The Hemp Doctor Introduces THCA Flower Subscription Box — Monthly Curated Rotating Strains, Pre-Rolls & Extras

The Hemp Doctor Introduces THCA Flower Subscription Box — Monthly Curated Rotating Strains, Pre-Rolls & Extras




The Hemp Doctor Introduces THCA Flower Subscription Box — Monthly Curated Rotating Strains, Pre-Rolls & Extras

The Hemp Doctor Flower Subscription Box

MOORESVILLE, N.C., Dec. 03, 2025 (GLOBE NEWSWIRE) — The Hemp Doctor, one of America’s leading hemp brands, announces the launch of its Fresh Bloom THCA Flower Subscription Box—delivering a curated monthly lineup of select THCA flower strains, premium pre-rolls, smoking accessories, and exclusive limited-run products.

It’s an exclusive monthly offering designed for consumers who want convenience, variety, and consistent access to top-shelf THCA flower in a box at an unbeatable 30% discount.

Handpicked by The Hemp Doctor’s in-house strain experts, affectionately known as “hemployees,” the flower subscription box showcases a fresh lineup and carefully balanced mix of premium selections:

A 7-gram jar of craft-quality THCA flower, prized for its potent cannabinoid profile, rich terpene expression, and slow-cured freshness. Each month features different rotating strains and limited-run strains.

A pair of ultra-potent infused pre-rolls made with THCA flower enhanced with Sugar Diamond concentrate for a stronger, smoother, crystal-coated smoke.

A five-pack of sleek, individually rolled .5g pre-rolls crafted from high-grade THCA flower

A single gram of The Hemp Doctor’s notoriously strong Phuk’d Up THCA flower—bold, powerful, and bred for heavy-hitting sessions.

  • One LJC Single “Lucky” Joint

A special joint from the LJC (Lucky Joint Club), The Hemp Doctor’s loyalty program.

Each box includes a 6-pack of authentic RAW pre-rolled cones, known for their clean, even burns and effortless pack-and-sesh convenience. You’ll also get a box of matches.

  • Bonus merch such as stickers and mystery items (while supplies last)

Fun extras like branded stickers and rotating surprise merch items curated monthly to add collectible flair to each box.

A Premium Subscription Experience With a Personal Touch

What sets The Hemp Doctor’s THCA Flower Subscription Box apart is the brand’s commitment to doing more than just bundling random products. Each box’s contents are intentionally curated by real cannabis experts who understand strain quality, terpene profiles, and user preferences. These curated selections highlight exceptional flavor, potency, and freshness, giving subscribers access to craft-level flower they might not encounter through regular shopping.

“I love seeing what our team comes up with each month,” said Robert, Founder of The Hemp Doctor. “It’s kind of like opening a little surprise every time. Some months you’ll find something mellow, other months something that really hits hard, but it’s always quality stuff that makes me excited to light up. I think our flower box subscribers feel that same buzz of discovery.”

The subscription model also introduces consumers to limited-edition and small-batch cultivars. This is an opportunity for consumers to explore rare strains not always available for individual purchase. With monthly rotation and surprise elements included, Fresh Bloom is designed to feel like an exclusive members-only drop, every single month.

The Fresh Bloom THCA Flower Subscription Box represents the brand’s mission to redefine convenience and elevate the consumer experience with every delivery.

The subscription box is now available for purchase at: https://thehempdoctor.com/product/fresh-bloom-thca-flower-subscription-box/

All subscriptions require a minimum of two orders before cancellation is allowed.

About The Hemp Doctor

The Hemp Doctor has been providing quality hemp-derived products since 2018. The North Carolina-based company is known for offering cannabinoid products ranging from the best THCA flower to pre-rolls, concentrates, Delta 9 gummies, vapes, and more.

The company stands out for its dedication to producing quality products at par with customer satisfaction. With over 250,000 satisfied returning customers, thousands of subscribers, 10,000+ great reviews, and a Trustpilot rating of 4.6 out of 5 stars, The Hemp Doctor has positioned itself as a leader in the industry.

As a company strictly adhering to lawful and safe human consumption, The Hemp Doctor’s array of products undergoes third-party DEA-certified lab testing.

For media inquiries, interviews, or additional information, please contact:

Tara Phoenix

tara@thehempdoctor.com

+1 917-797-8347

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/f6b5f810-eae5-421c-8de8-57ef8afda7a6

Hapbee Appoints Hasan Shahid to Board of Directors to Strengthen Capital Markets & Strategic Growth Capabilities

Hapbee Appoints Hasan Shahid to Board of Directors to Strengthen Capital Markets & Strategic Growth Capabilities




Hapbee Appoints Hasan Shahid to Board of Directors to Strengthen Capital Markets & Strategic Growth Capabilities

Seasoned technologist, investor, and capital markets leader joins Hapbee’s Board

VANCOUVER, British Columbia, Dec. 03, 2025 (GLOBE NEWSWIRE) — Hapbee Technologies, Inc. (TSXV: HAPB; OTCQB: HAPBF; FWB: HA1) (“Hapbee” or the “Company”) is pleased to announce the appointment of Hasan Shahid to its Board of Directors. Mr. Shahid brings more than 25 years of experience across technology, digital transformation, capital markets, and alternative investments, strengthening the Company’s strategic capabilities as it continues scaling its platform and partnerships.

Hasan Shahid is the Founder and Chief Investment Officer of League Capital, a New York–based hedge fund specializing in technology, artificial intelligence, digital assets, and alternative investment strategies. Under his leadership, League Capital has delivered exceptional performance while serving private clients and family offices.

