Month: September 2026

Binding term sheet with PsyLabs provides Psyence BioMed’s Texas subsidiary with exclusive U.S. development, supply and distribution rights to PsyLabs’ pharmaceutical-grade ibogaine, subject to a definitive agreement

NEW YORK, Sept. 28, 2026 (GLOBE NEWSWIRE) — Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence BioMed” or the “Company”) today announced that its wholly-owned Texas subsidiary, Texas Ibogaine Research Corporation (“TIRC”), has entered into a binding term sheet with Psyence Labs Ltd. (“PsyLabs”) under which PsyLabs will grant TIRC an exclusive license, supply and wholesale distribution arrangement for PsyLabs’ pharmaceutical-grade ibogaine in the United States. The term sheet is binding on the parties and is to be superseded by a definitive agreement, which the parties have agreed to conclude on or before November 30, 2026; if a definitive agreement is not signed by that date, the term sheet will lapse.

Under the term sheet, PsyLabs will grant TIRC an exclusive license in the United States to PsyLabs’ know-how, trade secrets, cultivation, extraction and processing methods, analytical methods, specifications, standard operating procedures, batch records and technical and regulatory information relating to its pharmaceutical-grade ibogaine hydrochloride, to the extent necessary or useful to develop, manufacture and commercialize ibogaine drug candidates in the United States. PsyLabs will be TIRC’s exclusive supplier of ibogaine, and TIRC will be appointed PsyLabs’ exclusive wholesaler and distributor of that product in the United States. PsyLabs retains all rights outside the United States. In consideration, TIRC will pay PsyLabs development and regulatory milestone payments totaling up to approximately US$1.3 million for the first drug candidate, an annual exclusivity fee commencing on the first anniversary of the first FDA approval and creditable against royalties, and a low single-digit percentage royalty on net sales of each drug candidate, together with a margin-sharing arrangement on any resale of product by TIRC. TIRC’s exclusivity is conditional on TIRC sourcing all of its ibogaine requirements for the United States from PsyLabs, subject to customary supply-failure step-in rights, and is expected to be subject to minimum development or sales performance thresholds to be set out in the definitive agreement. PsyLabs, which is a significant shareholder of Psyence BioMed and in which Psyence BioMed holds an ownership interest, is licensed in its operating jurisdiction to cultivate, extract and export ibogaine and operates from an ISO 22000 and GMP-compliant production and processing facility.

TIRC, which is wholly-owned and financed by Psyence BioMed, intends to pursue a U.S. ibogaine development program under the license, subject to conclusion of the definitive agreement and to the manufacturing, nonclinical and regulatory work required before any clinical investigation can be proposed.

“Exclusivity matters. This term sheet is intended to give TIRC a defined position in U.S. ibogaine development, backed by access to PsyLabs’ material, manufacturing know-how and technical documentation. For any federal agency, state programme or clinical partner, we believe that the question of who to work with on ibogaine in the USA has a clear answer.”

— Jody Aufrichtig, Chief Executive Officer, Psyence BioMed and Texas Ibogaine Research Corporation

“This term sheet is intended to give TIRC access to PsyLabs’ material, know-how and technical and regulatory documentation, which we believe will allow our development programme to start at speed rather than from scratch. We believe that very few compounds anywhere come with this much of the groundwork already done; and most importantly we believe that it gets us closer to being able to offer treatment to patients in need.”

— Dr. John Thorne, Project Lead, Texas Ibogaine Research Corporation

The Company intends to provide further updates as TIRC advances through manufacturing, regulatory and clinical milestones under the license, including conclusion of the definitive agreement.

ABOUT PSYENCE BIOMED
Psyence Biomedical Ltd. (Nasdaq: PBM) is a Nasdaq-listed company with its subsidiary, Texas Ibogaine Research Corporation, headquartered in Texas. It is one of the few multi-asset, vertically integrated biopharmaceutical companies specializing in neuroplastogen-based therapeutics and the manufacture of pharmaceutical-grade drug candidates. It is the first life sciences biotechnology company focused on developing nature-derived, non-synthetic psilocybin and ibogaine-based neuroplastogen medicine to be listed on Nasdaq. The Company is dedicated to addressing unmet mental health needs and is committed to an evidence-based approach to developing safe, effective and FDA-approved nature-derived neuroplastogen treatments across a range of mental health disorders.

ABOUT PSYLABS
PsyLabs is a neuroplastogen active pharmaceutical ingredient development company, federally licensed in its operating jurisdiction to cultivate, extract and export psilocybin mushrooms and other neuroplastogen compounds, including psilocybin, psilocin, mescaline, ibogaine and dimethyltryptamine, to lawful medical and research markets. PsyLabs operates from an ISO 22000 and GMP-compliant facility, with a focus on natural compound purification, regulatory support and global distribution. www.psylabs.life

CONTACTS
Psyence Biomedical Ltd. • ir@psyencebiomed.com • media@psyencebiomed.com • info@psyencebiomed.com • +1 416-477-1708
Investor contact: Michael Kydd, Investor Relations Advisor — michael@psyencebiomed.com

FORWARD-LOOKING STATEMENTS
This communication contains “forward-looking statements” within the meaning of applicable securities laws, including the U.S. Private Securities Litigation Reform Act of 1995. These include statements regarding the negotiation and conclusion of a definitive agreement with PsyLabs; the scope, duration, exclusivity and expected benefits of the license, supply and distribution arrangements; the milestone, exclusivity fee and royalty payments that may become payable; TIRC’s intended role in United States ibogaine development, supply and distribution; the manufacturing, nonclinical, regulatory and clinical activities TIRC intends to pursue; and the Company’s expected participation in federal and state programs. Forward-looking statements may be identified by words such as “will,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates” and similar expressions.

