Bristol Myers Squibb Announces Accepted Amounts and Pricing Terms of its Tender Offers




Bristol Myers Squibb Announces Accepted Amounts and Pricing Terms of its Tender Offers

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) (“Bristol Myers Squibb”), today announced the accepted amounts and pricing terms of the previously announced tender offers to purchase for cash its outstanding notes listed in the tables below.

The outstanding debt securities listed in (i) the first table below labeled “Pool 1” are referred to collectively as the “Pool 1 Notes” and (ii) the second table below labeled “Pool 2” are referred to collectively as the “Pool 2 Notes.” The Pool 1 Notes and the Pool 2 Notes are referred to collectively as the “Notes” and each series of Notes is referred to as a “series.” We refer to each offer to purchase a series of Notes for cash as an “Offer,” the offers to purchase the Pool 1 Notes collectively as the “Pool 1 Offers,” the offers to purchase the Pool 2 Notes collectively as the “Pool 2 Offers,” and all the offers to purchase Notes are referred to collectively as the “Offers.”

As previously announced, Bristol Myers Squibb (i) decreased the maximum aggregate purchase price of the Pool 1 Notes it will accept for purchase from the previously announced amount of $4,000,000,000 to an amount sufficient (the “Amended Pool 1 Maximum”) to accept for purchase all Pool 1 Notes that were validly tendered and not validly withdrawn prior to the Early Tender Deadline and (ii) increased the maximum aggregate purchase price of the Pool 2 Notes it will accept for purchase from the previously announced amount of $3,000,000,000 to an amount sufficient (the “Amended Pool 2 Maximum”) to accept for purchase all Pool 2 Notes with an acceptance priority level at 1 through 4 (as set forth in the second table below) that were validly tendered and not validly withdrawn prior to the Early Tender Deadline as well as up to $250,000,000 in principal amount of Bristol Myers Squibb’s 5.900% Notes due 2033 (the “2033 Notes”). The Amended Pool 1 Maximum and Amended Pool 2 Maximum have now been established as approximately $3.99 billion and $3.51 billion, respectively.

The tables below indicate, among other things, the aggregate principal amount of Notes tendered as of 5:00 p.m. (New York City time) on November 17, 2025, (the “Early Tender Deadline”) and accepted in each Offer, the Offer Yield (each as defined below), the proration factor, if any, and the total consideration for each $1,000 principal amount of each series of Notes validly tendered at or prior to the Early Tender Deadline and accepted for purchase (the “Total Consideration”), as calculated at 10:00 a.m. (New York City time) today, November 18, 2025 in accordance with the terms of the Offer to Purchase dated November 3, 2025 (as amended or supplemented from time to time, the “Offer to Purchase”).

Since all of the Pool 1 Notes, and all of the Pool 2 Notes with an acceptance priority level at 1 through 4 that were validly tendered and not validly withdrawn prior to the Early Tender Deadline have been accepted for purchase by Bristol Myers Squibb, no proration procedures will be required for the Pool 1 Notes and the Pool 2 Notes with an acceptance priority level at 1 through 4. Since the aggregate principal amount of 2033 Notes exceeds $250,000,000, Bristol Myers has accepted the 2033 Notes on a prorated basis in accordance with the terms and conditions of the Offer to Purchase. No Pool 2 Notes with an acceptance priority level at 6 through 9, as set forth in the second table below, have been accepted for purchase. Bristol Myers Squibb has accepted Notes for purchase according to the Acceptance Priority Procedures and the terms and conditions described in the Offer to Purchase. Holders of Notes (each, a “Holder” and collectively, “Holders”) validly tendered at or prior to the Early Tender Deadline that are accepted for purchase by Bristol Myers Squibb will receive the applicable Total Consideration, in cash. As described in the Offer to Purchase, Notes tendered and not accepted for purchase will be promptly returned to the tendering Holder’s account.

Pool 1

Offers to purchase for cash up to the Amended Pool 1 Maximum of the securities listed in the priority order below.

(1) The “Offer Yield” is equal to the sum of (i) the applicable Reference Yield (as defined in the Offer to Purchase), which is based on the bid-side price of the applicable Reference U.S. Treasury Security (as specified in the Offer to Purchase), plus (ii) the applicable Fixed Spread (as specified in the Offer to Purchase).

(2) Includes the Early Tender Premium (as defined in the Offer to Purchase). Payable per each $1,000 principal amount of each specified series of Notes validly tendered at or prior to the Early Tender Deadline and accepted for purchase.

Pool 2

Offers to purchase for cash up to the Amended Pool 2 Maximum of the securities listed in the priority order below.

(1) The “Offer Yield” is equal to the sum of (i) the applicable Reference Yield (as defined in the Offer to Purchase), which is based on the bid-side price of the applicable Reference U.S. Treasury Security (as specified in the Offer to Purchase), plus (ii) the applicable Fixed Spread (as specified in the Offer to Purchase).

(2) Includes the Early Tender Premium (as defined in the Offer to Purchase). Payable per each $1,000 principal amount of each specified series of Notes validly tendered at or prior to the Early Tender Deadline and accepted for purchase.

The withdrawal rights for the Offers expired at 5:00 p.m. (New York City time) on November 17, 2025. As previously announced, all conditions of the Offers were deemed satisfied or waived by Bristol Myers Squibb by the Early Tender Deadline and Bristol Myers Squibb has elected to exercise its Early Settlement Right (as defined in the Offer to Purchase). The Early Settlement Date (as defined in the Offer to Purchase) will occur on November 20, 2025. The Offers will each expire at 5:00 p.m. (New York City time) on December 3, 2025, unless extended or earlier terminated by Bristol Myers Squibb. However, since the aggregate principal amount of Pool 1 Notes and Pool 2 Notes validly tendered and not validly withdrawn at or prior to the Early Tender Deadline met or exceeded the Amended Pool 1 Maximum and Amended Pool 2 Maximum, respectively, Bristol Myers Squibb expects that there will be no Final Settlement Date (as defined in the Offer to Purchase) and no tenders of Notes after the Early Tender Deadline will be accepted for purchase by Bristol Myers Squibb.

The Total Consideration that will be paid on the Early Tender Deadline for each series of Notes accepted for purchase does not include a cash payment equal to accrued and unpaid interest on such Notes to, but not including, the Early Settlement Date. For the avoidance of doubt, interest will cease to accrue on the Early Settlement Date for all Notes accepted in the Offers. Under no circumstances will any interest be payable to Holders because of any delay on the part of Global Bondholder Services Corporation, as the tender agent and information agent, The Depository Trust Company or any other party in the transmission of funds to Holders. See the Offer to Purchase for additional information.

All Notes accepted in the Offers will be cancelled and retired and will no longer remain outstanding obligations of Bristol Myers Squibb.

Bristol Myers Squibb has retained Citigroup Global Markets Inc., Deutsche Bank Securities Inc., Goldman Sachs & Co. LLC and Morgan Stanley & Co. LLC as lead dealer managers, BofA Securities, Inc., Barclays Capital Inc., J.P. Morgan Securities LLC and Wells Fargo Securities, LLC as dealer managers and Academy Securities, Inc. as a co-dealer manager for the Offers. Questions regarding terms and conditions of the Offers should be directed to Citigroup Global Markets Inc. at (800) 558-3745 (toll-free) or (212) 723-6106 (collect) or Deutsche Bank Securities Inc. at (866) 627-0391 (toll-free) or (212) 250-2955 (collect) or Goldman Sachs & Co. LLC at (800) 828-3182 (toll-free) or (212) 357-1452 (collect) or Morgan Stanley & Co. LLC at (800) 624-1808 (toll-free) or (212) 761-1057 (collect). Global Bondholder Services Corporation is acting as the tender agent and the information agent for the Offers (the “Tender and Information Agent”).

