Tevogen CEO Donates Personal Shares to Support Local Fire Department




Tevogen CEO Donates Personal Shares to Support Local Fire Department

WARREN, N.J., Dec. 19, 2025 (GLOBE NEWSWIRE) — Tevogen (“Tevogen Bio Holdings Inc.” or “Company”) (Nasdaq: TVGN), today announced that its Founder and CEO, Dr. Ryan Saadi has donated 50,000 shares of his personal holdings of Tevogen common stock to the Mt. Bethel Fire Company, supporting the organization’s mission to protect the Warren Township community. The donations reflect Dr. Saadi’s continued commitment to supporting first responders and the Warren Township community.

“On behalf of the Mt. Bethel Fire Company, we’re sincerely grateful to Dr. Saadi for this generous donation. This support will help strengthen our readiness and enhance the equipment and resources our members rely on to serve the Warren Township community safely and effectively,” commented Assistant Chief, Derek Reedman, Mt. Bethel Fire Company.

“I’m pleased to be able to directly support the Warren Township community and the first responders who serve it every day. Building Tevogen here has always been intentional, not only to advance important science, but to create meaningful jobs and long-term economic impact locally,” added Ryan Saadi, Founder and CEO, Tevogen. “What began as a concept has evolved into a company with an estimated $10 billion asset valuation and a secured cash runway through commercialization. More importantly, it is a platform with the potential to deliver solutions for diseases that remain largely untreatable today. Supporting the community where this work is being built is both a responsibility and a privilege.”

The contributed shares are intended to support Mt. Bethel Fire Company initiatives that enhance safety, readiness, and emergency response capabilities. The donation was conducted in accordance with SEC Rule 144 and Dr. Saadi will not receive any proceeds from the disposal of the securities.

About Tevogen

Tevogen is a next-generation, socially integrated healthcare enterprise built on the principles of affordability, efficiency, and scientific rigor. The company leverages industry-leading artificial intelligence and precision T cell therapy platforms, a patient-first and cost-disciplined operating model, and strategic engagements with global technology leaders to support the development of advanced, life-saving therapies across multiple therapeutic areas and scalable solutions for the broader healthcare system.

Tevogen Bio, the company’s lead initiative, has completed a proof-of-concept clinical trial demonstrating the potential of its single-HLA–restricted, genetically unmodified allogeneic T cells. The Tevogen Bio pipeline spans virology, oncology, and neurology, with programs built on the company’s proprietary ExacTcell™ platform.

Tevogen.AI is designed to transform drug development by accelerating target detection, helping reduce failure rates, and supporting optimized clinical trial design through proprietary predictive technologies. The platform utilizes cloud and data services from leading technology providers, including Microsoft and Databricks, to advance its long-term ambition to predict the proteome for any given protein–HLA combination, enabling rapid and cost-efficient therapeutic discovery.

Tevogen is exploring future strategic initiatives that may include domestic generics, biosimilars, medical devices, and innovative insurance solutions for healthcare providers. Together, these programs reflect Tevogen’s mission to advance sustainable innovation and broaden patient access through a faster, more efficient, and more equitable healthcare model.

Forward Looking Statements

This press release contains certain forward-looking statements, including without limitation statements relating to: Tevogen’s plans for its research and manufacturing capabilities; expectations regarding future growth; expectations regarding the healthcare and biopharmaceutical industries; and Tevogen’s development of, the potential benefits of, and patient access to its product candidates for the treatment of infectious diseases and cancer. Forward-looking statements can sometimes be identified by words such as “may,” “could,” “would,” “expect,” “anticipate,” “possible,” “potential,” “goal,” “opportunity,” “project,” “believe,” “future,” and similar words and expressions or their opposites. These statements are based on management’s expectations, assumptions, estimates, projections and beliefs as of the date of this press release and are subject to a number of factors that involve known and unknown risks, delays, uncertainties and other factors not under the company’s control that may cause actual results, performance or achievements of the company to be materially different from the results, performance or other expectations expressed or implied by these forward-looking statements.

