Galectin Therapeutics Provides Regulatory Update Following FDA Written Response and Announces an Additional $10 Million Line of Credit from Richard E. Uihlein Sufficient to Cover Expected Expenditures Through March 2027




Galectin Therapeutics Provides Regulatory Update Following FDA Written Response and Announces an Additional $10 Million Line of Credit from Richard E. Uihlein Sufficient to Cover Expected Expenditures Through March 2027

NORCROSS, Ga., Dec. 19, 2025 (GLOBE NEWSWIRE) — Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of galectin-3-targeted therapeutics for patients with MASH cirrhosis and portal hypertension, today announced that the U.S. Food and Drug Administration (FDA) has provided a written response, and subsequent communications, to the Company’s previously submitted Type C meeting request regarding the development program for belapectin, its investigational galectin-3 inhibitor. The FDA converted the Company’s initial request for an in-person or teleconference meeting to a written response.

Based on FDA’s written feedback, the Company believes there is alignment with the Agency on the patient population proposed for enrollment in a registration trial. In addition, Galectin Therapeutics had previously reached an agreement with the FDA on the use of a centralized, blinded endoscopy review for esophageal variceal assessment and plans to apply a similar approach for variceal evaluation in its next study.

Pursuant to the written response from FDA, Galectin Therapeutics will pursue a follow-up Type C meeting to finalize remaining components of the next clinical trial design that were not fully resolved in the written response. This follow-up meeting will also provide an opportunity to present recently generated biomarker data, including findings highlighted at last month’s American Association for the Study of Liver Diseases (AASLD) meeting, which could not be incorporated in the original submission due to our stated objective of obtaining FDA feedback before the end of 2025.

The Company views this next FDA interaction as an important step toward ensuring full clarity as it advances belapectin towards subsequent clinical development in a pivotal Phase 3 clinical trial. Galectin Therapeutics is also encouraged that the planned meeting will allow participation from prominent key opinion leaders, whose insights could not be integrated into the prior written-only exchange.

Galectin Therapeutics remains committed to advancing belapectin’s development for patients with advanced fibrotic liver disease and continues to engage constructively with the FDA as it progresses the program.

Dr. Khurram Jamil, Chief Medical Officer at Galectin Therapeutics, stated, “We appreciate the FDA’s written feedback and are encouraged by the agency’s evolving consideration of non-invasive tools and surrogate markers into clinical development for MASH cirrhosis. We look forward to discussing our updated data set within that regulatory context and further refining the clinical development strategy for belapectin.”

Separately, the Company has entered into a new $10 million unsecured, convertible line of credit financing agreement provided by its chairman, Richard E. Uihlein. In connection with this agreement, the maturity dates of all of the Company’s convertible lines of credit and convertible notes payable to its chairman have been extended through June 30, 2027. The Company now believes that its cash resources, together with availability under these credit facilities, are sufficient to fund currently expected expenditures through at least March 2027.

Joel Lewis, Chief Executive Officer at Galectin Therapeutics, added, “Our focus remains on advancing belapectin for patients with MASH cirrhosis and portal hypertension. We were pleased to receive feedback prior to year-end and look forward to continued dialogue as we work to finalize the next stage of clinical development. The strength of the data generated to date reinforces our confidence in belapectin’s potential, and we look forward to advancing this program with continued momentum. Finally, I would like to express our gratitude to Mr. Uihlein for once again increasing his commitment to the Company through the newest $10 million line of credit. This additional financing will enable us to continue to explore multiple strategies for the advancement of belapectin. We will provide updates as they become available.”

About Galectin Therapeutics
Galectin Therapeutics is dedicated to developing novel therapies to improve the lives of patients with chronic liver disease and cancer. Galectin’s lead drug belapectin is a carbohydrate-based drug that inhibits the galectin-3 protein, which is directly involved in multiple inflammatory, fibrotic, and malignant diseases, for which it has Fast Track designation by the U.S. Food and Drug Administration. The lead development program is in metabolic dysfunction-associated steatohepatitis (MASH, formerly known as nonalcoholic steatohepatitis, or NASH) with cirrhosis, the most advanced form of MASH-related fibrosis. Liver cirrhosis is one of the most pressing medical needs and a significant drug development opportunity. Additional development programs are in treatment of combination immunotherapy for advanced head and neck cancers and other malignancies. Advancement of these additional clinical programs is largely dependent on the Company’s cash resources and finding a suitable partner. Galectin seeks to leverage extensive scientific and development expertise as well as established relationships with external sources to achieve cost-effective and efficient development. Additional information is available at www.galectintherapeutics.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as “may,” “estimate,” “could,” “expect”, “look forward”, “believe”, “hope” and others. They are based on management’s current expectations and are subject to factors and uncertainties that could cause actual results to differ materially from those described in the statements. These statements include those regarding the hope that Galectin’s development program for belapectin will lead to the first therapy for the treatment of MASH, formerly known as NASH, with cirrhosis and those regarding the hope that our lead compounds will be successful in cancer immunotherapy and in other therapeutic indications. Factors that could cause actual performance to differ materially from those discussed in the forward-looking statements include, among others, full analysis of the NAVIGATE trial data may not produce positive data; Galectin may not be successful in developing effective treatments and/or obtaining the requisite approvals for the use of belapectin or any of its other drugs in development; the Company may not be successful in scaling up manufacturing and meeting requirements related to chemistry, manufacturing and control matters; the Company’s current clinical trial and any future clinical studies may not produce positive results in a timely fashion, if at all, and could require larger and longer trials, which would be time consuming and costly; plans regarding development, approval and marketing of any of Galectin’s drugs are subject to change at any time based on the changing needs of the Company as determined by management and regulatory agencies; regardless of the results of any of its development programs, Galectin may be unsuccessful in developing partnerships with other companies or raising additional capital that would allow it to further develop and/or fund any studies or trials. Galectin has incurred operating losses since inception, and its ability to successfully develop and market drugs may be impacted by its ability to manage costs and finance continuing operations. For a discussion of additional factors impacting Galectin’s business, see the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent filings with the SEC. You should not place undue reliance on forward-looking statements. Although subsequent events may cause its views to change, management disclaims any obligation to update forward-looking statements.

