On November 6, 2025 Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage, small molecule precision medicine company developing potentially life-changing therapies for patients living with cancer and genetic disease, reported third quarter 2025 financial results and corporate updates.

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"We are pleased with the clinical progress we’ve made across all three of our RLY-2608 trials in breast cancer and vascular malformations," said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics. "In conjunction with our company’s focus on clinical execution, we are pleased to welcome to our Board, Mr. Coats and Mr. Dable, whose extensive experiences in late-stage development and commercialization will help to guide us as we advance our programs."

Board of Directors Updates

Effective November 4, 2025, Lonnel Coats and Habib Dable were appointed to Relay Therapeutics’ Board of Directors.

Lonnel Coats is the former Chief Executive Officer and director of Lexicon Pharmaceuticals, Inc., a biopharmaceutical company. Prior to his time at Lexicon, from 1996 to 2014, Mr. Coats served in a series of leadership positions at Eisai Inc. and Eisai Corporation of North America, U.S. subsidiaries of Tokyo-based Eisai Co., Ltd., a Japanese pharmaceutical company, including as Chief Executive Officer of Eisai Inc. from 2010 to 2014 and as President and Chief Operating Officer of Eisai Inc. from 2004 to 2010. As President and Chief Executive Officer of Eisai, Mr. Coats oversaw the commercialization of Eisai products in the therapeutic areas of oncology, neurology, gastro-intestinal, epilepsy and metabolic disorders. Prior to joining Eisai, Mr. Coats spent eight years with Janssen Pharmaceuticals, Inc., a division of Johnson & Johnson, where he held a variety of management and sales positions. Mr. Coats is a former member of the board of directors of Blueprint Medicines and Verve Therapeutics. Mr. Coats holds a B.S. in Public Administration from Oakland University.

Habib Dable has over 30 years of experience in the healthcare industry and is currently an advisor at RA Capital Management, L.P. Most recently, Mr. Dable was President and Chief Executive Officer of Acceleron Pharma Inc., a biopharmaceutical company targeting leading-edge therapies for patients with serious and rare diseases, until its acquisition by Merck in 2021. Prior to joining Acceleron in 2016, Mr. Dable spent 22 years at Bayer AG where he served as President of U.S. Pharmaceuticals; Executive Vice President, Global Head Specialty Medicine; Vice President, Ophthalmology; Global Launch Team Head, EYLEA; Global Head, Neurology and Ophthalmology; and Vice President, Regional Head, Hematology

and Cardiology. He also serves on the board of directors of Day One Biopharmaceuticals, PepGen Inc. and BioLink.org. Mr. Dable is also a former member of the board of directors of Blueprint Medicines, Millendo Therapeutics, Aerovate Therapeutics and Albireo Pharma. Mr. Dable received a B.B.A and M.B.A. from the University of New Brunswick.

RLY-2608 Highlights

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Breast Cancer Clinical Trial Execution
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Continued Phase 3 ReDiscover-2 trial of RLY-2608 + fulvestrant in PI3Kα-mutated, CDK4/6 pre-treated, HR+/HER2- advanced breast cancer
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Continued Phase 1/2 ReDiscover trial, advancing the ongoing triplet cohorts with RLY-2608 + fulvestrant + atirmociclib, palbociclib, or ribociclib
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Vascular Malformations Clinical Trial
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Continued execution of ongoing Phase 1/2 ReInspire clinical trial in vascular malformations

Third Quarter 2025 Financial Results

Cash, Cash Equivalents and Investments: As of September 30, 2025, cash, cash equivalents and investments totaled $596.4 million, as compared to $781.3 million as of December 31, 2024. The company expects its current cash, cash equivalents, and investments will be sufficient to fund its operating expenses and capital expenditure requirements into 2029.

R&D Expenses: Research and development expenses were $68.3 million for the third quarter of 2025, as compared to $76.6 million for the third quarter of 2024. The decrease of $8.4 million was primarily due to the series of strategic choices made to streamline the research organization throughout 2024 and 2025, as well as cost avoidance on continued development of lirafugratinib after execution of the license agreement with Elevar Therapeutics, Inc. in December 2024, offset by increases in costs for the ReDiscover-2 Trial and ReInspire Trial.

G&A Expenses: General and administrative expenses were $12.1 million for the third quarter of 2025, as compared to $19.8 million for the third quarter of 2024. The decrease of $7.6 million was primarily due to a decrease in stock compensation expense, as well as other employee compensation costs.

