Range Impact Announces Two Major Land Acquisitions in Kentucky and Sale of Abandoned Mine Land Services Business

Range Impact Announces Two Major Land Acquisitions in Kentucky and Sale of Abandoned Mine Land Services Business




Range Impact Announces Two Major Land Acquisitions in Kentucky and Sale of Abandoned Mine Land Services Business

CLEVELAND, OHIO, Jan. 07, 2026 (GLOBE NEWSWIRE) — Range Impact, Inc. (OTCQB: RNGE) (“Range Impact” or the “Company”), a public company dedicated to acquiring, reclaiming and repurposing distressed coal mine properties throughout Appalachia, announced the acquisition of the Premier Elkhorn mine complex (“Premier Elkhorn Mine Complex”) and Cambrian Coal mine complex (“Cambrian Coal Mine Complex”), both located in eastern Kentucky, from Continental Land Co., LLC on December 31, 2025. On the same day, the Company sold all the common stock of Collins Building & Contracting, Inc., a wholly owned subsidiary (“Collins Building”), completing the Company’s exit from its abandoned mine land reclamation services business.

Premier Elkhorn and Cambrian Coal Acquisitions

The Company, through a newly created subsidiary, Range Bluegrass Land LLC (“Range Bluegrass”), acquired all of the real and personal property of the Premier Elkhorn Mine Complex and the Cambrian Coal Mine Complex in exchange for assuming the reclamation obligations of the mine permit holder, Reckoning Reclamation LLC.

The Premier Elkhorn Mine Complex is a former coal mine site comprised of approximately 13,000 surface acres and 42,500 mineral interest acres. The Premier Elkhorn Mine Complex contains metallurgical and thermal coal reserves with 34 mining permits and $44 million of reclamation bonds. The Premier Elkhorn Mine Complex also includes significant legacy investments in coal processing infrastructure, rail, roads, and utilities.

The Cambrian Coal Mine Complex is a former coal mine site comprised of approximately 2,600 surface acres and additional leasable acres of mineral interests. The Cambrian Coal Mine Complex contains metallurgical and thermal coal reserves with 9 mining permits and $10 million of reclamation bonds. The Cambrian Coal Mine Complex is located near the Premier Elkhorn Mine Complex and had previously used the Premier Elkhorn Mine Complex’s coal infrastructure, rail, roads, and utilities when it was operating.

In connection with these land acquisitions, Range Bluegrass entered into an Option Agreement with MRR CNG, LLC (“MRR”), a landfill developer and operator, granting MRR the option to acquire approximately 1,500 acres of surface land at the Premier Elkhorn Mine Complex for the future development and operation of a new waste disposal facility. The option grant was effective as of December 31, 2025. MRR paid Range Bluegrass $500,000 at the time of the grant and would be required to pay the fair market value of the land upon exercise.

Range Bluegrass also entered into a Membership Interest Option and Cash Distribution Right Agreement with Wicks Building LLC (“Wicks Building”), an affiliate of MRR, pursuant to which Wicks Building is entitled to receive 50% of any cash distributions made by Range Bluegrass and is permitted to convert such right into the ownership of 50% of the membership interests of Range Bluegrass. This transaction closed on December 31, 2025 and Wicks Building paid Range Bluegrass $500,000 at closing.

The Company also entered into Consulting Agreements with MRR and F & G LLC (“F & G”), an affiliate of MRR, pursuant to which the Company has agreed to provide certain reclamation and bond release services to MRR and F & G in connection with the potential development of MRR’s waste disposal facility at the Premier Elkhorn Mine Complex. The Company received an initial fee of $1.0 million upon execution of the agreements on December 31, 2025, and, unless the agreements are earlier terminated, is scheduled to receive additional fees of $2.0 million in each of 2026 and 2027.

“With the two large acquisitions announced today, the Company now owns four significant land investments – the Fola and Hobet Mine Complexes in West Virginia, and the Premier Elkhorn and Cambrian Coal Mine Complexes in Kentucky – representing ownership of approximately 30,000 acres of surface land and 150,000 acres of mineral interests,” stated Michael Cavanaugh, the Company’s Chief Executive Officer. Cavanaugh continued, “Range is clearly differentiating itself as a creative problem solver for the region’s most difficult social, economic and environmental challenges caused by legacy coal mine sites and is in the process of assembling one of the largest and most unique portfolios of strategic land assets in Appalachia.”

Collins Building Sale

On December 31, 2025, the Company sold all its common stock of Collins Building to Collins Reclamation LLC, an unaffiliated entity, in exchange for Collins Reclamation’s assumption of two remaining abandoned mine land reclamation contracts in West Virginia.

Mr. Cavanaugh noted, “In its early days, Range Impact had focused primarily on generating revenue by providing reclamation and incidental mining and security services to third party mining companies, permit holders and private owners with abandoned mine land property. However, beginning in early 2025, our strategy evolved from a service-based business model to a land ownership business model designed to create shareholder value by unlocking the underlying value of land we own through our reclamation activities, and then creating multiple streams of long-term recurring revenue with a diverse group of third-party lessees focused on next-generation uses.” Mr. Cavanaugh continued, “The Collins Building sale completes our exit from service-based reclamation work for third-party customers and allows our team to focus all of our attention, energy and capital on the reinvigoration and reimagination of former coal mine sites that we own in Appalachia.”

About Range Impact, Inc.

Headquartered in Cleveland, Ohio, Range Impact is a public company (OTC: RNGE) dedicated to improving the health and wellness of people and the planet through a novel and innovative approach to impact investing. Range Impact owns and operates several complementary operating businesses focused on developing long-term solutions to environmental, social, and health challenges, with a particular focus on acquiring, reclaiming and repurposing mine sites and other undervalued land in economically disadvantaged communities throughout Appalachia. Range Impact takes an opportunistic approach to impact investing by leveraging its competitive advantages and looking at solving old problems in new ways. Range Impact seeks to thoughtfully allocate its capital into strategic opportunities that are expected to make a positive impact on the people-planet ecosystem and generate strong investment returns for its shareholders.

Notice Regarding Forward-Looking Statements

This press release contains “forward-looking statements” as that term is defined in Section 27(a) of the Securities Act of 1933, as amended and Section 21(e) of the Securities Exchange Act of 1934, as amended. Statements in this press release which are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, expectations or intentions regarding the future. Although we believe that these statements are based on reasonable assumptions, they are subject to numerous factors that could cause actual outcomes and results to be materially different from those indicated in such statements. Such factors include, among others, the inherent uncertainties associated with new projects, changes in business strategy and new lines of business. These forward-looking statements are made as of the date of this press release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Although we believe that any beliefs, plans, expectations and intentions contained in this press release are reasonable, there can be no assurance that any such beliefs, plans, expectations or intentions will prove to be accurate. Investors should consult all of the information set forth herein and should also refer to the risk factors disclosure outlined in our annual report on Form 10-K for the most recent fiscal year, our quarterly reports on Form 10-Q and other periodic reports filed from time-to-time with the Securities and Exchange Commission.

