Slides
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NASDAQ: CDTX Corporate Presentation JUNE 2025
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2 Forward-looking Statements These slides contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words “ m a y,”“will, ”“e s t i m a t e,”“ p l a n ”,“anticipate, ”“expect, ”“potential, ”“could, ”“project, ”and similar expressions (including the negative thereof), are intended to identify forward-looking statements. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding Cidara’s research and development efforts; preclinical and clinical development activities; plans, projections and expectations for and the potential effectiveness, safety and benefits of, its product candidates, including CD388 and other product candidates from the Cloudbreak platform; whether CD388 may have significant advantages beyond and in addition to flu vaccines; and advancement of its strategic plans. Projections, assumptions and estimates of the future performance of the markets in which Cidara operates are necessarily subject to a high degree of uncertainty and risk, including, Cidara's ability to obtain additional financing; the success and timing of Cidara’s preclinical studies, clinical trials and other research and development activities; receipt of necessary regulatory approvals for development, as well as changes to applicable regulatory laws in the United States and foreign countries; changes in Cidara's plans to develop its product candidates; Cidara's ability to obtain and maintain intellectual property protection for its product candidates; and the loss of key scientific or management personnel. These and other risks and uncertainties are described more fully in Cidara's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the United States Securities and Exchange Commission ("SEC“’) on March 6, 2025, and in Cidara’s other filings with the SEC. Additional risks and uncertainties may emerge from time to time, and it is not possible for Cidara’s management to predict all risk factors and uncertainties. Cidara cautions that the foregoing list of factors is not exclusive and not to place undue reliance upon any forward-looking statements which speak only as of the date of this presentation. Except as required by law, Cidara does not undertake any obligation to update publicly any forward- looking statements for any reason after the date of this presentation to conform these statements to actual results or to changes in its expectations.
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3 Revolutionizing influenza protection 3
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4 Cidara Therapeutics Overview Abbreviations: BARDA, Biomedical Advanced Research and Development Authority; HCS, human challenge study; ID, Infectious Disease; IND, investigation new drug; JNJ, Johnson & Johnson. CD388: A Novel Antiviral with Broad Potential • CD388 is a Drug-Fc-Conjugate that combines an approved antiviral drug with a human antibody fragment CD388: Ph 2b NAVIGATE Trial • 5,041 participants dosed – late Sep to early Dec: – Three dose groups (150 mg, 300 mg, 450 mg) vs. placebo • 2024-2025 flu season substantially more severe than expected • Ph 2b top line data expected in 1H 2025 HQ: San Diego, CA Employees: ~40 NASDAQ: CDTX Zanamivir dimer Fc Flexible linker CD388 2018 CD388 discovery program begins 2021 CD388 partnership with JNJ on Pre-IND data IND filed 2022 CD388 Ph 1 program & initiation of Ph 2a HCS 2023 JNJ elects to proceed with CD388 based on Ph 2a HCS data JNJ Exits ID Space 2024 Cidara buys back rights to CD388 from JNJ NAVIGATE study enrollment completed Dec ‘24 2025 NAVIGATE data 1H ‘25 BARDA submission under review Ph 3 readiness
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5 DFCs: A Novel Drug Class CD388 is a Drug-Fc-Conjugate (DFC) that arrays multiple copies of zanamivir, the active ingredient of FDA-approved influenza drug Relenza® , on a clinically validated human antibody fragment engineered for extended half-life Our Innovation See Nature Microbiology manuscript for more details: https://doi.org/10.1038/s41564-025-01955-3 The multivalent presentation of zanamivir on CD388 significantly enhances its activity