A seasoned operator and investor, Mr. Shahid has founded and led multiple ventures throughout his career. He launched iDream Labs, an angel investment and incubation platform for disruptive technologies spanning AI, crypto, fintech, and cloud infrastructure. His portfolio includes notable early investments such as:

  • Miner One (the first Bitcoin mining initiative launched in space)
  • Apex Fund (the first tokenized fund of funds)
  • Jurny (AI hospitality management SaaS)
  • Substack (subscription-based publishing platform)
  • Wefunder (startup crowdfunding marketplace)
  • Waterloop (SpaceX Hyperloop competition finalist)

Mr. Shahid holds a Systems Design Engineering degree from the University of Waterloo and dual MBAs from Columbia Business School and London Business School. His experience spans digital transformations, structured finance, corporate governance, and scaling high-growth technology organizations – all valuable competencies for a public company board.

“Hasan’s appointment fills a major strategic capability need for Hapbee, particularly as we expand our capital markets readiness and deepen our pipeline of institutional partnerships,” said Riz Shah, Chairman of Hapbee. “His combination of investment acumen, technology leadership, and experience guiding high-growth organizations will be instrumental as we execute our next phase of growth. We are excited to welcome Hasan to the Board.”

The Company also announces that Rachid Lassal has stepped down from the Board of Directors. The board of Hapbee thanks Mr. Lassal for his service and contributions to the Company and wishes him the very best in his future endeavors.

About Hapbee

Hapbee Technologies, Inc. is a digital wellness company that helps people optimize their sleep, relaxation, mood, and performance using patented ultra-low-frequency technology. Delivered through the Hapbee Neckband, Sleep Pad, and a growing ecosystem of future form factors, Hapbee enables users to choose how they feel — safely, non-invasively, and without chemicals or drugs.

For more information, visit www.hapbee.com.

Forward-Looking Information and Statements

This news release contains “forward-looking information” which may include, but is not limited to, statements with respect to the Company’s planned operations, business strategy and developments. Forward-looking statements are based on the opinions and estimates of management as of the date such statements are made and are based on various assumptions.

Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include, among others, the receipt of applicable regulatory approvals; anticipated product development; consumer confidence; and general business, economic, competitive, political and social uncertainties. Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Forward-looking statements contained herein are made as of the date of this news release and the Company disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or results, except as may be required by applicable securities laws. There can be no assurance that forward-looking statements will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements.

Neither TSXV nor its Regulation Services Provider accepts responsibility for the adequacy or accuracy of this release.

On behalf of the Board of Directors:
Krishna Subramanian – Chief Financial Officer and Director
1 888 841 7086
invest@hapbee.com

For further information, please contact:
Media Contact: Jonathan Sheeri
jon@hapbee.com
T: 1 888-841-7086
www.hapbee.com

Axogen Announces FDA Approval of Biologics License Application for AVANCE® (acellular nerve allograft–arwx)

Axogen Announces FDA Approval of Biologics License Application for AVANCE® (acellular nerve allograft–arwx)




Axogen Announces FDA Approval of Biologics License Application for AVANCE® (acellular nerve allograft–arwx)

ALACHUA, Fla. and TAMPA, Fla., Dec. 03, 2025 (GLOBE NEWSWIRE) — Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical technologies for the restoration of peripheral nerve function, today announced that the U.S. Food and Drug Administration (the “FDA”) has approved the Biologics License Application (“BLA”) for AVANCE® (acellular nerve allograft-arwx).

Avance is an acellular nerve scaffold for the treatment of adult and pediatric patients aged 1 month or older with sensory, mixed, and motor peripheral nerve discontinuities.

The indications for sensory nerve discontinuities >25mm and for mixed and motor nerve discontinuities were approved under FDA’s Accelerated Approval pathway based on the effect on static two-point discrimination in sensory nerve gaps ≤25mm, which provided empirical evidence to reasonably predict clinical benefit given similarities in pathophysiology and anticipated therapeutic effects. Continued approval for these indications depends on verification and description of clinical benefit in confirmatory studies.

“All stakeholders in Axogen’s mission to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care should take great pride in today’s approval,” said Michael Dale, Axogen’s Chief Executive Officer. “This approval represents a meaningful shift from our historical classification as a human tissue product and brings the product in line with FDA’s classification of Avance as a biologic. This milestone clarifies and strengthens our regulatory footing and confirms approval for use of Avance as an acceptable therapeutic option for treating peripheral nerve discontinuities in all of Axogen’s present nerve repair use cases. The approved BLA and successful transition of Avance to a biologic regulatory framework should give all stakeholders the assurance that Avance has been rigorously evaluated and determined to be safe, pure, and potent for its intended use, and that its benefits outweigh its known or potential risks. We want to thank FDA and the surgical community for the tremendous work and collaboration over more than a decade to make this therapy available to patients.”

Commercial availability of the licensed Avance product is expected early in the second quarter of 2026. In the meantime, Avance remains available under the current tissue framework.

About Avance

Indications

AVANCE® is an acellular nerve scaffold indicated for the treatment of adult and pediatric patients aged one month and older with:

  • Sensory nerve discontinuity (≤25mm)
  • Sensory nerve discontinuity (>25mm); Approved under accelerated approval based on static two-point discrimination (s2PD) at 12 months in sensory nerve gaps ≤25 mm, which reasonably predicts clinical benefit. Continued approval is contingent upon confirmatory clinical trial results.
  • Mixed and motor nerve discontinuity; Approved under accelerated approval based on s2PD outcomes in sensory nerves; continued approval is contingent upon confirmatory clinical trial results.

Important Safety Information

Warnings and Precautions

  • Procedural Complications: Monitor for procedural complications, including pain, hyperesthesia, infection, implant site swelling, adhesions, hypertrophic scar formation, impaired motor or sensory function, bleeding, and neuroma formation, and manage accordingly.
  • Transmission of Infectious Diseases: Because AVANCE is made from human donor tissue, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Adverse Reactions

The most common adverse reactions (≥2%) were procedural pain (4%) and hyperesthesia (3%).

See full prescribing information for complete warnings, precautions, and risk information. Full Prescribing Information is available at www.avancenervegraft.com or by calling 1-888-296-4631.