Factors that could cause actual results, performance, or achievements to differ from those expressed or implied by forward-looking statements include, but are not limited to: changes in the markets in which Tevogen competes, including with respect to its competitive landscape, technology evolution, or regulatory changes; changes in domestic and global general economic conditions; the risk that Tevogen may not be able to execute its growth strategies or may experience difficulties in managing its growth and expanding operations; the risk that Tevogen may not be able to develop and maintain effective internal controls; the failure to achieve Tevogen’s commercialization and development plans and identify and realize additional opportunities, which may be affected by, among other things, competition, the ability of Tevogen to grow and manage growth economically and hire and retain key employees; the risk that Tevogen may fail to keep pace with rapid technological developments to provide new and innovative products and services or make substantial investments in unsuccessful new products and services; that Tevogen will need to raise additional capital to fully realize its business plans; risks related to the ability to develop, license or acquire new therapeutics; the risk of regulatory lawsuits or proceedings relating to Tevogen’s business; uncertainties inherent in the execution, cost, and completion of preclinical studies and clinical trials; risks related to regulatory review, approval and commercial development; risks associated with intellectual property protection; Tevogen’s limited operating history; and those factors discussed or incorporated by reference in Tevogen’s Annual Report on Form 10-K and subsequent filings with the SEC.

You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Tevogen undertakes no obligation to update any forward-looking statements, except as required by applicable law.

Contacts

Tevogen Bio Communications
T: 1 877 TEVOGEN, Ext 701
Communications@Tevogen.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/3a118701-a82b-4462-a7d1-4b20bf0854b7

Tevogen CEO Donates Personal Shares to Support Local Fire Department




Tevogen CEO Donates Personal Shares to Support Local Fire Department

WARREN, N.J., Dec. 19, 2025 (GLOBE NEWSWIRE) — Tevogen (“Tevogen Bio Holdings Inc.” or “Company”) (Nasdaq: TVGN), today announced that its Founder and CEO, Dr. Ryan Saadi has donated 50,000 shares of his personal holdings of Tevogen common stock to the Mt. Bethel Fire Company, supporting the organization’s mission to protect the Warren Township community. The donations reflect Dr. Saadi’s continued commitment to supporting first responders and the Warren Township community.

“On behalf of the Mt. Bethel Fire Company, we’re sincerely grateful to Dr. Saadi for this generous donation. This support will help strengthen our readiness and enhance the equipment and resources our members rely on to serve the Warren Township community safely and effectively,” commented Assistant Chief, Derek Reedman, Mt. Bethel Fire Company.

“I’m pleased to be able to directly support the Warren Township community and the first responders who serve it every day. Building Tevogen here has always been intentional, not only to advance important science, but to create meaningful jobs and long-term economic impact locally,” added Ryan Saadi, Founder and CEO, Tevogen. “What began as a concept has evolved into a company with an estimated $10 billion asset valuation and a secured cash runway through commercialization. More importantly, it is a platform with the potential to deliver solutions for diseases that remain largely untreatable today. Supporting the community where this work is being built is both a responsibility and a privilege.”

The contributed shares are intended to support Mt. Bethel Fire Company initiatives that enhance safety, readiness, and emergency response capabilities. The donation was conducted in accordance with SEC Rule 144 and Dr. Saadi will not receive any proceeds from the disposal of the securities.

About Tevogen

Tevogen is a next-generation, socially integrated healthcare enterprise built on the principles of affordability, efficiency, and scientific rigor. The company leverages industry-leading artificial intelligence and precision T cell therapy platforms, a patient-first and cost-disciplined operating model, and strategic engagements with global technology leaders to support the development of advanced, life-saving therapies across multiple therapeutic areas and scalable solutions for the broader healthcare system.

Tevogen Bio, the company’s lead initiative, has completed a proof-of-concept clinical trial demonstrating the potential of its single-HLA–restricted, genetically unmodified allogeneic T cells. The Tevogen Bio pipeline spans virology, oncology, and neurology, with programs built on the company’s proprietary ExacTcell™ platform.

Tevogen.AI is designed to transform drug development by accelerating target detection, helping reduce failure rates, and supporting optimized clinical trial design through proprietary predictive technologies. The platform utilizes cloud and data services from leading technology providers, including Microsoft and Databricks, to advance its long-term ambition to predict the proteome for any given protein–HLA combination, enabling rapid and cost-efficient therapeutic discovery.

Tevogen is exploring future strategic initiatives that may include domestic generics, biosimilars, medical devices, and innovative insurance solutions for healthcare providers. Together, these programs reflect Tevogen’s mission to advance sustainable innovation and broaden patient access through a faster, more efficient, and more equitable healthcare model.