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6 CD388 Can Complement Influenza Vaccines 1Cidara IND report (NC-CD388-055). 2Options XII presentation www.cidara.com/wp-content/uploads/2024/10/Sandison_Options-XII-Oral-Presentation_FINAL_updated.pdf 3Webster et al. Clin Pharmacokinet 1999; 36 Suppl. 1: 51-58 0312-5963/99/0001-0051/$04.00/0. 4Laforce et al. Clin Ther. 2007 Aug;29(8):1579-90 doi: 10.1016/j.clinthera.2007.08.023. Abbreviations: HA, hemagglutinin; HAI, hemagglutinin inhibition; mAb, monoclonal antibody; NA, neuraminidase; NAi, neuraminidase inhibitor. • HA and NA mechanistically complement each other and are essential for virulence • Preclinical and Ph 2a challenge study data suggest that CD388 will not interfere with vaccine/virus-induced HAI responses1,2 • Zanamivir does not interfere with HAI antibody production when co-administered with inactivated trivalent vaccines3 • Zanamivir efficacy was not impacted by vaccination status in a prophylaxis clinical trial in at-risk participants4 Replication Viral entry CD388 Cell Influenza virus Antibody HA NA CD388 Vaccine-induced antibodies and CD388 bind in two spatially different locations on the flu virus Conserved binding pocket is not affected by seasonal flu mutations Antibody HA NA Viral entry inhibited by antibodies Viral exit inhibited by CD388 CD388 has the Potential to Overcome the Limitations of Vaccines
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7 Influenza Disease Burden The Problem 1CDC: Preliminary Estimated Flu Disease Burden 2024-2025 Flu Season; 2CDC: WONDER; 3National Cancer Institute Cancer Stat Facts; 4American Cancer Society. 5CDC: Kidney Disease Mortality by State; 6CDC: Mortality in the United States, 2023; 7CDC: U.S. Cancer Statistics Breast Cancer Stat Bite; 8Leukemia & Lymphoma Society: Facts and Statistics Overview; 9CDC: Preliminary Estimates of RSV Burden for 2024-2025. Abbreviations: CRC, colorectal cancer; RSV, respiratory syncytial virus. Influenza continues to drive significant morbidity and mortality despite available vaccines and antivirals In the United States (Each Season)1 CDC estimates since Oct 1, 2024 Sorted by Mortality (Range/Estimate) Influenza Mortality in the US is Similar to Breast Cancer, CRC, & All Blood Cancers3,4 46M – 81M Influenza illnesses 600K – 1.3M Influenza hospitalizations 0 20,000 40,000 60,000 80,000 100,000 120,000 140,000 CRC3Kidney disease5,6 Heme malignancies8 Breast7 RSV9 Influenza1 Influenza typically causes ~78K deaths/yr2 26K – 130K Influenza deaths
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8 No Existing Solution Offers Adequate Protection for At-risk Subjects Competitive Analysis 1https://www.cdc.gov/flu-vaccines-work/php/effectiveness-studies/index.html. Accessed 21OCT2024. 2https://tinyurl.com/9y3bh9f6; (last 3-years flu season average for any influenza infection in adults over 18). 3Hughes K, Middleton DB, Nowalk MP, et al. Effectiveness of Influenza Vaccine for Preventing Laboratory -Confirmed Influenza Hospitalizations in Immunocompromised Adults. Clin Infect Dis. 2021;73(11): e4353-e4360. 4Influenza VE in Elderly over 65 (https://tinyurlˌcom/2xt89p4c). Existing vaccines and antivirals have significant limitations Treatment Interventions Influenza Therapeutics and Vaccines Limitations Traditional Flu Vaccines • Widely available but low efficacy (~40% in healthy subjects) • Lower efficacy with strain mismatches and/or reduced health status Enhanced Vaccines • Modest efficacy improvements (~20% relative increase in efficacy) • At-risk groups remain exposed to flu infections and burden Antivirals • Effective only when initiated <48 hrs of diagnosis or exposure • Short half-life limits use for pre-exposure prophylaxis (PrEP)
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9 Broad Influenza Prophylaxis Preclinical Link to Manuscript for Additional Details: www.biorxiv.org/content/10.1101/2024.06.04.597465v3 Abbreviations: BXA, baloxavir acid; OST, oseltamivir carboxylate; ZAN, zanamivir. Cytopathic Effect Activity Versus Influenza Strain Panels
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10 CD388 Remains Active Against Resistant Strains Preclinical Studies 15 mice/group treated a single IM dose of CD388 2-hours after viral challenge. Zanamivir dosed IN once daily for 5-days starting 2-hours after infection. Survival monitored for 21 days. Abbreviations: IM, intramuscular; IN, intranasal; NA, neuraminidase; NAI, neuraminidase inhibitor. In Vitro Activity of CD388 and NAI Comparators vs NAI Resistant Strains Influenza Strain NA Genotype CD388 IC 50 [nM] Oseltasmivir IC 50 [nM] Zanamivir IC 50 [nM] A/Illinois/45/2019 (H1N1)pdm09 H275 1.30 0.3 0.19 A/Alabama/03/2020 (H1N1)pdm09 H275Y 0.98 426.8 0.16 B/Laos/0080/2016 H134 7.44 33.35 2.61 B/Laos/0654/2016 H134N 4.66 171.8 310.8 Influenza Strain Protective Dose (mg/kg), Lethal Challenge Model1 CD388 IC 50 [nM] Zanamivir IC 50 [nM] B/Laos/0080/2016 H134 (NAI-S) 0.3 1 B/Laos/0654/2016 H134N (NAI-R) 0.3 10 In Vivo Activity of CD388 vs Zanamivir >5X Shifts in NA inhibition IC50 or protective dose are highlighted in orange
