended December 31, 2014: Revenues $474 $341 $160 $178 Operating expenses 9,205 9,004 10,067 9,189 Net loss (8,440) (8,734) (9,549) (8,947)Basic and diluted net loss per share $(0.06)$(0.06)$(0.06)$(0.06)(1)The third quarter of 2015 includes the full recognition of the $35,000,000 upfront payment from Janssen as collaboration revenue. SeeNote 4 on Collaboration and License Agreement.Table of Contents ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE None. ITEM 9A. CONTROLS AND PROCEDURES (I) Evaluation of Disclosure Controls and Procedures We have carried out an evaluation under the supervision and with the participation of management, including our principal executive officer andprincipal financial officer, of our disclosure controls and procedures (as defined in Rule 13a-15(e) of the Securities Exchange Act of 1934, as amended) as ofthe end of the period covered by this annual report on Form 10-K. Based on their evaluation, our principal executive officer and principal financial officerconcluded that our disclosure controls and procedures were effective as of December 31, 2015. It should be noted that any system of controls, however well designed and operated, can provide only reasonable assurance, and not absolute assurance,that the objectives of the system are met. In addition, the design of any control system is based in part upon certain assumptions about the likelihood offuture events. Because of these and other inherent limitations of control systems, there can be no assurance that any design will succeed in achieving itsstated goals in all future circumstances. Accordingly, our disclosure controls and procedures are designed to provide reasonable, not absolute, assurance thatthe objectives of our disclosure control system are met and, as set forth above, our principal executive officer and principal financial officer have concluded,based on their evaluation as of the end of the period covered by this report, that our disclosure controls and procedures were effective to provide reasonableassurance that the objectives of our disclosure control system were met.(II) Changes in Internal Control over Financial Reporting There was no change in our internal control over financial reporting during the quarter ended December 31, 2015 that has materially affected, or isreasonably likely to materially affect, our internal control over financial reporting.125Table of Contents(III) Management's Report on Internal Control over Financial Reporting Internal control over financial reporting refers to the process designed by, or under the supervision of, our Chief Executive Officer and Chief FinancialOfficer, and effected by our board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financialreporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles, and includes thosepolicies and procedures that:(1)Pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of our assets; (2)Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance withgenerally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of ourmanagement and directors; and (3)Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that couldhave a material effect on the financial statements. Management is responsible for establishing and maintaining an adequate internal control over financial reporting for us. Internal control over financialreporting cannot provide absolute assurance of achieving financial reporting objectives because of its inherent limitations. Internal control over financialreporting is a process that involves human diligence and compliance and is subject to lapses in judgment and breakdowns resulting from human failures.Internal control over financial reporting also can be circumvented by collusion or improper management override. Because of such limitations, there is a riskthat material misstatements may not be prevented or detected on a timely basis by internal control over financial reporting. However, these inherentlimitations are known features of the financial reporting process. Therefore, it is possible to design into the process safeguards to reduce, though noteliminate, this risk. Under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, weconducted an evaluation of the effectiveness of our internal control over financial reporting based on the framework set forth in "Internal Control—IntegratedFramework" issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework). Based on our evaluation under theframework set forth in "Internal Control—Integrated Framework," our management concluded that our internal control over financial reporting was effectiveas of