Forward Looking Statements

This press release contains certain forward-looking statements, including without limitation statements relating to: Tevogen’s plans for its research and manufacturing capabilities; expectations regarding future growth; expectations regarding the healthcare and biopharmaceutical industries; and Tevogen’s development of, the potential benefits of, and patient access to its product candidates for the treatment of infectious diseases and cancer. Forward-looking statements can sometimes be identified by words such as “may,” “could,” “would,” “expect,” “anticipate,” “possible,” “potential,” “goal,” “opportunity,” “project,” “believe,” “future,” and similar words and expressions or their opposites. These statements are based on management’s expectations, assumptions, estimates, projections and beliefs as of the date of this press release and are subject to a number of factors that involve known and unknown risks, delays, uncertainties and other factors not under the company’s control that may cause actual results, performance or achievements of the company to be materially different from the results, performance or other expectations expressed or implied by these forward-looking statements.

Factors that could cause actual results, performance, or achievements to differ from those expressed or implied by forward-looking statements include, but are not limited to: changes in the markets in which Tevogen competes, including with respect to its competitive landscape, technology evolution, or regulatory changes; changes in domestic and global general economic conditions; the risk that Tevogen may not be able to execute its growth strategies or may experience difficulties in managing its growth and expanding operations; the risk that Tevogen may not be able to develop and maintain effective internal controls; the failure to achieve Tevogen’s commercialization and development plans and identify and realize additional opportunities, which may be affected by, among other things, competition, the ability of Tevogen to grow and manage growth economically and hire and retain key employees; the risk that Tevogen may fail to keep pace with rapid technological developments to provide new and innovative products and services or make substantial investments in unsuccessful new products and services; that Tevogen will need to raise additional capital to fully realize its business plans; risks related to the ability to develop, license or acquire new therapeutics; the risk of regulatory lawsuits or proceedings relating to Tevogen’s business; uncertainties inherent in the execution, cost, and completion of preclinical studies and clinical trials; risks related to regulatory review, approval and commercial development; risks associated with intellectual property protection; Tevogen’s limited operating history; and those factors discussed or incorporated by reference in Tevogen’s Annual Report on Form 10-K and subsequent filings with the SEC.

You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Tevogen undertakes no obligation to update any forward-looking statements, except as required by applicable law.

Contacts

Tevogen Bio Communications
T: 1 877 TEVOGEN, Ext 701
Communications@Tevogen.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/3a118701-a82b-4462-a7d1-4b20bf0854b7

Tiziana Life Sciences Announces Acquisition of Shares by Executive Chairman




Tiziana Life Sciences Announces Acquisition of Shares by Executive Chairman

BOSTON, Dec. 19, 2025 (GLOBE NEWSWIRE) — Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announces that its Executive Chairman and Founder, Mr. Gabriele Cerrone, has purchased 97,687 common shares, bringing his total holding to 43,374,830 common shares, which is 36.08% of issued share capital.

About Foralumab

Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 14 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program (NCT06802328) with either an improvement or stability of disease seen within 6 months in all patients. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (NCT06292923).

Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development. Immunomodulation by intranasal foralumab represents a novel avenue for the treatment of neuroinflammatory and neurodegenerative human diseases.^[1],[2]

About Tiziana Life Sciences

Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative intranasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb currently in clinical development, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.

For more information about Tiziana Life Sciences and its innovative pipeline of therapies, please visit www.tizianalifesciences.com.

For further inquiries:

Tiziana Life Sciences Ltd
Paul Spencer, Business Development, and Investor Relations
+44 (0) 207 495 2379
email: info@tizianalifesciences.com

___________________
[1] https://www.pnas.org/doi/10.1073/pnas.2220272120
[2] https://www.pnas.org/doi/10.1073/pnas.2309221120

Tiziana Life Sciences Announces Acquisition of Shares by Executive Chairman




Tiziana Life Sciences Announces Acquisition of Shares by Executive Chairman

BOSTON, Dec. 19, 2025 (GLOBE NEWSWIRE) — Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announces that its Executive Chairman and Founder, Mr. Gabriele Cerrone, has purchased 97,687 common shares, bringing his total holding to 43,374,830 common shares, which is 36.08% of issued share capital.

