Allogene Therapeutics Reports Favorable Result for Servier in Arbitration with Cellectis




Allogene Therapeutics Reports Favorable Result for Servier in Arbitration with Cellectis

• Arbitration Ruling Reaffirms Allogene’s Full Control of Cemacabtagene Ansegedleucel (Cema-Cel)
• Decision Reconfirms Allogene’s Expanded Sub-License Covering EU and UK Rights with Options for Japan and China, Clearing the Path for Allogene to Acquire Full Global Rights
• 1H 2026 Interim Futility Analysis from the Pivotal Phase 2 ALPHA3 Trial with Cema-Cel in First-Line (1L) Consolidation Large B-Cell Lymphoma (LBCL) Remains on Track

SOUTH SAN FRANCISCO, Calif., Dec. 15, 2025 (GLOBE NEWSWIRE) — Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, today noted the favorable outcome for Servier in its arbitration with Cellectis (Euronext Growth: ALCLS –  NASDAQ: CLLS) as it relates to cemacabtagene ansegedleucel (cema-cel). This decisive win reconfirmed Allogene’s full development and commercial control of cema-cel in the United States, all EU Member States, and the United Kingdom, while clearing the path to obtain full global commercialization rights from Servier.

In particular, the tribunal:

• Rejected Cellectis’s allegations relating to alleged breaches by Servier of its development obligations;
• Rejected Cellectis’s financial claims, finding that milestone payments tied to the pivotal trial are not due until U.S. Food and Drug Administration acceptance of a Biologics License Application (BLA); and
• Ordered only a partial termination of the license strictly limited to the UCART19 V1 product (formerly known as ALLO-501, which was discontinued in 2021 in favor of ALLO-501A/cema-cel) and directed Cellectis to negotiate in good faith a direct license to Allogene on terms substantially similar to the existing agreement, if Allogene elects to pursue it.

With this legal matter resolved, Allogene enters 2026 with improved fundamentals. The company is approaching one of the most meaningful catalyst periods in the allogeneic CAR T field, including a 1H 2026 interim futility analysis comparing MRD conversion with cema-cel following standard fludarabine/cyclophosphamide lymphodepletion versus observation in first line patients with large B-cell lymphoma (LBCL).

About Allogene Therapeutics
Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow Allogene Therapeutics on X and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. This press release may, in some cases, use terms such as “expect,” “project,” “plan,” “scheduled,” “on track,” “aim,” “will,” “may,” “could,” “guidance,” “estimate,” “can,” and “potential,” and similar expressions that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses, or current expectations concerning, among other things: the timing for Allogene’s interim futility analysis from the pivotal phase 2 ALPHA3 trial in cema-cel; whether Allogene is approaching one of the most meaningful catalyst periods in the allogeneic CAR T field; and the potential for Allogene to obtain full global commercialization rights from Servier for cema-cel. Various factors may cause material differences between Allogene’s expectations and actual results, including risks and uncertainties related to: clinical development risks, including our novel allogeneic CAR T approach and the unproven first-line consolidation setting in LBCL, the possibility that early or Phase 1 data may not predict later outcomes, trial delays or enrollment challenges, and adverse events (including those previously observed in certain ALPHA3 arms); contractual and counterparty risks; regulatory risks, including potential FDA or foreign authority disagreement with plans or interpretations, requests for additional data or trials, and possible requirements related to MRD assays; manufacturing and CMC risks, including challenges in consistent, scalable manufacturing and technology implementation that could affect timelines, outcomes, or availability; reliance on third parties, including licensors and collaborators (e.g., Cellectis, Servier, and Foresight Diagnostics); and financial risks relating to continued operating losses, the need for additional financing, and the possibility of not meeting financial guidance. These and other risks are discussed in greater detail in Allogene’s filings with the Securities and Exchange Commission (SEC), including, without limitation, under the “Risk Factors” heading in its Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, filed with the SEC on November 6, 2025. Any forward-looking statements made in this press release speak only as of the date of this press release. Allogene assumes no obligation to update forward-looking statements, whether as a result of new information, future events, or otherwise, after the date of this press release.

Allogene’s investigational AlloCAR T oncology products utilize Cellectis technologies. Cemacabtagene ansegedleucel (cema-cel) was developed based on an exclusive license granted by Cellectis to Servier. Servier has granted Allogene exclusive rights to cema-cel in the U.S., all EU Member States and the United Kingdom. 

Allogene Media/Investor Contact:
Christine Cassiano
EVP, Chief Corporate Affairs & Brand Strategy Officer
Christine.Cassiano@allogene.com

Vivos Therapeutics to Participate in Online Fireside Chat with Water Tower Research on December 16, 2025, at 11 am EST




Vivos Therapeutics to Participate in Online Fireside Chat with Water Tower Research on December 16, 2025, at 11 am EST

LITTLETON, Colo., Dec. 15, 2025 (GLOBE NEWSWIRE) — Vivos Therapeutics, Inc. (“Vivos” or the “Company’’) (NASDAQ: VVOS), a leading medical device and healthcare services company specializing in the delivery of highly effective diagnostic procedures and proprietary treatments for sleep related breathing disorders, including obstructive sleep apnea (OSA), today announced that the Company’s CEO Kirk Huntsman and CFO Brad Amman will participate in a fireside chat with Robert Sassoon, senior research analyst of Water Tower Research (“WTR”) on Tuesday, December 16, 2025, at 11:00 am ET.

Vivos management will discuss the strategic business model pivot and operational execution; the market opportunity and competitive environment; and Vivos’ growth and financial strategies.

To register for this listen-only event, please visit:

Fireside Chat

The replay of the fireside chat will be available for 30 days in the “Investor Relations” section on Vivos’ website at www.vivos.com.

About Vivos Therapeutics, Inc.

Vivos Therapeutics, Inc. (NASDAQ: VVOS) is a medical technology company focused on developing and commercializing innovative diagnostic and treatment methods for patients suffering from breathing and sleep issues arising from certain dentofacial abnormalities such as obstructive sleep apnea (OSA) and snoring in adults. Vivos’ devices have been cleared by the U.S. Food and Drug Administration (FDA) for adult patients diagnosed with all severity levels of OSA and moderate-to-severe OSA in children ages 6 to 17. Vivos’ groundbreaking Complete Airway Repositioning and Expansion (CARE) devices are the only FDA 510(k) cleared technology for treating severe OSA in adults and the first to receive clearance for treating moderate to severe OSA in children. 

