On August 8, 2025 Oncolytics Biotech Inc. (Nasdaq: ONCY) (TSX: ONC) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, reported financial results and recent highlights for the second quarter of 2025. All dollar amounts are expressed in Canadian currency unless otherwise noted (Press release, Oncolytics Biotech, AUG 8, 2025, View Source [SID1234655039]).

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"We have turned the corner from proof-of-concept studies and will be sprinting toward regulatory clarity for the remainder of the year," said Jared Kelly, Chief Executive Officer of Oncolytics. "As we shore up our intellectual property, get a clear registration path for pelareorep, and allow our GOBLET data to mature, we will establish our position as the only platform immunotherapy in gastrointestinal tumors."

Second Quarter and Subsequent Highlights

Poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting features translational data further demonstrating pelareorep’s mechanism of action. Additional analyses of the combination of pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab in first-line ("1L") metastatic pancreatic ductal adenocarcinoma ("mPDAC") patients enhance the understanding of pelareorep’s ability to stimulate the immune system and enable treatment regimens to be effective in a traditionally hostile tumor microenvironment (click here for the PR, click here for the poster). Pelareorep expands reovirus-specific T cells, increases cytokines and chemokines, and increases tumor-infiltrating lymphocytes ("TILs") in the blood.

New Chief Executive Officer Jared Kelly and Chief Business Officer Andrew Aromando hired to optimize pelareorep’s development path. Both are experienced biotech executives with decades of experience advising companies, advancing clinical programs, and navigating successful transactions. They were both instrumental in guiding the sale of Ambrx Biopharma to Johnson & Johnson.

Analyses of clinical data show pelareorep’s ability to improve survival, and translational data confirming how the intended benefits are achieved. Recently highlighted survival data in mPDAC and breast cancer point to meaningful survival benefits for patients treated with pelareorep-based regimens compared to either control arms or historical data (click here for the PR). In 1L mPDAC, a review of landmark studies shows a historical benchmark of 9.2% two-year survival for chemotherapy regimens, in contrast to the 21.9% two-year survival rate recorded for 100 patients receiving pelareorep and chemotherapy. Translational data from multiple studies and tumor types provide evidence as to how these impressive results have been achieved (click here for the PR). In the GOBLET and AWARE-1 studies, pelareorep converted immunologically "cold" tumors to "hot" ones as a result of the upregulation of interferons, CXCL9/10/11, and PD-L1 in addition to the expansion and mobilization of TILs in the blood, which is correlated with a reduction in tumor size.

Key Opinion Leader ("KOL") webinar discussion solidifies pelareorep’s opportunity in mPDAC and other gastrointestinal cancers. Presentations from KOLs and a roundtable discussion of pelareorep’s clinical data in mPDAC and gastrointestinal cancers point to a potentially significant opportunity for an immunotherapeutic drug candidate that already has shown the ability to extend survival for patients (click here for the PR). Specifically, 1L mPDAC would be ideal for pelareorep as there are no immunotherapies approved for that line of treatment, multiple 1L studies have already demonstrated pelareorep’s ability to improve survival in that patient population, and it is backed up by translational data showing the ability to activate the immune system and alter the tumor microenvironment so it is more amenable to therapeutic intervention.

Strategic decision to pursue registration-enabling pivotal study for pelareorep in 1L mPDAC. Discussions with regulators are underway to finalize the approval pathway for pelareorep in 1L mPDAC (click here for the PR). This includes decisions on which treatment regimens will be involved, whether to collaborate with a third party on the study, and formalizing overall survival as the primary endpoint. The prioritization of the pancreatic cancer program is based on the compelling survival and translational data from previous studies involving over 100 patients, and the particularly high unmet medical need in this indication. Pelareorep has already received Fast Track and Orphan Drug designation from the U.S. Food and Drug Administration (the "FDA") for mPDAC. If discussions with regulators proceed as expected and the feedback is positive, start-up activities for the study are expected to commence as early as Q4 2025.

