On September 29, 2025, ARS Pharmaceuticals, Inc. (the "Company") and certain direct and indirect subsidiaries of the Company who may become a party thereto from time to time, as guarantors (the "Guarantors"), and ARS Pharmaceuticals Operations, Inc., a wholly owned subsidiary of the Company, as the borrower (the "Borrower" and, collectively with the Guarantors, the "Credit Parties"), reported to have entered into a credit agreement (the "Credit Agreement") with RA Capital Agency Services, LLC (as the "Administrative Agent" and as the "Collateral Agent"), and affiliates of OMERS Administration Corporation and RA Capital Management, L.P., as lenders, and such other lenders from time to time party thereto (the "Lenders"), providing for up to $250.0 million of term loans from the Lenders to the Borrower (the "Term Loans") (Filing, ARS Pharmaceuticals, SEP 29, 2025, View Source [SID1234656313]). The proceeds of the Term Loans will be used to (i) fund research, development and other product development and commercialization activities of the Company’s products and (ii) for other general corporate purposes.

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Pursuant to the terms of the Credit Agreement, the Term Loans may be advanced in four tranches. The first tranche (the "Term A Loan") was advanced in the principal amount of $100.0 million on September 29, 2025 ("Closing Date"). The second tranche (the "Term B Loan") in a principal amount of $25.0 million may be advanced at the Borrower’s election during the period commencing on the six-month anniversary of the Closing Date and ending no later than the one-year anniversary of the Closing Date, subject to customary conditions. The third tranche (the "Term C Loan") in a principal amount of $25.0 million may be advanced at the Borrower’s election during the period commencing on and including the Closing Date and ending no later than the two-year anniversary of the Closing Date, subject to achieving trailing 12-month ("TTM") net revenues for neffy of at least $100.0 million and customary conditions. The fourth tranche (the "Term D Loan") of up to $100.0 million is uncommitted and may be advanced at the Borrower’s election, subject to the consent of all of the Lenders who agree to provide the Term D Loan and customary conditions. The Term Loans will mature on the five-year anniversary of the Closing Date ("Maturity Date"). In connection with entering into the Credit Agreement and drawing the Term A Loan, the Credit Parties entered into a security agreement and pledge agreement and delivered other customary deliverables.

The Term Loans will initially bear interest at a per annum rate of 5.50% plus the greater of (i) three-month forward-looking term SOFR or (ii) 3.00%, which interest rate may be reduced by 25 to 50 basis points based on achieving certain TTM net revenues milestones. At Borrower’s election and subject to certain conditions, 100% of accrued interest in the first two years and 50% of accrued interest in the last three years may be paid-in-kind, in which case the applicable interest rate for the Term Loans shall increase by 1.00% per annum for the portion of such Term Loans that is paid-in-kind. The Borrower will pay certain fees with respect to the Term Loans, including an upfront fee, an administration fee, a repayment premium and an exit fee, as well as certain other fees and expenses of the Administrative Agent and the Lenders.

The obligations of the Borrower under the Credit Agreement are guaranteed on a full and unconditional basis by the Company and the Guarantors and are secured by substantially all of the respective Credit Parties’ tangible and intangible assets and property, including intellectual property, subject to certain exceptions.

The Credit Agreement includes representations and warranties, affirmative covenants (including reporting obligations), negative covenants (including restrictions on making certain investments, incurring additional indebtedness, granting liens, disposing of assets, making certain payments (e.g., dividends), prepayments of other indebtedness, and failing to maintain a minimum liquidity threshold) and events of default that are usual and customary for facilities of this type, in each case, subject to certain permitted exceptions as set forth therein.

The Administrative Agent and Collateral Agent, as well as a Lender, are affiliates of RA Capital Management, L.P. ("RA Capital"). The general partner of RA Capital is RA Capital Management GP, LLC, of which Peter Kolchinsky, Ph.D. and Rajeev Shah are controlling persons. RA Capital Healthcare Fund, L.P. and RA Capital Nexus Fund II, L.P. collectively hold in excess of 10% of the Company’s outstanding common stock and are currently the Company’s largest stockholder. RA Capital serves as the investment adviser for each of RA Capital Healthcare Fund, L.P. and RA Capital Nexus Fund II, L.P. Dr. Kolchinsky serves as a member of the Company’s board of directors.

The foregoing summary of the Credit Agreement is not complete and is qualified in its entirety by reference to the Credit Agreement, a copy of which is filed as Exhibit 10.1 to this report.