OSA affects over 1 billion people worldwide, yet 90% remain undiagnosed and unaware of their condition. This chronic disorder is not just a sleep issue—it is closely linked to many serious chronic health conditions. While the medical community has made strides in treating sleep disorders, breathing and sleep health remain areas that are still not fully understood. As a result, legacy OSA treatments like CPAP are often mechanistic and fail to address the root causes of OSA. 

Founded in 2016 and based in Littleton, Colorado, Vivos is working to change this. Through innovative technology, education, and acquisitions of, or commercial collaborations with, sleep healthcare providers, Vivos is empowering healthcare providers to address the complex needs of OSA patients more thoroughly.

Vivos calls the use of its appliances and protocols to treat OSA The Vivos Method, which offers a proprietary, clinically effective solution that is nonsurgical, noninvasive, and nonpharmaceutical, providing hope to allow patients to Breathe New Life.

For more information, visit www.vivos.com. 

Cautionary Note Regarding Forward-Looking Statements

This press release, the online presentation described herein, including statements of the Company’s management and other parties made in connection therewith, contain “forward-looking statements” (as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended) concerning future events. Words such as “may”, “would”, “should”, “expects”, “projects,” “potential,” “intends”, “plans”, “believes”, “anticipates”, “hopes”, “estimates”, “goal”. “aim” and variations of such words and similar expressions are intended to identify forward-looking statements. In this press release, forward-looking statements include, without limitation, those relating to (i) the actual future impact of Vivos’ strategic acquisition and alliance model on its future revenues and results of operations and (ii) the anticipated benefits and potential expansion of Vivos’ marketing and distribution model as described herein. These statements involve significant known and unknown risks and are based upon several assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond Vivos’ control. Actual results may differ materially and adversely from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to: (i) the risk that Vivos may be unable to continue to integrate business from the acquisition and alliance model into its own or otherwise implement sales, marketing and other strategies that increase revenues, (ii) the risk that some patients may not achieve the desired results from using Vivos’ products, (iii) risks associated with regulatory scrutiny of and adverse publicity in the sleep apnea diagnosis and treatment sector; (iv) the risk that Vivos may be unable to secure additional financing to acquire additional sleep centers practices on reasonable terms when needed, if at all, or maintain its Nasdaq listing, (v) market and other conditions that could impact Vivos’ business or ability to obtain financing, and (vi) other risk factors described in Vivos’ filings with the Securities and Exchange Commission (“SEC”). Vivos’ filings can be obtained free of charge on the SEC’s website at www.sec.gov. Except to the extent required by law, Vivos expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Vivos’ expectations with respect thereto or any change in events, conditions, or circumstances on which any statement is based.

Media Inquiries: 
Jennifer Hauser, Executive Assistant to the CEO
Investor Relations Contact
investors@vivoslife.com

XOMA Royalty Enters into Agreement to Acquire Generation Bio




XOMA Royalty Enters into Agreement to Acquire Generation Bio

– Acquisition provides XOMA Royalty with potential milestone and royalty payments under Generation Bio’s collaboration with Moderna –

– Generation Bio’s cell-targeted lipid nanoparticles (ctLNP) delivery platform for small interfering RNA (siRNA) and other nucleic acid therapies to be included in XOMA Royalty’s portfolio –

EMERYVILLE, Calif. and CAMBRIDGE, Mass., Dec. 15, 2025 (GLOBE NEWSWIRE) — XOMA Royalty Corporation (“XOMA Royalty”) (NASDAQ: XOMA), the biotech royalty aggregator, announced today it has entered into an agreement to acquire Generation Bio Co. (“Generation Bio”) (NASDAQ: GBIO) for a cash price of $4.2913 per share at the closing of the merger. Generation Bio stockholders also will receive one non-transferable contingent value right (“CVR”) per share that entitles holders to receive potential payments of a pro rata portion of:

• 100% of the amount by which net cash at closing, as finally determined pursuant to the CVR agreement, exceeds $29 million;
• either 90% or 100% of any savings realized by XOMA Royalty on the Company’s Cambridge office lease obligations, subject to the timing of resolution of the lease obligations;
• a share of any proceeds from Generation Bio’s existing license agreement with Moderna, which includes potential development and commercial milestones and royalties on commercial sales, calculated on a sliding scale delivering up to 90% of such payments to CVR holders; and
• a share of payments from any out license or sale of the Generation Bio ctLNP delivery platform, calculated on a sliding scale delivering up to 70% of such payments to CVR holders 

following the closing.

Following a thorough review process conducted with the assistance of its legal and financial advisors, Generation Bio’s board of directors has determined that the acquisition by XOMA Royalty is in the best interests of all Generation Bio stockholders and has unanimously approved the Merger Agreement.

Terms
Pursuant and subject to the terms of the Merger Agreement, a wholly owned subsidiary of XOMA Royalty will commence a tender offer (the “Offer”) within 15 business days, to acquire all outstanding shares of Generation Bio common stock. Closing of the Offer is subject to certain conditions, including the tender of Generation Bio common stock representing at least a majority of the total number of outstanding shares and other customary closing conditions. Immediately following the closing of the tender offer, Generation Bio will merge with a subsidiary of XOMA Royalty, and all remaining shares not tendered in the offer, other than appraisal shares, will be converted into the right to receive the same cash and CVR consideration per share as is provided in the tender offer.

Generation Bio stockholders in possession of approximately 15% of Generation Bio common stock have signed support agreements under which such stockholders agreed to tender their shares in the Offer and support the merger. The acquisition is expected to close in February 2026.

Advisors
XOMA Royalty was represented by Gibson, Dunn & Crutcher LLP. TD Cowen served as financial advisor, and Wilmer Cutler Pickering Hale and Dorr LLP served as legal counsel, to Generation Bio.