Range Impact, Inc.
Investor Relations
P: +1 (216) 304-6556
E: ir@rangeimpact.com
W: www.rangeimpact.com

LENZ Therapeutics Reports Fourth Quarter 2025 Preliminary Unaudited Financial Results and Recent Corporate Updates

LENZ Therapeutics Reports Fourth Quarter 2025 Preliminary Unaudited Financial Results and Recent Corporate Updates




LENZ Therapeutics Reports Fourth Quarter 2025 Preliminary Unaudited Financial Results and Recent Corporate Updates

Launched VIZZ™ (aceclidine ophthalmic solution) 1.44% in October 2025 for the treatment of presbyopia, with broad product availability in mid-November 2025

Achieved approximately $1.6 million in net product revenue with over 20,000 prescriptions filled in Q4 2025

Over 6,500 unique ECPs prescribed VIZZ; more than 55% have prescribed multiple times in Q4 2025

SAN DIEGO, Jan. 07, 2026 (GLOBE NEWSWIRE) — LENZ Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the “Company”), a pharmaceutical company focused on the commercialization of VIZZ™ (aceclidine ophthalmic solution) 1.44%, the first and only aceclidine-based eye drop for the treatment of presbyopia, today reported certain preliminary unaudited financial results for the fourth quarter ended December 31, 2025 and recent corporate updates.

“We are proud of the strong execution delivered in our first quarter of launch, as the team established a solid foundation of awareness, confidence, and willingness to prescribe VIZZ across the eye care professional community,” said Eef Schimmelpennink, President and Chief Executive Officer of LENZ Therapeutics. “More than 6,500 eye care professionals have already written a prescription for VIZZ, the majority of whom prescribed multiple times, signaling early confidence in VIZZ as a convenient and effective alternative to reading glasses. At the same time, over 20,000 prescriptions were filled during our first quarter of launch, exceeding our expectations and reinforcing the early momentum behind VIZZ. Building on this progress, and together with our campaign spokesperson Sarah Jessica Parker, we look forward to launching the VIZZ DTC campaign this quarter.”

Fourth Quarter 2025 Commercial Highlights

  • First commercial product sale of VIZZ in October 2025, the first and only aceclidine-based eye drop for the treatment of presbyopia
  • Full multi-channel access established through epharmacy and substantially all retail pharmacies by mid-November 2025
  • VIZZ net product revenue of approximately $1.6 million in Q4 2025
  • Over 20,000 prescriptions filled through Q4 2025
  • Rapid uptake by prescribing ECPs with over 6,500 unique prescribing ECPs; more than 55% prescribed multiple times in Q4 2025

Additional Recent Corporate Updates

  • In January 2026, the Company announced an exclusive commercialization partnership for VIZZ with Lunatus in the Middle East. Under the terms of the agreement, LENZ will receive upfront, regulatory and commercial milestone payments, in addition to a significant share of revenue generated in the region through a pre-determined minimum product supply price. This agreement represents the fourth commercialization partnership for VIZZ outside the United States.

About LENZ Therapeutics

LENZ Therapeutics is a pharmaceutical company focused on the commercialization of VIZZTM (aceclidine ophthalmic solution) 1.44%, the first and only FDA-approved aceclidine-based eye drop for the treatment of presbyopia, a condition impacting an estimated 1.8 billion people globally and 128 million people in the United States. LENZ is commercializing VIZZ in the United States and continues to establish licensing partnerships internationally to provide access to VIZZ globally. LENZ is headquartered in San Diego, California. For more information, visit www.VIZZ.com and www.LENZ-tx.com.

About Presbyopia

Presbyopia is the inevitable loss of near vision associated with aging, impacting the daily lives of nearly all people over the age of 45. As people age, the crystalline lens in their eyes gradually hardens and becomes less able to change shape. This loss of elasticity of the lens reduces the ability of the lens to focus incoming light from near objects onto the retina. Adults over 50 years of age lose, on average, 1.5 lines of near vision every six years. Although the progression of presbyopia is gradual, presbyopes often experience an abrupt change in their daily life as the symptoms become more pronounced starting in their mid-40s, when reading glasses or other corrective aids are suddenly necessary to read text or conduct close-up work. Presbyopia is typically self-diagnosed and self-managed with over-the-counter reading glasses, or managed, after evaluation by an ECP, with prescription reading or bifocal glasses or multifocal contact lenses.

About VIZZ (aceclidine ophthalmic solution) 1.44%

VIZZ (aceclidine ophthalmic solution) 1.44% is a once-daily eye drop developed to restore clear near vision for up to 10 hours. Aceclidine is the sole active ingredient in VIZZ and provides rapid and durable near vision improvement. VIZZ is preservative-free and provided in single-dose vials. VIZZ is a predominantly pupil selective miotic that interacts with the iris with minimal ciliary muscle stimulation. VIZZ causes contraction of the iris sphincter muscle, resulting in a pinhole effect that extends depth of focus to improve vision. For more information, please visit www.VIZZ.com.

VIZZ Indication and Important Safety Information

INDICATION

VIZZ (aceclidine ophthalmic solution) 1.44% is a prescription eye drop used to treat age-related blurry near vision (presbyopia) in adults.

IMPORTANT SAFETY INFORMATION

  • Do not use VIZZ if allergic to any of the ingredients.
  • To help avoid potential eye injury or contamination of the product, do not allow the vial tip to touch the eye or any surfaces. Discard the opened vial immediately after use.
  • Contact lenses should be removed before using VIZZ. After dosing, contact lenses can be reinserted after 10 minutes.
  • If using more than one topical eye medication, the medicines should be administered at least 5 minutes apart.
  • Temporary dim or dark vision may be experienced after using VIZZ. Do not drive or operate machinery if vision is not clear.
  • Seek immediate medical care if sudden onset of flashing lights, floaters, or vision loss is experienced.

ADVERSE REACTIONS

The most common reported adverse reactions of participants were instillation site irritation (20%), dim vision (16%), and headache (13%). Adverse reactions reported in >5% of participants were conjunctival hyperemia (8%) and ocular hyperemia (7%). The majority of adverse reactions were mild, transient, and self-resolving.