On September 29, 2025 Genmab A/S (Nasdaq: GMAB) and Merus N.V. (Nasdaq: MRUS) reported that they have entered into a transaction agreement pursuant to which Genmab intends to acquire all the shares of Merus, a clinical-stage biotechnology company with its late-stage breakthrough therapy asset petosemtamab, which is in Phase 3 development, for USD 97.00 per share in an all-cash transaction representing a transaction value of approximately USD 8.0 billion (Press release, Genmab, SEP 29, 2025, View Source [SID1234656300]). The transaction has been unanimously approved by the Boards of Directors of both companies. A wholly owned subsidiary of Genmab ("Purchaser") will commence a tender offer for 100% of Merus’ common shares, which is anticipated to close by early in the first quarter of 2026.

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The proposed acquisition of Merus is expected to meaningfully accelerate Genmab’s shift to a wholly owned model, expanding and diversifying the company’s revenue, driving sustained growth into the next decade and contributing to Genmab’s evolution into a biotechnology leader. The addition of petosemtamab, Merus’ lead asset, to Genmab’s promising late-stage pipeline is a compelling strategic fit with Genmab’s portfolio and aligns with Genmab’s expertise in antibody therapy development and commercialization in oncology. Following the closing of the transaction, Genmab will have four proprietary programs expected to drive multiple new drug launches by 2027.

"The proposed acquisition of Merus clearly aligns with our long-term strategy. It has the potential to significantly accelerate our evolution into a global biotechnology leader by providing durable growth for the company well into the next decade," said Jan van de Winkel, Ph.D., President and Chief Executive Officer of Genmab. "Petosemtamab has the potential to be a transformational therapy for patients living with head and neck cancer. With our proven track record of success, both in clinical development and in commercialization, we are confident that we will be able to unlock the promise of petosemtamab."

"We are excited for the opportunity to join Genmab, a leader in antibody therapeutics, to further develop and bring petosemtamab to patients. Our two companies have a rich history of innovation with multiple approvals in the field of multispecific antibodies. We believe Genmab has the right vision and experience to advance petosemtamab in recurrent/metastatic head and neck cancer and beyond," said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. "I’m immensely proud of the Merus team who have pioneered our foundational platform technologies to make better medicines and who have demonstrated – with an approved product and a product candidate, petosemtamab, in registrational studies – an ability to deliver on our promise to close in on cancer."

Petosemtamab is an EGFRxLGR5 bispecific antibody with the potential to be both first- and best-in-class in head and neck cancer. It has been granted two Breakthrough Therapy Designations (BTD) by the U.S. Food and Drug Administration (FDA) for first- and second-line plus head and neck cancer indications. Of note, compelling Phase 2 data was presented at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting showing both an overall response rate and median progression free survival that were substantially higher than standard of care.

Merus is currently running two Phase 3 trials in first- and second/third line head and neck cancer, with topline interim readout of one or both trials anticipated in 2026. Based on Genmab’s experience in late-stage development and excellence in commercial execution, Genmab anticipates the potential for the initial launch of petosemtamab in 2027, subject to clinical results and regulatory approvals. Genmab also intends to broaden and accelerate petosemtamab’s development with potential expansion into earlier lines of therapy. Following its initial anticipated approval, Genmab believes that petosemtamab will be accretive to EBITDA with at least one-billion-dollar annual sales potential by 2029, with multi-billion-dollar annual revenue potential thereafter.

Details of the Transaction and Financing
Under the transaction agreement, Purchaser, a wholly owned subsidiary of Genmab, will commence a tender offer for all the outstanding common shares of Merus. Following the closing of the tender offer, Merus and Genmab will effect a series of transactions resulting in Genmab owning 100% of the common shares of Merus (or a successor entity). Depending on the structure of the back end transactions, Merus shareholders that do not tender their shares into the tender offer will either receive the same consideration for their common shares as the common shares tendered into the tender offer (subject to applicable withholding taxes) or a fair price for their common shares determined by a Dutch court in statutory buy-out proceedings. The closing of the tender offer is subject to the satisfaction of customary closing conditions for similar transactions, including a minimum acceptance condition of at least 80% of Merus’ common shares (which threshold may be reduced to 75% unilaterally by Genmab if all other closing conditions are satisfied), approval by Merus’ shareholders of resolutions relating to Merus’ post-closing governance and the back end transactions at Merus’ extraordinary shareholders meeting to be held for that purpose, and completion of the relevant works councils consultation processes.

The USD 97.00 per common share purchase price payable in the tender offer represents a premium of approximately 41% over Merus’ closing stock price on September 26, 2025, of USD 68.89 and approximately 44% over Merus’ 30-day volume weighted average price of USD 67.42.

The transaction is not subject to a financing condition. Consideration is expected to be funded through a combination of cash on hand and approximately $5.5 billion of non-convertible debt financing. Genmab has obtained a funding commitment from Morgan Stanley Senior Funding, Inc. for this amount.