About Axogen

Axogen (NASDAQ: AXGN) is focused on the science, development and commercialization of technologies for peripheral nerve repair. With a mission to make nerve repair the expected standard of care, Axogen advances the field through research, education, and collaboration with surgeons and healthcare providers across a global network.

Axogen’s product portfolio includes Avance® (acellular nerve allograft-arwx), Axoguard Nerve Connector®, Axoguard Nerve Protector®, Axoguard HA+ Nerve Protector™, Axoguard Nerve Cap®, and Avive+ Soft Tissue Matrix™. The Axogen portfolio of products is available in the United States, Canada, Germany, the United Kingdom, Spain and several other countries.​ For more information, visit www.axogeninc.com.

Cautionary Statements Concerning Forward-Looking Statements

This press release contains “forward-looking” statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations or predictions of future conditions, events, or results based on various assumptions and management’s estimates of trends and economic factors in the markets in which we are active, as well as our business plans. Words such as “expects,” “anticipates,” “priorities,” “objectives,” “targets,” “intends,” “plan(s),” “believes,” “seeks,” “estimates,” “projects,” “forecasts,” “continue,” “may,” “should,” “will,” “goals,” and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements include, but are not limited to, statements regarding the commercial availability of AVANCE in early 2026 and future confirmatory clinical trials required under accelerated approval, as well as statements related to Axogen’s ability to continue to serve all clinical nerve repair use cases. Actual results or events could differ materially from those described in any forward-looking statements as a result of various factors, including, without limitation, potential disruptions from global supply chain issues, inflation, hospital staffing challenges, product development timelines, regulatory processes, financial performance, surgeon and product adoption rates, market awareness of our products, and other risks described in our filings with the SEC. Forward-looking statements are not a guarantee of future performance, and actual results may differ materially from those projected. The forward-looking statements are representative only as of the date they are made, and, except as required by applicable law, we assume no responsibility to publicly update or revise any forward-looking statements.

Media Contact:
Axogen, Inc.
InvestorRelations@axogeninc.com

Axogen Announces FDA Approval of Biologics License Application for AVANCE® (acellular nerve allograft–arwx)

Axogen Announces FDA Approval of Biologics License Application for AVANCE® (acellular nerve allograft–arwx)




Axogen Announces FDA Approval of Biologics License Application for AVANCE® (acellular nerve allograft–arwx)

ALACHUA, Fla. and TAMPA, Fla., Dec. 03, 2025 (GLOBE NEWSWIRE) — Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical technologies for the restoration of peripheral nerve function, today announced that the U.S. Food and Drug Administration (the “FDA”) has approved the Biologics License Application (“BLA”) for AVANCE® (acellular nerve allograft-arwx).

Avance is an acellular nerve scaffold for the treatment of adult and pediatric patients aged 1 month or older with sensory, mixed, and motor peripheral nerve discontinuities.

The indications for sensory nerve discontinuities >25mm and for mixed and motor nerve discontinuities were approved under FDA’s Accelerated Approval pathway based on the effect on static two-point discrimination in sensory nerve gaps ≤25mm, which provided empirical evidence to reasonably predict clinical benefit given similarities in pathophysiology and anticipated therapeutic effects. Continued approval for these indications depends on verification and description of clinical benefit in confirmatory studies.

“All stakeholders in Axogen’s mission to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care should take great pride in today’s approval,” said Michael Dale, Axogen’s Chief Executive Officer. “This approval represents a meaningful shift from our historical classification as a human tissue product and brings the product in line with FDA’s classification of Avance as a biologic. This milestone clarifies and strengthens our regulatory footing and confirms approval for use of Avance as an acceptable therapeutic option for treating peripheral nerve discontinuities in all of Axogen’s present nerve repair use cases. The approved BLA and successful transition of Avance to a biologic regulatory framework should give all stakeholders the assurance that Avance has been rigorously evaluated and determined to be safe, pure, and potent for its intended use, and that its benefits outweigh its known or potential risks. We want to thank FDA and the surgical community for the tremendous work and collaboration over more than a decade to make this therapy available to patients.”

Commercial availability of the licensed Avance product is expected early in the second quarter of 2026. In the meantime, Avance remains available under the current tissue framework.

About Avance

Indications

AVANCE® is an acellular nerve scaffold indicated for the treatment of adult and pediatric patients aged one month and older with:

  • Sensory nerve discontinuity (≤25mm)
  • Sensory nerve discontinuity (>25mm); Approved under accelerated approval based on static two-point discrimination (s2PD) at 12 months in sensory nerve gaps ≤25 mm, which reasonably predicts clinical benefit. Continued approval is contingent upon confirmatory clinical trial results.
  • Mixed and motor nerve discontinuity; Approved under accelerated approval based on s2PD outcomes in sensory nerves; continued approval is contingent upon confirmatory clinical trial results.

Important Safety Information

Warnings and Precautions

  • Procedural Complications: Monitor for procedural complications, including pain, hyperesthesia, infection, implant site swelling, adhesions, hypertrophic scar formation, impaired motor or sensory function, bleeding, and neuroma formation, and manage accordingly.
  • Transmission of Infectious Diseases: Because AVANCE is made from human donor tissue, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Adverse Reactions

The most common adverse reactions (≥2%) were procedural pain (4%) and hyperesthesia (3%).

See full prescribing information for complete warnings, precautions, and risk information. Full Prescribing Information is available at www.avancenervegraft.com or by calling 1-888-296-4631.

About Axogen

Axogen (NASDAQ: AXGN) is focused on the science, development and commercialization of technologies for peripheral nerve repair. With a mission to make nerve repair the expected standard of care, Axogen advances the field through research, education, and collaboration with surgeons and healthcare providers across a global network.

Axogen’s product portfolio includes Avance® (acellular nerve allograft-arwx), Axoguard Nerve Connector®, Axoguard Nerve Protector®, Axoguard HA+ Nerve Protector™, Axoguard Nerve Cap®, and Avive+ Soft Tissue Matrix™. The Axogen portfolio of products is available in the United States, Canada, Germany, the United Kingdom, Spain and several other countries.​ For more information, visit www.axogeninc.com.