December 31, 2015. The effectiveness of our internal control over financial reporting as of December 31, 2015 has been audited by Ernst & Young LLP,an independent registered public accounting firm, as stated in their report which is included herein.126Table of Contents(IV) Report of Independent Registered Public Accounting FirmThe Board of Directors and Stockholders of Geron Corporation We have audited Geron Corporation's internal control over financial reporting as of December 31, 2015, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria). GeronCorporation's management is responsible for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness ofinternal control over financial reporting included in the accompanying Management's Report on Internal Control over Financial Reporting. Ourresponsibility is to express an opinion on the company's internal control over financial reporting based on our audit. We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards requirethat we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in allmaterial respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weaknessexists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures aswe considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion. A company's internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financialreporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company's internalcontrol over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately andfairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary topermit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the companyare being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regardingprevention or timely detection of unauthorized acquisition, use, or disposition of the company's assets that could have a material effect on the financialstatements. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluationof effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree ofcompliance with the policies or procedures may deteriorate. In our opinion, Geron Corporation maintained, in all material respects, effective internal control over financial reporting as of December 31, 2015 basedon the COSO criteria. We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the balance sheets of GeronCorporation as of December 31, 2015 and 2014, and the related statements of operations, comprehensive loss, stockholders' equity and cash flows for each ofthe three years in the period ended December 31, 2015 of Geron Corporation and our report dated March 10, 2016 expressed an unqualified opinion thereon./s/ Ernst & Young LLPRedwood City, CaliforniaMarch 10, 2016 ITEM 9B. OTHER INFORMATION None.127Table of Contents PART III Certain information required by Part III is omitted from this annual report on Form 10-K because we will file with the U.S. Securities and ExchangeCommission a definitive proxy statement pursuant to Regulation 14A in connection with the solicitation of proxies for Geron's Annual Meeting ofStockholders expected to be held in May 2016, or the Proxy Statement, not later than 120 days after the end of the fiscal year covered by this annual reporton Form 10-K, and certain information included therein is incorporated herein by reference. ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE Identification of Directors and Nominees for Director The information required by this item concerning our directors and nominees for director is incorporated by reference from the section captioned"Proposal 1: Election of Directors" contained in our Proxy Statement.Identification of Executive Officers The information required by this item concerning our executive officers is set forth in Part I, Item 1 of this annual report on Form 10-K.Code of Ethics We have adopted a Code of Conduct with which every person who works for Geron, including our board of directors, is expected to comply. The Code ofConduct is publicly available on our website under the Investor Relations section at www.geron.com. This website address is intended to be an inactive,textual reference only; none of the material on this website is part of this annual report on Form 10-K. If any substantive amendments are made to the Code ofConduct or any waiver granted, including any implicit waiver, from a provision of the Code to our Chief Executive Officer, Chief Financial Officer orCorporate Controller, we will disclose the nature of such amendment or waiver on that website or in a report on Form 8-K. Copies of the Code of Conduct will be furnished without charge to any person who submits a written request directed to the