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
+39 (0) 392 77 999 33

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.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

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).

Contacts

Media Contacts:

John Cummins

john.cummins2@merck.com

Michael Levey

michael.levey@merck.com

Investor Contacts:

Peter Dannenbaum

(732) 594-1579

Steven Graziano

(732) 594-1583

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

JSR Life Sciences Enters Definitive Agreement to Transfer Crown Bioscience to Adicon Holdings Limited




JSR Life Sciences Enters Definitive Agreement to Transfer Crown Bioscience to Adicon Holdings Limited

Strategic Transaction Positions Crown Bioscience for Accelerated Growth in Translational Oncology

SAN DIEGO–(BUSINESS WIRE)–JSR Life Sciences LLC (“JSR Life Sciences”), a global leader in life sciences materials and services, today announced it has entered into a definitive agreement to transfer Crown Bioscience Inc. (“Crown Bioscience”) to Adicon Holdings Limited (“Adicon”), a premier independent clinical laboratory provider in China and a portfolio company of The Carlyle Group. The transaction, subject to customary closing conditions, is expected to close in 2026.

This strategic move will enable Crown Bioscience to operate as a standalone entity under Adicon’s ownership. Crown Bioscience’s comprehensive portfolio of translational oncology services, including its world-leading patient-derived xenograft (PDX) models, tumor organoid platforms, immuno-oncology assays, and bioinformatics solutions, will transition to Adicon, positioning the company to accelerate advancements in precision medicine and drug discovery for oncology.

Crown Bioscience’s Global Biospecimens business, headquartered in Hamburg, Germany, with facilities in Frederick, MD, will remain fully integrated within JSR Life Sciences. The Biospecimens team will continue to benefit from JSR’s robust global resources, innovation ecosystem, and focus on ethical sourcing, custom procurement, and advanced sample processing and storage capabilities.

“After careful strategic review, we believe this transaction represents an optimal path forward for both Crown Bioscience and JSR Life Sciences,” said Tim Lowery, President and CEO of JSR Life Sciences. “Adicon’s deep domain expertise and financial backing from The Carlyle Group will empower Crown to scale its groundbreaking oncology services to new heights. As part of our long-standing onshore strategy, Crown remains firmly committed to serving clients through its global network of facilities, including its headquarters in San Diego and recent investments in the US and Europe. Initiatives like the launch of new Model Development Center in North Carolina and the expansion of biomarker and imaging capabilities in the UK ensure that customers have access to the same exceptional Crown experience, no matter where they choose to conduct their study.”

Adicon, recognized as one of China’s largest independent clinical laboratory service providers, brings complementary strengths in high-throughput testing and data analytics to the partnership. Backed by global investment firm Carlyle’s extensive network and resources in healthcare and life sciences industry, Adicon is well-positioned to support Crown Bioscience’s growth trajectory.

Ms. Yang Ling, Chairwoman of Adicon and Head of Asia Healthcare at Carlyle, commented, “This acquisition represents an important milestone in Adicon’s growth journey. With Crown Bioscience’s world-class CRO capabilities, Adicon is expanding its reach across the global healthcare value chain– from clinical diagnostics to drug discovery and translational research. This transaction reinforces Adicon’s vision to become a trusted partner for biopharma innovation and precision diagnostics.”

Until the transaction closes, Crown Bioscience will continue to operate as a wholly owned subsidiary of JSR Life Sciences, with no anticipated disruptions to ongoing services, projects, or customer relationships. JSR and Adicon are committed to a smooth transition, maintaining the highest standards of quality, compliance, and innovation across all operations.

About JSR Life Sciences LLC

JSR Life Sciences LLC is a division of JSR Corporation, a Tokyo-based global leader in high-performance materials for life sciences, electronics, and other industries. With a focus on enabling breakthroughs in precision medicine, JSR Life Sciences delivers innovative solutions in cell culture, bioseparation, and bioprocessing, supporting customers from research to commercialization. For more information, visit www.jsrlifesciences.com.

About Crown Bioscience Inc.

Crown Bioscience, a JSR Life Sciences company and global CRO, specializes in oncology and immuno-oncology drug discovery and development. We partner with biotech and pharmaceutical companies to provide innovative, tailored solutions spanning preclinical research, translational platforms, and clinical trial support. With over 1000 tumor organoid models and the largest commercially available PDX collection, our expertise spans in vivo, in vitro, ex vivo, and in silico methods. We operate in multiple facilities across the US, Europe, and APAC, meeting the highest industry standards, including accreditation by the College of American Pathologists (CAP) and the International Organization for Standardization (ISO).