About XOMA Royalty Corporation
XOMA Royalty is a biotechnology royalty aggregator playing a distinctive role in helping biotech companies achieve their goal of improving human health. XOMA Royalty acquires the potential future economics associated with pre-commercial and commercial therapeutic candidates that have been licensed to pharmaceutical or biotechnology companies. When XOMA Royalty acquires the future economics, the sellers receive non-dilutive, non-recourse funding they can use to advance their internal drug candidate(s) or for general corporate purposes. XOMA Royalty has an extensive and growing portfolio of assets (asset defined as the right to receive potential future economics associated with the advancement of an underlying therapeutic candidate). For more information about XOMA Royalty and its portfolio, please visit www.xoma.com or follow XOMA Royalty Corporation on LinkedIn.

About Generation Bio
Generation Bio is a biotechnology company that was historically working to change what’s possible for people living with T cell-driven autoimmune diseases. Generation Bio’s approach leveraged cell-targeted lipid nanoparticles (ctLNP) to selectively deliver small interfering RNA (siRNA) to T cells.

For more information, please visit www.generationbio.com.

XOMA Royalty Forward-Looking Statements/Explanatory Notes
Certain statements contained in this press release are forward-looking statements, including statements regarding the expected timing and ability to satisfy the conditions required to close the tender offer, the merger and transactions related to the Merger Agreement, the ability of XOMA Royalty to monetize Generation Bio’s delivery platform for the benefit of XOMA Royalty and Generation Bio stockholders, and the ability to achieve any dispositions within the disposition period under the CVR. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “approximately,” “look to,” “plan,” “expect,” “may,” “will,” “could” or “should,” the negative of these terms or similar expressions.  These forward-looking statements are not a guarantee of XOMA Royalty’s performance, and you should not place undue reliance on such statements. These statements are based on assumptions that may not prove accurate, and actual results could differ materially from those anticipated due to certain risks including the risk that XOMA Royalty does not achieve anticipated net cash after winding down Generation Bio’s operations and concluding remaining activities, the risk that XOMA Royalty is unable to develop or otherwise enter into dispositions related to the Generation Bio programs, and risks that the conditions to the closing the merger in the Merger Agreement are not satisfied. Other potential risks to XOMA Royalty meeting these expectations are described in more detail in XOMA Royalty’s most recent filing on Form 10-Q and in other filings with the Securities and Exchange Commission. Any forward-looking statement in this press release represents XOMA Royalty’s beliefs and assumptions only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. XOMA Royalty disclaims any obligation to update any forward-looking statement, except as required by applicable law.

EXPLANATORY NOTE: Any references to “portfolio” in this press release refer strictly to milestone and/or royalty rights associated with a basket of drug products in development. Any references to “assets” in this press release refer strictly to milestone and/or royalty rights associated with individual drug products in development.

Generation Bio Cautionary Note Regarding Forward-Looking Statement
This press release contains “forward-looking” statements that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those implied by the forward-looking statements. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding the proposed transactions between XOMA Royalty and Generation Bio, including the Offer and merger, the expected timetable for completing the proposed transactions, the potential benefits of the transactions, the potential consideration amount from the proposed transactions and the terms of the Merger Agreement and CVR agreement, and any other statements about Generation Bio’s management’s future expectations, beliefs, goals, plans or prospects. Generation Bio may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including, among other things, the risk that the proposed transactions may not be completed in a timely manner, or at all, which may adversely affect Generation Bio’s business and the price of its common stock; the possibility that various closing conditions of the Offer or the merger may not be satisfied or waived; uncertainty regarding how many of Generation Bio’s stockholders will tender their shares in the Offer; the risk that competing offers or acquisition proposals will be made; the occurrence of any event, change or other circumstance that could give rise to the termination of the Merger Agreement and the transactions; uncertainty as to the ultimate transaction costs; the possibility that milestone payments related to the CVR will never be achieved and that no milestone payments may be made; the effect of the announcement or pendency of the proposed transactions on Generation Bio’s trading price, business, operating results and relationships with collaborators, vendors, competitors and others; the risk that stockholder litigation or legal proceedings in connection with the proposed transactions may result in significant costs of defense, indemnification and liability, or present risks to the timing or certainty of the closing of the proposed transactions; the outcome of any stockholder litigation or legal proceedings that may be instituted against Generation Bio related to the Merger Agreement or the proposed transactions; changes in Generation Bio’s businesses during the period between announcement and closing of the proposed transactions; uncertainties pertaining to other business effects, including the effects of industry, market, economic, political or regulatory conditions, future exchange and interest rates and changes in tax and other laws, regulations, rates and policies; and other risks and uncertainties, any of which could cause Generation Bio’s actual results to differ from those contained in the forward-looking statements, that are described in greater detail in the section entitled “Risk Factors” in Generation Bio’s Quarterly Report on Form 10-Q for the period ended September 30, 2025 filed with the SEC on November 5, 2025, as well as in other filings Generation Bio may make with the SEC in the future and in the Schedule TO and related Offer documents to be filed by XOMA Royalty. Any forward-looking statements contained in this filing speak only as of the date hereof, and Generation Bio does not undertake and expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. 

Important Information and Where to Find It
The Offer for the outstanding shares of Generation Bio referenced in this press release has not yet commenced. This press release is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell securities, nor is it a substitute for the Offer materials that XOMA Royalty and its subsidiary will file with the SEC. At the time the Offer is commenced, XOMA Royalty and its subsidiary will file Offer materials on Schedule TO, and, thereafter, Generation Bio will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the Offer.

THE OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 WILL CONTAIN IMPORTANT INFORMATION. HOLDERS OF SHARES OF GENERATION BIO’S COMMON STOCK ARE URGED TO READ THESE DOCUMENTS CAREFULLY WHEN THEY BECOME AVAILABLE (AS EACH MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME) BECAUSE THEY WILL EACH CONTAIN IMPORTANT INFORMATION THAT HOLDERS OF SHARES OF GENERATION BIO’S COMMON STOCK SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR SHARES.

The Offer to Purchase, related Letter of Transmittal and certain other Offer documents will be made available to Generation Bio common stock holders at no expense upon request and will be made available to the public for free at the SEC’s website at www.sec.gov or by accessing the Investor Relations section of both companies website at https://www.investors.xoma.com and https://investors.generationbio.com/investor-relations.