For additional information, please see the full Prescribing Information available at www.VIZZ.com/full-prescribing-information.pdf.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws. You can identify forward-looking statements by words such as “may,” “will,” “could,” “can,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “poised,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, but not all forward-looking statements will contain these words. ” Forward-looking statements in this press release include statements regarding the timing and availability of VIZZ, including the VIZZ DTC campaign; potential market size for VIZZ; its ability to meet patient needs and become standard of care; LENZ commercialization plans, including international partnering plans, and the quotations of LENZ management. These statements are based on numerous assumptions concerning VIZZ, target markets and involve substantial risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievement to be materially different from the information expressed or implied by these forward-looking statements, including those risk factors described in the section titled “Risk Factors” in our Quarterly Report on Form 10-Q filed for the quarter ended September 30, 2025 and our subsequent filings with the SEC. The unaudited results in this press release, including Q4 2025 net product revenue, are preliminary and subject to the completion of accounting and annual audit procedures and are therefore subject to adjustment. We cannot assure you that the forward-looking statements in this press release or the assumptions upon which they are based will prove to be accurate. The forward-looking statements in this press release are as of the date of this press release. Except as otherwise required by applicable law, LENZ disclaims any duty to update any forward-looking statements. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. 

Contact:
Dan Chevallard
LENZ Therapeutics
IR@LENZ-Tx.com 

Correction: Transactions of Managers and Closely Associated Persons

Correction: Transactions of Managers and Closely Associated Persons




Correction: Transactions of Managers and Closely Associated Persons

Attached are copies of two filings with the Luxembourg Commission de Surveillance du Secteur Financier (CSSF) regarding transactions of managers and closely associated persons. ATP Holdings ehf. announced two transactions, an acquisition of 4,812,257 shares in Alvotech on December 17, 2025, and a sale of 2,110,640 shares in Alvotech on December 19, 2025. The transaction price in both cases was SEK 44.06 per share.

(In the original version of the announcement issued on January 6, 2025, the December 19, 2025, transaction was incorrectly referred to as an acquisition of shares.)

Attachments

Abivax Provides 2026 Corporate Outlook

Abivax Provides 2026 Corporate Outlook




Abivax Provides 2026 Corporate Outlook

Abivax Provides 2026 Corporate Outlook

  • New market insights indicate significant future expansion of the ulcerative colitis (UC) market, with obefazimod well positioned to become a future market leader in the IBD space
  • ABTECT Phase 3 Data Safety Monitoring Board (DSMB) meeting on December 18, 2025, found no new safety signals with over 80% of participants having completed the 44-week double blind maintenance trial
  • ABTECT-UC Phase 3 maintenance topline results expected late Q2 2026, with a subsequent US regulatory filing planned for late 2026
  • ENHANCE-CD Phase 2b induction trial of obefazimod in moderate-to-severely active Crohn’s disease (CD) ongoing; induction results expected late 2026
  • 22 abstracts accepted for upcoming February 2026 European Crohn’s and Colitis Organization (ECCO) conference including oral presentation of obefazimod impact on fibrosis in in-vitro and preclinical models
  • Cash runway expected into Q4 2027, after full debt reimbursement in Q4 2025

PARIS, France – January 7, 2026 – 10:05 PM CETAbivax 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, today announced its 2026 corporate outlook, highlighting new market insights, progress in the ABTECT-UC and ENHANCE-CD trials, and advances in its therapeutic pipeline. Updates from the ABTECT Phase 3 maintenance trial evaluating obefazimod for the treatment of moderate-to-severely active UC reinforce the therapy’s safety profile and inform potential future combination strategies.

Marc de Garidel, MBA, Chief Executive Officer of Abivax, commented: “As I reflect on our advances in 2025, I am beyond thankful for the patients and physicians who have helped advance our trials and for the Abivax employees and investors who supported this progress. This past year was a monumental one for Abivax as we announced positive data from our ABTECT Phase 3 8-week induction trial demonstrating obefazimod’s safety and potential as a first-in-class oral therapy for UC, we shared updates at major international meetings, and we closed a successful significant fundraising round. In 2026, I look forward to continuing this momentum as we evaluate the ABTECT-UC Phase 3 maintenance and ENHANCE-CD Phase 2 induction data and identify new opportunities for advancement of our pipeline. The findings shared today from the updated market research and DSMB safety analyses demonstrate the significant opportunity we have for making a real impact for the millions of patients inadequately addressed by current treatment options.”

LOOKING AHEAD TO 2026:

Ulcerative Colitis Market Opportunity

Multiple third-party industry analyses forecast significant growth in the ulcerative colitis (UC) market over the coming years, driven by increased use of advanced therapies and the launch of innovative mechanisms of action (MOAs). In one recently published report, worldwide UC sales are expected to more than double, increasing from $9.2 billion in 2025 to $21.2 billion by 2032.

In this context, market research following the announcement of the ABTECT Phase 3 induction results in July 2025 indicates that obefazimod may emerge as the future market leader in UC, potentially outperforming both currently approved therapies and anticipated future entrants, including TL1A inhibitors and oral IL-23 agents.

The research estimated that roughly 500K patients within the United States are currently on conventional therapies (5ASA’s/corticosteroids), with approximately 60% of these patients being moderate/severe (~300K patients). Physicians indicated they would likely initiate treatment with obefazimod for this population where reluctance to advanced therapies hinder their use.

ABTECT Phase 3 DSMB Update, Maintenance Topline Results, and Expected US Filing Timing

The ABTECT Phase 3 DSMB meeting occurred on December 18, 2025, and reported no new safety signals with over 80% of participants having completed the 44-week double blind maintenance phase of the trial.

Topline results from the ongoing ABTECT Phase 3 maintenance trial are expected in late Q2 2026 which has the potential to further demonstrate the durability of obefazimod treatment in UC and extended duration of therapy versus the currently available treatment options.

Ongoing New Drug Application (NDA) preparation includes planned engagement with the FDA in anticipation of planned filing in late 2026.

Pipeline Advancement

Obefazimod has a first-in-class mechanism of action that targets the site of inflammation and, together with preclinical evidence of a clear anti-fibrotic effect in Crohn’s disease, underscores its potential as a differentiated treatment option for patients with the condition. Detailed results, including 22 abstracts, will be shared at the 2026 European Crohn’s and Colitis Organization (ECCO) Annual Meeting taking place in Stockholm, Sweden on February 18-21, 2026.

The ENHANCE-CD Phase 2b, designed to evaluate the safety and efficacy of obefazimod in patients with moderate-to-severely active Crohn’s disease (CD), is actively progressing. The 12-week induction trial results are anticipated in late 2026 and will help inform the design of subsequent registrational studies.

Throughout 2026, initial preclinical results from ongoing studies evaluating obefazimod in combination with other agents (currently targeted combination MOAs include IL-23, a4b7, PDE-4 and AhR) will be shared, with a lead combination candidate selected to advance into development by year-end.

The company is also continuing to evaluate follow-on miR-124 enhancers in various chronic inflammatory models to further extend the mechanistic framework established with obefazimod. In parallel, the team is evaluating potential in-licensing opportunities for innovative, mechanistically complementary assets in inflammatory bowel disease to strengthen its portfolio.