The financing package includes a meaningful portion of prepayable debt, in line with Genmab’s commitment to deleveraging with a target of gross leverage <3x within two years after the closing of the proposed transaction. Today’s news does not impact Genmab’s financial guidance for the full year 2025, last issued on August 7, 2025. Genmab will provide its financial outlook for the full year 2026 in conjunction with its full year 2025 earnings report in February 2026.

PJT Partners and Morgan Stanley & Co. International plc are acting as joint financial advisors to Genmab and A&O Shearman and Kromann Reumert as its legal advisors.

Jefferies LLC is acting as financial advisor to Merus and Latham & Watkins and NautaDutilh as its legal advisors.

Conference Call Details
Genmab will hold a conference call to discuss the transaction today, September 29, 2025 at 1:00 PM CEST / 12:00 PM BST / 7:00 AM EDT. To join the call please use the following registration link View Source Registered participants will receive an email with a link to access dial-in information as well as a unique personal PIN. A live and archived webcast of the calls and relevant slides will be available at View Source

On September 28, 2025 Veracyte, Inc. (Nasdaq: VCYT), a leading genomic diagnostics company, reported that new data from the prospective, randomized integral biomarker BALANCE trial (NCT03371719) finds that the PAM50 molecular signature predicts which patients with recurrent prostate cancer benefit from hormone therapy with apalutamide in addition to salvage radiation therapy (Press release, Veracyte, SEP 28, 2025, View Source [SID1234656299]). The prostate PAM50 biomarker is currently available for Research Use Only on the Decipher GRID (Genomic Resource for Intelligent Discovery) research tool.

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The new findings were shared today by Daniel Spratt, M.D., University Hospitals Seidman Cancer Center, Case Western Reserve University, in a podium presentation at ASTRO 2025, the annual meeting of the American Society for Radiation Oncology, being held in San Francisco.

"Our findings mark the first time, to my knowledge, that a predictive biomarker has been validated in a prospective, biomarker-driven, randomized trial in non-metastatic prostate cancer," said Dr. Spratt. "Thus, this is an unprecedented advancement for patients who can be more-precisely selected to receive hormone therapy or forego the treatment and the potential side effects."

For the study, 295 men with recurrent, non-metastatic prostate cancer following prostate-removal surgery were randomly assigned to salvage radiation therapy with a placebo or apalutamide for 6 months. The PAM50 biomarker was a key stratification variable to ensure each arm had a similar proportion of luminal B and non-luminal B subtypes. They were followed for a median of 5 years during which they were evaluated for biochemical failure, which is a rise in levels of prostate-specific antigen (PSA) post treatment—an early sign of salvage therapy failure. Among the 127 men with luminal B molecular subtype tumors (as determined by the PAM50 signature), 72% of those taking apalutamide did not experience biochemical failure, as compared to the 54% rate in the placebo group [HR 0.45 (80% CI 0.29-0.68), p=0.0062]. In the non-luminal B subset, there was no difference between those taking apalutamide versus placebo (70% vs 71%) [HR 0.95 (80% CI 0.65-1.41), p=0.44].

"These results from NRG GU006 represent the highest level of evidence to support routine biomarker testing in recurrent prostate cancer patients planned to receive secondary radiotherapy," Dr. Spratt added. "With such a strong difference in the metastasis-free survival response to hormone therapy between luminal B and non-luminal-B tumors, the use of the predictive PAM50 biomarker is a game changer to help personalize treatment for men with recurrent prostate cancer beyond merely prognostic tools."

The PAM50 signature is the third biomarker—assessed through the whole-transcriptome-based Decipher platform—that a major study has shown predicts benefit from hormone therapy, radiation therapy or chemotherapy. Another trial—PREDICT-RT—recently completed enrollment two years early and is evaluating the Decipher Prostate test’s ability to predict benefit of combined hormone therapy (ADT and apalutamide) concurrent with radiation in patients with high-risk prostate cancer at initial diagnosis.

"Prostate cancer, like all cancers, is a disease of the genome," said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology. "Our Decipher GRID tool uniquely enables researchers to better pinpoint adverse molecular features that are associated with poor outcomes. This can ultimately lead to more-personalized care for each patient based on their tumor’s unique molecular make-up. We are proud to partner with the world’s leading prostate cancer researchers to help uncover insights that can change the trajectory of care for each individual patient and also help deliver the next generation of prostate cancer diagnostics."

The BALANCE trial results are among 9 Decipher-focused abstracts being presented at the ASTRO 2025 conference. More information can be found here.