Cautionary Statements Concerning Forward-Looking Statements

This press release contains “forward-looking” statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations or predictions of future conditions, events, or results based on various assumptions and management’s estimates of trends and economic factors in the markets in which we are active, as well as our business plans. Words such as “expects,” “anticipates,” “priorities,” “objectives,” “targets,” “intends,” “plan(s),” “believes,” “seeks,” “estimates,” “projects,” “forecasts,” “continue,” “may,” “should,” “will,” “goals,” and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements include, but are not limited to, statements regarding the commercial availability of AVANCE in early 2026 and future confirmatory clinical trials required under accelerated approval, as well as statements related to Axogen’s ability to continue to serve all clinical nerve repair use cases. Actual results or events could differ materially from those described in any forward-looking statements as a result of various factors, including, without limitation, potential disruptions from global supply chain issues, inflation, hospital staffing challenges, product development timelines, regulatory processes, financial performance, surgeon and product adoption rates, market awareness of our products, and other risks described in our filings with the SEC. Forward-looking statements are not a guarantee of future performance, and actual results may differ materially from those projected. The forward-looking statements are representative only as of the date they are made, and, except as required by applicable law, we assume no responsibility to publicly update or revise any forward-looking statements.

Media Contact:
Axogen, Inc.
InvestorRelations@axogeninc.com

NovaBridge Announces Presentation of Ragistomig Expanded Phase 1 Data at ESMO-IO

NovaBridge Announces Presentation of Ragistomig Expanded Phase 1 Data at ESMO-IO




NovaBridge Announces Presentation of Ragistomig Expanded Phase 1 Data at ESMO-IO

  • Ragistomig is a 4-1BB X PD-L1 bispecific antibody, designed to treat patients who are relapsed or refractory to checkpoint inhibitors, a multi-billion dollar drug class hampered by widespread resistance
  • The Phase 1 ragistomig study achieved its objective, as the new Q6W extended dosing interval produced strong anti-tumor efficacy in PD-L1-non-responders, with an improved safety profile
  • The interim results, including immunological data on CD8+ cell proliferation and memory T-cell activation, are expected to be presented in a poster session at ESMO-IO on December 10, 2025

ROCKVILLE, Md., Dec. 03, 2025 (GLOBE NEWSWIRE) — NovaBridge Biosciences (Nasdaq: NBP) (NovaBridge or the Company) a global biotechnology platform company committed to accelerating access to innovative medicines, today announced that new data from the expanded Phase 1 dosing study for ragistomig, a 4-1BB X PD-L1 bispecific antibody, will be presented in a poster at the European Society for Medical Oncology – Immuno-Oncology Congress 2025 (ESMO-IO 2025) by co-developer ABL Bio. The poster (Abstract #688) will be presented by Gerald Falchook, MD, Director of the Sarah Cannon Research Institute (SCRI) at HealthONE Denver, on Wednesday, December 10th at 5:30 PM GMT.

“The expanded Phase 1 dosing study achieved its objective of extending the therapeutic window for ragistomig by defining a new dosing schedule that could provide strong anti-tumor efficacy and a more manageable tolerability profile, including improved hepatic safety. The data build on promising Phase 1 data presented at ASCO 2024 and support progression to combination studies which could significantly advance patient care,” said Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge.

“Ragistomig was designed to deliver new therapeutic options for patients who have developed resistance or relapsed after treatment with checkpoint inhibitors, a multi-billion dollar drug class that serves as the cornerstone of care for many cancers. We are encouraged by the promising ragistomig advancements and data that will be presented at ESMO-IO and look forward to continuing the program in collaboration with our partner, ABL Bio,” said Sean Fu, PhD, Chief Executive Officer of NovaBridge.

ESMO-IO Meeting information:

  • Title: Phase 1 Clinical Trial of Ragistomig (ABL503/TJ-L14B: PD-L1 × 4-1BB bispecific antibody) Q6W Dosing Balances Favorable Safety and Sustained Efficacy Through Extended Immunologic Memory and Reinvigoration of CD8+ T Cells
  • Abstract #688
  • Date and Time: Wednesday, December 10th at 5:30 PM GMT

A copy of the poster will be available here after the session. To review an overview of the Phase 1 dose escalation data, click here.

About Ragistomig

Ragistomig (also known as ABL503) is a differentiated novel bispecific that integrates a single-chain, Fc-silent PD-L1 segment as a tumor engager and 4-1BB segment as a conditional T cell activator. It was developed using ABL Bio’s “Grabody-T” bispecific antibody platform technology to overcome resistance to PD-(L)1 inhibition and stimulate 4-1BB activation only in the presence of PD-L1 expressing tumor cells, to minimize the risk of off-tumor toxicity. Preclinical studies demonstrated that the bispecific antibody showed better anti-tumor activity than its single-agent components. A Phase 1 dose expansion study (NCT04762641) is currently being conducted in the U.S. and South Korea. The study was designed with a primary endpoint of defining the dose-limiting toxicity and adverse event profile of ragistomig, as well as to observe the objective response rate, pharmacokinetic and immunogenicity profiles and other secondary endpoints.

Ragistomig (also known as ABL503) is being jointly developed with ABL Bio

ASCO 2024: the 2024 American Society for Clinical Oncology Annual Meeting; Q6W: every six weeks

About NovaBridge

NovaBridge is a global biotechnology platform company committed to accelerating access to innovative medicines. We combine deep business development expertise with agile translational clinical development to identify, accelerate, and advance breakthrough assets. By bridging science, strategy, and execution, NovaBridge enables transformative therapies to progress rapidly from discovery toward patients in need.

The Company’s differentiated pipeline is led by givastomig, a potential best-in-class, bispecific antibody (Claudin 18.2 x 4-1BB), and VIS-101, a second-in-class, potentially best-in-class bifunctional biologic, targeting VEGF-A and ANG2.