Company Contact:

Jack Callicutt, Chief Financial Officer
(678) 620-3186
ir@galectintherapeutics.com

Investors Relations Contacts:

Kevin Gardner
kgardner@lifesciadvisors.com

Galectin Therapeutics and its associated logo is a registered trademark of Galectin Therapeutics Inc. Belapectin is the USAN assigned name for Galectin Therapeutics’ galectin-3 inhibitor belapectin.

Cue Biopharma Announces Pricing of $10 Million Public Offering




Cue Biopharma Announces Pricing of $10 Million Public Offering

BOSTON, Dec. 19, 2025 (GLOBE NEWSWIRE) — Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease, today announced the pricing of an underwritten public offering of 35,714,286 shares of its common stock (or pre-funded warrants to purchase shares of common stock in lieu thereof) and accompanying common stock warrants to purchase an aggregate of 17,857,143 shares of common stock. Each share of common stock (or pre-funded warrant to purchase shares of common stock in lieu thereof) and accompanying common stock warrant are being sold together at a combined public offering price of $0.28 (or $0.279, in the case of pre-funded warrants to purchase shares of common stock). The aggregate gross proceeds of the offering are expected to be approximately $10 million, before deducting underwriting discounts and commissions and other offering expenses. Each common stock warrant will have an exercise price of $0.30 per share, will be exercisable immediately and will expire five years from the date of issuance. The offering is expected to close on or about December 22, 2025, subject to satisfaction of customary closing conditions. In addition, Cue Biopharma has granted the underwriters an option for a period of 30 days to purchase up to an additional 5,357,140 shares of its common stock and/or warrants to purchase up to 2,678,570 shares of common stock at the public offering price, less underwriting discounts and commissions. All of the securities are being offered by Cue Biopharma.

H.C. Wainwright & Co. is acting as sole book-running manager for the offering. Newbridge Securities Corporation is acting as co-manager for the offering.

The securities are being offered pursuant to an effective shelf registration statement on Form S-3 (File No. 333-271786) that was filed with the Securities and Exchange Commission (the “SEC”) on May 9, 2023, and declared effective on May 26, 2023. The offering was made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering have been filed with the SEC and may be obtained for free by visiting the SEC’s website at www.sec.gov. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC. When available, copies of the final prospectus supplement and accompanying prospectus relating to the offering may also be obtained by contacting: H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856-5711 or e-mail at placements@hcwco.com.

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

About Cue Biopharma
Cue Biopharma, a clinical-stage biopharmaceutical company, is developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body. The company’s proprietary platform, Immuno-STAT® (Selective Targeting and Alteration of T cells), and biologics are designed to harness the curative potential of the body’s intrinsic immune system without the adverse effects of broad systemic immune modulation.

Headquartered in Boston, Massachusetts, we are led by an experienced management team with deep expertise in immunology and protein engineering as well as the design and clinical development of protein biologics.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, those regarding: the public offering, including the satisfaction of customary closing conditions relating to the offering, the expected closing of the public offering, and the underwriters’ option to purchase additional securities. Forward-looking statements, which are based on certain assumptions and describe the company’s future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “goal,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “seek,” “strategy,” “future,” “vision,” “should,” ‘‘target”, “will,” “would,” “likely” or other comparable terms, although not all forward-looking statements contain these identifying words.

Cue Biopharma may not actually achieve the plans, intentions or expectations disclosed in its forward-looking statements, and you should not place undue reliance on its forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements Cue Biopharma makes as a result of various risks and uncertainties, including but not limited to the satisfaction of customary closing conditions related to the public offering, Cue Biopharma’s limited operating history, limited cash and a history of losses, Cue Biopharma’s ability to achieve profitability, Cue Biopharma’s ability to obtain adequate financing to fund its business operations in the near-term, Cue Biopharma’s ability to successfully remediate its current “going concern” determination that it does not have sufficient capital on hand to continue operations beyond the next twelve months, Cue Biopharma’s reliance on licensors, collaborators, contract research organizations, suppliers and other business partners, potential setbacks in Cue Biopharma’s research and development efforts including negative or inconclusive results from its preclinical studies or clinical trials or Cue Biopharma’s ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates and other risks and uncertainties described in the Risk Factors and Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of Cue Biopharma’s most recently filed Annual Report on Form 10-K and any subsequently filed Quarterly Reports on Form 10-Q. Any forward-looking statement made by Cue Biopharma in this press release is based only on information currently available to Cue Biopharma and speaks only as of the date on which it is made. Cue Biopharma undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Investor Contact
Marie Campinell
Senior Director, Corporate Communications
Cue Biopharma, Inc.
mcampinell@cuebio.com