About Decipher Prostate

The Decipher Prostate Genomic Classifier is a 22-gene test, developed using RNA whole-transcriptome analysis and machine learning, that helps inform treatment decisions for patients across the full spectrum of prostate cancer. The test is performed on biopsy or surgically resected samples and conveys the aggressiveness of the cancer. For patients with localized or regional prostate cancer, the Decipher score indicates a patient’s risk of metastasis, helping to determine treatment timing and intensity. For patients with metastatic prostate cancer, the Decipher score indicates the likelihood of cancer progression and survival benefit with treatment intensification. Armed with this information, physicians can better personalize their patients’ care. The Decipher Prostate test’s performance and clinical utility has been demonstrated in over 90 studies involving more than 200,000 patients. It is the only gene expression test to achieve "Level I" evidence status and inclusion in the risk-stratification table in the most recent NCCN Guidelines* for prostate cancer. More information about the Decipher Prostate test can be found.

On September 26, 2025 Soligenix, Inc. (Nasdaq: SNGX) ("Soligenix" or the "Company"), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported the pricing of its "reasonable best efforts" public offering with existing and certain healthcare focused institutional investors for the purchase and sale of 5,555,560 shares of common stock of the Company (or common stock equivalents in lieu thereof) and warrants to purchase up to 5,555,560 shares of common stock at a combined purchase price of $1.35 per share and accompanying warrant (the "Offering") (Press release, Soligenix, SEP 26, 2025, View Source [SID1234656278]). The warrants will have an exercise price of $1.35 per share, will be exercisable immediately and will expire five years from the issuance date.

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The Company also has agreed that certain existing May 2023, April 2024 and July 2024 warrants (together, the "Existing Warrants") to purchase an aggregate of 1,162,064 shares of common stock will be amended such that the Existing Warrants will have a reduced exercise price of $1.35 per share and shall expire commensurate with the warrants sold in the Offering.

The closing of the Offering is expected to occur on or about September 29, 2025, subject to the satisfaction of customary closing conditions. The gross proceeds from the Offering are expected to be approximately $7.5 million, before deducting placement agent fees and other estimated Offering expenses. The Company intends to use the net proceeds of this Offering to fund research and development and commercialization activities, working capital and general corporate purposes.

A.G.P./Alliance Global Partners is acting as the sole placement agent in connection with the Offering.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-290413), previously filed with the Securities and Exchange Commission ("SEC") on September 19, 2025, which became effective on September 25, 2025. The Offering is being made only by means of a prospectus forming part of the effective registration statement. A preliminary prospectus relating to the Offering has been filed with the SEC. An electronic copy of the final prospectus will be filed with the SEC and may be obtained, when available, on the SEC’s website located at View Source and may also be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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 the registration or qualification under the securities laws of any such state or other jurisdiction.

On September 26, 2025 Onconetix, Inc. (Nasdaq: ONCO) ("Onconetix" or the "Company") a commercial stage biotechnology company focused on the research, development and commercialization of innovative solutions for men’s health and oncology, reported the September 22, 2025 signing and closing of a private placement of (i) shares of the Company’s Series D Convertible Preferred Stock, $0.00001 par value (the "Series D Preferred Stock"), and (ii) warrants (the "Warrants") to purchase up to an aggregate of 4,362,827 shares of the Company’s common stock, $0.00001 par value per share (the "Common Stock"), for an aggregate purchase price of approximately $12.9 million (the "Financing Transaction") (Press release, Onconetix, SEP 26, 2025, View Source [SID1234656277]). Approximately $9.3 million was paid in cash and the balance was used to offset certain amounts owed by the Company to certain investors. The Series D Preferred Stock are initially convertible into an aggregate of 4,362,827 shares of Common Stock, subject to certain anti-dilution adjustments. The Warrants will have an initial exercise price of $3.6896 per share, subject to certain anti-dilution adjustments, and are exercisable beginning on the issuance date (the "Initial Exercisability Date") and expiring on the third anniversary of the Initial Exercisability Date.

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The Company has filed a Current Report on Form 8-K with the Securities and Exchange Commission on September 26, 2025, with additional details of the transaction. The Company agreed to seek stockholder approval for the issuance of all of the shares of Common Stock issuable upon conversion of the Series D Preferred Stock and exercise of the Warrants in accordance with the rules and regulations of the Nasdaq Stock Market.

In full satisfaction of the Company’s approximately $8.8 million debt to Veru, Inc., approximately $6.3 million of the cash proceeds from the Financing Transaction was paid to Veru, Inc., and the remaining $2.5 million of debt was converted into 3,125 shares of Series D Preferred Stock and 846,975 warrants as part of the Financing Transaction. The Company intends to use the remaining net cash proceeds from the Financing Transaction to cover costs and expenses associated with the termination of a previously contemplated business combination with Ocuvex, Inc., and for working capital and general corporate purposes.