attention of our CorporateSecretary, at our offices located at 149 Commonwealth Drive, Suite 2070, Menlo Park, California, 94025.Section 16(a) Compliance Information concerning Section 16(a) beneficial ownership reporting compliance is incorporated by reference from the section captioned "Section 16(a)Beneficial Ownership Reporting Compliance" contained in the Proxy Statement.Certain Corporate Governance Matters The information required by this item concerning our audit committee, audit committee financial expert and procedures by which stockholders mayrecommend nominees to our board of directors, may be found under the section captioned "Corporate Governance Matters" contained in the Proxy Statement. ITEM 11. EXECUTIVE COMPENSATION The information required by this item is incorporated by reference from the sections captioned "Compensation Discussion and Analysis," "CompensationCommittee Report," "Executive Compensation Tables," "Compensation of Directors" and "Compensation Committee Interlocks and Insider Participation"contained in the Proxy Statement.128Table of Contents ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS The information required by this item is incorporated by reference from the sections captioned "Equity Compensation Plans" and "Security Ownership ofCertain Beneficial Owners and Management" contained in the Proxy Statement. ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE The information required by this item is incorporated by reference from the sections captioned "Proposal 1: Election of Directors" and "CertainTransactions" contained in the Proxy Statement. ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES The information required by this item is incorporated by reference from the section captioned "Principal Accountant Fees and Services" contained in theProxy Statement. PART IV ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES (a)(1) Financial Statements Included in Part II, Item 8 of this Report:(2)Financial Statement Schedules Financial statement schedules are omitted because they are not required or the information is disclosed in the financial statements listed in Item 15(a)(1)above.(3)Exhibits See Exhibit Index.129 Page Report of Independent Registered Public Accounting Firm 89 Balance Sheets—December 31, 2015 and 2014 90 Statements of Operations—Years Ended December 31, 2015, 2014 and 2013 91 Statements of Comprehensive Loss—Years Ended December 31, 2015, 2014 and 2013 92 Statements of Stockholders' Equity—Years Ended December 31, 2015, 2014 and 2013 93 Statements of Cash Flows—Years Ended December 31, 2015, 2014 and 2013 94 Notes to Financial Statements 95 Table of Contents SIGNATURES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on itsbehalf by the undersigned, thereunto duly authorized.130 GERON CORPORATIONDate: March 10, 2016 By: /s/ OLIVIA K. BLOOMOLIVIA K. BLOOMExecutive Vice President, Finance,Chief Financial Officer and TreasurerTable of Contents POWER OF ATTORNEY KNOW BY ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints, jointly and severally, JohnA. Scarlett, M.D., and Olivia K. Bloom, and each one of them, attorneys-in-fact for the undersigned, each with the power of substitution, for the undersignedin any and all capacities, to sign any and all amendments to this annual report on Form 10-K, and to file the same, with exhibits thereto and other documentsin connection therewith, with the Securities and Exchange Commission, hereby ratifying and confirming all that each of said attorneys-in-fact, or his or hersubstitutes, may do or cause to be done by virtue hereof. IN WITNESS WHEREOF, each of the undersigned has executed this Power of Attorney as of the date indicated opposite his/her name. Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of theRegistrant and in the capacities and on the dates indicated.131Signature Title Date /s/ JOHN A. SCARLETTJOHN A. SCARLETT President, Chief Executive Officer and Director(Principal Executive Officer) March 10, 2016/s/ OLIVIA K. BLOOMOLIVIA K. BLOOM Executive Vice President, Finance, ChiefFinancial Officer and Treasurer (PrincipalFinancial and Accounting Officer) March 10, 2016/s/ DANIEL M. BRADBURYDANIEL M. BRADBURY Director March 10, 2016/s/ KARIN EASTHAMKARIN EASTHAM Director March 10, 2016/s/ HOYOUNG HUHHOYOUNG HUH Director March 10, 2016/s/ V. BRYAN LAWLISV. BRYAN LAWLIS Director March 10, 2016/s/ SUSAN M. MOLINEAUXSUSAN M. MOLINEAUX Director March 10, 2016/s/ ROBERT J. SPIEGELROBERT J. SPIEGEL Director March 10, 2016Table of Contents EXHIBIT INDEX Incorporation by ReferenceExhibitNumber Description ExhibitNumber Filing Filing