Net Loss: Net loss was $74.1 million for the third quarter of 2025, or a net loss per share of $0.43, as compared to a net loss of $88.1 million for the third quarter of 2024, or a net loss per share of $0.63.

(Press release, Relay Therapeutics, NOV 6, 2025, View Source [SID1234659588])

On November 6, 2025 RAPT Therapeutics, Inc. (Nasdaq: RAPT) ("RAPT" or the "Company"), a clinical-stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing novel therapies for patients living with inflammatory and immunological diseases, reported financial results for the third quarter and nine months ended September 30, 2025.

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"We have considerable momentum heading into the end of the year. We see tremendous potential for ozureprubart in large IgE-driven indications such as food allergy and CSU, and our recent financing gives us additional capital to advance our programs," said Brian Wong, President and CEO of RAPT. "Looking ahead, we plan to report topline results from Jeyou’s Phase 2 trial of ozureprubart in asthma and to provide additional details from the recently reported Phase 2 clinical trial in CSU at a medical meeting next year. We also plan to meet with the FDA and other regulatory agencies to discuss the registrational pathway in CSU."

Recent Highlights

In September, announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) Application to proceed to a Phase 2b clinical trial of ozureprubart (RPT904) in food allergy. In October, the Company initiated the prestIgE Phase 2b trial, a randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of ozureprubart dosed every 8 weeks (Q8W) and every 12 weeks (Q12W) as a treatment for food allergy.

In October, together with Shanghai Jeyou Pharmaceutical Co., Ltd. (Jeyou), announced positive topline data from Jeyou’s Phase 2 trial of ozureprubart as monotherapy in chronic spontaneous urticaria (CSU). Results from this study, which was conducted in China, indicate that ozureprubart dosed Q8W or Q12W has comparable efficacy and safety to omalizumab dosed Q4W, and the companies believe these results warrant advancing ozureprubart to Phase 3 development in CSU. Although the study was not a formal non-inferiority study and no statistical hypothesis was tested, the data from both the ozureprubart Q8W and Q12W treatment arms showed numerically greater improvement on the UAS7 endpoint and numerically higher proportion of patients with UAS7=0 at all timepoints (Weeks 8, 12 and 16) compared to omalizumab Q4W.
In October, completed an underwritten public offering of 8,333,334 shares of common stock at a price of $30.00 per share for gross proceeds of $250 million. The Company’s current cash balance is projected to fund operations to mid-2028, which includes the planned initiation of Phase 3 studies of ozureprubart in CSU.
Financial Results for the Third Quarter and Nine Months Ended September 30, 2025

All share and per share amounts in this press release have been adjusted to reflect the 1-for-8 reverse split of the Company’s common stock effected on June 16, 2025.

Third Quarter Ended September 30, 2025

Net loss for the third quarter of 2025 was $17.6 million, compared to $18.4 million for the third quarter of 2024.

Research and development expenses for the third quarter of 2025 were $12.0 million, compared to $13.3 million for the third quarter of 2024. The decrease in research and development expenses was primarily due to decreases in costs related to development of zelnecirnon and tivumecirnon, personnel, lab supplies, non-cash stock-based compensation and facilities, partially offset by increases in consulting costs and costs related to development of ozureprubart and early-stage programs.

General and administrative expenses for the third quarter of 2025 were $7.3 million, compared to $6.4 million for the third quarter of 2024. The increase in general and administrative expenses was primarily due to increases in non-cash stock-based compensation, consulting costs and facilities costs.

Nine Months Ended September 30, 2025

Net loss for the nine months ended September 30, 2025 was $52.4 million, compared to $76.6 million for the same period in 2024.

Research and development expenses for the nine months ended September 30, 2025 were $36.4 million, compared to $60.8 million for the same period in 2024. The decrease in research and development expenses was primarily due to decreases in costs related to development of zelnecirnon and tivumecirnon, personnel, lab supplies, non-cash stock-based compensation and facilities, partially offset by increases in consulting costs and costs related to development of ozureprubart and early-stage programs.

General and administrative expenses for the nine months ended September 30, 2025 were $21.8 million, compared to $20.9 million for the same period of 2024. General and administrative expenses increased primarily due to increases in non-cash stock-based compensation, consulting costs and facilities costs, partially offset by a decrease in personnel costs.