Media Contact
Jonathan Pappas
LifeSci Communications
jpappas@lifescicomms.com

Cue Biopharma Announces Pricing of $10 Million Public Offering




Cue Biopharma Announces Pricing of $10 Million Public Offering

BOSTON, Dec. 19, 2025 (GLOBE NEWSWIRE) — Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease, today announced the pricing of an underwritten public offering of 35,714,286 shares of its common stock (or pre-funded warrants to purchase shares of common stock in lieu thereof) and accompanying common stock warrants to purchase an aggregate of 17,857,143 shares of common stock. Each share of common stock (or pre-funded warrant to purchase shares of common stock in lieu thereof) and accompanying common stock warrant are being sold together at a combined public offering price of $0.28 (or $0.279, in the case of pre-funded warrants to purchase shares of common stock). The aggregate gross proceeds of the offering are expected to be approximately $10 million, before deducting underwriting discounts and commissions and other offering expenses. Each common stock warrant will have an exercise price of $0.30 per share, will be exercisable immediately and will expire five years from the date of issuance. The offering is expected to close on or about December 22, 2025, subject to satisfaction of customary closing conditions. In addition, Cue Biopharma has granted the underwriters an option for a period of 30 days to purchase up to an additional 5,357,140 shares of its common stock and/or warrants to purchase up to 2,678,570 shares of common stock at the public offering price, less underwriting discounts and commissions. All of the securities are being offered by Cue Biopharma.

H.C. Wainwright & Co. is acting as sole book-running manager for the offering. Newbridge Securities Corporation is acting as co-manager for the offering.

The securities are being offered pursuant to an effective shelf registration statement on Form S-3 (File No. 333-271786) that was filed with the Securities and Exchange Commission (the “SEC”) on May 9, 2023, and declared effective on May 26, 2023. The offering was made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering have been filed with the SEC and may be obtained for free by visiting the SEC’s website at www.sec.gov. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC. When available, copies of the final prospectus supplement and accompanying prospectus relating to the offering may also be obtained by contacting: H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856-5711 or e-mail at placements@hcwco.com.

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

About Cue Biopharma
Cue Biopharma, a clinical-stage biopharmaceutical company, is developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body. The company’s proprietary platform, Immuno-STAT® (Selective Targeting and Alteration of T cells), and biologics are designed to harness the curative potential of the body’s intrinsic immune system without the adverse effects of broad systemic immune modulation.

Headquartered in Boston, Massachusetts, we are led by an experienced management team with deep expertise in immunology and protein engineering as well as the design and clinical development of protein biologics.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, those regarding: the public offering, including the satisfaction of customary closing conditions relating to the offering, the expected closing of the public offering, and the underwriters’ option to purchase additional securities. Forward-looking statements, which are based on certain assumptions and describe the company’s future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “goal,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “seek,” “strategy,” “future,” “vision,” “should,” ‘‘target”, “will,” “would,” “likely” or other comparable terms, although not all forward-looking statements contain these identifying words.

Cue Biopharma may not actually achieve the plans, intentions or expectations disclosed in its forward-looking statements, and you should not place undue reliance on its forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements Cue Biopharma makes as a result of various risks and uncertainties, including but not limited to the satisfaction of customary closing conditions related to the public offering, Cue Biopharma’s limited operating history, limited cash and a history of losses, Cue Biopharma’s ability to achieve profitability, Cue Biopharma’s ability to obtain adequate financing to fund its business operations in the near-term, Cue Biopharma’s ability to successfully remediate its current “going concern” determination that it does not have sufficient capital on hand to continue operations beyond the next twelve months, Cue Biopharma’s reliance on licensors, collaborators, contract research organizations, suppliers and other business partners, potential setbacks in Cue Biopharma’s research and development efforts including negative or inconclusive results from its preclinical studies or clinical trials or Cue Biopharma’s ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates and other risks and uncertainties described in the Risk Factors and Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of Cue Biopharma’s most recently filed Annual Report on Form 10-K and any subsequently filed Quarterly Reports on Form 10-Q. Any forward-looking statement made by Cue Biopharma in this press release is based only on information currently available to Cue Biopharma and speaks only as of the date on which it is made. Cue Biopharma undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Investor Contact
Marie Campinell
Senior Director, Corporate Communications
Cue Biopharma, Inc.
mcampinell@cuebio.com

Media Contact
Jonathan Pappas
LifeSci Communications
jpappas@lifescicomms.com

IN8bio Announces Pricing of Private Placement of up to $40.2 Million to Advance Novel Gamma-Delta T Cell Engager




IN8bio Announces Pricing of Private Placement of up to $40.2 Million to Advance Novel Gamma-Delta T Cell Engager

$20.1 million upfront with a milestone-driven additional $20.1 million to advance INB-619, IN8bio’s novel gamma-delta (“γδ”) T cell engager through an Investigational New Drug (“IND”) application

Financing led by Coastlands Capital with participation from new and existing biotechnology investors

Initial proceeds extend cash runway into the first half of 2027

NEW YORK, Dec. 19, 2025 (GLOBE NEWSWIRE) — IN8bio, Inc. (“IN8Bio” or the “Company”) (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative γδ T cell therapies for cancer and autoimmune diseases, today announced that it has entered into a definitive securities purchase agreement (“SPA”) with certain institutional and accredited investors for up to approximately $40.2 million in gross proceeds through a private placement, priced at-the-market under Nasdaq rules. The net proceeds from the initial tranche of the financing are expected to fund the Company’s current operating plans into the first half of 2027.

The private placement includes new and existing investors including Coastlands Capital, Stonepine Capital Management and 683 Capital Partners, LP along with directors and officers of the Company.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the private placement.

