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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)–
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.”

__________________________

1 Including short term investments (€6.1 million) and non-current financial instruments (€10.4 million).

 

Webcast and conference call will be held today at 2:00pm CET (8:00am ET)

 

The live webcast will be available at the following link:

https://events.q4inc.com/attendee/424851735

 

Analysts may also join via telephone, click here to register

 

This information can also be found on the Investors section of the Innate Pharma website,

www.innate-pharma.com. A replay of the webcast will be available on the Company website for 90 days following the event.

 

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

ISIN code

FR0010331421

Ticker code

Euronext: IPH Nasdaq: IPHA

LEI

9695002Y8420ZB8HJE29

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.

For additional information, please contact:

Innate Pharma

Stéphanie Cornen

[email protected]

Investor Relations

[email protected]

Medias

[email protected]

KEYWORDS: Maryland Europe United States North America France

INDUSTRY KEYWORDS: Biotechnology Pharmaceutical Health Oncology

MEDIA:

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Ionis Prices Convertible Notes Offering to Refinance 2026 Convertible Notes

Ionis Prices Convertible Notes Offering to Refinance 2026 Convertible Notes

– Refinancing transaction with proceeds to be utilized to repurchase or repay the 2026 Convertible Notes prior to or at maturity

CARLSBAD, Calif.–(BUSINESS WIRE)–
Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) announced today the pricing of $700.0 million aggregate principal amount of 0.00% Convertible Senior Notes due 2030 (the “notes”) in a private placement (the “offering”) to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). Ionis also granted the initial purchasers of the notes an option to purchase, within the 13-day period beginning on, and including, the date on which the notes are first issued, up to an additional $70.0 million aggregate principal amount of notes from Ionis. The sale of the notes is expected to close on November 17, 2025, subject to customary closing conditions.

The notes will be general unsecured obligations of Ionis, and will not bear regular interest and the principal amount of the notes will not accrete. The notes will mature on December 1, 2030, unless earlier converted, redeemed or repurchased.

Ionis estimates that the net proceeds from the offering will be approximately $682.8 million (or approximately $751.2 million if the initial purchasers exercise their option to purchase additional notes in full), after deducting the initial purchasers’ discounts and commissions and estimated offering expenses payable by Ionis.

Ionis expects to use approximately $267.6 million of the net proceeds from the offering to repurchase for cash $200.0 million in aggregate principal amount of its 0% Convertible Senior Notes due 2026 (the “2026 notes”) pursuant to the concurrent note repurchase transactions described below. Ionis expects to use the remaining net proceeds from the offering for additional repurchases of the 2026 notes from time to time following the offering, including the repayment of any remaining 2026 notes at maturity, and for general corporate purposes.

Before September 1, 2030, holders will have the right to convert their notes only upon the satisfaction of specified conditions and during certain periods. On or after September 1, 2030 until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert all or any portion of their notes at any time. Upon conversion, Ionis will pay or deliver, as the case may be, cash, shares of its common stock or a combination of cash and shares of its common stock, at its election. The conversion rate for the notes will initially be 10.1932 shares of Ionis’ common stock per $1,000 principal amount of notes (equivalent to an initial conversion price of approximately $98.10 per share of Ionis’ common stock). The initial conversion price represents a premium of approximately 35.0% over the last reported sale price of $72.67 per share of Ionis’ common stock on November 12, 2025. The conversion rate will be subject to adjustment in some events but will not be adjusted for any accrued or unpaid special interest, if any.

Ionis may not redeem the notes prior to December 6, 2028. Ionis may redeem for cash all or any portion of the notes (subject to certain limitations), at its option, on a redemption date on or after December 6, 2028 if the last reported sale price of Ionis’ common stock has been at least 130% of the conversion price for the notes then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which Ionis provides notice of redemption at a redemption price equal to 100% of the principal amount of the notes to be redeemed, plus accrued and unpaid special interest, if any, to, but excluding, the redemption date. However, Ionis may not redeem less than all of the outstanding notes unless at least $100.0 million aggregate principal amount of notes are outstanding and not called for redemption as of the time Ionis sends the related notice of redemption. No sinking fund is provided for the notes.

If Ionis undergoes a “fundamental change” (as defined in the indenture that will govern the notes), then, subject to certain conditions and limited exceptions, holders may require Ionis to repurchase for cash all or any portion of their notes at a fundamental change repurchase price equal to 100% of the principal amount of the notes to be repurchased, plus accrued and unpaid special interest, if any, to, but excluding, the fundamental change repurchase date. In addition, following certain corporate events that occur prior to the maturity date or if Ionis delivers a notice of redemption, Ionis will, in certain circumstances, increase the conversion rate for a holder who elects to convert its notes in connection with such a corporate event or convert its notes called (or deemed called) for redemption during the related redemption period (as defined in the indenture that will govern the notes), as the case may be.

Concurrently with the pricing of the notes in the offering, Ionis entered into separate and individually negotiated transactions with certain holders of the 2026 notes to repurchase for cash $200.00 million in aggregate principal amount of the 2026 notes on terms negotiated with each holder (each, a “concurrent note repurchase transaction”). This press release is not an offer to repurchase the 2026 notes, and the offering of the notes is not contingent upon the repurchase of any of the 2026 notes.

In connection with any repurchase of the 2026 notes, Ionis expects that holders of the 2026 notes who agree to have their 2026 notes repurchased and who have hedged their equity price risk with respect to such notes (the “hedged holders”) will unwind all or part of their hedge positions by purchasing Ionis’ common stock and/or entering into or unwinding various derivative transactions with respect to Ionis’ common stock. The amount of Ionis’ common stock to be purchased by the hedged holders or in connection with such derivative transactions may be substantial in relation to the historic average daily trading volume of Ionis’ common stock. This activity by the hedged holders could increase (or reduce the size of any decrease in) the market price of Ionis’ common stock, including concurrently with the pricing of the notes, resulting in a higher effective conversion price of the notes. Ionis cannot predict the magnitude of such market activity or the overall effect it will have on the price of the notes or Ionis’ common stock.