To learn more, visit www.crownbio.com.

About Adicon

Adicon Holdings Limited (HKEX: 9860.HK) is one of China’s leading independent clinical laboratory service providers, offering comprehensive diagnostic testing services primarily to hospitals, health check centers and biopharmaceuticals through an integrated network of self-operated laboratories across the country. The company provides a broad testing portfolio covering routine and esoteric tests across multiple disease areas, supported by internationally accredited laboratories that meet ISO15189 standards. With a proven track record of operational excellence, national coverage, and strong quality assurance, Adicon has established itself as a trusted partner to healthcare institutions and professionals, contributing to the advancement of precision diagnostics and improved healthcare outcomes in China.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that could cause actual results to differ materially, including but not limited to regulatory approvals, market conditions, and integration challenges. For a discussion of these risks, please refer to the companies’ filings with relevant regulatory authorities.

Contacts

Media Inquiries:

Crown Bioscience

Sarah Martin-Tyrrell

pr@crownbio.com

Flipping the script: Scripta Therapeutics raises $12M to find disease-modifying drugs that alter transcription factor activity




Flipping the script: Scripta Therapeutics raises $12M to find disease-modifying drugs that alter transcription factor activity

• $12 million seed funding round led by Oxford Science Enterprises and Apollo Health Ventures, with AlbionVC, YZR Capital, and Parkwalk Advisors, and support from Oxford University Innovation
• Scripta takes a biology-first approach to discover disease-modifying drugs that modulate transcription factor activity and reprogram biology
• Ray Barlow joins board as Non-Executive Director

OXFORD, England–(BUSINESS WIRE)–Techbio startup Scripta Therapeutics emerges from stealth by announcing a $12 million seed round to upend conventional approaches to drug discovery.

Scripta combines AI, imaging, and unique patient-derived models to create and modulate disease maps based on transcriptional networks, building a new biology-first paradigm to decode and undo the programs that drive disease.

The round is led jointly by Oxford Science Enterprises (OSE) and Apollo Health Ventures, with further investment from AlbionVC, YZR Capital, and Parkwalk Advisors, and support from Oxford University Innovation.

Modulating transcription factor activity to reprogram biology

Scripta’s unique approach is based on the concept that transcription factors, the master controllers of gene expression, are core drivers of disease and act as detailed and dynamic maps of the mechanisms that underpin it.

Through a data-rich, lab-in-the-loop combination of experimental biology with cutting-edge AI and informatics, Scripta aims to efficiently identify therapeutics that modulate these maps to restore healthy cell states.

Biology decoded, disease undone

While the platform can be applied to any disease, the team is focusing first on Alzheimer’s disease and other neurodegenerative conditions in collaboration with scientific co-founder Noel Buckley, Professor of Neurobiology at the University of Oxford.

Peter Hamley, founder and CEO of Scripta, said, “We’re flipping the script on conventional target-based drug discovery to find therapies that genuinely move the needle for patients. By focusing on understanding and manipulating the master controllers of biology, we’re searching for drugs with the potential not just to delay disease progression but to stop it in its tracks.”

Experienced biotech business builder Ray Barlow, CEO of SynOx Therapeutics, has also been brought on to strengthen Scripta’s board as a Non-Executive Director.

He said, “Scripta brings fresh thinking and a novel biology-led, data-rich approach to a traditionally challenging area of drug discovery. I am looking forward to working with this outstanding team to deliver effective new medicines that are long overdue for so many patients.”

Claire Brown, Partner at OSE and board member of Scripta, said, “We’re proud to be backing Scripta – a brilliant team that exemplifies the next generation of technology-enabled drug discovery and capitalises on the strength of the University of Oxford and the wider Oxford ecosystem.”

Marianne Mertens, Partner at Apollo Health Ventures, said, “Manipulating transcription factors in disease has long been seen as an intractable challenge, yet it holds tremendous promise for treating neurodegeneration and other life-limiting conditions. Scripta’s innovative approach could deliver transformational therapies and exemplifies one of Apollo’s key investment strategies: reprogramming diseased cells into healthy ones to tackle the root causes of age-related diseases and enable disease-modifying treatments.”

Find out more at scriptatherapeutics.com.

