Group 1 - Cidara Therapeutics, Inc. (CDTX) has reached a key level of support and is showing potential for a bullish breakout due to a "golden cross" formation, where the 50-day simple moving average has crossed above the 200-day simple moving average [1] - The golden cross indicates a positive trend reversal after a downtrend, consisting of three stages: a downtrend, the crossover of moving averages, and continued upward momentum [1] - CDTX has experienced a significant price increase of 44% over the last four weeks, suggesting a potential breakout [2] Group 2 - The earnings expectations for CDTX have improved, with changes higher compared to none lower over the past 60 days, indicating a positive outlook [2][3] - The Zacks Consensus Estimate for CDTX has also moved up, reinforcing the bullish sentiment among investors [3] - The current technical indicators and positive earnings revisions suggest that investors may want to monitor CDTX for further gains in the near future [3]

Group 1 - Cidara Therapeutics (NASDAQ: CDTX) is advancing its drug-FC conjugate (DFC) utilizing the proprietary Cloudbreak technology platform [2] - The DFC molecules are designed to inhibit the proliferation of targeted pathogens, showcasing the potential of the Cloudbreak platform in drug development [2] Group 2 - The Biotech Analysis Central service offers extensive resources for healthcare investors, including a library of over 600 biotech investing articles and a model portfolio of small and mid-cap stocks [2]

Core Viewpoint - Cidara Therapeutics reported its third-quarter financial results and provided updates on its clinical programs, particularly focusing on the CD388 candidate for influenza prevention, while also announcing organizational changes to enhance resource efficiency [1][2][3]. Corporate Highlights - The initiation of the Phase 2b NAVIGATE clinical trial for CD388 marks a significant milestone, aiming to evaluate its efficacy and safety for seasonal influenza prevention [2][3]. - The trial will enroll 5,000 healthy, unvaccinated adults, comparing the rates of influenza between those receiving CD388 and a placebo [3]. - Positive data from previous studies were presented at conferences, indicating CD388's potential for effective prevention with a single dose [3]. - The Scientific Advisory Board was strengthened with four experts in infectious diseases to support the CD388 trial [3]. - A workforce reduction of approximately 30% was implemented to focus on CD388's clinical development, expected to lower capital needs [3]. Financial Results - As of September 30, 2024, cash and cash equivalents were $127.4 million, a significant increase from $35.8 million at the end of 2023 [4][10]. - Revenue for the third quarter was zero, down from $9.2 million in the same period of 2023, primarily due to the termination of the collaboration agreement with Janssen [4]. - Research and development expenses increased to $12.4 million for the third quarter, compared to $10.4 million in 2023, driven by costs associated with the CD388 trial [4]. - The net loss for the third quarter was $16.0 million, compared to a net loss of $9.1 million in the same period of 2023 [4][9]. - Total assets as of September 30, 2024, were $162.3 million, up from $67.0 million at the end of 2023 [10].

