On November 4, 2025 Relmada Therapeutics, Inc. (Nasdaq: RLMD, "Relmada" or the "Company"), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system indications, reported the pricing of its underwritten offering of 40,142,000 shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase up to 5,315,000 shares of common stock. The shares of common stock are being sold at an offering price of $2.20 per share, and the pre-funded warrants are being sold at an offering price of $2.199 per pre-funded warrant, which represents the per share offering price for the common stock less the $0.001 per share exercise price for each such pre-funded warrant. The gross proceeds to Relmada from the offering, before deducting underwriting discounts and commissions and other expenses payable by Relmada, and excluding the exercise of any pre-funded warrants, are expected to be approximately $100 million. The offering is expected to close on November 5, 2025, subject to customary closing conditions. Investors in the offering included Janus Henderson Investors, Ferring Ventures SA, Squadron Capital Management, Marshall Wace, Spruce Street Capital, OrbiMed, Columbia Threadneedle Investments and Driehaus Capital Management.

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Jefferies and Leerink Partners are acting as joint book-running managers for the offering. Mizuho is acting as book-runner for the offering.

Relmada intends to use the net proceeds from the offering, together with existing cash, cash equivalents, and short-term investments, for working capital and general corporate purposes, which includes, without limitation, clinical studies required to gain regulatory approvals, implementation of adequate systems and controls to allow for regulatory approvals, further development of its product candidates, investing in or acquiring companies that are synergistic with or complementary to its technologies, licensing activities related to its current and future product candidates, the development of emerging technologies, investing in or acquiring companies that are developing emerging technologies, licensing activities, or the acquisition of other businesses.

The securities described above were offered by Relmada pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was declared effective by the Securities and Exchange Commission ("SEC") on September 12, 2024. A final prospectus supplement describing the terms of the offering will be filed with the SEC. Copies of the final prospectus supplement and the accompanying base prospectus, when available, may also be obtained by request by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, or by telephone at (877) 821-7388, or by e-mail at [email protected]; Leerink Partners LLC, Syndicate Department, 53 State Street, 40th Floor, Boston, Massachusetts 02109, by telephone at (800) 808-7525 ext. 6105, or by emailing [email protected]; or Mizuho Securities USA LLC, Attention: Equity Capital Markets Desk, at 1271 Avenue of the Americas, New York, New York 10020, or by email at [email protected].

This press release is for informational purposes only and does not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of any securities of Relmada, 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.

(Press release, Relmada Therapeutics, NOV 4, 2025, View Source [SID1234661916])

On November 4, 2025 Imugene Limited (ASX:IMU), a clinical-stage immuno-oncology company, reported that an abstract regarding azer-cel has been selected for oral presentation at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, to be held from 6-9 December 2025 in Orlando, Florida.

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The ASH (Free ASH Whitepaper) Annual Meeting is the world’s premier event in malignant and non-malignant haematology, attracting more than 30,000 clinicians, scientists, and industry representatives from over 100 countries. Each year, the meeting highlights the most significant scientific and clinical advances in the field, with oral abstracts representing the highest tier of accepted submissions.

Imugene’s abstract, titled "Azer-cel, an allogeneic (allo) CD19 CAR T, in combination with low-dose interleukin-2 (IL-2) demonstrates clinical activity in patients with large B-cell lymphoma (LBCL) who relapsed after autologous (auto) CAR T", has been selected for presentation within the session "Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Next Generation CAR-T Clinical Trials in Relapsed/Refractory B-cell NonHodgkin Lymphoma and Multiple Myeloma."

The oral presentation will take place on Saturday 6 December 2025, from 2:30pm to 2:45pm US Eastern Time in West Hall D2 of the Orange County Convention Center.

The abstract published overnight includes clinical activity and safety data from the Company’s azer-cel (allogeneic CD19 CAR T) program, evaluating the combination with low-dose IL-2 in patients with relapsed or refractory large B-cell lymphoma (LBCL) following prior autologous CAR T-cell therapy. The abstract is linked on Imugene’s website at View Source

Imugene’s Managing Director and Chief Executive Officer, Leslie Chong, said: "We are honoured that azer-cel has been selected for oral presentation at ASH (Free ASH Whitepaper), it being the world’s leading haematology conference. This puts a spotlight on the growing clinical interest in allogeneic CAR T approaches and represents an exciting opportunity to share new insights from our ongoing study with the global haematology community."