Offer and Distribution Restrictions

This announcement is for informational purposes only. This announcement is not an offer to sell or purchase, a solicitation of an offer to sell or purchase, or the solicitation of tenders with respect to any of Notes described herein. The Offers are being made solely pursuant to the Offer to Purchase. The Offers are not being made to Holders of Notes in any jurisdiction in which the making or acceptance thereof would not be in compliance with the securities, blue sky or other laws of such jurisdiction. In any jurisdiction in which the securities laws or blue sky laws require the Offers to be made by a licensed broker or dealer, the Offers will be deemed to be made on behalf of Bristol Myers Squibb by the dealer managers or one or more registered brokers or dealers that are licensed under the laws of such jurisdiction.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains certain forward-looking statements regarding, among other things, the timing, terms, conditions and other aspects of the Offers. You can identify these forward-looking statements by the fact that they use words such as “should,” “could,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe,” “will” and other words and terms of similar meaning and expression in connection with any discussion of, among other things, the Offers, although not all forward-looking statements contain such terms. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. No forward-looking statement can be guaranteed.

Forward-looking statements are based on current expectations and projections about Bristol Myers Squibb’s future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them, that are difficult to predict, may be beyond its control and could cause its future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. Such risks, uncertainties and other matters include, but are not limited to: general market conditions which might affect the Offers; interest rate and currency exchange rate fluctuations, credit and foreign exchange risk management; and access to capital markets.

Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in its Annual Report on Form 10-K for the year ended December 31, 2024, as updated by the subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC. The forward-looking statements included in this press release are made only as of the date of this press release and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

About Bristol Myers Squibb: Transforming Patients’ Lives Through Science

At Bristol Myers Squibb, our mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We are pursuing bold science to define what’s possible for the future of medicine and the patients we serve.

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Contacts

Media Relations:
media@bms.com

Investor Relations:
investor.relations@bms.com

Arrowhead Pharmaceuticals Announces FDA Approval of REDEMPLO® (plozasiran) to Reduce Triglycerides in Adults with Familial Chylomicronemia Syndrome (FCS)




Arrowhead Pharmaceuticals Announces FDA Approval of REDEMPLO® (plozasiran) to Reduce Triglycerides in Adults with Familial Chylomicronemia Syndrome (FCS)

– REDEMPLO is the first and only FDA-approved medicine to be studied in patients with genetically confirmed and clinically diagnosed FCS

– People living with FCS have extremely high triglyceride levels and a substantially higher risk of acute pancreatitis and related long-term complications, often resulting in a reduced quality of life

– The FDA approval is based on positive results from the Phase 3 PALISADE study where REDEMPLO significantly reduced triglycerides from baseline and lowered the numerical incidence of acute pancreatitis compared to placebo

– Arrowhead will host a conference call and webcast today at 1:30 p.m. ET

PASADENA, Calif.–(BUSINESS WIRE)–$arwr–Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the U.S. Food and Drug Administration (FDA) has approved REDEMPLO (plozasiran), a small interfering RNA (siRNA) medicine, as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). FCS is a severe, rare disease, with an estimated 6,500 people in the U.S. living with genetic or clinical FCS, characterized by triglyceride levels that can be 10 to 100 times higher than normal leading to a substantially higher risk of developing acute, recurrent, and potentially fatal pancreatitis. REDEMPLO is the first and only FDA-approved siRNA medicine for people living with FCS and can be self-administered at home with a simple subcutaneous injection once every three months. REDEMPLO utilizes the proprietary and differentiated Targeted RNAi Molecule (TRiM™) platform and is Arrowhead’s first FDA-approved medicine, marking a major milestone for the company as it transitions into commercial-stage.

“The FDA approval of REDEMPLO is a transformational milestone for Arrowhead. This is a proud moment for all those involved in the discovery and development process and represents new hope for the estimated 6,500 people in the U.S. living with genetic or clinical FCS. This approval, and subsequent launch, marks the beginning of a new chapter in our journey—one rooted in our unwavering commitment to delivering life-changing therapies to patients with serious diseases,” said Christopher Anzalone, Ph.D., President and CEO at Arrowhead Pharmaceuticals. “REDEMPLO also represents the first FDA-approval for a medicine that leverages Arrowhead’s proprietary and differentiated Targeted RNAi Molecule (TRiM™) platform. Arrowhead continues to lead the field in innovation, with the TRiM™ platform now potentially capable of delivering siRNA to seven different cell types in the body and the potential to simultaneously silence the expression of two genes in one molecule. The breadth of this technology with our growing commercial capabilities dramatically expands the diseases we can potentially address and the number of lives we can change.”

The FDA approval was supported by clinical data from the Phase 3 PALISADE study, a randomized, double-blind, placebo-controlled trial in adults with clinically diagnosed or genetically confirmed FCS. The PALISADE study met its primary endpoint and all multiplicity-controlled key secondary endpoints, including demonstrating significant reductions in triglycerides and APOC3. In PALISADE, 25 mg REDEMPLO achieved deep and durable reductions in triglycerides, with a median change from baseline of -80% versus -17% in the pooled placebo group, and a lower numerical incidence of acute pancreatitis compared with placebo.

Lindsey Sutton Bryan, co-founder and co-president of the FCS Foundation added, “Today’s approval marks a pivotal moment for people living with familial chylomicronemia syndrome and the physicians who support them. Because FCS symptoms are mostly invisible, this community historically has been often overlooked and misunderstood, making their journey to effective treatment especially difficult. We’re grateful to Arrowhead for listening to patients and caregivers and incorporating their lived experiences into the development of this transformative therapy. Plozasiran offers real hope for a better future and shows what’s possible when innovation is driven by empathy and collaboration addressing patients in need.”

The most common adverse reactions in REDEMPLO treated patients (incidence ≥10% of patients treated with REDEMPLO and > 5% more frequently than with placebo) are hyperglycemia, headache, nausea, and injection site reaction. The US approved package insert contains no contraindications, warnings, or precautions associated with the use of REDEMPLO.

The efficacy and safety results from the PALISADE study were presented at the European Society of Cardiology (ESC) Congress 2024 and the American Heart Association Scientific Sessions 2024 (AHA24) and simultaneously published in The New England Journal of Medicine and Circulation, respectively. ESC, AHA24, and other plozasiran presentations may be accessed on the Events and Presentations page in the Investors section of the Arrowhead website.

Underscoring the company’s commitment to improving patient outcomes, ensuring access for patients, and providing value to the health system, Arrowhead is developing best-in-class solutions for the FCS community. Arrowhead is launching Rely On REDEMPLO, a patient support program providing support services and resources for patients at each stage of the treatment journey with REDEMPLO, including financial assistance options for eligible patients.

REDEMPLO will be available in the U.S. before the end of the year.

REDEMPLO was granted Breakthrough Therapy Designation, Fast Track Designation, and Orphan Drug Designation by the FDA for the treatment of patients with FCS and was granted Orphan Medicinal Product Designation by the European Medicines Agency for the treatment of patients with FCS.

Webcast and Conference Call and Details

Arrowhead will host a conference call and webcast to discuss the REDEMPLO FDA approval today at 1:30 p.m. ET.

A live webcast may be accessed on the Events and Presentations page under the Investors section of the Arrowhead website. A replay of the webcast will be available approximately two hours after the conclusion of the call.

About FCS

Familial chylomicronemia syndrome (FCS) is a severe and rare disease leading to extremely high triglyceride (TG) levels, typically over 880 mg/dL. Such severe elevations can lead to various serious signs and symptoms including acute and potentially fatal pancreatitis, chronic abdominal pain, diabetes, hepatic steatosis, and cognitive issues. Currently, there are limited therapeutic options to adequately treat FCS.