Commitment to limiting dilutive financing and maximizing shareholder value. Oncolytics intends to terminate its At-the-Market financing facility with Cantor Fitzgerald and Equity Line of Credit with Alumni Capital. The Company believes it has sufficient capital to reach critical regulatory and clinical milestones this fall and pursue strategic opportunities that demonstrate pelareorep’s potential without the need for near-term dilutive financings at this time. Additionally, as separately announced, the Company has given formal notice to delist from the Toronto Stock Exchange (the "TSX"). Once delisted from the TSX, the Company’s common shares will continue to trade under the symbol "ONCY" on the Nasdaq.

Financial Highlights

•As of June 30, 2025, the Company reported $14.6 million in cash and cash equivalents, projecting a cash runway through key milestones and into the first quarter of 2026.

•The net loss for the second quarter of 2025 was $6.2 million, compared to a net loss of $7.3 million for the second quarter of 2024. The basic and diluted loss per share was $0.07 in the second quarter of 2025, compared to a basic and diluted loss per share of $0.10 in the second quarter of 2024.

•Research and development ("R&D") expenses for the second quarter of 2025 were $2.8 million, compared to $4.6 million for the second quarter of 2024. The decrease was primarily attributable to lower clinical trial expenses as the Company focused its R&D efforts on Cohort 5 of the GOBLET study, which is supported by the Pancreatic Cancer Action Network ("PanCAN") Therapeutic Accelerator Award.

•General and administrative expenses for the second quarter of 2025 were $2.9 million, compared to $3.4 million for the second quarter of 2024. The decrease was primarily due to lower public company-related expenses, and partially offset by higher personnel-related expenses associated with changes to the management team.

•Net cash used in operating activities for the six months ended June 30, 2025, was $12.0 million, compared to $14.3 million for the six months ended June 30, 2024. The decrease reflected lower operating activities in 2025, partially offset by higher non-cash working capital changes.

Anticipated Milestones

•Q3 2025: Provide an updated clinical timeline for the registration-enabling pivotal study for pelareorep in 1L mPDAC.
•As early as Q4 2025: Initiate start-up activities for the registration-enabling study for pelareorep in 1L mPDAC.
•End of 2025: Updated clinical data regarding safety and efficacy in Cohort 4 of the GOBLET study investigating pelareorep combined with atezolizumab in anal carcinoma.
•Q4 2025: Initial responses from the U.S. Patent and Trademark Office ("PTO") regarding the company’s application to extend patent protection for pelareorep.

Annual General Meeting and Conference Call Change

Management is hosting the Annual General Meeting later today at 10:00 a.m. ET, August 8, 2025. Oncolytics’ Chief Executive Officer, Jared Kelly, will provide a brief update after the formal portion of the meeting. To access the meeting as a guest (i.e., a non-voting shareholder):
•Visit the webcast site: https://virtual-meetings.tsxtrust.com/en/1824/
•Click the button "I am a Guest" and complete the form
•If necessary, provide the case-sensitive password: onc2025

Information on how to vote your shares by proxy and attend the meeting as a shareholder is available in the Company’s most recent Management Information Circular (the "Circular") dated June 18, 2025. The Circular is available on the Reports page of the investor relations section of the Company’s website at View Source and in Canadian and American securities filings.

Going forward, Oncolytics will continue to announce quarterly financial results via press releases and in securities filings, but will no longer host quarterly conference calls with the management team.

On August 8, 2025 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a clinical-stage precision oncology company, reported financial results for the second quarter ended June 30, 2025 (Press release, Repare Therapeutics, AUG 8, 2025, View Source [SID1234655040]).

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"We remain focused on exploring strategic alternatives and partnerships across our portfolio to enhance long-term shareholder value, as exemplified by our recent worldwide licensing agreement with Debiopharm for lunresertib and out-licensing of early-stage discovery platforms to DCx," said Steve Forte, President, Chief Executive Officer and Chief Financial Officer of Repare. "In parallel to evaluating these strategic opportunities for our remaining programs, we expect to deliver initial data from the LIONS and POLAR trials in the fourth quarter."