Under the terms of the SPA, the private placement includes an initial closing of approximately $20.1 million in gross proceeds. At the initial closing, the Company will sell 5,127,029 shares of common stock at a purchase price of $1.38 per share and, in lieu of common stock, pre-funded warrants to purchase up to 9,452,677 shares of common stock, at a purchase price $1.3799 for each pre-funded warrant. The pre-funded warrants will have an exercise price of $0.0001 per share and will be immediately exercisable. The Company will be eligible to receive up to an additional approximately $20.1 million in gross proceeds in exchange for up to 14,579,706 shares of common stock (or, for certain investors, pre-funded warrants in lieu of common stock), subject to achieving certain milestone-driven conditions related to preclinical data for the Company’s CD-19 targeting INB-619 product candidate and share price.

IN8bio intends to use the net proceeds from the private placement to fund the IND enabling studies of INB-619, for use in oncology and autoimmune diseases. The Company expects to generate early animal model data for initial discussions with the U.S. Food and Drug Administration (“FDA”) in 2026 with pivotal animal model data and potential IND submission in 2027. The Company also intends to use a portion of the net proceeds to fund the submission of data from the INB-200 and INB-400 Phase 1 and Phase 2 clinical programs in newly diagnosed glioblastoma to the FDA. Funds will be used to seek FDA feedback and guidance on any potential registrational pathway, as well as for working capital and general corporate purposes.

The initial closing of the private placement is expected to occur on or about December 22, 2025, subject to satisfaction of customary closing conditions.

The offer and sale of the foregoing securities is being made in a private placement pursuant to an exemption under the Securities Act of 1933, as amended (the “Securities Act”), and the securities have not been registered under the Securities Act or applicable state securities laws. The securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws. Concurrently with the execution of the securities purchase agreement, the Company and the investors entered into a registration rights agreement pursuant to which the Company has agreed to file a registration statement with the Securities and Exchange Commission (the “SEC”) registering the resale of the shares of common stock and shares of common stock issuable upon the exercise of the warrants following the closing of each tranche.

This press release shall not constitute an offer to sell or a 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 the registration or qualification under the securities laws of any such state or other jurisdiction.

About IN8bio

IN8bio is a clinical-stage biopharmaceutical company developing γδ T cell product candidates for unmet medical needs. γδ T cells are a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue. The Company’s lead program, INB-100, is focused on acute myeloid leukemia, evaluating haplo-matched allogeneic γδ T cells given to patients following a hematopoietic stem cell transplant. The Company is also evaluating autologous DeltEx DRI γδ T cells, in combination with standard of care, for glioblastoma in its INB-200 and 400 programs, and INB-600, advancing novel γδ T cell engagers for potential oncology and autoimmune indications.

Forward Looking Statements

This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. 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 press release include, but are not limited to, statements regarding the timing and completion of the private placement, including the milestone-driven closing, the use of the net proceeds from the private placement, IN8bio’s ability to achieve anticipated milestones, including the presentation of preclinical data for INB-619, the timing of IN8bio’s interactions with the FDA and IN8bio’s cash runway. IN8bio may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: the uncertainties related to market and other conditions and the completion of the public offering; risks to patient enrollment and follow-up, as well as IN8bio’s ability to meet anticipated deadlines and milestones; and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements. These and other factors are described in greater detail in the section entitled “Risk Factors” in IN8bio’s most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC, as well as in other filings IN8bio may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and IN8bio expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

Investors and Corporate Contact:

IN8bio, Inc.
Patrick McCall
646.933.5603
pfmccall@IN8bio.com

Media Contact
Kimberly Ha
KKH Advisors
917.291.5744
kimberly.ha@kkhadvisors.com

IN8bio Announces Pricing of Private Placement of up to $40.2 Million to Advance Novel Gamma-Delta T Cell Engager




IN8bio Announces Pricing of Private Placement of up to $40.2 Million to Advance Novel Gamma-Delta T Cell Engager

$20.1 million upfront with a milestone-driven additional $20.1 million to advance INB-619, IN8bio’s novel gamma-delta (“γδ”) T cell engager through an Investigational New Drug (“IND”) application

Financing led by Coastlands Capital with participation from new and existing biotechnology investors

Initial proceeds extend cash runway into the first half of 2027

NEW YORK, Dec. 19, 2025 (GLOBE NEWSWIRE) — IN8bio, Inc. (“IN8Bio” or the “Company”) (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative γδ T cell therapies for cancer and autoimmune diseases, today announced that it has entered into a definitive securities purchase agreement (“SPA”) with certain institutional and accredited investors for up to approximately $40.2 million in gross proceeds through a private placement, priced at-the-market under Nasdaq rules. The net proceeds from the initial tranche of the financing are expected to fund the Company’s current operating plans into the first half of 2027.

The private placement includes new and existing investors including Coastlands Capital, Stonepine Capital Management and 683 Capital Partners, LP along with directors and officers of the Company.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the private placement.

Under the terms of the SPA, the private placement includes an initial closing of approximately $20.1 million in gross proceeds. At the initial closing, the Company will sell 5,127,029 shares of common stock at a purchase price of $1.38 per share and, in lieu of common stock, pre-funded warrants to purchase up to 9,452,677 shares of common stock, at a purchase price $1.3799 for each pre-funded warrant. The pre-funded warrants will have an exercise price of $0.0001 per share and will be immediately exercisable. The Company will be eligible to receive up to an additional approximately $20.1 million in gross proceeds in exchange for up to 14,579,706 shares of common stock (or, for certain investors, pre-funded warrants in lieu of common stock), subject to achieving certain milestone-driven conditions related to preclinical data for the Company’s CD-19 targeting INB-619 product candidate and share price.