About the PALISADE Phase 3 Study

The PALISADE study (NCT05089084) was a Phase 3 placebo-controlled study to evaluate the efficacy and safety of plozasiran in adults with genetically confirmed or clinically diagnosed FCS. The primary endpoint of the study was percent change from baseline in fasting TG versus placebo at Month 10. A total of 75 subjects distributed across 39 different sites in 18 countries were randomized to receive 25 mg plozasiran, 50 mg plozasiran, or matching placebo once every three months. Participants who completed the randomized period were eligible to continue in a 2-part extension period, where all participants receive plozasiran.

About REDEMPLO^® (plozasiran)

REDEMPLO (plozasiran) is approved by the U.S. Food and Drug Administration as an adjunct to diet to reduce triglycerides for adults with Familial Chylomicronemia Syndrome (FCS). REDEMPLO is an siRNA therapeutic designed to suppress the production of apoC-III, a protein produced in the liver that raises triglyceride levels by slowing their breakdown and clearance. By targeting apoC-III with sustained silencing, REDEMPLO delivers significant reductions in triglyceride levels. REDEMPLO is the first and only siRNA FDA-approved treatment studied in both genetically confirmed and clinically diagnosed patients living with FCS.

For more information about REDEMPLO, visit Our Medicines.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

None.

ADVERSE REACTIONS

Most common adverse reactions in REDEMPLO treated patients (incidence ≥10% of patients treated with REDEMPLO and >5% more frequently than with placebo) are hyperglycemia, headache, nausea, and injection site reaction.

Please see full Prescribing Information for REDEMPLO^®.

About Plozasiran

Plozasiran is a first-in-class investigational RNA interference (RNAi) therapeutic designed to reduce production of apolipoprotein C-III (apoC-III) which is a component of triglyceride rich lipoproteins (TRLs) and a key regulator of triglyceride metabolism. ApoC-III increases triglyceride levels in the blood by inhibiting breakdown of TRLs by lipoprotein lipase and uptake of TRL remnants by hepatic receptors in the liver. The goal of treatment with plozasiran is to reduce the level of apoC-III, thereby reducing triglycerides and restoring lipids to more normal levels.

In addition to the FDA approval of REDEMPLO as an adjunct to diet to reduce triglycerides for adults with Familial Chylomicronemia Syndrome, plozasiran has been submitted to additional global regulatory authorities for review and marketing authorization. Plozasiran is also being investigated in the SHASTA-3, SHASTA-4, and SHASTA-5 Phase 3 studies in patients with severe hypertriglyceridemia and the MUIR Phase 3 study in patients with mixed hyperlipidemia.

About Arrowhead Pharmaceuticals

Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.

For more information, please visit www.arrowheadpharma.com, or follow us on X (formerly Twitter) at @ArrowheadPharma, LinkedIn, Facebook, and Instagram. To be added to the Company’s email list and receive news directly, please visit http://ir.arrowheadpharma.com/email-alerts.

Safe Harbor Statement under the Private Securities Litigation Reform Act:

This news release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this release except for historical information may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “may,” “will,” “expect,” “believe,” “anticipate,” “hope,” “intend,” “plan,” “project,” “could,” “estimate,” “continue,” “target,” “forecast” or “continue” or the negative of these words or other variations thereof or comparable terminology are intended to identify such forward-looking statements. In addition, any statements that refer to projections of our future financial performance, trends in our business, expectations for our product pipeline, products or product candidate or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements include, but are not limited to, statements about our beliefs and expectations regarding the long-term impacts of REDEMPLO (plozasiran) on patient health and the health care system; our beliefs and expectations regarding the pricing, value, or expected timing for availability of our drugs and drug candidates; and our believes and expectations around the potential uses and value of the TRiM™ platform. These statements are based upon our current expectations and speak only as of the date hereof. Actual results or outcomes may differ materially and adversely from those expressed in any forward-looking statements as a result of numerous factors and uncertainties the safety and efficacy of our products and product candidates, pricing and reimbursement decisions related to our products, demand for our products, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in our clinical programs, our ability to finance our operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of our scientific studies, the timing for starting and completing clinical trials, rapid technological change in our markets, the enforcement of our intellectual property rights, and the other risks and uncertainties described in our most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other documents filed with the Securities and Exchange Commission from time to time. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances.

Source: Arrowhead Pharmaceuticals, Inc.

Contacts

Arrowhead Pharmaceuticals, Inc.

Vince Anzalone, CFA

626-304-3400

ir@arrowheadpharma.com

Investors:
LifeSci Advisors, LLC

Brian Ritchie
212-915-2578

britchie@lifesciadvisors.com

Media:
HAVAS PR

Erick Edwing

941-468-7534

Erick.edwing@havasred.com

Lifordi Immunotherapeutics Secures Strategic Investment from Sanofi Ventures and Additional Capital from Existing Investors




Lifordi Immunotherapeutics Secures Strategic Investment from Sanofi Ventures and Additional Capital from Existing Investors

Company Raised $112 Million to Date and is on Track to Generate Initial Clinical Data by Year End

BURLINGTON, Mass.–(BUSINESS WIRE)–#ADCs–Lifordi Immunotherapeutics, Inc., a clinical-stage biotech company developing antibody-drug conjugates (ADCs) for the treatment of autoimmune and inflammatory disorders, today announced a strategic investment from Sanofi Ventures, the venture arm of global healthcare leader Sanofi, and funding from existing investors ARCH Ventures, 5AM Ventures, and Atlas Venture. The new funds bring the total raised to $112 million and support an ongoing Phase 1 study in Rheumatoid Arthritis (RA) designed to evaluate LFD-200, an ADC delivering a potent glucocorticoid (GC) directly to immune cells. It also provides for Chemistry Manufacturing and Controls (CMC) preparations to ensure that Phase 2 clinical supply is available without incurring an unnecessary delay. As part of the investment, Christopher Gagliardi, Ph.D., Principal at Sanofi Ventures, will join as an observer on Lifordi’s Board of Directors.

“Sanofi has demonstrated a strong commitment to invest in new treatments for autoimmune and inflammatory diseases, and we are fortunate to have this support from Chris and the Sanofi Ventures team alongside our current investors to advance LFD-200 and our targeted ADC delivery pipeline for immune-mediated conditions,” said Arthur Tzianabos, Ph.D., President & Chief Executive Officer. “Enrollment and dosing in our Phase 1 study of LFD-200 in RA is progressing as planned, and we look forward to sharing initial data from healthy participants in the coming months.”

“We continue to search for new approaches to improve the treatment of autoimmune and inflammatory diseases and were intrigued by Lifordi’s targeted ADC approach to deliver glucocorticoids without toxicity,” said Christopher Gagliardi, Ph.D. “Once we met the team and did our due diligence on the proof-of-concept data in multiple animal models of autoimmune disease together with extensive nonclinical studies, we made the decision to invest in Lifordi now. This enables Sanofi to share our expertise and experiences to help guide LFD-200 through clinical studies and support pipeline development using this approach to deliver other drug payloads, such as ASOs or siRNAs.”

Lifordi’s Phase 1 clinical trial is currently enrolling and dosing healthy participants. The study is designed to evaluate the safety and efficacy of LFD-200, and initial healthy participant data will include both safety and pharmacodynamic measures. Following single and multiple ascending dosing (SAD/MAD studies), the Company plans to evaluate LFD-200 in patients with moderate to severe rheumatoid arthritis. Lifordi recently presented non-clinical data at the American College of Rheumatology (ACR) 2025 meeting showing that clinically relevant doses of LFD-200 given subcutaneously every 7 days for 13 weeks maintained glucocorticoid exposure in immune cells without evidence of systemic toxicity. By harnessing the efficacy of GCs while limiting the toxicity, LFD-200 has the potential to solve the problem that has limited the broad and long-term use of GCs for the past 75 years.