About Foralumab

Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 14 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program (NCT06802328) with either an improvement or stability of disease seen within 6 months in all patients. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (NCT06292923).

Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development. Immunomodulation by intranasal foralumab represents a novel avenue for the treatment of neuroinflammatory and neurodegenerative human diseases.^[1],[2]

About Tiziana Life Sciences

Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative intranasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb currently in clinical development, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.

For more information about Tiziana Life Sciences and its innovative pipeline of therapies, please visit www.tizianalifesciences.com.

For further inquiries:

Tiziana Life Sciences Ltd
Paul Spencer, Business Development, and Investor Relations
+44 (0) 207 495 2379
email: info@tizianalifesciences.com

___________________
[1] https://www.pnas.org/doi/10.1073/pnas.2220272120
[2] https://www.pnas.org/doi/10.1073/pnas.2309221120

OncoInv and MaxBloch Partner to Expand Early Cancer Detection Across Central America




OncoInv and MaxBloch Partner to Expand Early Cancer Detection Across Central America

OncoInv has signed a distribution partnership with MaxBloch Clinical Laboratories to introduce the OncoSeek® multi-cancer early detection blood test in El Salvador, expanding access to affordable early cancer detection.

HOUTEN, The Netherlands, Dec. 19, 2025 (GLOBE NEWSWIRE) — OncoInv, a Netherlands-based company focused on multi-cancer early detection, has signed a distribution agreement with MaxBloch Clinical Laboratories to introduce OncoSeek^®, its multi-cancer early detection blood test, in El Salvador. The agreement marks the official start of the collaboration and expands access to early cancer detection in Central America.

Through the partnership, OncoSeek^® will be made available via MaxBloch’s nationwide laboratory network, allowing healthcare providers across El Salvador to offer the test using existing laboratory infrastructure. The collaboration is designed to improve access to affordable, early multi-cancer detection in a healthcare system where early diagnosis remains uneven.

Access to early detection solutions

“This partnership is part of our ongoing mission to bridge global health inequalities,” said Jesper Verhey, Chief Commercial Officer at OncoInv. “The cancer burden is growing, but so is our ability to act. By joining forces with MaxBloch Clinical Laboratories, we bring OncoSeek^® closer to the people who need it most.”

“At MaxBloch, we believe early multi-cancer detection is one of the strongest tools to improve patient outcomes,” said Lisette Bloch, Chief Executive Officer of MaxBloch Clinical Laboratories. “Introducing OncoSeek^® in El Salvador allows us to offer a scientifically robust and accessible solution aligned with our long-standing commitment to high-quality, ethical diagnostics.”

The partnership reflects a shared commitment to reducing cancer-related health inequalities by expanding access to early detection solutions across Central America.

Detects nine high-mortality cancer types

The cancer burden in Latin America is expected to continue rising sharply. Estimates based on demographic trends project a 67% increase in new cancer cases by 2040, reaching around 2.4 million new cases annually if current rates persist.

OncoSeek^® is a low-cost, scalable blood test capable of detecting nine high-mortality cancer types from a single blood sample. The test analyses six Protein Tumour Markers, with results processed through cloud-based software applying machine learning and big data analytics. The algorithm is operated by OncoInv, a wholly owned subsidiary of the non-profit foundation Inspire2Live. It is fully GDPR compliant, and CE-marked. In low- and middle-income countries, OncoSeek^® is offered on a not-for-profit basis in the public sector, supporting global health equity.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/2891f79d-95bf-4600-b1ba-36f4f4442a2c/en

CONTACT: Contact:
Jesper Verhey
jesper.verhey@oncoinv.org

OncoInv and MaxBloch Partner to Expand Early Cancer Detection Across Central America




OncoInv and MaxBloch Partner to Expand Early Cancer Detection Across Central America

OncoInv has signed a distribution partnership with MaxBloch Clinical Laboratories to introduce the OncoSeek® multi-cancer early detection blood test in El Salvador, expanding access to affordable early cancer detection.

HOUTEN, The Netherlands, Dec. 19, 2025 (GLOBE NEWSWIRE) — OncoInv, a Netherlands-based company focused on multi-cancer early detection, has signed a distribution agreement with MaxBloch Clinical Laboratories to introduce OncoSeek^®, its multi-cancer early detection blood test, in El Salvador. The agreement marks the official start of the collaboration and expands access to early cancer detection in Central America.