The notes and any shares of Ionis’ common stock issuable upon conversion of the notes have not been and will not be registered under the Securities Act, any state securities laws or the securities laws of any other jurisdiction, and unless so registered, may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws.

This press release is neither an offer to sell nor a solicitation of an offer to buy any of these securities nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification thereof under the securities laws of any such state or jurisdiction.

About Ionis Pharmaceuticals

For three decades, Ionis has invented medicines that bring better futures to people with serious diseases. Ionis has marketed medicines and a leading pipeline in neurology, cardiometabolic and other areas of high patient need. As the pioneer in RNA-targeted medicines, Ionis continues to drive innovation in RNA therapies in addition to advancing new approaches in gene editing. A deep understanding of disease biology and industry-leading technology propels our work, coupled with a passion and urgency to deliver life-changing advances for patients.

Ionis’ Forward-looking Statement

This press release includes forward-looking statements regarding the offering, including statements regarding the anticipated completion and timing of the offering, the expected repurchase of 2026 notes, including the concurrent note repurchase transactions, the expected unwind by the hedged holders of their hedge positions and the anticipated effects of such actions, and Ionis’ expected use of proceeds from the offering. Any statement describing Ionis’ expectations, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, including, without limitation, changes in market conditions, whether Ionis will be able to satisfy closing conditions related to the offering, whether and on what terms Ionis may repurchase or repay any of the 2026 notes, the concurrent note repurchase transactions, the actions of the hedged holders and unanticipated uses of capital. Ionis’ forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Ionis’ forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Ionis. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Ionis’ programs are described in additional detail in Ionis’ annual report on Form 10-K for the year ended December 31, 2024 and most recent Form 10-Q, which are on file with the Securities and Exchange Commission, as well as other subsequent filings Ionis makes with the Securities and Exchange Commission from time to time. Copies of these and other documents are available from Ionis.

In this press release, unless the context requires otherwise, “Ionis,” “Company,” “we,” “our,” and “us” refers to Ionis Pharmaceuticals and its subsidiaries.

Ionis Pharmaceuticals® is a trademark of Ionis Pharmaceuticals, Inc.

Ionis Investor Contact:

D. Wade Walke, Ph.D.

[email protected]

760-603-2331

Ionis Media Contact:

Hayley Soffer

[email protected]

760-603-4679

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Health Neurology Genetics Pharmaceutical Cardiology Biotechnology

MEDIA:

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enGene Announces Pricing of $130 Million Public Offering of Common Shares and Pre-Funded Warrants

enGene Announces Pricing of $130 Million Public Offering of Common Shares and Pre-Funded Warrants

BOSTON & MONTREAL–(BUSINESS WIRE)–
enGene Holdings Inc. (Nasdaq: ENGN, “enGene” or the “Company”), a clinical-stage, non-viral genetic medicines company, today announced the pricing of its previously announced underwritten public offering of 12,558,823 common shares at a public offering price of $8.50 per share and pre-funded warrants to purchase 2,735,295 shares of its common shares at an offering price of $8.4999 per pre-funded warrant, in each case, before underwriting discounts and commissions. The aggregate gross proceeds to enGene from the offering, before deducting the underwriting discounts and commissions and offering expenses payable by enGene, are expected to be approximately $130 million. All securities to be sold in the offering will be offered by enGene. In addition, enGene has granted to the underwriters a 30-day option to purchase up to 2,294,117 additional common shares at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about November 14, 2025, subject to the satisfaction of customary closing conditions.

Jefferies, Leerink Partners and Wells Fargo Securities are acting as joint book running managers for the offering. Raymond James and Van Lanschot Kempen are acting as co-lead managers for the offering. H.C. Wainwright & Co. is acting as co-manager for the offering.

The securities described above are being offered by enGene pursuant to its effective shelf registration statement on Form S-3 (File No. 333-283201) filed with the U.S. Securities and Exchange Commission (the “SEC”) on November 13, 2024 and declared effective on November 21, 2024. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available for free on the SEC’s website at http://www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, New York 10022, telephone: (877) 821-7388, or by emailing [email protected]; Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; or Wells Fargo Securities, LLC, 90 South 7th Street, 5th Floor, Minneapolis, MN 55402, by telephone at (800) 645-3751 (option #5), or by email at [email protected].

No securities are being offered or sold, directly or indirectly, in Canada or to any resident of Canada.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

About enGene

enGene is a clinical-stage biotechnology company mainstreaming genetic medicine through the delivery of therapeutics to mucosal tissues and other organs, with the goal of creating new ways to address diseases with high clinical needs. enGene’s lead program is detalimogene voraplasmid (also known as detalimogene, and previously EG-70) for patients with non-muscle invasive bladder cancer (NMIBC), a disease with a high clinical burden. Detalimogene is being evaluated in the ongoing multi-cohort LEGEND Phase 2 trial, which includes a pivotal cohort studying detalimogene in high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive patients with carcinoma in situ (CIS) with or without concomitant papillary disease. Detalimogene was developed using enGene’s proprietary Dually Derivatized Oligochitosan® (DDX) platform, which enables penetration of mucosal tissues and delivery of a wide range of sizes and types of cargo, including DNA and various forms of RNA.