Marc de Garidel continued: “This past year we have worked diligently to advance obefazimod in both ulcerative colitis and Crohn’s disease, showcasing the immense opportunity we have in expanding the current market and the potential for movement into first- and second-line therapy options. With our recently secured funding poised to support us into Q4 2027, we are now focused on completing our ABTECT Phase 3 maintenance trial to support potential NDA filing by the end of the year, completing our Phase 2b Crohn’s disease trial, and evaluating additional opportunities for advancement across our pipeline. We look forward to sharing additional updates throughout the year as we aim to offer a safer, more effective and durable treatment option for those impacted by chronic inflammatory diseases like UC and Crohn’s.”

Abivax 2026 Financial Reporting Calendar

March 23, 2026:                    Fiscal Year 2025 Financial Results

June 1, 2026:                        Q1 2026 Financial Results

June 5, 2026:                         Annual General Meeting / Extraordinary General Meeting

September 14, 2026:             H1 2026 Financial Results

December 14, 2026:              Q3 2026 Financial Results

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.

Contact:
Patrick Malloy
SVP, Investor Relations
Abivax SA
patrick.malloy@abivax.com
+1 847 987 4878
Media Contacts:
LifeSci Communications
Karissa Cross, Ph.D.
Associate Director
kcross@lifescicomms.com

 

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements, forecasts and estimates, including those relating to the Company’s business. Words such as “anticipate,” “expect,” “potential” and variations of such words and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements concerning the Company’s expectations for 2026, including the Company’s anticipated timing for topline results of its ABTECT Phase 3 maintenance and timing of the Company’s planned NDA filing, results of its ENHANCE-CD Phase 2 induction clinical trials, the potential therapeutic benefit and market opportunity of obefazimod, planned announcement of combination therapy, progress of the Company’s follow-on compound and expected cash runway. 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 for 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.

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

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




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

LONDON, Jan. 07, 2026 (GLOBE NEWSWIRE) — Kiniksa Pharmaceuticals International, plc (Nasdaq: KNSA) today announced that it will present at the 44th Annual J.P. Morgan Healthcare Conference on Monday, January 12, 2026 at 2:15 p.m. Pacific Time (5:15 p.m. Eastern Time).

A live webcast of Kiniksa’s presentation will be accessible through the Investors section of the company’s website at www.kiniksa.com. A replay of the event will also be available on Kiniksa’s website within approximately 48 hours after the event.

About Kiniksa
Kiniksa is a biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating diseases by discovering, acquiring, developing, and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. Kiniksa’s portfolio of assets is based on strong biologic rationale or validated mechanisms and offers the potential for differentiation. For more information, please visit www.kiniksa.com.

Every Second Counts! ®

Kiniksa Investor & Media Contact
Jonathan Kirshenbaum
(781) 829-3949
jkirshenbaum@kiniksa.com

Genelux Corporation Announces Proposed Public Offering of Common Stock

Genelux Corporation Announces Proposed Public Offering of Common Stock




Genelux Corporation Announces Proposed Public Offering of Common Stock

WESTLAKE VILLAGE, Calif., Jan. 07, 2026 (GLOBE NEWSWIRE) — Genelux Corporation (“Genelux”) (Nasdaq: GNLX), a late clinical-stage immuno-oncology company, today announced that it has commenced a proposed underwritten public offering of its common stock. In addition, Genelux expects to grant the underwriter a 30-day option to purchase up to an additional 15% of the number of shares of common stock sold in connection with the proposed offering. All shares are being offered by Genelux. The proposed offering is subject to market and other customary closing 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.

Lucid Capital Markets is acting as the sole book-running manager for the proposed offering.

The proposed offering is being made by Genelux pursuant to an effective shelf registration statement previously filed by Genelux with the U.S. Securities and Exchange Commission (the “SEC”) on February 2, 2024 and declared effective on February 13, 2024. This proposed offering is being made only by means of a preliminary prospectus supplement and the accompanying base prospectus that form a part of the registration statement. A preliminary prospectus supplement and the accompanying base prospectus relating to and describing the terms of the proposed offering will be filed with the SEC and may be obtained for free by visiting the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying base prospectus relating to the proposed offering may also be obtained by contacting: Lucid Capital Markets, LLC, 570 Lexington Avenue, 40th Floor, New York, NY 10022.

This press release shall 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 other 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.

About Genelux

Genelux is a late clinical-stage biopharmaceutical company focused on developing next-generation oncolytic immunotherapies for patients suffering from aggressive and/or difficult-to-treat solid tumor types. Olvi-Vec currently is being evaluated in two U.S.-based clinical trials: OnPrime/GOG-3076, a multi-center, randomized, open-label Phase 3 registrational trial evaluating the efficacy and safety of Olvi-Vec in combination platinum-doublet + bevacizumab compared with physician’s choice of chemotherapy and bevacizumab in patients with platinum-resistant/refractory ovarian cancer; and VIRO-25, a multi-center, randomized, open-label Phase 2 trial evaluating the efficacy and safety of Olvi-Vec & platinum-doublet + physician’s choice of immune checkpoint inhibitor compared to docetaxel in non-small-cell lung cancer. Additionally, Olvi-Vec currently is being evaluated for dose selection in Olvi-Vec-SCLC-202, a China-based, multi-center, open label Phase 1b/2 trial evaluating the efficacy and safety of Olvi-Vec & platinum-doublet in recurrent small-cell lung cancer. The core of Genelux’s discovery and development efforts revolves around its proprietary CHOICE™ platform from which the Company has developed an extensive library of isolated and engineered oncolytic vaccinia virus immunotherapeutic product candidates, including Olvi-Vec. 

Forward-Looking Statements

This release contains or may imply “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include, but are not limited to, statements regarding the completion, timing and size of the proposed public offering and the anticipated grant to the underwriter of an option to purchase additional shares. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks and uncertainties related to market conditions and satisfaction of customary closing conditions related to the proposed public offering. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Genelux’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2025 and in other filings that Genelux makes with the SEC from time to time. There can be no assurance that any of the forward-looking information provided herein will be proven accurate. These forward-looking statements speak only as of the date hereof and Genelux undertakes no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

Investor Contact

Austin Murtagh
Precision AQ
austin.murtagh@precisionaq.com

Media Contact

Ashley Murphy
Precision AQ
ashley.murphy@precisionaq.com

Source: Genelux Corporation

Monte Rosa Therapeutics Announces Proposed Public Offering of Common Stock and Pre-Funded Warrants

Monte Rosa Therapeutics Announces Proposed Public Offering of Common Stock and Pre-Funded Warrants




Monte Rosa Therapeutics Announces Proposed Public Offering of Common Stock and Pre-Funded Warrants

BOSTON, Jan. 07, 2026 (GLOBE NEWSWIRE) — Monte Rosa Therapeutics, Inc. (“Monte Rosa”) (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, today announced that it has commenced an underwritten public offering of $200.0 million of shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of common stock. All of the shares of common stock and pre-funded warrants to purchase shares of common stock in the proposed offering are to be sold by Monte Rosa. Monte Rosa also intends to grant the underwriters a 30-day option to purchase up to an additional $30.0 million of shares of its common stock. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Jefferies, TD Cowen and Piper Sandler are acting as joint book-running managers for the offering. Wedbush PacGrow and LifeSci Capital are acting as passive bookrunners for this offering.