Through the partnership, OncoSeek^® will be made available via MaxBloch’s nationwide laboratory network, allowing healthcare providers across El Salvador to offer the test using existing laboratory infrastructure. The collaboration is designed to improve access to affordable, early multi-cancer detection in a healthcare system where early diagnosis remains uneven.

Access to early detection solutions

“This partnership is part of our ongoing mission to bridge global health inequalities,” said Jesper Verhey, Chief Commercial Officer at OncoInv. “The cancer burden is growing, but so is our ability to act. By joining forces with MaxBloch Clinical Laboratories, we bring OncoSeek^® closer to the people who need it most.”

“At MaxBloch, we believe early multi-cancer detection is one of the strongest tools to improve patient outcomes,” said Lisette Bloch, Chief Executive Officer of MaxBloch Clinical Laboratories. “Introducing OncoSeek^® in El Salvador allows us to offer a scientifically robust and accessible solution aligned with our long-standing commitment to high-quality, ethical diagnostics.”

The partnership reflects a shared commitment to reducing cancer-related health inequalities by expanding access to early detection solutions across Central America.

Detects nine high-mortality cancer types

The cancer burden in Latin America is expected to continue rising sharply. Estimates based on demographic trends project a 67% increase in new cancer cases by 2040, reaching around 2.4 million new cases annually if current rates persist.

OncoSeek^® is a low-cost, scalable blood test capable of detecting nine high-mortality cancer types from a single blood sample. The test analyses six Protein Tumour Markers, with results processed through cloud-based software applying machine learning and big data analytics. The algorithm is operated by OncoInv, a wholly owned subsidiary of the non-profit foundation Inspire2Live. It is fully GDPR compliant, and CE-marked. In low- and middle-income countries, OncoSeek^® is offered on a not-for-profit basis in the public sector, supporting global health equity.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/2891f79d-95bf-4600-b1ba-36f4f4442a2c/en

CONTACT: Contact:
Jesper Verhey
jesper.verhey@oncoinv.org

Mangoceuticals, Inc. Announces Closing of $2.5 Million Registered Direct and Private Placements




Mangoceuticals, Inc. Announces Closing of $2.5 Million Registered Direct and Private Placements

DALLAS, TX, Dec. 19, 2025 (GLOBE NEWSWIRE) — Mangoceuticals, Inc. (NASDAQ: MGRX) (the “Company”), a company focused on developing, marketing, and selling a variety of health and wellness products via a secure telemedicine platform under the brands MangoRx and PeachesRx, today announced the closing of its previously announced registered direct offering and concurrent private placement with institutional investors. The Company issued shares of Common Stock and pre-funded warrants in a registered direct offering. In a concurrent private placement, the Company also issued to the same investors investor warrants. Aggregate gross proceeds to the Company from both transactions were approximately $2.5 million. The transactions closed on December 19, 2025. The transactions were priced at the market under Nasdaq rules.

The transactions consisted of the sale of 1,930,502 Common Units (or Pre-Funded Units), each consisting of (i) one (1) share of Common Stock or one (1) Pre-Funded Warrant and (ii) one (1) PIPE Common Warrant to purchase one (1) share of Common Stock per warrant at an exercise price of $1.4245. The offering price per Common Unit is $1.295 (or $1.29499 for each Pre-Funded Unit, which is equal to the offering price per Common Unit sold in the offering minus an exercise price of $0.00001 per Pre-Funded Warrant). The Pre-Funded Warrants are immediately exercisable and may be exercised at any time until exercised in full. For each Pre-Funded Unit sold in the offering, the number of Common Units in the offering will be decreased on a one-for-one basis.

Aggregate gross proceeds to the Company were approximately $2.5 million. The transaction closed on December 19, 2025. The Company expects to use the net proceeds from the offerings, together with its existing cash, for general corporate purposes and working capital.

Aegis Capital Corp. acted as exclusive placement agent for the offerings. Lucosky Brookman LLP acted as counsel to the Company. Kaufman & Canoles, P.C. acted as counsel to Aegis Capital Corp.

The registered direct offering was being made pursuant to an effective shelf registration statement on Form S-3 (No. 333-288039) previously filed with the U.S. Securities and Exchange Commission (SEC) and declared effective by the SEC on June 24, 2025. A final prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying prospectus may be obtained, when available, by contacting Aegis Capital Corp., Attention: Syndicate Department, 1345 Avenue of the Americas, 27th floor, New York, NY 10105, by email at syndicate@aegiscap.com, or by telephone at +1 (212) 813-1010.

