Anaptys Initiates Litigation Against Tesaro, a GSK Subsidiary




Anaptys Initiates Litigation Against Tesaro, a GSK Subsidiary

SAN DIEGO, Nov. 21, 2025 (GLOBE NEWSWIRE) — AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, announced it has filed a Verified Complaint in Delaware Chancery Court, requesting a court declaration that TESARO, Inc. (“Tesaro”) has materially breached the parties’ Collaboration and Exclusive License Agreement (“Collaboration Agreement”) and that GSK (Tesaro’s corporate parent) has tortiously interfered with the Collaboration Agreement. Anaptys has requested that the court declare that Anaptys is entitled to all rights and remedies under the Collaboration Agreement.

The Complaint contends that Tesaro breached, and GSK induced Tesaro to breach, multiple material Collaboration Agreement terms. Under these terms, Tesaro agreed that it would not conduct or participate in research, development, manufacturing or commercialization of any PD-1 antagonist other than those licensed by Anaptys to Tesaro. The Collaboration Agreement also provides that Tesaro will “use Commercially Reasonable Efforts to . . . obtain the optimum commercial return for [Jemperli] in all major markets throughout the world.”

Despite these obligations, the Complaint contends that Tesaro (i) violated its exclusivity obligations by participating in past, ongoing, and upcoming governed clinical trials with PD-1 antagonists that compete with Jemperli, including Keytruda, and (ii) failed to use Commercially Reasonable Efforts to obtain the “optimum commercial return” for Jemperli by, among other things, participating in a course of conduct with GSK to favor GSK’s antibody-drug conjugate (ADC) product candidates, including by pairing those ADCs with PD-1 antagonists that directly compete with Jemperli.

In 2020, Anaptys similarly filed a complaint against GSK regarding breaches of its obligations under the Collaboration Agreement. Those breaches at the time related to GSK’s planned clinical trial of Zejula, another of GSK’s oncology programs, in combination with Keytruda, without the consent of Anaptys. This planned trial violated Tesaro’s exclusivity obligations. This complaint resulted in a settlement that included a cash payment, a royalty on Zejula and a substantial increase in royalties on sales of Jemperli due to Anaptys.

While Anaptys had approached Tesaro to engage in good faith discussions to potentially resolve these claims, on Nov. 20, 2025, Tesaro, without notice, initiated a lawsuit against Anaptys. Tesaro’s complaint includes requests for injunctive relief, claiming that Anaptys has breached the Collaboration Agreement. Tesaro’s claim for breach is predicated on an allegation that Anaptys has improperly alleged that Tesaro had breached the Collaboration Agreement. Tesaro seeks to improperly restrain Anaptys from exercising its legal rights under the Collaboration Agreement in violation of Delaware’s anti-SLAPP statute and other legal protections. Anaptys contends that Tesaro’s claims are entirely without merit and intends to pursue all appropriate legal remedies against Tesaro, including dismissal of such claims at the earliest opportunity and the potential for additional litigation.

The parties have agreed to request an expedited schedule with the Delaware Chancery Court, with trial anticipated in July 2026.

Milestone and royalty payment obligations to Anaptys pursuant to the Collaboration Agreement continue to be due during the proceedings.

About the Collaboration and Exclusive License Agreement

In March 2014, Anaptys entered into the Collaboration Agreement with Tesaro, an oncology-focused biopharmaceutical company now a part of GSK. Currently, under the Collaboration Agreement, Tesaro is developing Jemperli (dostarlimab) as a monotherapy, and in combination with additional therapies, for various solid tumor indications.

Anaptys is eligible to receive royalties upon sales of Jemperli, equal to 8% of net sales below $1.0 billion, 12% of net sales between $1.0 billion and $1.5 billion, 20% of net sales between $1.5 billion and $2.5 billion and 25% of net sales above $2.5 billion. In Q4 2025, Anaptys anticipates accruing a one-time $75 million commercial sales milestone from Tesaro once Jemperli achieves $1 billion in worldwide net sales.

The royalty term under this collaboration extends at least through expiration of composition of matter coverage on the molecule which expires in 2035 in the U.S. and in 2036 in the EU.

Currently, Jemperli receivables from Tesaro are payable to Sagard as a result of prior capped non-recourse monetizations and will terminate once Sagard has received an aggregate of either $600 million by March 31, 2031, or $675 million any time thereafter. Anaptys estimates Sagard will have accrued $250 million in royalties and sales milestones through year end 2025¹ and anticipates the full paydown of $600 million between Q2 2027 and Q2 2028. 