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11 0 3 6 9 12 15 18 21 0 20 40 60 80 100 Days Post Infection % Survivial PBS OST (5 mg/kg, PO, BID x 5) BXM (15 mpk, PO, BID x 1) CD388 (1 mg/kg) Protect Immunocompromised Individuals Preclinical 1Treatment initiated 2 hours post viral challenge. A/Puerto Rico/8/1934(H1N1). Single IM dose. 2All treatments initiated 2 hours prior to viral challenge. A/Puerto Rico/8/1934(H1N1). For CD388, single IM dose. Abbreviations: IM, intramuscular; PBS, phosphate-buffered saline; BXA, baloxavir acid; OST, oseltamivir carboxylate; ZAN, zanamivir. CD388 demonstrated superior protection to human equivalent doses of baloxavir (BXM) and oseltamivir (OST) in Severe Combined Immunodeficient (SCID) mice Results suggest that CD388 will perform well in immunocompromised and at-risk populations Survival, SCID Mice2Survival, Immune Competent Mice1 0 3 6 9 12 15 18 21 0 20 40 60 80 100 Days Post Infection % Survivial PBS CD388 (1 mg/kg) CD388 (0.3 mg/kg)
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12 Target minimum efficacious concentration (1 µg/mL) from mouse lethal challenge prophylaxis models Clinical Data Support the Potential for a Single Seasonal Dose Safety Observations • No treatment-emergent serious adverse events • No study drug discontinuation or withdrawals due to safety • Most TEAEs Gr 1 (90%), few Gr 2, all resolved; incidence not dose-dependent • Few injection site events (pain, IM route mainly), Gr 1, all resolved spontaneously • Repeat dosing with 150 mg and 450 mg revealed no ADAs or hypersensitivity reactions • No clinically relevant ECG, vital signs, or physical exams PK / Activity • Single CD388 dose of 150 mg to 450 mg supports seasonal coverage • CD388 demonstrated protection in Ph 2a human challenge study: – Significantly reduced nasal viral load vs. placebo – Statistically significant lower incidence of qRT-PCR–confirmed influenza infection vs. placebo Clinical Data from First in Human Study (N=8 per arm) Abbreviations: ADA, anti-drug antibodies; ECG, electrocardiogram; Gr, grade; IM, intramuscular; PK, pharmacokinetics; qRT-PCR, quantitative reverse transcription PCR. CD388 has completed two Phase 1 studies and a Phase 2a study CD388 was well tolerated with potential for once per season dosing Single CD388 Dose Can Provide Seasonal Coverage Differentiation between doses expected near the end of the flu season
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13 CD388 Demonstrated Protection in Human Challenge Model Clinical: Ph 2a 1RT-PCR-confirmed influenza infection: 2 quantifiable [≥LLOQ] qRT-PCR measurements (reported on 2 or more independent samples over 2 days), from Day 1 (pm) up to Day 8 (am). 2RT-PCR- confirmed symptomatic influenza infection: RT-PCR-confirmed influenza infection (2 quantifiable [≥LLOQ] qRT-PCR measurements [reported on 2 or more independent samples over 2 days]), from Day 1 (pm) up to Day 8 (am), AND symptoms ≥2 at a single time point; 3RT-PCR-confirmed moderate to severe symptomatic influenza infection: RT-PCR confirmed influenza infection (2 quantifiable [≥LLOQ] qRT-PCR measurements [reported on 2 or more independent samples over 2 days]), from Day 1 (pm) up to Day 8 (am), AND any symptoms of grade ≥2 at a single time point. Abbreviations: AUC, area under curve; D, day; E, evening; LLOQ, lower limit of quantification; M, morning; qRT-PCR, quantitative reverse transcription PCR; VL, viral load. Endpoint Placebo N=28 CD388, 150 mg N=28 Placebo-adjusted efficacy qRT-PCR confirmed influenza infection1 14 (50%) 6 (21%) 57% qRT-PCR confirmed symptomatic influenza infection2 9 (32%) 4 (14%) 56% qRT-PCR confirmed moderately to severe symptomatic influenza infection 3 7 (25%) 3 (11%) 57% Mean VL From qRT-PCR Primary endpoint: AUC viral load-time_ qRT-PCR One-sided p-value Wilcoxon rank sum test: 0.0390 Mean (+/- CI 95%) - VL From qRT-PCR (log10 copies/mL) Visit / Timepoint Viral challenge Placebo CD388, 150 mg Mean – 95% Confidence interval
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14 CD388 Results May Underestimate Risk Reduction (RR) in Ph 2b Clinical: Ph 2a 1Hayden FG, et al. Oral oseltamivir in human experimental influenza B infection. Antivir Ther. 2000 Sep;5(3):205-13. PMID: 11075941. 2Welliver R, et al. Oseltamivir Post Exposure Prophylaxis Investigator Group. Effectiveness of oseltamivir in preventing influenza in household contacts: a randomized controlled trial. JAMA. 2001 Feb 14;285(6):748-54. doi: 10.1001/jama.285.6.748. PMID: 11176912. High inoculum intranasal administration vs. infection via aerosols and reduced disease severity in human challenge studies limit their potential for translation to real-world results. Abbreviations: qRT-PCR, quantitative reverse transcription PCR; SQ, subcutaneous. Prophylactic human challenge studies with neuraminidase inhibitors (NAIs) that achieve systemic exposure may underestimate performance in preventing symptomatic clinical influenza Prophylaxis Study Performance: Challenge Study Efficacy vs. Prevention of Lab-confirmed Symptomatic Influenza Ph 3 Study2 B PEP ≥12, ~15% vaccinated (75 mg daily x 7) Lab confirmed clinical influenza (37.2o C + 2 symptoms) 78.5 Ph 2b Study A(H1N1, H3N2) and B Healthy, 18-65, unvaccinated (150, 300, 450 mg single) Lab confirmed clinical influenza (38o C + 2 symptoms) Top-line data June ‘25 Challenge Study A(H3N2) Healthy, 18-65, unvaccinated (150 mg single) Lab confirmed infection (qRT PCR) 57 Challenge Study1 B Healthy, 18-65, unvaccinated (75, 150 mg daily x 7) Lab confirmed infection (Viral culture+) ~24 Strain Study Population (dose(s), # days) Primary Endpoint RR (%) Oseltamivir (Oral) CD388 (SQ Injection)