About Scripta Therapeutics

Scripta Therapeutics is an Oxford-based techbio company on a mission to deliver transformative therapeutics through cutting edge technology. By focusing on altering the activity of transcription factors – the master controllers of biology – Scripta is searching for drugs with the potential not just to delay disease progression, but to halt or even reverse it. Combining pharma, biotech, and disease biology expertise with the computational power to push the boundaries of biology, Scripta aims to deliver disease-modifying therapeutics that transform outcomes for patients.

Contacts

Media contact: Kat Arney scripta@firstcreatethemedia.com

Virometix AG Announces Completion of $15 Million Financing Round to Advance Development of V-212 and Next-Generation Synthetic Vaccines




Virometix AG Announces Completion of $15 Million Financing Round to Advance Development of V-212 and Next-Generation Synthetic Vaccines

SCHLIEREN, Switzerland–(BUSINESS WIRE)–Virometix AG, a clinical-stage biotechnology company pioneering fully synthetic vaccines, today announced the completion of a $15 million financing round from existing shareholders. The funds will support continued clinical and development activities for V-212, Virometix’s lead serotype-independent pneumococcal vaccine candidate, currently in Phase I clinical evaluation.

Proceeds from the financing will be used to:

• Advance the ongoing Phase I clinical trial of V-212, with topline results expected in Q1 2026.
• Prepare for a planned Phase Ib combination trial evaluating V-212 with an approved pneumococcal conjugate vaccine (PCV).
• Complete OPK assay validation to support immunogenicity and functional data read-outs.
• Implement platform enhancements to the company’s proprietary Synthetic Virus-Like Particle (SVLP) technology.
• Progress next-generation serotype-independent pneumococcal vaccine programs toward preclinical development.

“This financing demonstrates the continued confidence and commitment of our investors to Virometix’s mission and platform,” said Anna Sumeray, Chief Executive Officer of Virometix. “Our fully synthetic SVLP technology enables the design of broad-spectrum, self-adjuvanted vaccines with highly scalable manufacturing. With V-212 in clinical development, we are well positioned to deliver a truly next-generation approach to pneumococcal prevention.”

About V-212

V-212 is a fully synthetic, serotype-independent, peptide-based vaccine designed to prevent Streptococcus pneumoniaeinfections. The vaccine incorporates multiple conserved antigenic epitopes from key pneumococcal surface proteins conjugated to Virometix’s proprietary SVLP nanoparticles, which include built-in adjuvant elements such as T-helper epitopes and Toll-like receptor (TLR) ligands. This unique design eliminates dependence on biological carrier proteins and allows for a streamlined, fully synthetic manufacturing process.

Preclinical studies demonstrated robust and durable immunogenicity in mouse and rabbit models, protection against lethal sepsis, and cross-reactivity with multiple pneumococcal serotypes, including non-PCV-13 types—underscoring V-212’s potential for broad protection.

The ongoing Phase I clinical trial (NCT06975319) is a randomized, double-blind, placebo-controlled, first-in-human study being conducted at the Centre for Vaccinology (CEVAC), Ghent University Hospital. Sixty healthy volunteers aged 18–45 have been enrolled, and topline safety and immunogenicity data are anticipated in the first quarter of 2026.

About Virometix

Virometix AG is a privately held biotechnology company developing a new generation of fully synthetic vaccines to elicit targeted and protective immune responses against infectious diseases and cancer. The company’s proprietary Synthetic Virus-Like Particle (SVLP) platform combines rational molecular design and chemical synthesis to rapidly generate optimized vaccine candidates with superior safety, efficacy, manufacturability, and stability profiles.

Learn more at www.virometix.com

Contacts

Media Contact
David Rosen

Argot Partners

Phone: +1 646.461.6387

Email: david.rosen@argotpartners.com

Innate Pharma Reports Third Quarter 2025 Business Update and Financial Results




Innate Pharma Reports Third Quarter 2025 Business Update and Financial Results

• Following FDA clearance for confirmatory Phase 3 trial TELLOMAK-3, lacutamab is progressing toward Phase 3 initiation in H1 2026 and potential accelerated approval in Sézary syndrome
• IPH4502 Nectin-4 ADC Phase 1 enrollment continues to progress well – pharmacologically active dose reached
• Monalizumab PACIFIC-9 on track to deliver data in H2 2026
• Cash position of € 56.4 million¹ as of September 30, 2025, anticipated cash runway until end Q3-2026
• Conference call to be held today at 2:00 p.m. CET / 8:00 a.m. ET

MARSEILLE, France–(BUSINESS WIRE)–#immunotherapy–Regulatory News:

Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced its business update and financial results for the first nine months of 2025.

