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RAPT Therapeutics Reports Third Quarter 2025 Financial Results and Recent Highlights

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])

Puma Biotechnology Reports Third Quarter 2025 Financial Results

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.

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])

Pliant Therapeutics Provides Corporate Update and Reports Third Quarter 2025 Financial Results

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.

"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])

PharmaMar receives a US$10 million milestone payment from Janssen for Yondelis

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.

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])

ORIC® Pharmaceuticals Announces Publication in Cancer Research on the Discovery and Development of Enozertinib, a Highly Selective, Brain-Penetrant EGFR Inhibitor

On November 6, 2025 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported the publication of a peer-reviewed research paper in Cancer Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). The scientific paper details the discovery and development of enozertinib (formerly ORIC-114), a highly brain-penetrant, orally bioavailable, irreversible inhibitor that targets EGFR exon 20 mutations with exquisite kinome selectivity.

EGFR mutations are common oncogenic drivers in non-small cell lung cancer (NSCLC), and approximately 50% of patients may develop brain metastases over the course of their disease. Additionally, patients with non-classical EGFR mutations, such as insertions in exon 20, have a worse prognosis compared to patients with classical EGFR mutations. There remains an unmet need for a highly selective EGFR inhibitor that is also brain-penetrant to effectively treat and control intracranial disease.

The Cancer Research publication details preclinical data demonstrating enozertinib’s exquisite kinome selectivity, strong potency, brain-penetrance, and anti-tumor activity, including in intracranial lung cancer models, across a broad range of atypical EGFR mutant contexts. This publication also highlights a patient vignette in which treatment with enozertinib resulted in a sustained complete response of all systemic and brain metastases in a patient with NSCLC whose tumors harbored an EGFR exon 20 insertion mutation. To ORIC’s knowledge, enozertinib is the only EGFR exon 20 inhibitor to demonstrate a systemic complete response and CNS complete response in a patient with untreated, active brain metastases.

"These studies affirm our belief that enozertinib is uniquely positioned to address the unmet needs in patients with NSCLC driven by EGFR exon 20 and atypical mutations," said Melissa Junttila, PhD., vice president, head of biology at ORIC, and first author of the publication. "We look forward to sharing additional clinical data for enozertinib later this year and in mid-2026 and further elucidating its best-in-class potential."

The full manuscript, titled "Enozertinib is a Selective, Brain-Penetrant EGFR Inhibitor for Treating Non-small Cell Lung Cancer with EGFR Exon 20 and Atypical Mutations," is available online at Cancer Research.

ORIC anticipates the following upcoming data milestones for enozertinib in NSCLC:

December 2025: 1L EGFR exon 20, 2L EGFR exon 20, 2L+ HER2 exon 20 and 2L+ EGFR atypical data to be presented at ESMO (Free ESMO Whitepaper) Asia 2025
Mid-2026: 1L EGFR atypical data and 1L EGFR exon 20 combination with SC amivantamab data

(Press release, ORIC Pharmaceuticals, NOV 6, 2025, View Source [SID1234659583])