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])

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.

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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])

On November 6, 2025 Nektar Therapeutics (Nasdaq: NKTR) reported financial results for the third quarter ended September 30, 2025.

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Cash and investments in marketable securities on September 30, 2025 were $270.2 million as compared to $269.1 million on December 31, 2024. Nektar’s cash and marketable securities at September 30, 2025 includes $107.2 million of net proceeds from the secondary offering closed on July 2, 2025 and $34.3 million of net proceeds for the issuance of registered stock under the Company’s filed at-the-market, "ATM", offering. Following the end of the third quarter, an additional $38.3 million of net proceeds were also raised from the ATM offering in October 2025. We expect our cash and investments in marketable securities to support our operations into the second quarter of 2027.

"We have made tremendous progress advancing rezpegaldesleukin, and the emerging data from the REZOLVE-AD study continue to demonstrate a highly differentiated profile for this first-in-class, novel regulatory T cell mechanism in moderate-to-severe atopic dermatitis," said Howard W. Robin, President and CEO of Nektar. "We will present important new findings from REZOLVE-AD this weekend at the ACAAI Scientific Meeting highlighting the potential of rezpegaldesleukin to treat atopic dermatitis and co-morbid asthma, which occurs in about 25% of atopic dermatitis patients. These compelling data give rezpegaldesleukin a unique position in the competitive landscape as this efficacy signal has not been observed with other biologic mechanisms recently approved or in advanced development. Notably, this year’s Nobel Prize in Physiology or Medicine, was awarded for discoveries establishing FOXP3-positive Tregs as essential for peripheral immune tolerance, and we were humbled that rezpegaldesleukin data were referenced in the background documents from the Nobel Committee. Finally, we look forward to reporting in December the topline data for rezpegaldesleukin in patients with severe-to-very-severe alopecia areata, a chronic auto-immune condition that greatly impacts quality of life and mental health for these patients."

Summary of Financial Results

Revenue in the third quarter of 2025 was $11.8 million as compared to $24.1 million in the third quarter of 2024. Revenue for the first nine months of 2025 was $33.4 million compared to $69.3 million in the first nine months of 2024. Revenue has decreased year over year because we no longer recognize product sales due to the sale of the Huntsville manufacturing facility in December 2024.

Total operating costs and expenses in the third quarter of 2025 were $43.5 million as compared to $58.5 million in the third quarter of 2024. Total operating costs and expenses in the first nine months of 2025 were $145.9 million compared to $188.8 million in the first nine months of 2024. Operating costs and expenses for the third quarter and first nine months of 2025 decreased due to the elimination of cost of goods sold following the sale of the Huntsville manufacturing facility and deceases in research and development expenses, as well as non-cash impairment charges recorded in the first nine months of 2024.

R&D expense in the third quarter of 2025 was $27.3 million as compared to $35.0 million for the third quarter of 2024. For the first nine months of 2025, R&D expense was $87.6 million compared to $92.2 million in the first nine months of 2024. R&D expense decreased in the first nine months of 2025 primarily due to a decrease in expense for the development of NKTR-255, partially offset by an increase in expenses for the development of rezpegaldesleukin and NKTR-0165.

G&A expense was $16.1 million in the third quarter of 2025 as compared to $19.0 million in the third quarter of 2024. G&A expense was $57.5 million for the first nine months of 2025 compared to $59.6 million in the first nine months of 2024. G&A expense decreased for both the third quarter and the first nine months of 2025 due to decreases in facilities and stock-based compensation expenses offset by an increase in legal expenses.

Non-cash restructuring and impairment charges were not material in the third quarter and the first nine months of 2025. Non-cash restructuring and impairment charges were less than $0.1 million in the third quarter of 2024 and $14.3 million in the first nine months of 2024. These non-cash charges were related to the declining San Francisco commercial real estate market and real estate lease obligations held by Nektar.

In the first quarter of 2025, we began accounting for our investment in the new portfolio company, Gannet BioChem, under the equity method of accounting which calculates our gain or loss based on the change in our share of Gannet BioChem’s equity each quarter. This resulted in non-cash losses from the equity method investment of $0.5 million in the third quarter of 2025 and $7.4 million for the first nine months of 2025.

Net loss for the third quarter of 2025 was $35.5 million or $1.87 basic and diluted loss per share as compared to a net loss of $37.1 million or $2.661 basic and diluted loss per share in the third quarter of 2024. Net loss in the first nine months of 2025 was $128.0 million or $8.14 basic and diluted loss per share compared to a net loss of $126.2 million or $9.271 basic and diluted loss per share in the first nine months of 2024. Excluding the $0.5 million and $7.4 million non-cash loss from our equity method investment in Gannet BioChem, net loss, on a non-GAAP basis, for the third quarter and the first nine months of 2025 were $35.0 million and $120.6 million, respectively, or $1.85 and $7.67 basic and diluted loss per share, respectively.

Recent Business Highlights

· In October of 2025, Nektar’s abstract "Rezpegaldesleukin, Novel Treg-Inducing Therapy, Demonstrates Efficacy in Atopic Dermatitis and Asthma in Phase 2b Trial" was accepted for a late-breaking oral abstract presentation at the American College of Allergy, Asthma and Immunology’s 2025 Annual Scientific Meeting (ACAAI). These data will be presented at ACAAI on Saturday, November 8, 2025 at 5:33pm ET.

1 The per share amounts have been retrospectively adjusted to reflect a one-for-fifteen reverse stock split completed on June 8, 2025.

· In September of 2025, Nektar presented data from the REZOLVE-AD Phase 2b study of rezpegaldesleukin in atopic dermatitis in a late-breaker oral presentation at European Academy of Dermatology and Venereology (EADV) 2025 Congress.

· In July of 2025, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for rezpegaldesleukin for the treatment of severe-to-very-severe alopecia areata (AA) in adults and pediatric patients 12 years of age and older who weigh at least 40 kilograms.

· In July of 2025, Nektar announced the successful closing of a public offering of its common stock including the full exercise of underwriters’ option to purchase additional shares, raising $115 million in gross proceeds.

Conference Call to Discuss Third Quarter 2025 Financial Results

Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time on November 6, 2025.

This press release and live audio-only webcast of the conference call can be accessed through a link that is posted on the Home Page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through February 6, 2025.

To access the conference call by phone, please pre-register at Nektar Earnings Call Registration. All registrants will receive dial-in information and a PIN allowing them to access the live call.

(Press release, Nektar Therapeutics, NOV 6, 2025, View Source [SID1234659582])