These statements are based on assumptions regarding government policy, continued interest in regulated neuroplastogen research, the availability of lawful development pathways, and the Company’s ability to maintain licenses, permits, supply arrangements and third-party relationships. These assumptions may prove incorrect. Risks and uncertainties that could cause actual results to differ materially include the possibility that the definitive agreement is not concluded by November 30, 2026, or at all, or is concluded on terms that differ from the term sheet; that the license is terminated, narrowed, converted to a non-exclusive license or disputed; that TIRC’s exclusivity becomes subject to minimum performance thresholds that TIRC does not meet; that licensed rights prove insufficient for the intended program; dependence on PsyLabs as exclusive licensor and supplier, and TIRC’s obligation to source ibogaine exclusively from PsyLabs; that the arrangements are between related parties and the terms agreed may differ from those that would be agreed between unrelated parties; changes in law, regulation or enforcement priorities in the United States, Southern Africa or elsewhere; the continuing status of ibogaine as a controlled substance; clinical, regulatory and approval risks; competition, including from parties developing ibogaine outside the licensed estate; financing risks; and the Company’s ability to maintain compliance with Nasdaq continued listing standards. This list is not exhaustive. These risks should be considered together with the risk factors described in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the fiscal year ended March 31, 2026 and in the Company’s other filings with the U.S. Securities and Exchange Commission. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. Readers should not place undue reliance on forward-looking statements, which speak only as of the date made. Except as required by law, the Company undertakes no obligation to update such statements.

The Company makes no medical, treatment or health benefit claims regarding its proposed products. The U.S. Food and Drug Administration, Health Canada and other regulatory authorities have not approved ibogaine or the Company’s other neuroplastogen compounds for therapeutic use, and their safety and efficacy have not been established through authorized clinical research. Rigorous scientific research and clinical trials are required. Any references to ibogaine stock, inventory or doses are the Company’s best estimates only. References to GMP-compliant mean production in a facility designed, operated and controlled in accordance with applicable Good Manufacturing Practice standards, and do not themselves constitute a representation of formal certification or approval by any regulatory authority unless expressly stated. References to a planned clinical trial describe an activity under evaluation only; no trial has been commenced, and no regulatory application in respect of it has been filed or accepted.

This communication is not an offer to sell or a solicitation of an offer to buy any securities.

Binding term sheet with PsyLabs provides Psyence BioMed’s Texas subsidiary with exclusive U.S. development, supply and distribution rights to PsyLabs’ pharmaceutical-grade ibogaine, subject to a definitive agreement

NEW YORK, Sept. 28, 2026 (GLOBE NEWSWIRE) — Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence BioMed” or the “Company”) today announced that its wholly-owned Texas subsidiary, Texas Ibogaine Research Corporation (“TIRC”), has entered into a binding term sheet with Psyence Labs Ltd. (“PsyLabs”) under which PsyLabs will grant TIRC an exclusive license, supply and wholesale distribution arrangement for PsyLabs’ pharmaceutical-grade ibogaine in the United States. The term sheet is binding on the parties and is to be superseded by a definitive agreement, which the parties have agreed to conclude on or before November 30, 2026; if a definitive agreement is not signed by that date, the term sheet will lapse.

Under the term sheet, PsyLabs will grant TIRC an exclusive license in the United States to PsyLabs’ know-how, trade secrets, cultivation, extraction and processing methods, analytical methods, specifications, standard operating procedures, batch records and technical and regulatory information relating to its pharmaceutical-grade ibogaine hydrochloride, to the extent necessary or useful to develop, manufacture and commercialize ibogaine drug candidates in the United States. PsyLabs will be TIRC’s exclusive supplier of ibogaine, and TIRC will be appointed PsyLabs’ exclusive wholesaler and distributor of that product in the United States. PsyLabs retains all rights outside the United States. In consideration, TIRC will pay PsyLabs development and regulatory milestone payments totaling up to approximately US$1.3 million for the first drug candidate, an annual exclusivity fee commencing on the first anniversary of the first FDA approval and creditable against royalties, and a low single-digit percentage royalty on net sales of each drug candidate, together with a margin-sharing arrangement on any resale of product by TIRC. TIRC’s exclusivity is conditional on TIRC sourcing all of its ibogaine requirements for the United States from PsyLabs, subject to customary supply-failure step-in rights, and is expected to be subject to minimum development or sales performance thresholds to be set out in the definitive agreement. PsyLabs, which is a significant shareholder of Psyence BioMed and in which Psyence BioMed holds an ownership interest, is licensed in its operating jurisdiction to cultivate, extract and export ibogaine and operates from an ISO 22000 and GMP-compliant production and processing facility.

TIRC, which is wholly-owned and financed by Psyence BioMed, intends to pursue a U.S. ibogaine development program under the license, subject to conclusion of the definitive agreement and to the manufacturing, nonclinical and regulatory work required before any clinical investigation can be proposed.

“Exclusivity matters. This term sheet is intended to give TIRC a defined position in U.S. ibogaine development, backed by access to PsyLabs’ material, manufacturing know-how and technical documentation. For any federal agency, state programme or clinical partner, we believe that the question of who to work with on ibogaine in the USA has a clear answer.”

— Jody Aufrichtig, Chief Executive Officer, Psyence BioMed and Texas Ibogaine Research Corporation

“This term sheet is intended to give TIRC access to PsyLabs’ material, know-how and technical and regulatory documentation, which we believe will allow our development programme to start at speed rather than from scratch. We believe that very few compounds anywhere come with this much of the groundwork already done; and most importantly we believe that it gets us closer to being able to offer treatment to patients in need.”

— Dr. John Thorne, Project Lead, Texas Ibogaine Research Corporation

The Company intends to provide further updates as TIRC advances through manufacturing, regulatory and clinical milestones under the license, including conclusion of the definitive agreement.

ABOUT PSYENCE BIOMED
Psyence Biomedical Ltd. (Nasdaq: PBM) is a Nasdaq-listed company with its subsidiary, Texas Ibogaine Research Corporation, headquartered in Texas. It is one of the few multi-asset, vertically integrated biopharmaceutical companies specializing in neuroplastogen-based therapeutics and the manufacture of pharmaceutical-grade drug candidates. It is the first life sciences biotechnology company focused on developing nature-derived, non-synthetic psilocybin and ibogaine-based neuroplastogen medicine to be listed on Nasdaq. The Company is dedicated to addressing unmet mental health needs and is committed to an evidence-based approach to developing safe, effective and FDA-approved nature-derived neuroplastogen treatments across a range of mental health disorders.