(Press release, Imugene, NOV 4, 2025, View Source [SID1234659294])

On November 4, 2025 Exelixis, Inc. (Nasdaq: EXEL) reported financial results for the third quarter of 2025, provided an update on progress toward achieving key corporate objectives, and outlined its commercial, clinical and pipeline development milestones.

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"In the third quarter of 2025, Exelixis gained momentum in the cabozantinib franchise and delivered on critical strategic priorities across the research & development portfolio," said Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. "The cabozantinib franchise continued to outperform with sustained growth in renal cell carcinoma and neuroendocrine tumors, where CABOMETYX built on its position as the leading oral therapy for new patient market share in second-line and later settings. In October, we presented the detailed positive results from the STELLAR-303 pivotal trial evaluating zanzalintinib in combination with atezolizumab in advanced colorectal cancer at the 2025 European Society for Medical Oncology Congress, along with a simultaneous publication in The Lancet. Based on these results, we intend to complete the submission of our first new drug application for zanzalintinib in the U.S. before year-end. We also made strong progress across the range of ongoing and planned zanzalintinib pivotal trials, as well as the four ongoing phase 1 clinical studies from our early-stage pipeline where we’re looking to profile and move the most promising candidates into full development. I want to thank the entire Exelixis team for their collective efforts and unwavering commitment as we work toward our goals of improving standards of care and helping more patients with cancer."

Third Quarter 2025 Financial Results
Total revenues for the quarter ended September 30, 2025 were $597.8 million, as compared to $539.5 million for the comparable period in 2024.
Total revenues for the quarter ended September 30, 2025 included net product revenues of $542.9 million, as compared to $478.1 million for the comparable period in 2024. The increase in net product revenues was primarily due to an increase in sales volume.
Collaboration revenues, composed of license revenues and collaboration services revenues, were $54.8 million for the quarter ended September 30, 2025, as compared to $61.5 million for the comparable period in 2024. The decrease in collaboration revenues was primarily related to lower milestone-related revenues recognized in the quarter and lower development cost reimbursements earned, partially offset by higher royalty revenues for the sales of cabozantinib outside the U.S. generated by Exelixis’ collaboration partner Ipsen Pharma SAS (Ipsen).
Research and development expenses for the quarter ended September 30, 2025 were $199.2 million, as compared to $222.6 million for the comparable period in 2024. The decrease in research and development expenses was primarily related to decreases in clinical trial costs and license and other collaboration costs.
Selling, general and administrative expenses for the quarter ended September 30, 2025 were $123.7 million, as compared to $111.8 million for the comparable period in 2024. The increase in selling, general and administrative expenses was primarily related to increases in stock-based compensation and consulting and outside services.
Provision for income taxes for the quarter ended September 30, 2025 was $58.8 million, as compared to $36.8 million for the comparable period in 2024.
Restructuring expenses for the quarter ended September 30, 2025 were $19.8 million. The restructuring expenses primarily consist of severance and employee-related costs. In August 2025, Exelixis’ Board of Directors authorized a corporate reorganization plan (the Plan) to reorganize the Company’s workforce and close the office located in King of Prussia, Pennsylvania. In connection with the Plan, the Company estimates that it will incur aggregate charges of approximately $20.5 million. The majority of these costs were incurred in the third quarter of 2025. The Plan was implemented in the third quarter of fiscal year 2025 and is expected to be substantially completed by the end of fiscal year 2025.
Impairment of long-lived assets for the quarter ended September 30, 2024 of $51.7 million was related to the non-cash asset impairment charge to certain of Exelixis’ leased facilities.
GAAP net income for the quarter ended September 30, 2025 was $193.6 million, or $0.72 per share, basic and $0.69 per share, diluted, as compared to GAAP net income of $118.0 million, or $0.41 per share, basic and $0.40 per share, diluted, for the comparable period in 2024. GAAP net income per share for the quarter ended September 30, 2025 was favorably impacted by lower weighted-average common shares outstanding for the quarter ended September 30, 2025, as compared to the comparable period in 2024, as a result of the stock repurchase programs.

(Press release, Exelixis, NOV 4, 2025, View Source [SID1234659354])

On November 4, 2025 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported results for the third quarter of 2025 and reaffirmed its outlook for solid profitable growth while raising its profitability targets.

