Cidara Therapeutics, Inc.

SAN DIEGO, Oct. 16, 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 two upcoming presentations at IDWeek 2024, to be held October 16–19, 2024 in Los Angeles, CA. The presentations will highlight clinical data on the safety, pharmacokinetics, and prophylactic activity of Cidara’s clinical-stage influenza DFC asset, CD388. “We are pleased to share these clinical results at this year’s IDWeek, which underscore the potential for CD388 as an effective and well-tolerated DFC for single-dose, season-long prevention of influenza,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “We hope to share the results of our ongoing NAVIGATE Phase 2b clinical trial of CD388 at next year’s meeting.” Oral Presentation Title:CD388, a Novel Drug-Fc Conjugate (DFC), Demonstrates Prophylactic Activity in an Influenza Human Challenge Model Presenter:Taylor Sandison, MD, MPH, Cidara TherapeuticsSession:Inhaling Insight: Advancements in Respiratory Viral InfectionsSession Location:408ADate/Time:Saturday, October 19, 2:21–2:39 PM Pacific Time (PT)Summary:An analysis was conducted to determine prophylactic activity of CD388 against influenza disease in a Phase 2a human challenge study. The study found that a single subcutaneous dose of CD388 administered 5 days prior to influenza challenge was effective in preventing symptomatic disease among those who demonstrated seroconversion following influenza challenge. Poster and Rapid-Fire Presentation: Title:Single-Dose and Repeat Single-Dose Ascending Dose Study Evaluating Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Intramuscular CD388, a Novel Long-acting Drug-Fc Conjugate for Universal Prevention of Seasonal and Pandemic InfluenzaPresenter:Shawn Flanagan, Ph.D., Cidara TherapeuticsSession:Novel AgentsSession Location:Halls JKDate/Time:Friday, October 18, 2024, 12:15–1:30 PM (12:15 - 12:45 for rapid fire presentation) PTSummary:The safety, tolerability, and pharmacokinetics (PK) of CD388 were evaluated in healthy subjects administered either intramuscularly or subcutaneously with varying dosages of the drug. Absorption of CD388 was rapid both intramuscularly and subcutaneously, and elimination was slow, indicating that seasonal influenza prevention could be achieved with one dose per season. There was a lack of anti-drug antibody formation with repeat administration, supporting annual use of CD388, and no safety concerns were noted. About CD388CD388 is an investigational drug-Fc conjugate (DFC) comprised of multiple copies of a potent small molecule neuraminidase inhibitor stably conjugated to a proprietary Fc fragment of a human antibody. DFCs are not vaccines or monoclonal antibodies but are low molecular weight biologics which are designed to function as long-acting small molecule inhibitors. CD388 was designed to provide universal protection against all known strains of seasonal and pandemic influenza with the potential to provide season-long protection with a single subcutaneous or intramuscular administration. Importantly, because CD388 is not a vaccine, its activity is not reliant on an immune response and thereby is expected to be efficacious in individuals regardless of immune status. More information can be found at: https://www.cidara.com/cloudbreak/influenza/. About Cidara TherapeuticsCidara Therapeutics is using its proprietary Cloudbreak® platform to develop novel drug-Fc conjugates (DFCs) comprising targeted small molecules or peptides coupled to a proprietary human antibody fragment (Fc). Cidara’s lead DFC candidate, CD388, is a long-acting antiviral designed to achieve universal prevention of seasonal and pandemic influenza with a single dose by directly inhibiting viral proliferation. In June 2023, CD388 was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA), and the Company announced initiation of a Phase 2b trial in September 2024. Additional DFCs have been developed for oncology and in July 2024 Cidara received IND clearance for CBO421 which is intended to target CD73 in solid tumors. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com. Forward-Looking StatementsThis release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “expect,” “may,” “believe,” “plan,” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to plans and timing for initiating a Phase 2b clinical trial for CD388 and whether the safety and pharmacokinetic data observed in clinical trials to date will be confirmed with larger studies in different patient populations. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, such as unanticipated delays in or negative results from Cidara’s preclinical or clinical trials, unanticipated impacts of the workforce reduction, difficulties in obtaining potential partners or other obstacles to clinical development. These and other risks are identified under the caption “Risk Factors” in Cidara’s most recent Quarterly Report on Form 10-Q and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise. INVESTOR CONTACT:Brian RitchieLifeSci Advisors(212) 915-2578britchie@lifesciadvisors.com MEDIA CONTACT:Michael FitzhughLifeSci Communicationsmfitzhugh@lifescicomms.com

Following the restructuring news, Shattuck’s stock was down by 44.99% at market close on 1 October, compared to market close on the previous day. Shutterstock: paper cut design / Shutterstock. Shattuck Labs has dropped by nearly 45% after it announced plans to reduce its headcount and discontinue its lead cancer therapy programme, SL-172154. The restructuring decision was made after interim data from a Phase Ib trial (NCT05275439) showed a lack of a definitive overall survival (OS) benefit in patients receiving SL-172154. The company added that the ‘modest’ improvements in the OS seen in Phase I would likely erode in larger late-stage studies. Following the announcement, Shattuck’s stock was down by 44.99% at market close on 1 October, compared to market close on the previous day. The company’s market cap currently stands at $81.6m. SL-172154 is a cluster of differentiation 47 (CD47) inhibitors, which were investigated as a treatment for myelodysplastic syndrome (MDS) and acute myeloid leukaemia (AML). In February, Shattuck licensed out multiple potential drug candidates, including SL-172154, to Ono Pharmaceuticals in a deal worth more than $227m. As part of the restructuring, the companies have mutually terminated the agreement and Shattuck is “no longer required to satisfy any remaining performance obligations and will not receive any future research activity reimbursements or upfront, milestone, or royalty payments from Ono”. See Also: ImmunoPrecise and Biotheus partner on bispecific antibodies to treat cancer Novaliq and Laboratoires Théa announce EC approval for dry eye disease therapy The cost-saving measures also cull 40% of the workforce by the end of the year and will cost between $1.5m and $1.75m. Shattuck reported cash reserves of $105.3m as of 30 June, as per the latest SEC filing by the company. The company plans to funnel its remaining resources into developing its antibody therapy, SL-325. The DR3 antagonist acts by modulating adaptive immunity, as DR3 is expressed on the cell surface of various immune cells. Shattuck is developing SL-325 as a treatment for inflammatory autoimmune diseases, including inflammatory bowel disease (IBD). The company plans to file an investigational new drug application (IND) for SL-325 in Q3 2025. Shattuck noted that it has sufficient funds to finance beyond its planned Phase I clinical trial of SL-325 and into 2027. Following the recent round of lay-offs, Shattuck joins the list of pharmaceutical companies, including Atreca , Candel Therapeutics , Cidara Therapeutics , Kinnate Bio , and NexImmune , which have cut their workforces to reallocate funds into their clinical development pipelines in the last few months.