Abivax Presents Third Quarter 2025 Financial Results




Abivax Presents Third Quarter 2025 Financial Results

Abivax Presents Third Quarter 2025 Financial Results

• Cash and cash equivalents of EUR 589.7 (as of September 30, 2025) with a cash runway into Q4 2027

PARIS, France, December 15, 2025, 10:05 p.m. CET – Abivax SA (Euronext Paris: FR0012333284 – ABVX / Nasdaq – ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases, announced today its key financial information for the nine months ended September 30, 2025. The unaudited interim condensed consolidated financial statements as of and for the three and nine months ending September 30, 2025, reviewed by the Company’s Board of Directors on December 11, 2025, have been reviewed by the Company’s external auditors.

Abivax provided, since the most recently released financial results press release, the following key updates on its business and operational goals in press releases published:

• On September 23, 2025, a press release titled “Abivax Announces Presentation of Late-Breaking Abstract of Obefazimod from the ABTECT Phase 3 Induction Trials at 2025 United European Gastroenterology (UEG) Meeting”
• On September 29, 2025, a press release titled “Abivax Announces Acceptance of Additional Late-Breaking Abstract from the ABTECT Phase 3 Induction Trials to be Presented at 2025 United European Gastroenterology (UEG) Meeting”
• On October 5, 2025, a press release titled “Abivax Announces Late-Breaking Presentation of 8-Week ABTECT Trial Results with Updated Safety Data”
• On October 6, 2025, a press release titled “Abivax Announces Late-Breaking Presentation of 8-Week ABTECT Induction Trial Results in Participants With and Without Prior Inadequate Response to Advanced Therapies”
• On November 3, 2025, a press release titled “Abivax Announces Patient-Reported Outcomes Data from the Phase 3 ABTECT Induction Trials of Obefazimod, Demonstrating Significant Improvements in Quality of Life for Patients with Moderate-to-Severely Active Ulcerative Colitis”

Third Quarter 2025 Financial Highlights (IFRS figures)
(Consolidated, unaudited results)

*Certain figures may not add or recalculate due to the use of rounded numbers.

• Operating loss increased by EUR 44.2M to EUR 174.4M for the nine months ending September 30, 2025 compared to EUR 130.2M for the same period in 2024. Operating income, consisting predominantly of research tax credit, subsidies, and issuance, cancellation and depositary fees collected on ADS transactions, decreased by EUR 4.0M to EUR 4.1M for the nine months ending September 30, 2025 compared to EUR 8.1M for the same period in 2024. The increase in operating loss was driven by an increase in operating expenses as described further below.

• Research and development (R&D) expenses increased by EUR 25.4M to EUR 133.4M for the nine months ending September 30, 2025 compared to EUR 107.9M for the same period in 2024. This increase was predominantly driven by:
  • A EUR 8.6M increase in costs related to the Company’s ulcerative colitis (UC) clinical program and continued progression of its phase 3 trials;
  • A EUR 5.4M increase in costs related to the Company’s Crohn’s Disease (CD) clinical program, driven by the progression of Phase 2b clinical trials for obefazimod in CD;
  • A EUR 6.0M increase in costs related to other obefazimod studies;
  • A EUR 5.9M increase in transversal expenses in CMC and supply chain costs related to the progression of clinical trials and anticipation of future commercial launch; and
  • A sharp rise in employer contributions related to the Company’s equity awards, in turn explained by the increase in the Company’s share price during the third quarter of 2025, which contributed to overall increase in spend across all operating expense categories, in an amount of €14.8 million (of which €14.5 million was attributable to the three-months ended September 30, 2025 compared to September 30, 2024.

• Sales and marketing (S&M) expenses decreased by EUR 1.7M to EUR 3.4M for the nine months ending September 30, 2025 compared to EUR 5.1M for the same period in 2024. The decrease was predominantly driven by a reduction in sales and marketing headcount as well as one-time costs of €1.8 million that were incurred in the prior year period for the Company’s corporate re-branding, including its new website.
• General and administrative (G&A) expenses increased by EUR 16.5M to EUR 41.8M for the nine months ending September 30, 2025 compared to EUR 25.3M for the same period in 2024. This increase was primarily due to:
  • An increase of EUR 16.1M in personnel costs, of which EUR 15.1M were employer tax and social contributions related to the Company’s AGAs, resulting from the increase in the Company’s share price during the third quarter of 2025; and
  • An increase of EUR 1.2M in spending related to legal and professional fees and other costs associated with operating as a dual-listed public company.
• For the nine months ended September 30, 2025, the EUR 79.7M financial gain (loss) was driven primarily by:
  • Increases in the fair value of the senior convertible notes (Heights Convertible Notes) issued in the August 2023 financing with Heights Capital Management and the warrants issued in August 2023 to Kreos Capital and Claret European Growth Capital (Kreos / Claret BSA) by EUR 36.0M and EUR 29.9M, respectively (driven by the increase in the Company’s share price prior to the conversion of the notes into ordinary shares);
  • Foreign exchange losses of EUR 11.4M, including EUR 9.1M non-cash impact of the revaluation of U.S. dollar-denominated cash and cash equivalents on hand as of September 30, 2025;
  • Interest expenses of EUR 9.3M in relation to borrowings and loans; and
  • Non-cash expense of EUR 15.1M in relation to royalty certificates;
  • Offset by EUR 11.7M of foreign exchange gains (including EUR 10.7M related to the Company’s July 2025 public offering), interest income of EUR 4.4M in relation to the invested proceeds from cash on hand, and EUR 3.6M of non-cash income related to the extinguishment of the Kreos / Claret minimal return indemnification liability (following the exercise of the Kreos / Claret BSA and conversion of the Kreos portion of the Tranche A OCABSA).