Givastomig conditionally activates T cells via the 4-1BB signaling pathway in the tumor microenvironment where Claudin 18.2 is expressed. Givastomig is being developed to treat Claudin 18.2-positive gastric cancer and other gastrointestinal malignancies. The Company is also collaborating with its partner, ABL Bio, for the development of ragistomig, a bispecific antibody integrating PD-L1 as a tumor engager and 4-1BB as a conditional T cell activator, in solid tumors. Additionally, NovaBridge owns worldwide rights outside of China to uliledlimab, an anti-CD73 antibody that targets adenosine-driven immunosuppression in cancer.

VIS-101 targets VEGF-A and ANG-2 to provide more potent and durable treatment benefits for patients with wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). VIS-101 is currently completing a large, randomized, dose-ranging Phase 2 study for wet AMD. NovaBridge is the majority shareholder of Visara, and Visara controls global rights to VIS-101, outside of Greater China and certain countries in Asia.

For more information, please visit https://www.novabridge.com and follow us on LinkedIn.

Forward Looking Statements

This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will”, “expects”, “believes”, “designed to”, “anticipates”, “future”, “intends”, “plans”, “potential”, “estimates”, “confident”, and similar terms or the negative thereof. NovaBridge may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the SEC), in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about the Company’s beliefs and expectations, are forward-looking statements. Forward-looking statements in this press release include, without limitation, statements regarding: the strategy, clinical development, plans, results, safety and efficacy of givastomig and VIS-101 and its other drug candidates, including ragistomg; the strategic and clinical development of NovaBridge’s drug candidates, including givastomig, ragistomig and VIS-101; anticipated clinical milestones and results, and related timing, and the impact of new leadership appointments. Forward-looking statements involve inherent risks and uncertainties that may cause actual results to differ materially from those contained in these forward-looking statements, including but not limited to the following: the Company’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may or may not support further development or New Drug Application/Biologics License Application (NDA/BLA) approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of the Company’s drug candidates; the Company’s ability to achieve commercial success for its drug candidates, if approved; the Company’s ability to obtain and maintain protection of intellectual property for its technology and drugs; the Company’s reliance on third parties to conduct drug development, manufacturing and other services; the Company’s limited operating history and the Company’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and those risks more fully discussed in the “Risk Factors” section in the Company’s annual report on Form 20-F filed with the SEC on April 3, 2025 as well as the discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the SEC. All forward-looking statements are based on information currently available to the Company. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law.

NovaBridge Investor & Media Contacts

PJ Kelleher
LifeSci Advisors
+1-617-430-7579
pkelleher@lifesciadvisors.com

NovaBridge Biosciences
+1-240-745-6330
IR@novabridge.com

NovaBridge Announces Presentation of Ragistomig Expanded Phase 1 Data at ESMO-IO

NovaBridge Announces Presentation of Ragistomig Expanded Phase 1 Data at ESMO-IO




NovaBridge Announces Presentation of Ragistomig Expanded Phase 1 Data at ESMO-IO

  • Ragistomig is a 4-1BB X PD-L1 bispecific antibody, designed to treat patients who are relapsed or refractory to checkpoint inhibitors, a multi-billion dollar drug class hampered by widespread resistance
  • The Phase 1 ragistomig study achieved its objective, as the new Q6W extended dosing interval produced strong anti-tumor efficacy in PD-L1-non-responders, with an improved safety profile
  • The interim results, including immunological data on CD8+ cell proliferation and memory T-cell activation, are expected to be presented in a poster session at ESMO-IO on December 10, 2025

ROCKVILLE, Md., Dec. 03, 2025 (GLOBE NEWSWIRE) — NovaBridge Biosciences (Nasdaq: NBP) (NovaBridge or the Company) a global biotechnology platform company committed to accelerating access to innovative medicines, today announced that new data from the expanded Phase 1 dosing study for ragistomig, a 4-1BB X PD-L1 bispecific antibody, will be presented in a poster at the European Society for Medical Oncology – Immuno-Oncology Congress 2025 (ESMO-IO 2025) by co-developer ABL Bio. The poster (Abstract #688) will be presented by Gerald Falchook, MD, Director of the Sarah Cannon Research Institute (SCRI) at HealthONE Denver, on Wednesday, December 10th at 5:30 PM GMT.

“The expanded Phase 1 dosing study achieved its objective of extending the therapeutic window for ragistomig by defining a new dosing schedule that could provide strong anti-tumor efficacy and a more manageable tolerability profile, including improved hepatic safety. The data build on promising Phase 1 data presented at ASCO 2024 and support progression to combination studies which could significantly advance patient care,” said Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge.

“Ragistomig was designed to deliver new therapeutic options for patients who have developed resistance or relapsed after treatment with checkpoint inhibitors, a multi-billion dollar drug class that serves as the cornerstone of care for many cancers. We are encouraged by the promising ragistomig advancements and data that will be presented at ESMO-IO and look forward to continuing the program in collaboration with our partner, ABL Bio,” said Sean Fu, PhD, Chief Executive Officer of NovaBridge.

ESMO-IO Meeting information:

  • Title: Phase 1 Clinical Trial of Ragistomig (ABL503/TJ-L14B: PD-L1 × 4-1BB bispecific antibody) Q6W Dosing Balances Favorable Safety and Sustained Efficacy Through Extended Immunologic Memory and Reinvigoration of CD8+ T Cells
  • Abstract #688
  • Date and Time: Wednesday, December 10th at 5:30 PM GMT

A copy of the poster will be available here after the session. To review an overview of the Phase 1 dose escalation data, click here.

