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Taiho Oncology Announces Acceptance of Abstract for Zipalertinib at the ESMO Congress 2025

On July 25, 2025 Taiho Oncology, Inc., a company developing and commercializing novel treatments for hematologic malignancies and solid tumors, reported it will present new data from the REZILIENT2 trial of zipalertinib at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, to be held Oct. 17-21, 2025, in Berlin, Germany (Press release, Taiho, JUL 25, 2025, View Source [SID1234654536]).

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The abstract accepted for a mini oral presentation includes the preliminary efficacy and safety data from the Phase 2b REZILIENT2 trial of zipalertinib, an oral, highly selective, irreversible EGFR tyrosine kinase inhibitor (TKI), in patients with advanced or metastatic NSCLC harboring EGFR ex20ins mutations or EGFR uncommon non-ex20ins mutations and active brain metastases and/or leptomeningeal disease.

"We look forward to presenting the latest findings from Cohort C of our REZILIENT2 trial, which focuses on a subset of patients with ex20ins NSCLC with central nervous system involvement, at this year’s ESMO (Free ESMO Whitepaper) Congress," said Harold Keer, MD, PhD, Chief Medical Officer, Taiho Oncology. "We are excited to share more details from our zipalertinib program, building upon its potential to make a meaningful impact in a disease area of unmet need."

The session title and information for the accepted abstract are listed below. Full abstract details will be available via the conference website at 12:05 CEST a.m. on Oct. 13, 2025.

Title: Activity of Zipalertinib Against Active Central Nervous System (CNS) Metastases in Patients With Non-Small Cell Lung Cancer (NSCLC) Harboring EGFR Exon 20 Insertion (Ex20ins)/Other Uncommon Mutations
Abstract Number: 3778
Session Name: Mini oral session 1: NSCLC metastatic
Session Type: Mini Oral Presentation
Session Date: Oct. 19, 2025
Session Time: 8:30 to 10 a.m. CEST

About Zipalertinib
Zipalertinib (development code: CLN-081/TAS6417) is an orally available small molecule designed to target activating mutations in EGFR. The molecule was selected because of its ability to inhibit EGFR variants with exon 20 insertion mutations, while sparing wild-type EGFR. Zipalertinib is designed as a next generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with non-small cell lung cancer. Zipalertinib has received Breakthrough Therapy Designation from the FDA. Zipalertinib is investigational and has not been approved by any health authority.

Zipalertinib is being developed by Taiho Oncology, Inc., its parent company, Taiho Pharmaceutical Co., Ltd., and in collaboration with Cullinan Therapeutics, Inc. in the U.S.

Servier Receives Positive CHMP Opinion for VORANIGO® (vorasidenib) for the Treatment of Adults and Adolescents with Grade 2 IDH-mutant Diffuse Glioma

On July 25, 2025 Servier reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of VORANIGO (vorasidenib) in the European Union (EU) for the treatment of predominantly non-enhancing Grade 2 astrocytoma or oligodendroglioma with an isocitrate dehydrogenase-1 (IDH1) R132 or isocitrate dehydrogenase-2 (IDH2) R172 mutation in adult and adolescent patients aged 12 years and older and weighing at least 40 kg who only had surgical intervention and who are not in immediate need of radiotherapy or chemotherapy (Press release, Servier, JUL 25, 2025, View Source [SID1234654535]).

The marketing authorization application for VORANIGO will now be reviewed by the European Commission (EC), which has the authority to approve medicines for use in the 27 member states of the EU. Decisions by the EC are also applicable in Norway, Liechtenstein, and Iceland.

"Today’s recommendation for EU approval brings us one step closer to offering VORANIGO to patients in the EU with Grade 2 IDH-mutant glioma who have historically had limited treatment options for this relentless disease," said Susan Pandya, M.D., Vice President Clinical Development and Global Head of Oncology LS/LCM, Servier. "We look forward to continuing conversations with the EMA and other regulatory bodies around the world to introduce VORANIGO as a potential new standard of care for patients with IDH-mutant gliomas."