ABOUT PSYLABS
PsyLabs is a neuroplastogen active pharmaceutical ingredient development company, federally licensed in its operating jurisdiction to cultivate, extract and export psilocybin mushrooms and other neuroplastogen compounds, including psilocybin, psilocin, mescaline, ibogaine and dimethyltryptamine, to lawful medical and research markets. PsyLabs operates from an ISO 22000 and GMP-compliant facility, with a focus on natural compound purification, regulatory support and global distribution. www.psylabs.life

CONTACTS
Psyence Biomedical Ltd. • ir@psyencebiomed.com • media@psyencebiomed.com • info@psyencebiomed.com • +1 416-477-1708
Investor contact: Michael Kydd, Investor Relations Advisor — michael@psyencebiomed.com

FORWARD-LOOKING STATEMENTS
This communication contains “forward-looking statements” within the meaning of applicable securities laws, including the U.S. Private Securities Litigation Reform Act of 1995. These include statements regarding the negotiation and conclusion of a definitive agreement with PsyLabs; the scope, duration, exclusivity and expected benefits of the license, supply and distribution arrangements; the milestone, exclusivity fee and royalty payments that may become payable; TIRC’s intended role in United States ibogaine development, supply and distribution; the manufacturing, nonclinical, regulatory and clinical activities TIRC intends to pursue; and the Company’s expected participation in federal and state programs. Forward-looking statements may be identified by words such as “will,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates” and similar expressions.

These statements are based on assumptions regarding government policy, continued interest in regulated neuroplastogen research, the availability of lawful development pathways, and the Company’s ability to maintain licenses, permits, supply arrangements and third-party relationships. These assumptions may prove incorrect. Risks and uncertainties that could cause actual results to differ materially include the possibility that the definitive agreement is not concluded by November 30, 2026, or at all, or is concluded on terms that differ from the term sheet; that the license is terminated, narrowed, converted to a non-exclusive license or disputed; that TIRC’s exclusivity becomes subject to minimum performance thresholds that TIRC does not meet; that licensed rights prove insufficient for the intended program; dependence on PsyLabs as exclusive licensor and supplier, and TIRC’s obligation to source ibogaine exclusively from PsyLabs; that the arrangements are between related parties and the terms agreed may differ from those that would be agreed between unrelated parties; changes in law, regulation or enforcement priorities in the United States, Southern Africa or elsewhere; the continuing status of ibogaine as a controlled substance; clinical, regulatory and approval risks; competition, including from parties developing ibogaine outside the licensed estate; financing risks; and the Company’s ability to maintain compliance with Nasdaq continued listing standards. This list is not exhaustive. These risks should be considered together with the risk factors described in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the fiscal year ended March 31, 2026 and in the Company’s other filings with the U.S. Securities and Exchange Commission. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. Readers should not place undue reliance on forward-looking statements, which speak only as of the date made. Except as required by law, the Company undertakes no obligation to update such statements.

The Company makes no medical, treatment or health benefit claims regarding its proposed products. The U.S. Food and Drug Administration, Health Canada and other regulatory authorities have not approved ibogaine or the Company’s other neuroplastogen compounds for therapeutic use, and their safety and efficacy have not been established through authorized clinical research. Rigorous scientific research and clinical trials are required. Any references to ibogaine stock, inventory or doses are the Company’s best estimates only. References to GMP-compliant mean production in a facility designed, operated and controlled in accordance with applicable Good Manufacturing Practice standards, and do not themselves constitute a representation of formal certification or approval by any regulatory authority unless expressly stated. References to a planned clinical trial describe an activity under evaluation only; no trial has been commenced, and no regulatory application in respect of it has been filed or accepted.

This communication is not an offer to sell or a solicitation of an offer to buy any securities.

FOSTER CITY, Calif., Sept. 28, 2026 (GLOBE NEWSWIRE) — Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced that it will host a virtual key opinion leader (KOL) event on Wednesday, September 30, 2026, at 1:00 PM ET featuring Julie Harper, MD, Founding Director and past President of the American Acne and Rosacea Society. To register, click here.

Dr. Harper will join company management for a review of the 52-week data from license partner Ascletis’ Phase 3 open-label extension clinical trial of denifanstat in moderate to severe acne vulgaris in China and an update on Sagimet’s planned U.S. Phase 3 AURORA clinical trial of denifanstat for the treatment of moderate to severe acne.

In the Phase 3 open-label extension clinical trial, subjects treated with denifanstat showed improvements in all efficacy endpoints (secondary endpoints of the trial) beyond those observed at 12 weeks in the original clinical trial. Denifanstat was generally well-tolerated in both the original clinical trial and the open-label extension clinical trial. These efficacy results will be presented at the European Academy of Dermatology and Venereology Congress (EADV 2026), building on the topline results announced in February 2026.

Sagimet’s AURORA Phase 3 clinical trial of denifanstat in moderate to severe acne in the U.S. is expected to initiate in the fourth quarter of 2026.

Denifanstat is a once-daily oral small molecule fatty acid synthase (FASN) inhibitor with a novel mechanism of action in development to address moderate to severe acne, a condition that impacts approximately 10 million people annually in the U.S.

A live question and answer session will follow the formal presentations. A replay of this event will be available in the Investors & Media section of Sagimet’s website at www.sagimet.com for 90 days following the live event.

About Julie Harper, MD

Julie Harper, MD is a board-certified dermatologist in private practice at the Dermatology and Skin Care Center of Birmingham in Birmingham, Alabama. She received her medical training at the University of Missouri-Columbia, where she also completed her internship and dermatology residency. Dr. Harper transitioned from residency training into an academic dermatology career at the University of Alabama-Birmingham (UAB). While at UAB, she was promoted to Associate Professor. During that time, she developed a special interest in acne and rosacea, participating in acne clinical trials and writing and speaking on the subject locally and nationally.