About Ragistomig

Ragistomig (also known as ABL503) is a differentiated novel bispecific that integrates a single-chain, Fc-silent PD-L1 segment as a tumor engager and 4-1BB segment as a conditional T cell activator. It was developed using ABL Bio’s “Grabody-T” bispecific antibody platform technology to overcome resistance to PD-(L)1 inhibition and stimulate 4-1BB activation only in the presence of PD-L1 expressing tumor cells, to minimize the risk of off-tumor toxicity. Preclinical studies demonstrated that the bispecific antibody showed better anti-tumor activity than its single-agent components. A Phase 1 dose expansion study (NCT04762641) is currently being conducted in the U.S. and South Korea. The study was designed with a primary endpoint of defining the dose-limiting toxicity and adverse event profile of ragistomig, as well as to observe the objective response rate, pharmacokinetic and immunogenicity profiles and other secondary endpoints.

Ragistomig (also known as ABL503) is being jointly developed with ABL Bio

ASCO 2024: the 2024 American Society for Clinical Oncology Annual Meeting; Q6W: every six weeks

About NovaBridge

NovaBridge is a global biotechnology platform company committed to accelerating access to innovative medicines. We combine deep business development expertise with agile translational clinical development to identify, accelerate, and advance breakthrough assets. By bridging science, strategy, and execution, NovaBridge enables transformative therapies to progress rapidly from discovery toward patients in need.

The Company’s differentiated pipeline is led by givastomig, a potential best-in-class, bispecific antibody (Claudin 18.2 x 4-1BB), and VIS-101, a second-in-class, potentially best-in-class bifunctional biologic, targeting VEGF-A and ANG2.

Givastomig conditionally activates T cells via the 4-1BB signaling pathway in the tumor microenvironment where Claudin 18.2 is expressed. Givastomig is being developed to treat Claudin 18.2-positive gastric cancer and other gastrointestinal malignancies. The Company is also collaborating with its partner, ABL Bio, for the development of ragistomig, a bispecific antibody integrating PD-L1 as a tumor engager and 4-1BB as a conditional T cell activator, in solid tumors. Additionally, NovaBridge owns worldwide rights outside of China to uliledlimab, an anti-CD73 antibody that targets adenosine-driven immunosuppression in cancer.

VIS-101 targets VEGF-A and ANG-2 to provide more potent and durable treatment benefits for patients with wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). VIS-101 is currently completing a large, randomized, dose-ranging Phase 2 study for wet AMD. NovaBridge is the majority shareholder of Visara, and Visara controls global rights to VIS-101, outside of Greater China and certain countries in Asia.

For more information, please visit https://www.novabridge.com and follow us on LinkedIn.

Forward Looking Statements

This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will”, “expects”, “believes”, “designed to”, “anticipates”, “future”, “intends”, “plans”, “potential”, “estimates”, “confident”, and similar terms or the negative thereof. NovaBridge may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the SEC), in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about the Company’s beliefs and expectations, are forward-looking statements. Forward-looking statements in this press release include, without limitation, statements regarding: the strategy, clinical development, plans, results, safety and efficacy of givastomig and VIS-101 and its other drug candidates, including ragistomg; the strategic and clinical development of NovaBridge’s drug candidates, including givastomig, ragistomig and VIS-101; anticipated clinical milestones and results, and related timing, and the impact of new leadership appointments. Forward-looking statements involve inherent risks and uncertainties that may cause actual results to differ materially from those contained in these forward-looking statements, including but not limited to the following: the Company’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may or may not support further development or New Drug Application/Biologics License Application (NDA/BLA) approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of the Company’s drug candidates; the Company’s ability to achieve commercial success for its drug candidates, if approved; the Company’s ability to obtain and maintain protection of intellectual property for its technology and drugs; the Company’s reliance on third parties to conduct drug development, manufacturing and other services; the Company’s limited operating history and the Company’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and those risks more fully discussed in the “Risk Factors” section in the Company’s annual report on Form 20-F filed with the SEC on April 3, 2025 as well as the discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the SEC. All forward-looking statements are based on information currently available to the Company. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law.

NovaBridge Investor & Media Contacts

PJ Kelleher
LifeSci Advisors
+1-617-430-7579
pkelleher@lifesciadvisors.com

NovaBridge Biosciences
+1-240-745-6330
IR@novabridge.com

Regentis Biomaterials Ltd. Announces Pricing of Initial Public Offering

Regentis Biomaterials Ltd. Announces Pricing of Initial Public Offering




Regentis Biomaterials Ltd. Announces Pricing of Initial Public Offering

Herzliya, Israel, Dec. 03, 2025 (GLOBE NEWSWIRE) — Regentis Biomaterials Ltd. (NYSE American: RGNT) (“Regentis”, or the “Company”), a regenerative medicine company dedicated to developing innovative tissue repair solutions that seek to restore the health and enhance the quality of life of patients, today announced the pricing of its initial public offering (the “Offering”) of 1,250,000 ordinary shares (“Ordinary Shares”) at an initial public offering price of $8.00 per Ordinary Share, for aggregate gross proceeds of $10,000,000 before deducting underwriting discounts and estimated offering expenses payable by the Company. In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 187,500 Ordinary Shares to cover over-allotments, if any.

The Ordinary Shares are expected to begin trading on the NYSE American LLC on December 4, 2025, under the symbol “RGNT”. The Offering is expected to close on or about December 5, 2025, subject to satisfaction of customary closing conditions.

The Company intends to use the net proceeds from the Offering primarily for development activities, including the completion of its pivotal trial, and preparation of the PMA submission for GerlinC, and also for corporate purposes including the repayment of certain debt and deferred compensation payments.

ThinkEquity is acting as sole book-running manager for the Offering.

A Registration Statement on Form F-1 (File No. 333-285692) and amendments thereto relating to the Ordinary Shares being sold in the Offering was filed with the U.S. Securities and Exchange Commission (“SEC”) and became effective, as amended, on November 12, 2025. The Offering is being made only by means of a prospectus. Copies of the preliminary prospectus and the final prospectus, when available, may be obtained from ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004.  The preliminary prospectus was filed with the SEC and is available, and the final prospectus will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov.