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15 CD388 NAVIGATE Trial Design* A Double-blind RCT of CD388 for Influenza Prophylaxis Clinical: Ph 2b Blinded, randomized, controlled trial of CD388 in 3 doses vs placebo as a single SQ administration to assess efficacy and safety of CD388 in prevention of influenza in subjects not at risk for influenza complications Primary Endpoint Preventive Efficacy (PE) = defined by all 3 criteria: • PCR-confirmed influenza • ≥2 respiratory or 1 respiratory and 1 systemic sign/symptom • Body temp ≥38o C Study Population Sites, N=58 • US, n=57 • UK, n=1 150 mg 300 mg 450 mg Placebo n=5000 across CD388 and placebo groups Study Size Generally healthy, unvaccinated adults aged 18-64 not at risk for complications of influenza R 1:1:1:1 *Ph 2b originally designed as dose-ranging trial without statistical significance testing to select optimal dose to advance to Ph 3. Abbreviations: PCR, polymerase chain reaction; RCT, randomized controlled trial; SQ, subcutaneous. First/Last Dosed Sep 2024/Dec 2024 (NCT06609460) Preventive Efficacy tells us the percentage by which a prevention method reduces the chance of getting sick compared to not using it
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16 Severity of 2024-25 Influenza Season Enabled Enhancement of Statistical Plan Clinical: Ph 2b Flu season runs from early October (shown as week 1, corresponding to epi week 40) to the end of May. Data Sources: CDC and Datawrapper. Abbreviations: ILI, influenza-like illness; MMWR, Morbidity and Mortality Week Report. 7.85 0 1 2 3 4 5 6 7 8 9 10 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 % of Visits for ILI MMWR Week 2002/2003 – 2023/2024 % of Visits to the Doctor for Fever and Cough or Sore Throat for 2024/2025 Flu Season 2024/2025 5,041 NAVIGATE Enrollment of 5,041 Subjects Achieved on Dec 3rd NAVIGATE enrollment curve Highest reported ILI since the 2009 H1N1 pandemic Peak rate of PCR-confirmed influenza = 31.6% of ILI
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17 Updated Statistical Plan Prioritizes Proof of Concept Testing Rationale • Primary efficacy (PE) analysis is now hierarchical and will start with the grouped dose analysis • If the grouped analysis is positive, all alpha will be recycled to the pair-wise analysis to look at each dose vs placebo (Hochberg step-up method) • If placebo attack rate is 2%, PE of 58% or greater will likely result in a positive result • If placebo attack rate is 3%, a PE of 50% or greater will likely result in a positive result Clinical: Ph 2b While maintaining ability to evaluate efficacy of individual doses Grouped Dose (300 mg + 450 mg) vs. Placebo 450 mg vs. Placebo 300 mg vs. Placebo 150 mg vs. Placebo 𝛼𝛼 = 0.05 𝛼𝛼 = 0.05 If positive, recycle Hochberg method for multiplicity orders the p-values from smallest to largest (most significant to least significant)
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18 What is the Bar for Success for Phase 2b? Clinical: Ph 2b Abbreviations: IC, immunocompromised; Ph, phase. CD388 is intended to be used in addition to seasonal vaccines; preventive efficacy >50% in any dose would be a success 10-20% 40% ≥50% 60 – 90%+ 0 20 40 60 80 100 Average Vaccine Efficacy in IC Population Average Vaccine Efficacy in General Population Clinically Meaningful Result in Ph 2b Potential Combined Efficacy with Vaccine
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19 Two randomized, well-controlled clinical trials for the approval of new antiviral drugs Regulatory Pathway Clinical: Ph 2b Abbreviations: Ph, phase; POC, proof of concept. • Collaborative and ongoing discussions continue with the FDA • Program granted Fast Track and Priority Review designations in 2023 • NAVIGATE as a blinded, randomized, placebo- controlled study may be eligible for one of two required adequate and well-controlled studies for FDA approval of Ph 3 population • Potentially expedites development program by 2-3 years and significantly lowers developmental expenses FDA Guidelines FDA guidance supports potential of Ph 2b trial to demonstrate POC and support registration of intended Ph 3 population Expedited Development Benefit