“This quarter highlights strong execution across our key programs,” said Jonathan Dickinson, Chief Executive Officer of Innate Pharma. “With FDA clearance to initiate TELLOMAK-3, we are advancing lacutamab toward its confirmatory Phase 3 and potential accelerated approval in Sézary syndrome. We remain on track for dose-escalation data, from IPH4502, our Nectin-4 ADC, in the first half of 2026, followed by monalizumab PACIFIC-9 results in the second half of 2026. Together, these milestones position us well to deliver meaningful value for patients and shareholders as we continue to advance our differentiated portfolio.”

Pipeline highlights:

Strategic focus

As previously announced, Innate Pharma is prioritizing its investment on what it believes are its highest-value clinical assets, IPH4502, lacutamab, and monalizumab (partnered with AstraZeneca); and advancing the next Antibody Drug Conjugates (ADCs) toward development, leveraging its pipeline of innovative targets.

Lacutamab (anti-KIR3DL2 antibody):

Cutaneous T Cell Lymphoma

• The Company announced on November 10 that the U.S. Food and Drug Administration (FDA) has completed its review of the confirmatory Phase 3 protocol for lacutamab in cutaneous T-cell lymphomas (CTCL), with no further comments, clearing the trial to proceed.
• The planned confirmatory Phase 3 trial, TELLOMAK-3, is an open-label, randomized study designed to demonstrate the efficacy of lacutamab in patients with Sézary syndrome and Mycosis fungoides, who failed at least one prior line of systemic therapy. The trial will include two independent cohorts: one enrolling patients with Sézary syndrome post-mogamulizumab treatment randomized 1:1 to receive lacutamab or romidepsin, and one enrolling patients with Mycosis fungoides randomized 1:1 to receive lacutamab or mogamulizumab. The primary endpoint of the study for both cohorts is progression-free survival (PFS) evaluated by blinded central review.
• Data from the Phase 2 TELLOMAK trial in CTCL demonstrated durable activity, a favorable safety profile, and improvements in patients’ quality of life. With this feedback from FDA, the Company is progressing towards the initiation of the confirmatory Phase 3 TELLOMAK-3 trial in H1 2026. FDA provided encouraging initial feedback on Innate Pharma’s proposed regulatory pathway, which could potentially include Accelerated Approval for Sézary syndrome, once the Phase 3 trial is underway.
• The Company held a KOL event on October 28, 2025 on lacutamab and provided updates on the planned Phase 3 trial, the regulatory pathway in CTCL, and the commercial opportunity for lacutamab.

Peripheral T Cell lymphoma (PTCL)

• The Phase 2 KILT (anti-KIR in T Cell Lymphoma) trial, an investigator-sponsored, randomized controlled trial led by the Lymphoma Study Association (LYSA) to evaluate lacutamab in combination with chemotherapy GEMOX (gemcitabine and oxaliplatin) versus GEMOX alone in patients with KIR3DL2-expressing relapsed/refractory PTCL is ongoing and continues to recruit patients.

IPH4502 (Nectin-4 exatecan ADC):

• The Phase 1 trial will assess the safety, tolerability, and preliminary efficacy of IPH4502 in advanced solid tumors known to express Nectin-4, including but not limited to urothelial carcinoma, non-small cell lung, breast, ovarian, gastric, esophageal, and colorectal cancers. The study plans to enroll approximately 105 patients.
• The first patient was dosed in the Phase 1 study in January 2025. Enrollment of the dose escalation part continues to progress well and is expected to be completed at the end of 2025 or in the first quarter of 2026. Pharmacologically active dose has been reached.

Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:

• The Phase 3 PACIFIC-9 trial run by AstraZeneca evaluating durvalumab (anti-PD‑L1) in combination with monalizumab or AstraZeneca’s oleclumab (anti-CD73) in patients with unresectable, Stage III non-small cell lung cancer (NSCLC) who have not progressed following definitive platinum-based concurrent chemoradiation therapy (CRT) is ongoing. Enrollment in the trial is complete, and data readouts are expected in H2 2026.