The CHMP opinion is based on the positive results of the Phase 3 INDIGO trial, a global Phase 3 randomized, double-blind placebo-controlled study of vorasidenib in patients with residual or recurrent Grade 2 glioma with an IDH1/2 mutation who have undergone surgery as their only treatment. Results were presented during the plenary session at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and published simultaneously in The New England Journal of Medicine.

VORANIGO was approved by the United States Food and Drug Administration (FDA) in August 2024 after being granted Fast Track, Breakthrough and Orphan Drug Designations and receiving Priority Review. VORANIGO has also been granted marketing authorization in Canada, Australia, Israel, the United Arab Emirates, Saudi Arabia, and Switzerland. Servier has also submitted marketing authorization applications in the United Kingdom, Japan and various other regions, and reviews by the appropriate health authorities are ongoing.

The use of VORANIGO is investigational in the EU and is not yet approved.

Portage Biotech Reports Results for Fiscal Year Ended March 31, 2025

On July 25, 2025 Portage Biotech Inc. ("Portage" or the "Company") (NASDAQ: PRTG), a clinical-stage immuno-oncology company formed under the laws of the British Virgin Islands, with a portfolio of novel multi-targeted therapies for use as monotherapy and in combination, reported its financial results for the fiscal year ended March 31, 2025 (Press release, Portage Biotech, JUL 25, 2025, View Source [SID1234654534]).

Financial Results from Year Ended March 31, 2025

The Company incurred a net loss of approximately $6.8 million during the fiscal year ended March 31, 2025 ("Fiscal 2025"), which includes approximately $0.2 million of net non-cash expenses. This compares to a net loss of approximately $75.4 million during the fiscal year ended March 31, 2024 ("Fiscal 2024"), which included approximately $60.9 million of net non-cash expenses. Net loss decreased by approximately $68.6 million year-over-year, which is primarily due to lower non-cash losses attributable to full impairment of the Company’s identifiable intangible assets, goodwill, and certain investments as of March 31, 2024.

Operating expenses, including research and development ("R&D") costs and general and administrative ("G&A") expenses, were $7.4 million in the Fiscal 2025, down from $18.2 million in the Fiscal 2024, a decrease of $10.8 million, as detailed below.

R&D expenses decreased by approximately $9.4 million, or approximately 75%, from approximately $12.5 million in Fiscal 2024, to approximately $3.1 million in Fiscal 2025. The decrease was primarily attributable to clinical trial costs (principally CRO-related), which decreased by approximately $3.4 million, from $5.2 million in Fiscal 2024 to $1.8 million in Fiscal 2025, due to the decision to pause enrollment in our sponsored clinical trials in the third and fourth quarters of Fiscal 2024. Manufacturing-related costs decreased by $1.6 million from $1.8 million in Fiscal 2024, compared to $0.2 million in Fiscal 2025, related to the iNKT and adenosine clinical trials. During Fiscal 2024, we deprioritized development of the iNKT program and closed the related clinical trial. In August 2024, we temporarily paused enrollment in the PORT-6 arm of the study. Enrollment resumed in March 2025 with the initiation of the final dose escalation cohort. Non-cash share-based compensation expense allocable to R&D decreased by $1.4 million, from $1.4 million in Fiscal 2024, compared to nil in Fiscal 2025, as the relevant share options fully vested by Fiscal 2024 and no new share option awards were allocable to R&D during Fiscal 2025. Payroll-related expenses decreased by $0.9 million from $1.6 million in Fiscal 2024 to $0.7 million in Fiscal 2025; the decrease in salaries is primarily due to reduced headcount. R&D services decreased by $0.5 million due to the pause of medical writing, analysis, and clinical studies at the beginning of Fiscal 2025. Scientific consulting fees decreased by approximately $0.6 million from $0.8 million in Fiscal 2024 to $0.2 million in Fiscal 2025 to reflect the decrease in activity year-over-year. Additionally, in Fiscal 2024, we incurred a one-time milestone payment of $0.5 million for dosing our first adenosine patients, and finally, $0.5 million in fees paid with respect to the transition of the iNKT study prior to discontinuing the study in Fiscal 2024.