The shares of common stock and pre-funded warrants to purchase shares of common stock are being offered by Monte Rosa pursuant to an effective shelf registration statement that was previously filed with the U.S. Securities and Exchange Commission (SEC) on March 20, 2025 and declared effective by the SEC on March 31, 2025 (File No. 333-285942). The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov.

When available, copies of the preliminary prospectus supplement relating to the offering may also be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, by telephone at (877) 821-7388 or by email at Prospectus_Department@Jefferies.com, TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by email at TDManualrequest@broadridge.com, Piper Sandler & Co., 350 North 5th Street, Suite 1000, Minneapolis, MN 55401, Attention: Prospectus Department, by telephone at (800) 747-3924, or by email at prospectus@psc.com, Wedbush Securities Inc., Attn: ECM Department, 600 Montgomery Street, 29th Floor, San Francisco, CA 94111 or via email at ecm@wedbush.com or LifeSci Capital LLC at 1700 Broadway, 40th Floor, New York, New York 10019, or by email at compliance@lifescicapital.com.

This press release shall not constitute an offer to sell or a 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 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.

Forward-Looking Statements 

This press release includes express and implied “forward-looking statements,” including forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements about Monte Rosa’s expectations regarding the timing, terms and size of the proposed public offering and the possibility that the proposed offering will be completed on the anticipated terms or at all. Forward-looking statements include all statements that are not historical facts and in some cases, can be identified by terms such as “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future.

Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, uncertainties related to market conditions. These and the risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Monte Rosa’s most recent Annual Report on Form 10-K, as well as the most recent Quarterly Reports on Form 10-Q and any subsequent filings with the SEC. In addition, any forward-looking statements represent Monte Rosa’s views only as of as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Monte Rosa explicitly disclaims any obligation to update any forward-looking statements subject to any obligations under applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

Investors  
Andrew Funderburk
ir@monterosatx.com 

Media  
Cory Tromblee, Scient PR
media@monterosatx.com 

Phathom Pharmaceuticals Announces Preliminary Fourth Quarter and Full Year 2025 Financial Results

Phathom Pharmaceuticals Announces Preliminary Fourth Quarter and Full Year 2025 Financial Results




Phathom Pharmaceuticals Announces Preliminary Fourth Quarter and Full Year 2025 Financial Results

FLORHAM PARK, N.J., Jan. 07, 2026 (GLOBE NEWSWIRE) — Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, today announced certain preliminary unaudited financial results for the fourth quarter and full year ended December 31, 2025.

Preliminary Fourth Quarter 2025 Financial Results

  • For the three months ended December 31, 2025, Phathom expects to report:
    • Net revenues of approximately $57 million to $58 million
    • GAAP operating expenses of approximately $59 million to $61 million
    • Non-GAAP operating expenses of approximately $51 million to $53 million, which excludes approximately $8 million of stock-based compensation
    • Fourth quarter 2025 net cash usage of approximately $6 million
    • Cash and cash equivalents of approximately $130 million as of December 31, 2025

Preliminary Full Year 2025 Financial Results

  • For the full year 2025, Phathom expects to report:
    • Net revenues of approximately $174.5 million to $175.5 million
    • GAAP operating expenses of approximately $315.5 million to $317.5 million
    • Non-GAAP operating expenses of approximately $284.5 million to $286.5 million, which excludes approximately $31 million of stock-based compensation

VOQUEZNA® 1 Million Prescription Milestone

  • During the fourth quarter 2025, Phathom surpassed one million prescriptions dispensed for VOQUEZNA products in the United States since launch

Path to Operating Profitability in H2 2026

  • Operating profitability anticipated in the second half of 2026, excluding stock-based compensation

Preliminary Financial Information
The preliminary financial results included in this press release are based on management’s initial analysis of operations for the fourth quarter and year ended December 31, 2025, and are subject to completion of Phathom’s financial closing procedures and audit. Actual results may differ materially from these preliminary estimates. Phathom’s independent registered public accounting firm has not audited, reviewed, examined, compiled, nor applied agreed-upon procedures with respect to the preliminary financial data.

Non-GAAP Financial Measures
This press release includes financial results prepared in accordance with accounting principles generally accepted in the United States (GAAP) and also certain non-GAAP financial measures. In particular, we have provided non-GAAP operating expenses, adjusted to exclude stock-based compensation, which is substantially dependent on changes in the market price of our common stock. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, we believe the presentation of non-GAAP operating expenses, when viewed in conjunction with GAAP results, provides investors with a more meaningful understanding of ongoing operating performance. In addition, this non-GAAP financial measure is among those indicators we use as a basis for evaluating performance, and planning and forecasting future periods. This non-GAAP financial measure is not intended to be considered in isolation or as a substitute for its most directly comparable GAAP financial measure. The difference between GAAP and non-GAAP operating expenses is included in the results presented above.

About VOQUEZNA®
VOQUEZNA® tablets contain vonoprazan, an oral small molecule potassium-competitive acid blocker (PCAB). PCABs are a novel class of medicines that block acid secretion in the stomach. VOQUEZNA is approved in the U.S. for the treatment of adults with Erosive Esophagitis, also known as Erosive GERD, the relief of heartburn associated with Erosive GERD, the relief of heartburn associated with Non-Erosive GERD, and for the treatment of H. pylori infection in combination with either amoxicillin or amoxicillin and clarithromycin. Phathom in-licensed the rights to vonoprazan for the U.S., Europe and Canada from Takeda, which markets the product in Japan and numerous other countries in Asia and Latin America. 