Date File No. 2.1 Asset Contribution Agreement by and among Geron Corporation, BioTime, Inc. andAsterias Biotherapeutics, Inc. (formerly known as BioTime Acquisition Corporation) 2.1 8-K January 8, 2013 000-20859 3.1 Restated Certificate of Incorporation 3.3 8-K May 18, 2012 000-20859 3.2 Certificate of Amendment of the Restated Certificate of Incorporation 3.1 8-K May 18, 2012 000-20859 3.3 Amended and Restated Bylaws of Registrant 3.1 8-K March 19, 2010 000-20859 4.1 Form of Common Stock Certificate 4.1 10-K March 15, 2013 000-20859 4.2 Form of 2011 Warrant Attachmentto 10.1 10-Q November 3, 2011 000-20859 10.1 Form of Indemnification Agreement 10.1 10-K March 7, 2012 000-20859 10.2 1996 Directors' Stock Option Plan, as amended* Appendix B Def 14A April 15, 2003 000-20859 10.3 Amended and Restated 2002 Equity Incentive Plan* 4.1 S-8 June 4, 2010 333-167349 10.4 Form of Stock Option Agreement under 2002 Equity Incentive Plan* 10.6 10-K March 15, 2013 000-20859 10.5 Amended and Restated 2006 Directors' Stock Option Plan* 10.5 10-Q November 7, 2013 000-20859 10.6 2011 Incentive Award Plan* 10.1 8-K May 16, 2011 000-20859 10.7 Form of Stock Option Agreement under 2011 Incentive Award Plan* 10.11 10-K March 15, 2013 000-20859 10.8 Form of Restricted Stock Award Agreement under 2011 Incentive Award Plan* 10.12 10-K March 15, 2013 000-20859 10.9 Form of Non-Employee Director Stock Option Agreement under 2011 IncentiveAward Plan* 10.2 10-Q May 7, 2015 000-20859 10.10 2014 Employee Stock Purchase Plan* 10.1 8-K May 23, 2014 000-20859 10.11 Stock Purchase Agreement between the Registrant and Angiochem, Inc., effective asof January 5, 2011 10.1 8-K January 7, 2011 000-20859 10.12†California Institute for Regenerative Medicine Notice of Loan Award 10.1 10-Q November 3, 2011 000-20859Table of Contents Incorporation by ReferenceExhibitNumber Description ExhibitNumber Filing Filing Date File No. 10.13 Amended and Restated Severance Plan, effective as of May 23, 2013* 10.1 8-K May 24, 2013 000-20859 10.14 Employment agreement between the Registrant and John A. Scarlett, M.D.,effective as of September 29, 2011* 10.2 10-Q November 3, 2011 000-20859 10.15 First Amendment to Employment Agreement between the Registrant and John A.Scarlett, M.D., effective as of February 11, 2014* 10.5 8-K February 14, 2014 000-20859 10.16 Employment agreement between the Registrant and Stephen N. Rosenfield,effective as of February 16, 2012* 10.32 10-K March 7, 2012 000-20859 10.17 First Amendment to Employment Agreement between the Registrant and StephenN. Rosenfield, effective as of September 24, 2013* 10.4 8-K September 27, 2013 000-20859 10.18 Employment agreement between the Registrant and Andrew J. Grethlein,effective as of September 17, 2012* 10.2 10-Q November 2, 2012 000-20859 10.19 First Amendment to Employment Agreement between the Registrant and AndrewJ. Grethlein, effective as of February 11, 2014* 10.4 8-K February 14, 2014 000-20859 10.20 Employment agreement between the Registrant and Olivia K. Bloom, effective asof December 7, 2012* 10.26 10-K March 15, 2013 000-20859 10.21 First Amendment to Employment Agreement between the Registrant and OliviaK. Bloom, effective as of September 24, 2013* 10.2 8-K September 27, 2013 000-20859 10.22 Second Amendment to Employment Agreement between the Registrant andOlivia K. Bloom, effective as of February 11, 2014* 10.1 8-K February 14, 2014 000-20859 10.23 Employment agreement between the Registrant and Melissa A. Kelly Behrs,effective as of January 31, 2013* 10.28 10-K March 15, 2013 000-20859 10.24 First Amendment to Employment Agreement between the Registrant and MelissaA. Kelly Behrs, effective as of September 24, 2013* 10.1 8-K September 27, 2013 000-20859Table of Contents Incorporation by ReferenceExhibitNumber Description ExhibitNumber Filing Filing Date File No. 10.25 Second Amendment to Employment Agreement between the Registrant andMelissa A. Kelly Behrs, effective as of February 11, 2014* 10.2 8-K February 14, 2014 000-20859 10.26†Office Lease Agreement by and between the Registrant and ExponentRealty, LLC, effective as of February 29, 2012 10.36 10-K/A March 27, 2012 000-20859 10.27 Fifth Amendment to Office Lease Agreement by and between the Registrant andExponent Realty, LLC, effective as of September 15, 2015 10.1 8-K September 18, 2015 000-20859 10.28 At Market Issuance Sales Agreement, dated August 28, 2015, by and between theRegistrant and MLV & Co. LLC 10.1 8-K August 28, 2015 000-20859 10.29†Collaboration and License Agreement by and between the Registrant andJanssen Biotech, Inc., dated November 13, 