Cidara Therapeutics Inc
Annual Report 2017

Plain-text annual report

UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington, D.C. 20549 FORM 10-K (Mark One)ýýANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the fiscal year ended December 31, 2017ORooTRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THETRANSITION PERIOD FROM TO Commission File Number 001-36912 CIDARA THERAPEUTICS, INC.(Exact name of Registrant as specified in its charter) Delaware 46-1537286(State or Other Jurisdiction ofIncorporation or Organization) (I.R.S. EmployerIdentification No.) 6310 Nancy Ridge Drive, Suite 101San Diego, CA 92121 (858) 752-6170(Address of Principal Executive Offices) (Registrant’s Telephone Number, Including Area Code)Securities registered pursuant to Section 12(b) of the Act: Common Stock, Par Value $0.0001 Per Share; Common Stock traded on the NASDAQ Global MarketSecurities registered pursuant to Section 12(g) of the Act: NoneIndicate by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. YES o NO ýIndicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. YES o NO ýIndicate 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 1934 during the preceding12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. YES ýNO oIndicate by check mark whether the Registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submittedand posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the Registrant was required to submit and post suchfiles). YES ý NO oIndicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of Registrant’sknowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. oIndicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growthcompany.Large accelerated filer o Accelerated filer xNon-accelerated filer o (Do not check if a small reporting company) Small reporting company oEmerging growth company x If an emerging growth company, indicate by check mark if the Registrant has elected not to use the extended transition period for complying with any new or revised financialaccounting standards provided pursuant to Section 13(a) of the Exchange Act. oIndicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES o NO ýThe aggregate market value of the voting and non-voting common equity held by non-affiliates of the Registrant, based on the closing price of the shares of common stock onThe NASDAQ Global Market on June 30, 2017, was approximately $102.8 million.The number of shares of Registrant’s common stock outstanding as of February 20, 2018 was 20,771,151.DOCUMENTS INCORPORATED BY REFERENCEPortions of the Registrant’s definitive Proxy Statement to be filed with the Securities and Exchange Commission pursuant to Schedule 14A in connection with the registrant’s2018 Annual Meeting of Stockholders, which will be filed subsequent to the date hereof, are incorporated by reference into Part III of this Form 10-K. Such definitive proxystatement will be filed with the Securities and Exchange Commission not later than 120 days following the end of the Registrant’s fiscal year ended December 31, 2017.CIDARA THERAPEUTICS, INC.Table of Contents PagePART I Item 1. Business3Item 1A. Risk Factors19Item 1B. Unresolved Staff Comments47Item 2. Properties47Item 3. Legal Proceedings47Item 4. Mine Safety Disclosures47 PART II Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities48Item 6. Selected Financial Data49Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations50Item 7A. Quantitative and Qualitative Disclosures About Market Risk57Item 8. Financial Statements and Supplementary Data58Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure75Item 9A. Controls and Procedures75Item 9B. Other Information75 PART III Item 10. Directors, Executive Officers and Corporate Governance77Item 11. Executive Compensation77Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters77Item 13. Certain Relationships and Related Transactions, and Director Independence77Item 14. Principal Accounting Fees and Services77 PART IV Item 15. Exhibits, Financial Statement Schedules78 SIGNATURES CIDARA THERAPEUTICS, INC.SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTSThis Annual Report on Form 10-K contains forward-looking statements. We may, in some cases, use words such as “anticipate,” “believe,” “could,”“estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of those terms, and similarexpressions that convey uncertainty of future events or outcomes to identify these forward-looking statements. Any statements contained hereinthat are not statements of historical facts may be deemed to be forward-looking statements. Forward-looking statements in this Annual Report onForm 10-K include, but are not limited to, statements about:•our anticipated timing for preclinical development, regulatory submissions, commencement and completion of clinical trials and productapprovals;•our plans to research, develop and commercialize our product candidates;•our ability to fund our working capital requirements;•our expected clinical trial designs and regulatory pathways;•our ability to obtain and maintain regulatory approval of our product candidates and any related restrictions, limitations, and/or warnings inthe label of an approved product candidate;•our ability to successfully commercialize, and our expectations regarding future therapeutic and commercial potential with respect to, ourproduct candidates;•the size and growth potential of the markets for our product candidates, and our ability to serve those markets;•the rate and degree of market acceptance of our products that are approved;•our ability to develop sales and marketing capabilities, whether alone or with potential future collaborators;•regulatory developments in the United States and foreign countries;•the performance of our third-party suppliers and manufacturers;•the success of competing therapies that are or may become available;•our expectations for the attributes of our product and development candidates, including pharmaceutical properties, efficacy, safety anddosing regimens;•our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to obtain additionalfinancing;•our ability to obtain and maintain intellectual property protection for our product candidates;•our ability to use our Cloudbreak immunotherapy platform to identify development candidates, or to expand our Cloudbreak immunotherapyplatform to other areas of infective disease;•our ability to identify and develop new product candidates;•the potential for prophylactic use of any of our product candidates;•our ability to retain and recruit key personnel;•our financial performance; and•developments and projections relating to our competitors or our industry.These forward-looking statements reflect our management’s beliefs and views with respect to future events and are based on estimates andassumptions as of the date of this Annual Report on Form 10-K and are subject to risks and uncertainties. We discuss many of these risks ingreater detail under “Risk Factors.” Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time totime. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to whichany factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we maymake. Given these uncertainties, you should not place undue reliance on these forward-looking statements.You should read this Annual Report on Form 10-K and the documents that we reference and have filed as exhibits to the Annual Report on Form10-K completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of theforward-looking statements in this Annual Report on Form 10-K by these cautionary statements. Except as required by law, we undertake noobligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.2CIDARA THERAPEUTICS, INC.PART IItem 1. Business.We are a biotechnology company focused on the discovery, development and commercialization of novel anti-infectives for the treatment ofdiseases that are inadequately addressed by current standard of care therapies. We are developing a balanced pipeline of product anddevelopment candidates, with an initial focus on serious fungal and bacterial infections. Our lead product candidate is rezafungin acetate, formerlyknown as CD101 IV, an intravenous formulation of a novel echinocandin. Rezafungin acetate has been approved as the internationalnonproprietary name, or INN, for CD101 by the World Health Organization, and as a United States Adopted Name, or USAN, for CD101 by theUSAN Council.Rezafungin is being developed as a once-weekly, high-exposure therapy for the treatment and prevention of serious, invasive fungal infections. Inaddition, we are developing our antibody-drug conjugates for multidrug-resistant bacterial infections as part of our proprietary Cloudbreak™platform, which is designed to discover compounds that directly kill pathogens and also direct a patient’s immune system to attack and eliminatebacterial, fungal or viral pathogens.We are focused on the anti-infectives market, which we believe has the following advantages for the development of innovative products:•a high correlation between efficacy in preclinical animal models and outcomes of clinical trials for systemic disease;•a regulatory environment that provides developers of anti-infectives opportunities to reduce development costs and time to market;•an ability to commercialize anti-infective products with a focused sales and marketing organization for inpatient and outpatient settings;and•attractive commercial opportunities in certain segments of the market, such as the estimated $4.2 billion global prescription systemicantifungal market in which there is high unmet need, high mortality rate and few new agents in development.RezafunginRezafungin is a novel molecule in the echinocandin class of antifungals. We are developing rezafungin for the treatment and prevention of serious,invasive fungal infections. These infections include candidemia and invasive candidiasis, fungal infections associated with high mortality rates.We have completed enrollment in a Phase 2 randomized clinical trial, called the STRIVE study, evaluating the safety, tolerability and efficacy ofonce-weekly dosing of rezafungin compared to once-daily dosing of caspofungin in patients with candidemia and invasive candidiasis. TheSTRIVE study was designed to enroll at least 90 patients in the microbiological intent-to-treat, or mITT, population, with a target of approximately30 patients in each of two rezafungin dosing arms and 30 patients receiving the comparator drug, caspofungin. We expect topline data from thisstudy in the first quarter of 2018. With this sample size, the study is not powered to detect statistical differences among the treatment andcomparator arms; the primary purpose of the study is to select a rezafungin dosing regimen for subsequent testing in a statistically powered Phase3 study versus caspofungin.Cloudbreak Immunotherapy PlatformWe continue to advance our Cloudbreak immunotherapy platform, which we believe has broad potential applications across a wide spectrum ofinfectious diseases, including bacterial, fungal and viral infections. We believe that our Cloudbreak immunotherapy platform is a fundamentallynew approach for the treatment of infectious disease. To date, we have generated preclinical, in vivo proof of concept data in both our Cloudbreakantibacterial program and our Cloudbreak antifungal program.We had selected a lead Cloudbreak development candidate, CD201, a bispecific antimicrobial immunotherapy for the treatment of multidrug-resistant Gram-negative bacterial infections. Based on preclinical studies of CD201 as well as preclinical studies of antibody-drug conjugates, orADCs, from our Cloudbreak program, we have decided to cease development of CD201 to focus on the more promising ADCs for the sameindication. We had received a grant from the Combating Antibiotic Resistance Accelerator, or CARB-X, to help advance the development ofCD201. Based on our decision to focus efforts on our ADCs, we will no longer be seeking funding under our CARB-X grant agreement relating toCD201.3CIDARA THERAPEUTICS, INC.Our StrategyOur objective is to become the leading biotechnology company in the discovery, development and commercialization of novel, best-in-class anti-infectives. Key elements of our strategy include:•Rapidly advance our initial antifungal and antibacterial candidates to commercialization. We plan to leverage the favorableregulatory environment for anti-infectives to expedite the development of our product and development candidates.•Continue to invest in our Cloudbreak immunotherapy platform. We believe that our Cloudbreak immunotherapy platform has broadpotential applications across a wide spectrum of infectious diseases, including bacterial, fungal and viral infections. We intend to pursuethe generation of new Cloudbreak development candidates to strengthen our pipeline. In addition, we will continue to establish intellectualproperty related to this platform, its applications and development candidates.•Commercialize products in the United States with a targeted sales force. The anti-infectives market benefits from an ability toaddress large sales opportunities with a relatively small, specialized commercial organization. We currently intend to build and manage atargeted sales and marketing organization to commercialize our products, if approved, in the United States, addressing the relatively smallbase of well-defined customers for the treatment and prevention of serious infections in both the hospital and outpatient settings. Ingeographies outside the United States, we may seek to collaborate with other parties to commercialize our products.RezafunginWe acquired rezafungin, a novel echinocandin antifungal agent, in 2014. We believe rezafungin has the potential to be differentiated from otherechinocandins and other classes of antifungal agents based on its prolonged half-life, high Cmax, or maximum concentration reached, safety andtolerability profile, lack of drug-drug interactions, tissue penetration and high AUC, or area under the curve, which measures the overall drugexposure per dose.Rezafungin is being developed as a once-weekly, high-exposure therapy for the treatment and prevention of serious, invasive fungal infections.Overview of Systemic Fungal Infections and the Antifungal MarketFungal infections pose significant medical challenges in both hospital and outpatient settings. While fungi are ubiquitous in our environment, theyare usually harmless for people with a normal immune system. If fungi access and proliferate in the bloodstream, these infections becomesystemic and potentially life-threatening. Risk factors for systemic fungal infections include recent gastrointestinal surgery, broad-spectrumantibiotic use, central vascular catheter placement, use of total parenteral nutrition, renal failure, solid organ transplantation, bone marrowtransplantation, and other forms of immune suppression.We estimate that the annual worldwide sales of prescription systemic antifungals are approximately $4.2 billion. This includes therapies used asprophylaxis (preventive) in the inpatient and outpatient setting, therapies used for the treatment of hospitalized patients, and therapies used for thetreatment of patients who are being discharged from the hospital.The majority of hospital infections are caused by two fungi, Candida and Aspergillus. These fungi are responsible for over 90% of theapproximately 97,000 annual deaths in the United States that we estimate are associated with fungal infections. Systemic Candida infectionsinclude candidemia and related cases of invasive candidiasis. In the United States, candidemia is the most common cause of hospital-acquiredbloodstream infections. While the limited data available on hospitalized patients varies widely, rates of between one and two cases per 1,000hospital admissions have been reported in the United States, Europe and Latin America.Despite advances achieved in the diagnosis and treatment of candidemia, these infections continue to cause high mortality rates. According to astudy published in Clinical Infectious Disease (2009), candidemia has a mortality rate of 35% within 12 weeks of diagnosis. By contrast, the CDCreports that the mortality rate due to MRSA infections is 12.8%. Further, it is estimated that each case of candidemia results in an additional 23days of hospitalization and over $68,000 in treatment costs.Physicians’ options for the treatment of fungal infections are limited by a lack of innovative therapies.Several factors have contributed to the low rate of antifungal and antibiotic drug development, including a previously challenging regulatoryenvironment that necessitated large and costly clinical trials. As a result, the number of anti-infectives in development has decreased, while anti-microbial resistance has increased due to overuse of existing agents.The current treatment alternatives for systemic fungal infections, including polyenes, azoles and currently-approved echinocandins, havelimitations that we believe may be addressed by novel antifungals. While these drugs have proven to4CIDARA THERAPEUTICS, INC.be efficacious in many patients, mortality rates remain high, and the polyenes and azoles may cause severe side effects warrantingdiscontinuation and are known to cause drug interactions that can limit their utility.Echinocandins, introduced in 2001, are increasingly recommended for the treatment of fungal infections in the United States. In December 2015,the Infectious Diseases Society of America, or the IDSA, released new clinical guidelines that recognize the important role of echinocandins in theinitial treatment of invasive fungal infections. The guidelines recommend a shift to echinocandins as first-line treatment for invasive candidiasisand candidemia. The approved echinocandins include caspofungin, micafungin, and anidulafungin, and are considered both well tolerated and safe relative to otherantifungal drug classes. However, they must be administered daily by IV infusion, potentially extending the hospitalization of patients for theduration of therapy and limiting their use mainly to the hospital setting. Despite this limitation, the use of echinocandins in the outpatient setting isgrowing at approximately ten percent per year, and the total days of therapy for this class are shifting from inpatient to outpatient therapy. Thistrend is reflective of an increased need for broad spectrum Candida coverage, increasing azole resistance and complications due to the complexityof patients, and a financial incentive to discharge patients earlier to reduce hospital costs.In addition, the U.S. Centers for Disease Control and Prevention, or the CDC, reports that certain species of Candida are becoming increasinglyresistant to available antifungals, such as the azoles and approved echinocandins. Widespread usage of antifungals in the azole class, inparticular, has stimulated an increase in resistance. Non-albicans Candida, which have a higher rate of azole resistance, now causeapproximately two-thirds of candidemia cases in the US. In a recent study of cancer patients with Candida infections from MD Anderson CancerCenter, patient prognosis was inversely correlated with resistance to caspofungin. Patients infected with the most drug-sensitive strains had a 28-day survival rate of 75% compared to only 25% for those with caspofungin-resistant strains.In order to be effective, an echinocandin drug should be present early in therapy at an exposure that is as high as is safely possible. The keypharmacokinetic parameters affecting exposure include the drug’s half-life, C max and AUC. The maximum dose that can be used is based on thedrug’s overall safety profile. With echinocandin drugs, high drug exposures early in therapy, as measured by C max or AUC, maximize theantifungal therapeutic benefit of these drugs.When a fungus starts to develop resistance to a drug, the minimum inhibitory concentration, or MIC, rises, which means that a higher drugexposure will be required in order for the drug to have the same efficacy as it has against sensitive strains. Having a C max and an AUC that arefar greater than the starting MIC provides the best chance of treating infections caused by strains resistant to other antifungals, including otherechinocandins. A recent analysis suggests that micafungin, the market leader in the US, achieves only 85% target attainment, meaning that 15%of the time, not enough drug is available to sufficiently kill Candida albicans. Additionally, the EU label for caspofungin requires higher doses inobese patients, suggesting pharmacokinetics are not optimized.Despite the widespread continued use of each class of antifungals, we believe that market opportunities exist for novel therapeutics whichcombine the spectrum and safety of the echinocandins with a more convenient dosing schedule enabled by improved pharmacokineticcharacteristics.Our Solution—Rezafungin for the Treatment and Prevention of Serious Fungal InfectionsDue to its novel chemical structure, rezafungin has a prolonged half-life, a high Cmax and a high AUC. In addition, rezafungin was tested in vitroagainst 23 echinocandin-non-susceptible Candida isolates and demonstrated equivalent or greater potency against these strains compared tocaspofungin, with up to eight-fold greater potency for several isolates. Rezafungin was also tested in vitro against 100 isolates of Candida auris, ahighly resistant emerging strain, including nine isolates that were resistant to other echinocandins, and showed equivalent or better potency thanthe currently available echinocandins, with up to eight-fold greater average potency against the echinocandin-resistant strains than the otherechinocandins.These factors are in contrast to all other echinocandins, and we believe they can allow rezafungin to be developed as a once-weekly IV therapy forthe treatment and prevention of systemic fungal infections. We are developing rezafungin to overcome the limitations of the echinocandin classand other antifungals by offering the following key benefits.•Potential to treat resistant pathogens. We believe that rezafungin can be used to treat fungal infections caused by drug-resistant fungi,including those currently resistant to echinocandins, due to its potency against resistant strains and its higher drug exposure early in thecourse of therapy. We expect that this higher exposure early in the course of disease will improve outcomes in infections caused by bothresistant as well as non-resistant pathogens.•Single-agent treatment. Rather than treating patients with an IV echinocandin followed by an oral azole solely to enable earlier hospitaldischarge, rezafungin would enable extended single-agent echinocandin treatment for the full course of therapy, thereby enabling treatmentthat is consistent with current guidance in the United States and European Union.5CIDARA THERAPEUTICS, INC.•Shorter and less costly hospital stays, and lower outpatient costs. Physicians with access to a once-weekly echinocandin canpotentially discharge appropriate patients earlier and thereby reduce hospital costs, which account for over 70% of the overall treatmentcost of candidemia. Furthermore, early discharge from the hospital setting may reduce the risk for contracting nosocomial infections. Forpatients discharged on an echinocandin, once-weekly rezafungin could eliminate significant outpatient infusion costs for once-daily IVechinocandin therapy. •Improved compliance. A once-weekly treatment of rezafungin could facilitate compliance by eliminating the need for patients to return toa hospital or outpatient center for a daily dose of an IV echinocandin, and could eliminate the likelihood of patient non-compliance forthose receiving oral step down therapy with a daily azole. •Enabling or improving prophylaxis regimens. Some patients cannot receive azole prophylactic therapy due to drug interactions or poortolerability. We expect that once weekly rezafungin therapy could provide for better prophylactic therapy on an inpatient and outpatientbasis, particularly for these patients.The FDA has granted rezafungin designations for orphan drug, Qualified Infectious Disease Product, or QIDP, and fast track for the treatment ofcandidemia and invasive candidiasis. The orphan drug designation provides eligibility for seven years of market exclusivity in the United Statesupon FDA approval, a waiver from payment of user fees, an exemption from performing clinical studies in pediatric patients, and tax credits for thecost of the clinical research. The QIDP designation, provided under the Generating Antibiotic Incentives Now Act, or the GAIN Act, offers certainincentives for the development of new antibacterial or antifungal drugs, including eligibility for fast track designation, priority review and, ifapproved by the FDA, eligibility for an additional five years of marketing exclusivity. Fast track designation enables more frequent interactionswith FDA to expedite drug development and review. The seven-year period of marketing exclusivity provided through orphan designation combinedwith an additional five years of marketing exclusivity provided by the QIDP designation positions rezafungin with a total of 12 years of marketingexclusivity to be granted at the time of FDA approval. We have also either applied for or are planning to seek QIDP, fast track and orphan drugdesignations for rezafungin for prophylaxis, as well as an orphan drug designation for rezafungin for treatment and prophylaxis in Europe.Rezafungin Clinical ResultsClinical StudiesIn November 2015, we obtained data from our single ascending dose, or SAD, study of rezafungin. This was a Phase 1, randomized, double-blind,placebo-controlled, dose-escalation study to determine the safety, tolerability, and pharmacokinetics of single intravenous doses of rezafungin inhealthy subjects. Results demonstrated that rezafungin was well tolerated in all dose cohorts after single doses of 50 mg, 100 mg, 200 mg, and400 mg. Rezafungin exhibited a pharmacokinetic profile consistent with preclinical data and supportive of once-weekly dosing.In January 2016, we obtained data from our multiple ascending dose, or MAD, Phase 1 study. This was a Phase 1, randomized, double-blind,placebo-controlled, dose-escalation study to determine the safety, tolerability, and pharmacokinetics of multiple intravenous doses of rezafungin inhealthy subjects. Results demonstrated that rezafungin was well tolerated in all dose cohorts after multiple doses of 100 mg, 200 mg, and 400 mg.Rezafungin exhibited a pharmacokinetic profile consistent with preclinical data and supportive of once-weekly dosing.For both Phase 1 studies, there were no serious adverse events, or SAEs, severe Treatment Emergent Adverse Events, or TEAEs, orrelationships for overall TEAEs. The majority of TEAEs were mild, and all TEAEs completely resolved by the end of the study. There were nodrug-related TEAEs resulting from clinically significant hematology or clinical chemistry laboratory abnormalities at any dose. In addition, therewere no safety issues related to electrocardiograms, vital signs, or physical exam findings.Based on clinical results to date, we expect a single dose of rezafungin to provide sufficient drug exposure for a period of seven days. In contrast,a single dose of anidulafungin provides sufficient drug exposure for only one day. The graph below presents the pharmacokinetic results from oursingle ascending dose Phase 1 clinical trial.6CIDARA THERAPEUTICS, INC.Pharmacokinetic Properties of Rezafungin Based on results from our single ascending dose trial, rezafungin has a prolonged half-life of greater than 80 hours in humans. Rezafungin has thepotential to be safely developed as a once-weekly IV drug for the effective and convenient treatment and prevention of serious, invasive fungalinfections in the inpatient or outpatient settings.Rezafungin demonstrated a Cmax and an AUC significantly higher than other approved echinocandins. Based on the higher drug exposuredemonstrated by rezafungin early in the course of therapy and high, sustained tissue concentration at the site of infection, we believe thatrezafungin can be used to treat some fungal infections caused by less susceptible fungi, including some of those currently resistant toechinocandins. We expect that this higher exposure and enhanced tissue penetration early in the course of disease will improve outcomes ininfections caused by both resistant as well as non-resistant pathogens.Clinical Development PlanWe have completed enrollment in the STRIVE Phase 2 randomized clinical trial evaluating the safety, tolerability and efficacy of once-weeklydosing of rezafungin compared to once-daily dosing of caspofungin in patients with candidemia and invasive candidiasis. The STRIVE study wasdesigned to enroll at least 90 patients in the microbiological intent-to-treat, or mITT, population, with a target of approximately 30 patients in eachof two rezafungin dosing arms and 30 patients receiving the comparator drug, caspofungin. We expect topline data from this study in the firstquarter of 2018. With this sample size, the study is not powered to detect statistical differences among the treatment and comparator arms; theprimary purpose of the study is to select a rezafungin dosing regimen for subsequent testing in a statistically powered Phase 3 study versuscaspofungin.We recently received feedback from the U.S. Food and Drug Administration, or FDA, that the results of the STRIVE Phase 2 study, along with theresults of a single Phase 3 study with a non-inferiority margin of 20%, together with data from our Phase 1 studies, may be supportive ofregistration for rezafungin in the U.S. for treatment of candidemia and invasive candidiasis in patients with limited or no treatment options,assuming positive efficacy and safety results.Pending final results from the STRIVE study, and subject to feedback from European regulators, we plan to conduct a single randomized, double-blind, controlled Phase 3 pivotal clinical trial in approximately 150 patients with candidemia and invasive candidiasis.With this Phase 3 study size, we estimate that the total number of patients exposed to our selected dose and duration of rezafungin treatment willbe less than the target safety database of 300 patients. For this reason, as well as to maintain enrollment momentum before the start of the Phase3 study, we are continuing enrollment at STRIVE study sites after STRIVE database lock. This continuation of the STRIVE study, which we callSTRIVE 400, will evaluate a dose selected from the STRIVE study in comparison to caspofungin in a 2:1 randomization regime. We have begunthe STRIVE 400 portion of the study using the 400mg weekly dose of rezafungin, and we will reevaluate the dose once we have the results fromthe initial portion of the STRIVE study.We believe there is significant unmet medical need for a safe and well tolerated agent with the spectrum of rezafungin in the prevention of fungalinfections in vulnerable patients, including those undergoing bone marrow or solid organ transplant or patients with hematologic malignanciesundergoing chemotherapy. We have conducted preclinical studies7CIDARA THERAPEUTICS, INC.demonstrating the efficacy of rezafungin in preventing Candida, Aspergillus and Pneumocystis infections in neutropenic animals. Based on thesestudies and in conjunction with clinical safety, tolerability and pharmacokinetic data, we believe that once-weekly rezafungin could be an effectiveprophylactic agent for invasive fungal infections in at-risk patients.Based on feedback from the FDA and the U.K. Medicines and Healthcare Products Regulatory Agency, or MHRA, we have received to date, andsubject to further European regulatory feedback, we plan to conduct a single, global, randomized, double-blind, controlled Phase 3 pivotal clinicaltrial in patients undergoing allogeneic bone marrow transplant to enable use of rezafungin in a 90-day prophylaxis regimen.Based on our interactions with the FDA and MHRA, we believe that our planned Phase 3 trial in prophylaxis, supported by the data from ourplanned Phase 3 clinical trial in the treatment of candidemia and invasive candidiasis and the remainder of our rezafungin treatment program, couldsuffice for approval of rezafungin for both the prophylaxis and treatment of invasive fungal infections.Subject to satisfactory topline results of the STRIVE study, adequate financial resources, further regulatory discussions and the completion ofpreclinical testing to support long-term dosing in prophylaxis, we believe that both Phase 3 studies could start in mid-2018 and produce toplineresults in mid-2020.Cloudbreak Immunotherapy PlatformWe continue to advance our Cloudbreak immunotherapy platform, which we believe has broad potential applications across a wide spectrum ofinfectious diseases, including bacterial, fungal and viral infections. We believe that our Cloudbreak immunotherapy platform is a fundamentally newapproach for the treatment of infectious disease. The design of the Cloudbreak immunotherapy platform recognizes that most infectious disease isdue to a temporary deficiency in the function of the immune system. Our Cloudbreak lead candidates are designed to address this deficiency byrecruiting components of the patient’s immune system to the site of infection, enabling more effective treatment. Similar to the way thatimmunotherapy has the potential to revolutionize the treatment of cancer by redirecting the immune system to destroy cancer cells, we believethat our Cloudbreak immunotherapy platform has the potential to transform the treatment of infectious disease caused by a variety of bacterial,fungal and viral pathogens.Cloudbreak has the potential to entail both small and large molecule approaches. In either case, the candidates would consist of a targetingmoiety, or TM, that recognizes a cell surface target and an effector moiety, or EM, that is recognized by the immune system. The coupling of theTM to the EM results in a bispecific molecule that can direct the immune system specifically to the targeted pathogen.Our Cloudbreak development candidates have the potential to feature the following attributes:•small or large molecule components with well-defined targets and efficient testing;•selective binding to pathogens to amplify their immunogenicity (recognition by the immune system) and thereby efficient recruitment of theinnate and adaptive immune system to assist in the rapid eradication of the pathogen;•use as adjunctive therapy along with standard of care regimens; and•broad applicability in the treatment of infectious diseases.To date, we have generated preclinical, in vivo proof of concept data in both our Cloudbreak antibacterial program and our Cloudbreak antifungalprogram.Overview of Antibacterials and ResistanceAntibacterials, also called antibiotics, are drugs used to treat infections that are caused by bacteria. Prior to the introduction of the first antibioticsin the 1930s and 1940s, bacterial infections were often fatal, and invasive surgery was accompanied by a high risk of infectious complications.Today, antibacterials are used routinely to treat and prevent infection. According to IMS Health, antibiotics accounted for $38.8 billion in salesglobally in 2012, with healthcare providers prescribing 272 million courses of antibacterials in the United States alone.There are two main varieties of bacteria, based on a common laboratory staining test known as the "Gram stain." Gram-positive bacteria aresurrounded by a single lipid membrane and a thick cell wall. Common Gram-positive pathogens include Staphylococcus aureus (includingmethicillin-resistant strains), Streptococcus species, and Clostridium difficile. In contrast, Gram-negative bacteria are encircled by two lipidmembranes, an inner membrane and an outer membrane, with a thinner cell wall in between. Gram-negative bacteria include P. aeruginosa, A.baumannii, and the Enterobacteriaceae, a family of related organisms that includes E. coli, K. pneumoniae, Enterobacter, Salmonella, and Shigellaspecies. Each membrane in Gram-negative bacteria excludes different types of chemical entities, requiring Gram-negative active antibiotics to bespecifically designed to permeate both membranes.8CIDARA THERAPEUTICS, INC.According to government agencies and physician groups, including the CDC and IDSA, one of the greatest needs for new antibiotics is to treatcarbapenem-resistant Enterobacteriaceae, or CRE, and other drug-resistant Gram-negative pathogens. CRE leads to mortality rates of up to 50%in patients with bloodstream infections. Based on the significant increase in resistance rates in recent years, we anticipate CRE will continue to bea major health problem. For example, CDC surveillance data indicates that the rate of carbapenem resistance in Klebsiella species, a member ofthe Enterobacteriaceae, increased from 1.6% to 10.4% in the hospital setting in the United States between 2001 and 2011. In Italy, K. pneumoniaecarbapenem resistance rates rose from 1 - 2% in 2006 to 32.9% in 2014.Further, a plasmid-borne resistance gene, mcr-1, has been discovered in bacteria that are resistant to colistin. The presence of the mcr-1 gene andits ability to share its colistin resistance with other bacteria such as CRE raise the risk that pan-resistant bacteria could develop. The gene hasbeen found primarily in Escherichia coli, but has also been identified in other members of the Enterobacteriaceae from human, animal, food andenvironmental samples on every continent.According to the CDC, at least two million people each year in the United States acquire serious infections with bacteria that are resistant to one ormore of the antibiotics designed to treat those infections, and each year, over 20,000 patients in the United States die from these infections.Similar problems exist throughout the world, and the World Health Organization has declared antibiotic resistance a threat to global health security.The development and spread of resistance is driven by the use of antibiotics. Once they arise, resistant bacteria can be transferred betweenpatients and antibiotic resistance mechanisms can be transferred between bacterial species, thus increasing the problem.Not only do antibiotic-resistant infections cause significant morbidity and mortality, but they also place a substantial cost burden on the healthcaresystem. In most cases, antibiotic-resistant infections require prolonged and/or costlier treatments, extend hospital stays, and necessitateadditional doctor visits and higher healthcare expenditures compared with infections that are easily treatable with antibiotics. The CDC estimatesthat the excess annual cost resulting from these infections in the United States is as high as $20 billion.Governments, in collaboration with the private sector, have begun to respond to this significant and growing unmet medical need by creatinggovernmental and non-governmental entities tasked with addressing the problem and progressing legislation for reimbursement and regulatoryreform, and economic incentives.Our SolutionWe had selected a lead Cloudbreak development candidate, CD201, a bispecific antimicrobial immunotherapy for the treatment of multidrug-resistant Gram-negative bacterial infections. Based on preclinical studies of CD201 as well as preclinical studies of ADCs from our Cloudbreakprogram, we decided in February 2018 to cease development of CD201 to focus on the more promising ADCs for the same indication. We hadreceived a grant from CARB-X to help advance the development of CD201. Based on our decision to focus efforts on our ADCs, we will no longerbe seeking funding under our CARB-X grant agreement relating to CD201.ManufacturingWe do not own or operate, and currently have no plans to establish, any manufacturing facilities. We currently rely, and expect to continue to rely,on third parties to manufacture supplies of rezafungin, any Cloudbreak development candidates, and any future product candidates.Our third-party contract manufacturers are currently producing, and will produce in the future, our product and development candidates for use inour preclinical studies and clinical trials utilizing reliable and reproducible processes and common manufacturing techniques. We obtain oursupplies from manufacturers on a purchase order basis and do not have any long-term arrangements. In addition, we do not currently have anylong-term arrangements in place for bulk drug substance or drug product services. We intend to identify and qualify additional manufacturers toprovide bulk drug substance and drug product services prior to submission of any NDA to the FDA as necessary to ensure sufficient commercialquantities of each product.Intellectual PropertyThe proprietary nature of, and protection for, rezafungin, our ADCs, our Cloudbreak immunotherapy platform, our processes and our know-how areimportant to our business. We seek to protect our proprietary position through patent protection in the United States and internationally whereavailable and when appropriate. Our policy is to pursue, obtain, maintain and defend patent rights, developed internally and/or potentially licensedfrom third parties, and to protect the technology, inventions and improvements that are commercially important to the development of ourbusiness. We also rely on trade secrets that may be important to the development of our business. We cannot be sure that patents will be grantedwith respect to any of our pending patent applications or with respect to any patent applications filed by us in the future, nor can we be sure thatany of our existing patents or any patents that may be granted to us in the future will be9CIDARA THERAPEUTICS, INC.commercially useful in protecting our inventions, improvements and technology. For this and more comprehensive risks related to our intellectualproperty, please see “Risk Factors-Risks Related to Our Intellectual Property.”Our success will depend significantly on our ability to:•obtain and maintain patent and other proprietary protection for the technology, inventions and improvements we consider important to ourbusiness;•defend and enforce our current and potential future patents;•preserve the confidentiality of our trade secrets; and•operate our business without infringing the patents and proprietary rights of third parties.We have established, and will continue to build, proprietary positions for rezafungin, any other product candidates and technology in the UnitedStates and abroad. As of February 27, 2018, our patent portfolio included 12 families of patent applications related to various aspects ofrezafungin, and nine families of patent applications related to our Cloudbreak immunotherapy platform.For our issued patents related to rezafungin, we expect the last to expire in 2033, excluding any additional term for patent term adjustments orapplicable patent term extensions.With respect to our Cloudbreak immunotherapy platform, any patents that result from our currently pending applications would be expected toexpire between 2034 and 2038, excluding any additional term for patent term adjustments or applicable patent term extensions.Market exclusivity is the exclusive marketing right granted by the FDA and certain foreign equivalents upon the approval of a drug if certainstatutory requirements are met. When granted, the applicable regulatory authority will not approve another application to market the same drug forthe same indication during the period of market exclusivity. The length of market exclusivity depends on the type of exclusivity granted. Weintend to seek market exclusivity on our product candidates where appropriate.We have received orphan drug designation from the FDA for rezafungin for the treatment of candidemia and invasive candidiasis. An orphan drugdesignation by the FDA makes rezafungin eligible for seven years of market exclusivity in candidemia and invasive candidiasis.In addition to the orphan drug designation, rezafungin was designated as a Qualified Infectious Disease Product under the GAIN Act, making iteligible for an additional five years of market exclusivity.Further, we seek trademark protection in the United States and internationally where available and when appropriate. We have filed for trademarkprotection in several countries for the Cidara trademark, which we use in connection with our pharmaceutical research and development servicesand our pharmaceutical compounds. We currently have registered trademarks for the Cidara mark in the United States, the European Union, andAustralia and pending trademark applications in Canada, and we have a registered trademark for the Cloudbreak mark in the United States for ourpharmaceutical preparations for the treatment or prevention of infectious diseases.CompetitionThe biopharmaceutical industry is characterized by intense and dynamic competition to develop new technologies and proprietary therapies. Anyproduct candidates that we successfully develop and commercialize will have to compete with existing therapies and new therapies that maybecome available in the future. We believe that rezafungin and any Cloudbreak development candidates we pursue in the future, paralleled with ourscientific and development expertise in the field of anti-infectives, provide us with competitive advantages over our peers. However, we facepotential competition from various sources, including larger and better-funded pharmaceutical, specialty pharmaceutical, and biotechnologycompanies, as well as from generic drug manufacturers, academic institutions, governmental agencies and public and private research institutions.Rezafungin will primarily compete with antifungal classes for the treatment of candidemia, which include polyenes, azoles and echinocandins. Theapproved branded therapies for this indication include Cancidas (caspofungin, marketed by Merck & Co.), Eraxis (anidulafungin, marketed byPfizer, Inc.) and Mycamine (micafungin, marketed by Astellas Pharma US, Inc.). There will be generics one or more of the current echinocandinsavailable at the time of rezafungin market approval, which will create added competition. In addition, there are other generic products approved forcandidemia, marketed by companies such as Baxter Healthcare Corporation, Mylan Inc. and Glenmark Generics Inc., among others. In addition toapproved therapies, we expect that rezafungin will compete with product candidates that we are aware of in clinical development by third parties,such as SCY-078, which is being developed by Scynexis, Inc.Cloudbreak antibacterial drug candidates will compete against approved and investigational agents for the treatment of bacterial infections. Weintend to develop other product candidates from our Cloudbreak immunotherapy platform for the10CIDARA THERAPEUTICS, INC.treatment of invasive fungal, bacterial or viral infections. We are aware of a number of approved and investigational therapies in these areas.Many of our competitors, either alone or with their strategic partners, have substantially greater financial, technical and human resources than wedo and significantly greater experience in the discovery and development of product candidates, obtaining FDA and other regulatory approvals oftreatments and commercializing those treatments. These same competitors may invent technology that competes with our Cloudbreakimmunotherapy platform.Mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated among asmaller number of our competitors. These competitors also compete with us in recruiting and retaining qualified scientific and managementpersonnel and establishing clinical study sites and subject enrollment for clinical studies, as well as in acquiring technologies complementary to, ornecessary for, our programs. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborativearrangements with large and established companies.We expect any treatments that we develop and commercialize to compete on the basis of, among other things, efficacy, safety, convenience ofadministration and delivery, price, the level of generic competition and the availability of reimbursement from government and other third-partypayers.Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective,have fewer or less severe side effects, are more convenient or are less expensive than any products that we may develop. Our competitors alsomay obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours, which could result in ourcompetitors establishing a strong market position before we are able to enter the market. In addition, we expect that our products, if approved, willbe priced at a significant premium over competitive generic products and our ability to compete may be affected in many cases by insurers orother third-party payers seeking to encourage the use of generic products.Government RegulationGovernment authorities in the United States, at the federal, state and local level and in other countries extensively regulate, among other things,the research, development, testing, manufacture, including any manufacturing changes, packaging, storage, recordkeeping, labeling, advertising,promotion, distribution, marketing, post-approval monitoring and reporting, import and export of pharmaceutical products, such as those we aredeveloping.United States Drug Approval ProcessIn the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or FDCA, and implementing regulations. Theprocess of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulationsrequires the expenditure of substantial time and financial resources. Failure to comply with the applicable United States requirements at any timeduring the product development process, approval process or after approval may subject an applicant to a variety of administrative or judicialsanctions, such as the FDA’s refusal to approve pending applications, withdrawal of an approval, imposition of a clinical hold, issuance of warningletters and untitled letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals ofgovernment contracts, restitution, disgorgement of profits or civil or criminal penalties.The process required by the FDA before a drug may be marketed in the United States generally involves the following:•contract manufacturing expenses, primarily for the production of clinical supplies;•completion of preclinical laboratory tests, animal studies and formulation studies in compliance with the FDA’s good laboratory practice, orGLP, regulations;•submission to the FDA of an investigational new drug application, or IND, which must become effective before human clinical trials maybegin;•approval by an independent institutional review board, or IRB, at each clinical site before each trial may be initiated;•performance of adequate and well-controlled human clinical trials in accordance with good clinical practices, or GCP, to establish thesafety and efficacy of the proposed drug for each indication;•submission to the FDA of a new drug application, or NDA;•satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assesscompliance with current good manufacturing practices, or cGMP, requirements and to assure11CIDARA THERAPEUTICS, INC.that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity; and•FDA review and approval of the NDA.Preclinical Studies and INDPreclinical studies include laboratory evaluation of product chemistry and formulation, as well as in vitro and animal studies to assess the potentialfor adverse events, and in some cases, to establish a rationale for therapeutic use. The conduct of preclinical studies is subject to federalregulations and requirements, including GLP regulations for safety/toxicology studies. An IND sponsor must submit the results of the preclinicaltests, together with manufacturing information, analytical data, any available clinical data or literature and plans for clinical trials, among otherthings, to the FDA as part of an IND. Some long-term preclinical testing, such as animal tests of reproductive adverse events and carcinogenicity,may continue after the IND is submitted. An IND automatically becomes effective 30 days after receipt by the FDA, unless before that time, theFDA raises concerns or questions related to one or more proposed clinical trials and places the trial on clinical hold. In such a case, the INDsponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. As a result, submission of an IND may not resultin the FDA allowing clinical trials to commence.Clinical TrialsClinical trials involve the administration of the investigational new drug to human subjects under the supervision of qualified investigators inaccordance with GCP requirements, which include, among other things, the requirement that all research subjects provide their informed consentin writing before their participation in any clinical trial. Clinical trials are conducted under written study protocols detailing, among other things, theobjectives of the study, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. A protocol for each clinicaltrial and any subsequent protocol amendments must be submitted to the FDA as part of the IND. In addition, an IRB at each institutionparticipating in the clinical trial must review and approve the plan for any clinical trial before it commences at that institution, and the IRB mustconduct continuing review. The IRB must review and approve, among other things, the study protocol and informed consent information to beprovided to study subjects. An IRB must operate in compliance with FDA regulations.Information about certain clinical trials must be submitted within specific timeframes to the National Institutes of Health for public dissemination atwww.clinicaltrials.gov. Human clinical trials are typically conducted in three sequential phases, which may overlap or be combined:•Phase 1: The drug is initially introduced into healthy human subjects or patients with the target disease or condition and tested for safety,dosage tolerance, absorption, metabolism, distribution, excretion and, if possible, to gain an early indication of its effectiveness.•Phase 2: The drug is administered to a limited patient population to identify possible adverse effects and safety risks, to preliminarilyevaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage.•Phase 3: The drug is administered to an expanded patient population in adequate and well-controlled clinical trials to generate sufficientdata to statistically confirm the efficacy and safety of the product for approval, to establish the overall risk-benefit profile of the productand to provide adequate information for the labeling of the product.Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA and, more frequently, if serious adverseevents occur. Phase 1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified period, or at all. Furthermore,the FDA or the sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research subjects arebeing exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinicaltrial is not being conducted in accordance with the IRB’s requirements or if the drug has been associated with unexpected serious harm topatients.Marketing ApprovalAssuming successful completion of the required clinical testing, the results of the preclinical studies and clinical trials, together with detailedinformation relating to the product’s chemistry, manufacture, controls and proposed labeling, among other things, are submitted to the FDA as partof an NDA requesting approval to market the product for one or more indications. Under federal law, the submission of most NDAs is additionallysubject to a substantial application fee, and the sponsor of an approved NDA is also subject to annual program fees, which are typically increasedannually.12CIDARA THERAPEUTICS, INC.The FDA conducts a preliminary review of all NDAs within the first 60 days after submission before accepting them for filing to determine whetherthey are sufficiently complete to permit substantive review. The FDA may request additional information rather than accept an NDA for filing. Inthis event, the application must be resubmitted with the additional information. The resubmitted application is also subject to review before theFDA accepts it for filing. Once the submission is accepted for filing, the FDA begins an in-depth substantive review. The FDA has agreed tospecified performance goals in the review of NDAs. Under these goals, the FDA has committed to review most such applications for non-priorityproducts within 10 months, and most applications for priority review products, that is, drugs that the FDA determines represent a significantimprovement over existing therapy, within six months from filing. The review process may be extended by the FDA for three additional months toconsider certain information or clarification regarding information already provided in the submission. The FDA may also refer applications for noveldrugs or products that present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians and otherexperts, for review, evaluation and a recommendation as to whether the application should be approved. The FDA is not bound by therecommendations of an advisory committee, but it considers such recommendations carefully when making decisions.Before approving an NDA, the FDA typically will inspect the facility or facilities where the product is manufactured. The FDA will not approve anapplication unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate toassure consistent production of the product within required specifications. In addition, before approving an NDA, the FDA will typically inspect oneor more clinical sites to assure compliance with GCP and integrity of the clinical data submitted.The testing and approval process requires substantial time, effort and financial resources, and each may take many years to complete. Dataobtained from clinical activities are not always conclusive and may be susceptible to varying interpretations, which could delay, limit or preventregulatory approval. The FDA may not grant approval on a timely basis, or at all. We may encounter difficulties or unanticipated costs in our effortsto develop our product candidates and secure necessary governmental approvals, which could delay or preclude us from marketing our products.After the FDA’s evaluation of the NDA and inspection of the manufacturing facilities, the FDA may issue an approval letter or a complete responseletter. An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications. A completeresponse letter generally outlines the deficiencies in the submission and may require substantial additional testing or information in order for theFDA to reconsider the application. If and when those deficiencies have been addressed to the FDA’s satisfaction in a resubmission of the NDA,the FDA will issue an approval letter. The FDA has committed to reviewing such resubmissions in two or six months depending on the type ofinformation included. Even with submission of this additional information, the FDA ultimately may decide that the application does not satisfy theregulatory criteria for approval and refuse to approve the NDA. Even if the FDA approves a product, it may limit the approved indications for use ofthe product, require that contraindications, warnings or precautions be included in the product labeling, require that post-approval studies, includingPhase 4 clinical trials, be conducted to further assess a drug’s safety after approval, require testing and surveillance programs to monitor theproduct after commercialization, or impose other conditions, including distribution restrictions or other risk management mechanisms, includingRisk Evaluation and Mitigation Strategies, or REMs, which can materially affect the potential market and profitability of the product. The FDA mayprevent or limit further marketing of a product based on the results of post-market studies or surveillance programs. After approval, some types ofchanges to the approved product, such as adding new indications, manufacturing changes and additional labeling claims, are subject to furthertesting requirements and FDA review and approval.Fast Track DesignationThe FDA is required to facilitate the development and expedite the review of drugs that are intended for the treatment of a serious or life-threatening condition for which there is no effective treatment and which demonstrate the potential to address unmet medical needs for thecondition. Under the fast track program, the sponsor of a new product candidate may request the FDA to designate the product for a specificindication as a fast track product concurrent with or after the submission of the IND for the product candidate. The FDA must determine if theproduct candidate qualifies for fast track designation within 60 days after receipt of the sponsor’s request.In addition to other benefits, such as the ability of the sponsor to use surrogate endpoints in the evaluation of the pivotal clinical trials and havemore frequent interactions with the FDA, the FDA may initiate review of sections of a fast track product’s NDA before the application is complete.This rolling review is available if the applicant provides and the FDA approves a schedule for the submission of the remaining information and theapplicant pays applicable user fees. However, the FDA’s time period goal for reviewing a fast track application does not begin until the last sectionof the NDA is submitted. In addition, the fast track designation may be withdrawn by the FDA if the FDA believes that the designation is no longersupported by data emerging in the clinical trial process.13CIDARA THERAPEUTICS, INC.Priority ReviewUnder FDA policies, a product candidate may be eligible for priority review, or review generally within a six-month time frame from the time acomplete application is received. Products regulated by the FDA’s Center for Drug Evaluation and Research, or CDER, are eligible for priorityreview if they provide a significant improvement compared to marketed products in the treatment, diagnosis or prevention of a disease. A fasttrack designated product candidate would ordinarily meet the FDA’s criteria for priority review.Breakthrough Therapy DesignationA breakthrough therapy is defined as a drug that is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the product candidate may demonstrate substantial improvementover existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinicaldevelopment. Drugs designated as breakthrough therapies are also eligible for accelerated approval. The FDA must take certain actions, such asholding timely meetings and providing advice, intended to expedite the development and review of an application for approval of a breakthroughtherapy. Even if a product candidate qualifies for one or more of these programs, the FDA may later decide that the product candidate no longermeets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened.Orphan DrugsUnder the Orphan Drug Act, the FDA may grant orphan drug designation to drugs intended to treat a rare disease or condition, which is generallydefined as a disease or condition that affects fewer than 200,000 individuals in the United States. Orphan drug designation must be requestedbefore submitting an NDA. After the FDA grants orphan drug designation, the generic identity of the drug and its potential orphan use are disclosedpublicly by the FDA. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approvalprocess. The first NDA applicant to receive FDA approval for a particular active ingredient to treat a particular disease with FDA orphan drugdesignation is entitled to a seven-year exclusive marketing period in the United States for that product and for that indication. During the seven-year exclusivity period, the FDA may not approve any other applications to market the same drug for the same orphan indication, except in limitedcircumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity in that it is shown to be safer, more effectiveor makes a major contribution to patient care. Orphan drug exclusivity does not prevent the FDA from approving a different drug for the samedisease or condition, or the same drug for a different disease or condition. Among the other benefits of orphan drug designation are tax credits forcertain research and a waiver of the NDA application user fee.Qualified Infectious Disease ProductsIn response to the growing unmet medical need in the area of serious bacterial infections, the Generating Antibiotic Incentives Now Act, or theGAIN Act, is intended to provide incentives, including, for example, access to expedited FDA review for approval and five years of potentialmarket exclusivity extension, for the development of new, qualified infectious disease products, or QIDP, including antibacterial or antifungal drugsintended to treat serious or life-threatening infections that are resistant to treatment, or that treat qualifying resistant pathogens identified by theFDA. A sponsor must request QIDP designation for a new drug before an NDA is submitted. If designated as a QIDP and approved, the drug iseligible for an additional five years of exclusivity beyond any period of exclusivity to which it would have otherwise been entitled. In addition, aQIDP receives NDA priority review and fast track designation.Pediatric Exclusivity and Pediatric UseUnder the Best Pharmaceuticals for Children Act, or the BPCA, certain drugs may obtain an additional six months of exclusivity if the sponsorsubmits information requested in writing by the FDA (a Written Request) relating to the use of the active moiety of the drug in children. The FDAmay issue a Written Request for studies on unapproved or approved indications, but it may not issue a Written Request where it determines thatinformation relating to the use of a drug in a pediatric population, or part of the pediatric population, may not produce health benefits in thatpopulation.In addition, the Pediatric Research Equity Act, or PREA, requires a sponsor to conduct pediatric studies for most drugs and biologics, for a newactive ingredient, new indication, new dosage form, new dosing regimen or new route of administration. Under PREA, original NDAs, biologicslicense applications and supplements thereto, must contain a pediatric assessment unless the sponsor has received a deferral or waiver. Unlessotherwise required by regulation, PREA does not apply to any drug for an indication for which an orphan drug designation has been granted. Therequired assessment must assess the safety and effectiveness of the product for the claimed indications in all relevant pediatric subpopulationsand support dosing and administration for each pediatric subpopulation for which the product is safe and14CIDARA THERAPEUTICS, INC.effective. The sponsor or FDA may request a deferral of pediatric studies for some or all of the pediatric subpopulations. A deferral may be grantedfor several reasons, including a finding that the drug or biologic is ready for approval for use in adults before pediatric studies are complete or thatadditional safety or effectiveness data needs to be collected before the pediatric studies begin.Other Regulatory RequirementsAny drug manufactured or distributed by us pursuant to FDA approvals is subject to pervasive and continuing regulation by the FDA, including,among other things, requirements relating to recordkeeping, periodic reporting, product sampling and distribution, advertising and promotion andreporting of adverse experiences with the product. After approval, most changes to the approved product, such as adding new indications or otherlabeling claims are subject to prior FDA review and approval.The FDA may impose a number of post-approval requirements, including REMs, as a condition of approval of an NDA. For example, the FDA mayrequire post-marketing testing, including Phase 4 clinical trials, and surveillance to further assess and monitor the product’s safety andeffectiveness after commercialization.In addition, drug manufacturers and other entities involved in the manufacture and distribution of approved drugs are required to register theirestablishments with the FDA and state agencies, and are subject to periodic unannounced inspections by the FDA and these state agencies forcompliance with cGMP requirements. Changes to the manufacturing process are strictly regulated and often require prior FDA approval beforebeing implemented. FDA regulations also require investigation and correction of any deviations from cGMP and impose reporting anddocumentation requirements upon us and third-party manufacturers that we may decide to use. Accordingly, manufacturers must continue toexpend time, money and effort in the areas of production and quality control to maintain cGMP compliance.Once an approval is granted, the FDA may withdraw the approval if compliance with regulatory requirements and standards is not maintained or ifproblems occur after the product reaches the market. Later discovery of previously unknown problems with a product, including adverse events ofunanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions tothe approved labeling to add new safety information, imposition of post-market studies or clinical trials to assess new safety risks or imposition ofdistribution or other restrictions under a REMs program. Other potential consequences include, among other things:•restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls;•fines, warning letters or holds on post-approval clinical trials;•refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of productlicense approvals;•product seizure or detention, or refusal to permit the import or export of products; or •consent decrees, injunctions or the imposition of civil or criminal penalties.The FDA strictly regulates marketing, labeling, advertising and promotion of products that are placed on the market. Drugs may be promoted onlyfor the approved indications and in accordance with the provisions of the approved label. The FDA and other agencies actively enforce the lawsand regulations prohibiting the promotion of off label uses, and a company that is found to have improperly promoted off label uses may be subjectto significant liability.Additional ProvisionsIn addition to FDA restrictions on marketing of pharmaceutical products, several other types of state and federal laws restrict our businessactivities, including certain marketing practices. These laws include, without limitation, anti-kickback laws, false claims laws, data privacy andsecurity laws, as well as transparency laws regarding payments or other items of value provided to healthcare providers.The federal healthcare program anti-kickback statute prohibits, among other things, knowingly and willfully offering, paying, soliciting or receivingremuneration to induce or in return for purchasing, leasing, ordering or arranging for the purchase, lease or order of any healthcare item, good,facility or service reimbursable under Medicare, Medicaid or other federal healthcare programs. The term “remuneration” has been broadlyinterpreted to include anything of value. This statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on theone hand and prescribers, purchasers and formulary managers on the other. Although there are a number of statutory exceptions and regulatorysafe harbors protecting certain common activities from prosecution or other regulatory sanctions, the exceptions and safe harbors are drawnnarrowly, and practices that involve remuneration that are alleged to be intended to induce prescribing, purchases or recommendations may besubject to scrutiny if they do not qualify for an exception or safe harbor. Failure to meet all of the requirements of a particular applicable statutoryexception or regulatory safe harbor15CIDARA THERAPEUTICS, INC.does not make the conduct per se illegal under the federal healthcare program anti-kickback statute. Instead, the legality of the arrangement willbe evaluated on a case-by-case basis based on a cumulative review of all its facts and circumstances. Several courts have interpreted thestatute’s intent requirement to mean that if any one purpose of an arrangement involving remuneration is to induce referrals of federal healthcarecovered business, the federal healthcare program anti-kickback statute has been violated. Additionally, the intent standard under the federalhealthcare program anti-kickback statute was amended by the Patient Protection and Affordable Care Act of 2010, as amended by the Health Careand Education Reconciliation Act of 2010, collectively the Affordable Care Act, to a stricter standard such that a person or entity no longer needsto have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. In addition, the Affordable Care Actcodified case law that a claim including items or services resulting from a violation of the federal healthcare program anti-kickback statuteconstitutes a false or fraudulent claim for purposes of the federal civil False Claims Act.Federal false claims laws, including the civil False Claims Act, and civil monetary penalties laws, prohibit any person or entity from, among otherthings, knowingly presenting, or causing to be presented, a false claim for payment to the federal government, or knowingly making, or causing tobe made, a false statement to have a false claim paid. Pharmaceutical and other healthcare companies have been prosecuted under these lawsfor, among other things, allegedly inflating drug prices they report to pricing services, which in turn were used by the government to set Medicareand Medicaid reimbursement rates, and for allegedly providing free product to customers with the expectation that the customers would bill federalprograms for the product. In addition, certain marketing practices, including off-label promotion, may also violate false claims laws.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 privatethird-party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation ofa healthcare offense, and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious orfraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services. Like the federal healthcare programanti-kickback statute, the Affordable Care Act amended the intent standard for certain healthcare fraud under HIPAA such that a person or entityno longer needs to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.In addition, we may be subject to data privacy and security regulation by both the federal government and the states in which we conduct ourbusiness. HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and its implementingregulations, imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information. Amongother things, HITECH makes HIPAA’s security standards directly applicable to business associates, independent contractors or agents of coveredentities that receive or obtain protected health information in connection with providing a service on behalf of a covered entity. HITECH alsocreated four new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates,and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA lawsand seek attorneys’ fees and costs associated with pursuing federal civil actions.Additionally, the federal Physician Payments Sunshine Act, created under the Affordable Care Act, and its implementing regulations, requirecertain manufacturers of drugs, devices, biologicals and medical supplies for which payment is available under Medicare, Medicaid or theChildren’s Health Insurance Program (with certain exceptions) to report annually information related to certain payments or other transfers of valueprovided to physicians and teaching hospitals, or to entities or individuals at the request of, or designated on behalf of, the physicians andteaching hospitals, and applicable manufacturers and group purchasing organizations to report annually certain ownership and investment interestsheld by physicians and their immediate family members.The majority of states also have statutes or regulations similar to the aforementioned federal fraud and abuse laws, some of which are broader inscope and apply to items and services reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payor.Further, some state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and therelevant compliance guidance promulgated by the federal government in addition to requiring drug manufacturers to report information related topayments or other transfers of value provided to physicians and other health care providers and entities or marketing expenditures.If our operations are found to be in violation of any of the health regulatory laws described above or any other laws that apply to us, we may besubject to potentially significant criminal and civil and/or administrative penalties, damages, fines, disgorgement, imprisonment, additionalreporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws, exclusion from participation in government healthcare programs, as well as contractual damages, reputational harm,administrative burdens, diminished profits and future earnings, and the curtailment or restructuring of our operations, any of which could adverselyaffect our ability to operate our business and our results of operations.16CIDARA THERAPEUTICS, INC.Coverage and ReimbursementSales of pharmaceutical products depend in significant part on the availability of coverage and adequate reimbursement by third-party payors.Patients who are prescribed treatments for their conditions and providers performing the prescribed services generally rely on third-party payors toreimburse all or part of the associated healthcare costs. Patients and providers are unlikely to use our products unless coverage is provided andreimbursement is adequate to cover a significant portion of the cost of therapies in which our products are used. In the United States, no uniformpolicy of coverage and reimbursement for products exists among third-party payors. Therefore, coverage and reimbursement for products candiffer significantly from payor to payor. Decisions regarding the extent of coverage and amount of reimbursement to be provided for each of ourproduct candidates will be made on a plan by plan basis. One payor’s determination to provide coverage for a product does not assure that otherpayors will also provide coverage, and adequate reimbursement, for the product. Additionally, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our product candidates to each payorseparately, with no assurance that coverage and adequate reimbursement will be obtained.Healthcare ReformCurrent and future legislative proposals to further reform healthcare or reduce healthcare costs may result in lower reimbursement for our products.The cost containment measures that payors and providers are instituting and the effect of any healthcare reform initiative implemented in thefuture could significantly reduce our revenues from the sale of our products.For example, implementation of the Affordable Care Act has substantially changed healthcare financing and delivery by both governmental andprivate insurers, and significantly impacted the pharmaceutical industry. The Affordable Care Act, among other things, established an annual,nondeductible fee on any entity that manufactures or imports certain specified branded prescription drugs and biologic agents, revised themethodology by which rebates owed by manufacturers to the state and federal government for covered outpatient drugs under the Medicaid DrugRebate Program are calculated, increased the minimum Medicaid rebates owed by most manufacturers under the Medicaid Drug Rebate Program,extended the Medicaid Drug Rebate program to utilization of prescriptions of individuals enrolled in Medicaid managed care organizations, andprovided incentives to programs that increase the federal government’s comparative effectiveness research. Since its enactment there have beenjudicial and Congressional challenges to certain aspects of the Affordable Care Act, as well as recent efforts by the Trump administration to repealand replace certain aspects of the Affordable Care Act, and we expect such challenges to continue. Since January 2017, President Trump hassigned two Executive Orders and other directives designed to delay the implementation of certain provisions of the Affordable Care Act orotherwise circumvent some of the requirements for health insurance mandated by the Affordable Care Act. Concurrently, Congress has consideredlegislation that would repeal or repeal and replace all or part of the Affordable Care Act. While Congress has not passed comprehensive repeallegislation, two bills affecting the implementation of certain taxes under the Affordable Care Act have been enacted. The Tax Cuts and Jobs Act of2017 includes a provision repealing, effective January 1, 2019, the tax-based shared responsibility payment imposed by the Affordable Care Acton certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individualmandate”. Additionally, on January 22, 2018, President Trump signed a continuing resolution on appropriations for fiscal year 2018 that delayed theimplementation of certain fees mandated by the Affordable Care Act, including the so-called “Cadillac” tax on certain high cost employer-sponsoredinsurance plans, the annual fee imposed on certain health insurance providers based on market share, and the medical device excise tax on non-exempt medical devices. Further, the Bipartisan Budget Act of 2018, or the BBA, among other things, amends the Affordable Care Act, effectiveJanuary 1, 2019, to close the coverage gap in most Medicare drug plans, and also increases in 2019 the percentage that a drug manufacturermust discount the cost of prescription drugs from 50 percent under current law to 70 percent. Congress also could consider additional legislation torepeal or repeal and replace other elements of the Affordable Care Act.In addition, other legislative changes have been proposed and adopted since the Affordable Care Act was enacted. In August 2011, the Presidentsigned into law the Budget Control Act of 2011, which, among other things, created the Joint Select Committee on Deficit Reduction to recommendto Congress proposals in spending reductions. The Joint Select Committee did not achieve a targeted deficit reduction of at least $1.2 trillion forthe years 2013 through 2021, triggering the legislation’s automatic reduction to several government programs. This includes reductions to Medicarepayments to providers of 2% per fiscal year, which went into effect in April 2013 and, due to subsequent legislative amendments, including theBBA, will remain in effect through 2027 unless additional congressional action is taken. Additionally, in January 2013, the President signed into lawthe American Taxpayer Relief Act of 2012, which, among other things, reduced Medicare payments to several providers and increased the statuteof limitations period for the government to recover overpayments to providers from three to five years.Further, there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products. At thefederal level there have been several recent U.S. Congressional inquiries and proposed and17CIDARA THERAPEUTICS, INC.enacted legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare,review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies fordrugs. Further, the Trump administration’s budget proposal for fiscal year 2019 contains additional drug price control measures that could beenacted during the 2019 budget process or in other future legislation, including, for example, measures to permit Medicare Part D plans tonegotiate the price of certain drugs under Medicare Part B, to allow some states to negotiate drug prices under Medicaid and to eliminate costsharing for generic drugs for low-income patients. While any proposed measures will require authorization through additional legislation to becomeeffective, Congress and the Trump administration have each indicated that it will continue to seek new legislative and/or administrative measuresto control drug costs. At the state level, legislatures are increasingly passing legislation and implementing regulations designed to controlpharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain productaccess and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countriesand bulk purchasing.We expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts thatfederal and state governments will pay for healthcare products and services, which could result in reduced demand for our products or additionalpricing pressure.Foreign RegulationIn order to market any product outside of the United States, we would need to comply with numerous and varying regulatory requirements of othercountries regarding safety and efficacy and governing, among other things, clinical trials, marketing authorization, commercial sales anddistribution of our products. Whether or not we obtain FDA approval for a product, we would need to obtain the necessary approvals by thecomparable regulatory authorities of foreign countries before we can commence clinical trials or marketing of the product in those countries. Theapproval process varies from country to country and can involve additional product testing and additional administrative review periods. The timerequired to obtain approval in other countries might differ from and be longer than that required to obtain FDA approval. Regulatory approval in onecountry does not ensure regulatory approval in another, but a failure or delay in obtaining regulatory approval in one country may negatively impactthe regulatory process in others.New Legislation and RegulationsFrom time to time, legislation is drafted, introduced and passed in Congress that could significantly change the statutory provisions governing thetesting, approval, manufacturing and marketing of products regulated by the FDA. In addition to new legislation, FDA regulations and policies areoften revised or interpreted by the agency in ways that may significantly affect our business and our products. It is impossible to predict whetherfurther legislative changes will be enacted or whether FDA regulations, guidance, policies or interpretations changed or what the effect of suchchanges, if any, may be.EmployeesAs of February 15, 2018, we had 61 employees, 21 of whom hold Ph.D. or M.D. degrees, 44 of whom were engaged in research and developmentactivities and 17 of whom were engaged in business development, finance, information systems, facilities, human resources or administrativesupport. None of our employees is subject to a collective bargaining agreement. We consider our relationship with our employees to be good.FacilitiesWe lease a 29,638 square foot facility in San Diego, California for administrative and research and development activities. Our lease expires onDecember 31, 2018 and we have two individual two-year extension option rights. We believe that our existing facilities are adequate to meet ourcurrent needs, and that suitable additional alternative spaces will be available in the future on commercially reasonable terms.Corporate InformationWe were incorporated in Delaware as K2 Therapeutics, Inc. in December 2012. In July 2014, we changed our name to Cidara Therapeutics, Inc.Our principal executive offices are located at 6310 Nancy Ridge Drive, Suite 101, San Diego, California 92121, and our telephone number is(858) 752-6170.We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act, or the JOBS Act. We will remain an emerginggrowth company until the earlier of (1) the last day of the fiscal year (a) following the fifth anniversary of the completion of our initial public offeringin April 2015, (b) in which we have total annual gross revenue of at least $1 billion or (c) in which we are deemed to be a large accelerated filer,which requires the market value of our common18CIDARA THERAPEUTICS, INC.stock that is held by non-affiliates to exceed $700 million as of the prior June 30th, or (2) the date on which we have issued more than $1 billion innon-convertible debt during the prior three-year period. References to “emerging growth company” in this Annual Report have the meaningassociated with it in the JOBS Act.In March 2016, we formed a wholly owned subsidiary, Cidara Therapeutics UK Limited, in England for the purpose of developing our productcandidates in Europe.Legal ProceedingsFrom time to time, we may be involved in various claims and legal proceedings relating to claims arising out of our operations. We are notcurrently a party to any legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business.Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of managementresources and other factors.Available InformationWe make available free of charge on or through our internet website our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, CurrentReports on Form 8-K and all amendments to those reports as soon as reasonably practicable after such material is electronically filed with orfurnished to the Securities and Exchange Commission. We also regularly post copies of our press releases as well as copies of presentations andother updates about our business on our website. Our website address is www.cidara.com. The information contained in or that can be accessedthrough our website is not part of this Annual Report on Form 10-K. Information is also available through the Securities and ExchangeCommission’s website at www.sec.gov or is available at the Securities and Exchange Commission’s Public Reference Room located at 100 FStreet, NE, Washington DC, 20549. Information on the operation of the Public Reference Room is available by calling the Securities and ExchangeCommission at 800-SEC-0330.Item 1A. Risk Factors.You should carefully consider the following risk factors, as well as the other information in this report and in our public filings, before decidingwhether to purchase, hold or sell shares of our common stock. The occurrence of any of the following risks could harm our business, financialcondition, results of operations and/or growth prospects or cause our actual results to differ materially from those contained in forward-lookingstatements we have made in this report and those we may make from time to time.Risks Related to Drug Discovery, Development and CommercializationWe are very early in our development efforts, which may not be successful.We have completed two Phase 1 clinical trials of rezafungin, and we have completed enrollment in a Phase 2 clinical trial of rezafungin incandidemia and invasive candidiasis. We are also conducting preclinical studies of antibody-drug conjugates, or ADCs, from our Cloudbreakprogram for infections caused by multidrug-resistant Gram-negative pathogens. Because of the early stage of our development efforts, the timingand costs of the clinical development and regulatory paths we will follow and marketing approvals remain uncertain. Our ability to generate productrevenue, which we do not expect will occur for many years, if ever, will depend heavily on the successful development and eventualcommercialization of our early-stage product candidates. The success of rezafungin and any other product candidates we may develop will dependon many factors, including the following:•successful completion of preclinical studies;•successful enrollment in, and completion of, clinical trials;•demonstrating safety and efficacy;•receipt of marketing approvals from applicable regulatory authorities;•establishing clinical and commercial manufacturing capabilities or making arrangements with third-party manufacturers;•obtaining and maintaining patent and trade secret protection and non-patent exclusivity for our product candidates and technologies;•launching commercial sales of the product candidates, if and when approved, whether alone or selectively in collaboration with others;•acceptance of the product candidates, if and when approved, by patients, the medical community and third-party payers;19CIDARA THERAPEUTICS, INC.•effectively competing with other therapies;•a continued acceptable safety profile of the products following approval; and•enforcing and defending intellectual property rights and claims.If we do not accomplish one or more of these goals in a timely manner, or at all, we could experience significant delays or an inability tosuccessfully commercialize our product candidates, which would harm our business.If clinical trials of our product candidates fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities or do nototherwise produce positive results, we may incur additional costs or experience delays in completing, or ultimately be unable tocomplete, the development and commercialization of our product candidates.Before obtaining marketing approval from regulatory authorities for the sale of our product candidates, we must complete preclinical developmentand then conduct extensive clinical trials to demonstrate the safety and efficacy of our product candidates in humans. Clinical testing isexpensive, difficult to design and implement, can take many years to complete and is uncertain as to outcome. A failure of one or more clinicaltrials could occur at any stage of testing. The outcome of preclinical testing and early clinical trials may not be predictive of the success of laterclinical trials, and interim results of a particular clinical trial do not necessarily predict final results of that trial.For example, although blinded data we disclosed from a subset of approximately the first half of the total number of patients to be enrolled in theSTRIVE study showed that the overall clinical response rate on the primary endpoint of investigator's assessment of cure at day 14 was trendinghigher, and the 30-day all-cause mortality rate was trending lower, than the respective response rates of caspofungin from prior pivotal clinicaltrials, and that the blinded safety assessment of this patient subset suggested that all doses in the study were well tolerated to date, these resultsare subject to change once the full, unblinded data set is analyzed and reported by us. Because these are blinded data, we have no way ofknowing whether there is a treatment effect in any of the treatment arms on either an absolute basis or relative to any of the other treatment arms. Further, this is a discrete study that is in no way related to or dependent upon any prior clinical study of caspofungin, so it is unclear how anyhistorical outcome rate from any such prior study would relate to outcomes from this study. In addition, these results represent a small samplesize, and interim data from clinical trials are subject to the risk that one or more of the clinical outcomes may materially change as patientenrollment continues and more patient data becomes available. Preliminary interim data also remain subject to audit and verification proceduresthat may result in the final data being materially different from the preliminary interim data we analyzed. For all of the above reasons, unduereliance should not be placed on preliminary blinded interim data, and such data should be viewed with caution until the final unblinded data areavailable.Moreover, preclinical and clinical data are often susceptible to multiple interpretations and analyses. Many companies that have believed theirproduct candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval of theirproducts. For example, the historically observed high rate of correlation for clinical efficacy for antifungals, antibacterials and other anti-infectivesbased on preclinical data may not apply for our current or future product candidates, and any of the potential benefits that we anticipate for humanclinical use may not be realized.We may experience numerous unforeseen events during, or as a result of, clinical trials that could delay or prevent our ability to receive marketingapproval or commercialize our product candidates, including that:•regulators or institutional review boards may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at aprospective trial site or in a given country;•regulators may require that trials or studies be conducted, or sized or otherwise designed in ways, that were unforeseen in order to obtainmarketing authorization;•we may have delays in reaching or fail to reach agreement on acceptable clinical trial contracts or clinical trial protocols with prospectivetrial sites;•clinical trials of our product candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, toconduct additional clinical trials, modify planned clinical trial designs or abandon product development programs;•the number of patients required for clinical trials of our product candidates may be larger than we anticipate;•enrollment in these clinical trials may be slower than we anticipate, clinical sites may drop out of our clinical trials or participants may dropout of these clinical trials at a higher rate than we anticipate;•our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, orat all;20CIDARA THERAPEUTICS, INC.•regulators or institutional review boards may require that we or our investigators suspend or terminate clinical research for various reasons,including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks dueto serious and unexpected side effects;•the cost of clinical trials of our product candidates may be greater than we anticipate;•the FDA or comparable foreign regulatory authorities could require that we perform more studies than, or evaluate clinical endpoints otherthan, those that we currently expect; and•the supply of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be delayed orinsufficient, or the quality of such materials may be inadequate.If we are required to conduct additional clinical trials or other tests of our product candidates beyond those that we currently contemplate, if we areunable to complete clinical trials of our product candidates or other tests successfully or in a timely manner, if the results of these trials or testsare not positive or are only modestly positive or if there are safety concerns, we may:•be delayed in obtaining marketing approval for our product candidates;•not obtain marketing approval at all;•obtain approval for indications or patient populations that are not as broad as intended or desired;•obtain approval with labeling that includes significant use or distribution restrictions or safety warnings, including boxed warnings;•be subject to additional post-marketing testing requirements;•be subject to significant restrictions on reimbursement from public and/or private payers; or•have the product removed from the market after obtaining marketing approval.Product development costs will also increase if we experience delays in testing or in receiving marketing approvals. We do not know whether anyclinical trials will begin as planned, will need to be restructured or will be completed on schedule, or at all. Significant clinical trial delays also couldshorten any periods during which we may have the exclusive right to commercialize our product candidates, could allow our competitors to bringproducts to market before we do, could increase competition from generics of the same class, and could impair our ability to successfullycommercialize our product candidates, any of which may harm our business and results of operations.If we experience delays or difficulties in enrolling patients in clinical trials, our receipt of necessary regulatory approvals could bedelayed or prevented.We may not be able to initiate or continue clinical trials for our product candidates if we are unable to identify and enroll a sufficient number ofeligible patients to participate in these trials as required by the FDA or analogous regulatory authorities outside the United States, or if we do notbelieve that the number of patients required by such regulatory agencies in any clinical trial can be enrolled in a reasonable timeframe. In addition,some of our competitors may have ongoing or new clinical trials for product candidates that would treat the same indications as our productcandidates or be used in the same patients, and therefore patients who would otherwise be eligible for our clinical trials may instead enroll inclinical trials of our competitors’ product candidates. Patient enrollment is also affected by other factors, including:•severity of the disease under investigation;•availability, safety and efficacy of approved medications or other investigational medications being studied clinically for the disease underinvestigation;•eligibility criteria for the trial in question;•perceived risks and benefits of the product candidate under study;•efforts to facilitate timely enrollment in clinical trials;•reluctance of physicians to encourage patient participation in clinical trials;•the ability to monitor patients adequately during and after treatment;•the proximity and availability of clinical trial sites for prospective patients;•delays or failures in maintaining an adequate supply of quality drug product for use in clinical trials; and•changing treatment patterns that may reduce the burden of disease which our product candidates address.21CIDARA THERAPEUTICS, INC.Our inability to enroll a sufficient number of patients for our clinical trials, or to enroll such patients in a timely manner, would result in significantdelays or may require us to abandon one or more clinical trials altogether. Enrollment delays in our clinical trials may result in increaseddevelopment costs for our product candidates, which would cause the value of our company to decline and limit our ability to obtain additionalfinancing.If serious adverse effects or unexpected characteristics of our product candidates are identified during development, we may need toabandon or limit our development of some or all of our product candidates.All of our programs are in preclinical development or are in early stages of clinical development and their risk of failure is high. It is impossible topredict when or if any of our product candidates will prove effective or safe in humans or will receive marketing approval. If our product candidatesare associated with undesirable side effects or have characteristics that are unexpected, we may need to abandon their development or limitdevelopment to certain uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe ormore acceptable from a risk-benefit perspective. For example, the pharmacokinetic properties, such as a longer half-life or less frequent dosingregimen, that differentiate rezafungin from other echinocandins could have side effects that we have not anticipated and the consequences of suchside effects could be more severe than have been seen with other echinocandins that have shorter half-lives or more frequent dosing regimens, orare dosed at lower concentrations than we expect for rezafungin. Further, the treatment advantages that we are predicting for rezafungin, such aslower healthcare costs resulting from an ability to administer rezafungin once-weekly or the predicted ability of rezafungin to be effective againstresistant strains of fungal pathogens, may not be realized. For our ADCs, the bispecific mechanism of action, including the use of the immunesystem, may lead to side effects that are not anticipated based on the preclinical work we have conducted to date.In the biotechnology industry, many agents that initially show promise in early stage testing may later be found to cause side effects that preventfurther development of the agents. In addition, fungal and bacterial infections can occur in patients with co-morbidities and weakened immunesystems, and there may be adverse events and deaths in our clinical trials that are attributable to factors other than investigational use of ourproduct candidates.We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidatesor indications that may be more profitable or for which there is a greater likelihood of success.We have limited financial resources. As a result, we may forego or delay pursuit of opportunities with other product candidates or for otherindications that later prove to have greater commercial potential than opportunities we pursue. For example, because we believe that an NDA filingfor rezafungin for prophylaxis can be supported by one Phase 3 trial in prophylaxis, together with the data from our planned Phase 3 clinical trial inthe treatment of candidemia and invasive candidiasis and the remainder of our rezafungin treatment program, if financial constraints require us tochoose between our planned rezafungin treatment and prophylaxis programs, we may be required to choose our treatment program and forego ordelay our prophylaxis program.Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spendingon current and future research and development programs and product candidates for specific indications may not yield any commercially viableproducts. If we do not accurately evaluate the commercial potential or target market for a particular product candidate or opportunity, we mayrelinquish valuable rights to that product candidate or opportunity through collaboration, licensing or other royalty arrangements in cases in which itwould have been more advantageous for us to retain sole development and commercialization rights to such product candidate or opportunity.Even if any of our product candidates receive marketing approval, they may fail to achieve the degree of market acceptance byphysicians, patients, third-party payers and others in the medical community necessary for commercial success.If any of our product candidates receive marketing approval, they may nonetheless fail to gain sufficient market acceptance by physicians,patients, third-party payers and others in the medical community for us to achieve commercial success. If our product candidates do not achievean adequate level of acceptance, we may not generate sufficient product revenue to become profitable. The degree of market acceptance of ourproduct candidates, if approved for commercial sale, will depend on a number of factors, including:•the efficacy and potential advantages compared to alternative therapies;•the size of the markets in the countries in which approvals are obtained;•terms, limitations or warnings contained in any labeling approved by the FDA or other regulatory agency;22CIDARA THERAPEUTICS, INC.•our ability to offer any approved products for sale at competitive prices;•convenience and ease of administration compared to alternative treatments;•the willingness of the target patient population to try new therapies or dosing regimens;•the willingness of physicians to prescribe these therapies and, in the case of rezafungin, transition to a once-weekly dosing regimen fromtraditional once-daily dosing;•the strength of marketing and distribution support;•the success of competing products and the marketing efforts of our competitors;•sufficient third-party coverage and adequate reimbursement; and•the prevalence and severity of any side effects.If, in the future, we are unable to establish sales and marketing capabilities or to selectively enter into agreements with third parties tosell and market our product candidates, we may not be successful in commercializing our product candidates, if and when they areapproved.We do not have a sales or marketing infrastructure and have no experience in the sale, marketing or distribution of pharmaceutical products. Toachieve commercial success for any approved product, we must either develop a sales and marketing organization or outsource these functions tothird parties.There are risks involved both with establishing our own sales and marketing capabilities and with entering into arrangements with third parties toperform these services. For example, recruiting and training a sales force is expensive and time consuming and could delay any product launch. Ifthe commercial launch of a product candidate for which we recruit a sales force and establish marketing capabilities is delayed or does not occurfor any reason, we would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly, and our investmentwould be lost if we cannot reposition our sales and marketing personnel.Factors that may inhibit our efforts to commercialize our product candidates on our own include:•our inability to recruit and retain adequate numbers of effective sales and marketing personnel;•the inability of sales personnel to obtain access to physicians or to achieve adequate numbers of prescriptions for any future products;and•unforeseen costs and expenses associated with creating an independent sales and marketing organization.If we enter into arrangements with third parties to perform sales, marketing and distribution services, our product revenue or the profitability ofthese product revenues to us may be lower than if we were to market and sell any products that we develop ourselves. In addition, we may not besuccessful in entering into arrangements with third parties to sell and market our product candidates or may be unable to do so on terms that arefavorable to us. We may have little control over such third parties, and any of them may fail to market and sell our products effectively, includingby failing to devote the necessary resources and attention. If we do not establish sales and marketing capabilities successfully, either on our ownor in collaboration with third parties, we will not be successful in commercializing our product candidates.We face substantial competition, which may result in others discovering, developing or commercializing products before or moresuccessfully than we do.The development and commercialization of new drug products is highly competitive. We face competition with respect to our current productcandidates, and will face competition with respect to any product candidates that we may seek to develop or commercialize in the future, frommajor pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide. Regulatory incentives to developdrugs for treatment of infectious diseases have increased interest and activity in this area and will lead to increased competition for clinicalinvestigators and clinical trial subjects, as well as for future prescriptions, if any of our product candidates are successfully developed andapproved. There are a number of large pharmaceutical and biotechnology companies that currently market and sell products or are pursuing thedevelopment of products for the treatment of the indications on which we are focusing our product development efforts. Some of these competitiveproducts and therapies are based on scientific approaches that are the same as or similar to our approach, and others are based on entirelydifferent approaches. Potential competitors also include academic institutions, government agencies and other public and private researchorganizations that conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturingand commercialization.Rezafungin will primarily compete with antifungal classes for the treatment and prevention of systemic fungal infections such as candidemia andinvasive candidiasis, which include polyenes, azoles and echinocandins. Approved branded23CIDARA THERAPEUTICS, INC.antifungal therapies include Cancidas (caspofungin, marketed by Merck & Co.), Eraxis (anidulafungin, marketed by Pfizer, Inc.) and Mycamine(micafungin, marketed by Astellas Pharma US, Inc.). There will be generics of one or more of the current echinocandins available at the time ofrezafungin market approval, which will create added competition. In addition, there are other generic products approved for candidemia, marketedby companies such as Baxter Healthcare Corporation, Mylan Inc. and Glenmark Generics Inc., among others. In addition to approved therapies,we expect that rezafungin will compete with product candidates that we are aware of in clinical development by third parties, such as SCY-078(being developed by Scynexis, Inc.).Our ADCs will compete against approved and investigational agents for the treatment of bacterial infections. We may develop other productcandidates from our Cloudbreak immunotherapy platform for the treatment of invasive bacterial, fungal or viral infections. We are aware of anumber of approved and investigational therapies in these areas.Our competitors may develop products that are more effective, safer, more convenient or less costly than any that we are developing or that wouldrender our product candidates obsolete or non-competitive. Our competitors may also obtain marketing approval from the FDA or other regulatoryauthorities for their products sooner than we may obtain approval for ours, which could result in our competitors establishing a strong marketposition before we are able to enter the market.Many of our competitors have significantly greater name recognition, financial resources and expertise in research and development,manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do. Mergersand acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smallernumber of our competitors. Smaller and other early stage companies may also prove to be significant competitors, particularly throughcollaborative arrangements with large and established companies. These same competitors may invent technology that competes with ourrezafungin program or our Cloudbreak immunotherapy platform.These third parties may compete with us in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sitesand patient enrollment for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.Even if we are able to commercialize any product candidates, these products may become subject to unfavorable pricing regulations,third-party reimbursement practices or healthcare reform initiatives, which would harm our business.The regulations that govern marketing approvals, pricing and reimbursement for new drugs vary widely from country to country. In the UnitedStates, new and future legislation may significantly change the approval requirements in ways that could involve additional costs and cause delaysin obtaining approvals. Some countries require approval of the sale price of a drug before it can be marketed. In many countries, the pricing reviewperiod begins after marketing or product-licensing approval is granted. In some foreign markets, prescription pharmaceutical pricing remainssubject to continuing governmental control even after initial marketing approval is granted. As a result, we might obtain marketing approval for adrug in a particular country, but then be subject to price regulations that delay its commercial launch, possibly for lengthy time periods, andnegatively impact the revenue we are able to generate from the sale of the drug in that country. Adverse pricing limitations may hinder our ability tocommercialize and generate revenue from one or more product candidates, even if our product candidates obtain marketing approval.Our ability to commercialize any product candidates successfully also will depend in part on the extent to which coverage and adequatereimbursement for these products and related treatments will be available from government health programs, private health insurers, integrateddelivery networks, and other third-party payers. Third-party payers decide which medications they will pay for and establish reimbursement levels.A significant trend in the U.S. healthcare industry and elsewhere is cost containment. Government authorities and third-party payers haveattempted to control costs by limiting coverage and the amount of payment for particular medications. Increasingly, third-party payers are requiringthat drug companies provide predetermined discounts from list prices and are challenging the prices charged for medical products. Coverage andreimbursement may not be available for any product that we commercialize and, if reimbursement is available, the level of reimbursement may notbe sufficient for commercial success. Coverage and reimbursement may impact the demand for, or the price of, any product candidate for whichwe obtain marketing approval. If coverage and reimbursement is not available or is available only to limited levels, we may not be able tosuccessfully commercialize any product candidate for which we obtain marketing approval.There may be significant delays in obtaining coverage and adequate reimbursement for newly approved products, and coverage may be morelimited than the purposes for which the product is approved by the FDA or similar regulatory authorities outside the United States. Moreover,eligibility for coverage and reimbursement does not imply that any product will be paid for in all cases or at a rate that covers our costs, includingresearch, development, manufacture, sale and distribution. Interim reimbursement levels for new drugs, if applicable, may also not be sufficient tocover our costs and may not be made permanent. Coverage and reimbursement rates may vary according to the use of the drug and the medicalcircumstances under which it is used, may be based on reimbursement levels already set for lower cost products24CIDARA THERAPEUTICS, INC.or procedures or may be incorporated into existing payments for other services. Net prices for drugs may be reduced by mandatory discounts orrebates required by government healthcare programs or private payers and by any future relaxation of laws that presently restrict imports of drugsfrom countries where they may be sold at lower prices than in the United States. Commercial third-party payers often rely upon Medicare coveragepolicies and payment limitations in setting their own reimbursement policies. Our inability to promptly obtain coverage and profitable payment ratesfrom both government-funded programs and private payers for any approved products that we develop could have a material adverse effect on ouroperating results, our ability to raise capital needed to commercialize our approved products and our overall financial condition.Product liability lawsuits against us could cause us to incur substantial liabilities and could limit the commercialization of any productcandidates we may develop.We face an inherent risk of product liability exposure related to the testing of our product candidates in human clinical trials, and we will face aneven greater risk if we commercially sell any products that receive marketing approval. If we cannot successfully defend ourselves against claimsthat our product candidates caused injuries, we could incur substantial liabilities. Regardless of merit or eventual outcome, liability claims mayresult in:•decreased demand for any product candidates that we may develop;•injury to our reputation and significant negative media attention;•withdrawal of clinical trial participants;•significant costs and distraction of management to defend any related litigation;•the initiation of investigations by regulatory bodies;•substantial monetary awards to trial participants or patients;•loss of revenue;•product recalls, withdrawals or labeling, marketing or promotional restrictions; and•the inability to commercialize any products we may develop.Although we have product liability insurance for our clinical trials, such insurance may not be adequate to cover all liabilities that we may incur. Weanticipate that we will need to increase our insurance coverage as we continue or expand our clinical trials and if we successfully commercializeany products. Insurance coverage is increasingly expensive. We may not be able to maintain insurance coverage at a reasonable cost or in anamount adequate to satisfy any liability that may arise.If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incurcosts that could harm our business.We are subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and thehandling, use, storage, treatment and disposal of hazardous materials and wastes. Our operations involve the use of hazardous and flammablematerials, including chemicals and biological and radioactive materials. Our operations also produce hazardous waste products. We generallycontract with third parties for the disposal of these materials and wastes. We cannot eliminate the risk of contamination or injury from thesematerials. In the event of contamination or injury resulting from our use of hazardous materials, we could be held liable for any resulting damages,and any liability could exceed our resources. We also could incur significant costs associated with civil or criminal fines and penalties.Although we maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees in ourworkplace, including those resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potentialliabilities. We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us in connection with ourstorage or disposal of biological, chemical, hazardous or radioactive materials.In addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. Thesecurrent or future laws and regulations may impair our research, development or production efforts. Failure to comply with these laws andregulations also may result in substantial fines, penalties or other sanctions.We may not be successful in our efforts to identify, discover, in-license or acquire potential product candidates.We are developing our ADCs for the treatment of multidrug-resistant bacterial infections, including those caused by pathogens harboring the mcr-1gene. We currently do not have any development candidates from the Cloudbreak25CIDARA THERAPEUTICS, INC.platform. Our Cloudbreak immunotherapy platform and other drug discovery efforts may not be successful in identifying additional molecules thatcould be developed as drug therapies. Our research programs may initially show promise in identifying such potential product candidates, yet failto yield product candidates for clinical development for a number of reasons. In particular, our research methodology used may not be successfulin identifying compounds with sufficient potency, bioavailability or efficacy to be potential product candidates. In addition, our potential productcandidates may, on further study, be shown to have harmful side effects or other negative characteristics.Research programs to identify new product candidates require substantial technical, financial and human resources. We may choose to focus ourefforts and resources on potential product candidates that ultimately prove to be unsuccessful. If we are unable to identify, in-license or acquiresuitable compounds for preclinical and clinical development, we will not be able to generate product revenue, which would harm our financialposition and adversely impact our stock price.Risks Related to Our Dependence on Third PartiesWe intend to continue to rely on third parties to conduct our clinical trials and to conduct some aspects of our research and preclinicaltesting, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials,research or testing.We currently rely and expect to continue to rely on third parties, such as contract research organizations, contract manufacturers of clinicalsupplies, clinical data management organizations, medical institutions and clinical investigators, to conduct our clinical trials and to conduct someaspects of our research and preclinical testing. Any of these third parties may terminate their engagements with us at any time. If these thirdparties do not successfully carry out their contractual duties, meet expected deadlines or conduct our studies in accordance with regulatoryrequirements or our stated protocols, we will not be able to obtain, or may be delayed in obtaining, marketing approvals for our product candidatesand will not be able to, or may be delayed in our efforts to, successfully commercialize our product candidates. Furthermore, these third partiesmay also have relationships with other entities, some of which may be our competitors. If we need to enter into alternative arrangements, it woulddelay our product development activities.Our reliance on these third parties for research and development activities will reduce our control over these activities but will not relieve us of ourresponsibilities. For example, we will remain responsible for ensuring that each of our clinical trials is conducted in accordance with the generalinvestigational plan and protocols for the trial. Moreover, the FDA and other international regulatory agencies require us to comply with standards,commonly referred to as Good Clinical Practices, for conducting, recording and reporting the results of clinical trials to assure that data andreported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected. We also are required toregister ongoing clinical trials and post the results of completed clinical trials on a government-sponsored database, available atwww.clinicaltrials.gov, within certain timeframes. Failure to do so can result in fines, adverse publicity and civil and criminal sanctions.We have no experience manufacturing product candidates on a clinical or commercial scale and will be dependent on third parties forthe manufacture of our product candidates. If we experience problems with any of these third parties, they could delay clinicaldevelopment or marketing approval of our product candidates or our ability to sell any approved products.We do not have any manufacturing facilities. We currently rely, and expect to continue to rely, on third-party manufacturers for the manufacture ofour product candidates for preclinical studies and clinical trials and for commercial supply of any of these product candidates for which we obtainmarketing approval.We may be unable to establish agreements with third-party manufacturers for preclinical, clinical or commercial supply on terms favorable to us, orat all. Even if we are able to establish agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks,including:•reliance on the third party for regulatory compliance and quality assurance;•the possible breach of the manufacturing agreement by the third party, including the inability to supply sufficient quantities or to meetquality standards or timelines; and•the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us.Third-party manufacturers may not be able to comply with current U.S. Good Manufacturing Practice requirements, or cGMPs, or similar regulatoryrequirements outside the United States. Our failure, or the failure of our third-party manufacturers, to comply with cGMPs or other applicableregulations, even if such failures do not relate specifically to our product candidates or approved products, could result in sanctions being imposedon us or the manufacturers, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizuresor recalls of26CIDARA THERAPEUTICS, INC.product candidates, operating restrictions and criminal prosecutions, any of which could adversely affect supplies of our product candidates andharm our business and results of operations.Any product that we develop may compete with other product candidates and products for access to these manufacturing facilities. There are alimited number of manufacturers that operate under cGMPs and that might be capable of manufacturing for us.Any performance failure on the part of our existing or future manufacturers, including a failure that may not relate specifically to our productcandidate or approved product, could delay clinical development or marketing approval or adversely impact our ability to generate commercialsales. If any one of our current contract manufacturers cannot perform as agreed, we may be required to replace that manufacturer.Our current and anticipated future dependence upon others for the manufacture of our product candidates or products may adversely affect ourfuture profit margins and our ability to commercialize any product candidates that receive marketing approval on a timely and competitive basis.We currently rely, and expect to continue to rely, on third parties to release, label, store and distribute drug supplies for our clinical trials. Anyperformance failure on the part of these third parties, including a failure that may not relate specifically to our product candidate or approvedproduct, could delay or otherwise adversely impact clinical development or marketing approval of our product candidates or commercialization ofour drugs, producing additional losses and depriving us of potential revenue.Moreover, our manufacturers and suppliers may experience difficulties related to their overall businesses and financial stability, which could resultin delays or interruptions of supply of our product candidates or approved products.We do not have alternate manufacturing plans in place at this time. If we need to change to other manufacturers, the FDA and comparable foreignregulators may have to approve these manufacturers’ facilities and processes prior to our use, which would require new testing and complianceinspections. In addition, the new manufacturers would have to be educated in or independently develop the processes necessary for production.This would result in delays and costs, and in the case of approved products, the potential loss of revenue.We may seek to selectively establish collaborations, and, if we are unable to establish them on commercially reasonable terms or at all,we may have to alter our development and commercialization plans.Our drug development programs and the potential commercialization of our product candidates will require substantial additional cash to fundexpenses. For some of our product candidates, we may decide to collaborate with other pharmaceutical and biotechnology companies for thedevelopment and potential