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20 CD388 Registrational Study Will Focus on Subjects with Highest Unmet Need Indications/Usage • Prevention of seasonal symptomatic influenza A and B in individuals at high- risk for complications of influenza • For use regardless of influenza vaccine status Clinical: Ph 3 1“Moderate” Includes HF (NYHA Class II – III), CAD (CAD-RADS 3), hypertensive heart disease, asthma (GINA Step 3), COPD (GOLD Stages 2 – 3), non-IPF ILDs, CKD (Stages 3a – 3b). “Severe” includes HF (NYHA Class IV), CAD (CAD-RADS 4 – 5), asthma (GINA Steps 4 – 5), COPD (GOLD Stage 4), IPF, CKD (Stage 4). 2“Moderate” includes primary immunodeficiency, secondary immunodeficiency (immunosuppressive therapy ≤12 months prior), solid tumors (recent Tx), hematologic malignancies (≤5 years prior), and SOT (≤5 years prior). “Severe” includes moderate-to-severe primary immunodeficiency, secondary immunodeficiency (active Tx), high dose corticosteroids (month prior), solid tumors (active Tx), hematologic malignancies (active Tx), CLL, NL, MM, acute leukemia (≤2 years prior), HSCT (≤2 years prior), SOT (≤2 years prior or on anti-rejection therapy). Strategy for the registrational study focuses on large populations with highest expected influenza burden Subjects with Moderate to Severe High-Risk Comorbidities1 Heart failure, heart disease High-risk COPD, asthma Advanced renal disease Moderate to Severe IC Status2: Solid tumors (recent chemotherapy) Hematologic malignancies Autoimmune diseases receiving certain therapies Solid-organ transplant receiving immunosuppressive therapy Primary & secondary immune deficiency Expected Registrational Study Populations
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21 *Not adjusted for overlap. Abbreviations: CV, cardiovascular; M, million. 1Compilation of CDC data and other sources - References available upon request. 2Total U.S. population of at-risk patients was segmented based on severity of comorbidities which is expected to correlate with risk of flu-related complications or negative outcomes. 3Prevalence values for asthma and IC are representative of the 12+ population, while all other segments are representative of the 18+ population. Note: Historical prevalence estimates were used to extrapolate to 2024. Mild includes CAD (CAD-RADS 1 – 2), asthma (GINA Steps 1 – 2), COPD (GOLD Stage 1), solid tumors (Dx ≤5 years prior or distant Tx). Moderate includes HF (NYHA Class II – III), CAD (CAD-RADS 3), hypertensive heart disease, asthma (GINA Step 3), COPD (GOLD Stages 2 – 3), non-IPF ILDs, CKD (Stages 3a – 3b), mild primary immunodeficiency, secondary immunodeficiency (immunosuppressive therapy ≤12 months prior), solid tumors (recent Tx) hematologic malignancies (≤5 years prior), and SOT (≤5 years prior). Severe includes HF (NYHA Class IV), CAD (CAD-RADS 4 – 5), asthma (GINA Steps 4 – 5), COPD (GOLD Stage 4), IPF, CKD (Stage 4), moderate-to-severe primary immunodeficiency, secondary immunodeficiency (active Tx), high dose corticosteroids (month prior), solid tumors (active Tx), hematologic malignancies (active Tx), CLL, NL, MM, acute leukemia (≤2 years prior), HSCT (≤2 years prior), SOT (≤2 years prior or on anti-rejection therapy). Defining the Populations at Greatest Risk from Influenza Addressable Market Select populations with >10X increase in influenza hospitalization rate1 Comorbidities: 61.1M IC: 4.8M 66% 34% CV 63% 38% Pulmonary 91% 9% Renal 54% 46% IC 100% Age 85+ 16.7M 23.2M 14.7M 4.8M3 6.5M Breakdown of At-Risk Population Based on Severity of Comorbidity and Level of Immunocompromised (IC) Status2 (U.S. 2024 Estimates) 2024 U.S. Prevalence (M) SevereModerate ~24.4M Severe* ~41.5M Moderate*
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22 Envisioned Ph 3 Study Design Focuses on Individuals at Highest Risk for Severe Complications from Influenza Clinical: Ph 3 *Ph 2b originally designed as dose-ranging trial without statistical significance testing to select optimal dose to advance to Ph 3. Abbreviations: PCR, polymerase chain reaction; RCT, randomized controlled trial; SQ, subcutaneous. Study Population CD388 Placebo Individuals at high-risk for complications of influenza and Immunocompromised Individuals R 1:1 Primary Endpoint • Laboratory-confirmed influenza and • Two or more symptoms of influenza [cough, sore throat, nasal congestion, T ≥ 37.2C (99F), headaches, fatigue, or body aches] or • Worsening of two or more baseline symptoms n=5000 to 7000 subjects to run over 2-3 Influenza seasons Statistical assumptions: 90% power, 1.5% placebo attack rate, 10% loss to follow up Interim analysis after 1 st flu season to trigger sample size increase if needed