2014 10.36 10-K March 11, 2015 000-20859 10.30 Non-Employee Director Compensation Policy, as amended* 12.1 Computation of Ratio of Earnings to Fixed Charges 23.1 Consent of Independent Registered Public Accounting Firm 24.1 Power of Attorney (see signature page) 31.1 Certification of Chief Executive Officer pursuant to Form of Rule 13a-14(a), asAdopted Pursuant to Section 302(a) of the Sarbanes-Oxley Act of 2002, datedMarch 10, 2016 31.2 Certification of Chief Financial Officer pursuant to Form of Rule 13a-14(a), asAdopted Pursuant to Section 302(a) of the Sarbanes-Oxley Act of 2002, datedMarch 10, 2016 Table of Contents Incorporation by ReferenceExhibitNumber Description ExhibitNumber Filing Filing Date File No. 32.1 Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, asAdopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, datedMarch 10, 2016** 32.2 Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, asAdopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, datedMarch 10, 2016** 101 The following materials from the Registrant's annual report on Form 10-K for theyear ended December 31, 2015, formatted in Extensible Business ReportingLanguage (XBRL) include: (i) Balance Sheets as of December 31, 2015 and2014, (ii) Statements of Operations, Comprehensive Loss, Stockholders' Equityand Cash Flows for each of the three years in the period ended December 31,2015, and (iii) Notes to Financial Statements. †Confidential treatment has been granted for certain portions of this exhibit. Omitted information has been filed separately with the Securities andExchange Commission. *Management contract or compensation plan or arrangement. **The certifications attached as Exhibits 32.1 and 32.2 that accompany this annual report on Form 10-K, are not deemed filed with the Securities andExchange Commission and are not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, orthe Securities Exchange Act of 1934, as amended (whether made before or after the date of this Form 10-K), irrespective of any general incorporationlanguage contained in such filing.EXHIBIT 10.30 GERON CORPORATIONNON-EMPLOYEE DIRECTOR COMPENSATION POLICY ORIGINALLY ADOPTED BY THE BOARD OF DIRECTORS: MARCH 10, 2014 AMENDED BY THE BOARD OF DIRECTORS: FEBRUARY 11, 2016 Each member of the board of directors (the “Board”) of Geron Corporation (the “Company”) who is not an Employee (as defined in the GeronCorporation 2011 Incentive Award Plan (the “2011 Plan”)) (each, a “Non-Employee Director”) will be eligible to receive cash and equity compensation asset forth in this Geron Corporation Non-Employee Director Compensation Policy (this “Policy”). The cash and equity compensation described in this Policywill be paid or granted, as applicable, automatically and without further action of the Board to each Non-Employee Director who is eligible to receive suchcash or equity compensation, unless such Non-Employee Director declines the receipt of such cash or equity compensation by written notice to theCompany. This Policy will become effective on the date it is approved by the Board (as set forth above). Capitalized terms not explicitly defined in thisPolicy but defined in the 2011 Plan will have the same definitions as in the 2011 Plan. 1. CASH COMPENSATION. (a) Annual Retainers. Each Non-Employee Director will be eligible to receive the following annual retainers for service as (i) a member and/orchairperson of the Board and (ii) a member or chairperson of a committee of the Board (“Committee”) set forth below, as applicable. Board or Committee Type of Retainer* Amount (Per Year)BoardChair$30,000Member$42,500Audit CommitteeChair$25,000Member (Non-Chair)$12,500Compensation CommitteeChair$15,000Member (Non-Chair)$7,500Nominating and Corporate Governance CommitteeChair$10,000Member (Non-Chair)$5,000 * The chairperson of the Board is eligible to receive a retainer for service as the chairperson and an additional retainer for service as a member of the Board. The chairperson of each Committee is eligible to receive a retainer for service as the chairperson, but not an additional retainer for service as a member ofthe Committee.  