G&A expenses decreased by approximately $1.4 million, or approximately 24.9%, from approximately $5.7 million in Fiscal 2024, to approximately $4.3 million in Fiscal 2025. The decreases are attributable to decreases in: non-cash share-based compensation expense allocable to G&A expenses by $0.9 million, from $1.2 million in Fiscal 2024 to $0.3 million in Fiscal 2025, primarily due to the vesting of certain share options granted in prior years fully vesting by Fiscal 2024 and lower fair value associated with more recent grants; professional fees by $0.7 million, from $2.3 million in Fiscal 2024, compared to $1.6 million in Fiscal 2025, primarily due to decline in public relations and accounting services related expenses; directors’ fees by $0.1 million, from $0.3 million in Fiscal 2024, compared to $0.2 million Fiscal 2025 due to the adoption of a new director compensation policy in March 2025; and general office related supplies and expenses by $0.1 million, from $0.2 million in Fiscal 2024, compared to $0.1 million in Fiscal 2025. These decreases were offset to some extent by an increase in payroll-related and consulting expenses by $0.4 million from $0.9 million in Fiscal 2024 to $1.3 million in Fiscal 2025 primarily attributable to $0.2 million in retention payments to an employee and a consultant included in payroll expenses allocable to general and administrative expenses.

The primary reasons for the year-over-year differences in the Company’s pre-tax items of income and expense were substantially non-cash in nature, aggregating approximately $0.6 million net gain in Fiscal 2025 compared to approximately $67.7 million net loss in Fiscal 2024. The net gain in year over year were attributable to $0.9 million net gain from the settlement and release of obligations and liabilities under the Master Services Agreement between iOx and Parexel partially offset to some extent by the $0.4 million non-cash loss from the change in the fair value of certain warrants accounted for as liabilities, issued in connection with a private placement offering in October 2023 in Fiscal 2025. In Fiscal 2024, the recognized full impairment of the carrying value of in-process research and development of $57.9 million for iOx and $23.6 million for Tarus, as well as a $1.0 million loss on the impairment of the Company’s investment in Stimunity and the Stimunity convertible note. These expenses were partially offset by the non-cash gains from the decrease in the fair value of the deferred purchase price payable to the former Tarus shareholders and the deferred obligation for the iOx milestone, totaling $11.3 million. These losses were offset to some extent by a $0.7 million gain on the sale of Intensity shares, accounted for under fair value through other comprehensive income (FVOCI), which had a carrying value of $2.1 million and a $2.4 million loss during Fiscal 2024 from the Company’s equity financing in October 2023, representing the excess of the fair value of certain warrants over the net proceeds. Additionally, a $6.9 million non-cash gain was recognized from the change in the fair value of certain warrants accounted for as liabilities issued in connection with this equity offering.

Additionally, the Company recognized a non-cash net deferred income tax benefit of $10.5 million in Fiscal 2024, compared to a non-cash net deferred income tax benefit of $3 thousand in Fiscal 2025. The benefit in Fiscal 2024 was primarily attributable to the tax effect of the non-cash impairment loss on IPR&D for iOx, partially offset by the derecognition of previously recognized losses.

As of March 31, 2025, the Company had cash and cash equivalents of approximately $1.7 million and total current liabilities of approximately $1.1 million.

Omeros Corporation Announces Pricing of $22 Million Registered Direct Offering

On July 25, 2025 Omeros Corporation (Nasdaq: OMER) ("Omeros" or the "Company") reported that on July 24, 2025 it entered into a securities purchase agreement with Polar Asset Management Partners to sell approximately $22 million of its common stock in a registered direct offering (Press release, Omeros, JUL 25, 2025, View Source [SID1234654528]).

Under the terms of the securities purchase agreement, the Company has agreed to sell 5,365,853 shares of its common stock at a price of $4.10 per share, which represents a premium of approximately 14% to the closing price of the Company’s common stock on the date of the securities purchase agreement.