IN8bio intends to use the net proceeds from the private placement to fund the IND enabling studies of INB-619, for use in oncology and autoimmune diseases. The Company expects to generate early animal model data for initial discussions with the U.S. Food and Drug Administration (“FDA”) in 2026 with pivotal animal model data and potential IND submission in 2027. The Company also intends to use a portion of the net proceeds to fund the submission of data from the INB-200 and INB-400 Phase 1 and Phase 2 clinical programs in newly diagnosed glioblastoma to the FDA. Funds will be used to seek FDA feedback and guidance on any potential registrational pathway, as well as for working capital and general corporate purposes.

The initial closing of the private placement is expected to occur on or about December 22, 2025, subject to satisfaction of customary closing conditions.

The offer and sale of the foregoing securities is being made in a private placement pursuant to an exemption under the Securities Act of 1933, as amended (the “Securities Act”), and the securities have not been registered under the Securities Act or applicable state securities laws. The securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws. Concurrently with the execution of the securities purchase agreement, the Company and the investors entered into a registration rights agreement pursuant to which the Company has agreed to file a registration statement with the Securities and Exchange Commission (the “SEC”) registering the resale of the shares of common stock and shares of common stock issuable upon the exercise of the warrants following the closing of each tranche.

This press release shall not constitute an offer to sell or a 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 the registration or qualification under the securities laws of any such state or other jurisdiction.

About IN8bio

IN8bio is a clinical-stage biopharmaceutical company developing γδ T cell product candidates for unmet medical needs. γδ T cells are a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue. The Company’s lead program, INB-100, is focused on acute myeloid leukemia, evaluating haplo-matched allogeneic γδ T cells given to patients following a hematopoietic stem cell transplant. The Company is also evaluating autologous DeltEx DRI γδ T cells, in combination with standard of care, for glioblastoma in its INB-200 and 400 programs, and INB-600, advancing novel γδ T cell engagers for potential oncology and autoimmune indications.

Forward Looking Statements

This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. 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 press release include, but are not limited to, statements regarding the timing and completion of the private placement, including the milestone-driven closing, the use of the net proceeds from the private placement, IN8bio’s ability to achieve anticipated milestones, including the presentation of preclinical data for INB-619, the timing of IN8bio’s interactions with the FDA and IN8bio’s cash runway. IN8bio may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: the uncertainties related to market and other conditions and the completion of the public offering; risks to patient enrollment and follow-up, as well as IN8bio’s ability to meet anticipated deadlines and milestones; and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements. These and other factors are described in greater detail in the section entitled “Risk Factors” in IN8bio’s most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC, as well as in other filings IN8bio may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and IN8bio expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

Investors and Corporate Contact:

IN8bio, Inc.
Patrick McCall
646.933.5603
pfmccall@IN8bio.com

Media Contact
Kimberly Ha
KKH Advisors
917.291.5744
kimberly.ha@kkhadvisors.com

NeurAxis Achieves Medical Coverage Policy Milestone, Expanding Access to Approximately 45 million additional Covered Lives




NeurAxis Achieves Medical Coverage Policy Milestone, Expanding Access to Approximately 45 million additional Covered Lives

Total national coverage footprint for PENFS increases to roughly 100 million covered lives

CARMEL, Ind., Dec. 19, 2025 (GLOBE NEWSWIRE) — NeurAxis, Inc. (“NeurAxis” or the “Company”) (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies for chronic and debilitating conditions in children and adults, today announced significant new medical policy coverage from a major national health insurer for Percutaneous Electrical Nerve Field Stimulation (“PENFS”). The coverage spans multiple states and represents approximately 45 million health plan members.

NeurAxis’ proprietary PENFS technology, IB-Stim, is FDA-cleared for the treatment of functional abdominal pain associated with irritable bowel syndrome (IBS) and Functional Dyspepsia (FD) including associated nausea symptoms in patients 8 years and older. IB-Stim is a non-invasive neuromodulation device that gently stimulates cranial nerve bundles in the ear to help regulate pain signaling between the gut and the brain. Currently, no FDA-approved drug therapies exist for pediatric patients with abdominal pain related to functional dyspepsia, a significant unmet medical need. In the absence of approved options, off-label prescription drugs are often used, despite limited efficacy data and potential safety concerns—underscoring IB-Stim’s unique position as the only FDA-cleared therapy specifically designed for this large and underserved pain related patient population.

“We are extremely pleased to see medical policy coverage for PENFS from one of the nation’s leading health insurers, and we are working aggressively to secure additional large national insurers,” said Brian Carrico, Chief Executive Officer of NeurAxis. “This milestone demonstrates the growing clinical and payer recognition of IB-Stim as a necessary, evidence-based therapy for pediatric gastrointestinal disorders. With a Category I CPT code taking effect January 1, 2026, and our proprietary PENFS technology incorporated into leading national society clinical practice guidelines, NeurAxis is well positioned for significant revenue growth and margin expansion. Supported by a strengthened balance sheet, the Company is prepared to capitalize on the accelerating demand ahead.”

About NeurAxis, Inc.
NeurAxis, Inc., is a medical technology company focused on neuromodulation therapies to address chronic and debilitating conditions in children and adults. NeurAxis is dedicated to advancing science and leveraging evidence-based medicine to drive adoption of its IB-Stim™ therapy, which is its proprietary Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, by the medical, scientific, and patient communities. IB-Stim™ is FDA cleared for functional abdominal pain associated with irritable bowel syndrome (IBS) and functional dyspepsia in patients 8 years and older. Additional clinical trials of PENFS in multiple pediatric and adult conditions with large unmet healthcare needs are underway.

For more information, please visit http://neuraxis.com.

For contraindications, precautions, warnings, and IFU, please see: https://ibstim.com/important-information/.