As of September 30, 2025, the Company had cash and cash equivalents and marketable securities of $157.3 million. In October 2025, the Company completed an underwritten public offering of 8,333,334 shares of common stock at a price of $30.00 per share for net proceeds of approximately $234.4 million, after deducting underwriting discounts and commissions and offering-related expenses.

(Press release, RAPT Therapeutics, NOV 6, 2025, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-reports-third-quarter-2025-financial-results [SID1234659587])

On November 6, 2025 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the third quarter ended September 30, 2025. Unless otherwise stated, all comparisons are for the third quarter of 2025 compared to the third quarter of 2024.

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Product revenue, net consists entirely of sales revenue from NERLYNX, Puma’s first commercial product. Product revenue, net in the third quarter of 2025 was $51.9 million, compared to $56.1 million in the third quarter of 2024. Product revenue, net in the first nine months of 2025 was $144.2 million, compared to $140.8 million in the first nine months of 2024.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported net income of $8.8 million, or $0.18 per basic share and $0.17 per diluted share, for the third quarter of 2025, compared to net income of $20.3 million, or $0.41 per basic and diluted share, for the third quarter of 2024. Net income for the first nine months of 2025 was $17.7 million, or $0.35 per basic and diluted share, compared to net income of $11.0 million, or $0.23 per basic share and $0.22 per diluted share, for the first nine months of 2024.

Non-GAAP adjusted net income was $10.5 million, or $0.21 per basic and diluted share, for the third quarter of 2025, compared to non-GAAP adjusted net income of $22.4 million, or $0.46 per basic share and $0.45 per diluted share, for the third quarter of 2024. Non-GAAP adjusted net income for the first nine months of 2025 was $23.0 million, or $0.46 per basic and diluted share, compared to non-GAAP adjusted net income of $17.5 million, or $0.36 per basic and diluted share, for the first nine months of 2024. Non-GAAP adjusted net income excludes stock-based compensation expenses. For a reconciliation of GAAP net income to non-GAAP adjusted net income and GAAP net income per share to non-GAAP adjusted net income per share, please see the financial tables at the end of this news release.

Net cash provided by operating activities for the third quarter of 2025 was $9.7 million, compared to $11.0 million in the third quarter of 2024. Net cash provided by operating activities for the first nine months of 2025 was $27.4 million, compared to net cash provided by operating activities of $23.3 million in the first nine months of 2024. At September 30, 2025, Puma had cash, cash equivalents and marketable securities of $94.4 million, compared to cash, cash equivalents and marketable securities of $101.0 million at December 31, 2024.

"We are very happy to report the continuation of our positive earnings trend, which is driven by increased demand for NERLYNX," said Alan H. Auerbach, Chairman, Chief Executive Officer, and President of Puma. "According to our current projections, 2025 will mark the first year-over-year demand increase for NERLYNX in the United States since 2018 and we are very pleased with our commercial execution, which contributed to this. We are also pleased with our continued clinical progress in the advancement of alisertib for patients facing chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer in ALISCATM-Breast1 and for patients with extensive-stage small cell lung cancer in ALISCATM-Lung1, where there continues to be a need for new treatment."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) presentation of interim data from ALISCA-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer (H1 2026) and (ii) presentation of additional interim data from the ALI-4201/ALISCA-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer (H1 2026)."

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX, Puma’s first commercial product, and royalty revenue. For the third quarter of 2025, total revenue was $54.5 million, of which $51.9 million was product revenue, net and $2.6 million was royalty revenue. This compares to total revenue of $80.5 million for the third quarter of 2024, of which $56.1 million was product revenue, net and $24.4 million was royalty revenue. This decrease in product revenue, net, compared to the three months ended September 30, 2024, was attributable to a decrease in product supply revenue to our international licensees (reduction in China sales), and higher Gross to Net reduction, partially offset by an increase in U.S. sales resulting from an 8% increase in bottles of NERLYNX sold in the U.S. market and an increase in net selling price. For the first nine months of 2025, total revenue was $152.9 million, of which $144.2 million was product revenue, net and $8.7 million was royalty revenue. This compares to total revenue of $171.4 million for the first nine months of 2024, of which $140.8 million was product revenue, net and $30.6 million was royalty revenue.

Operating Costs and Expenses

Total operating costs and expenses were $44.9 million for the third quarter of 2025, compared to $58.4 million for the third quarter of 2024. Operating costs and expenses in the first nine months of 2025 were $132.7 million, compared to $153.8 million in the first nine months of 2024.