Other Clinical stage assets

IPH6501 (ANKET^® anti-CD20 with IL-2V, proprietary): The Phase 1/2 clinical trial is evaluating IPH6501 in B-cell Non-Hodgkin’s lymphoma (B-NHL). The study is planned to enroll up to 184 patients. Clinical sites are open in the US, Australia, and France. Enrollment in the dose escalation phase of the trial is complete. Clinical data are expected to be presented in 2026.

IPH6101 (ANKET^® anti-CD123, proprietary): Innate regained the rights to SAR’579/IPH6101 in July 2025. Data from the Sanofi-led Phase 1/2 study and Phase 2 preliminary dose expansion of the trial have been transferred to Innate and the Company is evaluating potential next steps.

IPH5201 (anti-CD39 antibody, partnered with AstraZeneca): The MATISSE Phase 2 clinical trial conducted by Innate in neoadjuvant lung cancer for IPH5201, an anti CD39 blocking monoclonal antibody developed in collaboration with AstraZeneca, is ongoing, and recruitment is on track.

IPH5301 (anti-CD73, proprietary): The investigator-sponsored CHANCES Phase 1 trial of IPH5301 with Institut Paoli-Calmettes is ongoing.

Corporate update

• As previously announced, in line with its strategic focus, the Company intends to streamline its organization. Planned layoffs will be implemented through a redundancy plan, expected to be completed during the first half of 2026. A consultation with the Workers’ Council is ongoing and the plan is subject to endorsement by the French authorities (Dreets).
• The ATM program, pursuant to which it may, from time to time, offer and sell to eligible investors a total gross amount of up to $75 million of American Depositary Shares (“ADS”) is still in place. As of September 30, 2025, no sales have been made under the program.

Financial Results

Cash, cash equivalents and financial assets of the Company amounted to €56.4 million as of September 30, 2025. At the same date, financial liabilities amounted to €24.8 million.

Revenues for the first nine months of 2025 amounted to €2.3 million (€10.2 million for the same period in 2024). For the nine-month period, ended September 30, 2025, revenue from collaboration and licensing agreements mainly resulted from the partial or entire recognition of the proceeds received pursuant to the agreements with AstraZeneca and Sanofi.

About Innate Pharma

Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Leveraging its expertise on antibody-engineering and innovative target identification, Innate Pharma is developing innovative and differentiated next-generation antibody therapeutics.

Innate Pharma is advancing a portfolio of differentiated potential first- and/or best-in-class assets, focused on areas of high unmet medical need, including IPH4502, a differentiated Nectin-4 ADC developed in solid tumors, lacutamab, an anti-KIR3DL2 antibody developed in cutaneous T cell lymphomas and peripheral T cell lymphomas, and monalizumab, an anti-NKG2A antibody developed in collaboration with AstraZeneca in non-small cell lung cancer.

Innate Pharma has established collaborations with leading biopharmaceutical companies, including Sanofi and AstraZeneca, as well as renowned academic and research institutions, to advance innovation in immuno-oncology.

Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US.

Learn more about Innate Pharma at www.innate-pharma.com and follow us on LinkedIn and X.

Information about Innate Pharma shares

Disclaimer on forward-looking information and risk factors

This press release contains certain forward-looking statements, including those within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995, including the statements regarding the timing of dose-escalation data for IPH4502, the timing of results for monalizumab PACIFIC-9, the timing of lacutamab Phase 3 and potential acceleration thereof, the contours and planned enrollment of the upcoming trials and studies, and the planned streamlining of the organization, including layoffs. The use of certain words, including “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “may,” “might,” “potential,” “should,” “will,” or the negative of these and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company’s reliance on third parties to manufacture its product candidates, the Company’s commercialization efforts and the Company’s continued ability to raise capital to fund its development. For an additional discussion of risks and uncertainties, which could cause the Company’s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque”) section of the Universal Registration Document filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website http://www.amf-france.org or on Innate Pharma’s website, and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2024, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public by the Company. References to the Company’s website and the AMF website are included for information only and the content contained therein, or that can be accessed through them, are not incorporated by reference into, and do not constitute a part of, this press release.

In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by the Company or any other person that the Company will achieve its objectives and plans in any specified time frame or at all. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.

Contacts

For additional information, please contact:

Innate Pharma
Stéphanie Cornen

stephanie.cornen@innate-pharma.fr

Investor Relations
investors@innate-pharma.fr

Medias
communication@innate-pharma.fr