Forward-Looking Statements

Certain statements contained in this press release may constitute “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, and “forward-looking information” within the meaning of Canadian securities laws (collectively, “forward-looking statements”). enGene’s forward-looking statements include, but are not limited to, statements regarding enGene’s management teams’ expectations, hopes, beliefs, intentions, goals, or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements, and they may also include statements express or implied, about enGene’s expectations regarding the offering, including the timing, structure and completion of the offering on the anticipated size and terms, the grant to the underwriters of the option to purchase additional shares and the potential value and clinical benefit of enGene’s product candidates. The words “anticipate”, “appear”, “approximate”, “believe”, “continue”, “could”, “estimate”, “expect”, “foresee”, “intends”, “may”, “might”, “plan”, “possible”, “potential”, “predict”, “project”, “seek”, “should”, “would”, and similar expressions (or the negative version of such words or expressions) may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking.

Many factors, risks, uncertainties, and assumptions could cause the Company’s actual results, performance, or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, uncertainties related to market conditions, the satisfaction of customary closing conditions related to the offering, general economic conditions, , and other risks and uncertainties detailed in filings with Canadian securities regulators on SEDAR+ and with the U.S. Securities and Exchange Commission (“SEC”) on EDGAR, including those described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the fiscal year ended October 31, 2024 (copies of which may be obtained at www.sedarplus.ca or www.sec.gov).

You should not place undue reliance on any forward-looking statements, which speak only as of the date on which they are made. enGene anticipates that subsequent events and developments will cause enGene’s assessments to change. While enGene may elect to update these forward-looking statements at some point in the future, enGene specifically disclaims any obligation to do so, unless required by applicable law. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved.

For media contact:

[email protected]

For investor contact:

[email protected]

KEYWORDS: United States North America Canada Massachusetts

INDUSTRY KEYWORDS: Health Biotechnology

MEDIA:

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IBM Study: Chief Data Officers Redefine Strategies as AI Ambitions Outpace Readiness

PR Newswire

  • 81% of Chief Data Officers surveyed prioritize investments that accelerate AI capabilities and initiatives.
  • 78% of surveyed leaders cite leveraging proprietary data is a top strategic objective to differentiate their organization in the market.
  • Nearly half of respondents
    identify advanced data skills as a top challenge – rising from 32% in 2023.


ARMONK, N.Y.
, Nov. 13, 2025 /PRNewswire/ — A new global study by the IBM (NYSE: IBM) Institute for Business Value reveals enterprise data strategies are rapidly evolving as organizations race to scale AI across their business. The findings suggest that while Chief Data Officers (CDOs) are at the helm of this transformation, many say their data is still not ready to unlock AI’s full potential.

Based on insights from 1,700 CDOs worldwide, the study* highlights a widening gap between AI ambition and readiness. Although 81% of surveyed CDOs report their organization’s data strategy is integrated with its technology roadmap and infrastructure investments –compared to 52% in 2023 — only 26% are confident their data can support new AI-enabled revenue streams. In addition, barriers such as data accessibility, completeness, integrity, accuracy, and consistency are preventing organizations from fully leveraging enterprise data for AI.

“Enterprise AI at scale is within reach, but success depends on organizations powering it with the right data. For CDOs, this means establishing a seamlessly integrated enterprise data architecture that fuels innovation and unlocks business value,” said Ed Lovely, VP and Chief Data Officer, IBM. “Organizations that get this right won’t just improve their AI, they’ll transform how they operate, make faster decisions, adapt to change more quickly and gain a competitive edge.”

Key findings include:

The CDO role is shifting from data custodian to business strategist as proving data’s value remains a challenge

  • The majority (92%) of CDOs surveyed say they must focus on business outcomes to succeed in their role.
  • Yet, only one-third of respondents strongly agree they can clearly convey how data facilitates business results, and just 29% have clear measures to determine the value of data-driven business outcomes.
  • Deploying data for competitive advantage is now the top priority for CDOs, ahead of governance and security as core responsibilities.
  • 84% of CDOs surveyed say their unique data products have already provided significant competitive advantages, and 78% cite leveraging proprietary data as a top strategic objective to differentiate their organization in the market.

AI ambitions remain high amid AI-data gap

  • 81% of CDOs surveyed prioritize investments that accelerate AI capabilities and initiatives.
  • Yet, only 26% of CDOs surveyed are confident their organization can use unstructured data in a way that delivers business value.
  • To help close this gap, 81% of CDOs surveyed say they bring AI to data rather than centralizing it.
  • While 80% of surveyed leaders have started developing diverse datasets to train AI agents, 79% admit being early in the process of defining how to scale and govern them.
  • Despite these challenges, 83% of respondents believe the potential benefits of deploying AI agents outweigh the risks, and 77% are comfortable with their organization relying on outcomes from AI agents.

A data-driven culture is viewed as essential, but talent gaps may slow progress

  • 82% of CDOs surveyed say data is wasted if their organization isn’t giving people access to it, and 80% say data democratization helps their organization move faster.
  • While 74% of respondents actively promote a culture of data stewardship among employees, fostering a data-driven culture remains a top strategic challenge for those surveyed.
  • At the same time, 47% of CDOs surveyed now say attracting, developing and retaining talent with advanced data skills is a top challenge – up from 32% in 2023.
  • 77% of surveyed leaders are struggling to fill key data roles, and only 53% say recruiting and retention efforts deliver the skills and experience needed – down from 75% in 2024.

To view the full study, visit: https://www.ibm.com/thought-leadership/institute-business-value/en-us/report/2025-cdo

*Study Methodology
The IBM Institute for Business Value, in cooperation with Oxford Economics, surveyed 1,700 senior data and analytics leaders holding titles such as Chief Data Officer, Chief Data and Analytics Officer, Chief Analytics Officer, Chief AI Officer and other senior roles. The survey was conducted across 27 geographies and 19 industries between July and September 2025. Survey topics included data strategy, data standards, quality, and integrity, data governance, data readiness for AI, talent, and organizational culture.