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QIAGEN reaffirmed its FY 2025 outlook for net sales growth of about 4-5% CER (about 5-6% CER core sales excluding divestments) and raised its adjusted diluted EPS target to about $2.38 CER (previously about $2.35 CER). QIAGEN also expects an adjusted operating income margin of about 29.5% (about 30% CER) in 2025 while absorbing headwinds from currency movements and tariffs.

QIAGEN also announced two strategic initiatives to strengthen its Sample technologies portfolio and enhance shareholder value. The acquisition of Parse Biosciences provides entry into the rapidly growing single-cell market. QIAGEN also announced plans to complete a $500 million synthetic share repurchase in early January 2026 to further increase shareholder returns, bringing total returns to more than $1 billion since 2024 and well ahead of its 2028 goal.

"QIAGEN continues to deliver in a challenging environment, with another quarter of results above our outlook and among the fastest growth rates in the industry," said Thierry Bernard, CEO of QIAGEN. "We are pleased with the sustained growth from QIAstat-Dx and QuantiFERON, along with solid momentum in Sample technologies as we prepare to launch three new instruments. The acquisition of Parse Biosciences is an excellent strategic fit, strengthening our leadership in Sample technologies by providing access to the high-growth single-cell market and the ability to offer solutions to drive large-scale AI-driven biology. It reflects our commitment to invest in innovation offering accretive returns and expand our addressable markets. As we update our targets for 2025, we are moving ahead on our ambitions to deliver solid profitable growth," he said.

"Our strong profitability and cash generation are allowing QIAGEN to step up shareholder returns," said Roland Sackers, CFO of QIAGEN. "With the execution of the $500 million repurchase in January 2026 that shareholders approved at our last Annual General Meeting, we are returning more than $1 billion to shareholders well ahead of our 2028 goal. We remain focused on generating the highest returns and are reviewing how to increase this target while also strengthening our portfolio through organic investments and targeted acquisitions such as Parse. We anticipate that our ongoing capital allocation decisions will bring our leverage ratio toward the industry average of about 2x in 2026."

Please find the full press release incl. tables as a PDF for download at the top of this page.

Investor presentation and conference call

A conference call is scheduled for Wednesday, November 5, 2025, at 15:30 Frankfurt Time / 14:30 London Time / 9:30 New York Time. A live audio webcast will be available in the Investor Relations section of the QIAGEN website (www.qiagen.com), with a recording accessible after the event. The accompanying presentation will be published in advance under "Events and Presentations" in the same section.

(Press release, Qiagen, NOV 4, 2025, View Source;EPS-Target-Announces-Parse-Acquisition-and-500-Million-Share-Repurchase/default.aspx [SID1234659370])

On November 4, 2025 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and NEC Corporation (NEC; TSE: 6701), a leader in IT, network and AI technologies, reported it will jointly present additional immunological data profiling the immune response after treatment with the individualized neoantigen therapeutic vaccine (INTV) TG4050 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. The conference will be held in National Harbor, Maryland, USA, from November 5 to 9, 2025.

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Comprehensive immunogenicity data confirm TG4050’s ability to induce neoantigen-specific cytotoxic CD8+ T cell responses capable of targeting and eliminating tumor cells, thereby contributing to the prevention of cancer relapse, when used as monotherapy.

Prof. Le Tourneau, MD, PhD, Medical Oncologist at Gustave Roussy, and Principal Investigator, commented: "These new immunological data provide compelling evidence confirming TG4050’s mechanism of action. They also offer a clear rationale for the sustained prevention of relapses, which is a critical outcome for long-term patient benefit."

Data presented at SITC (Free SITC Whitepaper) demonstrate that TG4050 in monotherapy induces a potent CD8+ T cell response consistent with durable anti-tumor immunity:

Vaccine-induced cytotoxic CD8+ T cells display effector phenotype biomarkers even one year after the end of treatment, suggesting potential long-term effector functions.
CD8+ T cells express high levels of cytotoxic and tissue-resident biomarkers, suggesting that these cells are effective at killing cancer cells and likely to be found not only in the blood but also in tissues, where they are designed to be able to scout for and eliminate tumor cells.
The abstract is available on both the new windowSITC and PDFTransgene websites. The poster presentation will take place on November 8 and will be available that day on both the SITC (Free SITC Whitepaper) and Transgene’s websites.