Forward-Looking Statements

Certain statements in this press release are 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. All statements other than statements of historical fact are forward-looking statements. Forward-looking statements are based on management’s current assumptions and expectations of future events and trends, which affect or may affect the Company’s business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. There are a number of important factors that could cause actual results, developments, business decisions or other events to differ materially from those contemplated by the forward-looking statements in this press release. These factors include, among other things, the conditions in the U.S. and global economy, the trading price and volatility of the Company’s stock, public health issues or other events, the Company’s compliance with applicable laws, the results of the Company’s clinical trials and perceptions thereof, the results of submissions to the FDA, and factors described in the Risk Factors section of NeurAxis’s public filings with the Securities and Exchange Commission (SEC). Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date of this press release and, except to the extent required by applicable law, the Company undertakes no obligation to update or revise these statements, whether as a result of any new information, future events and developments or otherwise.

Contacts:

Company
NeurAxis, Inc.
info@neuraxis.com
For contraindications, precautions, warnings, and IFU, please see: https://ibstim.com/important-information/.

Investor Relations
Lytham Partners
Ben Shamsian
646-829-9701
shamsian@lythampartners.com

NeurAxis Achieves Medical Coverage Policy Milestone, Expanding Access to Approximately 45 million additional Covered Lives




NeurAxis Achieves Medical Coverage Policy Milestone, Expanding Access to Approximately 45 million additional Covered Lives

Total national coverage footprint for PENFS increases to roughly 100 million covered lives

CARMEL, Ind., Dec. 19, 2025 (GLOBE NEWSWIRE) — NeurAxis, Inc. (“NeurAxis” or the “Company”) (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies for chronic and debilitating conditions in children and adults, today announced significant new medical policy coverage from a major national health insurer for Percutaneous Electrical Nerve Field Stimulation (“PENFS”). The coverage spans multiple states and represents approximately 45 million health plan members.

NeurAxis’ proprietary PENFS technology, IB-Stim, is FDA-cleared for the treatment of functional abdominal pain associated with irritable bowel syndrome (IBS) and Functional Dyspepsia (FD) including associated nausea symptoms in patients 8 years and older. IB-Stim is a non-invasive neuromodulation device that gently stimulates cranial nerve bundles in the ear to help regulate pain signaling between the gut and the brain. Currently, no FDA-approved drug therapies exist for pediatric patients with abdominal pain related to functional dyspepsia, a significant unmet medical need. In the absence of approved options, off-label prescription drugs are often used, despite limited efficacy data and potential safety concerns—underscoring IB-Stim’s unique position as the only FDA-cleared therapy specifically designed for this large and underserved pain related patient population.

“We are extremely pleased to see medical policy coverage for PENFS from one of the nation’s leading health insurers, and we are working aggressively to secure additional large national insurers,” said Brian Carrico, Chief Executive Officer of NeurAxis. “This milestone demonstrates the growing clinical and payer recognition of IB-Stim as a necessary, evidence-based therapy for pediatric gastrointestinal disorders. With a Category I CPT code taking effect January 1, 2026, and our proprietary PENFS technology incorporated into leading national society clinical practice guidelines, NeurAxis is well positioned for significant revenue growth and margin expansion. Supported by a strengthened balance sheet, the Company is prepared to capitalize on the accelerating demand ahead.”

About NeurAxis, Inc.
NeurAxis, Inc., is a medical technology company focused on neuromodulation therapies to address chronic and debilitating conditions in children and adults. NeurAxis is dedicated to advancing science and leveraging evidence-based medicine to drive adoption of its IB-Stim™ therapy, which is its proprietary Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, by the medical, scientific, and patient communities. IB-Stim™ is FDA cleared for functional abdominal pain associated with irritable bowel syndrome (IBS) and functional dyspepsia in patients 8 years and older. Additional clinical trials of PENFS in multiple pediatric and adult conditions with large unmet healthcare needs are underway.

For more information, please visit http://neuraxis.com.

For contraindications, precautions, warnings, and IFU, please see: https://ibstim.com/important-information/.

Forward-Looking Statements

Certain statements in this press release are 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. All statements other than statements of historical fact are forward-looking statements. Forward-looking statements are based on management’s current assumptions and expectations of future events and trends, which affect or may affect the Company’s business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. There are a number of important factors that could cause actual results, developments, business decisions or other events to differ materially from those contemplated by the forward-looking statements in this press release. These factors include, among other things, the conditions in the U.S. and global economy, the trading price and volatility of the Company’s stock, public health issues or other events, the Company’s compliance with applicable laws, the results of the Company’s clinical trials and perceptions thereof, the results of submissions to the FDA, and factors described in the Risk Factors section of NeurAxis’s public filings with the Securities and Exchange Commission (SEC). Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date of this press release and, except to the extent required by applicable law, the Company undertakes no obligation to update or revise these statements, whether as a result of any new information, future events and developments or otherwise.

Contacts:

Company
NeurAxis, Inc.
info@neuraxis.com
For contraindications, precautions, warnings, and IFU, please see: https://ibstim.com/important-information/.

Investor Relations
Lytham Partners
Ben Shamsian
646-829-9701
shamsian@lythampartners.com

Alvotech and Teva Secure U.S. Settlement Date for AVT06, a Proposed Biosimilar to Eylea®




Alvotech and Teva Secure U.S. Settlement Date for AVT06, a Proposed Biosimilar to Eylea®

• According to the settlement agreement, the proposed biosimilar to Eylea^® (aflibercept) can be marketed in the U.S., if approved by the FDA, in the fourth quarter of 2026, or earlier under certain circumstances

REYKJAVIK, Iceland and TEL AVIV, Israel, Dec. 19, 2025 (GLOBE NEWSWIRE) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that they have reached a settlement and license agreement with Regeneron Pharmaceuticals Inc. concerning the launch of AVT06, Alvotech’s proposed biosimilar to Eylea^® (aflibercept) in the United States. The settlement grants a license entry date for AVT06 in the United States in the fourth quarter of 2026, or earlier under certain circumstances.