• The net loss for the nine months ended September 30, 2025 of EUR 254.1 million includes the following significant (greater than EUR 1.5M) non-cash expenses/(income):

• Cash and cash equivalents as of September 30, 2025 was EUR 589.7M compared to EUR 144.2M as of December 31, 2024. The increase was primarily due to the EUR 608.1M in net proceeds, including foreign exchange gains from the period of the close of the fundraise to the receipt of cash, from the Company’s July 2025 public offering. This was partially offset by EUR 137.9M used in operations and EUR 23.4M related to principal and interest paid on the Company’s debt facilities.
• On July 28, 2025, Abivax completed its underwritten public offering of 11,679,400 American Depositary Shares, each representing one ordinary share, EUR 0.01 nominal value per share, of the Company, in the United States. The aggregate gross proceeds amounted to approximately $747.5 million, equivalent to approximately EUR 637.5 million, before deduction of underwriting commissions and offering expenses. The net proceeds, after deducting underwriting commissions and offering expenses, were approximately $700.3 million, equivalent to approximately EUR 597.2 million.
• During the nine months ending September 30, 2025, Heights Capital Management converted the Heights Convertible Notes (corresponding to the entirety of the outstanding principal amount of EUR 21.9 million) into 920,377 new ordinary shares of the Company at a conversion price of EUR 23.7674 per ordinary share in accordance with the terms and conditions of the Heights Convertible Notes. Following these share issuances, Abivax no longer holds any debt with Heights Capital Management.
• On August 6, 2025, Kreos Capital VII(UK) Limited converted its portion of the Tranche A convertible OCABSA resulting in the issuance of 785,389 ordinary shares of the Company.   In addition, on the same date Kreos Capital VII Aggregator SCSp exercised its share warrants (the tranche A-B BSA and tranche C BSA) resulting in the issuance of 319,251 ordinary shares of the Company.
• On August 28, 2025, Claret European Growth Capital Fund III SCSp, exercised its share warrants (the tranche A-B BSA and tranche C BSA) resulting in the issuance of 206,662 ordinary shares of the Company.
• On November 25, 2025, Claret European Growth Capital Fund III SCSp converted its portion of the Tranche A convertible OCABSA resulting in the issuance of 392,695 ordinary shares of the Company. Following this conversion Abivax no longer holds any debt related to Tranche A of the Kreos/Claret structured debt.
• On November 28, 2025, the Company notified the bondholders of its intention to prepay in full the outstanding balances of Tranches B and C of the Kreos / Claret financing. The transaction is expected to be completed before December 31, 2025. Following this redemption, the Company will no longer hold any debt related to the entire Kreos / Claret financing.

Based on the Company’s existing cash and cash equivalents of EUR 589.7 million as of September 30, 2025, the Company expects, as of the date of issuance of the unaudited interim condensed consolidated financial statements included in the Company’s third quarter report, to be able to fund its forecasted cash flow requirements into the fourth quarter of 2027.

*****

About Abivax
Abivax is a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases. Based in France and the United States, Abivax’s lead drug candidate, obefazimod (ABX464), is in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis. More information on the Company is available at www.abivax.com. Follow us on LinkedIn and on X, formerly Twitter, @ABIVAX.

Contacts:
Abivax Investor Relations
Patrick Malloy
patrick.malloy@abivax.com
+1 847 987 4878

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements, forecasts and estimates, including those relating to the Company’s business and financial objectives. Words such as “design,” “expect,” “forward,” “future,” “potential,” “plan,” “project,” “will” and variations of such words and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements concerning or implying Abivax’s intention to and timing for repaying in full the outstanding balances of Tranches B and C of the Kreos / Claret financing, Abivax’s cash runway, and other statements that are not historical fact. Although Abivax’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks, contingencies and uncertainties, many of which are difficult to predict and generally beyond the control of Abivax, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. A description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the French Autorité des Marchés Financiers pursuant to its legal obligations including its universal registration document (Document d’Enregistrement Universel) and in its Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on March 24, 2025 under the caption “Risk Factors.” These risks, contingencies and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug candidate, as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates. and the availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements. Special consideration should be given to the potential hurdles of clinical and pharmaceutical development including further assessment by the Company and regulatory agencies and IRBs/ethics committees following the assessment of preclinical, pharmacokinetic, carcinogenicity, toxicity, CMC and clinical data. Furthermore, these forward-looking statements, forecasts and estimates are made only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Abivax disclaims any obligation to update these forward-looking statements, forecasts or estimates to reflect any subsequent changes that the Company becomes aware of, except as required by law. Information about pharmaceutical products (including products currently in development) that is included in this press release is not intended to constitute an advertisement. This press release is for information purposes only, and the information contained herein does not constitute either an offer to sell, or the solicitation of an offer to purchase or subscribe securities of the Company in any jurisdiction. Similarly, it does not give and should not be treated as giving investment advice. It has no connection with the investment objectives, financial situation or specific needs of any recipient. It should not be regarded by recipients as a substitute for exercise of their own judgment. All opinions expressed herein are subject to change without notice. The distribution of this document may be restricted by law in certain jurisdictions. Persons into whose possession this document comes are required to inform themselves about and to observe any such restrictions.

AEON Biopharma Announces Execution of Exchange Agreement with Daewoong




AEON Biopharma Announces Execution of Exchange Agreement with Daewoong

– AEON and Daewoong Pharmaceutical have executed definitive documentation to exchange $15 million of notes plus accrued interest into new equity, $1.5 million of new notes due 2030, and a cash-exercise warrant for 8 million shares of common stock –

– Exchange remains subject to shareholder approval –

IRVINE, Calif., Dec. 15, 2025 (GLOBE NEWSWIRE) — AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE American: AEON), a biopharmaceutical company seeking accelerated and full-label U.S. market entry by developing ABP-450 (prabotulinumtoxinA) as a BOTOX (onabotulinumtoxinA) biosimilar, today announced that the Company and Daewoong Pharmaceutical (“Daewoong”) have entered into a definitive agreement to exchange the Company’s $15 million of convertible notes plus accrued interest into new equity, $1.5 million of new notes due 2030, and a cash-exercise warrant for 8 million shares of common stock, on the same terms as the warrants in the private placement financing announced in November 2025 (the “Exchange”). The cash-exercise warrants, if exercised, represent over $8 million in potential additional cash proceeds to AEON.

“We are pleased to report the signing of definitive documentation for our exchange of Daewoong’s existing AEON-issued debt,” said Rob Bancroft, President & Chief Executive Officer of AEON. “While the transaction remains subject to a shareholder vote, this is an impotant step forward in deleveraging the company and we believe sets the stage for continued progress for our ABP-450 biosimiliar strategy in 2026.”

Previously, AEON and Daewoong entered into a binding term sheet contemplating the Exchange. The parties have now completed the definitive documentation for the Exchange, which documentation aligns with the terms agreed upon in the binding term sheet. The consummation of the Exchange remains subject to stockholder approval.