The IBM Institute for Business Value, IBM’s thought leadership think tank, combines
global research and performance data with expertise from industry thinkers and leading academics to deliver insights that make business leaders smarter. For more world-class thought leadership, visit: www.ibm.com/ibv. To receive more insights, subscribe to the IdeaWatch newsletter: https://ibm.co/ibv-ideawatch. 

About IBM
IBM is a leading provider of global hybrid cloud and AI, and consulting expertise. We help clients in more than 175 countries capitalize on insights from their data, streamline business processes, reduce costs and gain the competitive edge in their industries. Thousands of government and corporate entities in critical infrastructure areas such as financial services, telecommunications and healthcare rely on IBM’s hybrid cloud platform and Red Hat OpenShift to affect their digital transformations quickly, efficiently and securely. IBM’s breakthrough innovations in AI, quantum computing, industry-specific cloud solutions and consulting deliver open and flexible options to our clients. All of this is backed by IBM’s long-standing commitment to trust, transparency, responsibility, inclusivity and service.  Visit www.ibm.com for more information.

Media Contact

Marisa Conway

IBM Corporate Communications
[email protected]

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SOURCE IBM

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Claritev Corporation Announces Pricing of Offering of Class A Common Stock by Selling Stockholders

Claritev Corporation Announces Pricing of Offering of Class A Common Stock by Selling Stockholders

MCLEAN, Va.–(BUSINESS WIRE)–
Claritev Corporation (“Claritev” or the “Company”) (NYSE: CTEV), a technology, data and insights company focused on making healthcare more affordable, transparent and fair for all, today announced the pricing of an underwritten public offering (the “Offering”) of 1,500,000 shares of its Class A common stock, par value $0.0001 per share (the “Class A common stock”), by certain affiliates of Hellman & Friedman (collectively, the “Selling Stockholders”) at a price to the public of $51.50 per share. The Selling Stockholders granted the underwriters a 30-day option to purchase up to an additional 225,000 shares of Class A common stock. The underwriters propose to offer the shares of Class A common stock to the public at a fixed price, which may be changed at any time without notice. Claritev will not sell any shares of its Class A common stock in the Offering and will not receive any proceeds from the sale of the shares of Class A common stock being offered by the Selling Stockholders. The Offering is expected to close by November 14, 2025, subject to customary closing conditions.

Barclays, Guggenheim Securities and Wells Fargo Securities are acting as joint-lead bookrunning managers for the Offering. Citigroup and Piper Sandler are acting as additional bookrunners for the Offering. The Offering may be made only by means of a prospectus supplement and accompanying prospectus. Claritev has filed a registration statement (including a prospectus) with the Securities and Exchange Commission (the “SEC”) for the Offering. A prospectus supplement and accompanying prospectus relating to the Offering will be filed with the SEC and will be available on the SEC’s website. Before you invest, you should read the prospectus supplement and accompanying prospectus and other documents Claritev has filed with the SEC for more complete information about Claritev and the Offering. You may get these documents for free, once available, by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, Barclays, Guggenheim Securities or Wells Fargo Securities will arrange to send you the prospectus supplement and accompanying prospectus relating to the Offering if you contact Barclays Capital Inc. at c/o Broadridge Financial Solutions, 1155 Long Island Avenue Edgewood, NY 11717, by telephone at (888) 603-5847, or by email at [email protected]; Guggenheim Securities, LLC at 330 Madison Avenue, 8th Floor, New York, NY 10017, Attention: Equity Syndicate Department, by telephone at (212) 518-9544, or by email at [email protected]; or Wells Fargo Securities, LLC at 90 South 7th Street, 5th Floor, Minneapolis, MN 55402, Attention: Wells Fargo Securities, by telephone at (800) 645-3751 (option #5) or by email at [email protected].

This press release shall not constitute an offer to sell, a solicitation to buy or an offer to purchase or sell any securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended.

About Claritev

Claritev is a healthcare technology, data and insights company focused on improving affordability, transparency and quality. Led by a team of deeply experienced associates, data scientists and innovators, Claritev provides tech-enabled solutions and services fueled by multiple data sources and over 40 years of claims repricing experience. Claritev utilizes world-class technology and AI solutions to power a robust enterprise platform that delivers meaningful insights to drive affordability in healthcare, brings price transparency and optimizes networks and benefits design. By focusing on purpose-built solutions that support all key players—including payors, employers, patients, providers and third parties—Claritev aims to make healthcare more accessible and affordable for all.

Claritev serves more than 700 healthcare payors, over 100,000 employers, 60 million consumers, and 1.4 million contracted providers.

Forward-Looking Statements

This press release includes statements that express our and our subsidiaries’ opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results and therefore are, or may be deemed to be, “forward-looking statements”. These forward-looking statements can generally be identified by the use of forward-looking terminology, including the terms “believes,” “estimates,” “anticipates,” “expects,” “seeks,” “projects,” “forecasts,” “intends,” “plans,” “may,” “will” or “should” or, in each case, their negative or other variations or comparable terminology. These forward-looking statements include all matters that are not historical facts, including statements related to the terms and timing of the Offering. Although we believe that these forward-looking statements are based on reasonable assumptions at the time they are made, you should be aware that these forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks, uncertainties and other assumptions include: market conditions; the satisfaction of customary closing conditions related to the Offering; the ability to complete the Offering on the anticipated terms or at all; other factors disclosed in our SEC filings; and other factors beyond our control.

The forward-looking statements contained in this press release are based on our current expectations and beliefs concerning future developments and their potential effects on our business. There can be no assurance that future developments affecting our business will be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors described in the prospectus supplement and accompanying prospectus relating to the Offering, our Annual Report on Form 10-K, our Quarterly Reports on Form 10-Q, and other documents filed or to be filed with the SEC by us. Should one or more of these risks or uncertainties materialize, or should any of the assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements.