“Following recent marketing approvals in both Japan and Europe, we are delighted to secure a U.S. settlement date for our biosimilar candidate to Eylea^®, an important biologic for the treatment of retinal diseases. This positions Alvotech and our commercial partner Teva very well for a successful launch in the U.S. market next year, pending FDA approval,” said Robert Wessman, Chairman and CEO of Alvotech.

AVT06 has been approved for marketing as an aflibercept biosimilar in the United Kingdom, Japan and the 30 countries of the European Economic Area, which includes all 27 member states of the European Union in addition to Norway, Iceland and Liechtenstein.

In January 2024, Alvotech announced positive top-line results from a confirmatory clinical study comparing the efficacy, safety, and immunogenicity of AVT06 to Eylea^® (aflibercept) in patients with neovascular (wet) AMD. The study met its primary endpoint, with results demonstrating high similarity between Alvotech’s biosimilar candidate and Eylea^® [1].

About AVT06
AVT06 is a proposed biosimilar to Eylea^® (aflibercept). Aflibercept binds vascular endothelial growth factors (VEGF), inhibiting the binding and activation of VEGF receptors, neovascularization, and vascular permeability [2]. AVT06 has been approved under the brand name Mynzepli^® (aflibercept) for marketing in the European Economic Area and under the name AFLIBERCEPT BS for marketing in Japan.

Sources
[1] Agostini, H. et.al. (2025). A randomized, double-masked parallel-group, multicenter clinical study evaluating the efficacy and safety of the biosimilar candidate AVT06 compared to the reference product aflibercept in participants with neovascular age-related macular degeneration. Expert Opinion on Biological Therapy, 1–15. https://doi.org/10.1080/14712598.2025.2519531

[2] Eylea^® product label, accessed on December 18, 2025, https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125387s087lbl.pdf

Use of trademarks
Eylea^® is a registered trademark of Regeneron Pharmaceuticals Inc.

About Alvotech
Alvotech is a biotechnolgy company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech’s current pipeline includes eight disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disease, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. For more information, please visit www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.

About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.

Forward-Looking Statements (Alvotech)
Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed.

Cautionary Note Regarding Forward-Looking Statements (Teva)
This Press Release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to commercialize the biosimilar product candidate to Eylea^® (aflibercept) under the strategic partnership with Alvotech, once regulatory approval is obtained; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to sustain and focus our portfolio of generic medicines; and other factors discussed in our Quarterly Report on Form 10-Q for the third quarter of 2025, and in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the sections captioned “Risk Factors” and “Forward-looking statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

CONTACTS
Alvotech Global Communications
Benedikt Stefansson
Sarah Macleod
alvotech.media@alvotech.com

Alvotech Investor Relations
Balaji Prasad (US)
Benedikt Stefansson (IS)
Patrik Ling (SE)
alvotech.ir@alvotech.com

Teva Media Inquiries:

TevaCommunicationsNorthAmerica@tevapharm.com

Teva Investor Relations Inquiries:

TevaIR@Tevapharm.com

Alvotech and Teva Secure U.S. Settlement Date for AVT06, a Proposed Biosimilar to Eylea®




Alvotech and Teva Secure U.S. Settlement Date for AVT06, a Proposed Biosimilar to Eylea®

According to the settlement agreement, the proposed biosimilar to Eylea® (aflibercept) can be marketed in the U.S., if approved by the FDA, in the fourth quarter of 2026, or earlier under certain circumstances

REYKJAVIK, Iceland and TEL AVIV, Israel and PARSIPPANY, N.J., Dec. 19, 2025 (GLOBE NEWSWIRE) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that they have reached a settlement and license agreement with Regeneron Pharmaceuticals Inc. concerning the launch of AVT06, Alvotech’s proposed biosimilar to Eylea^® (aflibercept) in the United States. The settlement grants a license entry date for AVT06 in the United States in the fourth quarter of 2026, or earlier under certain circumstances.

“Following recent marketing approvals in both Europe and Japan, we are delighted to secure a U.S. settlement date for our biosimilar candidate to Eylea^®, an important biologic for the treatment of retinal diseases. This positions Alvotech and our commercial partner Teva very well for a successful launch in the U.S. market next year, pending FDA approval,” said Robert Wessman, Chairman and CEO of Alvotech.

AVT06 has been approved for marketing as an aflibercept biosimilar in the United Kingdom, Japan and the 30 countries of the European Economic Area, which includes all 27 member states of the European Union in addition to Norway, Iceland and Liechtenstein.

In January 2024, Alvotech announced positive top-line results from a confirmatory clinical study comparing the efficacy, safety, and immunogenicity of AVT06 to Eylea^® (aflibercept) in patients with neovascular (wet) AMD. The study met its primary endpoint, with results demonstrating high similarity between Alvotech’s biosimilar candidate and Eylea^® [1].