About Lifordi

Lifordi Immunotherapeutics, Inc. is a clinical-stage biotechnology company leading the way by leveraging the success of antibody-drug conjugates (ADCs) to develop treatments for autoimmune and inflammatory disorders. The Company’s lead ADC, LFD-200, is in a Phase 1 clinical trial. Preclinical studies demonstrated efficacy in multiple disease models by targeting myeloid and lymphoid cells using a highly internalized cell surface membrane protein (VISTA). Lifordi has also applied its novel drug delivery platform to other diverse payloads, such as small molecules, antisense oligonucleotides (ASOs) and siRNA. As experienced drug developers in immunology and inflammatory diseases, together with expert clinical advisors, a strong partnering track record, and funding from ARCH Venture Partners, 5AM Ventures, and Atlas Venture, Lifordi is committed to changing how immune and inflammatory diseases are treated. For more information, please visit www.lifordi.com.

About Sanofi Ventures

Sanofi Ventures is the corporate venture capital arm of Sanofi, investing globally in early-stage biotech and digital health companies aligned with Sanofi’s mission to chase the miracles of science. Areas of focus include immunology, oncology, rare diseases, vaccines, and digital innovation.

Contacts

Theresa McNeely

Chief Communications Officer

tmcneely@lifordi.com
(508) 523-9511

CELFULL Showcases Aging Intervention Technology at SupplySide Global to Lead New Trends 2026




CELFULL Showcases Aging Intervention Technology at SupplySide Global to Lead New Trends 2026

LAS VEGAS–(BUSINESS WIRE)–The recently concluded SupplySide Global 2025 was hailed as “the best ever” by a senior dietary supplement expert, who highlighted bioavailability as the defining frontier for health supplements in 2026. As “high content” gives way to “high absorption,” CELFULL – a clinically driven anti-aging health brand – unveiled Celfavor NADH, a controlled-release microsphere technology that elevates nutrient absorption to an unprecedented level, which is of epoch-making significance.

This innovative ingredient, formulated using the company’s proprietary Celfavor™ active delivery technology, establishes a new benchmark in stability and bioavailability for the highly labile NADH molecule.

As a critical coenzyme involved in cellular energy production and defense against oxidative stress, NADH has historically posed significant formulation challenges due to its inherent instability, typically degrading substantially within months under ambient conditions.

The novel microsphere delivery system employed in Celfavor™ NADH effectively shields the NADH from exposure to oxygen, moisture, and light, extending its room-temperature shelf life to an unprecedented 36 months—more than six times that of conventional NADH formulations.

Furthermore, the technology ensures near-complete preservation of NADH in gastric acid over a period of up to four hours, facilitating targeted release and optimal absorption in the intestinal tract.

“Celfavor™ NADH represents a milestone advancement in NADH innovation. Comprehensive testing, conducted both internally and through independent third-party laboratories including SGS, confirms that no currently available NADH ingredient on the market achieves comparable stability in gastric conditions alongside efficient intestinal release,” stated Dr. Juliane Hitzel, Research Lead at CELFULL.

The ingredient is free from gluten, lactose, and genetically modified organisms (GMOs), and is manufactured through a sustainable green biosynthesis process. It is protected by seven internationally granted invention patents.

Additionally, the Celfavor™ platform enables the precise co-formulation of NADH with other bioactive compounds such as vitamins and peptides, opening new possibilities for advanced nutraceutical formulations targeting energy metabolism, cognitive functions.

Industry observers note that more companies like CELFULL—those that continue to invest in R&D and expand their product and service ecosystems—are well positioned to drive the next phase of development with high-quality, high-efficiency and naturally derived ingredients and solutions.

Contacts

Company: CELFULL

Contact: Maggie Jane

Email: maggie@celfull.com
Website: www.celfull.com

Sofinnova Partners Closes €650M ($750M) Capital XI, Greatly Exceeding Initial Target to Back Early-Stage Healthcare Deals




Sofinnova Partners Closes €650M ($750M) Capital XI, Greatly Exceeding Initial Target to Back Early-Stage Healthcare Deals

• Total capital raised across Sofinnova’s platform reaches €1.5Bn over the past year
• Sofinnova Capital XI is actively investing in early-stage biotech and medtech companies across Europe and the US

PARIS–(BUSINESS WIRE)–Sofinnova Partners (“Sofinnova”), a leading European life sciences venture capital firm based in Paris, London, and Milan, today announced the close of its latest flagship fund, Sofinnova Capital XI, at €650 million ($750 million), greatly exceeding its initial target.

Sofinnova Capital XI will back a new generation of pioneering biopharmaceutical and medical technology companies addressing urgent unmet clinical needs. In keeping with Sofinnova’s multi-strategy platform model, Capital XI draws on the strength of its experienced team, including Partners Maina Bhaman, Anta Gkelou, Karl Naegler, Antoine Papiernik, Henrijette Richter, and Graziano Seghezzi.

Sofinnova Capital XI attracted strong support from a global base of blue-chip institutional investors—among them sovereign wealth funds, leading pharmaceutical companies and other corporates, as well as insurance companies, foundations, and family offices. Commitments came from across Europe, North America, Asia, and the Middle East, with a majority of returning LPs and a significant number of new top-tier investors. This reflects enduring confidence in Sofinnova’s disciplined strategy and long-standing track record.

Antoine Papiernik, Managing Partner and Chairman of Sofinnova Partners, said: “This fundraising marks a pivotal moment for Sofinnova. It gives us the firepower to double down on early-stage opportunities and reinforces our uniquely collaborative, science-driven investment approach. We’re excited to continue backing visionary entrepreneurs and advancing the next wave of breakthroughs in science and medicine to bring them to patients worldwide.”

He added: “Achieving this milestone in today’s volatile fundraising environment speaks to the strength of our model and the confidence our investors continue to place in us.”

Sofinnova Capital XI is actively deploying capital, with investments already made in a few portfolio companies. The fund will continue to support early-stage biotech and medtech ventures across Europe and North America, participating in both initial and follow-on rounds.

About Sofinnova Partners

Sofinnova Partners is a leading European venture capital firm in life sciences, specializing in healthcare and sustainability. Based in Paris, London and Milan, the firm brings together a team of professionals from all over the world with strong scientific, medical and business expertise. Sofinnova Partners is a hands-on company builder across the entire value chain of life sciences investments, from seed to later-stage.

Founded in 1972, Sofinnova Partners is a deeply established venture capital firm in Europe, with 50 years of experience backing over 500 companies and creating market leaders around the globe. Today, Sofinnova Partners manages over €4 billion in assets. For more information, please visit: sofinnovapartners.com.

Contacts

Sofinnova Partners
Bommy Lee
Head of Communications

blee@sofinnovapartners.com
+33 (0) 6 47 71 38 11

Media inquiries

United Kingdom
Optimum Strategic Communications

Eleanor Cooper

sofinnova@optimumcomms.com
+44 (0) 20 4604 4016

France
Strategies & Image (S&I)

Anne Rein

anne.rein@strategiesimage.com
+33 (0) 6 03 35 92 05

Italy
Havas PR Milan

Pierluigi Cavarai

pierluigi.cavaraiext@havaspr.com
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HSS Researchers Report Benefits of Robotic-Assisted Spine Surgery for Adolescent Athletes with Back Pain Due to Pars Fractures




HSS Researchers Report Benefits of Robotic-Assisted Spine Surgery for Adolescent Athletes with Back Pain Due to Pars Fractures

DENVER–(BUSINESS WIRE)–Spine surgeons at Hospital for Special Surgery (HSS) reported promising findings for adolescent athletes suffering from pars fracture, a common cause of adolescent back pain that may not always heal on its own and can result in chronic discomfort later in life. Minimally invasive robotic-assisted pars repair enabled most patients to return to sports in as little as six weeks. The findings were reported at the 40th Annual Meeting of the North American Spine Society, held November 14-16 in Denver.