We do not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Investor Relations Contact

Todd Friedman

VP, Investor Relations

Claritev

866-909-7427

[email protected]

KEYWORDS: United States North America Virginia

INDUSTRY KEYWORDS: Other Health Health Data Management Other Technology Technology

MEDIA:

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Annexon Announces Pricing of $75 Million Public Offering of Common Stock and Pre-Funded Warrants

BRISBANE, Calif., Nov. 12, 2025 (GLOBE NEWSWIRE) — Annexon, Inc. (“Annexon”) (Nasdaq: ANNX), a biopharmaceutical company advancing a late-stage clinical platform targeting neuroinflammation across life-changing complement-mediated diseases of the body, brain, and eye, today announced the pricing of its previously announced underwritten public offering of 25,096,153 shares of its common stock at a price to the public of $2.60 per share and, in lieu of shares of common stock to certain investors, pre-funded warrants to purchase 3,750,000 shares of common stock at a purchase price of $2.599 per share, which equals the public offering price per share of the common stock less the $0.001 exercise price per share of each pre-funded warrant.

The gross proceeds to Annexon from the offering are expected to be $75 million, before deducting underwriting discounts and commissions and other offering expenses payable by Annexon. The offering is expected to close on November 14, 2025, subject to the satisfaction of customary closing conditions. In addition, Annexon has granted the underwriters a 30-day option to purchase up to an additional 4,326,922 shares of common stock.

Goldman Sachs & Co. LLC, TD Cowen and Wells Fargo Securities are acting as joint book-running managers for the offering.

The shares of common stock and pre-funded warrants are being offered by Annexon pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was filed with the Securities and Exchange Commission (the “SEC”) on March 26, 2024 and subsequently declared effective by the SEC on April 1, 2024. The offering is being made only by means of a prospectus supplement and the accompanying prospectus that will form a part of the registration statement. These documents can be accessed for free through the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus, when available, may be obtained from: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526 or by email at [email protected]; TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, NY 10017, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at [email protected]; or Wells Fargo Securities, 90 South 7th Street, 5th Floor, Minneapolis, MN 55402, by telephone at 800-645-3751 (option #5), or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Annexon

Annexon, Inc. (Nasdaq: ANNX) is developing the next generation of complement inhibitors to stop neuroinflammation as first-in-kind treatments for millions of people living with serious neuroinflammatory diseases of the body, brain and eye. Our novel scientific approach focuses on C1q, the initiating molecule of classical complement’s potent inflammatory pathway that when misdirected can lead to tissue damage and loss in a host of diseases. By targeting C1q, our immunotherapies are designed to stop this neuroinflammatory cascade before it starts. Our pipeline spans three diverse therapeutic areas – autoimmunity, neurodegeneration and ophthalmology – and includes targeted investigational drug candidates designed to address the unmet needs of nearly 10 million people worldwide. Annexon’s mission is to deliver game-changing therapies to patients so that they can live their best lives.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “suggest,” “target,” “on track,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements about the expected gross proceeds from the offering and the closing date of the offering. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to, among other things, market conditions and the satisfaction of customary closing conditions related to the public offering. These and other risks are described in greater detail under the section titled “Risk Factors” contained in the preliminary prospectus supplement and the accompanying prospectus, the company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and the company’s other filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, the company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Joyce Allaire
LifeSci Advisors
[email protected]

Media Contact:

Beth Keshishian
917-912-7195
[email protected]



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/C O R R E C T I O N — Enliven Therapeutics, Inc./

PR Newswire

In the news release, Enliven Therapeutics Reports Third Quarter Financial Results and Provides a Business Update, issued 12-Nov-2025 by Enliven Therapeutics, Inc., the Company clarified details surrounding the status of the Phase 1b portion of the ENABLE clinical trial of ELVN-001 in CML.

Enliven Therapeutics Reports Third Quarter Financial Results and Provides a Business Update

Completed enrollment of the randomized Phase 1b cohorts of the ongoing ENABLE trial of ELVN-001 in CML

Remains on track to initiate Phase 3 pivotal trial of ELVN-001 in 2026

Strong balance sheet with $478 million in cash, cash equivalents and marketable securities, which is expected to provide cash runway into the first half of 2029


BOULDER, Colo.
, Nov. 12, 2025 /PRNewswire/ — Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, today reported financial results for the third quarter ended September 30, 2025, and provided a business update, including highlights of pipeline progress.

“We continue to make great progress advancing the ENABLE Phase 1 trial of ELVN-001 in people living with CML. I’m pleased to report that during the quarter, we completed enrollment of the randomized Phase 1b portion of the ENABLE trial and achieved key readiness milestones across multiple geographies, positioning us to rapidly launch our Phase 3 trial globally next year,” said Sam Kintz, Co-Founder and Chief Executive Officer of Enliven. “Since we announced our positive, updated ENABLE data in June, we have had oral presentations at multiple medical meetings, which is a testament to the strength of the data and the potential for ELVN-001 as a selective active-site inhibitor. Additionally, we are pleased that the CML community continues to validate our work and enthusiastically supports ELVN-001 as we move through clinical trials. We remain focused on clinical execution as we look to initiate our Phase 3 pivotal trial in 2026.”

Pipeline Updates

ELVN-001 is a potent, highly selective, small molecule kinase inhibitor designed to specifically target the BCR::ABL gene fusion, the oncogenic driver for patients with chronic myeloid leukemia (CML).