Cost of Sales

Cost of sales was $12.2 million for the third quarter of 2025, compared to $29.1 million for the third quarter of 2024. Cost of sales was $35.0 million for the first nine months of 2025, compared to $50.5 million for the first nine months of 2024. The year-to-date decrease was primarily due to timing of sales made into China by our sub-licensee and the related cost of products shipped and royalty expense.

Selling, General and Administrative Expenses

Selling, general and administrative (SG&A) expenses were $16.8 million for the third quarter of 2025, unchanged from the third quarter of 2024. SG&A expenses for the first nine months of 2025 were $52.5 million, compared to $63.5 million for the first nine months of 2024. The $11.0 million year-over-year decrease in SG&A expenses resulted primarily from legal fees associated with the AstraZeneca litigation in 2024.

Research and Development Expenses

Research and development (R&D) expenses were $15.9 million for the third quarter of 2025, compared to $12.5 million for the third quarter of 2024. R&D expenses for the first nine months of 2025 were $45.2 million, compared to $39.8 million for the first nine months of 2024. The $5.4 million year-over-year increase in R&D expenses resulted primarily from increased alisertib study activity.

(Press release, Puma Biotechnology, NOV 6, 2025, View Source [SID1234659586])

On November 6, 2025 Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical-stage biotechnology company focused on the discovery and development of integrin-based therapeutics, reported a corporate update and announced third quarter 2025 financial results.

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"During the third quarter, our team continued to advance our portfolio while winding down activities surrounding the BEACON-IPF trial," said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant. "Looking ahead, we continue to evaluate a range of opportunities to create shareholder value."

Third Quarter and Recent Developments

Oncology Program

•Phase 1 open-label trial of PLN-101095 in solid tumors has completed enrollment. PLN-101095 is an oral, small molecule, dual selective inhibitor of αvβ8 and αvβ1 integrins designed to overcome checkpoint resistance by blocking TGF-β activation in the tumor microenvironment. The Phase 1 open-label, dose-escalation trial of PLN-101095 as monotherapy and in combination with pembrolizumab is in patients with solid tumors that are resistant to immune checkpoint inhibitors. In March of 2025 we announced interim data from this trial showing PLN-101095 was well tolerated and displayed an objective response rate of 50% in the third of five ascending dose cohorts. The trial has now completed enrollment of all five dose cohorts. Data from the trial, including the two highest dose cohorts, is expected by the end of 2025.

Bexotegrast
•BEACON-IPF close out activities to be completed in fourth quarter. Close out activities from the BEACON-IPF Phase 2b/3 clinical trial are expected to be completed in the fourth quarter of 2025 with full results from the trial to be submitted for future publication.

Corporate Highlights
•In October, the Company announced that it completed a voluntary prepayment of all outstanding principal, accrued and unpaid interest, fees, costs and expenses under the March 11, 2024 Loan Agreement with Oxford Finance LLC.

Third Quarter 2025 Financial Results

•Research and development expenses were $17.9 million as compared to $47.8 million for the prior-year quarter. The decrease was primarily driven by the discontinuation of BEACON-IPF.
•General and administrative expenses were $10.3 million as compared to $14.3 million for the prior-year quarter. The decrease was primarily due to lower personnel-related costs resulting from the strategic restructuring of our workforce.
•Net loss was $26.3 million as compared to $57.8 million for the prior-year quarter. The decrease was primarily attributable to the discontinuation of BEACON-IPF coupled with the decrease in personnel-related costs resulting from the strategic restructuring of our workforce.
•As of September 30, 2025, the Company had cash, cash equivalents and short-term investments of $243.3 million.

(Press release, Pliant Therapeutics, NOV 6, 2025, View Source [SID1234659585])

On November 6, 2025 PharmaMar Group (MSE: PHM) reported it has received a payment of $10 million from Janssen Products, LP, a Johnson & Johnson company, after reaching a commercial milestone for Yondelis (trabectedin) in the United States as defined in the licensing agreement.

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In August 2019, PharmaMar entered into a new licensing agreement with Johnson & Johnson, which replaced a 2001 licensing agreement, under which Johnson & Johnson retained the right to sell and distribute, on an exclusive basis, trabectedin in the USA.

Today, trabectedin is approved in more than 70 countries for the treatment of soft tissue sarcoma and in some of these countries for ovarian cancer as well.

(Press release, PharmaMar, NOV 6, 2025, View Source [SID1234659584])