The Exchange will result in the elimination of more than 90% of AEON’s outstanding debt, strengthen Daewoong’s long-term strategic alignment with the Company and the Company’s stockholders, and transform AEON’s capital structure.

About the U.S. Biosimilar Pathway

The U.S. Food and Drug Administration (“FDA”) regulates biosimilars under the Public Health Service Act’s 351(k) pathway, which require developers to demonstrate that a proposed product is highly similar to an approved reference biologic with no clinically meaningful differences in safety, purity, or potency. Analytical similarity is the scientific foundation of this process, representing the most critical and data-intensive phase of development. Once analytical comparability across key quality attributes is established, subsequent FDA interactions focus on confirming whether any residual uncertainty requires limited clinical evaluation.

About AEON Biopharma

AEON Biopharma is a biopharmaceutical company seeking accelerated and full-label access to the U.S. therapeutic neurotoxin market via biosimilarity to BOTOX. The U.S. therapeutic neurotoxin market exceeds $3.0 billion annually, representing a major opportunity for biosimilar entry. The Company’s lead asset is ABP-450 for debilitating medical conditions. ABP-450 is the same botulinum toxin complex currently approved and marketed for cosmetic indications by Evolus, Inc. under the name Jeuveau®. ABP-450 is manufactured by Daewoong Pharmaceutical in compliance with current Good Manufacturing Practice, or cGMP, in a facility that has been approved by the U.S. Food and Drug Administration, Health Canada, and European Medicines Agency. The product is approved as a biosimilar in India, Mexico, and the Philippines. AEON has exclusive development and distribution rights for therapeutic indications of ABP-450 in the United States, Canada, the European Union, the United Kingdom, and certain other international territories. To learn more about AEON, visit www.aeonbiopharma.com.

Forward-Looking Statements

Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or AEON’s future financial or operating performance. For example, statements regarding expected meetings with the FDA or the expected benefits of AEON’s previously announced PIPE transaction are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “plan”, “possible”, “forecast”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. 

These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by AEON and its management, are inherently uncertain. Factors that may cause actual results to differ materially from current expectations include, but are not limited ) the ability of the Company to obtain stockholder approval for the Exchange and the ability of the Company to satisfy other closing conditions; and other risks and uncertainties set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s filings with the Securities and Exchange Commission (the “SEC”), which are available on the SEC’s website at www.sec.gov.

Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. AEON does not undertake any duty to update these forward-looking statements.

No Offer or Solicitation

This press release shall not constitute a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed transaction. This press release is not intended to nor does it constitute an offer to sell or purchase, nor a solicitation of an offer to sell, buy or subscribe for any securities, nor is it a solicitation of any vote in any jurisdiction pursuant to the proposed exchange transaction or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. No offer of securities shall be deemed to be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act, or an exemption therefrom.

Additional Information and Where to Find It

This press release may be deemed to be solicitation material in respect of obtaining stockholder approval in connection with the Exchange. In connection with obtaining stockholder approval, the Company expects to file a proxy statement on Schedule 14A and other relevant materials with the SEC. This press release does not constitute a solicitation of any vote or approval. SECURITY HOLDERS OF THE COMPANY ARE URGED TO READ CAREFULLY AND IN THEIR ENTIRETY ALL RELEVANT DOCUMENTS (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) FILED WITH THE SEC, INCLUDING THE COMPANY’S PROXY STATEMENT, WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE COMPANY, THE EXCHANGE AGREEMENT AND THE TRANSACTIONS CONTEMPLATED THEREBY, INCLUDING THE EXCHANGE. Copies of the proxy statement and other relevant materials and any other documents filed by the Company with the SEC may be obtained free of charge at the SEC’s website, at www.sec.gov. In addition, stockholders may obtain free copies of the proxy statement and other relevant materials through the website maintained by the SEC at http://www.sec.gov. or by directing a request to: AEON Biopharma, Inc., 5 Park Plaza, Suite 1750, Irvine, CA 92614 or via email at investor.relations@aeonbiopharma.com.

Participants in the Solicitation

The Company and its directors and executive officers and other members of management and employees may be deemed to be participants in the solicitation of proxies from the Company’s stockholders in respect of the stockholder approval needed for the Exchange. Information about the directors and executive officers of the Company is set forth in the Company’s Schedule 14A filed with the SEC on April 29, 2025. Other information regarding the persons who may be deemed participants in the proxy solicitations in connection with the Exchange, and a description of any interests that they have in the Exchange, by security holdings or otherwise, will be contained in the proxy statement and other relevant materials to be filed with the SEC when they become available. Stockholders, potential investors and other interested persons should read the proxy statement carefully when it becomes available before making any voting or investment decisions. You may obtain free copies of these documents from the sources indicated above.

Contacts

Investor Contact:
Laurence Watts
New Street Investor Relations
+1 619 916 7620
laurence@newstreetir.com

Source: AEON Biopharma

Madrigal Pharmaceuticals to Present at the 44th Annual J.P. Morgan Healthcare Conference




Madrigal Pharmaceuticals to Present at the 44th Annual J.P. Morgan Healthcare Conference

CONSHOHOCKEN, Pa., Dec. 15, 2025 (GLOBE NEWSWIRE) — Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL) today announced that the company will participate in the J.P. Morgan Annual Healthcare Conference on Monday, January 12, 2026 at 1:30pm PST.

The presentation will be broadcast live and can be accessed here or by visiting Madrigal’s Investor Relations Events and Presentations page. A replay of the webcast will be available after the event.

About Madrigal
Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with high unmet medical need. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). For more information, visit www.madrigalpharma.com.