The annual retainers will be paid in arrears in four equal quarterly installments, earned upon the completion of service in each calendar quarter. Notwithstanding the foregoing, each person who is elected or appointed to be a Non-Employee Director or who is appointed to serve on one of theCommittees set forth above or as the chairperson of the Board or one of the Committees set forth above, in each case other than on the first day of a calendarquarter, will be eligible to receive a pro rata amount of the annual retainers described above with respect to the calendar quarter in which such personbecomes a Non-Employee Director, a member of one of the Committees, or the chairperson of the Board or one of the Committees, as applicable, which prorata amount reflects a reduction for each day during the calendar quarter prior to the date of such election or appointment. The annual retainers will be paid on a pro-rata basis in arrears after the end of each quarter in the form of cash, or alternatively, at each Non-Employee Director’s election in January each calendar year during an open trading window in the form of fully vested shares of Common Stock issued underthe 2011 Plan based on the fair market value of the Common Stock (as determined in accordance with the 2011 Plan) on the date the retainer payment wouldotherwise have been paid (i.e., the last day of the quarter). An election to be paid in Common Stock will be applied to each quarter’s payment during thecalendar year of such election. (b) Expenses. Each Non-Employee Director will be eligible for reimbursement from the Company for all reasonable out-of-pocket expensesincurred by the Non-Employee Director in connection with his or her attendance at Board and Committee meetings. To the extent that any taxable reimbursements are provided to a Non-Employee Director, they will be provided in accordance with Section 409A ofthe Internal Revenue Code of 1986, as amended, and the Treasury Regulations and other guidance thereunder and any state law of similar effect, including,but not limited to, the following provisions: (i) the amount of any such expenses eligible for reimbursement during the Non-Employee Director’s taxable yearmay not affect the expenses eligible for reimbursement in any other taxable year; (ii) the reimbursement of an eligible expense must be made no later than thelast day of the Non-Employee Director’s taxable year that immediately follows the taxable year in which the expense was incurred; and (iii) the right to anyreimbursement may not be subject to liquidation or exchange for another benefit. 2. EQUITY COMPENSATION. The options described in this Policy will be granted under the 2011 Plan and will be subject to the terms andconditions of the 2011 Plan and the applicable Award Agreements. (a) Initial Grants. Each person who first becomes a Non-Employee Director, whether through election by the stockholders of the Company orappointment by the Board to fill a vacancy, automatically will be granted a nonqualified stock option to purchase 100,000 shares of Common Stock (a “FirstDirector Option”) on the date of his or her initial election or appointment to be a Non-Employee Director. For the avoidance of doubt, the ExecutiveChairman of the Board will not be eligible to receive a First Director Option pursuant to this Section 2(a). 2 (b) Annual Grants. On the date of each annual meeting of the Company’s stockholders, each person who is then a Non-Employee Director andwill be continuing as a Non-Employee Director following the date of such annual meeting (other than any Non-Employee Director receiving a First DirectorOption on the date of such annual meeting) automatically will be granted a nonqualified stock option to purchase 50,000 shares of Common Stock (a“Subsequent Director Option”). For the avoidance of doubt, the Executive Chairman of the Board will not be eligible to receive a Subsequent DirectorOption pursuant to this Section 2(b). (c) Terms of Options. (i) Exercise Price. The exercise price of each First Director Option and Subsequent Director Option will be equal to 100% of the fairmarket value of the Common Stock subject to such option (as determined in accordance with the 2011 Plan) on the date such option is granted. (ii) Vesting. Each First Director Option and Subsequent Director Option will vest and become exercisable as follows: (A) Each First Director Option will vest and become exercisable in installments cumulatively as to 33 1/3% of the shares ofCommon Stock subject to such option on each of the first, second and third anniversaries of the date of grant of such option, subject to the Non-EmployeeDirector’s continuous service with the Company or an Affiliate through such dates. (B) Each Subsequent Director Option will vest and become exercisable as to 100% of the shares of Common Stock subject tosuch option on the earlier of (i) the date of the next annual meeting of the Company’s stockholders or (ii) the first anniversary of the date of grant of suchoption, subject to the Non-Employee Director’s continuous service with the Company or an Affiliate through such dates. (C) Notwithstanding Sections 2(c)(ii)(A) and 2(c)(ii)(B) above, the vesting of a First Director Option and Subsequent DirectorOption will be subject to (i) full acceleration in the event of a Change in Control and (ii) partial acceleration in the event of the Non-Employee Director’sTermination of Service by reason of the Non-Employee Director’s total and permanent disability (as defined in Section 22(e)(3) of the Code) or deathpursuant to, and in accordance with, each Award Agreement. 