Second Quarter 2025 and Recent Portfolio Highlights:

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Entered into a worldwide licensing agreement with Debiopharm for lunresertib
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In July 2025, Repare entered into an exclusive worldwide licensing agreement with Debiopharm International S.A. ("Debiopharm") for lunresertib, a first-in-class precision oncology PKMYT1 inhibitor. Under the terms of the agreement, Repare will receive a $10 million upfront payment, and is eligible to receive up to $257 million in potential clinical, regulatory, commercial and sales milestones, including up to $5 million in potential near-term payments, and single-digit royalties on global net sales. This agreement builds on the success of Repare and Debiopharm’s clinical study and collaboration agreement to explore the synergy between lunresertib and Debio 0123, a potential best-in-class, brain penetrant and highly selective WEE1 inhibitor. Debiopharm will assume sponsorship of the MYTHIC study and take over existing and future development activities related to lunresertib.

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Announced out-licensing of its discovery platforms to DCx Biotherapeutics
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In May 2025, Repare out-licensed its early-stage discovery platforms, including certain platform and program intellectual property, to DCx Biotherapeutics Corporation ("DCx"), a newly-launched Canadian biotechnology company developing next generation precision drug conjugates supported by Amplitude Ventures. In connection with this agreement, Repare received a $1 million upfront payment and is expected to receive $3 million in near-term payments. In addition, Repare received a 9.99% equity position in DCx, including certain dilution protection rights, and is eligible to receive potential future out-licensing, clinical and commercial milestone payments, as well as low single-digit sales royalties for the development of certain products by DCx. In connection with this transaction, Repare recognized a $5.7 million gain during the quarter.
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RP-3467: Potential best-in-class, oral Polθ ATPase/helicase inhibitor
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Repare is conducting a Phase 1 clinical trial of RP-3467 (POLAR), dosing patients alone and in combination with the poly-ADP ribose polymerase (PARP) inhibitor, olaparib. POLAR is a multicenter, open-label, dose-escalation Phase 1 clinical trial designed to investigate the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of RP-3647 alone or in combination with olaparib in adults with locally advanced or metastatic epithelial ovarian cancer, metastatic breast cancer, metastatic castration-resistant prostate cancer, or pancreatic adenocarcinoma.
o
Upcoming expected milestone:
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Q4 2025: Topline safety, tolerability and early efficacy data from the POLAR trial in monotherapy and in combination with olaparib.
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RP-1664: First-in-class, oral selective PLK4 Inhibitor
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Repare completed enrolment of 29 patients in its Phase 1 LIONS clinical trial, evaluating RP-1664 as a monotherapy in adult and adolescent patients with TRIM37-high solid tumors. LIONS is a first-in-human, multicenter, open-label Phase 1 clinical trial designed to investigate safety, pharmacokinetics, pharmacodynamics and the preliminary efficacy of RP-1664.
o
Upcoming expected milestone:
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Q4 2025: Initial topline safety, tolerability and early efficacy data from the LIONS trial.
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Amended our collaboration and license agreement with Bristol-Myers Squibb Company to include an additional druggable target in the collaboration
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Repare recognized $0.3 million during the quarter as revenue related to druggable targets, reflecting this option fee payment.
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Exploring strategic alternatives to maximize shareholder value
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Repare continues to actively explore strategic alternatives, partnerships and sale opportunities across its portfolio to maximize shareholder value.

Second Quarter 2025 Financial Results

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Cash, cash equivalents and marketable securities: Cash, cash equivalents and marketable securities as of June 30, 2025 were $109.5 million.
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Revenue from collaboration agreements: Revenue from collaboration agreements were $0.3 million for the three and six months ended June 30, 2025, respectively, as compared to $1.1 million and $53.5 million for three and six months ended June 30, 2024.
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Research and development expense, net of tax credits (Net R&D): Net R&D expenses were $14.3 million and $34.6 million for the three and six months ended June 30, 2025, respectively, as compared to $30.1 million and $63.1 for the three and six months ended June 30, 2024.
•
General and administrative (G&D) expenses: G&A expenses were $6.0 million and $13.7 million for the three and six months ended June 30, 2025, respectively, compared to $8.3 million and $16.9 million for the three and six months ended June 30, 2024.
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Net loss: Net loss was $16.7 million, or $0.39 per share, and $46.8 million, or $1.09 per share, in the three and six months ended June 30, 2025, respectively, compared to $34.8 million, or $0.82 per share, and $21.6 million, or $0.51 per share, in the three and six months ended June 30, 2024, respectively.