Dr. Harper is a Founding Director of the American Acne and Rosacea Society and is the organization’s past-President. In 2007, Dr. Harper founded a private practice in dermatology where she practices general medical, surgical and cosmetic dermatology. She is a Fellow of the American Academy of Dermatology (AAD) and recently served on the AAD’s Acne Work Group, tasked with writing acne treatment guidelines. Dr. Harper is also a member of the Women’s Dermatologic Society and a former President of the Alabama Dermatological Society.

About the AURORA Phase 3 Clinical Trial

The AURORA multi-center, randomized, double-blind, placebo-controlled Phase 3 clinical trial of denifanstat in moderate to severe acne is intended to enroll approximately 800 U.S. patients aged 12 years and older, of which 450 are expected to be adolescents aged 12 to 17 years. Patients will be randomized 2:1 to receive denifanstat 50 mg or placebo once daily for 12 weeks. The trial will have three co-primary endpoints that will be assessed at week 12: the proportion of patients achieving treatment success in a global assessment score, defined as at least a 2-point reduction from baseline with a score of 0 (clear) or 1 (almost clear); absolute change in inflammatory skin lesion counts from baseline; and absolute change in non-inflammatory skin lesion counts from baseline. A subset of approximately 530 patients completing the double-blind period will be eligible to enter a 40-week open-label extension evaluating the long-term safety of denifanstat.

About Denifanstat

Denifanstat is an oral, once-daily FASN inhibitor in development for the treatment of moderate to severe acne. In trials conducted by Sagimet’s license partner, Ascletis BioScience Co. Ltd. (Ascletis) in China, denifanstat met all primary and secondary endpoints in a 12 week randomized, double-blind Phase 3 clinical trial in moderate to severe acne vulgaris and was generally well-tolerated and showed improvements in all efficacy endpoints measured at 52 weeks (secondary endpoints of the trial) in an open-label extension clinical trial evaluating denifanstat’s long-term safety in patients with moderate to severe acne. Denifanstat is being developed by Ascletis as ASC40 for acne in China and by Sagimet in the rest of world.

About Acne

Acne is one of the most common skin conditions in the U.S., with approximately 50 million Americans affected annually and more than 5 million seeking medical treatment for acne each year. Acne affects around 85% of persons between the ages of 12 and 24. Moderate to severe acne accounts for 20% of acne sufferers, or approximately 10 million people in the U.S. annually. There is no cure for acne, and due to its pathology, most patients require chronic management and multiple annual courses of treatment for flare control.

About Sagimet Biosciences

Sagimet is a clinical-stage biopharmaceutical company developing novel FASN inhibitors designed to target dysfunctional metabolic and fibrotic pathways in conditions resulting from the overproduction of the fatty acid, palmitate. FASN is a regulator of lipid synthesis, a key pathway implicated in multiple diseases, such as acne, MASH and certain FASN-dependent tumor types. For additional information about Sagimet, please visit www.sagimet.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, The Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding the expected timing of the presentation of data from ongoing clinical trials, Sagimet’s clinical development plans and related timelines and anticipated development milestones, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause Sagimet’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, these statements can be identified by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this press release are only predictions. Sagimet has based these forward-looking statements largely on its current expectations and projections about future events and financial trends that Sagimet believes may affect its business, financial condition and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Sagimet’s control, including, among others: the clinical development and therapeutic potential of denifanstat, TVB-3567 or any other drug candidates or combination therapies developed by Sagimet; Sagimet’s ability to advance drug candidates into and successfully complete clinical trials within anticipated timelines; Sagimet’s relationship with Ascletis, and the success of its development and registration efforts for denifanstat; the accuracy of Sagimet’s estimates regarding its capital requirements and Sagimet’s ability to maintain and successfully enforce adequate intellectual property protection. These and other risks and uncertainties are described more fully in the “Risk Factors” section of Sagimet’s most recent filings with the Securities and Exchange Commission and available at www.sec.gov. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in these forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, Sagimet operates in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that Sagimet may face. Except as required by applicable law, Sagimet does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Investor Contact:
Joyce Allaire 
LifeSci Advisors 
JAllaire@LifeSciAdvisors.com

Media Contact:
Maggie Whitney
LifeSci Communications
mwhitney@lifescicomms.com

FOSTER CITY, Calif., Sept. 28, 2026 (GLOBE NEWSWIRE) — Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced that it will host a virtual key opinion leader (KOL) event on Wednesday, September 30, 2026, at 1:00 PM ET featuring Julie Harper, MD, Founding Director and past President of the American Acne and Rosacea Society. To register, click here.

Dr. Harper will join company management for a review of the 52-week data from license partner Ascletis’ Phase 3 open-label extension clinical trial of denifanstat in moderate to severe acne vulgaris in China and an update on Sagimet’s planned U.S. Phase 3 AURORA clinical trial of denifanstat for the treatment of moderate to severe acne.

In the Phase 3 open-label extension clinical trial, subjects treated with denifanstat showed improvements in all efficacy endpoints (secondary endpoints of the trial) beyond those observed at 12 weeks in the original clinical trial. Denifanstat was generally well-tolerated in both the original clinical trial and the open-label extension clinical trial. These efficacy results will be presented at the European Academy of Dermatology and Venereology Congress (EADV 2026), building on the topline results announced in February 2026.

Sagimet’s AURORA Phase 3 clinical trial of denifanstat in moderate to severe acne in the U.S. is expected to initiate in the fourth quarter of 2026.

Denifanstat is a once-daily oral small molecule fatty acid synthase (FASN) inhibitor with a novel mechanism of action in development to address moderate to severe acne, a condition that impacts approximately 10 million people annually in the U.S.

A live question and answer session will follow the formal presentations. A replay of this event will be available in the Investors & Media section of Sagimet’s website at www.sagimet.com for 90 days following the live event.