3. TERM OF POLICY. This Policy shall continue in effect until the expiration of the 2011 Plan; provided, however, that it may be revised orrescinded by action of the Board prior to such date. 3QuickLinks -- Click here to rapidly navigate through this document EXHIBIT 12.1 RATIO OF EARNINGS TO FIXED CHARGES Our earnings were insufficient to cover fixed charges for the years ended December 31, 2014, 2013, 2012 and 2011. The following table sets forth ourratio of earnings to fixed charges for the year ended December 31, 2015 and our deficiency of earnings to cover fixed charges for the years endedDecember 31, 2014, 2013, 2012 and 2011. Amounts shown are in thousands. Year Ended December 31, 2015 2014 2013 2012 2011 Earnings: Income (loss) before tax $46 $(35,670)$(38,379)$(68,881)$(96,853)Fixed charges(1) 219 234 356 369 452 Total earnings $265 $(35,436)$(38,023)$(68,512)$(96,401)Ratio of earnings to fixed charges(2) 1.2 N/A N/A N/A N/A Coverage deficiency N/A $(35,436)$(38,023)$(68,512)$(96,401)(1)Fixed charges consist of estimated interest expense on outstanding lease liabilities, amortization of debt discount and accrual ofinterest on outstanding debt. (2)The ratio of earnings to fixed charges was computed by dividing total earnings by fixed charges.QuickLinksEXHIBIT 12.1RATIO OF EARNINGS TO FIXED CHARGESQuickLinks -- Click here to rapidly navigate through this document EXHIBIT 23.1 CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM We consent to the incorporation by reference in the following Registration Statements:1)Registration Statement (Form S-3 No. 333-206659) and in the related prospectuses and prospectus supplements, 2)Registration Statement (Form S-3 No. 333-171611) and in the related prospectuses and prospectus supplements, 3)Registration Statement (Form S-8 No. 333-174350) pertaining to the 2011 Incentive Award Plan, the 2002 Equity Incentive Plan, the 1996Directors' Stock Option Plan and the 1992 Stock Option Plan, 4)Registration Statement (Form S-8 No. 333-167349) pertaining to the 2002 Equity Incentive Plan, 5)Registration Statement (Form S-8 No. 333-161035) pertaining to the 2002 Equity Incentive Plan, 6)Registration Statement (Form S-8 No. 333-136330) pertaining to the 2002 Equity Incentive Plan and the 2006 Directors' Stock Option Plan, 7)Registration Statement (Form S-8 No. 333-107276) pertaining to the 1996 Directors' Stock Option Plan, and 8)Registration Statement (Form S-8 No. 333-196677) pertaining to the 2014 Employee Stock Purchase Plan;of our reports dated March 10, 2016, with respect to the financial statements of Geron Corporation and the effectiveness of internal control over financialreporting of Geron Corporation, included in this Annual Report (Form 10-K) of Geron Corporation for the year ended December 31, 2015.Redwood City, CaliforniaMarch 10, 2016 /s/ Ernst & Young LLPQuickLinksEXHIBIT 23.1CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMQuickLinks -- Click here to rapidly navigate through this document EXHIBIT 31.1 CERTIFICATION PURSUANT TOFORM OF RULE 13A-14(A)AS ADOPTED PURSUANT TOSECTION 302(A) OF THE SARBANES-OXLEY ACT OF 2002 I, John A. Scarlett, M.D., certify that:1.I have reviewed this annual report on Form 10-K of Geron Corporation; 2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport; 3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; 4.The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: (a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, toensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within thoseentities, particularly during the period in which this report is being prepared; (b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under oursupervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements forexternal purposes in accordance with generally accepted accounting principles; (c)Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and (d)Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recentfiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely tomaterially affect, the registrant's internal control over financial