The offer and sale of the securities in the private placement were made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The securities were offered only to accredited investors. Pursuant to a registration rights agreement with the investors, the Company has agreed to file one or more registration statements with the SEC covering the resale of the Common Stock and the Shares issuable upon exercise of the pre-funded warrants and warrants.

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 offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Mangoceuticals, Inc.

MangoRx is focused on developing a variety of men’s health and wellness products and services via a secure telemedicine platform. To date, the Company has identified men’s wellness telemedicine services and products as a growing sector and especially related to the area of erectile dysfunction (ED), hair growth, hormone replacement therapies, and weight management. Interested consumers can use MangoRx’s telemedicine platform for a smooth experience. Prescription requests will be reviewed by a physician and, if approved, fulfilled and discreetly shipped through MangoRx’s partner compounding pharmacy and right to the patient’s doorstep. To learn more about MangoRx’s mission and other products, please visit www.MangoRx.com.

Forward-Looking Statements

The foregoing material may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Forward-looking statements include all statements that do not relate solely to historical or current facts, including without limitation statements regarding the Company’s product development and business prospects, and can be identified by the use of words such as “may,” “will,” “expect,” “project,” “estimate,” “anticipate,” “plan,” “believe,” “potential,” “should,” “continue” or the negative versions of those words or other comparable words. Forward-looking statements are not guarantees of future actions or performance. These forward-looking statements are based on information currently available to the Company and its current plans or expectations and are subject to a number of risks and uncertainties that could significantly affect current plans. Should one or more of these risks or uncertainties materialize, or the underlying assumptions prove incorrect, actual results may differ significantly from those anticipated, believed, estimated, expected, intended, or planned. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee future results, performance, or achievements. Except as required by applicable law, including the security laws of the United States, the Company does not intend to update any of the forward-looking statements to conform these statements to actual results.

FOR INVESTOR RELATIONS
Mangoceuticals Investor Relations
Email: investors@mangorx.com

Spero Announces NDA Resubmission of Tebipenem HBr by GSK to the FDA for the Treatment of Complicated Urinary Tract Infections, Including Pyelonephritis




Spero Announces NDA Resubmission of Tebipenem HBr by GSK to the FDA for the Treatment of Complicated Urinary Tract Infections, Including Pyelonephritis

CAMBRIDGE, Mass., Dec. 19, 2025 (GLOBE NEWSWIRE) — Spero Therapeutics, Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announced that its development partner, GSK, filed a New Drug Application (NDA) resubmission to the U.S. Food and Drug Administration (FDA) for tebipenem HBr, an investigational oral carbapenem antibiotic being developed for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis. The NDA submission triggers a $25 million milestone payment to Spero, expected to be received in Q1 2026.

The NDA resubmission is supported by results from the successful Phase 3 PIVOT-PO trial (NCT number – NCT06059846). The trial was stopped early for efficacy in May, 2025 following a planned interim analysis. Trial results were presented as a late breaker at the IDWeek conference in October 2025.

Spero has granted GSK an exclusive license to commercialize tebipenem HBr in all territories except for certain Asian territories, where Meiji retains development and commercialization rights.

Tebipenem HBr Research Support
Select tebipenem HBr studies have been funded in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; and Biomedical Advanced Research and Development Authority, under contract number HHSO100201800015C.

About Spero Therapeutics
Spero Therapeutics, headquartered in Cambridge, Massachusetts, is a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and MDR bacterial infections with high unmet need. For more information, visit www.sperotherapeutics.com.

Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the timing of a $25 million milestone payment expected to be received by Spero in Q1 2026. In some cases, forward-looking statements may be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intent,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue,” the negative of these terms or other similar expressions; however, the absence of these words does not mean that statement is not forward looking . Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of important risks, uncertainties and other factors that may cause actual results to differ materially from those indicated by such forward looking statements, including whether the results of any of Spero’s clinical trials will warrant submission for approval from the FDA or equivalent foreign regulatory agencies; whether the FDA will ultimately approve tebipenem HBr and, if so, the timing of any such approval, taking into account the effects of possible regulatory delays; whether the FDA will require any additional clinical data or place labeling restrictions on the use of tebipenem HBr that would delay approval and/or reduce the commercial prospects of tebipenem HBr; whether a successful commercial launch can be achieved and market acceptance of tebipenem HBr can be established; Spero’s reliance on third parties to manufacture, develop, and commercialize its product candidates, if approved; Spero’s reliance on GSK pursuant to the exclusive GSK License Agreement to develop tebipenem HBr and GSK’s right thereunder to determine, in its sole discretion, whether to further develop tebipenem HBr; Spero’s need for additional funding; Spero’s ability to retain key personnel; whether Spero’s cash resources will be sufficient to fund its continuing operations for the periods anticipated; and other factors discussed in the “Risk Factors” set forth in filings that Spero periodically makes with the Securities Exchange Commission. The forward-looking statements included in this press release represent Spero’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, Spero explicitly disclaims any obligation to update any forward-looking statements.

Investor Relations Contact:
Shai Biran, PhD
Spero Therapeutics
IR@Sperotherapeutics.com

Media Inquiries:
media@sperotherapeutics.com

Spero Announces NDA Resubmission of Tebipenem HBr by GSK to the FDA for the Treatment of Complicated Urinary Tract Infections, Including Pyelonephritis




Spero Announces NDA Resubmission of Tebipenem HBr by GSK to the FDA for the Treatment of Complicated Urinary Tract Infections, Including Pyelonephritis

CAMBRIDGE, Mass., Dec. 19, 2025 (GLOBE NEWSWIRE) — Spero Therapeutics, Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announced that its development partner, GSK, filed a New Drug Application (NDA) resubmission to the U.S. Food and Drug Administration (FDA) for tebipenem HBr, an investigational oral carbapenem antibiotic being developed for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis. The NDA submission triggers a $25 million milestone payment to Spero, expected to be received in Q1 2026.

The NDA resubmission is supported by results from the successful Phase 3 PIVOT-PO trial (NCT number – NCT06059846). The trial was stopped early for efficacy in May, 2025 following a planned interim analysis. Trial results were presented as a late breaker at the IDWeek conference in October 2025.

Spero has granted GSK an exclusive license to commercialize tebipenem HBr in all territories except for certain Asian territories, where Meiji retains development and commercialization rights.

Tebipenem HBr Research Support
Select tebipenem HBr studies have been funded in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; and Biomedical Advanced Research and Development Authority, under contract number HHSO100201800015C.

About Spero Therapeutics
Spero Therapeutics, headquartered in Cambridge, Massachusetts, is a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and MDR bacterial infections with high unmet need. For more information, visit www.sperotherapeutics.com.

Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the timing of a $25 million milestone payment expected to be received by Spero in Q1 2026. In some cases, forward-looking statements may be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intent,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue,” the negative of these terms or other similar expressions; however, the absence of these words does not mean that statement is not forward looking . Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of important risks, uncertainties and other factors that may cause actual results to differ materially from those indicated by such forward looking statements, including whether the results of any of Spero’s clinical trials will warrant submission for approval from the FDA or equivalent foreign regulatory agencies; whether the FDA will ultimately approve tebipenem HBr and, if so, the timing of any such approval, taking into account the effects of possible regulatory delays; whether the FDA will require any additional clinical data or place labeling restrictions on the use of tebipenem HBr that would delay approval and/or reduce the commercial prospects of tebipenem HBr; whether a successful commercial launch can be achieved and market acceptance of tebipenem HBr can be established; Spero’s reliance on third parties to manufacture, develop, and commercialize its product candidates, if approved; Spero’s reliance on GSK pursuant to the exclusive GSK License Agreement to develop tebipenem HBr and GSK’s right thereunder to determine, in its sole discretion, whether to further develop tebipenem HBr; Spero’s need for additional funding; Spero’s ability to retain key personnel; whether Spero’s cash resources will be sufficient to fund its continuing operations for the periods anticipated; and other factors discussed in the “Risk Factors” set forth in filings that Spero periodically makes with the Securities Exchange Commission. The forward-looking statements included in this press release represent Spero’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, Spero explicitly disclaims any obligation to update any forward-looking statements.

Investor Relations Contact:
Shai Biran, PhD
Spero Therapeutics
IR@Sperotherapeutics.com

Media Inquiries:
media@sperotherapeutics.com

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.