On August 8, 2025 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, reported financial results for the second quarter ended June 30, 2025 (Press release, Y-mAbs Therapeutics, AUG 8, 2025, View Source [SID1234655041]).

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Recent Transaction Announcement with SERB

● On August 5, 2025, Y-mAbs announced it has entered into a definitive agreement with affiliated entities of SERB Pharmaceuticals ("SERB"), under which SERB, a global specialty pharmaceutical company, agreed to acquire Y-mAbs in a transaction at an equity value of $412.0 million. The transaction was unanimously approved by the Y-mAbs Board of Directors. Under the terms of the merger agreement, SERB is obligated to commence a tender offer by August 19, 2025 to purchase all outstanding shares of Y-mAbs for $8.60 per share in cash, representing a 105% premium to Y-mAbs’ closing share price on August 4, 2025, the last full trading day prior to the transaction announcement;
● The transaction is expected to close by the fourth quarter of 2025, assuming a majority of outstanding Y-mAbs shares are tendered into, and not withdrawn from, the tender offer, and subject to the satisfaction of customary conditions, including the receipt of a majority of Y-mAbs shares in the tender offer and expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

Financial Results

Revenues

Total revenues for the quarter ended June 30, 2025 were $19.5 million, which was a 14% decrease from the $22.8 million of total revenues for the quarter ended June 30, 2024, driven by a $2.9 million decrease in Ex-U.S. DANYELZA net product revenues and a $0.9 million decrease in U.S. DANYELZA net product revenues, partially offset by a $0.5 million increase related to license revenue recognized in the three months ended June 30, 2025. Total DANYELZA net product revenues for the quarter ended June 30, 2025 were $19.0 million, which was a 17% decrease over $22.8 million total DANYELZA net product revenues for the quarter ended June 30, 2024.

Total revenues for the six months ended June 30, 2025 were $40.4 million, which was a 5% decrease from the $42.7 million of total revenues for the six months ended June 30, 2024, driven by a $6.1 million decrease in U.S DANYELZA net product revenues, partially offset by a $3.8 million increase in Ex-U.S. DANYELZA net product revenues. The total revenues in the six months ended June 30, 2025 and 2024 include $0.5 million license revenue, respectively.

The Company’s U.S. DANYELZA net product revenues for the quarter ended June 30, 2025 were $14.3 million, representing a decrease of 6% from the same period in 2024. The decline in the U.S. DANYELZA net product revenues was driven by declining patient volume due to enrollments in clinical studies and competition in the three months ended June 30, 2025.

The Company’s Ex-U.S. DANYELZA net product revenues for the quarter ended June 30, 2025 were $4.7 million, representing a decrease of $2.9 million from the same period in 2024. Ex-U.S. DANYELZA net product revenues include $2.1 million from Western Europe and $3.4 million from Eastern Asia for the three months ended June 30, 2024, which was a result of stocking orders from Western Europe and Eastern Asia in 2024. The Company did not have any stocking orders from Western Europe or Eastern Asia in the three months ended June 30, 2025. The decrease in Ex-U.S. DANYELZA net product revenues was partially offset by a $2.0 million increase in DANYELZA net product revenues in Western Asia, where a named patient program launched in Turkey in late 2024.

During the three and six months ended June 30, 2025, the Company recognized $0.5 million license revenue, which was earned in prior periods, in connection with sales-based milestone achievements by our partner in Israel. There was no license revenue in the three months ended June 30, 2024. During the six months ended June 30, 2024, the Company had license revenues of $0.5 million, which included license revenue from the Latin America distribution partner, Adium, related to price approval for DANYELZA in Brazil from the Brazilian Medicines Market Regulation Chamber.

Cost of Goods Sold

Cost of goods sold was $2.7 million and $3.0 million for the three months ended June 30, 2025 and 2024, respectively. The decrease in cost of goods sold in the three months ended June 30, 2025 compared to the same period in 2024 was primarily driven by decreased sales.