Dr. Emmanuelle Dochy, MD, Chief Medical Officer of Transgene, said: "We are extremely proud to present new immunological data that further characterize the CD8+ T cell responses against the selected neoantigens. These translational data confirm that the vaccine selected neoantigens that induce an efficient immune response. TG4050 is currently being evaluated in the Phase II part of our ongoing Phase I/II study. The first immunogenicity data from this Phase II part are expected to be available in the second half of 2026."

Motoo Nishihara, Corporate EVP and CTO, at NEC, added: "These findings highlight the strong potential of NEC’s AI-driven platform in enabling the development of individualized neoantigen therapeutic vaccines. The confirmation of the mechanism of action and evidence of durable relapse prevention mark important milestones that reinforce our dedication to revolutionizing cancer treatment through cutting-edge AI innovation."

Transgene and NEC previously shared data (see PDFpress release) illustrating that CD8+ T cells specific to tumor neoantigens have been detected in patients treated with TG4050. These cells target multiple neoantigens encoded in the vaccine and their responses persist for up to two years after the start of the treatment.

New data provide key mechanistic insights into how TG4050 induces and sustains potent, CD8+ T cell responses in operable HNSCC* patients

Comprehensive immunogenicity data demonstrate TG4050’s ability to induce neoantigen-specific cytotoxic CD8+ T cell responses capable of targeting and eliminating tumor cells, supporting its potential to reduce risk of relapse

Conference call scheduled on November 14 at 4 p.m. CET (in English). See details below.

Strasbourg, France & Tokyo, Japan, November 4, 2025, 5:45 p.m. CET – Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and NEC Corporation (NEC; TSE: 6701), a leader in IT, network and AI technologies, will jointly present additional immunological data profiling the immune response after treatment with the individualized neoantigen therapeutic vaccine (INTV) TG4050 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. The conference will be held in National Harbor, Maryland, USA, from November 5 to 9, 2025.

Comprehensive immunogenicity data confirm TG4050’s ability to induce neoantigen-specific cytotoxic CD8+ T cell responses capable of targeting and eliminating tumor cells, thereby contributing to the prevention of cancer relapse, when used as monotherapy.

Prof. Le Tourneau, MD, PhD, Medical Oncologist at Gustave Roussy, and Principal Investigator, commented: "These new immunological data provide compelling evidence confirming TG4050’s mechanism of action. They also offer a clear rationale for the sustained prevention of relapses, which is a critical outcome for long-term patient benefit."

Data presented at SITC (Free SITC Whitepaper) demonstrate that TG4050 in monotherapy induces a potent CD8+ T cell response consistent with durable anti-tumor immunity:

Vaccine-induced cytotoxic CD8+ T cells display effector phenotype biomarkers even one year after the end of treatment, suggesting potential long-term effector functions.
CD8+ T cells express high levels of cytotoxic and tissue-resident biomarkers, suggesting that these cells are effective at killing cancer cells and likely to be found not only in the blood but also in tissues, where they are designed to be able to scout for and eliminate tumor cells.
The abstract is available on both the new windowSITC and PDFTransgene websites. The poster presentation will take place on November 8 and will be available that day on both the SITC (Free SITC Whitepaper) and Transgene’s websites.

Dr. Emmanuelle Dochy, MD, Chief Medical Officer of Transgene, said: "We are extremely proud to present new immunological data that further characterize the CD8+ T cell responses against the selected neoantigens. These translational data confirm that the vaccine selected neoantigens that induce an efficient immune response. TG4050 is currently being evaluated in the Phase II part of our ongoing Phase I/II study. The first immunogenicity data from this Phase II part are expected to be available in the second half of 2026."

Motoo Nishihara, Corporate EVP and CTO, at NEC, added: "These findings highlight the strong potential of NEC’s AI-driven platform in enabling the development of individualized neoantigen therapeutic vaccines. The confirmation of the mechanism of action and evidence of durable relapse prevention mark important milestones that reinforce our dedication to revolutionizing cancer treatment through cutting-edge AI innovation."

Transgene and NEC previously shared data (see PDFpress release) illustrating that CD8+ T cells specific to tumor neoantigens have been detected in patients treated with TG4050. These cells target multiple neoantigens encoded in the vaccine and their responses persist for up to two years after the start of the treatment.

Transgene will host a webcast (in English) to discuss the SITC (Free SITC Whitepaper) data on November 14, 2025, from 10:00 a.m. to 11:00 a.m. ET (4 p.m. to 5 p.m. CET).

Webcast link to English language conference call:
new windowView Source

(Press release, Transgene, NOV 4, 2025, View Source [SID1234659388])