The gross proceeds to the Company from the registered direct offering are estimated to be approximately $22 million, before deducting the placement agent’s fees and other estimated offering expenses. The offering is expected to close on or about July 28, 2025, subject to the satisfaction of customary closing conditions.

The proposed offering of the common stock described above is being offered by the Company pursuant to a "shelf" Registration Statement on Form S-3 (File No. 333-268269) filed with the Securities and Exchange Commission (the "SEC") and declared effective by the SEC on November 17, 2022, and the accompanying prospectus contained therein.

The offering is being made only by means of a prospectus supplement and accompanying prospectus. A prospectus supplement describing the terms of the public offering will be filed with the SEC and will form a part of the effective registration statement.

D. Boral Capital LLC is acting as exclusive placement agent for the offering.

Copies of the prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, on the SEC’s website at www.sec.gov.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities of the Company, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Lyell Immunopharma Announces up to $100 Million Equity Private Placement

On July 25, 2025 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing next-generation CAR T-cell therapies for patients with cancer, reported that it has entered into a securities purchase agreement for a private placement with certain institutional and other accredited investors, for gross proceeds of up to approximately $100 million (Press release, Lyell Immunopharma, JUL 25, 2025, View Source [SID1234654527]).

The initial closing of approximately $50 million of common stock at a price of $13.32 per share is anticipated to occur on or about July 25, 2025, subject to customary closing conditions.

The Company has the right, but not the obligation, to require the investors to purchase approximately $50 million of additional common stock and/or pre-funded warrants in lieu of common stock at a closing (the "Milestone Closing") upon achievement, within 12 months following the initial closing, of a clinical milestone relating to the Company’s ongoing LYL314 PiNACLE pivotal trial or certain other corporate milestones (each, a "Milestone Event"). The purchase price per share of common stock in the Milestone Closing will be $25.61, unless the closing price of the common stock on the day before the Milestone Closing is less than $10.41, in which case it will be $10.41 per share (although in such instance, the Company has the right to not proceed with the Milestone Closing).

Each investor will also have the right, but not the obligation, at any time before the Milestone Closing, to purchase at a closing (each, an "Investor Call Closing") the same dollar amount of common stock (or pre-funded warrants in lieu thereof) it has committed to purchase in the Milestone Closing, at a purchase price per share of $30.73, until the later of 12 months following the initial closing and 40 days after the investors receive notice of the achievement of a Milestone Event. If any investor exercises its right to hold its Investor Call Closing, it will not participate in any subsequent Milestone Closing.

If the number of additional shares to be purchased by an investor in the Milestone Closing or an Investor Call Closing would result in the investor owning more than 19.99% (or, at an investor’s election, 9.99%) of Lyell’s issued and outstanding shares of common stock, in lieu of purchasing shares in excess of such threshold, the investor will buy pre-funded warrants at the same price as the common stock less the nominal $0.0001 per share exercise price of the pre-funded warrants.

After deducting offering expenses, Lyell expects to use net proceeds from the private placement, together with the Company’s existing cash, cash equivalents, and marketable securities, to fund two pivotal-stage clinical trials of LYL314 as well as working capital for other general corporate purposes. With this private placement, Lyell expects its cash, cash equivalents and marketable securities balances will be sufficient to meet working capital and capital expenditure needs into mid-2027, including through expected data from the LYL314 PiNACLE pivotal trial from which Lyell intends to submit a Biologics License Application later in 2027 for patients with large B-cell lymphoma (LBCL) relapsed and/or refractory to two or more lines of prior therapy. The funds are also expected to provide capital through the following additional milestones: a clinical trial data update from LYL314 at the end of this year, initiation and conduct of a Phase 3 randomized controlled trial evaluating LYL314 in patients with relapsed or refractory LBCL in the second-line setting and initiation of a clinical trial evaluating an internally-developed new fully-armed CAR T-cell therapy candidate targeting an undisclosed solid tumor indication.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The investors have been granted customary resale Form S-3 registration rights for the shares of common stock issued to them in the financing.

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.