commercialization of those product candidates. We do not currently have any such collaborations.We face significant competition in seeking appropriate collaborators. Whether we reach a definitive agreement for a collaboration will depend,among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaborationand the proposed collaborator’s evaluation of a number of factors.Those factors may include:•the design or results of preclinical studies or clinical trials;•the likelihood of approval by the FDA or similar regulatory authorities outside the United States;•the potential market for the subject product candidate;•the costs and complexities of manufacturing and delivering such product candidate to patients;•the potential of competing products;•the existence of uncertainty with respect to our ownership of technology, which can exist if there is a challenge to such ownership withoutregard to the merits of the challenge; and•industry and market conditions generally.The collaborator may also consider alternative product candidates for similar indications that may be available to collaborate on and whether sucha collaboration could be more attractive than the one with us for our product candidate.To the extent we enter into any collaborations, we may depend on collaborators for the development and commercialization of ourproduct candidates. If those collaborations are not successful, we may not be able to capitalize on the market potential of our productcandidates.We may selectively seek third-party collaborators for the development and commercialization of our product candidates. Our likely potentialcollaborators include large and mid-size pharmaceutical companies, regional and national27CIDARA THERAPEUTICS, INC.pharmaceutical companies and biotechnology companies. We do not currently have any such arrangements and if we enter into any sucharrangements with any third parties in the future, we will likely have limited control over the amount and timing of resources that our collaboratorsdedicate to the development or commercialization of our product candidates. Our ability to generate revenue from these arrangements will dependon our collaborators’ abilities to successfully perform the functions assigned to them in these arrangements.Collaborations involving our product candidates pose many risks to us, including that:•collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations;•collaborators may not pursue development and commercialization of our product candidates or may elect not to continue or renewdevelopment or commercialization programs based on clinical trial results, changes in the collaborator’s strategic focus or availablefunding or external factors such as an acquisition that diverts resources or creates competing priorities;•collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a productcandidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;•collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our productcandidates or products if the collaborators believe that competitive products are more likely to be successfully developed or can becommercialized under terms that are more economically attractive than ours;•a collaborator with marketing and distribution rights to one or more product candidates or products may not commit sufficient resources tothe marketing and distribution of such drugs;•collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as toinvite litigation that could jeopardize or invalidate our intellectual property rights or proprietary information or expose us to potentiallitigation;•disputes may arise between the collaborators and us that result in the delay or termination of the research, development orcommercialization of our product candidates or products or that result in costly litigation or arbitration that diverts management attentionand resources;•we may lose certain valuable rights under circumstances identified in our collaboration agreements if we undergo a change of control;•collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development orcommercialization of the applicable product candidates;•collaboration agreements may not lead to development or commercialization of product candidates in the most efficient manner, or at all;and •if a future collaborator of ours were to be involved in a business combination, the continued pursuit and emphasis on our productdevelopment or commercialization program under such collaboration could be delayed, diminished or terminated.If our ability to generate revenue under any of our collaboration agreements is adversely impacted by any of these risks, our share of the revenuesgenerated by the product, if approved, under the terms of the collaboration could be insufficient to allow us to achieve or maintain profitability, orthe product may be less valuable to us than if we had not entered into the collaboration.Risks Related to Regulatory Approval of Our Product Candidates and Other Legal Compliance MattersIf we are unable to take full advantage of regulatory programs designed to expedite drug development or provide other incentives, ourdevelopment programs may be adversely impacted. There are a number of incentive programs administered by the FDA and other regulatory bodies to facilitate development of drugs in areas ofunmet medical need. Rezafungin received the designations as a Qualified Infectious Disease Product, or QIDP, a fast track product, and anorphan drug in the U.S. for the treatment of candidemia and invasive candidiasis. We have also either applied for or are planning to seek QIDP,fast track and orphan drug designations for rezafungin for prophylaxis, as well as an orphan drug designation for rezafungin for treatment andprophylaxis in Europe. Our product candidates may not qualify for or maintain designations under these or other incentive programs under any ofthe FDA’s existing or future programs to expedite drug development in areas of unmet medical need. Our inability to fully take advantage of theseincentive programs may require us to run larger trials, incur delays, lose opportunities that may28CIDARA THERAPEUTICS, INC.not otherwise be available to us, lose marketing exclusivity for which we would otherwise be eligible, and incur greater expense in the developmentof our product candidates.If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to commercialize, orwill be delayed in commercializing, our product candidates, and our ability to generate revenue will be impaired.Our product candidates and the activities associated with their development and commercialization, including their design, testing, manufacture,release, safety, efficacy, regulatory filings, recordkeeping, labeling, storage, approval, advertising, promotion, sale and distribution, are subject tocomprehensive regulation by the FDA and other regulatory agencies in the United States and by comparable authorities in other countries. Forexample, in order to commence clinical trials of our product candidates in the United States, we must file an IND and obtain FDA agreement toproceed. The FDA may place our development program on clinical hold and require further preclinical testing prior to allowing our clinical trials toproceed.We must obtain marketing approval in each jurisdiction in which we market our products. Failure to obtain marketing approval for a productcandidate will prevent us from commercializing the product candidate. We have not submitted a marketing application or received approval tomarket any of our product candidates from regulatory authorities in any jurisdiction. We have only limited experience in filing and supporting theapplications necessary to gain marketing approvals and expect to rely on third-party contract research organizations to assist us in this process.Securing regulatory approval requires the submission of extensive preclinical and clinical data and supporting information to the various regulatoryauthorities for each indication to establish the product candidate’s safety and efficacy. Securing regulatory approval also requires the submissionof information about the product manufacturing process, testing and release, and inspection of manufacturing facilities and personnel by therelevant regulatory authority. Our product candidates may not be effective, may be only moderately effective or may prove to have undesirable orunintended side effects, toxicities or other characteristics that may preclude our obtaining marketing approval or prevent or limit commercial use.The process of obtaining marketing approvals, both in the United States and elsewhere, is expensive, may take many years and can varysubstantially based upon a variety of factors, including the type, complexity and novelty of the product candidates involved. We cannot assure youthat we will ever obtain any marketing approvals in any jurisdiction. Changes in marketing approval policies during the development period,changes in or the enactment of additional statutes or regulations or changes in regulatory review for each submitted product application may causedelays in the approval or rejection of an application. The FDA and comparable authorities in other countries have substantial discretion in theapproval process and may refuse to accept any application or may decide that our data is insufficient for approval and require additional preclinicalor other studies, changes in the manufacturing process or facilities, or clinical trials. Moreover, approval by the FDA or an equivalent foreignauthority does not ensure approval by regulatory authorities in any other countries or jurisdictions, but a failure to obtain marketing approval in onejurisdiction may adversely impact the likelihood of approval in other jurisdictions. In addition, varying interpretations of the data obtained frompreclinical testing, manufacturing and product testing and clinical trials could delay, limit or prevent marketing approval of a product candidate.Additionally, any marketing approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render theapproved product not commercially viable.Any product candidate for which we obtain marketing approval could be subject to marketing restrictions or withdrawal from the market,and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with ourproducts.Any product candidate for which we obtain marketing approval, along with the manufacturing processes and facilities, post-approval clinical data,labeling, advertising and promotional activities for such product, will be subject to continual requirements of and review by the FDA and otherregulatory authorities. These requirements include submissions of promotional materials and safety and other post-marketing information andreports, registration and listing requirements, cGMP requirements for product facilities, quality assurance and corresponding maintenance ofrecords and documents and requirements regarding the distribution of samples to physicians and related recordkeeping. Even if marketingapproval of a product candidate is granted, the approval may be subject to limitations on the indicated uses for which the product may bemarketed or to the conditions of approval, or contain requirements for costly post-marketing testing and surveillance to monitor the safety orefficacy of the medicine. The FDA closely regulates the post-approval marketing and promotion of drugs to ensure that they are marketed only forthe approved indications and in accordance with the provisions of the approved labeling. The FDA imposes stringent restrictions on manufacturers’communications regarding off-label use and if we do not comply with these restrictions, we may be subject to enforcement actions.In addition, later discovery of previously unknown problems with our products, manufacturers or manufacturing processes and facilities, or failureto comply with regulatory requirements, may result in, among other things:29CIDARA THERAPEUTICS, INC.•restrictions on such products, manufacturers or manufacturing processes or facilities;•restrictions on the labeling, marketing, distribution or use of a product;•requirements to conduct post-approval clinical trials, other studies, or other post-approval commitments;•warning or untitled letters;•withdrawal of the products from the market;•refusal to approve pending applications or supplements to approved applications that we submit;•recall of products;•fines, restitution or disgorgement of profits or revenue;•suspension or withdrawal of marketing approvals;•refusal to permit the import or export of our products;•product seizure; and•injunctions or the imposition of civil or criminal penalties.Our relationships with customers, health care professionals and third-party payers will be subject to applicable healthcare laws, whichcould expose us to penalties, including administrative, civil or criminal penalties, damages, fines, imprisonment, exclusion fromparticipation in federal healthcare programs such as Medicare and Medicaid, reputational harm, the curtailment or restructuring of ouroperations and diminished future profits and earnings.Healthcare professionals and third-party payers will play a primary role in the recommendation and prescription of any product candidates for whichwe obtain marketing approval. Our current and future arrangements with customers, healthcare professionals and third-party payers may exposeus to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements andrelationships through which we conduct research, market, sell and distribute our medicines for which we obtain marketing approval. Restrictionsunder applicable federal and state healthcare laws and regulations include the following, among others:•the federal healthcare anti-kickback statute, which prohibits persons and entities from, among other things, knowingly and willfullysoliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of anindividual for, or the purchase, lease, order or recommendation of, any good, facility, item or service, for which payment may be madeunder federal and state healthcare programs such as Medicare and Medicaid;•the federal false claims laws, which impose criminal and civil penalties, including civil whistleblower or qui tam actions under the federalCivil False Claims Act, against individuals or entities for, among other things, knowingly presenting, or causing to be presented, to thefederal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal anobligation to pay money to the federal government;•HIPAA, as amended by HITECH, which imposes criminal and civil liability for, among other things, executing a scheme to defraud anyhealthcare benefit program and also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy,security and transmission of individually identifiable health information; •the federal false statements statute enacted under HIPAA, which prohibits knowingly and willfully falsifying, concealing or covering up amaterial fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items orservices;•the federal transparency requirements under the Affordable Care Act, which require, among other things, certain manufacturers of drugs,devices, biologics and medical supplies to report annually to the Department of Health and Human Services information related tophysician payments and other transfers of value and physician ownership and investment interests; and•analogous state laws and regulations, such as state anti-kickback and false claims laws, which may apply to our business activities,including sales or marketing arrangements and claims involving healthcare items or services including, in some states, those reimbursedby non-governmental third-party payers, including private insurers, and some state laws which require pharmaceutical companies tocomply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by thefederal government in addition to requiring drug manufacturers to report information related to payments or other transfers of valueprovided to physicians and other health care providers and entities or marketing expenditures.30CIDARA THERAPEUTICS, INC.Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations will involvesubstantial costs. Interpretations of standards of compliance under these laws and regulations are rapidly changing and subject to varyinginterpretations, and it is possible that governmental authorities will conclude that our business practices may not comply with current or futurestatutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be inviolation of any of these laws or any other laws that may apply to us, we may be subject to significant civil, criminal and administrative penalties,damages, fines, exclusion from government funded healthcare programs, such as Medicare and Medicaid, reputational harm, imprisonment,additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations ofnon-compliance with these laws, and the curtailment or restructuring of our operations, any of which could diminish our future profits or earnings. Ifany of the physicians or other providers or entities with whom we expect to do business are found to be not in compliance with applicable laws,they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs.We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-moneylaundering laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic andinternational markets. We can face criminal liability and other serious consequences for violations, which can harm our business.We are subject to export control and import laws and regulations, including the U.S. Export Administration Regulations, U.S. Customs regulations,various economic and trade sanctions regulations administered by the U.S. Treasury Department’s Office of Foreign Assets Controls, the U.S.Foreign Corrupt Practices Act of 1977, as amended, or FCPA, the U.S. domestic bribery statute contained in 18 U.S.C. § 201, the U.S. TravelAct, the USA PATRIOT Act, and other state and national anti-bribery and anti-money laundering laws in the countries in which we conductactivities. Anti-corruption laws are interpreted broadly and prohibit companies and their employees, agents, contractors, and other collaboratorsfrom authorizing, promising, offering, or providing, directly or indirectly, improper payments or anything else of value to recipients in the public orprivate sector. We may engage third parties for clinical trials outside of the United States, to sell our products abroad once we enter acommercialization phase, and/or to obtain necessary permits, licenses, patent registrations, and other regulatory approvals. We have direct orindirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities, and other organizations. We can be held liable for the corrupt or other illegal activities of our employees, agents, contractors, and other collaborators, even if we do notexplicitly authorize or have actual knowledge of such activities. Any violations of the laws and regulations described above may result insubstantial civil and criminal fines and penalties, imprisonment, the loss of export or import privileges, debarment, tax reassessments, breach ofcontract and fraud litigation, reputational harm, and other consequences.Recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercializeour product candidates and affect the prices we may obtain.In the United States and some foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changesregarding the healthcare system that could prevent or delay marketing approval of our product candidates, restrict or regulate post-approvalactivities and affect our ability to profitably sell any product candidates for which we obtain marketing approval.For example, in March 2010, President Obama signed into law the Affordable Care Act, a sweeping law intended to, among other things, broadenaccess to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add newtransparency requirements for health care and health insurance industries, impose new taxes and fees on the health industry and imposeadditional health policy reforms. The Affordable Care Act and subsequent regulations revised the definition of “average manufacturer price” forreporting purposes, which could increase the amount of Medicaid drug rebates to states. Further, the law imposes a significant annual fee oncompanies that manufacture or import branded prescription drug products. Substantial new provisions affecting compliance have also beenenacted, which may affect our business practices with healthcare practitioners. Since its enactment there have been judicial and Congressionalchallenges to certain aspects of the Affordable Care Act, as well as recent efforts by the Trump administration to repeal and replace certainaspects of the Affordable Care Act, and we expect such challenges to continue. Since January 2017, President Trump has signed two ExecutiveOrders and other directives designed to delay the implementation of certain provisions of the Affordable Care Act or otherwise circumvent some ofthe requirements for health insurance mandated by the Affordable Care Act. Concurrently, Congress has considered legislation that would repeal orrepeal and replace all or part of the Affordable Care Act. While Congress has not passed comprehensive repeal legislation, two bills affecting theimplementation of certain taxes under the Affordable Care Act have been enacted. The Tax Cuts and Jobs Act of 2017 includes a provisionrepealing, effective January 1, 2019, the tax-based shared responsibility payment imposed by the Affordable Care Act on certain individuals whofail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate”. Additionally, on January22,31CIDARA THERAPEUTICS, INC.2018, President Trump signed a continuing resolution on appropriations for fiscal year 2018 that delayed the implementation of certain feesmandated by the Affordable Care Act, including the so-called “Cadillac” tax on certain high cost employer-sponsored insurance plans, the annualfee imposed on certain health insurance providers based on market share, and the medical device excise tax on non-exempt medical devices.Further, the Bipartisan Budget Act of 2018, or the BBA, among other things, amends the Affordable Care Act, effective January 1, 2019, to closethe coverage gap in most Medicare drug plans, and also increases in 2019 the percentage that a drug manufacturer must discount the cost ofprescription drugs from 50 percent under current law to 70 percent. Congress also could consider additional legislation to repeal or repeal andreplace other elements of the Affordable Care Act. Although the full effect of the Affordable Care Act remains uncertain, the law appears likely tocontinue the pressure on pharmaceutical pricing, especially under the Medicare program, and may also increase our regulatory burdens andoperating costs.Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities forpharmaceutical products. In addition, there have been several recent Congressional inquiries and proposed and enacted legislation designed to,among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, andreform government program reimbursement methodologies for drug products. Further, the Trump administration’s budget proposal for fiscal year2019 contains additional drug price control measures that could be enacted during the 2019 budget process or in other future legislation, including,for example, measures to permit Medicare Part D plans to negotiate the price of certain drugs under Medicare Part B, to allow some states tonegotiate drug prices under Medicaid and to eliminate cost sharing for generic drugs for low-income patients. While any proposed measures willrequire authorization through additional legislation to become effective, Congress and the Trump administration have each indicated that it willcontinue to seek new legislative and/or administrative measures to control drug costs. At the state level, legislatures are increasingly passinglegislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursementconstraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases,designed to encourage importation from other countries and bulk purchasing. We cannot be sure whether additional legislative changes will beenacted, or whether the FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketingapprovals of our product candidates, if any, may be. In addition, increased scrutiny by the U.S. Congress of the FDA’s approval process maysignificantly delay or prevent marketing approval, as well as subject us to more stringent product labeling and post-marketing testing and otherrequirements.We expect that additional healthcare reform measures will be adopted within and outside the United States in the future, any of which could adddifficulty to the regulatory approval processes for our product candidates or limit the amounts that governments will pay for healthcare productsand services, which could result in reduced demand for our product candidates or additional pricing pressures. The continuing efforts of third-partypayors to contain or reduce costs of healthcare may adversely affect the demand for any drug products for which we may obtain regulatoryapproval, our ability to set a price that we believe is fair for our products, our ability to obtain coverage and reimbursement approval for a product,our ability to generate revenues and achieve or maintain profitability, and the level of taxes that we are required to pay.Risks Related to Our Intellectual PropertyIf our efforts to protect the proprietary nature of the intellectual property related to rezafungin, our Cloudbreak compounds or our otherproduct candidates or compounds are not adequate, we may not be able to compete effectively in our markets.We rely upon a combination of patents, trademarks, trade secret protection and confidentiality agreements to protect the intellectual propertyrelated to rezafungin and our other product candidates and compounds. Any involuntary disclosure to or misappropriation by third parties of ourproprietary information could enable competitors to quickly duplicate or surpass our technological achievements, thus eroding our competitiveposition in our markets.The strength of patents in the biotechnology and pharmaceutical field involves complex legal and scientific questions and can be uncertain, andour commercial success will depend on our ability to obtain patents and maintain adequate protection for rezafungin, our ADCs and othercompounds and product candidates in the United States and other countries. We currently hold issued U.S. utility and foreign patents, and multiplepending U.S. utility patent applications, pending U.S. provisional patent applications, and pending international, foreign national and regionalcounterpart patent applications covering various aspects of rezafungin, our ADCs and our Cloudbreak immunotherapy platform, and othertechnology. The patent applications may fail to result in issued patents in the United States or in foreign countries or jurisdictions. Even if theapplications do successfully issue, third parties may challenge the patents.Further, the existing and/or future patents, if any, may be too narrow to prevent third parties from developing or designing around these patents. Ifthe sufficiency of the breadth or strength of protection provided by the patent and patent applications we own with respect to rezafungin or ourADCs or the patents we pursue related to any of our other product32CIDARA THERAPEUTICS, INC.candidates or compounds is threatened, it could dissuade companies from collaborating with us to develop and threaten our ability tocommercialize the product candidates or compounds. Further, if we encounter delays in our clinical trials, the period of time during which we couldmarket our product candidates under patent protection would be reduced, although a patent term extension or supplementary protection certificatehaving varied scope may be available in certain jurisdictions to compensate for some of the lost patent term. In addition, we do not know whether:•we were the first to make the inventions covered by each of our pending patent applications or our issued patents;•we were the first to file patent applications for these inventions;•others will independently develop similar or alternative technologies or duplicate any of our technologies;•any of our pending patent applications will result in issued patents;•any of our patents, once issued, will be valid or enforceable or will issue with claims sufficient to protect our products, or will be challengedby third parties;•any patents issued to us will provide us with any competitive advantages;•we will develop additional proprietary technologies that are patentable; or•the patents of others will have an adverse effect on our business.In addition, patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and theenforcement or defense of our issued patents. In September 2011, the Leahy-Smith America Invents Act, or the Leahy-Smith Act, was signed intolaw. The Leahy-Smith Act includes a number of significant changes to U.S. patent law. These include provisions that affect the way patentapplications are prosecuted and may also affect patent litigation. The United States Patent and Trademark Office, or USPTO, developed newregulations and procedures to govern administration of the Leahy-Smith Act and many of the substantive changes to patent law associated withthe Leahy-Smith Act, and in particular, the first to file provisions, only became effective in March 2013. The Leahy-Smith Act and itsimplementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defenseof our issued patents, all of which could have a material adverse effect on our business, financial condition and prospects.In addition to the protection afforded by patents, we rely on trade secret protection and confidentiality agreements to protect proprietary know-howthat is not patentable in one or more jurisdictions, inventions for which patents are difficult to enforce and any other elements of our drug discoveryprogram that involve proprietary know-how, information and technology that is not covered by patents. Although we require all of our employees,consultants, advisers and third parties who have access to our proprietary know-how, information and technology to enter into confidentialityagreements, we cannot be certain that this know-how, information and technology will not be disclosed or used in an unauthorized manner or thatcompetitors will not otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques.There also may be challenges or other disputes concerning the inventorship, ownership, or right to use our intellectual property. For example, ourconsultants and advisors may have obligations to assign certain inventions and/or know-how that they develop to third-party entities in certaininstances, and these third parties may challenge our ownership or other rights to our intellectual property, which would adversely affect ourbusiness.An inability to obtain, enforce and defend patents covering our proprietary technologies would materially and adversely affect our businessprospects and financial condition. Further, the laws of some foreign countries do not protect proprietary rights to the same extent as the laws ofthe United States. We may encounter significant problems in protecting, enforcing, and defending our intellectual property both in the United Statesand abroad. If we are unable to prevent unauthorized material disclosure of the intellectual property related to our technologies to third parties, orare otherwise unable to protect, enforce or defend our intellectual property, we will not be able to establish or, if established, maintain a competitiveadvantage in our markets, which could materially adversely affect our business, operating results and financial condition.Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee paymentand other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or applications will be due to be paid tothe USPTO and various foreign or jurisdictional governmental patent agencies in several stages over the lifetime of the patents and/orapplications. We have systems in place to remind us to pay these fees, and we employ an outside firm to pay these fees due to foreign patentagencies. The USPTO and various foreign33CIDARA THERAPEUTICS, INC.governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during thepatent application process.We employ reputable law firms and other professionals to help us comply, and in many cases, an inadvertent lapse can be cured by payment of alate fee or by other means in accordance with the applicable rules. However, there are situations in which noncompliance can result inabandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.Noncompliance events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respondto official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. Suchnoncompliance events are outside of our direct control for (1) non-U.S. patents and patent applications owned by us, and (2) if applicable in thefuture, patents and patent applications licensed to us by another entity. In such an event, our competitors might be able to enter the market, whichwould have a material adverse effect on our business.Third-party claims of intellectual property infringement may prevent or delay our drug discovery and development efforts.Our commercial success depends in part on our avoiding infringement of the patents and proprietary rights of third parties. Third parties mayassert that we are employing their proprietary technology without authorization. There may be third-party patents with claims to materials, methodsof manufacture or methods of treatment related to the use or manufacture of rezafungin, our ADCs and/or our other product candidates orcompounds. If any third-party patents were held by a court of competent jurisdiction to cover the rezafungin or ADC manufacturing process, anymolecules formed during these processes or the final products or any use thereof, the holders of any such patents may be able to block our abilityto commercialize the product unless we obtained a license under the applicable patent or patents, or until such patents expire. These same issuesand risks arise in connection with any other product candidates we develop as well. We cannot predict whether we would be able to obtain alicense on commercially reasonable terms, or at all. Any inability to obtain such a license under the applicable patents on commercially reasonableterms, or at all, would have a material adverse effect on our ability to commercialize the affected product until such patents expire.In addition, third parties may obtain patents in the future and claim that our product candidates and/or the use of our technologies infringes uponthese patents. Furthermore, parties making claims against us may obtain injunctive or other equitable relief, which could effectively block ourability to further develop and commercialize one or more of our product candidates. Defense of these claims, regardless of their merit, wouldinvolve substantial litigation expense and would be a substantial diversion of management and other employee resources from our business. In theevent of a successful claim of infringement against us, we may have to pay substantial damages, including treble damages and attorneys’ fees inthe case of willful infringement, obtain one or more licenses from third parties, pay royalties and/or redesign our infringing products, which may beimpossible and/or require substantial time and monetary expenditure. In addition, even in the absence of litigation, we may need to obtain licensesfrom third parties to advance our research or allow commercialization of one or more of our product candidates. We may fail to obtain any of theselicenses at a reasonable cost or on reasonable terms, or at all. In that event, we would not be able to further develop and commercialize suchproduct candidates, which could harm our business significantly.We may be required to file lawsuits or take other actions to protect or enforce our patents, which could be expensive, time consumingand unsuccessful.Competitors may infringe our current or future patents. To counter infringement or unauthorized use, we may be required to file infringementclaims, which can be expensive and time-consuming. In addition, in an infringement proceeding, a court may decide that one or more of ourasserted patents is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that ourpatents do not cover the technology in question. An adverse result in any litigation or defense proceedings could put one or more of our patents atrisk of being invalidated, held unenforceable or interpreted narrowly and could put our patent applications at risk of not issuing. Pursuit of theseclaims would involve substantial litigation expense and would be a substantial diversion of management and other employee resources from ourbusiness.Interference proceedings or derivative proceedings provoked by third parties or brought by the USPTO may be necessary to determine theentitlement to patent protection with respect to our patents or patent applications. An unfavorable outcome could result in a loss of our patentrights and could require us to cease using the related technology or to attempt to license rights to it from the prevailing party. Our business couldbe harmed if the prevailing party does not offer us a license on commercially reasonable terms, or at all. Litigation or patent office proceedingsmay result in a decision adverse to our interests and, even if we are successful, may result in substantial costs and distract our management andother employees. We may not be able to prevent misappropriation of our trade secrets or confidential information, particularly in countries wherethe laws or legal process may not protect those rights as fully as in the United States.34CIDARA THERAPEUTICS, INC.Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some ofour confidential information could be compromised by disclosure during this type of litigation. In addition, there could be public announcements ofthe results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to benegative, it could have a substantial adverse effect on the price of our common stock.Issued patents covering our product candidates and technologies could be found invalid or unenforceable if challenged in court or theUSPTO.If we initiate legal proceedings against a third party to enforce a patent covering one of our product candidates or our technologies, the defendantcould counterclaim that the patent covering our product candidate or our technology, as applicable, is invalid and/or unenforceable. In patentlitigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace, and there are numerousgrounds upon which a third party can assert invalidity or unenforceability of a patent. Third parties may also raise similar claims beforeadministrative bodies in the United States or abroad, even outside the context of litigation. Such mechanisms include re-examination, post grantreview, and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings). Such proceedings could result in revocation oramendment to our patents in such a way that they no longer cover our product candidates or our technologies. The outcome following legalassertions of invalidity and/or unenforceability is unpredictable. With respect to the validity question, for example, we cannot be certain that thereis no invalidating prior art or that prior art that was cited during prosecution, but not relied on by the patent examiner, will not be revisited. If adefendant were to prevail on a legal assertion of invalidity and/or unenforceability, we would lose at least part, and perhaps all, of the patentprotection directed to our product candidates or technologies. Such a loss of patent rights could have a material adverse impact on our business.Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.As is the case with other pharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining andenforcing patents in the pharmaceutical industry involve both technological and legal complexity, and are therefore costly, time-consuming andinherently uncertain. In addition, the United States has implemented wide-ranging patent reform legislation, including patent office administrativeproceedings that offer broad opportunities to third parties to challenge issued patents. Recent U.S. Supreme Court rulings have narrowed thescope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. In addition toincreasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect tothe value of patents, once obtained. Depending on decisions by the U.S. Congress, the federal courts, the USPTO, and foreign governmentalbodies and tribunals, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain newpatents or to enforce our existing patents and patents that we might obtain in the future. For example, in Assoc. for Molecular Pathology v. MyriadGenetics, Inc., the U.S. Supreme Court held in 2013 that certain claims to DNA molecules are not patentable, and lower courts have since beenapplying this case in the context of other types of biological subject matter. We cannot predict how future decisions by the courts, the U.S.Congress, the USPTO, or foreign governmental bodies or tribunals may impact the value of our patent rights.We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world.We have limited intellectual property rights outside the United States. Filing, prosecuting and defending patents on product candidates in allcountries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United Statescan be less extensive than those in the United States. In addition, the laws and legal processes of some foreign countries do not protectintellectual property to the same extent as federal and state laws in the United States. Consequently, we may not be able to prevent third partiesfrom practicing our inventions in all countries outside the United States, or from selling or importing products made using our inventions in and intothe United States or other jurisdictions. Competitors may use our technologies in jurisdictions where we have not obtained patents to develop theirown products and further, may export otherwise infringing products to territories where we have patents but enforcement is not as strong as that inthe United States. These products may compete with our products, and our patents or other intellectual property rights may not be effective orsufficient to prevent them from competing.Many companies have encountered significant problems in protecting and defending intellectual property in foreign jurisdictions. The legal systemsof certain countries, particularly China and certain other developing countries, do not favor the enforcement of patents, trade secrets and otherintellectual property, particularly those relating to pharmaceutical products, which could make it difficult for us to stop the infringement of ourpatents or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in foreign35CIDARA THERAPEUTICS, INC.jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put any of our patentsat risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing, and could provoke third parties to assert claimsagainst us. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded, if any, may not be commerciallymeaningful. The requirements for patentability may differ in certain countries, particularly developing countries. Furthermore, generic drugmanufacturers or other competitors may challenge the scope, validity or enforceability of any of our current or future patents, requiring us toengage in complex, lengthy and costly litigation or other proceedings. Certain countries in Europe and developing countries, including China andIndia, have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In those countries, we mayhave limited remedies if any of our patents are infringed or if we are compelled to grant a license to a third party, which could materially diminishthe value of those patents. This could limit our potential revenue opportunities. Accordingly, our efforts to enforce our intellectual property rightsaround the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.If our trademarks and trade names are not adequately protected, we may not be able to build name recognition in our markets of interestand our business may be adversely affected.Our trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks. Wemay not be able to protect our rights to these trademarks and trade names or may be forced to stop using these names, which we need for namerecognition by potential partners or customers in our markets of interest. If we are unable to establish name recognition based on our trademarksand trade names, we may not be able to compete effectively and our business may be adversely affected.We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidentialinformation of third parties.We have received confidential and proprietary information from third parties. In addition, we employ individuals who were previously employed atother biotechnology or pharmaceutical companies, including our competitors or potential competitors, and academic or research institutions. Wemay be subject to claims that we or our employees, consultants or independent contractors have inadvertently or otherwise used or disclosedconfidential information of these third parties or our employees’ former employers. Litigation may be necessary to defend against these claims.Even if we are successful in defending against these claims, litigation could result in substantial cost and be a distraction to our management andemployees.Provisions in our contract with the Trustees of Boston University, or BU, relating to the Combating Antibiotic Resistant BacteriaAccelerator, or CARB-X, program, required by the U.S. government or the Wellcome Trust may affect our intellectual property rights.Certain of our activities relating to our CD201 program were subject to reimbursement under our Cost Reimbursement Research SubawardAgreement, or the CARB-X Subaward Agreement, with the Trustees of Boston University. CARB-X is funded by the U.S. Biomedical AdvancedResearch and Development Authority, or BARDA, and the Wellcome Trust, or Wellcome, a global charitable foundation. When new technologiesare developed with U.S. government funding, the government obtains certain rights in any resulting patents, including the right to a nonexclusivelicense authorizing the government to use the invention. These rights may permit the government to disclose our confidential information to thirdparties and to exercise “march-in” rights to use or allow third parties to use our patented technology. The government can exercise its march-inrights if it determines that action is necessary because we fail to achieve practical application of the U.S. government-funded technology, becauseaction is necessary to alleviate health or safety needs, to meet requirements of federal regulations, or to give preference to U.S. industry. Inaddition, U.S. government-funded inventions must be reported to the government, U.S. government funding must be disclosed in any resultingpatent applications, and our rights in such inventions may be subject to certain requirements to manufacture products in the U.S.In addition, subject to such march-in rights, if we have not exploited or further developed intellectual property rights relating to the productcandidates subject to reimbursement under the CARB-X program by the date that is five years after the end of the activities funded by CARB-Xunder the CARB-X Subaward Agreement in any country, Wellcome will have the option to take responsibility for the exclusive commercializationand exploitation of such intellectual property rights in such country. In such event, such intellectual property rights relating to such country will beassigned to Wellcome, and Wellcome will share revenues and equity holdings relating to such exploitation with us on a 50%/50% basis, net ofWellcome’s related costs. In the event we license such intellectual property rights to a third party prior to the exercise of such option rights byWellcome, such option rights shall terminate, provided that the third party license agreement contains a requirement for the licensee to use diligentefforts to exploit such intellectual property rights, with a reversion right to us in the event of a violation of such diligence requirement, and providedthat Wellcome has approved such third party license agreement in writing.36CIDARA THERAPEUTICS, INC.We have decided to discontinue development of CD201. If the U.S. government or Wellcome takes any of these actions with respect to ourintellectual property rights, such actions may adversely impact our product candidates or our ability to develop future candidates, we may beunable to obtain a significant commercial advantage from our intellectual property, and our potential revenue opportunities could be limitedsubstantially.Risks Related to U.S. Government Contracts and GrantsOur use of government funding adds uncertainty to our research and commercialization efforts and may impose requirements thatincrease our costs.Contracts funded by the U.S. government and its agencies, including our CARB-X Subaward Agreement, include provisions that reflect thegovernment’s substantial rights and remedies, many of which are not typically found in commercial contracts, including powers of the governmentto:•terminate agreements, in whole or in part, for any reason or no reason;•reduce or modify the government’s obligations under such agreements without the consent of the other party;•claim rights, including intellectual property rights, in products and data developed under such agreements;•audit contract-related costs and fees, including allocated indirect costs;•suspend the contractor from receiving new contracts pending resolution of alleged violations of procurement laws or regulations;•impose U.S. manufacturing requirements for products that embody inventions conceived or first reduced to practice under suchagreements;•suspend or debar the contractor from doing future business with the government;•control and potentially prohibit the export of products; and•pursue criminal or civil remedies under the Federal Civil Monetary Penalties Act and the Federal Civil False Claims Act and similar remedyprovisions specific to government agreements.In addition, government contracts contain additional requirements that may increase our costs of doing business, reduce our profits, and exposeus to liability for failure to comply with these terms and conditions. These requirements include, for example:•specialized accounting systems unique to government contracts;•mandatory financial audits and potential liability for price adjustments or recoupment of government funds after such funds have beenspent;•public disclosures of certain contract information, which may enable competitors to gain insights into our research program; and•mandatory socioeconomic compliance requirements, including labor standards, anti-human-trafficking, non-discrimination, and affirmativeaction programs and environmental compliance requirements.If we fail to maintain compliance with these requirements, we may be subject to potential liability and to termination of our contracts.If we do not receive all of the funds under our CARB-X Subaward Agreement or are unable to generate additional revenues fromadditional contracts, we may be forced to suspend or terminate one or more of our preclinical programs.A substantial amount of our development activities relating to our CD201 program were funded under our CARB-X Subaward Agreement. Based onour decision to cease development of CD201, we will no longer be seeking funding for CD201 under this agreement. There can be no assurancesthat we will be able to enter into new contracts with the United States government or other sources of funding to support any program resultingfrom our Cloudbreak platform. The process of obtaining government contracts is lengthy and uncertain and we will have to compete with othercompanies and institutions for each contract. Further, changes in government budgets and agendas may result in a decreased and de-prioritizedemphasis on supporting the discovery and development of anti-infective products. If we cannot obtain or maintain government or other funding forour programs, we may be forced to discontinue those programs.37CIDARA THERAPEUTICS, INC.Our business is subject to audit by the U.S. government under our CARB-X Subaward Agreement, and a negative audit could adverselyaffect our business.United States government agencies routinely audit and investigate government contractors and recipients of Federal grants. These agenciesreview a contractor’s performance under its contracts, cost structure and compliance with applicable laws, regulations and standards. BU also hasthe right to audit our activities under our CARB-X Subaward Agreement.Government agencies also review the adequacy of, and a contractor’s compliance with, its internal control systems and policies, including thecontractor’s purchasing, property, estimating, compensation and management information systems. Any costs found to be improperly allocated toa specific contract will not be reimbursed, while such costs already reimbursed must be refunded.If an audit uncovers improper or illegal activities, we may be subject to civil and criminal penalties and administrative sanctions, including:•termination of contracts;•forfeiture of profits;•suspension of payments;•fines; and•suspension or prohibition from conducting business with the United States government.In addition, we could suffer serious reputational harm if allegations of impropriety were made against us, which could cause our stock price todecrease.Laws and regulations affecting government contracts make it more expensive and difficult for us to successfully conduct our business.We must comply with numerous laws and regulations relating to the formation, administration and performance of government contracts, which canmake it more difficult for us to retain our rights under our CARB-X Subaward Agreement. These laws and regulations affect how we conductbusiness with government agencies. Among the most significant government contracting regulations that affect our business are:•the Federal Acquisition Regulations, or FAR, and agency-specific regulations supplemental to the FAR, which comprehensively regulatethe procurement, formation, administration and performance of government contracts;•business ethics and public integrity obligations, which govern conflicts of interest and the hiring of former government employees, restrictthe granting of gratuities and funding of lobbying activities and include other requirements such as the Anti-Kickback Statute and ForeignCorrupt Practices Act;•export and import control laws and regulations; and•laws, regulations and executive orders restricting the use and dissemination of information classified for national security purposes andthe exportation of certain products and technical data.Any changes in applicable laws and regulations could restrict our ability to maintain our existing CARB-X Subaward Agreement and obtain newcontracts, which could limit our ability to conduct our business and materially adversely affect our results of operations.Risks Related to Our Financial Position and Need for Additional CapitalWe are an early stage biotechnology company that has incurred significant operating losses since our inception, and we anticipate thatwe will continue to incur substantial operating losses for the foreseeable future. We may never achieve or maintain profitability.Since our inception, we have incurred significant operating losses. Our net loss was $55.7 million and $48.2 million for our 2017 and 2016 fiscalyears, respectively. As of December 31, 2017, we had an accumulated deficit of $149.4 million. To date, we have financed our operations primarilythrough private placements of convertible preferred stock and convertible notes, our initial public offering of our common stock, or our IPO, ourOctober 2016 term loan facility with Pacific Western Bank, or Pacific Western, our October 2016 follow-on public offering of common stock, ourOctober 2017 private placement of common stock and sales of common stock during the fourth quarter of 2017 and the first quarter of 2018 underour controlled equity sales agreement with Cantor Fitzgerald & Co. We have devoted substantially all of our financial resources and efforts toresearch and development. We are currently conducting a Phase 2 clinical trial of rezafungin and preclinical studies of our ADCs. We expect thatit will be many years, if ever, before we receive regulatory38CIDARA THERAPEUTICS, INC.approval and have a product candidate available for commercialization. We expect to continue to incur significant expenses and increasingoperating losses for the foreseeable future. Our net losses may fluctuate significantly from quarter to quarter and year to year. We anticipate thatour expenses will increase substantially if and as we:•submit INDs to the FDA and equivalent filings to other regulatory authorities, and seek approval of our clinical protocols by institutionalreview boards, or IRBs, at clinical trial sites;•advance rezafungin through clinical development;•continue the preclinical development of our ADCs or any other product candidates from our Cloudbreak immunotherapy platform orotherwise, and advance one or more of such product candidates into clinical trials;•seek marketing approvals for our product candidates;•establish or contract for a sales, marketing and distribution infrastructure to commercialize any product candidates for which we obtainmarketing approval;•maintain, expand and enforce our intellectual property portfolio;•hire additional manufacturing, clinical, regulatory, quality assurance and scientific personnel;•add operational, financial and management information systems and personnel, including personnel to support product development; and•acquire or in-license other product candidates and technologies.To become and remain profitable, we must develop and eventually commercialize one or more products with significant market potential. This willrequire us to be successful in a range of challenging activities, including completing preclinical studies and clinical trials of our product candidates,obtaining marketing approval for these product candidates, manufacturing, marketing and selling those product candidates for which we may obtainmarketing approval, and satisfying any post-marketing requirements. We may never succeed in these activities and, even if we do, may nevergenerate revenue that is significant or large enough to achieve profitability. Our failure to become and remain profitable would decrease the valueof the company and could impair our ability to raise capital, maintain our research and development efforts, expand our business or continue ouroperations. A decline in the value of our company could also cause you to lose all or part of your investment.We will need substantial additional funding to advance the development of our product candidates. If we are unable to raise capital whenneeded, we would be forced to delay, reduce or eliminate our drug development and discovery programs or commercialization efforts.We expect our expenses to increase in connection with our ongoing activities, particularly as we continue the research and development of, initiateclinical trials of and seek marketing approval for our product candidates. In addition, if we obtain marketing approval for any of our productcandidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution of theapproved product. Furthermore, we expect to incur additional costs associated with operating as a public company. Our future capital requirementswill depend on many factors, including:•the scope, progress, results and costs of drug discovery, preclinical development, laboratory testing and clinical trials for our productcandidates and Cloudbreak platform;•the costs, timing and outcome of any regulatory review of our product candidates;•the costs and timing of commercialization activities, including manufacturing, marketing, sales and distribution, for any product candidatesthat receive marketing approval;•the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defendingintellectual property-related claims;•our ability to establish and maintain collaborations, when and if necessary, on favorable terms, if at all; and•the extent to which we acquire or in-license other product candidates and technologies.Identifying potential development candidates and conducting preclinical studies and clinical trials are time consuming, expensive and uncertainprocesses that take years to complete, and we may never generate the necessary data or results required to obtain marketing approval andachieve product sales for any of our current or future product candidates. In addition, our product candidates, if approved, may not achievecommercial success.Our commercial revenue, if any, will be derived from sales of products that we do not expect to be commercially available for many years, if at all.39CIDARA THERAPEUTICS, INC.Accordingly, we will need substantial additional funding in connection with our continuing operations and to achieve our goals. Since December 6,2012 (inception) through December 31, 2017, our operations have been financed primarily by gross proceeds of approximately $210.9 million fromthe issuance of convertible debt securities, the sale of shares of convertible preferred stock, the sale of shares of our common stock in our IPO,our October 2016 term loan facility with Pacific Western, our October 2016 follow-on public offering of common stock, our October 2017 privateplacement of common stock and sales of common stock during the fourth quarter of 2017 and the first quarter of 2018 under our controlled equitysales agreement with Cantor Fitzgerald & Co. As of December 31, 2017, we had cash, cash equivalents, and short-term investments of $75.3million.We have prepared cash flow forecasts which indicate, based on current cash resources available, that we will have sufficient resources to fund ourbusiness for at least the next 12 months from the issuance of these financial statements. We plan to continue to fund our operating expenses andcapital expenditure requirements through debt and equity financing, through government funding, or through collaborations or partnerships withother entities. Debt or equity financing, government funding, or collaborations and partnerships with other entities may not be available on a timelybasis, on acceptable terms, or at all. We have developed a plan to implement cost cutting measures to reduce our working capital requirementsover the next 12 months if an adequate level of financing is not secured. The plan includes the delay of certain of our development activities, adelay in hiring and a reduction of other discretionary expenditures that are within our control. Any of the actions contemplated by theimplementation of this plan, if required, could have an adverse impact on our ability to achieve certain of our planned objectives during 2018, andthus, materially harm our business.If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or eliminate our research anddevelopment programs or future commercialization efforts, or to make reductions in spending, extend payment terms with suppliers, or liquidate orgrant rights to assets where possible, or suspend or curtail planned programs.Any of these actions could materially harm our business, results of operations and future prospects. Adequate additional financing may not beavailable to us on acceptable terms, or at all. In addition, we may seek additional financing due to favorable market conditions or strategicconsiderations, even if we believe we have sufficient funds for our operating plans.Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to ourtechnologies or product candidates.Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity anddebt financings, as well as potentially entering into collaborations, strategic alliances and licensing arrangements or receiving government and/orcharitable grants or contracts. Other than our controlled equity sales agreement with Cantor Fitzgerald & Co. and our term loan facility with PacificWestern, each of which is subject to the fulfillment of specified conditions, we do not currently have any committed external source of funds. Tothe extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and theterms of these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder. Debt financing, ifavailable, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additionaldebt, making capital expenditures or declaring dividends, and may be secured by all or a portion of our assets. There can be no assurances thatwe will be able to enter into contracts with or receive grants from the United States government or charitable organizations to support ourprograms. The process of obtaining grants and contracts is lengthy and uncertain and we will have to compete with other companies andinstitutions for each grant or contract. United States government grants and contracts typically contain unfavorable termination provisions and aresubject to audit and modification by the government at its sole discretion, which will subject us to additional risks. If we receive a United Statesgovernment grant or contract, we would be required to comply with numerous laws and regulations relating to the formation, administration andperformance of the grant or contract, which can make it more difficult for us to retain our rights under such grant or contract and result in increasedcosts. If we raise funds by entering into collaborations, strategic alliances or licensing arrangements with third parties, or by receiving charitablegrants, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grantlicenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or throughcollaborations, strategic alliances, licensing arrangements or government or charitable programs when needed, we may be required to delay, limit,reduce or terminate our drug development or future commercialization efforts or grant rights to develop and market product candidates that wewould otherwise prefer to develop and market ourselves.40CIDARA THERAPEUTICS, INC.Our short operating history may make it difficult for you to evaluate the success of our business to date and assess our future viability.We were founded in December 2012 and our operations to date have been limited to organizing and staffing our company, business planning,raising capital, developing our technology, identifying potential development and product candidates, undertaking preclinical studies andconducting clinical trials. We have not yet demonstrated our ability to successfully complete large-scale, pivotal clinical trials required forregulatory approval of our product candidates, obtain marketing approvals, manufacture a commercial scale product, or arrange for a third party todo so on our behalf, or conduct sales and marketing activities necessary for successful commercialization. Typically, it takes many years todevelop one new product from the time it is discovered to when it is commercially available. Consequently, any predictions made about our futuresuccess or viability may not be as accurate as they could be if we had a longer operating history or if we had product candidates in advancedclinical trials.In addition, as a new business, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factorsthat may alter or delay our plans. We will need to continue to transition from a company with a research focus to a company capable of supportinglate-stage development activities and, if a product candidate is approved, a company with commercial activities. We may not be successful in anystep of such a transition.The terms of our term loan facility place restrictions on our operating and financial flexibility, and failure to comply with covenants or tosatisfy certain conditions of the agreement governing the debt facility may result in acceleration of our repayment obligations andforeclosure on our pledged assets, which could significantly harm our liquidity, financial condition, operating results, business andprospects and cause the price of our common stock to decline.In October 2016, we entered into a loan and security agreement with Pacific Western, or the loan agreement, under which we borrowed $10.0million and may borrow up to an additional $10.0 million on or prior to October 3, 2018, subject to certain terms and conditions set forth therein,including our achievement of certain milestones.The outstanding principal balance under the loan agreement is secured by a security interest in substantially all of our assets, other thanintellectual property, which is subject to a double negative pledge. The loan agreement requires us to comply with a number of customaryaffirmative and restrictive covenants, including covenants that limit our ability to, among other things: transfer any part of our business or property;merge or consolidate with another entity or otherwise experience a change in control; incur additional indebtedness; encumber the collateralsecuring the loan; declare or pay any cash dividend or make distributions on our capital stock; repurchase or redeem any class of stock or otherequity interest; acquire, own or make investments; and make certain capitalized expenditures over a specified threshold, in each case subject toexceptions. In addition, the loan agreement contains an operating covenant, which requires us to achieve positive data from a Phase 2 clinical trialof rezafungin on or before March 31, 2018. The operating covenant will be reset in 2018. The loan agreement also includes standard events ofdefault, including a provision that Pacific Western could declare an event of default upon the occurrence of any event that it interprets as having amaterial adverse effect on (i) our operations, business or financial condition and subsidiaries taken as a whole; (ii) our ability to perform or pay thesecured obligations under the loan agreement and related agreements; or (iii) the collateral pledged to Pacific Western under the loanagreement. Upon such determination, Pacific Western could declare all obligations under the loan agreement immediately due andpayable. Although, in and of itself, the occurrence of adverse results or delays in any clinical study or the denial, delay or limitation of approval ofor taking of any other regulatory action by the FDA or another governmental entity will not constitute a material adverse effect under the loanagreement, Pacific Western may determine that such an event together with contemporaneous events or circumstances constitutes a materialadverse effect upon our business, operations, properties, assets, or financial condition or upon our ability to perform or pay the secured obligationsunder the loan agreement. If we default under the facility, Pacific Western may accelerate all of our repayment obligations. At such time, we maynot have enough available cash or be able to raise additional funds on satisfactory terms, if at all, through equity or debt financings to repay ourindebtedness at the time any such repayment is required. If we are unable to access funds to meet those obligations or to renegotiate the loanagreement, Pacific Western could take control of and may sell our pledged assets. In such an event, we may be required to delay, limit, reduce orterminate our product development or commercialization efforts or grant to others rights to develop and market product candidates that we wouldotherwise prefer to develop and market ourselves. If our assets were liquidated, Pacific Western’s right to repayment would be senior to the rightsof our stockholders to receive any proceeds from the liquidation. Any declaration by Pacific Western of an event of default could significantly harmour liquidity, financial condition, operating results, business, and prospects and cause the price of our common stock to decline.We may incur additional indebtedness in the future. The debt instruments governing such indebtedness may contain provisions that are as, ormore, restrictive than the provisions governing our existing indebtedness under the loan agreement. If we are unable to repay, refinance orrestructure our indebtedness when payment is due, the lenders could proceed against the collateral or force us into bankruptcy or liquidation.41CIDARA THERAPEUTICS, INC.Risks Related to Employee Matters and Managing GrowthOur future success depends on our ability to retain our senior management team and to attract, retain and motivate qualified personnel.We are highly dependent upon our senior management team, as well as the other principal members of our research and development teams. Allof our executive officers are employed “at will,” meaning we or they may terminate the employment relationship at any time. We maintain “keyperson” insurance for our Chief Executive Officer but not for any of our other executives or employees. The loss of the services of any of thesepersons could impede the achievement of our research, development and commercialization objectives.Recruiting and retaining qualified scientific, clinical, manufacturing, regulatory, quality assurance, and sales and marketing personnel will also becritical to our success. We may not be able to attract and retain these personnel on acceptable terms given the competition among numerouspharmaceutical and biotechnology companies for similar personnel. We also experience competition for the hiring of scientific and clinicalpersonnel from universities and research institutions. In addition, we rely on consultants and advisers, including scientific, regulatory, qualityassurance, and clinical advisers, to assist us in formulating our research and development and commercialization strategy. Our consultants andadvisers may be employed by employers other than us and may have commitments under consulting or advisory contracts with other entities thatmay limit their availability to us.We expect to expand our operations, and may encounter difficulties in managing our growth, which could disrupt our business.We expect to expand the scope of our operations, particularly in the areas of drug development, manufacturing, clinical, regulatory affairs, qualityassurance, and sales and marketing. To manage our anticipated future growth, we must continue to implement and improve our managerial,operational and financial systems, expand our facilities and continue to recruit and train additional qualified personnel. We may not be able toeffectively manage the expected expansion of our operations or recruit and train additional qualified personnel. Moreover, the expected expansionof our operations may lead to significant costs and may divert our management and business development resources. Any inability to managegrowth could delay the execution of our business plans or disrupt our operations.We may engage in acquisitions that could disrupt our business, cause dilution to our stockholders or reduce our financial resources.In the future, we may enter into transactions to acquire other businesses, products or technologies and our ability to do so successfully isunproven. If we do identify suitable candidates, we may not be able to make such acquisitions on favorable terms, or at all. Any acquisitions wemake may fail to strengthen our competitive position, and these transactions may be viewed negatively by customers or investors. We maydecide to incur debt in connection with an acquisition or issue our common stock or other equity securities to the stockholders of the acquiredcompany, which would reduce the percentage ownership of our existing stockholders. We could incur losses resulting from undiscovered liabilitiesof the acquired business that are not covered by the indemnification we may obtain from the seller. In addition, we may not be able to successfullyintegrate the acquired personnel, technologies and operations into our existing business in an effective, timely and non-disruptive manner.Acquisitions may also divert management attention from day-to-day responsibilities, increase our expenses and reduce our cash available foroperations and other uses. We cannot predict the number, timing or size of future acquisitions or the effect that any such transactions might haveon our operating results.Risks Related to Ownership of our Common StockThe price of our stock may be volatile, and you could lose all or part of your investment.The trading price of our common stock is likely to be highly volatile and could be subject to wide fluctuations in response to various factors, someof which are beyond our control, including limited trading volume. In addition to the factors discussed in this “Risk Factors” section and elsewherein this report, these factors include:•the commencement, timing, enrollment or results of the current and planned clinical trials of our product candidates or any future clinicaltrials we may conduct, or changes in the development status of our product candidates;•any delay in our regulatory filings for our product candidates and any adverse development or perceived adverse development with respectto the applicable regulatory authority’s review of such filings, including without limitation the FDA’s issuance of a “refusal to file” letter,"complete response" letter, or a request for additional information;42CIDARA THERAPEUTICS, INC.•adverse results, suspensions, terminations, or delays in pre-clinical or clinical trials;•our decision to initiate a clinical trial, not to initiate a clinical trial, or to terminate an existing clinical trial or development program;•adverse regulatory decisions, including failure to receive regulatory approval of our product candidates;•changes in laws or regulations applicable to our products, including but not limited to requirements for approvals;•adverse developments concerning our contract manufacturers;•our inability to obtain adequate product supply for any approved product or inability to do so at acceptable prices or acceptable quality;•our inability to establish collaborations if needed;•our failure to commercialize our product candidates successfully or at all;•additions or departures of key scientific or management personnel;•unanticipated serious safety concerns related to the use of our product candidates;•the introduction of new products or services offered by us or our competitors;•announcements of significant acquisitions, strategic partnerships, joint ventures, government grants or contracts or capital commitmentsby us or our competitors;•our ability to effectively manage our growth; •the size and growth of our fungal infection, bacterial infection or other target markets;•our ability to successfully enter new markets or develop additional product candidates;•actual or anticipated variations in quarterly operating results;•our cash position and our ability to raise additional capital and the manner and terms on which we raise it;•our failure to meet the estimates and projections of the investment community or that we may otherwise provide to the public;•publication of research reports or other media coverage about us or our industry, or our therapeutic approaches in particular, or positive ornegative recommendations or withdrawal of research coverage by securities analysts;•changes in the market valuations of similar companies;•overall performance of the equity markets;•sales of our common stock by us or our stockholders in the future;•the trading volume of our common stock;•changes in accounting practices;•ineffectiveness of our internal controls;•disputes or other developments relating to proprietary rights, including patent rights, litigation matters and our ability to obtain patentprotection for our technologies;•significant lawsuits, including patent or stockholder litigation;•general political and economic conditions; and•other events or factors, many of which are beyond our control.In addition, the stock market in general, and The NASDAQ Global Market and pharmaceutical companies in particular, have experienced extremeprice and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. Broad marketand industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance. You may notrealize any return on your investment in us and may lose some or all of your investment. In the past, securities class action litigation has oftenbeen instituted against companies following periods of volatility in the market price of a company’s securities. This type of litigation, if instituted,could result in substantial costs and a diversion of management’s attention and resources, which would harm our business, operating results orfinancial condition.43CIDARA THERAPEUTICS, INC.We do not intend to pay dividends on our common stock, so any returns will be limited to the value of our stock.We currently anticipate that we will retain future earnings for the development, operation and expansion of our business and do not anticipatedeclaring or paying any cash dividends for the foreseeable future. Any return to stockholders will therefore be limited to the appreciation of theirstock.Our principal stockholders and management own a significant percentage of our stock and are able to exert significant control overmatters subject to stockholder approval.Our executive officers, directors, and 5% stockholders and their affiliates currently beneficially own a significant percentage of our outstandingvoting stock. These stockholders have the ability to influence us through this ownership position. These stockholders may be able to determine allmatters requiring stockholder approval. For example, these stockholders may be able to control elections of directors, amendments of ourorganizational documents, or approval of any merger, sale of assets, or other major corporate transaction. This may prevent or discourageunsolicited acquisition proposals or offers for our common stock that you may feel are in your best interest as one of our stockholders.We are an emerging growth company, and we cannot be certain if the reduced reporting requirements applicable to emerging growthcompanies will make our common stock less attractive to investors.We are an emerging growth company, as defined in the Jumpstart Our Business Startups Act, or the JOBS Act, enacted in April 2012. For as longas we continue to be an emerging growth company, we may take advantage of exemptions from various reporting requirements that are applicableto other public companies that are not emerging growth companies, including not being required to comply with the auditor attestation requirementsof Section 404 of the Sarbanes-Oxley Act of 2002, as amended, or the Sarbanes-Oxley Act, reduced disclosure obligations regarding executivecompensation in our periodic reports and proxy statements and exemptions from the requirements of holding nonbinding advisory votes onexecutive compensation and stockholder approval of any golden parachute payments not previously approved. We could be an emerging growthcompany through 2020, although circumstances could cause us to lose that status earlier. We will remain an emerging growth company until theearlier of (a) December 31, 2020, (b) the last day of the fiscal year in which we have total annual gross revenue of at least $1 billion, (c) the lastday of the fiscal year in which we are deemed to be a large accelerated filer, which requires the market value of our common stock that is held bynon-affiliates to exceed $700 million as of the prior June 30th, and (d) the date on which we have issued more than $1 billion in non-convertibledebt during the prior three-year period.Under the JOBS Act, emerging growth companies can also delay adopting new or revised accounting standards until such time as those standardsapply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and,therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies. Asa result, changes in rules of U.S. generally accepted accounting principles or their interpretation, the adoption of new guidance or the application ofexisting guidance to changes in our business could significantly affect our financial position and results of operations.We incur significant costs as a result of operating as a public company, and our management will be required to devote substantial timeto compliance initiatives.As a public company, we incur significant legal, accounting and other expenses that we did not incur as a private company. We are subject to thereporting requirements of the Securities Exchange Act of 1934, which require, among other things, that we file with the Securities and ExchangeCommission, or the SEC, annual, quarterly and current reports with respect to our business and financial condition. In addition, the Sarbanes-Oxley Act, as well as rules subsequently adopted by the SEC and The NASDAQ Global Market to implement provisions of the Sarbanes-OxleyAct, impose significant requirements on public companies, including requiring establishment and maintenance of effective disclosure and financialcontrols and changes in corporate governance practices. Further, in July 2010, the Dodd-Frank Wall Street Reform and Consumer Protection Act,or the Dodd-Frank Act, was enacted. There are significant corporate governance and executive compensation related provisions in the Dodd-FrankAct that require the SEC to adopt additional rules and regulations in these areas such as “say on pay” and proxy access. Recent legislationpermits emerging growth companies to implement many of these requirements over a longer period and up to five years from the pricing of ourIPO. We intend to take advantage of this legislation but cannot guarantee that we will not be required to implement these requirements sooner thanbudgeted or planned and thereby incur unexpected expenses. Stockholder activism, the political environment and the level of governmentintervention and regulatory reform may lead to substantial new regulations and disclosure obligations, which may lead to additional compliancecosts and impact the manner in which we operate our business in ways we cannot currently anticipate.We expect the rules and regulations applicable to public companies to continue to result in substantial legal and financial compliance costs and tomake some activities more time-consuming and costly. If these requirements divert the attention of our management and personnel from otherbusiness concerns, they could have a material adverse effect on our44CIDARA THERAPEUTICS, INC.business, financial condition and results of operations. These costs could decrease our net income or increase our net loss, and may require us toreduce costs in other areas of our business or increase the prices of our products or services. For example, these rules and regulations couldmake it more difficult and more expensive for us to obtain director and officer liability insurance and we may be required to incur substantial coststo maintain the same or similar coverage. We cannot predict or estimate the amount or timing of additional costs we may incur to respond to theserequirements. The impact of these requirements could also make it more difficult for us to attract and retain qualified persons to serve on our boardof directors, our board committees or as executive officers.Sales of a substantial number of shares of our common stock by our existing stockholders in the public market could cause our stockprice to fall.If our existing stockholders sell, or indicate an intention to sell, substantial amounts of our common stock in the public market, the trading price ofour common stock could decline. We had 20,525,688 shares of common stock outstanding as of December 31, 2017. We are unable to predict theeffect that sales may have on the prevailing market price of our common stock.Sales of our common stock by current stockholders may make it more difficult for us to sell equity or equity-related securities in the future at atime and price that we deem reasonable or appropriate, and may make it more difficult for you to sell shares of our common stock. In addition,shares of common stock that are either issuable upon the exercise of outstanding options or reserved for future issuance under our employeebenefit plans will become eligible for sale in the public market to the extent permitted by the provisions of various vesting schedules and Rule 144and Rule 701 under the Securities Act. If these additional shares of common stock are sold, or if it is perceived that they will be sold, in the publicmarket, the trading price of our common stock could decline.Certain holders of our securities are entitled to rights with respect to the registration of their shares under the Securities Act. Registration of theseshares under the Securities Act would result in the shares becoming freely tradable without restriction under the Securities Act, except for sharesheld by affiliates, as defined in Rule 144 under the Securities Act. Any sales of securities by these stockholders could have a material adverseeffect on the trading price of our common stock.Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our equity incentive plans,could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall.We expect that significant additional capital may be needed in the future to continue our planned operations, including conducting clinical trials,commercialization efforts, expanded research and development activities and costs associated with operating as a public company. To raisecapital, we may sell common stock, convertible securities or other equity securities in one or more transactions at prices and in a manner wedetermine from time to time. If we sell common stock, convertible securities or other equity securities, investors may be materially diluted bysubsequent sales, and new investors could gain rights, preferences and privileges senior to our existing stockholders.Pursuant to our 2015 Equity Incentive Plan, or the 2015 EIP, our management is authorized to grant stock options to our employees, directors andconsultants. The number of shares of our common stock reserved for issuance under the 2015 EIP will automatically increase on January 1 ofeach year through and including January 1, 2025, by 4% of the total number of shares of our capital stock outstanding on December 31 of thepreceding calendar year, or a lesser number of shares determined by our board of directors. Additionally, the number of shares of our commonstock reserved for issuance under our 2015 Employee Stock Purchase Plan, or the ESPP, will automatically increase on January 1 of each yearthrough and including January 1, 2025, by the lesser of 1% of the total number of shares of our capital stock outstanding on December 31 of thepreceding calendar year, or 490,336 shares. Unless our board of directors elects not to increase the number of shares available for future granteach year under the 2015 EIP and the ESPP, our stockholders may experience additional dilution, which could cause our stock price to fall.We have broad discretion in the use of working capital and may not use it effectively.Our management will have broad discretion in the application of our working capital. Because of the number and variability of factors that willdetermine our use of our working capital, its ultimate use may vary substantially from its currently intended use. Our management might not applyour working capital in ways that ultimately increase the value of your investment. We expect to use our working capital to fund research anddevelopment activities and general operating expenses. The failure by our management to apply this working capital effectively could harm ourbusiness. Pending its use, we may invest our working capital in short-term, investment-grade, interest-bearing securities. These investments maynot yield a favorable return to our stockholders. If we do not invest or apply our working capital in ways that enhance stockholder value, we mayfail to achieve expected financial results, which could cause our stock price to decline.45CIDARA THERAPEUTICS, INC.Anti-takeover provisions under our charter documents and Delaware law could delay or prevent a change of control which could limit themarket price of our common stock and may prevent or frustrate attempts by our stockholders to replace or remove our currentmanagement.Our amended and restated certificate of incorporation and amended and restated bylaws contain provisions that could delay or prevent a change ofcontrol of our company or changes in our board of directors that our stockholders might consider favorable. Some of these provisions include:•a board of directors divided into three classes serving staggered three-year terms, such that not all members of the board will be electedat one time;•a prohibition on stockholder action through written consent, which requires that all stockholder actions be taken at a meeting of ourstockholders;•a requirement that special meetings of stockholders be called only by the chairman of the board of directors, the chief executive officer, orby a majority of the total number of authorized directors;•advance notice requirements for stockholder proposals and nominations for election to our board of directors;•a requirement that no member of our board of directors may be removed from office by our stockholders except for cause and, in additionto any other vote required by law, upon the approval of not less than two-thirds of all outstanding shares of our voting stock then entitled tovote in the election of directors;•a requirement of approval of not less than two-thirds of all outstanding shares of our voting stock to amend any bylaws by stockholderaction or to amend specific provisions of our certificate of incorporation; and •the authority of the board of directors to issue preferred stock on terms determined by the board of directors without stockholder approvaland which preferred stock may include rights superior to the rights of the holders of common stock.In addition, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporate Law,which may prohibit certain business combinations with stockholders owning 15% or more of our outstanding voting stock. These anti-takeoverprovisions and other provisions in our amended and restated certificate of incorporation and amended and restated bylaws could make it moredifficult for stockholders or potential acquirers to obtain control of our board of directors or initiate actions that are opposed by the then-currentboard of directors and could also delay or impede a merger, tender offer or proxy contest involving our company. These provisions could alsodiscourage proxy contests and make it more difficult for you and other stockholders to elect directors of your choosing or cause us to take othercorporate actions you desire. Any delay or prevention of a change of control transaction or changes in our board of directors could cause themarket price of our common stock to decline.Because we have an even number of members of our board of directors, deadlocks may occur in our board of directors’ decision-making process, which may delay or prevent critical decisions from being made.Since we currently have an even number of directors, deadlocks may occur when such directors disagree on a particular decision or course ofaction. Our amended and restated certificate of incorporation and amended and restated bylaws do not contain any mechanisms for resolvingpotential deadlocks. While our directors are under a duty to act in the best interest of our company, any deadlocks may impede the furtherdevelopment of our business in that such deadlocks may delay or prevent critical decisions regarding our development.Our amended and restated bylaws provide that the Court of Chancery of the State of Delaware will be the exclusive forum forsubstantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicialforum for disputes with us or our directors, officers or employees.Our amended and restated bylaws provide that the Court of Chancery of the State of Delaware is the exclusive forum for any derivative action orproceeding brought on our behalf; any action asserting a breach of fiduciary duty; any action asserting a claim against us arising pursuant to theDelaware General Corporation Law, our certificate of incorporation or our bylaws; or any action asserting a claim against us that is governed by theinternal affairs doctrine. The choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable fordisputes with us or our directors, officers or other employees, which may discourage such lawsuits against us and our directors, officers and otheremployees. Alternatively, if a court were to find the choice of forum provision contained in our amended and restated bylaws to be inapplicable orunenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could adversely affectour business and financial condition.46CIDARA THERAPEUTICS, INC.If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stockprice and trading volume could decline.The trading market for our common stock will depend in part on the research and reports that securities or industry analysts publish about us orour business. If one or more of the analysts who covers us downgrades our stock or publishes inaccurate or unfavorable research about ourbusiness, our stock price may decline. If one or more of these analysts ceases coverage of our company or fails to publish reports on us regularly,demand for our stock could decrease, which might cause our stock price and trading volume to decline.Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.Under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, if a corporation undergoes an “ownership change” (generallydefined as a greater than 50% change (by value) in its equity ownership over a three-year period), the corporation’s ability to use its pre-change netoperating loss carryforwards and other pre-change tax attributes to offset its post-change income may be limited. As a result of capital raising andother transactions that have occurred since our inception in 2012, we may or may not have experienced an “ownership change.” We may alsoexperience ownership changes in the future as a result of subsequent shifts in our stock ownership. As of December 31, 2017, we had U.S. netoperating loss carryforwards of approximately $122.5 million, which begin to expire in 2033, which could be limited if we experience an “ownershipchange.”Our business and operations would suffer in the event of system failures.Despite the implementation of security measures, our internal computer systems and those of our contractors and consultants are vulnerable todamage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. While wehave not experienced any such system failure, accident or security breach to date, if such an event were to occur and cause interruptions in ouroperations, it could result in a material disruption of our drug development programs. For example, the loss of clinical trial data from completed orongoing or planned clinical trials could result in delays in our regulatory approval efforts and we may incur substantial costs to attempt to recoveror reproduce the data. If any disruption or security breach resulted in a loss of or damage to our data or applications, or inappropriate disclosure ofconfidential or proprietary information, we could incur liability and/or the further development of our product candidates could be delayed.Our operations are vulnerable to interruption by natural disasters, power loss, terrorist activity and other events beyond our control, theoccurrence of which could materially harm our business.Businesses located in California have, in the past, been subject to electrical blackouts as a result of a shortage of available electrical power, andany future blackouts could disrupt our operations. We are vulnerable to a major earthquake, wildfire, inclement weather and other natural and man-made disasters, and we have not undertaken a systematic analysis of the potential consequences to our business as a result of any such naturaldisaster and do not have an applicable recovery plan in place. We carry only limited business interruption insurance that would compensate us foractual losses from interruption of our business that may occur, and any losses or damages incurred by us in excess of insured amounts couldcause our business to materially suffer.Item 1B. Unresolved Staff Comments.Not applicable.Item 2. Properties.We lease a 29,638 square foot facility in San Diego, California for administrative, research and development activities. Our lease currently expiresin December 2018, subject to our option to renew for up to two additional two-year terms. We believe that our facility is sufficient to meet ourneeds and that suitable additional space will be available as and when needed.Item 3. Legal Proceedings.None.Item 4. Mine Safety Disclosures.Not applicable.47CIDARA THERAPEUTICS, INC.PART IIItem 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.Market InformationOur common stock is traded on The NASDAQ Global Market under the symbol “CDTX.” The following table sets forth the high and low salesprices per share of our common stock as reported on The NASDAQ Global Market for the periods indicated. High LowYear ended December 31, 2016 First quarter ended March 31, 2016$17.29 $9.48Second quarter ended June 30, 2016$15.91 $9.51Third quarter ended September 30, 2016$12.95 $10.23Fourth quarter ended December 31, 2016$11.85 $8.65 Year ended December 31, 2017 First quarter ended March 31, 2017$11.75 $6.65Second quarter ended June 30, 2017$8.03 $5.65Third quarter ended September 30, 2017$8.80 $5.60Fourth quarter ended December 31, 2017$8.80 $6.15Holders of RecordAs of February 20, 2018, there were approximately 34 holders of record for our common stock.Dividend PolicyWe do not anticipate declaring or paying, in the foreseeable future, any cash dividends on our capital stock. In addition, the terms of our loanagreement with Pacific Western restrict our ability to declare or pay any cash dividends or make any other distribution or payment on account of orin redemption, retirement or purchase of any capital stock, subject to certain limited exceptions. We currently intend to retain all available fundsand any future earnings to support our operations and finance the growth and development of our business. Any future determination related to ourdividend policy will be made at the discretion of our board of directors and will depend upon, among other factors, our results of operations,financial condition, capital requirements, contractual restrictions, business prospects and other factors our board of directors may deem relevant.Securities Authorized for Issuance under Equity Compensation PlansInformation about our equity compensation plans is incorporated herein by reference to Part III, Item 12 of this Annual Report.Performance GraphThe following graph shows a comparison from April 15, 2015 (the date our common stock commenced trading on The NASDAQ Global Market)through December 31, 2017 of the cumulative total return for our common stock, the NASDAQ Biotechnology Index (NBI) and the NASDAQComposite Index (IXIC). The graph assumes an initial investment of $100 on April 15, 2015. The comparisons in the graph are not intended toforecast or be indicative of possible future performance of our common stock.48CIDARA THERAPEUTICS, INC.Use of ProceedsOn April 14, 2015, our Registration Statements on Form S-1 (file Nos. 333-202740 and 333-203434) were declared effective by the SEC for ourinitial public offering of common stock, which was completed on April 20, 2015.We received approximately $69.3 million in net proceeds from our initial public offering. Through December 31, 2017, we used $51.4 million of thenet proceeds from the offering to fund our ongoing research and development activities. We intend to use the remaining proceeds to fund ourongoing and future clinical development of rezafungin; the development of our ADCs and/or any other Cloudbreak development candidates;research and discovery efforts related to the expansion of our Cloudbreak immunotherapy platform; and working capital, including general operatingexpenses. Pending such uses, we plan to continue investing the unused proceeds from this offering in short- and intermediate-term, interest-bearing obligations, investment-grade instruments, certificates of deposit or direct or guaranteed obligations of the U.S. government.Item 6. Selected Financial Data.The selected financial data set forth below is derived from our audited consolidated financial statements and may not be indicative of futureoperating results. The following selected financial data should be read in conjunction with the consolidated financial statements and notes theretoand Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included elsewhere in this Annual Report.The selected financial data in this section are not intended to replace our consolidated financial statements and the related notes. Our historicalresults are not necessarily indicative of our future results. Amounts are in thousands, except share and per share data.Statement of Operations Data Year ended December 31,(In thousands, except share and per share data)2017 2016 2015Operating expenses: Research and development$42,823 $35,699 $23,475General and administrative12,898 12,737 8,838Total operating expenses55,721 48,436 32,313Loss from operations(55,721) (48,436) (32,313)Other income (expense): Interest income (expense), net(7) 271 120Total other income (expense)(7) 271 120Net loss$(55,728) $(48,165) $(32,193)Net loss per common share, basic and diluted$(3.18) $(3.32) $(3.25)Weighted average shares outstanding used to compute net loss per share, basic and diluted17,500,853 14,488,987 9,920,38249CIDARA THERAPEUTICS, INC.Balance Sheet Data December 31, 2017 2016 2015Cash, cash equivalents, and short-term investments$75,314 $104,619 $107,514Working capital65,585 96,489 102,244Total assets79,035 106,962 109,974Accumulated deficit(149,390) (93,662) (45,497)Total stockholders' equity59,744 88,179 103,912Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.You should read the following discussion and analysis together with “Item 6. Selected Financial Data” and our consolidated financial statementsand related notes included elsewhere in this Annual Report.Forward-Looking StatementsThe following discussion contains forward-looking statements that involve risks and uncertainties. These forward-looking statements involve risksand uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation,the risks set forth in Part II, Item 1A, “Risk Factors” in this Annual Report. See “Special Note Regarding Forward-Looking Statements.”OverviewWe are a biotechnology company focused on the discovery, development and commercialization of novel anti-infectives for the treatment ofdiseases that are inadequately addressed by current standard of care therapies. We are developing a balanced pipeline of product anddevelopment candidates, with an initial focus on serious fungal and bacterial infections. Our lead product candidate is rezafungin acetate, formerlyknown as CD101 IV, an intravenous formulation of a novel echinocandin. Rezafungin acetate has been approved as the internationalnonproprietary name, or INN, for CD101 by the World Health Organization, and as a United States Adopted Name, or USAN, for CD101 by theUSAN Council.Rezafungin is being developed as a once-weekly, high-exposure therapy for the treatment and prevention of serious, invasive fungal infections. Inaddition, we are developing our antibody-drug conjugates, or ADCs, for multidrug-resistant bacterial infections as part of our proprietaryCloudbreak™ platform, which is designed to discover compounds that directly kill pathogens and also direct a patient’s immune system to attackand eliminate bacterial, fungal or viral pathogens.RezafunginRezafungin is a novel molecule in the echinocandin class of antifungals. We are developing rezafungin for the treatment and prevention of serious,invasive fungal infections, including candidemia and invasive candidiasis, associated with high mortality rates.We have completed enrollment in a Phase 2 randomized clinical trial, called the STRIVE study, evaluating the safety, tolerability and efficacy ofonce-weekly dosing of rezafungin compared to once-daily dosing of caspofungin in patients with candidemia and invasive candidiasis. TheSTRIVE study was designed to enroll at least 90 patients in the microbiological intent-to-treat, or mITT, population, with a target of approximately30 patients in each of two rezafungin dosing arms and 30 patients receiving the comparator drug, caspofungin. We expect topline data from thisstudy in the first quarter of 2018. With this sample size, the study is not powered to detect statistical differences among the treatment andcomparator arms; the primary purpose of the study is to select a rezafungin dosing regimen for subsequent testing in a statistically powered Phase3 study versus caspofungin.Cloudbreak Immunotherapy PlatformWe continue to advance our Cloudbreak immunotherapy platform, which we believe has broad potential applications across a wide spectrum ofinfectious diseases, including bacterial, fungal and viral infections. We believe that our Cloudbreak immunotherapy platform is a fundamentally newapproach for the treatment of infectious disease. To date, we have generated preclinical, in vivo proof of concept data in both our Cloudbreakantibacterial program and our Cloudbreak antifungal program.We had selected a lead Cloudbreak development candidate, CD201, a bispecific antimicrobial immunotherapy for the treatment of multidrug-resistant Gram-negative bacterial infections. Based on preclinical studies of CD201 as well as preclinical studies of ADCs from our Cloudbreakprogram, we decided in February 2018 to cease development of CD20150CIDARA THERAPEUTICS, INC.to focus on the more promising ADCs for the same indication. We had received a grant from the Combating Antibiotic Resistance Accelerator, orCARB-X, to help advance the development of CD201. Based on our decision to focus efforts on our ADCs, we will no longer be seeking fundingunder our CARB-X grant agreement relating to CD201.FINANCIAL OPERATIONS OVERVIEWRevenuesTo date, we have not generated any revenues. In the future, we may generate revenue from a combination of license fees and other upfrontpayments, research and development payments, milestone payments, product sales, government and other third-party funding, and royalties inconnection with strategic alliances. We expect that any revenue we generate will fluctuate from quarter-to-quarter as a result of the timing of ourachievement of preclinical, clinical, regulatory and commercialization milestones, if achieved at all, the timing and amount of payments relating tosuch milestones and the extent to which any of our products are approved and successfully commercialized. If we are unable to fund ourdevelopment costs, or we are unable to develop product candidates in a timely manner or obtain regulatory approval for them, our ability togenerate future revenues and our results of operations and financial position would be adversely affected.Research and development expensesTo date, our research and development expenses have related primarily to preclinical development of our product candidates rezafungin acetate,formerly called CD101, and CD201 and our Cloudbreak immunotherapy technology platform, as well as clinical development of rezafungin.Research and development expenses consist of wages, benefits and stock-based compensation for research and development employees, as wellas the cost of scientific consultants, facilities and overhead expenses, laboratory supplies, manufacturing expenses, and preclinical and clinicaltrial costs. We accrue clinical trial expenses based on work performed, which relies on estimates of total costs incurred based on patientenrollment, completion of studies or activities within studies and other events.Research and development costs are expensed as incurred and costs incurred by third parties are expensed as the contracted work is performed.We accrue for costs incurred as the services are being provided by monitoring the status of the study or project and the invoices received from ourexternal service providers. We adjust our accruals as actual costs become known.Research and development activities are central to our business model. Product candidates in later stages of clinical development generally havehigher development costs than those in earlier stages of development, primarily due to the increased size and duration of later-stage clinical trials.We expect our research and development expenses to increase over the next several years as we continue to conduct preclinical and clinicalstudies, expand our research and development pipeline and progress our product candidates through clinical trials. However, it is difficult todetermine with certainty the duration, costs and timing to complete our current or future preclinical programs and clinical trials of our productcandidates.The duration, costs and timing of clinical trials and development of our product candidates will depend on a variety of factors that include, but arenot limited to, the following:•per patient trial costs;•the number of patients that participate in the trials;•the number of sites included in the trials;•the countries in which the trials are conducted;•the length of time required to enroll eligible patients;•the number of doses that patients receive;•the drop-out or discontinuation rates of patients;•potential additional safety monitoring or other studies requested by regulatory agencies;•the duration of patient follow-up; •the phase of development of the product candidate; and•the efficacy and safety profile of the product candidates.51CIDARA THERAPEUTICS, INC.Research and development expenses by major program or category were as follows (in thousands): Year ended December 31, 2017 2016 2015Rezafugin$24,394 $11,230 $7,753CD101 topical1,385 7,604 3,830Cloudbreak immunotherapy platform2,915 2,915 2,249Personnel costs11,022 10,084 6,752Other research and development expenses3,107 3,866 2,891Total research and development expenses$42,823 $35,699 $23,475We typically deploy our employees, consultants and infrastructure resources across our programs. Thus, some of our research and developmentexpenses are not attributable to an individual program but are included in other research and development expenses as shown above.In addition, the probability of success for each product candidate will depend on numerous factors, including competition, manufacturing capabilityand commercial viability. We will determine which programs to pursue and how much to fund each program in response to the scientific andclinical success of each product candidate, as well as an assessment of each product candidate’s commercial potential.For the year ended December 31, 2017, we recognized reductions to research and development expenses of $0.5 million for costs eligible forreimbursement under the CARB-X grant agreement.In February 2017, we reported results from our Phase 2 clinical trial of rezafungin topical, which was designed to evaluate gel and ointment topicalformulations of rezafungin in women with moderate-to-severe VVC. The study found that while the gel and ointment topical formulations ofrezafungin tested in the study were well tolerated, both formulations were similar in efficacy to each other but lower in clinical and mycological curerates compared to oral fluconazole. As a result, we have discontinued the rezafungin topical development program for VVC.General and administrative expensesGeneral and administrative expenses consist primarily of salaries and related benefits, including stock-based compensation, related to ourexecutive, finance, legal, business development, commercial planning and support functions. Other general and administrative expenses includefacility and overhead costs not otherwise included in research and development expenses, consultant expenses, travel expenses and professionalfees for auditing, tax, legal, and other services. We expect that general and administrative expenses will increase in the future as we expand ouroperating activities and incur additional costs associated with operating as a publicly traded company. These increases will likely include legalfees, accounting fees, directors’ and officers’ liability insurance premiums and costs associated with investor relations.Other income (expense), netOther income (expense) consists primarily of interest income and expense, and various income or expense items of a non-recurring nature. Weearn interest income from interest-bearing accounts and money market funds for cash and cash equivalents and marketable securities and for ourshort-term investments. Interest expense represents interest payable related to term loans and the amortization of debt issuance costs.CRITICAL ACCOUNTING POLICIES AND ESTIMATESOur discussion and analysis of our financial condition and results of operations is based upon financial statements that we have prepared inaccordance with accounting principles generally accepted in the United States. The preparation of these financial statements requiresmanagement to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses, and related disclosures. Onan on-going basis, we evaluate these estimates, including those related to preclinical and clinical trial accruals and share-based compensation.Estimates are based on historical experience, information received from third parties and various other assumptions that are believed to bereasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilitiesthat are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. Theitems in our financial statements requiring significant estimates and judgments are as follows:Preclinical and Clinical Trial AccrualsWe make estimates of our accrued expenses as of each balance sheet date in our financial statements based on the facts and circumstancesknown to us at that time. Our accrued expenses for preclinical studies and clinical trials are52CIDARA THERAPEUTICS, INC.based on estimates of costs incurred and fees that may be associated with services provided by contract research organizations, or CROs,clinical trial investigational sites and other clinical trial-related activities. Payments under certain contracts with such parties depend on factorssuch as successful enrollment of patients, site initiation and the completion of clinical trial milestones. In accruing for these services, we estimatethe time period over which services will be performed and the level of effort to be expended in each period. If possible, we obtain informationregarding unbilled services directly from these service providers. However, we may be required to estimate these services based on otherinformation available to us. If we underestimate or overestimate the activities or fees associated with a study or service at a given point in time,adjustments to research and development expenses may be necessary in future periods. Historically, our estimated accrued liabilities haveapproximated actual expense incurred. Subsequent changes in estimates may result in a material change in our accruals.Stock-based compensationThe Company accounts for stock-based compensation expense related to employee stock options, restricted stock and restricted stock units, orRSU, grants, and employee stock purchase plan rights by estimating the fair value on the date of grant. The fair value of RSUs granted toemployees is estimated based on the closing price of our common stock on the date of grant. For awards subject to time-based vestingconditions, stock-based compensation expense is recognized ratably over the requisite service period of the awards, net of estimated forfeitures.For awards subject to performance-based vesting conditions, we assess the probability of achievement of the individual milestones under thestock-based awards and recognize stock-based compensation expense over the implicit service period commencing once we believe theperformance criteria is probable of achievement. We account for stock awards granted to non-employees using the fair value approach. Theseawards are subject to periodic revaluation over their vesting terms.We estimate the fair value of stock option awards to employees and non-employees using the Black-Scholes option pricing model, which requiresthe input of highly subjective assumptions, including (a) the risk-free interest rate, (b) the expected volatility of our stock, (c) the expected term ofthe award, and (d) the expected dividend yield. Due to the lack of an adequate history of a public market for the trading of our common stock anda lack of adequate company-specific historical and implied volatility data, we have based our estimate of expected volatility on the historicalvolatility of a group of similar companies that are publicly traded. For these analyses, we have selected companies with comparablecharacteristics to ours, including enterprise value, risk profiles, and position within the industry, and with historical share price informationsufficient to meet the expected life of the stock-based awards. We compute the historical volatility data using the daily close prices for theselected companies’ shares during the equivalent period of the calculated expected term of our stock-based awards. We will continue to apply thisprocess until a sufficient amount of historical information regarding the volatility of our common stock price becomes available. We haveestimated the expected life of our employee stock options using the “simplified” method, whereby the expected life equals the average of thevesting term and the original contractual term of the option. The risk-free interest rates for periods within the expected life of the option are basedon the yields of zero-coupon U.S. treasury securities. See Note 8 of the Notes to the Financial Statements for additional information.RESULTS OF OPERATIONSComparison of the years ended December 31, 2017 and 2016The following table summarizes our results of operations for the years ended December 31, 2017 and 2016 (in thousands): Year ended December 31, 2017 2016 ChangeResearch and development$42,823 $35,699 7,124General and administrative12,898 12,737 161Other income (expense), net(7) 271 (278)Research and development expensesResearch and development expenses were $42.8 million for the year ended December 31, 2017 compared to $35.7 million for the year endedDecember 31, 2016. The majority of the increase in research and development expense is due to higher clinical expenses associated with therezafungin STRIVE study. Increases in rezafungin expenses were partially offset by decreases in CD101 topical expenses due to thediscontinuation of that program in February 2017.53CIDARA THERAPEUTICS, INC.General and administrative expensesGeneral and administrative expenses were $12.9 million for the year ended December 31, 2017 compared to $12.7 million for the year endedDecember 31, 2016. The increase in general and administrative expenses was primarily related to personnel costs.Other income (expense)Other income (expense) for the years ended December 31, 2017 and 2016 relates to income generated from cash held in interest-bearinginvestments, offset by the cash and non-cash interest associated with our October 2016 term loan.Comparison of the year ended December 31, 2016 and 2015The following table summarizes our results of operations for the years ended December 31, 2016 and 2015 (in thousands): Year ended December 31, 2016 2015 ChangeResearch and development$35,699 $23,475 12,224General and administrative12,737 8,838 3,899Other expense, net271 120 151Research and development expensesResearch and development expenses were $35.7 million for the year ended December 31, 2016 compared to $23.5 million for the yearended December 31, 2015. Expenses increased in 2016 as we initiated and conducted our Phase 2 clinical trials for rezafungin and CD101topical. In addition, we continued preclinical development activities on our Cloudbreak platform. Personnel costs were greater due to increases inheadcount to support these activities.General and administrative expensesGeneral and administrative expenses were $12.7 million for the year ended December 31, 2016 compared to $8.8 million for the yearended December 31, 2015. The increase in general and administrative expenses was primarily related to personnel costs, legal fees for corporateand intellectual property matters, and market research costs.Other Income (Expense)Other income for the year ended December 31, 2016 and 2015 relates to income generated from cash held in interest-bearing investments, offsetduring the year ended December 31, 2016 by the cash and non-cash interest associated with our October 2016 term loan.LIQUIDITY AND CAPITAL RESOURCESSince our inception, we have received $210.9 million in gross proceeds to fund our operations, primarily through private placements of convertiblepreferred stock, convertible notes, public offerings of common stock and term loan draws.As of December 31, 2017, we had $60.8 million in cash and cash equivalents and $14.5 million in short-term investments. The following tableshows a summary of our cash flows for the years ended December 31, 2017, 2016 and 2015 (in thousands): Year ended December 31, 2017 2016 2015Net cash provided by (used in): Operating activities$(49,909) $(39,771) $(25,959)Investing activities4,471 25,482 (46,088)Financing activities20,884 37,094 111,813Net increase in cash and cash equivalents$(24,554) $22,805 $39,76654CIDARA THERAPEUTICS, INC.Operating activitiesNet cash used in operating activities was $49.9 million for the year ended December 31, 2017 compared to $39.8 million and $26.0 million for theyears ended December 31, 2016 and 2015, respectively. The increase in net cash used in operating activities was attributable to a net loss of$55.7 million for the year ended December 31, 2017 compared to net losses of $48.2 million and $32.2 million for the years ended December 31,2016 and 2015, respectively. For all periods presented, the primary use of cash was to fund increased levels of research and developmentactivities for our product candidates, which activities and uses of cash we expect to continue to increase for the foreseeable future.Investing activitiesOur primary investing activities during the years ended December 31, 2017, 2016, and 2015 consisted of purchases and maturities of short-terminvestments. For the years ended December 31, 2017, 2016, and 2015 we purchased approximately $19.5 million, $69.6 million, and $54.9 million,respectively, of short-term investments and received proceeds of $24.3 million, $95.5 million, and $10.0 million, respectively, from the maturity ofshort-term investments. We invest cash in excess of our immediate operating requirements with staggered investment duration or maturity tooptimize our return on investment while satisfying our liquidity needs. Net cash used for the purchase of property and equipment was $0.3 million,$0.4 million, and $1.2 million for the years ended December 31, 2017, 2016, and 2015, respectively.Financing activitiesNet cash provided by financing activities was $20.9 million for the year ended December 31, 2017 compared to $37.1 million and $111.8 million forthe years ended December 31, 2016 and 2015, respectively. During the year ended December 31, 2017, net proceeds from the sale of commonstock was $20.7 million. During the year ended December 31, 2016, net proceeds from the sale of common stock and issuance of the term loanwere $26.6 million and $9.9 million, respectively. During the year ended December 31, 2015, net proceeds from the sale of our Series B convertiblepreferred stock and our initial public offering were $41.9 million and $69.5 million, respectively.Operating Capital RequirementsTo continue to fund operations, we will need to raise additional capital. We may obtain additional financing in the future through the issuance of ourcommon stock, through other equity or debt financings, through government funding or through collaborations or partnerships with othercompanies. We may not be able to raise additional capital on terms acceptable to us, or at all, and any failure to raise capital as and when neededcould compromise our ability to execute on our business plan. If we are unable to raise capital when needed or on attractive terms, we could beforced to delay, reduce or eliminate our research and development programs or future commercialization efforts, or to make reductions inspending, extend payment terms with suppliers, or liquidate or grant rights to assets where possible, or suspend or curtail planned programs. Anyof these actions could materially harm our business, results of operations and future prospects. We have prepared cash flow forecasts which indicate, based on current cash resources available, that we will have sufficient resources to fund ourbusiness for at least the next 12 months from the issuance of financial statements. We plan to continue to fund our operating expenses andcapital expenditure requirements through debt and equity financing, through government funding, or through collaborations or partnerships withother entities. Debt or equity financing, government funding, or collaborations and partnerships with other entities may not be available on at timelybasis, on acceptable terms, or at all. We have developed a plan to implement cost cutting measures to reduce our working capital requirementsover the next 12 months if an adequate level of financing is not secured. The plan includes the delay of certain of our development activities, adelay in hiring and a reduction of other discretionary expenditures that are within our control. Any of the actions contemplated by theimplementation of this plan, if required, could have an adverse impact on our ability to achieve certain of our planned objectives during 2018, andthus, materially harm our business.Our ability to successfully transition to profitability will be dependent upon achieving a level of product sales adequate to support our coststructure. We cannot assure you that we will ever be profitable or generate positive cash flow from operating activities.In May 2016, we entered into a Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co., or Cantor, pursuant to which we mayoffer and sell shares of our common stock in “at the market” offerings (as defined in Rule 415 of the Securities Act of 1933, as amended) havingan aggregate offering price up to $35.0 million in gross proceeds from time to time through Cantor acting as sales agent. During the year endedDecember 31, 2017, we received gross proceeds of approximately $1.9 million, net of $56,000 of offering costs, from the sale of 240,178 shares ofour common stock. As of December 31, 2017, we have the capacity to issue additional shares of our common stock to generate up toapproximately $33.1 million of gross proceeds under the sales agreement. Future sales, if any, will depend on a variety of factors including, but notlimited to, market conditions, the trading price of our common stock and our capital needs.55CIDARA THERAPEUTICS, INC.CONTRACTUAL OBLIGATIONS AND COMMITMENTSThe following is a summary of our long-term contractual obligations as of December 31, 2017 (in thousands):Numbers to be updatedPayments due by periodContractual ObligationsTotal Less than 1year 1-3 years 3-5 years More than 5yearsMinimum lease payments required under operating leaseof laboratory and office space$746 $746 $— $— $—Principal under Term Note, excluding accrued interest10,000 2,667 7,333 — —Total minimum contractual obligations$10,746 $3,413 $7,333 $— $—Off-Balance Sheet ArrangementsAs of December 31, 2017, we did not have any off-balance sheet arrangements.56CIDARA THERAPEUTICS, INC.Item 7A. Quantitative and Qualitative Disclosures about Market Risk.The primary objectives of our investment activities are to ensure liquidity and to preserve principal while at the same time maximizing the incomewe receive from our cash and cash equivalents without significantly increasing risk. Additionally, we established guidelines regarding approvedinvestments and maturities of investments, which are designed to maintain safety and liquidity.The market risk inherent in our financial instruments and in our financial position is the potential loss arising from adverse changes in interestrates. We generally hold our cash in checking and savings accounts and invest excess capital in money market funds, certificates of deposit,corporate debt, and commercial paper. Our primary exposure to market risk is interest rate sensitivity, which is affected by changes in the generallevel of U.S. interest rates. To minimize our exposure to adverse shifts in interest rates, we invest in short-term securities and ensure that themaximum average maturity of our investments does not exceeded 12 months. If a 10% change in interest rates had occurred on December 31,2017, this change would not have had a significant impact on the fair value of our investment portfolio as of that date.57CIDARA THERAPEUTICS, INC.Item 8. Consolidated Financial Statements and Supplementary Data.Report of Independent Registered Public Accounting FirmTo the shareholders and the board of directors of Cidara Therapeutics, Inc.Opinion on the Financial StatementsWe have audited the accompanying consolidated balance sheets of Cidara Therapeutics, Inc. (the Company) as of December 31, 2017 and 2016,and the related consolidated statements of operations and comprehensive loss, convertible preferred stock and stockholders‘ equity (deficit), andcash flows, for each of the three years in the period ended December 31, 2017, and the related notes (collectively referred to as the “consolidatedfinancial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of theCompany at December 31, 2017 and 2016, and the results of its operations and its cash flows for each of the three years in the period endedDecember 31, 2017, in conformity with U.S. generally accepted accounting principles.Basis for OpinionThese financial statements are the responsibility of the Company‘s management. Our responsibility is to express an opinion on the Company‘sfinancial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (UnitedStates) (PCAOB) and are required to be independent with respect to the Company in accordance with the US federal securities laws and theapplicable rules and regulations of the Securities and Exchange Commission and the PCAOB.We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtainreasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is notrequired to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required toobtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of theCompany’s internal control over financial reporting. Accordingly, we express no such opinion.Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud,and performing procedures that respond to those risks. Such procedures include examining, on a test basis, evidence regarding the amounts anddisclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made bymanagement, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis forour opinion./s/ Ernst & Young LLPWe have served as the Company's auditor since 2014.San Diego, CaliforniaFebruary 27, 201858CIDARA THERAPEUTICS, INC.Consolidated Balance Sheets December 31, 2017 December 31, 2016(In thousands, except share and per share data) ASSETS Current assets: Cash and cash equivalents$60,813 $85,367Short-term investments14,501 19,252Accounts receivable321 —Prepaid expenses and other current assets2,035 779Total current assets77,670 105,398Property and equipment, net1,044 1,374Other assets321 190Total assets$79,035 $106,962LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable$2,590 $2,909Accrued liabilities4,257 3,338Accrued compensation and benefits2,571 2,662Current portion of term loan2,667 —Total current liabilities12,085 8,909Term loan, less debt issuance costs7,206 9,794Other long-term liabilities— 80Total liabilities19,291 18,783Commitments and contingencies Stockholders' equity: Preferred stock, $0.0001 par value; 10,000,000 shares authorized and no shares issued oroutstanding at December 31, 2017 and 2016, respectively— —Common stock, $0.0001 par value; 200,000,000 shares authorized at December 31, 2017 and2016; 20,534,993 and 20,525,688 shares issued and outstanding, respectively, at December 31,2017; 16,837,126 and 16,773,232 shares issued and outstanding, respectively, at December 31,20162 2Additional paid-in capital209,140 181,840Accumulated other comprehensive loss(8) (1)Accumulated deficit(149,390) (93,662)Total stockholders' equity59,744 88,179Total liabilities and stockholders' equity$79,035 $106,962See accompanying notes.59CIDARA THERAPEUTICS, INC.Consolidated Statements of Operations and Comprehensive Loss Years ended December 31,(In thousands, except share and per share data)201720162015Operating expenses: Research and development$42,823 $35,699 $23,475General and administrative12,898 12,737 8,838Total operating expenses55,72148,43632,313Loss from operations(55,721)(48,436)(32,313)Other income (expense): Interest income (expense), net(7) 271 120Total other income (expense)(7)271120Net loss$(55,728)$(48,165)$(32,193)Other comprehensive income (loss): Unrealized gain (loss) on short-term investments(7) 7 (8)Comprehensive loss$(55,735)$(48,158)$(32,201)Basic and diluted net loss per share$(3.18) $(3.32) $(3.25)Shares used to compute basic and diluted net loss per share17,500,853 14,488,987 9,920,382See accompanying notes.60CIDARA THERAPEUTICS, INC.Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit) Series A ConvertiblePreferred StockSeries B ConvertiblePreferred StockCommon StockAdditional Paid-InCapitalAccumulatedDeficitOtherComprehensiveIncome (Loss)TotalStockholders'Equity (Deficit)(In thousands, exceptshare data)SharesAmountSharesAmountSharesAmountBalance, January 1,201597,526,081 $32,548—$—1,132,738$—$1,859$(13,304)$— $(11,445)Issuance of Series Bconvertible preferredstock, net of issuancecosts of $99— — 94,533,183 41,921 — — — — — —Conversion of Series Aand Series B convertiblepreferred upon initialpublic offering(97,526,081) (32,548) (94,533,183) (41,921) 7,561,380 1 74,468 — — 74,469Public offering ofcommon stock, net ofissuance costs— — — — 4,800,000 — 69,271 — — 69,271Stock-basedcompensation— — — — — — 3,033 — — 3,033Issuance of commonstock under EmployeeStock Purchase Plan— — — — 19,164 — 225 — — 225Vesting of restrictedshares— — — — 249,465 — 499 — — 499Issuance of commonstock for exercise ofstock options— — — — 23,538 — 61 — — 61Unrealized loss onmarketable securities— — — — — — — — (8) (8)Net loss— — — — — — — (32,193) — (32,193)Balance, December 31,2015———— 13,786,2851149,416(45,497)(8) 103,912Public offering ofcommon stock, net ofissuance costs— — — — 2,752,637 1 26,621 — — 26,622Stock-basedcompensation— — — — — — 4,344 — — 4,344Vesting of restrictedshares— — — — 90,423 — 197 — — 197Issuance of commonstock for exercise ofstock options— — — — 83,353 — 525 — — 525Issuance of commonstock under EmployeeStock Purchase Plan— — — — 58,616 — 562 — — 562Issuance of warrants inconnection with term loan— — — — — — 175 — — 175Unrealized gain onmarketable securities— — — — — — — — 7 7Net loss— — — — — — — (48,165) — (48,165)Balance, December 31,2016— — — — 16,771,314 2 181,840 (93,662) (1) 88,179Sale of common stock,net of issuance costs— — — — 3,600,178 — 20,771 — — 20,771Stock-basedcompensation— — — — — — 5,696 — — 5,696Vesting of restrictedshares— — — — 19,055 — 44 — — 44Issuance of commonstock for exercise ofstock options— — — — 38,332 — 228 — — 228Issuance of commonstock for restricted shareunits vested— — — — 2,500 — 18 — — 18Issuance of commonstock under EmployeeStock Purchase Plan— — — — 94,309 — 543 — — 543Unrealized loss onmarketable securities— — — — — — — — (7) (7)Net loss— — — — — — — (55,728) — (55,728)Balance, December 31,2017— $— — $— 20,525,688 $2 $209,140 $(149,390) $(8) $59,744See accompanying notes.61CIDARA THERAPEUTICS, INC.Consolidated Statements of Cash Flows Years ended December 31,(In thousands)201720162015Operating activities: Net loss$(55,728) $(48,165) $(32,193)Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization667 732 461Stock-based compensation5,714 4,344 3,033Non-cash interest expense61 17 —Amortization of discount or premium on short-term investments(33) (176) (42)Amortization of debt issue costs18 5 22Deferred rent(29) (8) 54Changes in operating assets and liabilities: Prepaid expenses and other current assets(1,481) (76) (487)Accounts payable and accrued liabilities642 1,913 2,143Accrued compensation453 1,760 1,050Other assets(193) (117) —Net cash used in operating activities(49,909) (39,771) (25,959)Investing activities: Purchases of short-term investments(19,523) (69,617) (54,918)Maturities of short-term investments24,300 95,500 10,000Purchases of property and equipment(306) (401) (1,170)Net cash provided by (used in) investing activities4,471 25,482 (46,088)Financing activities: Proceeds from issuance of common stock, net of offering costs20,735 26,622 69,505Proceeds from issuance of Series B convertible preferred stock, net of offering costs— — 41,921Proceeds from issuance of Term Loan, net of offering costs— 9,947 —Proceeds from exercise of stock options228 525 387Repurchase of unvested restricted stock(79) — —Net cash provided by financing activities20,884 37,094 111,813Net increase (decrease) in cash and cash equivalents(24,554) 22,805 39,766Cash and cash equivalents at beginning of year85,367 62,562 22,796Cash and cash equivalents at end of year$60,813 $85,367 $62,562Supplemental disclosure of cash flows: Interest paid$511 $— $—Non-cash investing activity: Property and equipment acquired but not yet paid$30 $21 $113Non-cash financing activities: Deferred initial public offering costs$— $— $234Conversion of Series A convertible preferred stock to common stock upon initial public offering$— $— $32,548Conversion of Series B convertible preferred stock to common stock upon initial public offering$— $— $41,921Issuance of warrants to purchase common stock upon execution of term loan$— $175 $—Vesting of early exercised stock options$44 $197 $499Purchase of shares pursuant to Employee Stock Purchase Plan$543 $562 $—Receivable for issuance of common stock, net of offering costs$36 $— $—See accompanying notes.62CIDARA THERAPEUTICS, INC.Notes to Consolidated Financial Statements1. THE COMPANY AND BASIS OF PRESENTATIONDescription of BusinessCidara Therapeutics, Inc., or the Company, was originally incorporated in Delaware in December 2012 as K2 Therapeutics, Inc., and its name waschanged to Cidara Therapeutics, Inc. in July 2014. The Company is a biotechnology company focused on the discovery, development andcommercialization of novel anti-infectives. In March 2016, the Company formed a wholly-owned subsidiary, Cidara Therapeutics UK Limited, inEngland for the purpose of developing its product candidates in Europe.Basis of PresentationThe Company has a limited operating history and the sales and income potential of the Company’s business and market are unproven. Theaccompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern, whichcontemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has experienced netlosses and negative cash flows from operating activities since its inception. At December 31, 2017, the Company had an accumulated deficit of$149.4 million. The Company expects to continue to incur net losses into the foreseeable future. Successful transition to attaining profitableoperations is dependent upon achieving a level of revenues adequate to support the Company’s cost structure.In accordance with ASU 2014-15, management is required to perform a two-step analysis over its ability to continue as a going concern.Management must first evaluate whether there are conditions and events that raise substantial doubt about the Company's ability to continue as agoing concern (step 1). If management concludes that substantial doubt is raised, management is also required to consider whether its plansalleviate that doubt (step 2). The evaluation period is through one year beyond the date the financial statements were released (assumed to bethrough February 28, 2019).The Company has prepared cash flow forecasts which indicate, based on the Company’s current cash resources available, that the Company willhave sufficient resources to fund its business for at least the next 12 months from the issuance of the financial statements. The Company plansto continue to fund its losses from operations and capital funding needs through debt and equity financing, through government funding or throughcollaborations or partnerships with other entities. Debt or equity financing, government funding or collaborations and partnerships with other entitiesmay not be available on a timely basis on terms acceptable to the Company, or at all. Management has developed a plan to implement costcutting measures to reduce its working capital requirements over the next 12 months if an adequate level of financing is not secured. The planincludes the delay of certain of the Company’s development activities, a delay in hiring and a reduction of other discretionary expenditures that arewithin the Company’s control. Any of the actions contemplated by the implementation of this plan, if required, could have an adverse impact on theCompany’s ability to achieve certain of its planned objectives during 2018, and thus, materially harm the Company’s business.Basis of Consolidation—The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary. Allsignificant intercompany accounts and transactions have been eliminated in consolidation.Use of Estimates—The preparation of financial statements in conformity with U.S. generally accepted accounting principles, or GAAP, requiresmanagement to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assetsand liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. The Company evaluates itsestimates and assumptions on an ongoing basis. The most significant estimates in the Company’s consolidated financial statements relate toestimating the fair value of the Company’s common shares used to account for share-based compensation and certain accruals, including thoserelated to preclinical and clinical activities. Although the estimates are based on the Company’s knowledge of current events, comparablecompanies, and actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions.Segment Information—Operating segments are identified as components of an enterprise about which separate discrete financial information isavailable for evaluation by the chief operating decision maker, the Chief Executive Officer, in making decisions regarding resource allocation andassessing performance. The Company views its operations and manages its business as one operating segment.2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIESCash and Cash Equivalents—The Company considers all short-term investments purchased with a maturity of three months or less whenacquired to be cash equivalents.63CIDARA THERAPEUTICS, INC.Notes to Consolidated Financial Statements — ContinuedInvestments Available-for-Sale— Available-for-sale securities are carried at fair value, with the unrealized gains and losses reported inaccumulated other comprehensive income (loss). The amortized cost of debt securities is adjusted for amortization of premiums and accretion ofdiscounts to maturity. The amortization of premiums and accretion of discounts is included in interest income. Realized gains and losses anddeclines in value judged to be other-than-temporary, if any, on available-for-sale securities are included in other income (expense). The cost ofsecurities sold is based on the specific identification method. Interest and dividends on securities classified as available-for-sale are included ininterest income. Securities with maturity dates of 12 months or less from the date of purchase are classified as short-term investments andsecurities with maturity dates of more than 12 months are classified as long-term investments.Property and Equipment— The Company records property and equipment at cost, which consists of lab equipment, computer equipment andsoftware, office equipment, furniture and fixtures and leasehold improvements. Property and equipment is depreciated using the straight-linemethod over the estimated useful lives (generally three to seven years). Leasehold improvements are amortized over the lesser of their useful lifeor the remaining lease term, including any renewal periods that are deemed to be reasonably assured. Repair and maintenance costs areexpensed as incurred.Concentration of Credit Risk—The Company’s financial instruments that are exposed to concentrations of credit risk consist primarily of cashand cash equivalents and short-term investments. Periodically, the Company maintains deposits in government insured financial institutions inexcess of government insured limits. The Company invests its cash balances in financial institutions that it believes have high credit quality, hasnot experienced any losses on such accounts and does not believe it is exposed to significant credit risk.Patent Costs— The Company expenses all costs as incurred in connection with patent applications (including direct application fees, and the legaland consulting expenses related to making such applications) and such costs are included in general and administrative expenses in theaccompanying statements of operations.Income Taxes—The Company follows the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 740,Income Taxes, or ASC 740, in reporting deferred income taxes. The ASC 740 requires a company to recognize deferred tax assets and liabilitiesfor expected future income tax consequences of events that have been recognized in the Company’s consolidated financial statements. Under thismethod, deferred tax assets and liabilities are determined based on temporary differences between financial statement carrying amounts and thetax basis of assets and liabilities using enacted tax rates in the years in which the temporary differences are expected to reverse. Valuationallowances are provided if, based on the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will notbe realized.The Company accounts for uncertain tax positions pursuant to ASC 740, which prescribes a recognition threshold and measurement process forfinancial statement recognition of uncertain tax positions taken or expected to be taken in a tax return. If the tax position meets this threshold, thebenefit to be recognized is measured as the tax benefit having the highest likelihood of being realized upon ultimate settlement with the taxingauthority. The Company recognizes interest accrued related to unrecognized tax benefits and penalties in the provision for income taxes.On December 22, 2017, the U.S. enacted the Tax Cuts and Jobs Act (the “Act”), which among other provisions, reduced the U.S. corporate taxrate from 35% to 21%, effective January 1, 2018. At December 31, 2017, we have not completed our accounting for the tax effects of enactmentof the Act; however we have made reasonable estimates of the effects on the existing deferred tax assets and liabilities.Revenue Recognition—The Company recognizes revenues when all four of the following criteria are met: (1) persuasive evidence of anarrangement exists; (2) delivery of the products and/or services has occurred; (3) the selling price is fixed or determinable; and (4) collectibility isreasonably assured.Grant Funding—The Company has received research and development funding through a grant from a nonprofit organization. The Company hasevaluated the terms of the grant to assess its obligations and the classification of funding received. Amounts billable for funded research anddevelopment are recognized in the statement of operations as a reduction to research and development expense over the grant period as therelated costs are incurred to meet the Company's obligations.Research and Development Costs—Research and development expenses consist of wages, benefits and stock-based compensation charges forresearch and development employees, scientific consultant fees, facilities and overhead expenses, laboratory supplies, manufacturing expenses,and preclinical and clinical trial costs. The Company accrues preclinical and clinical trial expenses based on work performed, which relies onestimates of total costs incurred based on patient enrollment, completion of studies, and other events.Costs incurred in purchasing technology assets and intellectual property are charged to research and development expense if the technology hasnot been conclusively proven to be feasible and has no alternative future use.Comprehensive Loss—Comprehensive loss is defined as the change in equity during a period from transactions and other events and/orcircumstances from non-owner sources. The Company’s only component of other comprehensive64CIDARA THERAPEUTICS, INC.Notes to Consolidated Financial Statements — Continuedloss is unrealized gains (losses) on marketable securities. Comprehensive gains (losses) have been reflected in the consolidated statements ofoperations and comprehensive loss and as a separate component of the statements of convertible preferred stock and stockholders’ equity(deficit) for all periods presented.Stock-based Compensation— The Company accounts for stock-based compensation expense related to employee stock options and employeestock purchase plan rights by estimating the fair value on the date of grant using the Black-Scholes option pricing model. The fair value ofRestricted Stock Units (RSUs) and Performance-based RSUs (PRSUs) granted to employees is estimated based on the closing price of theCompany's common stock on the date of grant. For awards subject to time-based vesting conditions, stock-based compensation expense isrecognized ratably over the requisite service period of the awards. For awards subject to performance-based vesting conditions, the Companyassesses the probability of achievement of the individual milestones under the stock-based awards and recognizes stock-based compensationexpense over the implicit service period commencing once the Company believes the performance criteria is probable of achievement. TheCompany accounts for stock options, RSUs, and PRSUs granted to non-employees using the fair value approach. These stock-based awards aresubject to periodic revaluation over their vesting terms.Net Loss Per Share—Basic net loss per share is computed by dividing the net loss by the weighted-average number of common sharesoutstanding for the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net lossby the weighted-average number of common shares and dilutive common stock equivalents outstanding for the period determined using thetreasury-stock and if-converted methods. Dilutive common stock equivalents are comprised of convertible preferred stock, unvested restrictedcommon stock subject to repurchase, warrants, and RSUs and options outstanding under the Company’s stock option plan. For all periodspresented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding.The following table sets forth the outstanding potentially dilutive securities that have been excluded in the calculation of diluted net loss per sharebecause to do so would be anti-dilutive (in common stock equivalent shares): December 31, 2017 2016Common stock options and RSUs issued and outstanding3,099,173 2,295,393Common stock warrants17,331 17,331Common stock subject to repurchase9,305 63,894Total3,125,809 2,376,618Fair Value of Financial Instruments— The Company follows authoritative guidance with respect to fair value reporting issued by the FASB forfinancial assets and liabilities, which defines fair value, provides guidance for measuring fair value and requires certain disclosures. The guidancedoes not apply to measurements related to share-based payments. The guidance discusses valuation techniques such as the market approach(comparable market prices), the income approach (present value of future income or cash flow), and the cost approach (cost to replace the servicecapacity of an asset or replacement cost). The guidance establishes a fair value hierarchy that prioritizes the inputs to valuation techniques usedto measure fair value into three broad levels.The Company’s financial instruments consist of cash and cash equivalents, marketable securities, accounts receivable, prepaid expenses,accounts payable, accrued liabilities and long-term debt. Fair value estimates of these instruments are made at a specific point in time based onrelevant market information. These estimates may be subjective in nature and involve uncertainties and matters of significant judgment andtherefore cannot be determined with precision. The carrying amount of cash and cash equivalents, accounts receivable, prepaid expenses,accounts payable, and accrued liabilities are generally considered to be representative of their respective fair values because of the short-termnature of those instruments. The fair value of short-term investments is based upon market prices quoted on the last day of the fiscal period orother observable market inputs. The Company believes that the fair value of long-term debt approximates its carrying value.Recently Issued Accounting Standards— During 2014, the FASB issued ASU 2014-09, "Revenue from Contracts with Customers (Topic 606),"which outlines a single comprehensive model for entities to use in accounting for revenue arising from contracts with customers and supersedesmost current revenue recognition guidance, including industry-specific guidance. ASU 2014-09 outlines a five-step process for revenue recognitionthat focuses on transfer of control, as opposed to transfer of risk and rewards, and also requires enhanced disclosures regarding the nature,amount, timing, and uncertainty of revenues and cash flows from contracts with customers. Numerous ASUs were issued in 2016 and 2017 torequire additional disclosures, to provide clarification on a number of specific issues pertaining to ASU 2014-09, and to defer the effective date forASU 2014-09 to interim and annual periods beginning after December 31, 2017. The Company has evaluated the impact of ASU 2014-09 on theCARB-X Subaward Agreement and based on the analysis, the Company determined that the pattern of recognition would not be impacted by theadoption of ASC 606 and that characterizing revenues under the Agreement as a reduction of research and development continues to beappropriate65CIDARA THERAPEUTICS, INC.Notes to Consolidated Financial Statements — Continuedafter the adoption of ASC 606. The Company will continue to assess any new contracts for revenue recognition under ASU 2014-09. The Companywill adopt ASU 2014-09 in the first quarter of 2018, and adoption of this guidance will not have a material impact on the Company's consolidatedfinancial statements.During 2016, the FASB issued ASU 2016-01, “Recognition and Measurement of Financial Assets and Financial Liabilities,” which eliminates therequirement for public companies to disclose the method(s) and significant assumptions used to estimate the fair value that is required to bedisclosed for financial instruments measured at amortized cost on the balance sheet. The standard also requires public entities to use the exitprice notion when measuring the fair value of financial instruments for disclosure purposes. Furthermore, the standard requires presentation ofassets and liabilities by measurement category and form of financial asset on the balance sheet or accompanying notes to the financialstatements. The updated guidance is effective for interim and annual periods beginning after December 15, 2017, and early adoption is permitted.The Company is currently assessing the impact that this standard will have on its consolidated financial statements.During 2016, the FASB issued ASU 2016-02, “Leases,” which requires that lease arrangements longer than 12 months result in an entityrecognizing an asset and liability. The updated guidance is effective for interim and annual periods beginning after December 15, 2018, and earlyadoption is permitted. The Company currently expects that its operating lease commitments will be subject to the new standard and recognized asright-of-use assets and operating lease liabilities upon the adoption of ASU 2016-02, which will increase the total assets and total liabilities that itreports relative to such amounts prior to adoption.During 2016, the FASB issued ASU 2016-15, "Statement of Cash Flows: Classification of Certain Cash Receipts and Cash Payments," whichaddresses the presentation and classification of certain cash receipts and payments in the statement of cash flows. The updated guidance iseffective for interim and annual reporting periods beginning after December 15, 2017, and early adoption is permitted. The adoption of this guidanceis not expected to have a material impact on the Company's consolidated financial statements.During 2017, the FASB issued ASU 2017-09, "Compensation - Stock Compensation: Scope of Modification Accounting," which provides clarityand guidance around which changes to the terms or conditions of a share-based payment award require an entity to apply modification accountingin Topic 718. The standard is effective for interim and annual periods beginning after December 15, 2017. The adoption of this guidance is notexpected to have a material impact on the Company's financial statements.During 2017, the FASB issued ASU 2017-12, Derivatives and Hedging (Topic 815): Targeted Improvements to Accounting for HedgingActivities. The objectives of ASU 2017-12 are to improve the financial reporting of hedging relationships to better portray the economic results ofan entity's risk management activities in its financial statements and to make certain targeted improvements to simplify the application of thehedge accounting guidance in current GAAP. ASU 2017-12 is effective for fiscal years beginning after December 15, 2018. The adoption of thisguidance is not expected to have a material impact on the Company's financial statements.3. SHORT-TERM INVESTMENTSThe following table summarizes the available-for-sale securities held at December 31, 2017 and 2016 (in thousands):As of December 31, 2017Amortized Cost Unrealized Gains Unrealized Losses Fair ValueCorporate debt$14,509 $— $(8) $14,501Total$14,509 $— $(8) $14,501 As of December 31, 2016Amortized Cost Unrealized Gains Unrealized Losses Fair ValueCommercial paper19,253 1 (2) 19,252Total$19,253 $1 $(2) $19,252All available-for-sale securities held at December 31, 2017 and 2016 mature in less than one year. Unrealized gains and losses on available-for-sale securities are included as a component of other comprehensive income (loss). The securities in unrealized loss positions have not been in acontinuous unrealized loss position for 12 months or longer. The Company does not intend to sell the investments and it is not more likely than notthat the Company will be required to sell the investments before recovery of their amortized cost bases, which may be at maturity. The Companyreviews its investments to identify and evaluate investments that have an indication of possible other-than-temporary impairment. Factorsconsidered in determining whether a loss is other-than-temporary include the length of time and extent to which fair value has been less than thecost basis, the financial condition and near-term prospects of the investee, and the Company’s intent and ability to hold the investment for a periodof time sufficient to allow for any anticipated recovery in market value.66CIDARA THERAPEUTICS, INC.Notes to Consolidated Financial Statements — Continued4. FAIR VALUE MEASUREMENTSThe Company follows ASC 820-10, Fair Value Measurements and Disclosures, which among other things, defines fair value, establishes aconsistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either arecurring or nonrecurring basis. Fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer aliability in an orderly transaction between market participants. As such, fair value is a market-based measurement determined based onassumptions that market participants would use in pricing an asset or liability.As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuringfair value as follows:Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities;Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; andLevel 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions,which reflect those that a market participant would use.The Company classifies investments in money market funds within Level 1 as the prices are available from quoted prices in active markets.Investments in commercial paper, corporate debt and reverse repurchase agreements are classified within Level 2 as these instruments are valuedusing observable market inputs including reported trades, broker/dealer quotes, bids and/or offers.None of the Company’s non-financial assets or liabilities are recorded at fair value on a non-recurring basis. No transfers between levels haveoccurred during the periods presented.The following tables summarize the Company’s financial instruments measured at fair value on a recurring basis (in thousands): TOTAL LEVEL 1 LEVEL 2 LEVEL 3December 31, 2017 Assets: Money market funds$11,556 $11,556 $— $—U.S Treasury reverse repurchase agreements48,000 — 48,000 —Corporate debt15,101 — 15,101 —Total assets at fair value$74,657 $11,556 $63,101 $—December 31, 2016 Assets: Money market funds$84,830 $84,830 $— $—Commercial paper$19,252 — 19,252 —Total assets at fair value$104,082 $84,830 $19,252 $—5. PROPERTY AND EQUIPMENTProperty and equipment consisted of the following (in thousands): December 31, 2017 2016Laboratory equipment$2,051 $1,771Leasehold improvements425 425Computer hardware and software327 295Office equipment119 111Furniture and fixtures142 142 3,064 2,744Less accumulated depreciation and amortization(2,020) (1,370)Total$1,044 $1,374Depreciation and amortization of property and equipment of $667,000 and $732,000 were recorded for the years ended December 31, 2017 and2016, respectively.67CIDARA THERAPEUTICS, INC.6. DEBTTerm LoansOn October 3, 2016, the Company entered into a loan and security agreement, (the "Loan Agreement"), with Pacific Western Bank, as thecollateral agent and a lender (the "Lender"), pursuant to which the Lender agreed to lend to the Company up to $20.0 million in a series of termloans. Contemporaneously, the Company borrowed $10.0 million from the Lender (the "Term A Loan").Under the terms of the Loan Agreement and subject to the achievement of positive Phase 2 clinical results from the STRIVE Phase 2 clinical trialof rezafungin acetate, formerly known as CD101, by March 31, 2018 (the "Milestone"), the Company may, at its sole discretion through October 3,2018, borrow from the Lender up to an additional $10.0 million (the "Term B Loan", and together with Term A Loan, the "Term Loans").The Company’s obligations under the Loan Agreement are secured by a first priority security interest in substantially all of the Company’s currentand future assets, other than its intellectual property, which is subject to a double negative pledge. The Term Loans mature on October 3, 2020 (the "Maturity Date"). Payments under the Term Loans will be interest-only through April 2, 2018,which will be extended by six months if the Milestone is achieved. The interest-only period will be followed by 30 equal monthly payments ofprincipal and interest; provided that there will be 24 equal monthly payments if the Milestone is achieved. The Term Loans will bear interest at avariable annual rate equal to the greater of (i) 4.5% or (ii) the Lender’s prime interest rate plus 1.0%. At December 31, 2017, the Term Loans bearinterest at 5.5%.The Company may prepay the borrowed amounts, provided that the Company will be obligated to pay a prepayment fee equal to (i) 2.0% of theapplicable principal amount of the Term Loan if the prepayment occurs before the first anniversary of the applicable funding date, and (ii) 1.0% ofthe applicable principal amount of the Term Loan if the prepayment occurs after the first anniversary of the funding date of such Term Loan but onor prior to the second anniversary of the funding date of such Term Loan.Pursuant to the Loan Agreement, on October 3, 2016, the Company issued to the Lender a warrant to purchase an aggregate of upto 17,331 shares of the Company’s common stock at an exercise price of $11.54 per share. If the Company borrows additional amounts under theLoan Agreement, it will, in connection with any such borrowing, issue the Lender an additional warrant to purchase that number of shares of theCompany’s common stock as is equal to 2.0% of the additional principal amount borrowed divided by the exercise price. The exercise price shallbe equal to the 30-day average closing price of the Company’s common stock, calculated as of the date immediately prior to the date of suchadditional borrowing. The warrants are immediately exercisable and will expire ten years from the date of the grant.While any amounts are outstanding under the Loan Agreement, the Company is subject to a number of affirmative and restrictive covenants,including covenants regarding dispositions of property, business combinations or acquisitions, incurring additional indebtedness and transactionswith affiliates, among other customary covenants. The Company is also restricted from paying dividends or making other distributions or paymentson its capital stock, subject to limited exceptions.Upon the occurrence of certain events, including but not limited to the Company’s failure to satisfy its payment obligations under the LoanAgreement, the breach of certain of its other covenants under the Loan Agreement, including the receipt of positive Phase 2 clinical data from therezafungin program by March 31, 2018, or the occurrence of a material adverse change, the collateral agent will have the right, among otherremedies, to declare all principal and interest and other amounts due to the Lender under the Loan Agreement immediately due and payable.As of December 31, 2017, future principal payments due under the Term A Loan are as follows (in thousands):Year ended:December 31, 2018$2,667December 31, 20194,000December 31, 20203,333Total future principal payments due under the Term A Loan$10,000The fair value of the warrants to purchase common stock issued in connection with Term Loan A was estimated on the date of issuance using theBlack-Scholes valuation model and recorded to additional paid-in capital. The fair68CIDARA THERAPEUTICS, INC.value of the warrants on the date of issuance as well as the debt issue costs incurred in connection with the entry into the Loan Agreement arepresented as a direct deduction from the carrying amount of the term loan on the consolidated balance sheet and are being amortized utilizing theeffective interest method over the term of the loan. The Company recorded interest expense for the amortization of the fair value of the warrantsand debt issue costs of $78,000 and $22,000 for the years ended December 31, 2017 and 2016, respectively, for the amortization of the fair valueof the warrants and debt issue costs.7. STOCKHOLDERS’ EQUITYPreferred Stock— Under the amended and restated certificate of incorporation, the Company’s board of directors has the authority, without furtheraction by the stockholders, to issue up to 10,000,000 shares of preferred stock in one or more series, to establish from time to time the number ofshares to be included in each such series, to fix the rights, preferences and privileges of the shares of each wholly unissued series and anyqualifications, limitations or restrictions thereon and to increase or decrease the number of shares of any such series, but not below the number ofshares of such series then outstanding. The Company had 10,000,000 shares of preferred stock authorized and no shares of preferred stockissued or outstanding at December 31, 2017.Common Stock—The Company had 200,000,000 shares of common stock authorized as of December 31, 2017. Holders of outstanding shares ofcommon stock are entitled to one vote for