  • Completed enrollment of the randomized Phase 1b cohorts of the ongoing ENABLE trial of ELVN-001 in CML (NCT05304377).
  • Presented encore data from the ENABLE Phase 1a/1b clinical trial of ELVN-001 at several medical meetings, including:
    • An oral and poster presentation at the Society of Hematologic Oncology (SOHO) 2025 Annual Meeting in Houston, Texas, on September 3, 2025.
    • An oral presentation at the European Society of Hematology International Chronic Myeloid Leukemia Foundation (ESH-iCMLf) 27th Annual John Goldman Conference on Chronic Myeloid Leukemia: Biology and Therapy in Estoril, Portugal, on October 10, 2025.
    • An oral presentation at the German, Austrian, and Swiss Societies for Hematology and Medical Oncology (DGHO) in Cologne, Germany, on October 25, 2025.
  • Featured in an oral presentation titled, ELVN-001 for the treatment of CML with and without T315I mutation: a Phase 1 trial in Japan, at the 87th Annual Meeting of the Japanese Society of Hematology (JSH) in Kobe, Japan, on October 10, 2025.
  • Remains on track to initiate a Phase 3 pivotal trial of ELVN-001 in 2026.

Upcoming Medical Meeting Presentations

The Company recently announced that data from the ENABLE Phase 1a/1b clinical trial of ELVN-001 in a subset of CML patients with atypical fusion transcripts will be presented at the 67th Annual American Society of Hematology (ASH) 2025 Annual Meeting and Exposition, taking place December 6-9, 2025, in Orlando, Florida. Andreas Hochhaus, M.D., will present the data in a poster presentation on December 7, 2025.

Upcoming Investor Conference Participation

Management will participate in a fireside chat at the Jefferies Global Healthcare Conference in London on Tuesday, November 18, 2025, at 2:00 p.m. GMT. The fireside chat will be webcast live and can be accessed by visiting the investor relations section of the Company’s website at https://ir.enliventherapeutics.com/. The webcast will be archived for a period of 90 days following the conclusion of the live event.

Third Quarter 2025 Financial Results

  • Cash Position: As of September 30, 2025, the Company had cash, cash equivalents and marketable securities totaling $477.6 million, which is expected to provide cash runway into the first half of 2029.
  • Research and development (R&D) expenses: R&D expenses were $18.2 million for the third quarter of 2025, compared to $21.3 million for the third quarter of 2024.
  • General and administrative (G&A) expenses: G&A expenses were $6.9 million for the third quarter of 2025, compared to $5.8 million for the third quarter of 2024.
  • Net Loss: Enliven reported a net loss of $20.1 million for the third quarter of 2025, compared to a net loss of $23.2 million for the third quarter of 2024.

About ELVN-001

ELVN-001 is a potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL gene fusion, the oncogenic driver for patients with chronic myeloid leukemia. As a highly selective active site inhibitor, ELVN-001 has a mechanism of action that is complementary to allosteric BCR::ABL1 inhibitors, which may play an increasingly important role in the standard of care. ELVN-001 was also designed to have activity against the T315I mutation, the most common BCR::ABL1 mutation, which confers resistance to nearly all approved TKIs, as well as activity against mutations known to confer resistance to allosteric BCR::ABL1 inhibitors.

About the ENABLE Trial

The ENABLE study (NCT05304377) is a Phase 1 study of ELVN-001 in patients with previously treated CML. The trial is currently in Phase 1a/1b development and is a dose escalation and expansion trial designed to evaluate safety and tolerability and to determine the recommended dose for further clinical evaluation of ELVN-001 in patients with CML with and without T315I mutations that is relapsed, refractory or intolerant to TKIs. Secondary endpoints include pharmacokinetics, MMR by central quantitative reverse transcriptase polymerase chain reaction, duration of MMR, BCR::ABL1 transcript levels and complete hematologic response. Enliven is preparing for the potential start of a pivotal trial for ELVN-001 in 2026.

About Enliven Therapeutics

Enliven is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics to help people not only live longer, but live better. Enliven aims to address existing and emerging unmet needs with a precision oncology approach that improves survival and enhances overall well-being. Enliven’s discovery process combines deep insights in clinically validated biological targets and differentiated chemistry to design potentially first-in-class or best-in-class therapies. Enliven is based in Boulder, Colorado.

Forward-Looking Statements

This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended) concerning Enliven and other matters that involve substantial risks and uncertainties. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations and financial condition, or otherwise, based on current beliefs of the management of Enliven, as well as assumptions made by, and information currently available to, management of Enliven. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” and other similar expressions or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Statements that are not historical facts are forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements regarding the potential of, and plans regarding, market opportunities, and expectations regarding Enliven’s ELVN-001 program;  expected milestones for ELVN-001, including the expected timing for the potential start of a Phase 3 pivotal trial for ELVN-001; Enliven’s expected cash runway; and statements by Enliven’s Co-founder and Chief Executive Officer. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various risks and uncertainties, including, without limitation: the limited operating history of Enliven; the ability to advance product candidates through clinical development; the ability to obtain regulatory approval for, and ultimately commercialize or license, product candidates; the outcome of preclinical testing and early clinical trials for product candidates and the potential that the outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials; Enliven’s limited resources; the risk of failing to demonstrate safety and efficacy of product candidates; Enliven’s limited experience as a company in designing and conducting clinical trials; the potential for interim, topline, and preliminary data from Enliven’s preclinical studies and clinical trials to materially change from the final data; potential delays or difficulties in the enrollment or maintenance of patients in clinical trials; developments relating to Enliven’s competitors and its industry, including competing product candidates and therapies; the decision to develop or seek strategic collaborations to develop Enliven’s current or future product candidates in combination with other therapies and the cost of combination therapies; the ability to attract, hire, and retain highly skilled executive officers and employees; the ability of Enliven to protect its intellectual property and proprietary technologies; the scope of any patent protection Enliven obtains or the loss of any of Enliven’s patent protection; reliance on third parties, including medical institutions, contract manufacturing organizations, contract research organizations and strategic partners; geo-political developments, general market or macroeconomic conditions; Enliven’s ability to obtain additional capital to fund Enliven’s general corporate activities and to fund Enliven’s research and development; and other risks and uncertainties, including those more fully described in Enliven’s filings with the Securities and Exchange Commission (SEC), which may be found in the section titled “Risk Factors” in Enliven’s Annual and Quarterly Reports on Form 10-K and 10-Q filed with the SEC and in Enliven’s future reports to be filed with the SEC. Except as required by applicable law, Enliven undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

This press release contains hyperlinks to information that is not deemed to be incorporated by reference into this press release.