A pars fracture ­— also called spondylolysis — is a break in the pars interarticularis, a narrow area of bone connecting two vertebrae in the spine. It typically occurs in the lumbar spine (lower back). About 7 percent of all adolescents experience a pars fracture, and that number can rise to as much as 50 percent among teens engaged in high-risk sports such as gymnastics, football, and soccer.

While these injuries can heal on their own after a six- to eight-week break from sports, one in five adolescents continues to experience a non-healing fracture (nonunion). The pain often returns after resuming activity, and some athletes have been told to quit sports entirely. “Nonunion can cause persistent back pain and, in certain cases, even require lumbar fusion later in life if the fracture results in a vertebral slip, where the vertebrae slip out of place,” explained Austin Kaidi, MD, an orthopedic surgery resident at HSS and the study’s lead author.

About seven years ago, HSS spine surgeon Sheeraz Qureshi, MD, Co-Chief of HSS Spine and the study’s senior author, began using a spine surgery robot to plan the placement of surgical screws in novel ways. His work sparked a shift in the way the HSS surgeons approached pars fracture repairs.

The new minimally invasive technique involves the placement of a single screw through a 1 cm incision — far smaller than traditional surgery to repair a pars fracture, which is performed through a larger incision and requires bone grafting. The robotic procedure is performed on an outpatient basis and is associated with an easier, shorter recovery.

Study: Robotic Pars Repair Allows Early Return to Activity for Adolescents with Symptomatic Spondylolysis: A Case Series

Dr. Kaidi, Dr. Qureshi, and their colleagues performed a retrospective review of nine adolescent patients with lumbar spondylolysis (mean age 16) who had robotic-assisted pars repair at HSS using the single-screw technique. Patients had endured back pain before the surgery for an average of 8 months. After surgery, they participated in an 8-week physical therapy program that started with walking and gradually re-introduced sports-specific exercises.

After a mean follow-up of 11.4 months, five patients had returned to the same or an even higher level of sports. One patient had residual back pain and did not return to sports. Three patients had CT scans at one year demonstrating union of the fracture. The athletes were able to return to activity in as little as six weeks. “Although nonsurgical treatment should always be tried before considering surgery, we were surprised by the effectiveness of this technique for enabling athletes to return to sport,” said Dr. Kaidi.

HSS is a leader in robotic-assisted single-screw pars repair and one of only a handful of institutions worldwide who have published on this technique. This study is the largest series ever reported in these patients.

“This safe and effective procedure is changing the way the medical community thinks about these injuries. We are moving away from ‘do nothing for 6 weeks’ to a more elegant, proactive solution,” concluded Dr. Qureshi. “Early minimally invasive spine surgery can prevent future complications. We’re not only caring for patients while they are young, but also helping them in the long run.”

Reference

Robotic Pars Repair Allows Early Return to Activity for Adolescents with Symptomatic Spondylolysis: A Case Series

Authors: Austin Kaidi MD, MSc, Michelle Zabat, MD, Amy Xu, MD, Adin Ehrlich, BS, Tomoyuki Asada, MD, PhD, Harvinder Sandhu, MD, Russel Huang, MD, Sravisht Iyer, MD, and Sheeraz Qureshi, MD, MBA

About HSS

HSS is the world’s leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the 16th consecutive year), No. 3 in rheumatology by U.S. News & World Report (2025-2026), and the best pediatric orthopedic hospital in NY, NJ and CT by U.S. News & World Report “Best Children’s Hospitals” list (2024-2025). In a survey of medical professionals in more than 20 countries by Newsweek, HSS is ranked world #1 in orthopedics for a fifth consecutive year (2025). Founded in 1863, the Hospital has the lowest readmission rates in the nation for orthopedics, and among the lowest infection and complication rates. HSS was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center five consecutive times. An affiliate of Weill Cornell Medical College, HSS has a main campus in New York City and facilities in New Jersey, Connecticut and in the Long Island and Westchester County regions of New York State, as well as in Florida. In addition to patient care, HSS leads the field in research, innovation and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair and tissue regeneration. In addition, more than 200 HSS clinical investigators are working to improve patient outcomes through better ways to prevent, diagnose, and treat orthopedic, rheumatic and musculoskeletal diseases. The HSS Innovation Institute works to realize the potential of new drugs, therapeutics and devices. The HSS Education Institute is a trusted leader in advancing musculoskeletal knowledge and research for physicians, nurses, allied health professionals, academic trainees, and consumers in more than 165 countries. The institution is collaborating with medical centers and other organizations to advance the quality and value of musculoskeletal care and to make world-class HSS care more widely accessible nationally and internationally. www.hss.edu.

Contacts

Rachael Rennich / Tracy Hickenbottom

mediarelations@hss.edu
(212) 606-1197

Repare Therapeutics Enters into Definitive Agreement to be Acquired by XenoTherapeutics, Inc.




Repare Therapeutics Enters into Definitive Agreement to be Acquired by XenoTherapeutics, Inc.

– Each shareholder is estimated to receive US$1.82 per share plus one CVR per common share –

– Transaction expected to close in the first quarter of 2026 –

– Additional portfolio monetization efforts continue –

– Company reports 3Q 2025 financial results –

– $112.6 million in cash and cash equivalents and marketable securities as of September 30, 2025, as compared to $109.5 million at June 30, 2025 –

CAMBRIDGE, Mass. & MONTREAL–(BUSINESS WIRE)–Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a clinical-stage precision oncology company, today announced that it has entered into a definitive arrangement agreement (the “Arrangement Agreement”) with XenoTherapeutics, Inc. and Xeno Acquisition Corp. (jointly, “Xeno”), a non-profit biotechnology company, pursuant to which Xeno will acquire (the “Transaction”) all of the issued and outstanding common shares of Repare (the “Common Shares”).

Under the terms of the Arrangement Agreement, Repare shareholders will receive a cash payment per Common Share that will be determined based upon Repare’s cash balance at closing of the Transaction (the “Closing”) after deducting certain transaction costs and the aggregate amount of outstanding liabilities (the “Closing Net Cash Amount”). Based on Repare’s current estimates of the Closing Net Cash Amount and the expected timing for Closing, it is currently estimated that each Repare shareholder will receive a cash payment of US$1.82 per Common Share at Closing. In addition, each Repare shareholder will also receive one non-transferable contingent value right (each, a “CVR”) for each Common Share that entitles the holder to receive certain cash payments, including:

1. 100% of certain additional receivables that may be received by Repare within ninety (90) days following the Closing (net of certain permitted deductions incurred in connection therewith);
2. A percentage of the net proceeds received from Repare’s existing partnerships with Bristol-Myers Squibb, Debiopharm and DCx Biotherapeutics, as follows: (i) 90% received from the Closing date until the 2nd anniversary thereof, (ii) 85% received from the 2nd anniversary of the Closing date until the 4th anniversary of the Closing date, (iii) 80% received from the 4th anniversary of the Closing date until the 6th anniversary of the Closing date, and (iv) 75% received from the 6th anniversary of the Closing date until the 10th anniversary of the Closing date;
3. 100% of the net proceeds received by the 10th anniversary of the Closing date for any license or disposition of Repare’s product candidates and/or intellectual property related to Repare’s RP-1664 program, RP-3500 (Camonsertib) program, or any other license or disposition of Repare’s product candidates or research programs if such license or disposition is entered into prior to the Closing date;
4. 100% of the net proceeds received by the 10th anniversary of the Closing date for any license or disposition of Repare’s Polθ program, RP-3467, to any person with whom negotiations were initiated prior to the Closing date; and
5. 50% of the net proceeds received by the 10th anniversary of the Closing date for any license or disposition of Repare’s product candidates and/or intellectual property that occurs within 10 years following the Closing date if such license or disposition is entered into following the Closing date.