About Julie Harper, MD

Julie Harper, MD is a board-certified dermatologist in private practice at the Dermatology and Skin Care Center of Birmingham in Birmingham, Alabama. She received her medical training at the University of Missouri-Columbia, where she also completed her internship and dermatology residency. Dr. Harper transitioned from residency training into an academic dermatology career at the University of Alabama-Birmingham (UAB). While at UAB, she was promoted to Associate Professor. During that time, she developed a special interest in acne and rosacea, participating in acne clinical trials and writing and speaking on the subject locally and nationally.

Dr. Harper is a Founding Director of the American Acne and Rosacea Society and is the organization’s past-President. In 2007, Dr. Harper founded a private practice in dermatology where she practices general medical, surgical and cosmetic dermatology. She is a Fellow of the American Academy of Dermatology (AAD) and recently served on the AAD’s Acne Work Group, tasked with writing acne treatment guidelines. Dr. Harper is also a member of the Women’s Dermatologic Society and a former President of the Alabama Dermatological Society.

About the AURORA Phase 3 Clinical Trial

The AURORA multi-center, randomized, double-blind, placebo-controlled Phase 3 clinical trial of denifanstat in moderate to severe acne is intended to enroll approximately 800 U.S. patients aged 12 years and older, of which 450 are expected to be adolescents aged 12 to 17 years. Patients will be randomized 2:1 to receive denifanstat 50 mg or placebo once daily for 12 weeks. The trial will have three co-primary endpoints that will be assessed at week 12: the proportion of patients achieving treatment success in a global assessment score, defined as at least a 2-point reduction from baseline with a score of 0 (clear) or 1 (almost clear); absolute change in inflammatory skin lesion counts from baseline; and absolute change in non-inflammatory skin lesion counts from baseline. A subset of approximately 530 patients completing the double-blind period will be eligible to enter a 40-week open-label extension evaluating the long-term safety of denifanstat.

About Denifanstat

Denifanstat is an oral, once-daily FASN inhibitor in development for the treatment of moderate to severe acne. In trials conducted by Sagimet’s license partner, Ascletis BioScience Co. Ltd. (Ascletis) in China, denifanstat met all primary and secondary endpoints in a 12 week randomized, double-blind Phase 3 clinical trial in moderate to severe acne vulgaris and was generally well-tolerated and showed improvements in all efficacy endpoints measured at 52 weeks (secondary endpoints of the trial) in an open-label extension clinical trial evaluating denifanstat’s long-term safety in patients with moderate to severe acne. Denifanstat is being developed by Ascletis as ASC40 for acne in China and by Sagimet in the rest of world.

About Acne

Acne is one of the most common skin conditions in the U.S., with approximately 50 million Americans affected annually and more than 5 million seeking medical treatment for acne each year. Acne affects around 85% of persons between the ages of 12 and 24. Moderate to severe acne accounts for 20% of acne sufferers, or approximately 10 million people in the U.S. annually. There is no cure for acne, and due to its pathology, most patients require chronic management and multiple annual courses of treatment for flare control.

About Sagimet Biosciences

Sagimet is a clinical-stage biopharmaceutical company developing novel FASN inhibitors designed to target dysfunctional metabolic and fibrotic pathways in conditions resulting from the overproduction of the fatty acid, palmitate. FASN is a regulator of lipid synthesis, a key pathway implicated in multiple diseases, such as acne, MASH and certain FASN-dependent tumor types. For additional information about Sagimet, please visit www.sagimet.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, The Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding the expected timing of the presentation of data from ongoing clinical trials, Sagimet’s clinical development plans and related timelines and anticipated development milestones, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause Sagimet’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, these statements can be identified by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this press release are only predictions. Sagimet has based these forward-looking statements largely on its current expectations and projections about future events and financial trends that Sagimet believes may affect its business, financial condition and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Sagimet’s control, including, among others: the clinical development and therapeutic potential of denifanstat, TVB-3567 or any other drug candidates or combination therapies developed by Sagimet; Sagimet’s ability to advance drug candidates into and successfully complete clinical trials within anticipated timelines; Sagimet’s relationship with Ascletis, and the success of its development and registration efforts for denifanstat; the accuracy of Sagimet’s estimates regarding its capital requirements and Sagimet’s ability to maintain and successfully enforce adequate intellectual property protection. These and other risks and uncertainties are described more fully in the “Risk Factors” section of Sagimet’s most recent filings with the Securities and Exchange Commission and available at www.sec.gov. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in these forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, Sagimet operates in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that Sagimet may face. Except as required by applicable law, Sagimet does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Investor Contact:
Joyce Allaire 
LifeSci Advisors 
JAllaire@LifeSciAdvisors.com

Media Contact:
Maggie Whitney
LifeSci Communications
mwhitney@lifescicomms.com

BOSTON, Sept. 28, 2026 (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 announced that the first three participants have all received their first dose of intranasal foralumab in the Phase 2a Healey ALS MyMatch BANYAN clinical trial.

The BANYAN Trial is evaluating intranasal foralumab in people living with amyotrophic lateral sclerosis (ALS). The study is sponsored by Tiziana Life Sciences and co-funded by the ALS Association through its Hoffman ALS Clinical Trial Awards Program. The trial is being conducted at the Healey & AMG Center (Boston, MA) and will be launched at The Les Turner ALS Center at Northwestern Medicine(Chicago, IL), University of Minnesota (Minneapolis, MN), and Nova Southeastern University (Davie, FL).

Trial Design

• Participants: 44 individuals with early ALS (≤ 24 months since symptom onset), slow vital capacity (SVC) ≥ 65%, and neurofilament light chain (NfL) ≥ 40 pg/mL.
• Randomization: 3:1 (active drug : placebo).
• Duration: 12-week randomized, controlled treatment period followed by a 12-week active extension treatment period.
• Primary Endpoint: Safety and tolerability of foralumab in patients with ALS.
• Secondary and Exploratory Endpoints:
  1. Immune reconstitution reflected by regulatory T cells (Tregs) and T-cell subset profiling.
  2. Immunologic gene expression assessed via single-cell RNA sequencing of T-cell subpopulations.
  3. Changes in neurofilament light chain (NfL) levels.
  4. Changes in microglial activation measured by brain TSPO-PET/MRI scans.