Enliven Therapeutics, Inc.


Selected Condensed Consolidated Financial Information


(in thousands, except per share data)


(unaudited)


Statements of Operations


Three Months Ended September 30, 


Nine Months Ended September 30, 


2025


2024


2025


2024

Operating expenses:

    Research and development

$               18,225

$               21,258

$               64,611

$               60,054

    General and administrative

6,871

5,810

20,762

17,604

Total operating expenses

25,096

27,068

85,373

77,658

Loss from operations

(25,096)

(27,068)

(85,373)

(77,658)

Other income (expense), net

4,948

3,912

11,346

11,814

Net loss

$             (20,148)

$             (23,156)

$              (74,027)

$              (65,844)

Net loss per share, basic and diluted

$                 (0.32)

$                 (0.48)

$                  (1.35)

$                  (1.43)

Weighted-average shares outstanding,
   basic and diluted

62,094

48,267

54,794

46,137


Balance Sheets


 September 30, 


 December 31, 


2025


2024


Assets

Current assets:

    Cash, cash equivalents and marketable securities     

$             477,565

$             313,440

    Restricted cash

—

54

    Prepaid expenses and other current assets

5,118

4,633

Total current assets

482,683

318,127

Property and equipment, net

399

458

Operating lease right-of-use assets

475

—

Deferred offering costs

217

—

Other long-term assets

7,101

7,175

Total assets

$             490,875

$             325,760


Liabilities and Stockholders’ Equity

Current liabilities:

    Accounts payable

$                 1,429

$                 1,342

    Accrued expenses and other current liabilities

13,221

14,573

Total current liabilities

14,650

15,915

Long-term liabilities

103

—

Total liabilities

14,753

15,915

Stockholders’ equity

476,122

309,845

Total liabilities and stockholders’ equity

$             490,875

$             325,760

 

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SOURCE Enliven Therapeutics, Inc.

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MRX Investors Have Opportunity to Lead Marex Group plc Securities Fraud Lawsuit

PR Newswire


NEW YORK
, Nov. 12, 2025 /PRNewswire/ —

Why: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Marex Group plc (NASDAQ: MRX) between May 16, 2024 and August 5, 2025, both dates inclusive (the “Class Period”), of the important December 8, 2025 lead plaintiff deadline.

So what: If you purchased Marex securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

What to do next: To join the Marex class action, go to https://rosenlegal.com/submit-form/?case_id=43100 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email [email protected] for information on the class action. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than December 8, 2025. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.

Why Rosen Law: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources, or any meaningful peer recognition. Many of these firms do not actually litigate securities class actions, but are merely middlemen that refer clients or partner with law firms that actually litigate the cases. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm achieved the largest ever securities class action settlement against a Chinese Company at the time. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs’ Bar. Many of the firm’s attorneys have been recognized by Lawdragon and Super Lawyers.

Details of the case: According to the lawsuit, during the Class Period, defendants made materially false and/or misleading statements and/or failed to disclose that: (1) Marex sold over-the-counter financial instruments to itself; (2) Marex had inconsistencies in its financial statements between its subsidiaries and related parties, including as to intercompany receivables and loans; (3) as a result of the foregoing, Marex’s financial statements could not be relied upon; and (4) as a result of the foregoing, defendants’ positive statements about Marex’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis. When the true details entered the market, the lawsuit claims that investors suffered damages.

To join the Marex class action, go to https://rosenlegal.com/submit-form/?case_id=43100 call Phillip Kim, Esq. toll-free at 866-767-3653 or email [email protected] for information on the class action.

No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.

Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm, on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm/.

Attorney Advertising. Prior results do not guarantee a similar outcome.

Contact Information:

      Laurence Rosen, Esq.
      Phillip Kim, Esq.
      The Rosen Law Firm, P.A.
      275 Madison Avenue, 40th Floor
      New York, NY 10016
      Tel: (212) 686-1060
      Toll Free: (866) 767-3653
      Fax: (212) 202-3827
      [email protected]
      www.rosenlegal.com

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SOURCE THE ROSEN LAW FIRM, P. A.

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MLTX Investors Have Opportunity to Lead MoonLake Immunotherapeutics Securities Fraud Lawsuit

PR Newswire


NEW YORK
, Nov. 12, 2025 /PRNewswire/ —

Why: New York, N.Y., November 12, 2025. Rosen Law Firm, a global investor rights law firm, reminds purchasers of common stock of MoonLake Immunotherapeutics (NASDAQ: MLTX) between March 10, 2024 and September 29, 2025, both dates inclusive (the “Class Period”), of the important December 15, 2025 lead plaintiff deadline.

So what: If you purchased MoonLake common stock during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

What to do next: To join the MoonLake class action, go to https://rosenlegal.com/submit-form/?case_id=45681 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email [email protected] for information on the class action. If you wish to serve as lead plaintiff, you must move the Court no later than December 15, 2025. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.