SAN DIEGO, Sept. 25, 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 two presentations at OPTIONS XII for the Control of Influenza conference, to be held September 29 through October 2, 2024 in Brisbane, Australia. The presentations, one oral and one poster, will highlight safety and pharmacokinetic (PK) data from clinical studies of CD388, Cidara’s influenza drug-Fc conjugate (DFC) candidate. “We are pleased to have the opportunity to present at this year’s OPTIONS XII conference and share the clinical data on our universally active influenza preventative, CD388,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “These data support the safety of CD388 administered over a range of doses via multiple routes of administration. Moreover, the pharmacokinetic data support the potential use of CD388 in immune compromised as well as immune competent populations to provide season-long protection against influenza A and B.” Oral PresentationTitle: Safety Data from Phase 1 and Phase 2a Studies of CD388, a Drug Fc-conjugate for Seasonal Pan-Influenza ProphylaxisPresenter: Taylor Sandison, MD, MPH, Chief Medical Officer, Cidara Therapeutics Date/Time: Tuesday, October 1, 2024, 15:51–16:04 AEST This presentation summarizes the safety data from three CD388 clinical trials that involved 108 subjects who were followed for approximately 5–14 months. There were no dose-, route- or repeat-dose-related treatment-emergent adverse events (TEAEs). Overall, CD388 administered via subcutaneous or intramuscular injection was safe and well-tolerated in all three clinical trials. These data support further clinical studies with CD388 for single-dose prevention of seasonal influenza. Poster PresentationTitle: Pharmacokinetics and Safety of CD388 Following Subcutaneous Administration in Healthy Japanese ParticipantsPresenter: Taylor Sandison, MD, MPH, Chief Medical Officer, Cidara Therapeutics Date/Time: Sunday, September 29, 18:30-20:30 AEST This presentation summarizes the pharmacokinetics (PK) and safety data of 27 healthy volunteers of Japanese descent dosed subcutaneously with a single dose of CD388 (50, 150, or 450 mg) or placebo. Overall PK parameters showed low-to-moderate variability across all doses and were similar to results from a previous Phase 1 clinical study in Western participants. Safety observations were comparable across the study arms. There were no clinically significant treatment-emergent adverse events (TEAE). These data support further clinical studies with CD388 in the Japanese population for prevention of seasonal influenza. About CD388CD388 is an investigational drug-Fc conjugate (DFC) comprised of multiple copies of a potent small molecule neuraminidase inhibitor stably conjugated to a proprietary Fc fragment of a human antibody. DFCs are not vaccines or monoclonal antibodies but are low molecular weight biologics which are designed to function as long-acting small molecule inhibitors. CD388 was designed to provide universal protection against all known strains of seasonal and pandemic influenza with the potential to provide season-long protection with a single subcutaneous or intramuscular administration. Importantly, because CD388 is not a vaccine, its activity is not reliant on an immune response and thereby is expected to be efficacious in individuals regardless of immune status. More information can be found at: https://www.cidara.com/cloudbreak/influenza/. About Cidara TherapeuticsCidara Therapeutics is using its proprietary Cloudbreak® platform to develop novel drug-Fc conjugates (DFCs) comprising targeted small molecules or peptides coupled to a proprietary human antibody fragment (Fc). Cidara’s lead DFC candidate, CD388, is a long-acting antiviral designed to achieve universal prevention of seasonal and pandemic influenza with a single dose by directly inhibiting viral proliferation. In June 2023, CD388 was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA), and the Company plans to advance CD388 into a Phase 2b trial in the 2024 Northern Hemisphere influenza season. Additional DFCs have been developed for oncology and in July 2024 Cidara received IND clearance for CBO421 which will be developed to target CD73 in solid tumors. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com. Forward-Looking StatementsThis release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “expect,” “may,” “believe,” “plan,” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to plans and timing for initiating a Phase 2b clinical trial for CD388 and whether the safety and pharmacokinetic data observed in clinical trials to date will be confirmed with larger studies in different patient populations. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, such as unanticipated delays in or negative results from Cidara’s preclinical or clinical trials, unanticipated impacts of the workforce reduction, difficulties in obtaining potential partners or other obstacles to clinical development. These and other risks are identified under the caption “Risk Factors” in Cidara’s most recent Quarterly Report on Form 10-Q and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise. INVESTOR CONTACT:Brian RitchieLifeSci Advisors(212) 915-2578britchie@lifesciadvisors.com MEDIA CONTACT:Michael FitzhughLifeSci Communicationsmfitzhugh@lifescicomms.com