On October 1, at 5:00pm ET,  the Sean M. Healey & AMG Center for Integrated ALS Care and Discovery at Mass General Brigham will host a community webinar with Tiziana to discuss the science behind foralumab. Register for the webinar here.

The trial (ClinicalTrials.gov identifier: NCT07688239) is led by Suma Babu, MBBS, MPH, Principal Investigator of Healey ALS MyMatch and Co-Director of the Neurological Clinical Research Institute (NCRI) at Mass General Brigham, and James Berry, MD, MPH, Director of the Mass General Brigham Neuroscience Institute Clinical Trials Center for Neurotherapeutics, Chief of the Division of ALS and Motor Neuron Diseases, and Director of the NCRI.

“This study serves as a significant step in advancing the development of foralumab for ALS,” said Dr. Babu. “The BANYAN trial is designed to answer important questions about foralumab, specifically, whether it has a biological effect on Treg pathway in ALS, as measured by biomarkers.”

“Dosing the first participants in the BANYAN Trial is a meaningful milestone for Tiziana and for the ALS community,” said Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences. “ALS is a devastating disease with urgent unmet medical need. Our intranasal foralumab represents a differentiated, non-invasive, and convenient approach designed to modulate neuroinflammation by inducing regulatory T cells that traffic to the central nervous system. We are deeply grateful for the partnership with the Healey & AMG Center, the ALS Association, the outstanding investigators, and trial sites, and most importantly, the people living with ALS and families who make this progress possible. We look forward to generating important biomarker and safety data that can help advance the field.”

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), as well as additional Phase 2 trials in AD and MSA.

Intranasal 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 the Healey ALS MyMatch Program and BANYAN Trial:
Healey ALS MyMatch is reshaping ALS clinical research through biomarker-driven, personalized trial approaches. By integrating an emerging, comprehensive genetic and plasma biomarker pNFL, which was the basis of a recent accelerated approval for a genetic form of ALS, the program matches subgroups of individuals with ALS to experimental therapies based on their disease markers. The program consists of an ongoing series of early-phase clinical trials designed to deepen understanding of the biological effects of investigational products and to identify the optimal populations for future Phase 2/3 studies. Each trial in the program is named after a tree to symbolize hope and the deep scientific roots from which it grows, and careful thought went into designing the trial that balances scientific rigor with reducing participant and caregiver burden.

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

BOSTON, Sept. 28, 2026 (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 announced that the first three participants have all received their first dose of intranasal foralumab in the Phase 2a Healey ALS MyMatch BANYAN clinical trial.

The BANYAN Trial is evaluating intranasal foralumab in people living with amyotrophic lateral sclerosis (ALS). The study is sponsored by Tiziana Life Sciences and co-funded by the ALS Association through its Hoffman ALS Clinical Trial Awards Program. The trial is being conducted at the Healey & AMG Center (Boston, MA) and will be launched at The Les Turner ALS Center at Northwestern Medicine(Chicago, IL), University of Minnesota (Minneapolis, MN), and Nova Southeastern University (Davie, FL).

Trial Design

• Participants: 44 individuals with early ALS (≤ 24 months since symptom onset), slow vital capacity (SVC) ≥ 65%, and neurofilament light chain (NfL) ≥ 40 pg/mL.
• Randomization: 3:1 (active drug : placebo).
• Duration: 12-week randomized, controlled treatment period followed by a 12-week active extension treatment period.
• Primary Endpoint: Safety and tolerability of foralumab in patients with ALS.
• Secondary and Exploratory Endpoints:
  1. Immune reconstitution reflected by regulatory T cells (Tregs) and T-cell subset profiling.
  2. Immunologic gene expression assessed via single-cell RNA sequencing of T-cell subpopulations.
  3. Changes in neurofilament light chain (NfL) levels.
  4. Changes in microglial activation measured by brain TSPO-PET/MRI scans.

On October 1, at 5:00pm ET,  the Sean M. Healey & AMG Center for Integrated ALS Care and Discovery at Mass General Brigham will host a community webinar with Tiziana to discuss the science behind foralumab. Register for the webinar here.

The trial (ClinicalTrials.gov identifier: NCT07688239) is led by Suma Babu, MBBS, MPH, Principal Investigator of Healey ALS MyMatch and Co-Director of the Neurological Clinical Research Institute (NCRI) at Mass General Brigham, and James Berry, MD, MPH, Director of the Mass General Brigham Neuroscience Institute Clinical Trials Center for Neurotherapeutics, Chief of the Division of ALS and Motor Neuron Diseases, and Director of the NCRI.

“This study serves as a significant step in advancing the development of foralumab for ALS,” said Dr. Babu. “The BANYAN trial is designed to answer important questions about foralumab, specifically, whether it has a biological effect on Treg pathway in ALS, as measured by biomarkers.”

“Dosing the first participants in the BANYAN Trial is a meaningful milestone for Tiziana and for the ALS community,” said Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences. “ALS is a devastating disease with urgent unmet medical need. Our intranasal foralumab represents a differentiated, non-invasive, and convenient approach designed to modulate neuroinflammation by inducing regulatory T cells that traffic to the central nervous system. We are deeply grateful for the partnership with the Healey & AMG Center, the ALS Association, the outstanding investigators, and trial sites, and most importantly, the people living with ALS and families who make this progress possible. We look forward to generating important biomarker and safety data that can help advance the field.”

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), as well as additional Phase 2 trials in AD and MSA.

Intranasal 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 the Healey ALS MyMatch Program and BANYAN Trial:
Healey ALS MyMatch is reshaping ALS clinical research through biomarker-driven, personalized trial approaches. By integrating an emerging, comprehensive genetic and plasma biomarker pNFL, which was the basis of a recent accelerated approval for a genetic form of ALS, the program matches subgroups of individuals with ALS to experimental therapies based on their disease markers. The program consists of an ongoing series of early-phase clinical trials designed to deepen understanding of the biological effects of investigational products and to identify the optimal populations for future Phase 2/3 studies. Each trial in the program is named after a tree to symbolize hope and the deep scientific roots from which it grows, and careful thought went into designing the trial that balances scientific rigor with reducing participant and caregiver burden.