About Phathom Pharmaceuticals, Inc.
Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases. Phathom has in-licensed the exclusive rights to vonoprazan, a first-in-class potassium-competitive acid blocker (PCAB), for the U.S., Europe and Canada. Phathom currently markets vonoprazan in the United States as VOQUEZNA® (vonoprazan) tablets for the relief of heartburn associated with Non-Erosive GERD in adults, the healing and maintenance of healing of Erosive GERD in adults and relief of associated heartburn, and as part of VOQUEZNA® TRIPLE PAK® (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA® DUAL PAK® (vonoprazan tablets, amoxicillin capsules) for the treatment of H. pylori infection in adults. For more information about Phathom, visit the company’s website at www.phathompharma.com and follow on LinkedIn and X.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our expectations as to fourth quarter and full-year 2025 financial results and operating profitability, excluding stock-based compensation, in the second half of 2026. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including the risk that: our actual results for the fourth quarter or full year 2025 may differ materially from our preliminary estimates as a result of changes to assumptions and estimates, the completion of review of internal controls over financial reporting or other quarter-end and year-end procedures, the availability of additional information, audit adjustments, post-closing or subsequent-event evaluations or for other reasons; we may not achieve results, revenues or growth from commercialization of VOQUEZNA at the levels to enable us to meet our expectations as to operating profitability; the market opportunity for VOQUEZNA may be significantly smaller than our expectations; market acceptance for VOQUEZNA from healthcare professionals, patients, and payors may be significantly lower than we anticipate; we may encounter coverage, reimbursement, market access, or other issues in the course of our commercialization efforts that may negatively impact our efforts and results; the unmet need for new treatment options in GERD may not be as high as we anticipate; our estimates of potential market size may not be accurate; our decisions as to where to allocate our resources and focus our efforts may not lead to the results we expect; we may be negatively impacted by regulatory developments or other governmental actions in the United States, including government healthcare reform; we may encounter unexpected adverse side effects or inadequate efficacy of VOQUEZNA that may limit or impair market acceptance; our operating expenses may be higher than we anticipate which could negatively impact our expectations as to operating profitability, including if we decide to engage in activities not currently in our plan or if we face unexpected, or higher than anticipated, expenses, including as the result of unexpected events such as litigation; depending on our results and activities, we may not achieve profitability on the timelines we expect or at all. For additional discussion of these and other risks related to our business, see the risk disclosures in our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to revise or update these statements to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

MEDIA CONTACT
Nick Benedetto
1-877-742-8466
media@phathompharma.com

INVESTOR CONTACT
Eric Sciorilli
1-877-742-8466
ir@phathompharma.com

© 2026 Phathom Pharmaceuticals. All rights reserved.
VOQUEZNA, VOQUEZNA DUAL PAK, VOQUEZNA TRIPLE PAK, Phathom Pharmaceuticals, and their respective logos are registered trademarks of Phathom Pharmaceuticals, Inc.

300 Exceptional Teen Scientists Recognized for Innovative STEM Research in Nation’s Oldest and Most Prestigious High School Competition

300 Exceptional Teen Scientists Recognized for Innovative STEM Research in Nation’s Oldest and Most Prestigious High School Competition




300 Exceptional Teen Scientists Recognized for Innovative STEM Research in Nation’s Oldest and Most Prestigious High School Competition

Regeneron Science Talent Search Marks Milestone 85th Year with $1.2 Million Awarded to Nation’s Most Promising Young Scientists and Their Schools

WASHINGTON, Jan. 07, 2026 (GLOBE NEWSWIRE) — Society for Science (the Society) today announced the top 300 scholars in the Regeneron Science Talent Search 2026, the nation’s oldest and most prestigious science and math competition for high school seniors.

Key Takeaways:

  • Over 2,600 students applied this year from 826 high schools across 46 states, Washington, D.C., Northern Mariana Islands, Puerto Rico, and 16 countries.
  • The 300 scholars are from 203 American and international high schools in 34 states, Washington, D.C. and China.
  • Each of the scholars will be awarded $2,000, and their schools will be awarded $2,000 for each enrolled scholar.
  • This year marks the milestone 85th Science Talent Search and the 10th Science Talent Search in partnership with Regeneron.
  • The full list of scholars can be viewed here: https://www.societyforscience.org/regeneron-sts/2026-scholars/

“Congratulations to the top 300 scholars in this year’s Regeneron Science Talent Search,” said Maya Ajmera, President and CEO, Society for Science and Publisher, Science News. “Their research highlights the creativity, rigor and determination that’s pushing forward the future of scientific discovery. We are honored to recognize their achievements and support their continued pursuit of STEM excellence.”

Scholars were chosen based on their outstanding research, leadership skills, community involvement, commitment to academics, creativity in asking scientific questions and exceptional promise as STEM leaders demonstrated through the submission of their original, independent research projects, essays and recommendations.

Scholars’ research projects cover 20 categories, from Animal Sciences to Space Science. Other students chose to focus on areas such as Behavioral Sciences, Biochemistry, and Environmental Science. The top 5 categories among scholars’ projects this year are:

  1. Cellular and Molecular Biology
  2. Medicine and Health
  3. Computational Biology and Bioinformatics
  4. Computer Science
  5. Engineering

“We are inspired by this year’s scholars for their remarkable projects and drive to use the power of STEM to improve the world around them,” said Christina Chan, Senior Vice President, Corporate Communications & Citizenship at Regeneron. “Our partnership with the Society for Science is all about empowering young scientists and inspiring them to use their creativity and inventiveness to advance solutions to the world’s biggest challenges. We congratulate the scholars on their achievement and look forward to seeing what each of their futures hold.”

Now in its 104th year, Society for Science has played a significant role in educating the public about scientific discoveries as well as in identifying future leaders in science, technology, engineering and math. This year marks the 85th Science Talent Search and its growing legacy of championing scientific curiosity and empowering young people who are driven to make our world better.

What’s Next: Important Dates for 2026

  • Top 40 Finalists Announced: January 21, 2026
  • Regeneron STS Finals Week: March 5-11, 2026
  • Public Exhibition of Projects: March 8, 2026
  • Winners Announced at Awards Ceremony: March 10, 2026

Resources:

What is the Regeneron Science Talent Search?

The Regeneron Science Talent Search, a program of Society for Science since 1942, is the nation’s oldest and most prestigious science and math competition for high school seniors. Each year, more than 2,000 student entrants submit original research in critically important scientific fields of study and are judged by leading experts in their fields. Unique among high school competitions in the U.S. and around the world, the Regeneron Science Talent Search focuses on identifying, inspiring and engaging the nation’s most promising young scientists who are generating innovative solutions to solve significant global challenges through rigorous research and discoveries. It provides students with a national stage to present new ideas and challenge conventional ways of thinking.

For over eight decades, the Science Talent Search has rewarded talented high school seniors who dedicate countless hours to original research projects and present their results in rigorous reports that resemble graduate school theses. Collectively, STS alumni have received millions of dollars in scholarships and gone on to be awarded Nobel Prizes, Fields Medals, MacArthur Fellowships and numerous other accolades.

What is Regeneron’s role?

In 2017, Regeneron became only the third sponsor of the Science Talent Search, with a 10-year $100 million commitment to help reward and celebrate the best and brightest young minds and encourage them to pursue careers in STEM as a way to positively impact the world. Throughout our partnership, Regeneron nearly doubled the overall award distribution to $3.1 million annually, increasing the top award to $250,000 and doubling the awards for the top 300 scholars to $2,000 and their schools to $2,000 for each enrolled scholar to inspire more young people to engage in science.

Learn more at https://www.societyforscience.org/regeneron-sts/.

Who is Society for Science?