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23 Precedent Antivirals Suggest Efficacy for CD388 Should Be Maintained When Moving from Ph 2b to Ph 3 Population Clinical: Ph 3 *10-mg dose is provided by 2 inhalations (one 5-mg blister per inhalation). 1Tamiflu Prescribing Information. 2Relenza Prescribing Information. 3Xofluza Prescribing Information. 4N Engl J Med 2020;383:309-20. DOI: 10.1056/NEJMoa1915341. Flu antivirals demonstrate that no dose adjustment required for efficacy in high-risk populations TAMIFLU (oseltamivir)1 RELENZA (zanamivir)2 XOFLUZA (baloxavir)3,4 Dosing for General Population Prevention in subjects ≥1 years (community outbreaks) 75 mg once daily for 6 weeks Prevention in subjects ≥5 years (community outbreaks) 10 mg once daily for 28 days* Prevention in subjects ≥5 years (household contacts) 80 mg tablet (adults) Dosing for High-Risk Population Prevention in nursing homes 75 mg once daily for 6 weeks Prevention in high-risk subjects 10 mg once daily for 28 days* Prevention in high-risk subjects 80 mg tablet (adults)
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24 2025 2026 2027 2028 2029 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 J A S O N D J F M A M J J A S O N D J F M A M J J A S O N D J F M A M J J A S O N D J F M A M J J A S O N D Ph 3 Study Timeline Offers Path to Regulatory Approval in Two Populations with Highest Unmet Need Clinical: Ph 3 As a risk mitigation of a less severe influenza season, we will plan a contingency third season (SH ‘26). Abbreviations: BLA, Biologics License Application; IC, immunocompromised; NH, Northern Hemisphere (Oct. to Mar.); SH, Southern Hemisphere (Apr. to Sep.). NH SH Influenza season Interim analysis output Base Case: Regular approval for High Risk and IC High-Risk + IC N=5000-7000 Interim Analysis to trigger sample size increase in NH season BLA prep, submission and review (Fast Track)
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25 16.7 23.2 14.7 4.8 6.5 (in Millions) CD388 Patient and Physician Segmentation Strategies for Commercial Effectiveness • Focus initially on segments with greatest concentration (e.g., CV / Pulm) • Target high-decile physicians and group practices • Standardized procedures for high-risk patient identification and CD388 use • Endorsement from physician societies and other influential organizations • Co-promotional relationships for CD388 and/or partner products Commercial Strategy and Opportunity for CD388 *Source: ClearView Partners. †Total for each physician segment includes all physicians as reported by the AMA (2023) and is NOT adjusted for active prescribers or prescriber concentration. Abbreviations: CV, cardiovascular; IC, immunocompromised; Pulm, pulmonary; M, million. Commercial execution will focus on a subset of the total market opportunity given the diverse customer base Patients CV Pulmonary Renal IC Age 85+ 65.9M 23 5 12 18 7 6.5 (in Thousands) Cardiology Pulmonology Nephrology Rheumatology Geriatrician 71.5K Heme/Onc Physicians† Patient and Physician Segmentation Moderate to Severe Comorbidities and IC Status* Cardiology and pulmonology alone represent ~40M high-risk patients in the US
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26 Specialist HCPs Acknowledge the High Importance of Their Role in Preventing Flu in High-Risk Patients Commercial Strategy and Opportunity for CD388 1Physicians were asked to rate the absolute importance of preventing flu in their specific patient population classified by severity. “Mild” includes CAD (CAD-RADS 1 – 2), asthma (GINA Steps 1 – 2), COPD (GOLD Stage 1), solid tumors (Dx ≤5 years prior or distant Tx), and CKD (Stages 1 and 2). “Moderate” includes HF (NYHA Class II – III), CAD (CAD-RADS 3), hypertensive heart disease, asthma (GINA Step 3), COPD (GOLD Stages 2 – 3), non-IPF ILDs, CKD (Stages 3a – 3b), mild primary immunodeficiency, secondary immunodeficiency (immunosuppressive therapy ≤12 months prior), solid tumors (recent Tx) hematologic malignancies (≤5 years prior), and SOT (≤5 years prior). “Severe” includes HF (NYHA Class IV), CAD (CAD-RADS 4 – 5), asthma (GINA Steps 4 – 5), COPD (GOLD Stage 4), IPF, CKD (Stage 4), moderate-to-severe primary immunodeficiency, secondary immunodeficiency (active Tx), high dose corticosteroids (month prior), solid tumors (active Tx), hematologic malignancies (active Tx), CLL, NL, MM, acute leukemia (≤2 years prior), HSCT (≤2 years prior), SOT (≤2 years prior or on anti-rejection therapy). Abbreviations: HCP, healthcare professional. Source: Physician Interviews; ClearView Partners. 4.0 4.2 3.0 3.4 4.8 4.6 4.8 4.5 5.0 0 1 2 3 4 5 Cardiology (n=6) Pulmonology (n=6) Nephrology (n=4) IC (n=5) Geriatrician (n=2) HCP Perception of the Absolute Importance of Preventing Flu in Their At-Risk Patients, Segmented by Severity, on a Scale of 1 – 5 (N=23)1 Moderate/SevereMild HCP Perception of Importance of Their Role in Preventing Influenza Infection in Their High-Risk Patients vs. Role of Other Stakeholders, on a Scale of 1 – 5 (N=23) 4.8 Specialist (Respondent) 4.4 PCP/IM 2.9 Other Specialists 3.5 Pharmacists ~80% of specialist reported stocking and administering flu vaccines in their clinics or at adjacent centers