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

About Regentis Biomaterials Ltd.

Regentis Biomaterials Ltd. is a regenerative medicine company dedicated to developing innovative tissue repair solutions that seek to restore the health and enhance the quality of life of patients. The Company’s current efforts are focused on orthopedic treatments using its Gelrin platform based on degradable hydrogel implants to regenerate damaged or diseased tissue. GelrinC is Regentis’ cartilage injury therapeutic based on a unique hydrogel, erodible and resorbable, matrix of polyethylene glycol. The Company’s lead product candidate, GelrinC, is a cell-free, off-the-shelf hydrogel that is cured into a temporary implant in the knee for the treatment of painful injuries to articular knee cartilage. GelrinC was approved as a device with a Conformité Européene mark in Europe, (CE mark number 3900600CE02). The Company plans to start commercialization efforts in Europe to bring its product to market, while being focused in parallel on completing its pivotal study for obtaining United States Food and Drug Administration approval. For more information, please visit https://www.regentis.co.il/

Forward Looking Statements

This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words, and include the expected start of trading of the Ordinary Shares on the NYSE American LLC, the expected use of proceeds, and the expected date of closing of the Offering. Forward-looking statements are based on Regentis’ current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. For a more detailed description of the risks and uncertainties affecting Regentis, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the section titled “Risk Factors” in the final prospectus related to the public offering filed with the SEC. Forward-looking statements contained in this announcement are made as of this date, and Regentis undertakes no duty to update such information except as required under applicable law.

For Investor Relations Inquiries

Arie Gordashnikov
arie@shimony.com
+972-3-6116629

Regentis Biomaterials Ltd. Announces Pricing of Initial Public Offering

Regentis Biomaterials Ltd. Announces Pricing of Initial Public Offering




Regentis Biomaterials Ltd. Announces Pricing of Initial Public Offering

Herzliya, Israel, Dec. 03, 2025 (GLOBE NEWSWIRE) — Regentis Biomaterials Ltd. (NYSE American: RGNT) (“Regentis”, or the “Company”), a regenerative medicine company dedicated to developing innovative tissue repair solutions that seek to restore the health and enhance the quality of life of patients, today announced the pricing of its initial public offering (the “Offering”) of 1,250,000 ordinary shares (“Ordinary Shares”) at an initial public offering price of $8.00 per Ordinary Share, for aggregate gross proceeds of $10,000,000 before deducting underwriting discounts and estimated offering expenses payable by the Company. In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 187,500 Ordinary Shares to cover over-allotments, if any.

The Ordinary Shares are expected to begin trading on the NYSE American LLC on December 4, 2025, under the symbol “RGNT”. The Offering is expected to close on or about December 5, 2025, subject to satisfaction of customary closing conditions.

The Company intends to use the net proceeds from the Offering primarily for development activities, including the completion of its pivotal trial, and preparation of the PMA submission for GerlinC, and also for corporate purposes including the repayment of certain debt and deferred compensation payments.

ThinkEquity is acting as sole book-running manager for the Offering.

A Registration Statement on Form F-1 (File No. 333-285692) and amendments thereto relating to the Ordinary Shares being sold in the Offering was filed with the U.S. Securities and Exchange Commission (“SEC”) and became effective, as amended, on November 12, 2025. The Offering is being made only by means of a prospectus. Copies of the preliminary prospectus and the final prospectus, when available, may be obtained from ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004.  The preliminary prospectus was filed with the SEC and is available, and the final prospectus will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov.

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

About Regentis Biomaterials Ltd.

Regentis Biomaterials Ltd. is a regenerative medicine company dedicated to developing innovative tissue repair solutions that seek to restore the health and enhance the quality of life of patients. The Company’s current efforts are focused on orthopedic treatments using its Gelrin platform based on degradable hydrogel implants to regenerate damaged or diseased tissue. GelrinC is Regentis’ cartilage injury therapeutic based on a unique hydrogel, erodible and resorbable, matrix of polyethylene glycol. The Company’s lead product candidate, GelrinC, is a cell-free, off-the-shelf hydrogel that is cured into a temporary implant in the knee for the treatment of painful injuries to articular knee cartilage. GelrinC was approved as a device with a Conformité Européene mark in Europe, (CE mark number 3900600CE02). The Company plans to start commercialization efforts in Europe to bring its product to market, while being focused in parallel on completing its pivotal study for obtaining United States Food and Drug Administration approval. For more information, please visit https://www.regentis.co.il/

Forward Looking Statements

This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words, and include the expected start of trading of the Ordinary Shares on the NYSE American LLC, the expected use of proceeds, and the expected date of closing of the Offering. Forward-looking statements are based on Regentis’ current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. For a more detailed description of the risks and uncertainties affecting Regentis, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the section titled “Risk Factors” in the final prospectus related to the public offering filed with the SEC. Forward-looking statements contained in this announcement are made as of this date, and Regentis undertakes no duty to update such information except as required under applicable law.

For Investor Relations Inquiries

Arie Gordashnikov
arie@shimony.com
+972-3-6116629

Mesoblast Participation at Piper Sandler Conference

Mesoblast Participation at Piper Sandler Conference




Mesoblast Participation at Piper Sandler Conference

NEW YORK, Dec. 03, 2025 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced its participation at the Piper Sandler 37th Annual Healthcare Conference in New York on December 2–4, 2025.

Silviu Itescu, Chief Executive of Mesoblast, is scheduled for a fireside chat at 12.00 p.m. ET on Thursday, December 4, 2025. A live webcast of the event will be available using this weblink https://event.webcasts.com/starthere.jsp?ei=1745867&tp_key=270ef917d6.

A replay of the webcast will be available following the completion of the event for up to 30 days on Mesoblast’s website at investorsmedia.mesoblast.com/events.

About Mesoblast
Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The therapies from the Company’s proprietary mesenchymal lineage cell therapy technology platform respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process.

