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SAN DIEGO - Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company specializing in immunotherapies, announced today the addition of four new members to its Scientific Advisory Board (SAB). The appointees, Rick Bright, Ph.D., Philip Krause, M.D., Mario Barro, Ph.D., and Frederick G. Hayden, M.D., FACP, bring a wealth of experience in pandemic preparedness, regulatory strategy, and infectious disease research.
The company's CEO, Jeffrey Stein, Ph.D., expressed confidence that the new advisors would provide valuable insights for the development of CD388, Cidara's lead antiviral drug candidate. The drug, which has received Fast Track Designation from the FDA, is slated for a Phase 2b trial during the 2024 Northern Hemisphere influenza season. The trial aims to test the efficacy of a single dose of CD388 in providing season-long protection against influenza A & B.
Dr. Bright, known for his expertise in pandemic preparedness, has previously served as the CEO of the Pandemic Prevention Institute at The Rockefeller Foundation. Dr. Krause's experience spans over 30 years at the Food and Drug Administration, where he has played a pivotal role in the evaluation and licensure of biological products. Dr. Barro, a Venture Partner at RA Capital Management, brings to the table over three decades of experience in vaccinology and immunology. Dr. Hayden, an emeritus professor at the University of Virginia School of Medicine, has been instrumental in the development of several antiviral agents and vaccines.
Cidara Therapeutics is leveraging its Cloudbreak® platform to create drug-Fc conjugates (DFCs) that couple targeted small molecules or peptides to a proprietary human antibody fragment (Fc). In addition to CD388, Cidara has developed other DFCs for oncology, including CBO421, which targets CD73 in solid tumors and received IND clearance in July 2024.
This announcement is based on a press release statement and contains forward-looking statements regarding the initiation of the Phase 2b clinical trial for CD388. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected.
In other recent news, Cidara Therapeutics has made several significant changes. The biopharmaceutical company announced a 30% workforce reduction to concentrate on the development of its influenza drug candidate, CD388. This restructuring is expected to be completed by November 2024, with severance and related benefit charges amounting to approximately $1.2 million. The company also plans to initiate a Phase 2b clinical trial of CD388 in the third quarter of 2024.
Cidara Therapeutics has appointed Jim Beitel as its new Chief Business Officer, aligning with the company's focus on its Cloudbreak drug-Fc conjugate pipeline. This follows the company's stock rating upgrade from Neutral to Buy by H.C. Wainwright, reflecting confidence in the Cloudbreak platform, particularly the CD388 program.
Further recent developments include the expansion of Cidara's authorized shares of common stock from 20 million to 50 million, providing the company with greater financial flexibility. This was approved during the Annual Meeting of Stockholders, along with the sanctioning of the company's 2024 Equity Incentive Plan.
The company also sold its rezafungin program to Mundipharma and re-acquired its Phase 2b-ready influenza program from Johnson & Johnson, followed by a $240 million private investment in public equity financing deal. These changes are part of the company's ongoing efforts to advance its clinical and preclinical initiatives.
InvestingPro Insights
As Cidara Therapeutics, Inc. (NASDAQ:CDTX) fortifies its Scientific Advisory Board with experts in pandemic preparedness and infectious disease research, the financial health and market performance of the company remain critical for investors monitoring its progress. With a market cap of $81.78 million, the company's financial metrics provide a mixed picture. Notably, Cidara holds more cash than debt on its balance sheet, which can be a reassuring signal of financial stability, especially as the company navigates the costly clinical trial phases of its lead antiviral drug, CD388.
On the other hand, Cidara's financial data underscores some challenges. The company's gross profit margin over the last twelve months as of Q2 2024 stands at -19.29%, reflecting the difficulties in maintaining profitability in the highly competitive biotech sector. Additionally, with a significant revenue decline of 13.72% during the same period, it is clear that Cidara is experiencing headwinds that could impact its ability to fund ongoing research and development without seeking additional capital.
InvestingPro Tips suggest that analysts are cautious about the company's near-term prospects. Two analysts have revised their earnings expectations downwards for the upcoming period, and there is a consensus that Cidara will not be profitable this year. These concerns are echoed in the company's negative price-to-earnings (P/E) ratio of -0.48, which signals investor skepticism about future earnings potential.
For investors seeking additional insights, there are 11 more InvestingPro Tips available, which can be accessed to gain a deeper understanding of Cidara Therapeutics' financial health and market outlook. These tips can provide valuable context for the company's strategic decisions, including the expansion of its Scientific Advisory Board and the progression of its drug candidates through clinical trials.
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