Investor Contact
Tina Ventura, IR@madrigalpharma.com

Media Contact
Christopher Frates, media@madrigalpharma.com

IO Biotech Announces Publication of Five-year Clinical Outcomes of Phase 1/2 Trial in Nature Communications




IO Biotech Announces Publication of Five-year Clinical Outcomes of Phase 1/2 Trial in Nature Communications

• Findings provide scientific insights into the contributions of IDO1 and PD-L1 vaccination to PD-1 blockade for the treatment of metastatic melanoma
• Five-year analysis of median progression free survival was 25.5 months
• These results reinforce the potential of immune-modulatory vaccination

NEW YORK, Dec. 15, 2025 (GLOBE NEWSWIRE) — IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines, today announced the publication in Nature Communications of the long-term clinical and immunological outcomes from MM1636, the Phase 1/2 trial evaluating the investigational peptide vaccine IO102-IO103 targeting both tumor cells and immune-suppressive cells expressing IDO1 and/or PD-L1, in combination with PD-1 blockade in the treatment of first line metastatic melanoma. The results of this trial supported a Breakthrough Therapy Designation for the treatment of unresectable/metastatic melanoma in combination with pembrolizumab by the US Food and Drug Administration (FDA) and, together with the available preclinical and translational data, served as the foundation for IO Biotech’s decision to initiate the Phase 3 clinical trial in first-line advanced melanoma (IOB-013/KN-D18).

The MM1636 results published today showed the five-year follow-up analysis of IO102-IO103 in combination with nivolumab in patients with metastatic melanoma, demonstrating durable clinical activity with a 25.5-month median progression-free survival (PFS). The results also showed the identification of potential vaccine-specific immune biomarkers of long-term benefit, not observed in a matched anti-PD-1 monotherapy cohort, suggesting a distinct vaccine-induced immune modulation increasing anti-tumor activity. These overall results provide a compelling rationale for integrating immune-modulatory vaccination into immunotherapy regimens for patients with melanoma.

“These are very exciting data that continue reinforcing the scientific foundation of our immune-modulatory therapeutic approach and strengthens our belief in its potential to transform patient care,” said Mads Hald Andersen, DMSc, PhD, Director of the Center for Cancer Immune Therapy (CCIT) and scientific co-founder of IO Biotech. “IDO1 and PD-L1 are immune suppressive targets expressed in many cancers hence, we believe that IO102-IO103 could have pan-tumor activity. I am proud to be part of the team that is further developing this potential new treatment option.”

“We are very encouraged that the long-term follow up data confirm the earlier results reported from this study. The notable median duration of response of more than 53 months and an impressive median overall survival of 60 months support the potential of IO102-IO103 as a first-line therapy for melanoma as part of a combination regimen.” said Inge Marie Svane, MD, PhD, Professor, Director of the National Center for Cancer Immune Therapy (CCIT) at the Copenhagen University Hospital, Herlev, clinical co-founder of IO Biotech and Principal Investigator in the IOB-013 Phase 3 Trial.

“There continues to be a significant unmet need for innovative therapies that improve outcomes for cancer patients,” said Mai-Britt Zocca, PhD, President and CEO of IO Biotech. “These data strengthen our belief in Cylembio and in our approach to develop off-the-shelf, immune modulatory therapeutics, with pan-cancer potential.“

The article, titled “Five-year clinical outcome and immune biomarkers of durable response from the MM1636 trial on IDO/PD-L1 vaccination and PD-1 blockade in first line metastatic melanoma”, is now available online at https://www.nature.com/articles/s41467-025-67508-8.

About IO Biotech

IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines based on its T-win^® platform. The T-win platform is based on a novel approach to cancer vaccines designed to activate T cells to target both tumor cells and the immune-suppressive cells in the tumor microenvironment. IO Biotech is advancing its lead cancer vaccine candidate, Cylembio^® (IO102-IO103), in clinical trials, and additional pipeline candidates through preclinical development. IO Biotech is headquartered in Copenhagen, Denmark and has US headquarters in New York, New York.

For further information, please visit www.iobiotech.com. Follow us on our social media channels on LinkedIn and X (@IOBiotech).

About the MM1636 Clinical Trial

The MM1636 trial (ClinicalTrials.gov: NCT03047928), an investigator-initiated trial at the Copenhagen University Hospital, Herlev, enrolled 30 patients with metastatic melanoma. In this Phase 1/2 clinical trial, patients received the multi-antigen immunotherapeutic, IO102-IO103, in combination with the anti-programmed death 1 (PD-1) antibody nivolumab as first line treatment. Patients were treated with nivolumab according to the approved label for melanoma (3mg/kg bi-weekly for up to two years). IO102-IO103 was given from the start of administration of nivolumab and every second week for the first six weeks and thereafter, every fourth week for 41 weeks. The trial objectives were to assess safety, immune response in blood and biopsies as well as efficacy.

About the IOB-013/KN-D18 Pivotal Phase 3 Clinical Trial

IOB-013/KN-D18 (ClinicalTrials.gov: NCT05155254) was an open label, randomized Phase 3 pivotal clinical trial evaluating Cylembio^® (IO102-IO103) in combination with Merck’s anti-PD-1 therapy, KEYTRUDA^® (pembrolizumab) versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma. Enrollment in the trial was completed by December 2023 with a total of 407 patients enrolled from more than 100 centers across the United States, Europe, Australia, Turkey, Israel and South Africa. The primary endpoint of the study was progression free survival. Secondary endpoints include overall response rate, overall survival, durable objective response rate, complete response rate, duration of response, time to complete response, disease control rate, and incidence of adverse events and serious adverse events (safety and tolerability). Biomarkers in the blood and tumor tissue will also be assessed as exploratory endpoints. The company reported topline results from this trial in the third quarter of 2025. IO Biotech is sponsoring the Phase 3 trial and Merck is supplying pembrolizumab.

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including statements regarding the timing or outcome of communications with regulatory authorities including the FDA, the timing or outcome of the submission of regulatory applications, including an IND for IO112, and statements regarding other current or future clinical trials, their timing, progress, enrollment or results, or the company’s financial position or cash runway, are based on IO Biotech’s current assumptions and expectations of future events and trends, which affect or may affect its business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Except to the extent required by law, IO Biotech undertakes no obligation to update these statements, whether as a result of any new information, future developments or otherwise.

Contact:

Investors and media:
Maryann Cimino, Director of Investor Relations & Corporate Communications
IO Biotech, Inc.
617-710-7305
mci@iobiotech.com

Monte Rosa Therapeutics to Present Updated MRT-2359 Phase 1/2 Study Results




Monte Rosa Therapeutics to Present Updated MRT-2359 Phase 1/2 Study Results

Conference call and webcast to be held at 8 a.m. ET on December 16, 2025

BOSTON, Dec. 15, 2025 (GLOBE NEWSWIRE) — Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, today announced that management will host a live conference call and webcast on Tuesday, December 16, 2025, at 8:00 a.m. ET. The webcast presentation will highlight interim clinical results from the ongoing Phase 1/2 study of the GSPT1-directed MGD MRT-2359 in heavily pretreated, metastatic castration-resistant prostate cancer (mCRPC) patients.