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27 HCPs Expect to Recommend CD388 to Majority of Their High-Risk Patients with Strong Patient Acceptance Target Physicians Can Be Successfully Engaged to Generate Demand for CD388 1Raw recommendation rates were down-adjusted by 15% to account for typical physician overstatement. 2Excluded N=1 cardiologist given perception of flu prophylaxis as being outside of their purview and N=1 rheumatologist given expectation of use only in unvaccinated patients. 3HCP recommendation rate for IC is average of the two TPP scenarios tested. Abbreviations: IC, immunocompromised. MI, myocardial infarction. Source: Physician Interviews; ClearView Partners. Quotes from HCP Research 80% 67% 53% 41% 73% 68% 67% 64% 96% 79% 0 25 50 75 100 Cardiologist (n=5)2 Pulmonologist (n=6) Nephrologist (n=4) Age 85+ (n=2) IC (n=4)2,3 Hcp rec rates adjusted downward for overstatement1 HCP Recommendation Rate for CD388 in Moderate and Severe Populations and HCP-Estimated Patient Uptake of CD388 in Those Recommended (N=23) Recommendation Rate and Patient Uptake of CD388 (%) HCP-Estimated Patient Uptake of CD388 in Those Recommended HCP Recommendation Rate There is a five-to-six-fold increase rate of MI several weeks from initial flu infection in older cardiac patients. ” –Cardiologist Patients more at risk are those on biologics or a PDE inhibitor for moderate to severe COPD or asthma. ” –Pulmonologist If current vaccines are only 30 – 50% then this is a lot better, and I would strongly recommend this to my patients. ” –Cardiologist This product looks promising, and I would love to see it used in my dialysis patients who could definitely benefit. ” –Nephrologist
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28 Opportunity for Favorable Pricing and Access CD388 Pricing and Access Levers1 • Payer acknowledgement of significant burden • Favorable US payer response to reduction in symptomatic influenza • Reduction in medical resource use with US payer acceptance of post-marketing studies • Streamline access with endorsement from physician societies and/or other organizations • Medical benefit access (office administration) • Feasibility of demonstrating evidence in high-risk subjects sufficient for ex-US markets Commercial Strategy and Opportunity for CD388 Source: Payer Interviews; ClearView Analysis. Abbreviations: ACIP, Advisory Committee on Immunization Practices; IC, immunocompromised; MCO, Managed Care Organization. MCO Payer Perception of the Burden of Influenza (N=5) Flu burden is high in patients who have comorbidities, particular cardiac and respiratory diseases, and ages 65 and older as this often leads to complications and will require further medical care. ” – MCO Med. Dir. Clinical Burden Low High Economic Burden Patients with Moderate-to-Severe Comorbidities Clinical Burden Low High Economic Burden Patients with Moderate-to-Severe IC Status
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29 US Commercial Payers Expect to Cover CD388 at Attractive Pricing Corridors Without Significant Restrictions Commercial Strategy and Opportunity for CD388 Source: Payer Interviews; ClearView Analysis. *Payers are subject to market research bias and tend to overstate expected restrictiveness and/or posture in discussions. As a result, it is expected that higher price points would be required to result in the restrictions illustrated in this slide. The payer feedback reported in this slide has NOT been adjusted to account for the expected bias. Abbreviations: IC, immunocompromised; MCO, Managed Care Organization; PA, physician assistant. MCO Payer Management Expectations Based on Pricing Corridors (N=5)* Price (one administration for season-long protection): $0 $250 $500 $750 $1,000 $1,250 I don’t think a price at ~$560 or below is worth enforcing a prior authorization given the associated costs and bandwidth for review. ” – MCO Med. Dir. Anything above ~$560 we would have a PA to label just making sure there is documentation of comorbidity/IC status as well as the frequency of use. ” – MCO Med. Dir. Some Restrictions ($560 – $1,000) Utilization limits (1x/yr), physician attestation, and/or PA to label* Few, if Any, Restrictions ($0 – $560) Utilization limits (1x/yr) Significant Restrictions (>$750) Utilization limits (1x/yr), physician attestation, PA to trial, and/or specialist Rx* If the price increases above $750, we expect to enforce PA to clinical trial and may be restricted to medical exception at $5,000. ” – MCO Med. Dir.