Why Rosen Law: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources, or any meaningful peer recognition. Many of these firms do not actually litigate securities class actions, but are merely middlemen that refer clients or partner with law firms that actually litigate the cases. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm achieved the largest ever securities class action settlement against a Chinese Company at the time. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs’ Bar. Many of the firm’s attorneys have been recognized by Lawdragon and Super Lawyers.

Details of the case: According to the complaint, throughout the Class Period, defendants made false and/or misleading statements, as well as failed to disclose material facts, regarding the distinction between the Nanobodies and monoclonal antibodies, including that: (1) SLK and BIMZELX share the same molecular targets (the inflammatory cytokines IL-17A and IL-17F); (2) SLK’s distinct Nanobody structure would not confer a superior clinical benefit over the traditional monoclonal structure of BIMZELX; (3) SLK’s distinct Nanobody structure supposed tissue penetration would not translate to clinical efficacy; and (4) based on the foregoing, defendants lacked a reasonable basis for their positive statements regarding SLK’s purported superiority to monoclonal antibodies. When the true details entered the market, the lawsuit claims that investors suffered damages.

To join the MoonLake Immunotherapeutics class action, go to https://rosenlegal.com/submit-form/?case_id=45681 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email [email protected] for information on the class action.

No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.

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Attorney Advertising. Prior results do not guarantee a similar outcome.

Contact Information:

Laurence Rosen, Esq.

Phillip Kim, Esq.

The Rosen Law Firm, P.A.
275 Madison Avenue, 40th Floor
New York, NY 10016
Tel: (212) 686-1060
Toll Free: (866) 767-3653
Fax: (212) 202-3827
[email protected]
www.rosenlegal.com

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SOURCE THE ROSEN LAW FIRM, P. A.

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Grant & Eisenhofer Files Class Action Lawsuit Against Primo Brands Corp.

Grant & Eisenhofer Files Class Action Lawsuit Against Primo Brands Corp.

NEW YORK–(BUSINESS WIRE)–
Today, Grant & Eisenhofer P.A. filed a class action lawsuit on behalf of Stuart Rosenblum against Primo Brands Corporation (“Primo Brands” or the “Company”) and three of the Company’s senior executives and directors, including CFO David Hass, Director C. Dean Metropoulos, and former CEO Robbert Rietbroek (collectively, the “Defendants”). The action alleges that Defendants defrauded investors by making materially false and/or misleading statements and by failing to disclose materially adverse facts concerning the merger between Primo Water Corporation (“Primo Water”) and an affiliate of BlueTriton Brands, Inc. (“BlueTriton Brands”), which together formed Primo Brands.

The action is brought on behalf of all persons or entities who purchased or acquired (i) the common stock of Primo Water between June 17, 2024 through November 8, 2024, inclusive, and/or (ii) the common stock of Primo Brands between November 11, 2024 through November 6, 2025, inclusive (collectively, the “Class Period”). The action, brought in the United States District Court for the District of Connecticut, is captioned Stuart Rosenblum v. Primo Brands Corp., et al., No. 3:25-cv-01902 (D. Conn.).

Primo Brands, formed following the November 8, 2024 merger between Primo Water and BlueTriton Brands, is a branded beverage company that offers beverage products across a variety of formats, channels, and price points.

The complaint alleges violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934. Specifically, the lawsuit alleges that throughout the Class Period, Defendants misrepresented and failed to disclose key facts about the merger between Primo Water and BlueTriton Brands, including facts regarding the progress of the merger integration. Defendants issued a series of materially false and misleading statements that led investors to believe the merger would accelerate growth, generate transformative operational efficiencies, achieve meaningful synergies, and deliver strong financial results, and that the merger integration was proceeding “flawlessly.”

Investors began to learn the truth on August 7, 2025 when the Company announced its second quarter 2025 earnings, revealing that the merger had “led to disruptions in product supply, delivery, and service.” In response to this disclosure, the price of the Company’s common stock declined approximately 9%, from $26.41 per share on August 6, 2025 to $24.00 per share on August 7, 2025.

The truth was fully revealed on November 6, 2025, when the Company stunned investors by slashing its full year 2025 net sales and adjusted EBITDA guidance and announcing the replacement of CEO Rietbroek. During a conference call held that day, newly appointed CEO Eric Foss admitted that Primo Brands “probably moved too far too fast on some of the various integration work streams” and that “[t]here’s no doubt that speed impacted our ability to get through a lot of the warehouse closures and route realignment without disruption.” Foss further revealed “customer services issues” as well as “integration issues related to the technology move over.” On this news, the price of the Company’s common stock declined more than 36%, from a close of $22.66 per share on November 5, 2025, to close at $14.46 per share on November 7, 2025. From the Company’s Class Period stock price closing high of $35.63 per share on April 3, 2025, Primo Brands’ stock price dropped $21.17 per share, or nearly 60%, erasing billions of dollars from the Company’s market capitalization.

Investors who purchased or acquired Primo Water’s and/or Primo Brands’ common stock during the Class Period are members of this proposed Class and may be able to seek appointment as lead plaintiff, which is a court-appointed representative of the Class, by complying with the relevant provisions of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). See 15 U.S.C. Section 78u-4(a)(2)(A)(i)-(iv).

If you wish to serve as lead plaintiff, you must move the Court by no later than January 12, 2026. You do not need to seek to become a lead plaintiff in order to share in any possible recovery. You may also retain counsel of your choice to represent you in this action.

If you wish to discuss this action or have any questions concerning this notice or your rights, please contact Vincent J. Pontrello at Grant & Eisenhofer at 646-722-8500, or via email at [email protected].

Vincent J. Pontrello

Grant & Eisenhofer P.A.

Tel.: (646) 722-8500

[email protected]

KEYWORDS: New York United States North America

INDUSTRY KEYWORDS: Class Action Lawsuit Professional Services Legal

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