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

News Summary:

• NVIDIA’s Board of Directors has authorized a $150 billion increase to the share repurchase program, raising the remaining total program to $235 billion.
• This marks the largest share repurchase authorization increase in history.

SANTA CLARA, Calif., Sept. 28, 2026 (GLOBE NEWSWIRE) — NVIDIA today announced that its Board of Directors has authorized an additional $150 billion under the company’s existing share repurchase program, increasing the total remaining amount authorized to $235 billion.

The company expects to execute the total remaining program through fiscal year 2028.

“NVIDIA’s growth is being driven by a once-in-a-generation platform shift to AI and accelerated computing,” said Jensen Huang, founder and CEO of NVIDIA. “Our cash generation gives us the capacity to invest in the technologies that advance this transformation and return capital to shareholders. This authorization reflects our confidence in the long-term opportunity ahead.”

About NVIDIA
NVIDIA (NASDAQ: NVDA) is the world leader in AI and accelerated computing.

For further information, contact:
Mylene Mangalindan
Corporate Communications
NVIDIA Corporation
press@nvidia.com  

Toshiya Hari
Investor Relations
NVIDIA Corporation
ir@nvidia.com

Certain statements in this press release including, but not limited to, statements as to: expectations with respect to NVIDIA’s share repurchase program, including execution timeline; NVIDIA’s growth driven by a once-in-a-generation platform shift to AI and accelerated computing; NVIDIA’s cash generation giving it the capacity to invest in the technologies that advance this transformation and return capital to shareholders; expectations with respect to the long-term opportunity ahead; and other statements that are not historical facts 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, which are subject to the “safe harbor” created by those sections based on management’s beliefs and assumptions and on information currently available to management and are subject to risks and uncertainties that could cause results to be materially different than expectations. Important factors that could cause actual results to differ materially include: global economic and political conditions; NVIDIA’s reliance on third parties to manufacture, assemble, package and test NVIDIA’s products; the impact of technological development and competition; development of new products and technologies or enhancements to NVIDIA’s existing products and technologies; market acceptance of NVIDIA’s products or NVIDIA’s partners’ products; design, manufacturing or software defects; changes in consumer preferences or demands; changes in industry standards and interfaces; unexpected loss of performance of NVIDIA’s products or technologies when integrated into systems; NVIDIA’s ability to realize the potential benefits of business investments or acquisitions; and changes in applicable laws and regulations, as well as other factors detailed from time to time in the most recent reports NVIDIA files with the Securities and Exchange Commission, or SEC, including, but not limited to, its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Copies of reports filed with the SEC are posted on NVIDIA’s website and are available from NVIDIA without charge. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, NVIDIA disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.

© 2026 NVIDIA Corporation. All rights reserved. NVIDIA, the NVIDIA logo, and other NVIDIA product and service names are trademarks and/or registered trademarks of NVIDIA Corporation in the U.S. and other countries and regions. Other company, product, and service names may be trademarks of the respective companies with which they are associated.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/39454f98-f1a6-4f6a-b3ab-43fe63dad6e3

News Summary:

• NVIDIA’s Board of Directors has authorized a $150 billion increase to the share repurchase program, raising the remaining total program to $235 billion.
• This marks the largest share repurchase authorization increase in history.

SANTA CLARA, Calif., Sept. 28, 2026 (GLOBE NEWSWIRE) — NVIDIA today announced that its Board of Directors has authorized an additional $150 billion under the company’s existing share repurchase program, increasing the total remaining amount authorized to $235 billion.

The company expects to execute the total remaining program through fiscal year 2028.

“NVIDIA’s growth is being driven by a once-in-a-generation platform shift to AI and accelerated computing,” said Jensen Huang, founder and CEO of NVIDIA. “Our cash generation gives us the capacity to invest in the technologies that advance this transformation and return capital to shareholders. This authorization reflects our confidence in the long-term opportunity ahead.”

About NVIDIA
NVIDIA (NASDAQ: NVDA) is the world leader in AI and accelerated computing.

For further information, contact:
Mylene Mangalindan
Corporate Communications
NVIDIA Corporation
press@nvidia.com  

Toshiya Hari
Investor Relations
NVIDIA Corporation
ir@nvidia.com

Certain statements in this press release including, but not limited to, statements as to: expectations with respect to NVIDIA’s share repurchase program, including execution timeline; NVIDIA’s growth driven by a once-in-a-generation platform shift to AI and accelerated computing; NVIDIA’s cash generation giving it the capacity to invest in the technologies that advance this transformation and return capital to shareholders; expectations with respect to the long-term opportunity ahead; and other statements that are not historical facts 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, which are subject to the “safe harbor” created by those sections based on management’s beliefs and assumptions and on information currently available to management and are subject to risks and uncertainties that could cause results to be materially different than expectations. Important factors that could cause actual results to differ materially include: global economic and political conditions; NVIDIA’s reliance on third parties to manufacture, assemble, package and test NVIDIA’s products; the impact of technological development and competition; development of new products and technologies or enhancements to NVIDIA’s existing products and technologies; market acceptance of NVIDIA’s products or NVIDIA’s partners’ products; design, manufacturing or software defects; changes in consumer preferences or demands; changes in industry standards and interfaces; unexpected loss of performance of NVIDIA’s products or technologies when integrated into systems; NVIDIA’s ability to realize the potential benefits of business investments or acquisitions; and changes in applicable laws and regulations, as well as other factors detailed from time to time in the most recent reports NVIDIA files with the Securities and Exchange Commission, or SEC, including, but not limited to, its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Copies of reports filed with the SEC are posted on NVIDIA’s website and are available from NVIDIA without charge. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, NVIDIA disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.