reporting; and 5.The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to theregistrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions): (a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and (b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internalcontrol over financial reporting.Date: March 10, 2016/s/ JOHN A. SCARLETTJOHN A. SCARLETT, M.D.President and Chief Executive Officer QuickLinksEXHIBIT 31.1CERTIFICATION PURSUANT TO FORM OF RULE 13A-14(A) AS ADOPTED PURSUANT TO SECTION 302(A) OF THE SARBANES-OXLEY ACT OF2002QuickLinks -- Click here to rapidly navigate through this document EXHIBIT 31.2 CERTIFICATION PURSUANT TOFORM OF RULE 13A-14(A)AS ADOPTED PURSUANT TOSECTION 302(A) OF THE SARBANES-OXLEY ACT OF 2002 I, Olivia K. Bloom, certify that:1.I have reviewed this annual report on Form 10-K of Geron Corporation; 2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport; 3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; 4.The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: (a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, toensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within thoseentities, particularly during the period in which this report is being prepared; (b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under oursupervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements forexternal purposes in accordance with generally accepted accounting principles; (c)Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and (d)Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recentfiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely tomaterially affect, the registrant's internal control over financial reporting; and 5.The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to theregistrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions): (a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and (b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internalcontrol over financial reporting.Date: March 10, 2016/s/ OLIVIA K. BLOOMOLIVIA K. BLOOMExecutive Vice President, Finance,Chief Financial Officer and Treasurer QuickLinksEXHIBIT 31.2CERTIFICATION PURSUANT TO FORM OF RULE 13A-14(A) AS ADOPTED PURSUANT TO SECTION 302(A) OF THE SARBANES-OXLEY ACT OF2002QuickLinks -- Click here to rapidly navigate through this document EXHIBIT 32.1 CERTIFICATION PURSUANT TO18 U.S.C. SECTION 1350,AS ADOPTED PURSUANT TOSECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 Pursuant to 18 U.S.C. Section 1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned officer of Geron Corporation (the"Company") hereby certifies, to such officer's knowledge, that:(i)the accompanying annual report on Form 10-K of the Company for the year ended December 31, 2015 (the "Report") fully complies with therequirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and (ii)the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of theCompany. This certification accompanies the Form 10-K to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to beincorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended(whether made before or after the date of the Form 10-K), irrespective of any general incorporation language contained in such filing.Dated: March 10, 2016 /s/ JOHN A. SCARLETTJOHN A. SCARLETT, M.D.President and Chief Executive OfficerQuickLinksEXHIBIT 32.1CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002QuickLinks -- Click here to rapidly navigate through this document EXHIBIT 32.2 CERTIFICATION PURSUANT TO18 U.S.C. SECTION 1350,AS ADOPTED PURSUANT TOSECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 Pursuant to 18 U.S.C. Section 1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned officer of Geron Corporation (the"Company") hereby certifies, to such officer's knowledge, that:(i)the accompanying annual report on Form 10-K of the Company for the year ended December 31, 2015 (the "Report") fully complies with therequirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and (ii)the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of theCompany. This certification accompanies the Form 10-K to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to beincorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended(whether made before or after the date of the Form 10-K), irrespective of any general incorporation language contained in such filing.Dated: March 10, 2016 /s/ OLIVIA K. BLOOMOLIVIA K. BLOOMExecutive Vice President, Finance,Chief Financial Officer and TreasurerQuickLinksEXHIBIT 32.2CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

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