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30 CD388 Commercial Success Does Not Rely on ACIP Endorsement Commercial Strategy and Opportunity for CD388 Cidara’s Strategy Anchors on Engaging Specialists and Related Medical Societies to Generate CD388 Demand in High-Risk Subjects Advisory Committee on Immunization Practices (“ACIP”) • Chartered under the Public Health Service Act for immunization recommendations • Leverages the Evidence-to-Recommendation framework (“EtR”) including cost-effectiveness • Includes active immunization (e.g., vaccines) OR passive immunization (e.g., antibodies) – Primarily focused on products for general populations that can be administered by pharmacists without a physician consult Key Features of CD388 and Cidara’s Commercial Strategy • As a long-acting antiviral Rx drug, CD388 is neither active nor passive immunization – No known precedent for ACIP review of antiviral drugs for influenza • Cidara strategy focuses on specific high-risk subjects managed by specialists • Opportunity for Cidara to collaborate with multiple organizations to develop recommendations for CD388 use in high-risk subjects – Ex: Infectious Disease Society of America (IDSA), American Society of Nephrology (ASN), American College of Cardiology
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31 Influenza Protection: A Multibillion-dollar Opportunity Addressable Market *CD388 Initial Positioning. 1Analog products for PrEP include nirsevimab (RSV long-acting mAb), oseltamivir (influenza antiviral), and pemivibart (COVID long-acting mAb). Abbreviations: PrEP, pre-exposure prophylaxis. Large Unmet Need in Specific At-risk Populations • Significant flu burden despite existing antivirals and vaccines Well-defined Populations Managed by Specialists • ~50M subjects with high-risk comorbidities or immunocompromised status in the US reachable via specialists CD388 Is Designed To Complement Vaccines • Combines long-acting neuraminidase antiviral activity with vaccine-induced antibodies Opportunity for Favorable Pricing and Market Access • Analogs indicate price points >$500 for antiviral PrEP for at-risk populations with access in physician clinics and pharmacies1 ~50 million at-risk subjects accessible via specialists with opportunity for favorable pricing and market access Target Population (US, Millions) Price Range ($ per dose) At-risk ~50M General >300M Vaccines $6-8B US Market CD388* >$5B US Market Opportunity Higher >$500 Lower <$80
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32 Financials Leadership & Financial Foundations 1As of March 31, 2025. 214,330,750 shares of common stock issuable upon the conversion of 204,725 shares of Series A Convertible Voting Preferred Stock. Each share of Series A Convertible Voting Preferred Stock is convertible into 70 shares of common stock. 3487,604 shares of common stock issuable upon the conversion of 975,208 Series X Convertible Preferred stock. Each share of Se ries X Convertible Preferred is convertible into 0.5 shares of common stock. 4Fully Diluted Common Shares Outstanding is the sum of common shares outstanding, Series A Convertible Voting Preferred Stock (as converted), Series X Convertible Preferred stock (as converted), common stock options, RSUs, and warrants issued and outstanding, and pre-funded warrants to purchase common stock (as exercised). 5Based on CDTX closing stock price as of March 31, 2025. Implied fully diluted market is obtained by multiplying CDTX’s closing stock price on March 31, 2025, by fully diluted common shares outstanding. Balance Sheet InformationCapital Structure 32,672,688 Fully Diluted Common Shares Outstanding4 12,209,150 Common Shares Outstanding1 487,604 Series X Convertible Preferred Stock (as converted)1,3 3,152,343 Common stock options, RSUs, PRSUs, warrants issued and outstanding 1 14,330,750 Series A Convertible Voting Preferred Stock shares of Common Stock issuable upon conversion 1,2 2,492,841 Pre-funded warrants to purchase Common Stock at an exercise price of $0.0001 per share outstanding 1 $703.8M Implied Fully Diluted Equity Value / Market Cap5 $174.5M Cash and Cash Equivalents1 $0 Debt $21.54 Closing stock price1
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33 Near-term Milestones Leadership & Financial Foundations Abbreviations: 2H, second half; EOP2, end of phase 2; Ph, phase; Q, quarter. 2024 2025 2026 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun NAVIGATE Trial Total N=5000 US=4,000 (57 Sites), UK=1,000 (1 Site) 12.4: Enrollment complete Database lock 5.22: Investor Day Top line data expected 2H Jun FDA EOP2 meeting Sep: Ph 2b NAVIGATE initiated Investor Day key topics • 2024/25 flu season and implications for the NAVIGATE Ph 2b study • Updates on Ph 3 timing and trial design • Commercial opportunity assessment for Ph 3 target populations 2024/25 Flu Season Planned Phase 3 Southern Hemisphere
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34 CD388 34 A Vision for the Future of Influenza Protection