Financial Performance - Revenue was zero for the three months ended September 30, 2024, and $1.3 million for the nine months ended September 30, 2024, compared to $9.2 million and $20.5 million for the same periods in 2023, respectively [3]. - Net loss for the three and nine months ended September 30, 2024, was $16.0 million and $117.5 million, respectively, compared to a net loss of $9.1 million and $19.7 million for the same periods in 2023 [5]. - Total revenues for the three months ended September 30, 2024, were $0, compared to $9,217,000 for the same period in 2023, representing a decrease of 100% [10]. - The net loss for the three months ended September 30, 2024, was $15,985,000, compared to a net loss of $9,107,000 in 2023, indicating a widening of 75.5% [10]. - Basic and diluted net loss per common share from continuing operations was $(2.38) for the three months ended September 30, 2024, compared to $(0.85) in 2023 [10]. - Basic and diluted net loss per common share for the nine months ended September 30, 2024, was $(22.61), compared to $(3.91) in 2023, indicating a significant increase in losses [10]. Expenses - Research and development expenses were $12.4 million for the three months ended September 30, 2024, compared to $10.4 million for the same period in 2023, primarily due to higher expenses associated with the CD388 Phase 2b NAVIGATE study [3]. - Selling, general and administrative (SG&A) expenses were $5.0 million for the three months ended September 30, 2024, compared to $3.3 million for the same period in 2023 [3]. - Total operating expenses for the three months ended September 30, 2024, were $17,394,000, compared to $13,685,000 in 2023, marking an increase of 27.5% [10]. - Research and development expenses increased to $12,429,000 for the three months ended September 30, 2024, up from $10,386,000 in 2023, reflecting a growth of 19.7% [10]. - Acquired in-process research and development expenses were $84.9 million for the nine months ended September 30, 2024, related to an upfront payment of $85.0 million paid to Janssen under the Janssen License Agreement [3]. Cash and Assets - Cash and cash equivalents totaled $127.4 million as of September 30, 2024, compared to $35.8 million as of December 31, 2023 [3]. - Cash and cash equivalents as of September 30, 2024, were $127,386,000, significantly up from $35,778,000 as of December 31, 2023, showing an increase of 255.5% [11]. - Total assets increased to $162,331,000 as of September 30, 2024, compared to $67,030,000 at the end of 2023, representing a growth of 142.5% [11]. - Total liabilities decreased to $46,701,000 as of September 30, 2024, down from $75,240,000 at December 31, 2023, reflecting a reduction of 37.9% [11]. - Total stockholders' equity improved to $115,630,000 as of September 30, 2024, compared to a deficit of $8,210,000 at December 31, 2023 [11]. Clinical Development - Cidara initiated a Phase 2b NAVIGATE trial targeting enrollment of 5,000 healthy, unvaccinated adult subjects for CD388, with subjects being followed for the remainder of the influenza season [1]. - Cidara's lead DFC candidate, CD388, received Fast Track Designation from the FDA in June 2023, and the company announced the initiation of a Phase 2b trial in September 2024 [7]. - Cidara restructured its workforce with an approximate 30% reduction to focus on the clinical development of CD388 [2]. Discontinued Operations - The sale of rezafungin assets to Napp Pharmaceutical Group Limited is classified as discontinued operations, with a net loss from discontinued operations of $0.5 million for the three months ended September 30, 2024 [5].

Drug Development and Clinical Trials - The company reacquired all rights to develop and commercialize CD388, a drug-Fc conjugate for influenza prophylaxis, through a license and technology transfer agreement with Janssen, resulting in a fee-bearing but royalty-free license[112]. - CD388 has completed two Phase 1 studies and one Phase 2a study, with the Phase 2b NAVIGATE study initiated in September 2024[115]. - The Phase 2a study showed that 21% of subjects receiving CD388 (150 mg) experienced RT-PCR-confirmed influenza infection compared to 50% in the placebo group, with a p-value of 0.0248[123]. - CD388 demonstrated a well-tolerated profile up to a maximum dose of 900 mg, with no serious adverse events reported[117]. - The U.S. FDA granted Fast Track designation to CD388 for preventing influenza A and B in high-risk adults, facilitating expedited development and review[115]. - CD388 is projected to provide seasonal influenza prevention with an extended half-life of 6-8 weeks, as demonstrated in Phase 1 studies[124]. - The oncology DFC candidate CBO421 targeting CD73 received IND clearance in July 2024, although no clinical trials for oncology products are planned at this time[114]. - CBO421, a CD73 inhibitor, received IND clearance in July 2024 and aims to enhance treatment for solid tumors, particularly triple negative breast cancer[128]. - CD388 Phase 2b NAVIGATE study initiated with a target enrollment of 5,000 subjects in the US and UK, with topline data expected in Q3 2025[127]. - The company does not plan to initiate new clinical trials for oncology products at this time but is in discussions for business development in oncology DFC programs[130]. Financial Performance and Funding - As of September 30, 2024, the company reported an accumulated deficit of $559.0 million and cash and cash equivalents of $127.4 million, expected to last through mid-Q4 2025[134]. - Total research and development expenses for Q3 2024 were $12.4 million, an increase from $10.4 million in Q3 2023[139]. - The company plans to fund ongoing operations through cash reserves and potential future equity offerings, with no assurance of additional funding availability[134]. - The company has experienced net losses and negative cash flows since inception, impacting its ability to generate future revenues[135]. - Collaboration revenue was $0 for the three months ended September 30, 2024, down from $9.2 million for the same period in 2023, due to the termination of the Janssen Collaboration Agreement[148]. - For the nine months ended September 30, 2024, collaboration revenue was $1.3 million, a decrease of $19.3 million from $20.5 million in 2023[155]. - Acquired in-process research and development expenses totaled $84.9 million for the nine months ended September 30, 2024, related to an upfront payment under the Janssen License Agreement[156]. - Research and development expenses for the nine months ended September 30, 2024, were $25.0 million, down from $28.8 million in 2023, mainly due to lower nonclinical expenses[157]. - Selling, general and administrative expenses increased to $13.3 million for the nine months ended September 30, 2024, compared to $10.1 million in 2023[158]. - Other income, net for the nine months ended September 30, 2024, was $3.998 million, an increase from $1.468 million in 2023, primarily from interest income[159]. - Net cash used in operating activities was $147.1 million for the nine months ended September 30, 2024, compared to $9.7 million for the same period in 2023, driven by a net loss of $117.5 million[165]. - Net cash provided by financing activities was $238.9 million for the nine months ended September 30, 2024, primarily from the sale of 240,000 shares of Series A Convertible Voting Preferred Stock[167]. - Cash and cash equivalents at the end of the period were $127.4 million as of September 30, 2024, up from $48.7 million at the end of September 2023[164]. - The company has no outstanding loan balances as of September 30, 2024[162]. - The company plans to continue funding its operations through cash on hand and potential future equity offerings or debt financings[169]. Corporate Actions and Market Conditions - A reverse stock split of 1-for-20 was approved to regain compliance with Nasdaq listing requirements, effective April 23, 2024[131]. - The stock market for pharmaceutical and biotechnology companies has seen significant declines, affecting the company's stock price[132]. - A workforce reduction of 20 employees, approximately 30% of the workforce, was completed by November 1, 2024, expected to reduce capital needs related to personnel costs[162]. - The company lost its Form S-3 eligibility for primary and secondary offerings until at least April 16, 2025, due to a failure to timely file its Annual Report[162]. Operational Results - Selling, general and administrative expenses rose to $5.0 million for the three months ended September 30, 2024, up from $3.3 million in 2023, driven by higher audit fees and legal costs[150]. - Loss from discontinued operations was $0.5 million for the three months ended September 30, 2024, a significant improvement from a loss of $5.3 million in the same period in 2023[153]. - Income from discontinued operations was $0.4 million for the nine months ended September 30, 2024, compared to a loss of $2.8 million in 2023, reflecting a positive shift in financial results[154]. - Income from discontinued operations was $0.4 million for the nine months ended September 30, 2024, primarily from $29.3 million in revenue related to the sale of rezafungin assets[161]. - Total net cash used in operating activities from discontinued operations was $18.1 million for the nine months ended September 30, 2024, compared to $9.3 million for the same period in 2023[168].