Society for Science is a champion for science, dedicated to promoting the understanding and appreciation of science and the vital role it plays in human advancement. Established in 1921, Society for Science is best known for its award-winning journalism through Science News and Science News Explores, its world-class science research competitions for students, including the Regeneron Science Talent Search, the Regeneron International Science and Engineering Fair and the Thermo Fisher Scientific Junior Innovators Challenge, and its STEM Outreach programming that seeks to ensure that all students have an opportunity to pursue a career in STEM. A 501(c)(3) membership organization, Society for Science is committed to inform, educate and inspire. Learn more at www.societyforscience.org and follow us on Facebook, Twitter, Instagram, and LinkedIn.

Media Contact
Gayle Kansagor, Society for Science
703-489-1131, gkansagor@societyforscience.org

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/19d92918-8031-4a9a-939a-c868d7dc31ef

AB Science reports fourth consecutive case of response from Phase 1 data for the combination of AB8939 with venetoclax for the treatment of refractory or relapsed acute myeloid leukemia

AB Science reports fourth consecutive case of response from Phase 1 data for the combination of AB8939 with venetoclax for the treatment of refractory or relapsed acute myeloid leukemia




AB Science reports fourth consecutive case of response from Phase 1 data for the combination of AB8939 with venetoclax for the treatment of refractory or relapsed acute myeloid leukemia

PRESS RELEASE

AB SCIENCE REPORTS FOURTH CONSECUTIVE CASE OF RESPONSE FROM PHASE 1 DATA FOR THE COMBINATION OF AB8939 WITH VENETOCLAX FOR THE TREATMENT OF REFRACTORY OR RELAPSED ACUTE MYELOID LEUKEMIA

  • The combination treatment was well-tolerated, with no hematological toxicity and no dose limiting toxicity
  • The fourth patient had a complex karyotype including a monosomy of chromosome 5 and TP53 mutation, and was in the third-line of treatment. He had a near complete response after 14 days of treatment with AB8939 at 21 mg/m2 plus venetoclax
  • This is the fourth patient responding to the combination from a total of 4 patients treated
  • The partial response rate is 100% (4/4), including one patient in complete remission, one near complete response and 2 partial responses
  • The results were obtained after the first cycle of treatment (14 days) in patients receiving third- or fourth-line treatment, two of whom had previously progressed on venetoclax in combination with other chemotherapies
  • These four patients all have very difficult to treat cytogenetic profiles, including complex karyotype, TP53 mutation, NRAS mutation, monosomy 5 and MECOM-rearrangement, that typically have a poor prognosis due to their aggressive disease course and treatment resistance
  • This diversity of responsive patients appears to corroborate the mechanism of action of AB8939, which is capable of destabilizing microtubules while evading multi-drug resistance and also targeting cancer stem cells without eliminating non tumoral stem cells
  • These results corroborate the positioning of AB8939 in patients with adverse genetics, complex karyotypes, TP53 mutations, NRAS and KRAS mutations, monosomy 5 and 7, and MECOM-rearrangement, which represents the highest unmet medical need.

Paris, 07 January 2026, 6pm CET

AB Science SA (Euronext – FR0010557264 – AB) today provides an update on the Phase 1 study of the molecule AB8939 and the fourth consecutive response with the combination of AB8939 + venetoclax in patients with acute myeloid leukemia (AML) associated with a very unfavorable genetic profile.

The fourth patient received AB8939 (21.3 mg/m²) plus venetoclax for 14 days.

The patient had AML with a very negative risk profile,

  • complex karyotype including a monosomy of chromosome 5 and also an identified TP53 mutation
  • in third-line of treatment, having progressed after CPX-351 treatment and Citarine + Idarrubincine + Fludarabine (3+7) regimen.

Under the AB8939 + venetoclax combination, the patient achieved a partial response.

This fourth result is consistent with the responses previously reported on October 14, 2025, in the first three patients who received AB8939 + venetoclax.

Nicholas J. Short, MD, Associate Professor and Co-Lead of the Section of Developmental Therapeutics, Department of Leukemia, MD Anderson Cancer Center, said, “This new data is very encouraging, particularly considering the very adverse risk profile of this patient’s leukemia. These early efficacy and safety data suggest that AB8939 can be combined with venetoclax and could have significant activity in the highest-risk subtypes of AML. There is a strong interest in continuing the development of this combination in patients whose AML has high-risk features that are expected to lead to resistance to venetoclax + azacitidine.

Professor Olivier Hermine, MD, President of the Scientific Committee of AB Science and member of the Académie des Sciences in France, said, “There is a strong rationale to combine AB8939 and venetoclax as both molecules have low hematologic toxicity and complementary mode of actions. These first results are supportive of this rationale.”

About AB8939

AB8939 is a drug candidate that targets (i) cancer cells by destabilizing microtubules (essential for cell division) and (ii) cancer stem cells by inhibiting ALDH1A1 and ALDH2 (enzymes essential for maintaining their physiological state and survival).

  • AB8939 has shown in vitro activity in Ara-C (cytarabine, which is one of the standards of care) resistant patient cell lines, including adverse genetic MECOM and TP53 mutations.
  • Analysis of cell lines responsive to AB8939 showed that AB8939 is effective in cell lines with TP53 mutations, MECOM, and complex karyotypes, whereas ARAC and azacitidine are not effective.
  • AB8939 increased survival and had an additive effect in combination with venetoclax (another standard of care) in vivo in a MECOM-grafted PDX mouse model.
  • AB8939 increased survival and had an additive effect in combination with Vidaza (azacitidine, another standard of care) in vivo in the MECOM PDX#C1005 mouse model of leukemia.
  • AB8939 eradicated Leukemia Cancer Stem Cells in vivo in a human PDX AML mouse model, which is compatible with targeting stem cells via ALDH.

AB8939 is currently being evaluated in a Phase 1 clinical trial (study AB18001, NCT05211570) in patients with refractory and relapsed AML.

The Phase 1 clinical trial of AB8939 has completed its first two stages, which consisted of determining the maximum tolerated dose (MTD) after 3 and 14 consecutive days of monotherapy. In both cases, the MTD was 21.3 mg/m².

The third stage, currently underway, involves evaluating the combination of AB8939 and venetoclax. Three patients were evaluated at the first dose level (AB8939 14 days at a dose of 16 mg/m² + venetoclax 14 days). The current dose level evaluates (AB8939 14 days at a dose of 21.3 mg/m² + venetoclax 14 days)

Medical need in AML and AB8939 mechanism of action

Although several drugs have been registered for AML, 70% of patients still relapse and die, creating a persistent unmet medical need for effective treatments. Acute myeloid leukemia remains the most lethal form of leukemia in humans.

AML is a heterogeneous disease, and its outcome is highly dependent on genetic factors. TP53 mutation has a very poor prognosis, with a median overall survival (OS) of 5.5 months. NRAS and KRAS mutants have a poor prognosis, with a median OS of 12.1 months. MECOM also has a very poor prognosis in AML, with a median OS of 5.5 months in relapsed or refractory settings.