Cost of goods sold was $5.7 million and $5.1 million for the six months ended June 30, 2025 and 2024, respectively. The increase in cost of goods sold in the six months ended June 30, 2025 compared to the same period in 2024 was primarily driven by increased cost of production.

Gross Profit

Gross profit stayed consistent at $16.8 million and $19.8 million for the three months ended June 30, 2025 and 2024, respectively. Gross margins were relatively flat at 86% and 87% for the three months ended June 30, 2025 and 2024, respectively.

Gross profit was $34.8 million and $37.6 million for the six months ended June 30, 2025 and 2024, respectively. Gross margins were 86% and 88% for the six months ended June 30, 2025 and 2024, respectively. The gross margin decreased primarily due to increased cost of production and lower product sales to Western Europe, where product sales generally have higher gross margin.

Operating Costs and Expenses

Research and Development

Research and development expenses were $11.1 million and $12.3 million for the three months ended June 30, 2025 and 2024, respectively. The $1.2 million decrease in research and development expenses was primarily driven by a decrease of $0.9 million in personnel and stock-based compensation costs which was primarily related to our business realignment announced in January 2025.

Research and development expenses were $22.5 million and $25.6 million for the six months ended June 30, 2025 and 2024, respectively. The $3.1 million decrease in research and development expenses was primarily driven by a $1.8 million decrease in personnel and stock-based compensation costs, which was primarily related to our business realignment announced in January 2025, and a total $0.4 million decrease in clinical trials and outsourced research and supplies due to the timing of completion in our GD2-SADA program and investment in our ongoing SADA PRIT programs.

Selling, General, and Administrative

Selling, general, and administrative expenses were $11.3 million and $17.2 million for the three months ended June 30, 2025 and 2024, respectively. The $5.9 million decrease in selling, general and administrative expenses was primarily attributable to a net impact of $3.8 million related to litigation settlements during the three months ended June 30, 2024 and a $1.7 million decrease in legal expenses.

Selling, general, and administrative expenses were $24.4 million and $28.7 million for the six months ended June 30, 2025 and 2024, respectively. The $4.3 million decrease in selling, general, and administrative expenses was primarily attributable to a net impact of $3.8 million related to litigation settlements in the six months ended June 30, 2024, as noted above.

Interest and Other Income

Interest and other income were $2.3 million and $0.6 million for the three months ended June 30, 2025 and 2024, respectively. Interest and other income increased by $1.7 million primarily due to $2.0 million of foreign currency transaction gains in the three months ended June 30, 2025, partially offset by a $0.3 million decrease in interest earned on cash and cash equivalents.

Interest and other income were $3.7 million and $1.1 million for the six months ended June 30, 2025 and 2024, respectively. Interest and other income increased by $2.6 million primarily due to $3.3 million of foreign currency transaction gains, partially offset by a $0.7 million decrease in interest earned on cash and cash equivalents.

Net Loss

Y-mAbs reported a net loss for the quarter ended June 30, 2025, of $3.2 million, or ($0.07) per basic and diluted share, compared to a net loss of $9.2 million, or ($0.21) per basic and diluted share, for the quarter ended June 30, 2024. The decrease in net loss for the quarter ended June 30, 2025 was primarily driven by the above noted $3.8 million in litigation settlements in the quarter end June 30, 2024 and the favorable impact of $2.0 million of foreign currency transaction gains in the quarter ended June 30, 2025.

Cash and Cash Equivalents

As of June 30, 2025, Y-mAbs had approximately $62.3 million in cash and cash equivalents. The Company continues its efforts to be capital efficient in its operations.

In light of the pending transaction, Y-mAbs will not be holding a webcast and conference call to discuss its second quarter 2025 results.

On August 8, 2025 Boehringer Ingelheim reported that HERNEXEOS (zongertinib tablets) has been approved by the U.S. Food and Drug Administration (FDA) (Press release, Boehringer Ingelheim, AUG 8, 2025, View Source [SID1234655042]). The kinase inhibitor is indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.1

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This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.1

"With the approval of zongertinib, we have an effective, targeted, orally administered treatment option for patients with HER2 (ERBB2)-mutant non-small cell lung cancer in the U.S. that not only elicits a durable response but, importantly, has a manageable safety profile," said Dr. John Heymach, MD, PhD, chair of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center, and coordinating investigator for the Beamion-LUNG 1 trial. "In a patient population where there are currently limited treatment options, this approval represents a significant advancement in cancer care."