Core Insights - Cidara Therapeutics is presenting clinical data on its influenza drug-Fc conjugate candidate, CD388, at the OPTIONS XII conference, highlighting its safety and pharmacokinetic data [1][2] Group 1: Clinical Data Presentations - An oral presentation will summarize safety data from three clinical trials involving 108 subjects, showing no treatment-emergent adverse events related to dose or administration route, supporting further studies for single-dose prevention of seasonal influenza [3] - A poster presentation will cover pharmacokinetics and safety data from 27 healthy Japanese volunteers, indicating low-to-moderate variability in PK parameters and no significant adverse events, supporting further studies in the Japanese population [4] Group 2: Product Overview - CD388 is an investigational drug-Fc conjugate designed to provide universal protection against seasonal and pandemic influenza with a single administration, functioning as a long-acting small molecule inhibitor [5] - The drug is not reliant on an immune response, making it potentially effective for individuals regardless of immune status [5] Group 3: Company Background - Cidara Therapeutics utilizes its Cloudbreak® platform to develop drug-Fc conjugates, with CD388 being the lead candidate aimed at achieving universal prevention of influenza [6] - The company received Fast Track Designation from the FDA for CD388 and plans to advance it into a Phase 2b trial in the 2024 Northern Hemisphere influenza season [6]

SAN DIEGO, Sept. 23, 2024 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced the first subjects dosed in the Phase 2b NAVIGATE trial to evaluate the efficacy and safety of CD388 for the pre-exposure prophylaxis of influenza during the current flu season. The Phase 2b clini ...

SAN DIEGO, Sept. 19, 2024 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced the appointment of Rick Bright, Ph.D., Philip Krause, M.D., Mario Barro, Ph.D., and Frederick G. Hayden, M.D., FACP to its Scientific Advisory Board (SAB). "We are honored that these four esteemed ...

SAN DIEGO, Sept. 12, 2024 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced a reduction in its workforce to focus on the clinical development of CD388, the Company's novel DFC candidate for influenza A and B. The planned reduction impacts approximately 30% of the Cidara w ...

SAN DIEGO, Aug. 19, 2024 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced that Jim Beitel, MBA, has joined the company as its Chief Business Officer ("CBO"). Following recent transactions, Cidara is focused exclusively on advancing its Cloudbreak DFC pipeline, which prov ...