As permitted under the Arrangement Agreement, Repare continues to endeavor to license or dispose of its product candidates and/or intellectual property related to its (i) RP-3467 and Polθ program, (ii) RP-1664 program, (iii) RP-3500 (Camonsertib) program, and/or (iv) any other of the Company’s product candidates or research programs. Cash proceeds that may be received prior to Closing with respect to any such transaction would increase the estimated Closing Net Cash Amount and, therefore, would also increase the cash payment to be received by Repare shareholders at Closing.

“Following a thorough and wide-ranging strategic review of potential opportunities, partnerships and transactions aimed at maximizing shareholder value, Repare’s Board of Directors has unanimously determined that the Transaction is in the best interests of Repare and its various stakeholders” said Steve Forte, President, Chief Executive Officer and Chief Financial Officer of Repare. “The Transaction provides a cash payment to shareholders and the opportunity for continued participation in milestones and royalties from existing and potential future partnerships. On behalf of the Company, I would like to acknowledge and thank our employees for their dedication and exceptional service.”

Transaction Details

The Transaction will be implemented by way of court-approved plan of arrangement under the Business Corporations Act (Québec) and will require the approval of at least: (i) 66 ⅔% of the votes cast by Repare shareholders; and (ii) a majority of the votes cast by Repare shareholders excluding votes held by certain “interested parties” required to be excluded pursuant to Multilateral Instrument 61-101, at a special meeting to be held to consider and approve the Transaction (the “Special Meeting”). In addition to shareholder approval, the Transaction is subject to the approval of the Superior Court of Québec and other customary closing conditions. The Transaction is expected to close in the first quarter of 2026.

The Arrangement Agreement provides for customary deal-protection provisions, including a non-solicitation covenant on the part of the Company and a right for Xeno to match any Superior Proposal (as defined in the Arrangement Agreement). The Arrangement Agreement includes a termination fee of US$2.0 million, payable by the Company under certain circumstances, including in connection with the Company’s entry into a definitive agreement with respect to a Superior Proposal. Each of the directors and senior officers of the Company, who currently collectively own approximately 0.25% of the outstanding Common Shares, have entered into support and voting agreements pursuant to which they have agreed to vote all of the securities beneficially owned by them in favor of the Transaction.

Following completion of the Transaction, Repare will become a privately held company, and the Common Shares are expected to be delisted from the Nasdaq Global Select Market. Repare will also apply to cease to be a reporting issuer under Canadian securities laws and to deregister the Common Shares under the United States Securities Exchange Act of 1934, as amended.

Board of Directors and Transaction Committee Recommendations

A transaction committee composed entirely of independent directors of Repare (the “Transaction Committee”) unanimously recommended entering into the Arrangement Agreement to Repare’s Board of Directors (the “Board”). The Board has evaluated the Arrangement Agreement with Repare’s management, legal and financial advisors and, following the receipt and review of the unanimous recommendation from the Transaction Committee and the opinion of the Transaction Committee’s financial advisors, the Board has unanimously approved the Transaction and determined that the Transaction is in the best interest of Repare. The Board will unanimously recommend that shareholders vote in favor of the Transaction at the Special Meeting.

Further information regarding the Transaction will be included in the management proxy statement that will be prepared, filed and mailed to Repare shareholders in advance of the Special Meeting (the “Proxy Statement”). Copies of the Arrangement Agreement and the Proxy Statement will be available under Repare’s profile on SEDAR+ and on EDGAR. The description of the Transaction in this news release does not purport to be complete and is subject to, and qualified in its entirety by reference to, the contents of the Arrangement Agreement. Shareholders are encouraged to carefully review the Proxy Statement when it becomes available.

Advisors

Leerink Partners is acting as the exclusive financial advisor to Repare. Cooley LLP and Stikeman Elliott LLP are acting as legal counsel to Repare. Blake, Cassels & Graydon LLP and Gibson, Dunn & Crutcher LLP are acting as legal counsel to Xeno. XOMA Royalty is acting as structuring agent and providing funding to Xeno. RBC Capital Markets, LLC is acting as financial advisor to XOMA Royalty.

Third Quarter 2025 Portfolio Update:

• RP-3467: Polθ ATPase inhibitor
  • As a result of the definitive agreement, Repare will no longer be reporting initial topline safety, tolerability and early efficacy data from the POLAR trial in monotherapy and in combination with Olaparib.

• RP-1664: First-in-class, oral selective PLK4 Inhibitor
  • The Company recently presented positive initial topline safety, tolerability and early efficacy data from its Phase 1 LIONS clinical trial, evaluating RP-1664 as a monotherapy in adult and adolescent patients with TRIM37-high solid tumors at the 37^th AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. The encouraging tolerability and efficacy data support the use of RP-1664 as a monotherapy in molecularly selected tumor specific cohorts and support further investigation of PLK4 inhibition as a therapeutic modality, especially among less pretreated patients.

Third Quarter 2025 Financial Results

• Cash, cash equivalents and marketable securities: Cash, cash equivalents and marketable securities as of September 30, 2025 were $112.6 million, as compared to $109.5 million as of June 30, 2025.
• Revenue from collaboration agreements: Revenue from collaboration agreements were $11.6 million and $11.9 million for the three and nine months ended September 30, 2025, respectively, as compared to nil and $53.5 million for three and nine months ended September 30, 2024.
• Research and development expense, net of tax credits (Net R&D): Net R&D expenses were $7.5 million and $42.1 million for the three and nine months ended September 30, 2025, respectively, as compared to $28.4 million and $91.5 million for the three and nine months ended September 30, 2024.
• General and administrative (G&A) expenses: G&A expenses were $4.5 million and $18.2 million for the three and nine months ended September 30, 2025, respectively, compared to $6.4 million and $23.4 million for the three and nine months ended September 30, 2024.
• Net income (loss): Net income of $3.3 million, or $0.08 diluted per share, and net loss of $43.5 million, or $1.02 per share, in the three and nine months ended September 30, 2025, respectively, compared to net loss of $34.4 million, or $0.81 per share, and net loss of $56.0 million, or $1.32 per share, in the three and nine months ended September 30, 2024, respectively.

About Repare Therapeutics Inc.

Repare Therapeutics is a clinical-stage precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics. Repare Therapeutics has developed highly targeted cancer therapies focused on genomic instability, including DNA damage repair. The Company’s clinical-stage pipeline includes RP-3467, a Phase 1 Polθ ATPase inhibitor; and RP-1664, a Phase 1 PLK4 inhibitor. For more information, please visit www.reparerx.com and follow @Reparerx on X (formerly Twitter) and LinkedIn

Forward Looking Statements

This news release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and “forward-looking information” within the meaning of applicable securities laws in Canada. All statements in this news release other than statements of historical facts are forward-looking statements and forward-looking information. 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 that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this news release include, but are not limited to, statements regarding: the proposed timing and completion of the Transaction; the amounts payable under the Transaction and pursuant to the CVRs; the timing and receipt of shareholder approval and court approval of the Transaction; the satisfaction of the conditions to the completion of the Transaction; the Company’s plans or ability to enter into, or complete, any potential transactions to license or dispose of its product candidates and/or intellectual property related to its (i) RP-3467 and Polθ program, (ii) RP-1664 program, (iii) RP-3500 (Camonsertib) program, and/or (iv) other product candidates and research programs; and the design, objectives, initiation, timing, progress and results of current and future clinical trials of the Company’s product candidates; and any other statements that are not statements of historical fact. These forward-looking statements are based on the Company’s expectations and assumptions as of the date of this news release. Each of these forward-looking statements involves risks and uncertainties, many of which are outside of the control of Repare, that could cause the Company’s actual results to differ materially from those expressed or implied by the forward-looking statements, including the consummation of the Transaction and the anticipated benefits thereof. Many factors may cause differences between current expectations and actual results, including: (i) the completion of the Transaction on anticipated terms and timing, including obtaining required shareholder and court approvals, and the satisfaction of other conditions to the completion of the Transaction; (ii) potential litigation relating to the Transaction that could be instituted by or against the Company, Xeno, XOMA Royalty or their respective directors or officers, including the effects of any outcomes related thereto; (iii) significant transaction costs and unknown liabilities associated with the Transaction; and (iv) the risks and uncertainties that will be described in the Proxy Statement which will be available on the Company’s EDGAR and SEDAR+ profiles. While the list of factors presented here is, and the list of factors to be presented in the Proxy Statement will be, considered representative, no such list should be considered a complete statement of all potential risks and uncertainties related to the Transaction.

