Neumora Therapeutics, Inc.

Neumora Therapeutics’ team is now assessing the factors that may explain the high placebo response in men to improve other trials.\n Neumora Therapeutics’ phase 3 fail was worse than analysts feared. The biotech provided a closer look at the data Tuesday, shutting down one source of hope analysts had clung to after the initial blow.The biotech reported the failure of its oral kappa opioid receptor antagonist to beat placebo in a phase 3 trial at the start of the year. At the time, Neumora said changes on a depression rating scale were exactly the same in the navacaprant and placebo groups after six weeks of daily dosing. The readout left scope for William Blair analysts to hope “a meaningful curve separation” was seen at earlier time points.Neumora snuffed out that hope in its presentation at the J.P. Morgan Healthcare Conference. Executives presented a chart showing scores on the MADRS depression scale were nearly identical in the drug and placebo groups at weeks 1, 4 and 6. Navacaprant had a slight numerical advantage over placebo at Week 2—and throughout the trial on the SHAPS pleasure scale—but analysts were distinctly underwhelmed.“We are obviously disappointed in the KOASTAL-1 study top line,” the William Blair analysts said, pointing to the “0-point placebo adjusted delta on the primary Week 6 MADRS endpoint, lack of placebo-adjusted anhedonia improvement on SHAPS and total population efficacy curves over time that largely overlap” to explain their frustration. Neumora highlighted a disconnect between how navacaprant performed in men and women as a cause for optimism when it shared the initial results earlier this month. Management built on the theme and its implications for further development of the drug candidate at JPM, explaining how the team is now assessing the factors that may explain the high placebo response in men to improve other trials.“The goal would be to incorporate those [insights] from a much richer data set than we had when we initiated the KOASTAL-1 study and make modifications to KOASTAL-2 and KOASTAL-3 to optimize the sites that we\'re utilizing in those ongoing studies, as well as to potentially optimize the patient to ensure that the most appropriate patients are entering the study,” Robert Lenz, M.D., Ph.D., head of R&D at Neumora, said.William Blair analysts pushed back against the idea that a high placebo response in men drove the result. The counterargument, according to the analysts, is that men on navacaprant “would have trended in line with the placebo response, rather than improve less compared to placebo.” Neumora management told the analysts they are unaware of another example of the drug’s mechanism working better in women.“The questions now become what can be done to reduce the risk of professional patient impact on placebo responses in KOASTAL-2 and -3 trials and if the potential sex difference signal is not a false positive, how can this be controlled for in these studies?,” the analysts said. Finding an answer may take time. Neumora has dropped its forecast that data from KOASTAL-2 and -3 will be available in the first half of the year. Instead, the biotech is now planning to update its program guidance when it files its annual financial report. With a cash runway that lasts into mid-2026, Neumora is content to take time to maximize the chance of achieving a better result in the next two trials.“Our financial flexibility gives us the firepower to really study these trends in great detail to identify the learnings and to incorporate those learnings into the ongoing development of navacaprant,” Neumora CEO Henry Gosebruch said. “The KOASTAL-1 study does not impact our confidence that navacaprant can be an important therapy for patients.”

SOUTH SAN FRANCISCO, Calif., Jan. 06, 2025 (GLOBE NEWSWIRE) -- RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing novel therapies for patients with inflammatory and immunological diseases, today announced the appointment of Lori Lyons-Williams as chair of its board of directors, succeeding William Rieflin, who stepped down from the board effective January 3, 2025. Mr. Rieflin will remain as a consultant for the company. “We are pleased to welcome Lori as chair of the board,” said Brian Wong, M.D., Ph.D., President and CEO of RAPT. “In the four years that Lori has served as a board member, she has provided invaluable guidance based on her leadership experience driving strategic and commercial success in both biotech and pharmaceutical companies. We look forward to her increased involvement as we pursue late-stage development and potential commercialization in the field of inflammatory diseases. We also thank Bill for his nine years on our board providing steady and wise counsel.” “It has been an honor and a pleasure to serve as chair of the RAPT board,” said Mr. Rieflin. “I have confidence in the board and the management team and believe that Lori has the skills and experience to help guide RAPT into the future.” Ms. Lyons-Williams, an industry veteran with more than 20 years of experience spanning multinational pharmaceutical and emerging biotech companies, is President and CEO of Abdera Therapeutics, a biopharmaceutical company leveraging antibody engineering to design and develop new precision radiopharmaceuticals for cancer. Previously, Lori was president and chief operating officer of Neumora Therapeutics and earlier served as chief commercial officer of Dermira, a biopharmaceutical company focused on immunology and medical dermatology, until its acquisition by Eli Lilly. Before that, she spent 15 years at Allergan in roles of increasing responsibility, where she successfully launched numerous commercial products, including multiple indications of BOTOX®. Lori currently serves on the boards of directors of Abdera Therapeutics and Contineum Therapeutics (Nasdaq: CTNM); she joined the RAPT board of directors in 2021. “I am excited to partner with Brian and his team as RAPT evolves as a company. I am particularly encouraged by the broad opportunity for RPT904 in food allergy and other allergic diseases as well as the promise and potential of the company’s CCR4-targeted drug candidates,” said Ms. Lyons-Williams. “I look forward to collaborating with my fellow board members as we continue to advance the company.” About RAPT Therapeutics, Inc.RAPT Therapeutics is a clinical-stage, immunology-based therapeutics company focused on discovering, developing and commercializing therapies for patients with inflammatory and immunological diseases. The company leverages its proprietary discovery and development platform to advance both biologics and selective small molecules aimed at normalizing critical immune drivers underlying these conditions. Forward-Looking StatementsThis press release contains forward-looking statements. These statements relate to future events and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future performances or achievements expressed or implied by the forward-looking statements. Each of these statements is based only on current information, assumptions and expectations that are inherently subject to change and involve a number of risks and uncertainties. Forward-looking statements include, but are not limited to, statements about the clinical development of RPT904, the commercial prospects of RPT904 and other statements that are not historical fact. Factors that may cause actual results to differ materially from the plans, intentions and expectations disclosed in these forward-looking statements include uncertainties inherent in the initiation, progress and completion of clinical trials and clinical development of RAPT’s product candidates; the risk that clinical trials may have unsatisfactory outcomes; risks associated with preclinical development of product candidates; risks that efforts to secure licensing and other business development opportunities may not be successful; and other important factors, detailed in RAPT’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, and subsequent filings made by RAPT with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. RAPT disclaims any obligation to update these forward-looking statements. Investor Contact:Sylvia Wheelerswheeler@wheelhouselsa.com Media Contact: Aljanae Reynoldsareynolds@wheelhouselsa.com