© 2026 NVIDIA Corporation. All rights reserved. NVIDIA, the NVIDIA logo, and other NVIDIA product and service names are trademarks and/or registered trademarks of NVIDIA Corporation in the U.S. and other countries and regions. Other company, product, and service names may be trademarks of the respective companies with which they are associated.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/39454f98-f1a6-4f6a-b3ab-43fe63dad6e3

GREENWICH, Conn., Sept. 28, 2026 (GLOBE NEWSWIRE) — GXO Logistics, Inc. (NYSE: GXO), the world’s largest pure-play contract logistics provider, today announced the appointment of Dan Davis as President of Aerospace & Defense, a newly created enterprise role focused on accelerating the Company’s growth and strengthening its position in one of its most strategic growth verticals. Davis joins GXO today, reporting to CEO Patrick Kelleher.

Aerospace & Defense represents one of the most significant growth opportunities for GXO, building on the company’s deep operational expertise and track record of serving complex, highly regulated industries around the world. In this role, Davis will lead GXO’s global Aerospace & Defense growth strategy to drive market development, customer acquisition, strategic partnerships and pipeline growth across the business.

“At GXO, we continue to invest in the leadership, capabilities and strategic focus needed to accelerate growth in the sectors where we see the greatest opportunity,” said GXO CEO Patrick Kelleher. “Aerospace & Defense is an increasingly important sector that requires a differentiated go-to-market engine. Dan brings a rare combination of military experience, industry expertise and commercial leadership that will help us deepen customer relationships, expand our capabilities and strengthen GXO’s position as a trusted partner for mission-critical supply chains.”

Davis joins GXO from FSI Defense, a FlightSafety International and Berkshire Hathaway company, where he served as President. In that role, he more than doubled the company’s growth pipeline while improving revenue, profitability and customer satisfaction. Previously, Davis spent fifteen years with Lockheed Martin working across multiple business areas in Program Management and Capture Management roles. A graduate of the United States Military Academy at West Point, he also served as a Field Artillery Officer in the U.S. Army.

Earlier this year, GXO took key strategic actions to strengthen its position in the defense sector. The company established a Defense Advisory Board, bringing together distinguished leaders with deep military expertise to provide strategic counsel and actionable insights on growth opportunities. GXO also joined Amentum, Accenture and A.P. Moller-Maersk as a founding member of Torus Defence Supply Chain, an alliance designed to help strengthen the future of the UK defense sector.

About GXO
GXO Logistics, Inc. (NYSE: GXO) is the world’s largest pure-play contract logistics provider and is positioned to capitalize on the rapid growth of ecommerce, automation and outsourcing. GXO has over 150,000 team members across more than 1,000 facilities, totaling more than 200 million square feet. The company serves the world’s leading blue-chip companies to solve complex logistics challenges with technologically advanced supply chain and ecommerce solutions, at scale and with speed. GXO corporate headquarters is in Greenwich, Connecticut. Visit GXO.com for more information and connect with GXO on LinkedIn, X, Facebook, Instagram and YouTube.

Media contacts

Matthew Schmidt 
+1 203-307-2809 
matt.schmidt@gxo.com

Kathleen Juviler
+1 203-921-9121
kathleen.juviler@gxo.com

Attachment

• GXO appoints Dan Davis as President of Aerospace & Defense

GREENWICH, Conn., Sept. 28, 2026 (GLOBE NEWSWIRE) — GXO Logistics, Inc. (NYSE: GXO), the world’s largest pure-play contract logistics provider, today announced the appointment of Dan Davis as President of Aerospace & Defense, a newly created enterprise role focused on accelerating the Company’s growth and strengthening its position in one of its most strategic growth verticals. Davis joins GXO today, reporting to CEO Patrick Kelleher.

Aerospace & Defense represents one of the most significant growth opportunities for GXO, building on the company’s deep operational expertise and track record of serving complex, highly regulated industries around the world. In this role, Davis will lead GXO’s global Aerospace & Defense growth strategy to drive market development, customer acquisition, strategic partnerships and pipeline growth across the business.

“At GXO, we continue to invest in the leadership, capabilities and strategic focus needed to accelerate growth in the sectors where we see the greatest opportunity,” said GXO CEO Patrick Kelleher. “Aerospace & Defense is an increasingly important sector that requires a differentiated go-to-market engine. Dan brings a rare combination of military experience, industry expertise and commercial leadership that will help us deepen customer relationships, expand our capabilities and strengthen GXO’s position as a trusted partner for mission-critical supply chains.”

Davis joins GXO from FSI Defense, a FlightSafety International and Berkshire Hathaway company, where he served as President. In that role, he more than doubled the company’s growth pipeline while improving revenue, profitability and customer satisfaction. Previously, Davis spent fifteen years with Lockheed Martin working across multiple business areas in Program Management and Capture Management roles. A graduate of the United States Military Academy at West Point, he also served as a Field Artillery Officer in the U.S. Army.

Earlier this year, GXO took key strategic actions to strengthen its position in the defense sector. The company established a Defense Advisory Board, bringing together distinguished leaders with deep military expertise to provide strategic counsel and actionable insights on growth opportunities. GXO also joined Amentum, Accenture and A.P. Moller-Maersk as a founding member of Torus Defence Supply Chain, an alliance designed to help strengthen the future of the UK defense sector.

About GXO
GXO Logistics, Inc. (NYSE: GXO) is the world’s largest pure-play contract logistics provider and is positioned to capitalize on the rapid growth of ecommerce, automation and outsourcing. GXO has over 150,000 team members across more than 1,000 facilities, totaling more than 200 million square feet. The company serves the world’s leading blue-chip companies to solve complex logistics challenges with technologically advanced supply chain and ecommerce solutions, at scale and with speed. GXO corporate headquarters is in Greenwich, Connecticut. Visit GXO.com for more information and connect with GXO on LinkedIn, X, Facebook, Instagram and YouTube.

Media contacts

Matthew Schmidt 
+1 203-307-2809 
matt.schmidt@gxo.com

Kathleen Juviler
+1 203-921-9121
kathleen.juviler@gxo.com

Attachment

• GXO appoints Dan Davis as President of Aerospace & Defense