Other factors that may cause the Company’s actual results to differ from those expressed or implied in the forward-looking statements in this news release are identified in the section titled “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the U.S. Securities and Exchange Commission (the “SEC”) and the Autorité des Marchés Financiers (Quebec) (“AMF”) on March 3, 2025, and in other filings made with the SEC and AMF from time to time, including the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025. The Company expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. For more information, please visit reparerx.com and follow Repare on X (formerly Twitter) at @RepareRx and on LinkedIn at https://www.linkedin.com/company/repare-therapeutics/.

Additional Information and Where to Find It

The Company intends to file the Proxy Statement with the SEC and furnish it to its shareholders, as along with other relevant documents concerning the proposed transaction. The Proxy Statement will contain important information about the proposed transaction and related matters. Investors and security holders of the Company are urged to carefully read the entire proxy statement (including any amendments or supplements thereto) when it becomes available because it will contain important information about the proposed transactions. A definitive version of the Proxy Statement will be sent to the shareholders of the Company seeking any required shareholder approvals.

Investors and security holders of the Company will be able to obtain a free copy of the Proxy Statement, as well as other relevant filings containing information about the Company and the proposed transaction, including materials that will be incorporated by reference into the Proxy Statement, without charge, at the SEC’s website (http://www.sec.gov) or from the Company by contacting the Company’s Investor Relations at (857) 412-7018, by submitting a contact form on the Company’s website at https://www.reparerx.com/contact/, or by going to the Company’s Investor Relations page on its website at https://ir.reparerx.com/investor-relations and clicking on the link titled “SEC Filings.”

Participants in the Solicitation

The Company and certain of its directors, executive officers and employees may be deemed to be participants in the solicitation of proxies in respect of the proposed transaction. Information regarding the interests of the Company’s directors and executive officers and their ownership of the Company’s common shares is set forth in the Company’s annual report on Form 10-K filed with the SEC on March 3, 2025 and the Company’s annual meeting proxy statement on Schedule 14A filed with the SEC on April 29, 2025. Other information regarding the participants in the proxy solicitation and a description of their direct and indirect interests in the proposed transaction, by security holdings or otherwise, will be contained in the Proxy Statement and other relevant materials to be filed with the SEC in connection with the proposed transaction. Copies of these documents may be obtained, free of charge, from the SEC or the Company as described in the preceding paragraph.

Contacts

Investor Relations & Media Contact:

Matthew DeYoung

Investor Relations and Media

Argot Partners

investor@reparerx.com

Enveric Biosciences Reports Third Quarter 2025 Financial and Corporate Results




Enveric Biosciences Reports Third Quarter 2025 Financial and Corporate Results

In Q3, Enveric continued toward clinical readiness for lead candidate EB-003, targeting neuropsychiatric indications, announcing additional positive data in a preclinical model of PTSD, successful completion of dose range finding studies, and receipt of FDA response to pre-IND meeting request.

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company advancing next-generation neuroplastogenic small molecules to address psychiatric and neurological disorders, today announced financial results for the third quarter ended September 30, 2025, and provided a comprehensive business update.

CEO Commentary:

“The third quarter of 2025 marked another highly productive period as we continue to advance our lead candidate EB-003 towards clinical trials in 2026,” said Joseph Tucker, Ph.D., Director and CEO of Enveric. “Importantly, we recently received a written response from the U.S. Food and Drug Administration (FDA) to our request for a Pre-Investigational New Drug (pre-IND) Type B meeting for EB-003, which we believe is consistent with our view that the preparations are sufficiently advanced to proceed to IND submission. Driving towards this significant inflection point, we also completed key chemistry, manufacturing, and controls (CMC) milestones, as well as dose range studies that helped to establish a maximum tolerated dose of EB-003.”

“In addition, our team continued to strengthen the profile of EB-003 across several neuropsychiatric indications, as we showed positive effects in a preclinical model of post-traumatic stress disorder (PTSD). Our research showed significantly decreased context-induced freezing behavior one-hour post-dose (p < 0.05) indicating a positive therapeutic effect in a well-established translational rodent model for PTSD.”

Dr. Tucker continued, “Intellectual property remains a cornerstone of Enveric’s value proposition, and during the third quarter we pursued opportunities to expand and defend our patent estate. Notably, we announced plans to contest a Post-Grant Review (PGR) petition filed by Gilgamesh Pharmaceuticals against Enveric’s issued U.S. Patent No. 12,138,276 entitled, ‘Halogenated Psilocybin Derivatives and Methods of Using.’ The IP in question concerns claims that may be relevant to the Bretisilocin molecule, which was recently acquired by AbbVie in $1.2 billion deal.”

“As we approach 2026, we are excited to be working towards a streamlined IND application for EB-003 in preparation of a first-in-human study. We believe EB-003 has the potential to uniquely address mental health disorders, where innovation has been lacking for decades, with its dual mechanism of action that potentially engages both 5-HT_2A and 5-HT_1B receptors. In addition to being designed to promote neuroplasticity without hallucinogenic effects, we are optimistic that the dual mechanism represents a potentially first-in-class therapeutic target with significant clinical opportunity.”

Third Quarter and Recent Corporate Highlights

Preclinical Development, Manufacturing and Regulatory Progress

• Successfully completed pre-IND dose range finding studies for EB-003, establishing a maximum tolerated dose and supporting progression toward IND-enabling studies and first-in-human clinical trials
• Demonstrated positive effects in preclinical model of PTSD, showing significantly decreased context-induced freezing behavior one-hour post-dose (p < 0.05) and indicating a positive therapeutic effect in a well-established translational rodent model
• Successfully completed key CMC milestones including:
  • Identification and production of pharmaceutically compatible salt form designed to potentially improve drug effectiveness and stability
  • Development and implementation of a scalable, reproducible synthetic process suitable for both current and future manufacturing of EB-003
  • Successfully produced a 1-kilogram batch of EB-003 as a pharmaceutically compatible salt to support IND enabling activities, including GLP toxicology studies and drug product formulation work
• Continued plans for EB-003 IND submission in 2026, after receiving the FDA response to the pre-IND package and meeting request.

Intellectual Property Activities

• Hired Fish and Richardson P.C. to defend U.S. Patent No. 12,138,276 with claims relevant to Bretisilocin, recently acquired by AbbVie in $1.2 billion deal
• Issued a U.S. Patent, broadening the patent coverage for aminated psilocybin derivatives in the EVM-301 Series
• Issued two U.S. Patents and received a U.S. Patent Allowance for potential next-generation, non-hallucinogenic mescaline derivatives in EVM401 Series
  • Patent-protected methylone-inspired analogs support pipeline expansion

Publications

• Announced publication of two peer-reviewed articles highlighting novel bioproduction methods for neuropsychiatric drug discovery. Research published in ACS Chemical Biology and BioDesign Research describes new approaches for producing tryptamine and MDMA-derived compounds

Corporate/Operational

• Relocated corporate headquarters to Cambridge, MA aligning with Company’s vision to leverage the Greater Boston biotech hub’s scientific and financial ecosystem and advance EB-003 into first-in-human trial in 2026
• Announced the closing of an exercise of certain outstanding series A warrants to purchase up to an aggregate of 101,042 shares of common stock of the Company and series B warrants to purchase up to an aggregate of 101,042 shares of common stock originally issued in February 2025, having an exercise price of $36.00 per share, at a reduced exercise price of $10.98 per share, adjusted for the reverse stock split. Gross proceeds to the Company from the exercise of the warrants were approximately $2.2 million, prior to deducting placement agent fees and estimated offering expenses
• After the end of the Third Quarter of 2025, the Company completed a reverse stock split of its common stock on October 28, 2025, at a ratio of 1 post-split share for every 12 pre-split shares. The Board determined the reverse split was in the best interest of the shareholders after receiving conditional approval at the Company’s annual meeting of stockholders on May 29, 2025 for an amendment to the Company’s Amended and Restated Certificate of Incorporation to effect a reverse stock if the Company were to receive a delisting determination from Nasdaq for failure to maintain the required minimum bid price. The Company received a bid price deficiency delisting determination from Nasdaq on October 22, 2025.