CONTACTS

Alvotech Media
Benedikt Stefansson
Sarah Macleod
alvotech.media@alvotech.com

Alvotech Investors
Balaji Prasad (US)
Benedikt Stefansson (IS)
Patrik Ling (SE)
alvotech.ir@alvotech.com

Teva Media Inquiries:
TevaCommunicationsNorthAmerica@tevapharm.com

Teva Investor Relations Inquiries:
TevaIR@Tevapharm.com

About AVT06
AVT06 is a proposed biosimilar to Eylea^® (aflibercept). Aflibercept binds vascular endothelial growth factors (VEGF), inhibiting the binding and activation of VEGF receptors, neovascularization, and vascular permeability [2]. AVT06 has been approved under the brand name Mynzepli^® (aflibercept) for marketing in the United Kingdom and European Economic Area and under the name AFLIBERCEPT BS for marketing in Japan.

Sources
[1] Agostini, H. et.al. (2025). A randomized, double-masked parallel-group, multicenter clinical study evaluating the efficacy and safety of the biosimilar candidate AVT06 compared to the reference product aflibercept in participants with neovascular age-related macular degeneration. Expert Opinion on Biological Therapy, 1–15. https://doi.org/10.1080/14712598.2025.2519531

[2] Eylea^® product label, accessed on December 18, 2025, https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125387s087lbl.pdf

Use of trademarks
Eylea^® is a registered trademark of Regeneron Pharmaceuticals Inc.

About Alvotech
Alvotech is a biotechnology company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech’s current pipeline includes eight disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disease, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. For more information, please visit www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.

About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.

Forward-Looking Statements (Alvotech)
Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed.

Cautionary Note Regarding Forward-Looking Statements (Teva)
This Press Release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to commercialize the biosimilar product candidate to Eylea^® (aflibercept) under the strategic partnership with Alvotech, once regulatory approval is obtained; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to sustain and focus our portfolio of generic medicines; and other factors discussed in our Quarterly Report on Form 10-Q for the third quarter of 2025, and in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the sections captioned “Risk Factors” and “Forward-looking statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

Alvotech and Teva Secure U.S. Settlement Date for AVT06, a Proposed Biosimilar to Eylea®




Alvotech and Teva Secure U.S. Settlement Date for AVT06, a Proposed Biosimilar to Eylea®

• According to the settlement agreement, the proposed biosimilar to Eylea® (aflibercept) can be marketed in the U.S., if approved by the FDA, in the fourth quarter of 2026, or earlier under certain circumstances 

REYKJAVIK, ICELAND & TEL AVIV, ISRAEL & PARSIPPANY, NJ (December 19, 2025) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that they have reached a settlement and license agreement with Regeneron Pharmaceuticals Inc. concerning the launch of AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept) in the United States. The settlement grants a license entry date for AVT06 in the United States in the fourth quarter of 2026, or earlier under certain circumstances. 

“Following recent marketing approvals in both Europe and Japan, we are delighted to secure a U.S. settlement date for our biosimilar candidate to Eylea®, an important biologic for the treatment of retinal diseases. This positions Alvotech and our commercial partner Teva very well for a successful launch in the U.S. market next year, pending FDA approval,” said Robert Wessman, Chairman and CEO of Alvotech. 

AVT06 has been approved for marketing as an aflibercept biosimilar in the United Kingdom, Japan and the 30 countries of the European Economic Area, which includes all 27 member states of the European Union in addition to Norway, Iceland and Liechtenstein.  

In January 2024, Alvotech announced positive top-line results from a confirmatory clinical study comparing the efficacy, safety, and immunogenicity of AVT06 to Eylea® (aflibercept) in patients with neovascular (wet) AMD. The study met its primary endpoint, with results demonstrating high similarity between Alvotech’s biosimilar candidate and Eylea® [1].  

CONTACTS 

Alvotech Media 

Benedikt Stefansson 

Sarah Macleod 

alvotech.media@alvotech.com 

Alvotech Investors 

Balaji Prasad (US) 

Benedikt Stefansson (IS) 

Patrik Ling (SE) 

alvotech.ir@alvotech.com 

Teva Media Inquiries: 

TevaCommunicationsNorthAmerica@tevapharm.com 

Teva Investor Relations Inquiries: 

TevaIR@Tevapharm.com 

About AVT06 

AVT06 is a proposed biosimilar to Eylea® (aflibercept). Aflibercept binds vascular endothelial growth factors (VEGF), inhibiting the binding and activation of VEGF receptors, neovascularization, and vascular permeability [2]. AVT06 has been approved under the brand name Mynzepli® (aflibercept) for marketing in the United Kingdom and European Economic Area and under the name AFLIBERCEPT BS for marketing in Japan.  

Sources 

[1] Agostini, H. et.al. (2025). A randomized, double-masked parallel-group, multicenter clinical study evaluating the efficacy and safety of the biosimilar candidate AVT06 compared to the reference product aflibercept in participants with neovascular age-related macular degeneration. Expert Opinion on Biological Therapy, 1–15. https://doi.org/10.1080/14712598.2025.2519531 

[2] Eylea® product label, accessed on December 18, 2025, https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125387s087lbl.pdf 

Use of trademarks 

Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.  

About Alvotech 

Alvotech is a biotechnology company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech’s current pipeline includes eight disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disease, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. For more information, please visit www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.  

About Teva 

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com. 

Forward–Looking Statements (Alvotech) 

Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed. 

Cautionary Note Regarding Forward-Looking Statements (Teva) 

This Press Release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that  

could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to commercialize the biosimilar product candidate to Eylea® (aflibercept) under the strategic partnership with Alvotech, once regulatory approval is obtained; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to sustain and focus our portfolio of generic medicines; and other factors discussed in our Quarterly Report on Form 10-Q for the third quarter of 2025, and in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the sections captioned “Risk Factors” and “Forward-looking statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.