Accelerated approval is based on data from the Phase Ib Beamion-LUNG 1 trial, demonstrating an objective response rate of 75% (N=71), 6% of patients had a complete response and 69% of patients had a partial response and a duration of response of ≥6 months in 58% of patients (n=53).1 Positive results from the Beamion-LUNG 1 trial were previously presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 and simultaneously published in The New England Journal of Medicine.2

Zongertinib demonstrated a manageable safety profile with a 2.9% discontinuation rate. In the pooled safety population, the most common (> 20%) adverse reactions were diarrhea (53%), hepatotoxicity (27%), rash (27%), fatigue (22%), and nausea (21%).1

"We are grateful to be able to bring forward HERNEXEOS, which has the potential to reset the benchmark for those living with HER2-mutant advanced non-small cell lung cancer, a condition associated with a particularly poor prognosis," said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim. "Believing in the power of scientific innovation, we aim to provide meaningful improvements to this patient population. Recognizing its potential, we accelerated development to deliver this new treatment option to patients within four years of starting the first clinical trial."

Harnessing the power of precision medicine by targeting HER2 mutations in lung cancer
HER2 (ERBB2) mutations occur in approximately 2–4% of NSCLC cases and are associated with a poor prognosis and higher incidence of brain metastases.3,4,5Alterations in the HER2 (ERBB2) gene, including mutations, amplification and overexpression, trigger uncontrolled cell proliferation, inhibiting cell death, and promoting tumor growth and spread.3,5 Comprehensive biomarker testing using next generation sequencing determines a patient’s eligibility for treatment with zongertinib by identifying HER2 (ERBB2)-mutant advanced NSCLC.1,5

"The advocacy community is thrilled about the approval of zongertinib, as it is another testament to the importance of personalized options for lung cancer that allow for a much more targeted approach for a subgroup of patients who have been waiting many years for innovative treatments," said Marcia Horn, President and CEO, International Cancer Advocacy Network and Executive Director of the Exon 20 Group/HER2 Warriors. "Understanding your cancer’s unique biomarkers, including HER2, through comprehensive testing is critical for all patients with NSCLC, as it can unlock targeted treatment options."

About non-small cell lung cancer (NSCLC)
Lung cancer claims more lives than any other cancer type and the incidence is set to increase to over 3 million cases worldwide by 2040.5,6 NSCLC is the most common type of lung cancer.3 Due to a lack of symptoms and misdiagnoses,7 most patients with NSCLC present at stage III or IV, where the disease has metastasized locally or to other organs.8 The estimated 5-year survival rate historically has been less than 10% for metastatic disease.9,10,11 People living with advanced NSCLC can experience a detrimental physical, psychological, and emotional impact on their daily lives.12,13,14

About zongertinib
Zongertinib is a tyrosine kinase inhibitor (TKI) that selectively inhibits HER2 (ERBB2).1 This orally administered, targeted therapy was approved as HERNEXEOS (zongertinib tablets) under the FDA’s Accelerated Approval Program, after securing Priority Review as well as Breakthrough Therapy and Fast Track Designations.1

The treatment is being evaluated in ongoing trials, across a range of advanced solid tumors with HER2 alterations.

On August 8, 2025 RemeGen Co., Ltd. (688331.SH/09995.HK) reported clearance of IND application by Food and Drug Administration (FDA) for phase II clinical trials for its independently-developed bispecific antibody, RC148, for the treatment of multiple advanced malignant solid tumors in the US (Press release, RemeGen, AUG 8, 2025, View Source [SID1234655043]).

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RC148 is a PD-1 and VEGF-targeting bispecific antibody, an innovative molecule developed by RemeGen using its bispecific antibody technology platform. Currently, the clinical trials of RC148 as monotherapy and combination therapy for the treatment of advanced solid tumor are proceeding in China.

The clearance of IND application by the FDA is a significant milestone for RC148 which should expedite its global development process.