Third Quarter 2025 Financial Results

Net loss attributable to common stockholders was $3.4 million for the quarter ending September 30, 2025, or $10.81 per share, compared to a net loss of $2.1 million, or $43.10 per share, for the same period in 2024, adjusted for the reverse stock split. The net loss for the quarter included approximately $0.2 million in non-cash expenses related to stock-based compensation and other non-cash charges. As of September 30, 2025, Enveric had cash and cash equivalents of $3.8 million. The Company continues to fund its operations through the use of various financing tools. The Company has raised net proceeds of $7.9 million for the nine months ended September 30, 2025.

About Enveric Biosciences

Enveric Biosciences (NASDAQ: ENVB) is a biotechnology company focused on developing next-generation, small-molecule neuroplastogenic therapeutics that address unmet needs in psychiatric and neurological disorders. By leveraging a differentiated drug discovery platform and a growing library of protected chemical structures, Enveric is advancing a pipeline of novel compounds designed to promote neuroplasticity without hallucinogenic effects. Enveric’s lead candidate, EB-003, is the first known compound designed to selectively engage both 5-HT_2A and 5-HT_1B receptors to deliver fast-acting, durable antidepressant and anxiolytic effects with outpatient convenience.

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

Forward-Looking Statements

This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward-looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as “plans,” “expects” or “does not expect,” “proposes,” “budgets,” “explores,” “schedules,” “seeks,” “estimates,” “forecasts,” “intends,” “anticipates” or “does not anticipate,” or “believes,” or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, should, would, or might occur or be achieved. Forward-looking statements may include statements regarding beliefs, plans, expectations, or intentions regarding the future and are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the ability of Enveric to: remain listed on Nasdaq, finalize and submit its IND filing to the U.S. Food and Drug Administration in 2026; achieve the value creation contemplated by technical developments; advance EB-003 toward clinical trials by 2026; avoid delays in planned clinical trials; establish that potential products are efficacious or safe in preclinical or clinical trials; establish or maintain collaborations for the development of therapeutic candidates; obtain appropriate or necessary governmental approvals to market potential products; obtain future funding for product development and working capital on commercially reasonable terms; scale-up manufacture of product candidates; respond to changes in the size and nature of competitors; hire and retain key executives and scientists; secure and enforce legal rights related to Enveric’s products, including patent protection; identify and pursue alternative routes to capture value from its research and development pipeline assets; continue as a going concern; and manage its future growth effectively.

A discussion of these and other factors, including risks and uncertainties with respect to Enveric, is set forth in Enveric’s filings with the Securities and Exchange Commission, including Enveric’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Enveric disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Contacts

Investor Relations
Tiberend Strategic Advisors, Inc.
David Irish

(231) 632-0002

dirish@tiberend.com

Media Relations
Tiberend Strategic Advisors, Inc.
Casey McDonald

(646) 577-8520

cmcdonald@tiberend.com

Merck to Participate in the Jefferies Global Healthcare Conference in London




Merck to Participate in the Jefferies Global Healthcare Conference in London

RAHWAY, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that Jannie Oosthuizen, president, Human Health U.S., and Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories, are scheduled to participate in a fireside chat at the Jefferies Global Healthcare Conference in London on Thursday, Nov. 20, 2025, at 9:30 a.m. ET / 2:30 p.m. GMT.

Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at this weblink.

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

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The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2024 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

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Media Contacts:

John Cummins

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Michael Levey

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Investor Contacts:

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(732) 594-1579

Steven Graziano

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Mursla Bio Collaborates With a Leading Global Pharma Company to Advance Biomarker-guided Precision Medicine in MASH




Mursla Bio Collaborates With a Leading Global Pharma Company to Advance Biomarker-guided Precision Medicine in MASH

Mursla Bio’s AI Precision Medicine Platform to inform drug development and patient stratification in metabolic liver disease

CAMBRIDGE, England & BOSTON–(BUSINESS WIRE)–Mursla Bio, a leader in Extracellular Vesicle (EV) science on a mission to advance precision diagnostics and significantly improve chronic disease outcomes for at-risk patients, today announced a collaboration with a leading global pharmaceutical company recognized for its expertise in precision medicine and biomarker-guided drug development.

Under the collaboration, Mursla Bio’s AI Precision Medicine Platform will generate hepatocyte-specific extracellular vesicle (h-EV) profiles from blood samples collected from a well-characterized cohort of patients with metabolic dysfunction-associated steatohepatitis (MASH) and matched healthy controls. The collaboration will explore mode-of-action (MoA)-related biomarkers and evaluate biomarker panels to identify patients most likely to benefit from the pharmaceutical company’s investigational therapy.

The initial phase will focus on generating insights into liver tissue biology in MASH by building tissue-labeled, high dimensional mRNA and protein datasets from h-EVs in blood. This data will help define MoA-related pathways and patient stratification signatures, while strengthening Mursla Bio’s AI liver disease models developed through its MEV01 clinical study¹ and extending their applicability across future programs.

Complementing Mursla Bio’s lead product, EvoLiver™¹, developed for liver cancer surveillance among cirrhotic patients, the partnership broadens the clinical and translational reach of its clinically validated platform across metabolic liver diseases. The same infrastructure that enabled EvoLiver™ to achieve FDA Breakthrough Device Designation² will be used to accelerate the translation of exploratory biomarkers into regulatory-grade companion diagnostics.

Pierre Arsène, Founder and CEO of Mursla Bio, said: “This collaboration reflects the growing demand from global pharmaceutical leaders for our AI Precision Medicine Platform. As the GLP-1 revolution reshapes obesity management, MASH is rapidly emerging as the next major therapeutic focus, and the need for precise liver-specific biomarkers has never been greater. By profiling intact hepatocyte biology protected within the cargo of h-EVs, we are enabling a new generation of biomarker-guided precision medicine in liver care. This partnership deepens our reach in hepatology, expanding on the foundation established with EvoLiver.”

MASH is an advanced stage of fatty liver disease, strongly associated with the global rise in obesity and type 2 diabetes³. MASH affects 5-7% of the world’s adult population with more than 75% of those classed as overweight, obese, and living with type 2 diabetes⁴. It is characterized by the buildup of excess fat in the liver, which causes inflammation and cell damage. MASH can progress to irreversible scarring (cirrhosis) and, in some cases, lead to liver failure or liver cancer.

Financial details were not disclosed.

1. EvoLiver™ and MEV01
2. Press release: Mursla Bio receives FDA Breakthrough Device Designation for EvoLiver™ test
3. Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) in People With Diabetes: The Need for Screening and Early Intervention. A Consensus Report of the American Diabetes Association
4. Systemic impacts of metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH) on heart, muscle, and kidney related diseases

Contacts

Media contact
Dr Ben Rutter

Zyme Communications

Tel: +44(0)7920 770 935

Email: ben.rutter@zymecommunications.com