A webcast of the presentation will be accessible via the “Events & Presentations” section of Monte Rosa’s website at ir.monterosatx.com. Registration for the conference call is available at the following link. An archived version of the webcast will be made available for 30 days following the presentation.

About Monte Rosa
Monte Rosa Therapeutics is a clinical-stage biotechnology company developing highly selective molecular glue degrader (MGD) medicines for patients living with serious diseases. MGDs are small molecule protein degraders that have the potential to treat many diseases that other modalities, including other degraders, cannot. Monte Rosa’s QuEEN™ (Quantitative and Engineered Elimination of Neosubstrates) discovery engine combines AI-guided chemistry, diverse chemical libraries, structural biology, and proteomics to rationally design MGDs with unprecedented selectivity. Monte Rosa has developed the industry’s leading pipeline of first-in-class and only-in-class MGDs, spanning autoimmune and inflammatory diseases, oncology, and beyond, with three programs in the clinic. Monte Rosa has ongoing collaborations with leading pharmaceutical companies in the areas of immunology, oncology and neurology. For more information, visit www.monterosatx.com.

Investors
Andrew Funderburk
ir@monterosatx.com

Media
Cory Tromblee, Scient PR
media@monterosatx.com

Kyverna Therapeutics Announces Proposed Public Offering of Common Stock




Kyverna Therapeutics Announces Proposed Public Offering of Common Stock

EMERYVILLE, Calif., Dec. 15, 2025 (GLOBE NEWSWIRE) — Kyverna Therapeutics, Inc. (Nasdaq: KYTX) (“Kyverna”), a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, today announced that it has commenced an underwritten public offering of $100,000,000 of shares of its common stock. Kyverna intends to grant the underwriters a 30-day option to purchase up to an additional $15,000,000 of shares of common stock offered in the public offering, at the public offering price, less underwriting discounts and commissions. All of the shares of common stock to be sold in the proposed offering will be sold by Kyverna. J.P. Morgan, Leerink Partners, Morgan Stanley and Wells Fargo Securities are acting as joint book-running managers for the offering. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed offering may be completed or as to the actual size or terms of the proposed offering.

The securities described above will be offered by Kyverna pursuant to an effective “shelf” registration statement on Form S-3 (File No. 333-286180) that was filed with the Securities and Exchange Commission (the “SEC”) on March 27, 2025 and declared effective on April 15, 2025. The securities may be offered only by means of a prospectus. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the proposed offering will be filed with the SEC. Electronic copies of the preliminary prospectus supplement and, when available, copies of the final prospectus supplement, and the accompanying prospectus relating to the offering may be obtained by visiting the SEC’s website at www.sec.gov or by contacting J.P. Morgan Securities LLC, Attention: c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or email: prospectus-eq_fi@jpmchase.com and postsalemanualrequests@broadridge.com; Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at syndicate@leerink.com; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, or by email at prospectus@morganstanley.com; and Wells Fargo Securities, 90 South 7th Street, 5th Floor, Minneapolis, MN 55402, at 800-645-3751 (option #5) or email a request to WFScustomerservice@wellsfargo.com.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, 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 jurisdiction.

About Kyverna Therapeutics

Kyverna Therapeutics, Inc. (Nasdaq: KYTX) is a clinical-stage biopharmaceutical company focused on liberating autoimmune patients through the curative potential of cell therapy. Kyverna’s lead autologous CD19-targeting CAR T-cell therapy candidate is miv-cel (mivocabtagene autoleucel, KYV-101). Kyverna is advancing its potentially first-in-class neuroimmunology franchise with its recently completed registrational trial in stiff person syndrome and an ongoing registrational trial for generalized myasthenia gravis. The Company is also harnessing other KYSA trials and investigator-initiated trials, including in multiple sclerosis and rheumatoid arthritis, to inform the next priority indications. Additionally, its next generation pipeline includes CAR T-cell therapies deploying novel innovations to improve patient access and experience.

Forward-Looking Statements

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words, without limitation, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Forward-looking statements in this press release include, without limitation, those related to: the proposed underwritten public offering, including the size, timing and structure of the proposed offering; and the completion of the proposed offering on the anticipated terms. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to general economic and market conditions; Kyverna’s ability to satisfy closing conditions applicable to the proposed offering; and other factors discussed in the “Risk Factors” section of Kyverna’s periodic filings with the SEC, including its most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and the preliminary prospectus supplement and the accompanying prospectus related to the proposed public offering to be filed with the SEC on or about the date hereof. Any forward-looking statements contained in this press release are based on the current expectations of Kyverna’s management team and speak only as of the date hereof, and Kyverna specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts:

Investors: InvestorRelations@kyvernatx.com
Media: media@kyvernatx.com

Tiziana Life Sciences Announces Purchase of Shares by Chief Executive Officer




Tiziana Life Sciences Announces Purchase of Shares by Chief Executive Officer

BOSTON, Dec. 15, 2025 (GLOBE NEWSWIRE) — Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced that its Chief Executive Officer, Ivor Elrifi, has purchased 163,400 shares of Tiziana common stock in the open market. This brings his current purchased shares total to 357,848.

About Foralumab

Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 14 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program (NCT06802328) with either an improvement or stability of disease seen within 6 months in all patients. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (NCT06292923).

Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development. Immunomodulation by intranasal foralumab represents a novel avenue for the treatment of neuroinflammatory and neurodegenerative human diseases.^[1],[2]

About Tiziana Life Sciences

Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb currently in clinical development, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.

For more information about Tiziana Life Sciences and its innovative pipeline of therapies, please visit www.tizianalifesciences.com.

For further inquiries:

Tiziana Life Sciences Ltd
Paul Spencer, Business Development, and Investor Relations
+44 (0) 207 495 2379
email: info@tizianalifesciences.com

[1] https://www.pnas.org/doi/10.1073/pnas.2220272120

[2] https://www.pnas.org/doi/10.1073/pnas.2309221120