each share held of record on all matters submitted to a vote of the holders of common stock. Subject tothe rights of the holders of any class of the Company’s capital stock having any preference or priority over common stock, the holders of commonstock are entitled to receive dividends that are declared by the Company’s board of directors out of legally available funds. In the event of aliquidation, dissolution or winding-up, the holders of common stock are entitled to share ratably in the net assets remaining after payment ofliabilities, subject to prior rights of preferred stock, if any, then outstanding. The common stock has no preemptive rights, conversion rights,redemption rights or sinking fund provisions, and there are no dividends in arrears or default. All shares of common stock have equal distribution,liquidation and voting rights, and have no preferences or exchange rights.On October 13, 2016, the Company completed a public offering of common stock in which it sold 2,752,637 shares of its common stock at anoffering price of $10.10 per share. The Company raised net proceeds of approximately $26.6 million after deducting underwriting discounts andcommissions and offering expenses.In October 2017 the Company closed a private placement transaction pursuant to which an aggregate of 3,360,000 shares of common stock weresold at a price of $6.00 per share. The Company received net proceeds of approximately $18.9 million after deducting placement agent fees andoffering expenses.In November 2017 the Company began to sell shares of common stock under a controlled equity sales agreement with Cantor Fitzgerald & Co.During the year ended December 31, 2017, the Company sold 240,178 shares of common stock for net proceeds of approximately $1.8 millionafter deducting placement agent fees.Common Stock Reserved for Future IssuanceCommon stock reserved for future issuance is as follows (in common stock equivalent shares): Years ended December 31, 2017 2016Common stock warrants17,331 17,331Stock options issued and outstanding3,099,173 2,295,393Authorized for future stock awards1,006,307 1,404,933Awards available under the ESPP380,875 306,813Total4,503,686 4,024,4708. EQUITY INCENTIVE PLANS2015 Equity Incentive PlanIn March 2015, the Company’s board of directors and stockholders approved and adopted the 2015 Equity Incentive Plan (“2015 EIP”). Under the2015 EIP, the Company may grant stock options, stock appreciation rights, restricted stock, RSUs, and other awards to individuals who areemployees, officers, directors or consultants of the Company. The number of shares of stock available for issuance under the 2015 EIP will beautomatically increased each January 1 by69CIDARA THERAPEUTICS, INC.Notes to Consolidated Financial Statements — Continued4% of the outstanding number of shares of the Company’s common stock on the immediately preceding December 31 or such lesser number asdetermined by the Company’s board of directors.Terms of stock award agreements, including vesting requirements, are determined by the board of directors, subject to the provisions of the 2015EIP. Stock options granted by the Company generally vest over a three- or four-year period. Certain stock options are subject to acceleration ofvesting in the event of certain change of control transactions. The stock options may be granted for a term of up to 10 years from the date ofgrant. The exercise price for stock options granted under the 2015 EIP must be at a price no less than 100% of the estimated fair value of theshares on the date of grant as determined by the board of directors, provided that for an incentive stock option granted to an employee who at thetime of grant owns stock representing more than 10% of the voting power of all classes of stock of the Company, the exercise price shall be noless than 110% of the estimated value on the date of grant.2015 Employee Stock Purchase PlanIn March 2015, the Company’s board of directors and stockholders approved and adopted the 2015 Employee Stock Purchase Plan("ESPP"). The number of shares of stock available for issuance under the ESPP will be automatically increased each January 1 by the lesser of(i) 1% of the outstanding number of shares of the Company’s common stock on the immediately preceding December 31, (ii) 490,336 shares, or(iii) such lesser number as determined by the Company’s board of directors.The ESPP allows substantially all employees to purchase the Company’s common stock through a payroll deduction at a price equal to 85% ofthe lower of the fair market value of the stock as of the beginning or the end of each purchase period. An employee’s payroll deductions under theESPP are limited to 15% of the employee’s eligible compensation. During the year ended December 31, 2017, 94,309 shares were issuedpursuant to the ESPP.Restricted StockThe Company permits early exercise prior to vesting of certain stock options. Any such unvested exercised shares are restricted and subject torepurchase by the Company until the conditions for vesting are met. At December 31, 2017 and 2016, the liabilities for the cash received from theearly exercise of stock options were $21,000 and $144,000, respectively, and were classified in accrued liabilities on the balance sheet. TheCompany reduces the liability as the underlying shares vest in accordance with the vesting terms outlined in the stock option agreements, whichgenerally are 4 years. At December 31, 2017, 9,305 unvested shares were subject to repurchase by the Company.Restricted Stock UnitsThe following table summarizes RSU and PRSU activity during the year ended December 31, 2017: Number ofRSUs and PRSUsOutstanding at December 31, 2016—RSUs and PRSUs granted240,000RSUs and PRSUs vested(2,500)RSUs and PRSUs canceled(10,000)Outstanding at December 31, 2017227,500For the year ended December 31, 2017, stock-based compensation expense related to RSUs and PRSUs was approximately $95,000. AtDecember 31, 2017, estimated unrecognized compensation expense related to RSUs and PRSUs granted to employees was approximately $1.4million.Stock OptionsThe following table summarizes stock option activity during the year ended December 31, 2017:CIDARA THERAPEUTICS, INC.Notes to Consolidated Financial Statements — Continued Number ofShares WeightedAverageExercise Price WeightedAverageRemainingContractual Lifein Years Total AggregateIntrinsic Value (inthousands)Outstanding at December 31, 20162,295,393 $7.82 8.20 $6,774Options granted1,043,950 7.76 Options exercised(38,332) 5.95 Options canceled(201,838) 9.21 Outstanding at December 31, 20173,099,173 $7.74 8.10 $2,264Vested and expected to vest at December 31, 20173,099,173 $7.74 8.10 $2,264Exercisable at December 31, 20171,860,030 $7.15 7.58 $2,205The following table summarizes the Black-Scholes option pricing model assumptions used to estimate the fair value of stock options granted toemployees under our equity incentive plans and the shares purchasable under our 2015 ESPP during the periods presented: For the years ended December 31, 2017 20162015 EIP Risk-free interest rate1.87% - 2.23% 1.14% - 2.09%Expected dividend yield0% 0%Expected volatility79% - 86% 80% - 82%Expected term (years)5.50 - 6.08 5.50 - 6.082015 ESPP Risk-free interest rate1.05% - 1.77% 0.48% - 1.08%Expected dividend yield0% 0%Expected volatility79% - 102% 80% - 107%Expected term (years)0.50 - 2.00 0.50 - 2.00Stock-based compensation expense recognized for restricted shares, RSUs, PRSUs, stock options, and the ESPP has been reported in thestatements of operations and comprehensive loss as follows (in thousands): Years ended December 31, 2017 2016Research and development$2,428 $2,005General and administrative3,286 2,339Total$5,714 $4,344The weighted-average grant date fair value of stock options granted to employees during the year ended December 31, 2017 was $5.54 per share.The total grant date fair value of stock options that vested during the year ended December 31, 2017 was $4.9 million. As of December 31, 2017,total unrecognized share-based compensation expense related to unvested employee stock options of the Company was approximately $7.6million. This unrecognized compensation cost is expected to be recognized over a weighted-average period of approximately 1.92 years.As of December 31, 2017, total unrecognized compensation expense related to the Company’s ESPP was approximately $0.6 million. Thisunrecognized compensation cost is expected to be recognized over approximately 1.0 years.9. SIGNIFICANT AGREEMENTS AND CONTRACTSCombating Antibiotic Resistant Bacteria Accelerator (CARB-X) Subaward AgreementOn March 30, 2017, the Company entered into a Cost Reimbursement Research Subaward Agreement (the "Subaward Agreement") with theTrustees of Boston University. Under the Subaward Agreement, the Company is a subawardee under the CARB-X program. CARB-X is a public-private partnership focused on antibacterials, created by the U.S. Department of Health and Human Services (HHS), Biomedical AdvancedResearch and Development Authority (BARDA),CIDARA THERAPEUTICS, INC.Notes to Consolidated Financial Statements — Continuedand National Institute of Allergy and Infectious Diseases (NIAID). CARB-X is funded by BARDA and the London-based Wellcome Trust, a globalcharitable foundation (Wellcome), and administered by the Boston University School of Law.The subaward supports development of the Company's CD201 product candidate. Under the Subaward Agreement, during an initial phase thatbegan on April 1, 2017 and ends upon acceptance by the U.S. Food and Drug Administration of an initial new drug application, CARB-X wouldreimburse up to $3.9 million of qualifying development expenses. If all of the milestones in such initial phase are met, the CARB-X Joint OversightCommittee will evaluate the progress made in such initial phase and determine whether to exercise its option to fund a second stage. During thesecond stage, CARB-X would reimburse up to $3.0 million of qualifying development expenses through a Phase 1 clinical trial. Such second stagewould be subject to a new subaward agreement.Under the Subaward Agreement, the Company is reimbursed for direct costs incurred plus allowable indirect costs which consist of fringe benefitsand allowable general and administrative expenses. For the year ended December 31, 2017, the Company recognized reductions to research anddevelopment expenses of $0.5 million for costs eligible for reimbursement under the Subaward Agreement. As of December 31, 2017, billedaccounts receivable were $0.1 million and unbilled accounts receivable were $0.2 million related to reimbursable expenses under the SubawardAgreement.The Subaward Agreement can be terminated upon the delivery of 30 days written notice to the Company for default or convenience. Upon receiptof a notice of termination, the Company must discontinue contract activities and CARB-X must pay the Company a final settlement based oneligible expenses incurred under the Subaward Agreement. Based on preclinical studies of CD201 as well as preclinical studies of antibody-drug conjugates (ADCs) from the Cloudbreak program, theCompany decided in February 2018 to cease development of CD201 to focus on the more promising ADCs for the same indication. Based on thedecision to focus efforts on the ADCs, the Company will no longer be seeking funding under the Subaward Agreement relating to CD201.10. INCOME TAXESThe Company accounts for income taxes under ASC 740. Deferred income tax assets and liabilities are determined based upon differencesbetween financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effectwhen the differences are expected to reverse.The following table provides a reconciliation between income taxes computed at the federal statutory rate of 34% and the provision for incometaxes (in thousands): Years Ended December 31, 2017 2016 2015Federal income taxes at 34%$(18,947) $(16,334) $(10,946)State income tax, net of federal benefit— (1) (1,821)Tax effect on nondeductible expenses3,389 1,650 341Research credits(8,125) (3,538) (676)Rate change— 267 —Change in valuation allowance5,133 14,996 13,084Reserve for uncertain tax positions1,451 2,883 —Tax Cuts and Jobs Act17,334 — —Other(235) 77 18Income tax expense$— $— $—CIDARA THERAPEUTICS, INC.Notes to Consolidated Financial Statements — ContinuedSignificant components of the Company’s net deferred tax assets are as follows (in thousands): Years Ended December 31, 2017 2016Deferred tax assets: Net operating losses$26,364 $27,309Research credits10,232 3,646Intangibles265 466Other1,722 2,030Total deferred tax assets38,583 33,451Less valuation allowance(38,583) (33,451)Income tax expense$— $—At December 31, 2017, the Company had federal and state net operating loss carryforwards of approximately $122.5 million and $81.5 million,respectively. The federal and state loss carryforwards begin to expire in 2033, unless previously utilized. The Company also has federal researchand development and orphan drug credit carryforwards totaling $12.5 million and state research and development credit carryforwards totaling $1.6million. The federal research and development credit and orphan drug credit carryforwards begin to expire in 2033, unless previously utilized. Thestate research and development credit carryforwards begin to expire in 2018.Management assesses the available positive and negative evidence to estimate if sufficient future taxable income will be generated to use theexisting deferred tax assets. Based on the weight of all evidence, including a history of operating losses, management has determined that it ismore likely than not that the net deferred tax assets will not be realized. A valuation allowance of $38.6 million and $33.5 million as ofDecember 31, 2017 and 2016, respectively, has been established to offset the deferred tax assets as realization of such assets is uncertain.Future utilization of the Company’s net operating loss and research and development credits carryforwards to offset future taxable income may besubject to an annual limitation, pursuant to Internal Revenue Code (IRC) Sections 382 and 383, as a result of ownership changes that may haveoccurred or that could occur in the future. An ownership change occurs when a cumulative change in ownership of more than 50% occurs within athree-year period. The Company has not completed an IRC Section 382/383 analysis regarding the limitation of net operating loss and researchand development credit carryforwards.The Tax Cuts and Jobs Act was enacted on December 22, 2017. The Act reduces the US federal corporate tax rate from 35% to 21%, requirescompanies to pay a one-time transition tax on earnings of certain foreign subsidiaries that were previously tax deferred, and creates new taxes oncertain foreign sourced earnings. At December 31, 2017, the Company has not completed accounting for the tax effects of enactment of the Act;however, in certain cases, as described below, the Company has made a reasonable estimate of the effects on its existing deferred tax balances.For items for which the Company was able to determine a reasonable estimate, it recognized a provisional amount of $17.3 million which wasoffset by a corresponding reduction to the valuation allowance. In all cases, the Company will continue to make and refine its calculations asadditional analysis is completed. In addition, its estimates may also be affected as the Company gains a more thorough understanding of the taxlaw.The Company recognizes a tax benefit from an uncertain tax position when it is more likely than not that the position will be sustained uponexamination, including resolutions of any related appeals or litigation processes, based on the technical merits. Income tax positions must meet amore likely than not recognition at the effective date to be recognized. At December 31, 2017 and 2016, the unrecognized tax benefits recordedwere approximately $10.8 million and $4.6 million, respectively. Approximately $8.6 million of the unrecognized tax benefits would reduce theCompany's annual effective tax rates, if recognized, subject to the valuation allowances. The Company does not anticipate a significant change inthe unrecognized tax benefits within the next 12 months.A reconciliation of the beginning and ending amount of gross unrecognized tax benefits for 2017, 2016 and 2015 is as follows (in thousands): Years Ended December 31, 2017 2016 2015Balance as of the beginning of the year$4,642 $356 $108Increases related to current year tax positions3,965 921 248Increases related to prior year tax positions2,149 3,365 —Balance as of the end of the year$10,756 $4,642 $35673CIDARA THERAPEUTICS, INC.Notes to Consolidated Financial Statements — ContinuedThe Company files tax returns as prescribed by the tax laws of the jurisdictions in which it operates. In the normal course of business, theCompany is subject to examination by the United States and state jurisdictions where applicable. There are currently no pending income taxexaminations. The Company’s tax years from inception in 2012 are subject to examination by the federal and state tax authorities due to thecarryforward of unutilized net operating losses and research and development credits. The Company’s practice is to recognize interest andpenalties related to income tax matters in income tax expense. The Company has not recognized interest or penalties since inception.11. COMMITMENTS AND CONTINGENCIESLitigation—From time to time, the Company may be involved in various lawsuits, legal proceedings, or claims that arise in the ordinary course ofbusiness. Management believes there are no claims or actions pending against the Company at December 31, 2017 which will have, individually orin the aggregate, a material adverse effect on its business, liquidity, financial position or results of operations. Litigation, however, is subject toinherent uncertainties, and an adverse result in such matters may arise from time to time that may harm the Company’s business.Lease Obligations—In June 2014, the Company entered into an operating lease agreement for laboratory and office space in San Diego,California. Amendments for additional space were entered into in February 2015, March 2015 and August 2015. The lease expires in December2018 with options for two individual two-year extensions. The lease is subject to charges for common area maintenance and other costs, and baserent is subject to 3% annual increases every July. Rent expense is being recorded on a straight-line basis over the life of the lease.Future minimum payments required under the lease as of December 31, 2017 are summarized as follows (in thousands):2018746Total minimum lease payments$746Rent expense was $704,000 and $733,000 for the years ended December 31, 2017 and 2016, respectively.Contractual Obligations—The Company enters into contracts in the normal course of business with vendors for research and developmentactivities, manufacturing, and professional services. These contracts generally provide for termination either on or within 30 days of notice.12. Subsequent Events"At-the-market" offering—In November 2017 the Company began to sell shares of common stock under a controlled equity sales agreement withCantor Fitzgerald & Co. During the period from January 1, 2018 through February 20, 2018, the Company sold 241,837 shares of common stockfor net proceeds of approximately $1.7 million after deducting placement agent fees.13. SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED) First Quarter Second Quarter Third Quarter Fourth Quarter2017 Operating expenses$13,398 $16,615 $12,249 $13,459Other income (expense)— (30) (8) 31Net loss(13,398) (16,645) (12,257) (13,428)Basic and diluted net loss per share$(0.80) $(0.99) $(0.73) $(0.69)Shares used to compute basic and diluted net loss per share16,795,366 16,831,960 16,864,211 19,489,3752016 Operating expenses$9,885 $11,862 $12,336 $14,353Other income (expense)96 107 109 (41)Net loss(9,789) (11,755) (12,227) (14,394)Basic and diluted net loss per share$(0.71) $(0.85) $(0.88) $(0.88)Shares used to compute basic and diluted net loss per share13,807,825 13,871,938 13,910,145 16,352,04674Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.None.Item 9A. Controls and Procedures.Evaluation of Disclosure Controls and ProceduresWe maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our periodic and currentreports that we file with the SEC is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms,and that such information is accumulated and communicated to our management, including our chief executive officer and principal financialofficer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures,management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable and notabsolute assurance of achieving the desired control objectives. In reaching a reasonable level of assurance, management necessarily wasrequired to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. In addition, the design of any systemof controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design willsucceed in achieving its stated goals under all potential future conditions; over time, control may become inadequate because of changes inconditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective controlsystem, misstatements due to error or fraud may occur and not be detected.As of December 31, 2017, we carried out an evaluation, under the supervision and with the participation of our management, including our principalexecutive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures, asdefined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Based on this evaluation, our principal executive officer and principal financialofficer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of December 31, 2017.Management’s Report on Internal Control over Financial Reporting.Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined inExchange Act Rule 13a-15(f). Our internal control over financial reporting is designed to provide reasonable assurance regarding the reliability offinancial reporting and the preparation of consolidated financial statements for external purposes in accordance with generally accepted accountingprinciples. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. In addition,projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes inconditions, or that the degree of compliance with the policies or procedures may deteriorate.Our management, with the participation of our principal executive officer and principal financial officer, assessed the effectiveness of our internalcontrol over financial reporting as of December 31, 2017. In making this assessment, management used the criteria set forth by the Committee ofSponsoring Organizations of the Treadway Commission (COSO) in its 2013 Internal Control — Integrated Framework. Based on this assessment,our management has concluded that, as of December 31, 2017, our internal control over financial reporting was effective.This Annual Report does not include an attestation report of our registered public accounting firm due to a transition period established by theJOBS Act that is applicable to emerging growth companies.Changes in Internal Control over Financial ReportingThere were no changes in our internal control over financial reporting that occurred during our latest fiscal quarter that have materially affected, orare reasonably likely to materially affect, our internal control over financial reporting.Item 9B. Other Information.On February 22, 2018, our board of directors approved an increase in its authorized size to seven members and appointed Chrysa Mineo, effectiveMarch 1, 2018, as a Class III director to fill the vacancy created by such increase, to serve in such capacity until our 2018 annual meeting ofstockholders.Ms. Mineo will receive compensation for her service as a director in accordance with our Non-Employee Director Compensation Policy, or theCompensation Policy. The Compensation Policy provides for annual cash compensation of $40,000 for service on our board of directors, payablein equal quarterly installments and prorated based on days served. In addition, pursuant to the Compensation Policy, on March 1, 2018 Ms. Mineowill be granted a stock option to purchase 20,000 shares of our common stock, with one-third of the shares vesting on the first anniversary of thedate of grant and the remaining shares vesting in equal monthly installments over the next two years.75CIDARA THERAPEUTICS, INC.Ms. Mineo also entered into our standard form of indemnification agreement for our directors and executive officers.There is no arrangement or understanding between Ms. Mineo and any other person pursuant to which Ms. Mineo was appointed as a director. Ms.Mineo is not a party to any transaction that would require disclosure under Item 404(a) of Regulation S-K promulgated under the Securities Act of1933, as amended.76PART IIIItem 10. Directors, Executive Officers and Corporate Governance.The information required by this item and not set forth below will be set forth in the section headed “Election of Directors” and “Executive Officers”in our Proxy Statement for our 2018 Annual Meeting of Stockholders, or Proxy Statement, to be filed with the SEC within 120 days after the fiscalyear ended December 31, 2017, and is incorporated herein by reference.We have adopted a code of ethics for directors, officers (including our principal executive officer, principal financial officer and principal accountingofficer) and employees, known as the Code of Business Conduct and Ethics. The Code of Business Conduct and Ethics is available on ourwebsite at http://www.cidara.com under the Corporate Governance section of our Investor Relations page. We will promptly disclose on ourwebsite (i) the nature of any amendment to the policy that applies to our principal executive officer, principal financial officer, principal accountingofficer, or persons performing similar functions and (ii) the nature of any waiver, including an implicit waiver, from a provision of the policy that isgranted to one of these specified individuals that is required to be disclosed pursuant to SEC rules and regulations, the name of such person whois granted the waiver and the date of the waiver. The information contained on, or that can be accessed through, our website is not part of thisAnnual Report, and the inclusion of our website address in this Annual Report is an inactive textual reference onlyItem 11. Executive Compensation.The information required by this item will be set forth in the section headed “Executive and Director Compensation” in our Proxy Statement and isincorporated herein by reference.Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.The information required by this item will be set forth under the headings “Equity Benefit Plans” and “Security Ownership of Certain BeneficialOwners and Management” in our Proxy Statement and is incorporated herein by reference.The information required by Item 201(d) of Regulation S-K will be set forth in the section headed “Executive and Director Compensation” in ourProxy Statement and is incorporated herein by reference.Item 13. Certain Relationships and Related Transactions, and Director Independence.The information required by this item will be set forth in the section headed “Certain Relationships and Related Party Transactions” in our ProxyStatement and is incorporated herein by reference.Item 14. Principal Accounting Fees and Services.The information required by this item will be set forth in the section headed “Principal Accountant Fees and Services” in our Proxy Statement andis incorporated herein by reference.77PART IVItem 15. Exhibits, Financial Statement Schedules.1.Financial Statements—We have filed the following documents in Item 8of this Annual Report: PageReport of Independent Registered Public Accounting Firm58Balance Sheets59Statements of Operations and Comprehensive Loss60Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit)61Statements of Cash Flows62Notes to Financial Statements632.Financial Statement Schedules—All other schedules are omitted because they are not required or the requiredinformation is included in the financial statements or notes thereto.3.Exhibits—For a list of exhibits filed with this Annual Report, refer to the exhibit index following the signature page on thisAnnual Report. The exhibits listed in the Exhibit Index are filed or incorporated by reference as part of this Annual Report.78Exhibit IndexExhibitNumber Description1.2 Controlled Equity OfferingSM Sales Agreement by and between the Registrant and Cantor Fitzgerald & Co., dated May 19,2016 (incorporated by reference to Exhibit 1.2 to the Registrant’s Registration Statement on Form S-3 (File No. 333-211472),filed on May 19, 2016).3.1 Amended and Restated Certificate of Incorporation of the Registrant, as currently in effect (incorporated by reference to Exhibit3.1 to the Registrant’s Current Report on Form 8-K, filed on April 24, 2015).3.2 Amended and Restated Bylaws of the Registrant, as currently in effect (incorporated by reference to Exhibit 3.2 to theRegistrant’s Current Report on Form 8-K, filed on April 24, 2015).4.1 Form of Common Stock Certificate of the Registrant (incorporated by reference to Exhibit 4.1 to the Registrant's RegistrationStatement on Form S-1 (File No. 333-202740), as amended, originally filed on March 13, 2015).4.2 Second Amended and Restated Investor Rights Agreement, by and among the Registrant and certain of its stockholders,dated February 10, 2015 (incorporated by reference to Exhibit 4.2 to the Registrant's Registration Statement on Form S-1 (FileNo. 333-202740), as amended, originally filed on March 13, 2015).4.3 Form of Warrant to Purchase Common Stock issued to Pacific Western Bank (incorporated by reference to Exhibit 10.2 to theRegistrant's Current Report on Form 8-K, filed on October 3, 2016).10.1+ Form of Indemnity Agreement by and between the Registrant and its directors and officers (incorporated by reference toExhibit 10.1 to the Registrant's Registration Statement on Form S-1 (File No. 333-202740), as amended, originally filed onMarch 13, 2015).10.2+ 2015 Equity Incentive Plan and Form of Grant Notice, Stock Option Agreement and Notice of Exercise thereunder(incorporated by reference to Exhibit 99.2 to the Registrant's Registration Statement on Form S-8 (File No. 333-203434), filedon April 15, 2015).10.3+ 2015 Employee Stock Purchase Plan (incorporated by reference to Exhibit 10.3 to the Registrant's Registration Statement onForm S-1 (File No. 333-202740), as amended, originally filed on March 13, 2015).10.4+ 2013 Stock Option and Grant Plan and Form of Stock Option Agreement, Notice of Exercise and Stock Option Grant Noticethereunder, as amended (incorporated by reference to Exhibit 10.4 to the Registrant's Registration Statement on Form S-1 (FileNo. 333-202740), as amended, originally filed on March 13, 2015).10.5+ Form of Amended and Restated Employment Agreement by and between the Registrant and its executive officers(incorporated by reference to Exhibit 10.2 to the Registrant's Quarterly Report on Form 10-Q, filed on November 10, 2016).10.6 Consulting and Independent Contractor Agreement by and between the Registrant and Dirk Thye, M.D., dated September 2,2016 (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed on September 1, 2016).10.7 Loan and Security Agreement by and between Registrant and Pacific Western Bank, dated October 3, 2016 (incorporated byreference to Exhibit 10.1 to the Registrant's Current Report on Form 8-K, filed on October 3, 2016).10.8 Asset Purchase Agreement by and between Registrant and Seachaid Pharmaceuticals, Inc., dated May 30, 2014 (incorporatedby reference to Exhibit 10.12 to the Registrant's Registration Statement on Form S-1 (File No. 333-202740), as amended,originally filed on March 13, 2015).10.9 Addendum to Asset Purchase Agreement by and between Registrant and Seachaid Pharmaceuticals, Inc., dated September23, 2014 and deemed effective as of May 30, 2014 (incorporated by reference to Exhibit 10.13 to the Registrant's RegistrationStatement on Form S-1 (File No. 333-202740), as amended, originally filed on March 13, 2015).10.10 Standard Industrial/Commercial Multi-Tenant Lease by and between the Registrant and Nancy Ridge Technology Center, L.P.,dated June 9, 2014 (incorporated by reference to Exhibit 10.14 to the Registrant's Registration Statement on Form S-1 (FileNo. 333-202740), as amended, originally filed on March 13, 2015).10.11 First Amendment to Lease by and between the Registrant and Nancy Ridge Technology Center, L.P., dated June 9, 2014(incorporated by reference to Exhibit 10.15 to the Registrant's Registration Statement on Form S‑1 (File No. 333-202740), asamended, originally filed on March 13, 2015).10.12 Second Amendment to Lease by and between the Registrant and Nancy Ridge Technology Center, L.P., dated February 15,2015 (incorporated by reference to Exhibit 10.16 to the Registrant's Registration Statement on Form S-1 (File No. 333-202740),as amended, originally filed on March 13, 2015).10.13 Third Amendment to Lease by and between the Registrant and Nancy Ridge Technology Center, L.P., dated July 1, 2015(incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q, filed on November 16, 2015).79ExhibitNumber Description10.14 Cost Reimbursement Research Subaward Agreement by and between Registrant and the Trustees of Boston University, datedMarch 30, 2017 (incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q, filed on May 10,2017).10.15+ Form of Restricted Stock Unit Award Grant Notice (incorporated by reference to Exhibit 10.2 to the Registrant’s QuarterlyReport on Form 10-Q, filed on May 10, 2017).10.16 Securities Purchase Agreement by and among the Registrant and each of the persons and entities, severally and not jointly,listed as a Purchaser on the Schedule of Purchasers attached as Schedule I thereto, dated October 19, 2017 (incorporated byreference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed on October 19, 2017).21.1* List of subsidiaries of the Registrant.23.1* Consent of Independent Registered Public Accounting Firm.24.1 Power of Attorney. Reference is made to the signature page hereto.31.1* Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.31.2* Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.32.1* Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of theSarbanes-Oxley Act of 2002.32.2* Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of theSarbanes-Oxley Act of 2002.101.INS XBRL Instance Document101.SCH XBRL Taxonomy Extension Schema Document101.CAL XBRL Taxonomy Extension Calculation Linkbase Document101.DEF XBRL Taxonomy Extension Definition Linkbase Document101.LAB XBRL Taxonomy Extension Label Linkbase Document.101.PRE XBRL Taxonomy Extension Presentation Linkbase Document. + Indicates management contract or compensatory plan.* Filed herewith.SIGNATURESPursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused thisReport to be signed on its behalf by the undersigned, thereunto duly authorized. Cidara Therapeutics, Inc. Date: February 27, 2018By:/s/ Jeffrey Stein, Ph.D. Jeffrey Stein, Ph.D. President and Chief Executive OfficerPOWER OF ATTORNEYKNOW ALL BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Jeffrey Stein, Ph.D. and MatthewOnaitis, and each of them, as his or her true and lawful attorneys-in-fact and agents, each with the full power of substitution, for him or her and inhis or her name, place or stead, in any and all capacities, to sign any and all amendments to this report, and to file the same, with all exhibitsthereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact andagents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in and aboutthe premises, as fully to all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or either of them, or his or her substitute or substitutes, may lawfully do or cause to be done by virtue hereof.Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this Report has been signed below by the following persons onbehalf of the Registrant in the capacities and on the dates indicated.80Name Title Date /s/ Jeffrey Stein, Ph.D. President and Chief Executive Officer February 27, 2018Jeffrey Stein, Ph.D. (Principal Executive Officer) /s/ Matthew Onaitis, J.D. Chief Financial Officer and General Counsel February 27, 2018Matthew Onaitis, J.D. (Principal Financial Officer and Principal Accounting Officer) /s/ Scott M. Rocklage, Ph.D Chairman of the Board of Directors February 27, 2018Scott M. Rocklage, Ph.D /s/ Daniel D. Burgess Member of the Board of Directors February 27, 2018Daniel D. Burgess /s/ Timothy R. Franson, M.D. Member of the Board of Directors February 27, 2018Timothy R. Franson, M.D. /s/ Robert J. Perez Member of the Board of Directors February 27, 2018Robert J. Perez /s/ Theodore R. Schroeder Member of the Board of Directors February 27, 2018Theodore R. Schroeder 81Exhibit 21.1Cidara Therapeutics, Inc. SubsidiariesThe following is a list of subsidiaries of the Company, doing business under the name stated.Name Country or State of IncorporationCidara Therapeutics UK Limited United KingdomExhibit 23.1Consent of Independent Registered Public Accounting FirmWe consent to the incorporation by reference in the following Registration Statements:(1)Registration Statement (Form S-3 No. 333-211472) of Cidara Therapeutics, Inc.,(2)Registration Statement (Form S-3 No. 333-221535) of Cidara Therapeutics, Inc., and(3)Registration Statements (Form S-8 Nos. 333-216722, 333-203434 and 333-210263) pertaining to the 2013 Stock Option and Grant Plan,the 2015 Equity Inventive Plan, and the 2015 Employee Stock Purchases Plan of Cidara Therapeutics, Inc.;of our report dated February 27, 2018, with respect to the consolidated financial statements of Cidara Therapeutics, Inc. included in this AnnualReport (Form 10-K) of Cidara Therapeutics, Inc. for the year ended December 31, 2017./s/ Ernst & Young LLPSan Diego, CaliforniaFebruary 27, 2018Exhibit 31.1CERTIFICATION PURSUANT TORULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002I, Jeffrey Stein, Ph.D., certify that:1.I have reviewed this Annual Report on Form 10-K of Cidara Therapeutics, Inc.;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 tomake the statements made, in light of the circumstances under which such statements were made, not misleading with respect to theperiod covered by this report;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all materialrespects the financial 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 and I are responsible for establishing and maintaining disclosure controls and procedures (asdefined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules13a-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 oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known tous by others within those entities, 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 designedunder our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation offinancial statements for external 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 conclusionsabout the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based onsuch evaluation; and(d)Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant'smost recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or isreasonably likely to materially affect, the registrant's internal control over financial reporting; and5.The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financialreporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalentfunctions):(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'sinternal control over financial reporting.Date: February 27, 2018By: /s/ Jeffrey Stein, Ph.D. Jeffrey Stein, Ph.D.President and Chief Executive Officer (Principal Executive Officer)Exhibit 31.2CERTIFICATION PURSUANT TORULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002I, Matthew Onaitis, certify that:1.I have reviewed this Annual Report on Form 10-K of Cidara Therapeutics, Inc.;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 tomake the statements made, in light of the circumstances under which such statements were made, not misleading with respect to theperiod covered by this report;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all materialrespects the financial 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 and I are responsible for establishing and maintaining disclosure controls and procedures (asdefined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules13a-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 oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known tous by others within those entities, 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 designedunder our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation offinancial statements for external 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 conclusionsabout the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based onsuch evaluation; and(d)Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant'smost recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or isreasonably likely to materially affect, the registrant's internal control over financial reporting; and5.The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financialreporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalentfunctions):(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'sinternal control over financial reporting.Date: February 27, 2018By: /s/ Matthew Onaitis Matthew OnaitisChief Financial Officer and General Counsel (Principal Financial Officer)Exhibit 32.1CERTIFICATION PURSUANT TO18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TOSECTION 906 OF THE SARBANES-OXLEY ACT OF 2002In connection with the Annual Report on Form 10-K of Cidara Therapeutics, Inc. (the “Company”) for the period ending December 31, 2017as filed with the Securities and Exchange Commission on the date hereof and to which this certification is attached as an exhibit (the “Report”), Icertify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:(1)The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended;and(2)The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations ofthe Company.Date: February 27, 2018By: /s/ Jeffrey Stein, Ph.D. Jeffrey Stein, Ph.D.President and Chief Executive Officer (Principal Executive Officer)Exhibit 32.2CERTIFICATION PURSUANT TO18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TOSECTION 906 OF THE SARBANES-OXLEY ACT OF 2002In connection with the Annual Report on Form 10-K of Cidara Therapeutics, Inc. (the “Company”) for the period ending December 31, 2017as filed with the Securities and Exchange Commission on the date hereof and to which this certification is attached as an exhibit (the “Report”), Icertify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:(1)The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended;and(2)The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations ofthe Company.Date: February 27, 2018By: /s/ Matthew Onaitis Matthew OnaitisChief Financial Officer and General Counsel (Principal Financial Officer)

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