Mesoblast’s Ryoncil® (remestemcel-L-rknd) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months and older is the first FDA-approved mesenchymal stromal cell (MSC) therapy. Please see the full Prescribing Information at www.ryoncil.com.

Mesoblast is committed to developing additional cell therapies for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. Ryoncil® is being developed for additional inflammatory diseases including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for heart failure and chronic low back pain. The Company has established commercial partnerships in Japan, Europe and China.

About Mesoblast intellectual property: Mesoblast has a strong and extensive global intellectual property portfolio, with over 1,000 granted patents or patent applications covering mesenchymal stromal cell compositions of matter, methods of manufacturing and indications. These granted patents and patent applications provide commercial protection extending through to at least 2044 in all major markets.

About Mesoblast manufacturing: The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.

Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and X: @Mesoblast

Forward-Looking Statements
This press release includes forward-looking statements and forecasts that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast’s preclinical and clinical studies, and Mesoblast’s research and development programs; Mesoblast’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast’s ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast’s RYONCIL for pediatric SR-aGVHD and any other product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast’s product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast’s ability to enter into and maintain established strategic collaborations; Mesoblast’s ability to establish and maintain intellectual property on its product candidates and Mesoblast’s ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast’s expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast’s financial performance; developments relating to Mesoblast’s competitors and industry; and the pricing and reimbursement of Mesoblast’s product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise, except where required by law or the ASX Listing Rules. Past performance given in this announcement is given for illustrative purposes only and should not be relied on as (and is not) an indication of future performance.

Not financial product advice

This announcement does not constitute financial product advice or investment advice (nor tax, accounting or legal advice) and has been prepared without taking into account the objectives, financial situation or needs of individuals. Before making an investment decision, prospective investors should consider the appropriateness of the information having regard to their own objectives, financial situation and needs and seek appropriate professional advice.

Disclaimer

To the maximum extent permitted by law, Mesoblast and its directors, officers, employees, advisers and agents disclaim any obligation or undertaking to release any updates or revisions to the information to reflect any change in expectations or assumptions, and disclaim all responsibility and liability for these forward-looking statements (including, without limitation, any liability for negligence).

Release authorized by the Chief Executive.

For more information, please contact:

Corporate Communications / Investors
Paul Hughes
T: +61 3 9639 6036
 
Media – Global
Allison Worldwide
Emma Neal
T: +1 603 545 4843
E: emma.neal@allisonworldwide.com
 
Media – Australia
BlueDot Media
Steve Dabkowski
T: +61 419 880 486
E: steve@bluedot.net.au

Mesoblast Participation at Piper Sandler Conference

Mesoblast Participation at Piper Sandler Conference




Mesoblast Participation at Piper Sandler Conference

NEW YORK, Dec. 03, 2025 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced its participation at the Piper Sandler 37th Annual Healthcare Conference in New York on December 2–4, 2025.

Silviu Itescu, Chief Executive of Mesoblast, is scheduled for a fireside chat at 12.00 p.m. ET on Thursday, December 4, 2025. A live webcast of the event will be available using this weblink https://event.webcasts.com/starthere.jsp?ei=1745867&tp_key=270ef917d6.

A replay of the webcast will be available following the completion of the event for up to 30 days on Mesoblast’s website at investorsmedia.mesoblast.com/events.

About Mesoblast
Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The therapies from the Company’s proprietary mesenchymal lineage cell therapy technology platform respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process.

Mesoblast’s Ryoncil® (remestemcel-L-rknd) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months and older is the first FDA-approved mesenchymal stromal cell (MSC) therapy. Please see the full Prescribing Information at www.ryoncil.com.

Mesoblast is committed to developing additional cell therapies for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. Ryoncil® is being developed for additional inflammatory diseases including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for heart failure and chronic low back pain. The Company has established commercial partnerships in Japan, Europe and China.

About Mesoblast intellectual property: Mesoblast has a strong and extensive global intellectual property portfolio, with over 1,000 granted patents or patent applications covering mesenchymal stromal cell compositions of matter, methods of manufacturing and indications. These granted patents and patent applications provide commercial protection extending through to at least 2044 in all major markets.

About Mesoblast manufacturing: The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.

Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and X: @Mesoblast

Forward-Looking Statements
This press release includes forward-looking statements and forecasts that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast’s preclinical and clinical studies, and Mesoblast’s research and development programs; Mesoblast’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast’s ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast’s RYONCIL for pediatric SR-aGVHD and any other product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast’s product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast’s ability to enter into and maintain established strategic collaborations; Mesoblast’s ability to establish and maintain intellectual property on its product candidates and Mesoblast’s ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast’s expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast’s financial performance; developments relating to Mesoblast’s competitors and industry; and the pricing and reimbursement of Mesoblast’s product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise, except where required by law or the ASX Listing Rules. Past performance given in this announcement is given for illustrative purposes only and should not be relied on as (and is not) an indication of future performance.

Not financial product advice

This announcement does not constitute financial product advice or investment advice (nor tax, accounting or legal advice) and has been prepared without taking into account the objectives, financial situation or needs of individuals. Before making an investment decision, prospective investors should consider the appropriateness of the information having regard to their own objectives, financial situation and needs and seek appropriate professional advice.

Disclaimer

To the maximum extent permitted by law, Mesoblast and its directors, officers, employees, advisers and agents disclaim any obligation or undertaking to release any updates or revisions to the information to reflect any change in expectations or assumptions, and disclaim all responsibility and liability for these forward-looking statements (including, without limitation, any liability for negligence).

Release authorized by the Chief Executive.

For more information, please contact:

Corporate Communications / Investors
Paul Hughes
T: +61 3 9639 6036
 
Media – Global
Allison Worldwide
Emma Neal
T: +1 603 545 4843
E: emma.neal@allisonworldwide.com
 
Media – Australia
BlueDot Media
Steve Dabkowski
T: +61 419 880 486
E: steve@bluedot.net.au