The challenge in AML is the recurrence of tumors due to a combination of two factors: the resistance of cancer cells to chemotherapy and relapse due to the persistence of cancer stem cells. This challenge may be overcome by AB8939’s dual mechanism of action.

  • First, AB8939 blocks the proliferation of leukemia cells through microtubule disruption. It is not subject to multi-drug resistance as it does not bind to PgP, which is responsible for efflux outside the cells, and is not degraded by myeloperoxidase.
    • Second, AB8939 targets leukemia cancer stem cells by inhibiting ALDH and promotes bone marrow repopulation of normal progenitors.

AB8939 + venetoclax combination

There is a strong rationale to combine AB8939 with venetoclax

  • Both molecules exhibit low hematologic toxicity. This combination is expected to be less toxic than azacitidine + venetoclax as first-line treatment for AML
  • These molecules have different and complementary targets in cancer cells. There is an additive, even synergistic, efficacy potential for the combination, with three mechanisms of action in a single treatment.
    • Venetoclax’s mechanism of action inhibits the BCL2 pathway, a protein that prevents apoptosis (programmed cell death) in cancer cells. BCL2 is a key factor in AML resistance, as it allows cancer cells to survive despite treatment
    • AB8939 is pro-apoptotic, destabilizing microtubules, and would benefit from BCL2 inhibition to optimize apoptosis
    • In addition, AB8939 specifically targets cancer stem cells by inhibiting ALDH, reducing resistance to treatment and limiting the risk of relapse

Next steps

The next step is to complete phase 1 in combination and launch an expansion study in approximately 15 AML patients eligible for AB8939 + venetoclax at the appropriate dose. The expansion phase is expected to generate robust preliminary evidence of efficacy in the AML label, sufficient to support the clinical development plan and a beneficial partnership agreement.

AB Science has started to discuss three possibilities for registration studies, which are not mutually exclusive, with the European Medicines Agency (EMA) and US Food and Drug Administration (FDA):

  • AB8939 + venetoclax as first-line treatment, with aged patients and/or patients with adverse genetics (complex karyotypes, TP53 mutations, NRAS and KRAS mutations, monosomy 5 and 7, and MECOM-rearrangement)
  • AB8939 + venetoclax as a second- or third-line treatment, in all patients or patients with adverse genetics
  • AB8939 as a single agent in MECOM as a second or third-line treatment.

Addressable market with AB8939 in relapsed/refractory AML

Treatments for relapsed or refractory AML represent an estimated market size potential of greater than EUR 2 billion per annum.

Region Incidence Case
(1)
% Relapse or Refractory (2,3) % Insured Patients (4) Drug Price (€) Market Size
(per in Mio EUR)
USA / CANADA 23,700 50%

 

 

 

 

 

90% 100,000(5) 1 000 000
EUROPE 27,600 90% 60,000 770 000
APAC 27,800 30% 60,000 250 000
INDIA 11,000 30% 60,000 100,000
LATAM 7,200 30% 60,000 65 000
MENA 3,900 30% 60,000 35 000
TOTAL 90,200       2 200 000

EUROPE = EU27 + Norway + United Kingdom + Switzerland ; APAC = Australia, People’s Republic of China , Japan, New Zealand, Singapore, Taiwan ; LATAM = Argentina, Brazil, Chile, Colombia, Costa Rica, Mexico ; MENA = Algeria, Bahrain, Egypt, Israel, Kuwait, Morocco, Oman, Qatar, Saudi Arabia, Tunisia, United Arab Emirates
(1)    Zhou, Y et al. Global, regional, and national burden of acute myeloid leukemia, 1990–2021: a systematic analysis for the global burden of disease study 2021. Biomark Res 12, 101 (2024).
(2)    Ravandi F. Relapsed acute myeloid leukemia: Why is there no standard of care Best Pract Res Clin Haematol. 2013;26(3):253-9
(3)    Walter RB et al. Resistance prediction in AML: analysis of 4601 patients from MRC/NCRI, HOVON/SAKK, SWOG and MD Anderson Cancer Center. Leukemia (2015) 29:312–20. .
(4)    Estimated
(5)    Choi M. et al. Costs per patient achieving remission with venetoclax-based combinations in newly diagnosed patients with acute myeloid leukemia ineligible for intensive induction chemotherapy. Journal of Managed Care & Specialty Pharmacy Volume 28, Number 9. https://doi.org/10.18553/jmcp.2022.22021

Intellectual property

AB8939 intellectual property rights in AML are secured until 2036 through a ‘composition of matter’ patent and potentially until 2041 with a 5 years extension. Two additional ‘second medical use’ patent applications have been filed to protect the use of AB8939 in the treatment of AML with specific chromosomal abnormalities. If these applications are accepted, the protection for AB8939 will be extended until 2044 and 2046 for these AML subpopulations.

AB8939 has also received orphan drug designation for AML by both the EMA and FDA. This orphan drug designation confers 10 and 7 years of marketing exclusivity in Europe and the US, respectively, from the date of product registration.

AB Science is the sole proprietary holder of AB8939 and its family of compounds.

About AB Science
Founded in 2001, AB Science is a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors (PKIs), a class of targeted proteins whose action are key in signaling pathways within cells. Our programs target only diseases with high unmet medical needs, often lethal with short term survival or rare or refractory to previous line of treatment.
AB Science has developed a proprietary portfolio of molecules and the Company’s lead compound, masitinib, has already been registered for veterinary medicine and is developed in human medicine in oncology, neurological diseases, inflammatory diseases and viral diseases. The company is headquartered in Paris, France, and listed on Euronext Paris (ticker: AB).

Further information is available on AB Science’s website:
www.ab-science.com.

Forward-looking Statements – AB Science
This press release contains forward-looking statements. These statements are not historical facts. These statements include projections and estimates as well as the assumptions on which they are based, statements based on projects, objectives, intentions and expectations regarding financial results, events, operations, future services, product development and their potential or future performance.

These forward-looking statements can often be identified by the words “expect”, “anticipate”, “believe”, “intend”, “estimate” or “plan” as well as other similar terms. While AB Science believes these forward-looking statements are reasonable, investors are cautioned that these forward-looking statements are subject to numerous risks and uncertainties that are difficult to predict and generally beyond the control of AB Science and which may imply that results and actual events significantly differ from those expressed, induced or anticipated in the forward-looking information and statements. These risks and uncertainties include the uncertainties related to product development of the Company which may not be successful or to the marketing authorizations granted by competent authorities or, more generally, any factors that may affect marketing capacity of the products developed by AB Science, as well as those developed or identified in the public documents published by AB Science. AB Science disclaims any obligation or undertaking to update the forward-looking information and statements, subject to the applicable regulations, in particular articles 223-1 et seq. of the AMF General Regulations.

For additional information, please contact:

AB Science
Financial Communication & Media Relations
investors@ab-science.com

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