SOUTH SAN FRANCISCO, Calif., Jan. 06, 2025 (GLOBE NEWSWIRE) -- RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing novel therapies for patients with inflammatory and immunological diseases, today announced the appointment of Lori Lyons-Williams as chair of its board of directors, succeeding William Rieflin, who stepped down from the board effective January 3, 2025. Mr. Rieflin will remain as a consultant for the company. “We are pleased to welcome Lori as chair of the board,” said Brian Wong, M.D., Ph.D., President and CEO of RAPT. “In the four years that Lori has served as a board member, she has provided invaluable guidance based on her leadership experience driving strategic and commercial success in both biotech and pharmaceutical companies. We look forward to her increased involvement as we pursue late-stage development and potential commercialization in the field of inflammatory diseases. We also thank Bill for his nine years on our board providing steady and wise counsel.” “It has been an honor and a pleasure to serve as chair of the RAPT board,” said Mr. Rieflin. “I have confidence in the board and the management team and believe that Lori has the skills and experience to help guide RAPT into the future.” Ms. Lyons-Williams, an industry veteran with more than 20 years of experience spanning multinational pharmaceutical and emerging biotech companies, is President and CEO of Abdera Therapeutics, a biopharmaceutical company leveraging antibody engineering to design and develop new precision radiopharmaceuticals for cancer. Previously, Lori was president and chief operating officer of Neumora Therapeutics and earlier served as chief commercial officer of Dermira, a biopharmaceutical company focused on immunology and medical dermatology, until its acquisition by Eli Lilly. Before that, she spent 15 years at Allergan in roles of increasing responsibility, where she successfully launched numerous commercial products, including multiple indications of BOTOX®. Lori currently serves on the boards of directors of Abdera Therapeutics and Contineum Therapeutics (Nasdaq: CTNM); she joined the RAPT board of directors in 2021. “I am excited to partner with Brian and his team as RAPT evolves as a company. I am particularly encouraged by the broad opportunity for RPT904 in food allergy and other allergic diseases as well as the promise and potential of the company’s CCR4-targeted drug candidates,” said Ms. Lyons-Williams. “I look forward to collaborating with my fellow board members as we continue to advance the company.” About RAPT Therapeutics, Inc. RAPT Therapeutics is a clinical-stage, immunology-based therapeutics company focused on discovering, developing and commercializing therapies for patients with inflammatory and immunological diseases. The company leverages its proprietary discovery and development platform to advance both biologics and selective small molecules aimed at normalizing critical immune drivers underlying these conditions. Forward-Looking Statements This press release contains forward-looking statements. These statements relate to future events and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future performances or achievements expressed or implied by the forward-looking statements. Each of these statements is based only on current information, assumptions and expectations that are inherently subject to change and involve a number of risks and uncertainties. Forward-looking statements include, but are not limited to, statements about the clinical development of RPT904, the commercial prospects of RPT904 and other statements that are not historical fact. Factors that may cause actual results to differ materially from the plans, intentions and expectations disclosed in these forward-looking statements include uncertainties inherent in the initiation, progress and completion of clinical trials and clinical development of RAPT’s product candidates; the risk that clinical trials may have unsatisfactory outcomes; risks associated with preclinical development of product candidates; risks that efforts to secure licensing and other business development opportunities may not be successful; and other important factors, detailed in RAPT’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, and subsequent filings made by RAPT with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. RAPT disclaims any obligation to update these forward-looking statements. Investor Contact: Sylvia Wheeler swheeler@wheelhouselsa.com Media Contact: Aljanae Reynolds areynolds@wheelhouselsa.com