About Anaptys

Anaptys is a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics for autoimmune and inflammatory diseases. The company’s pipeline includes rosnilimab, a pathogenic T cell depleter, which has completed a Phase 2b trial for rheumatoid arthritis; ANB033, a CD122 antagonist, in a Phase 1b trial for celiac disease with plans to expand development into an additional indication; and ANB101, a BDCA2 modulator, in a Phase 1a trial. Anaptys has also discovered and out-licensed in financial collaborations multiple therapeutic antibodies, including a PD-1 antagonist (Jemperli (dostarlimab-gxly)) to GSK and an IL-36R antagonist (imsidolimab) to Vanda Pharmaceuticals. To learn more, visit www.AnaptysBio.com or follow us on LinkedIn.

Anaptys recently announced the intent to separate its biopharma operations from its substantial royalty assets by year-end 2026, enabling investors to align their investment philosophies and portfolio allocation with the strategic opportunities and financial objectives of each company. Learn more here.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the potential termination of the Collaboration Agreement, the timing and potential outcome of proceedings in Delaware Chancery Court, the return of Jemperli to the company, and the nature of the remedies we may obtain in such proceedings. Statements including words such as “plan,” “continue,” “expect,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause the company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company’s ability to advance its product candidates, obtain regulatory approval of and ultimately commercialize its product candidates, the timing and results of preclinical and clinical trials, the company’s ability to fund development activities and achieve development goals, the company’s ability to protect intellectual property and other risks and uncertainties described under the heading “Risk Factors” in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. 

Contact:
Nick Montemarano
Executive Director, Investor Relations
858.732.0178
investors@anaptysbio.com

^{1. Anticipate ~$250 million of Sagard accruals by YE 2025 including $143 million paid through June 30, 2025, approximately $75 million accrued in the third quarter of 2025 and assumes a ~15% quarter-over-quarter growth rate for Jemperli in Q4 2025}

BioAtla Enters into Agreements for up to $22.5 Million Flexible Financing




BioAtla Enters into Agreements for up to $22.5 Million Flexible Financing

• These agreements are designed to be a flexible financing solution to support operations while finalizing a strategic partnership
• Company is in advanced stages to finalize a strategic transaction with a potential partner, and it remains on track to complete the transaction by year end
• These agreements ensure BioAtla can maintain operational momentum while completing that process

SAN DIEGO, Nov. 21, 2025 (GLOBE NEWSWIRE) — BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics for the treatment of solid tumors, today announced that it has entered into Pre-paid Advance Agreements with an affiliate of Yorkville Advisors Global (Yorkville) and funds managed by of Anson Advisors Inc. to provide an aggregate $7.5 million advance to the Company. BioAtla also entered into a Standby Equity Purchase Agreement in which Yorkville has a commitment to buy, if the Company exercises its option, for up to a total of $15 million of common stock at a 3% discount to the then current market prices over three years, subject to certain conditions.

“These agreements provide us with financial flexibility and ensure BioAtla can maintain operational momentum as we work to finalize a strategic partnership that we believe will unlock significant value for BioAtla and our shareholders,” said Jay M. Short, Ph.D., Chairman, CEO and co-founder of BioAtla. “We remain on-track to complete this transaction by year end.”

Key terms of the pre-paid advance include $7.5 million purchased at 95% of face value for $7.125 million gross proceeds received at closing. This advance accrues interest at 4% and may be repaid in cash or converted into common stock based on a conversion price equal to the lower of $1.39 or 95% of the lowest daily VWAP over trading day look back period. The trading day look back period will begin no earlier than November 18, 2025.

Tungsten Advisors acted as the sole placement agent for these agreements.

A more detailed description of the agreements can be found in BioAtla’s Form 8-K filed with the U.S Securities and Exchange Commission (the “SEC”).

Legal Notice
The shares issuable under the Pre-Paid Advance Agreement and the Standby Equity Purchase Agreement are being offered by BioAtla pursuant to an effective shelf registration statement on Form S-3 (File No. 333-269148) previously filed with the SEC on January 6, 2023 and was declared effective on January 17, 2023. A prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, electronic copies of the prospectus supplement and the accompanying prospectus may also be obtained from Tungsten Advisors, 767 Third Ave, 29th Floor, New York, NY 10017, by phone at (917) 268-1097 or email at prospectus@tungstenadv.com.

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

About BioAtla^®, Inc. 
BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and in Beijing, China through its contractual relationship with BioDuro-Sundia, a provider of preclinical development services. Utilizing its proprietary CAB platform technology, BioAtla develops novel, reversibly active monoclonal and bispecific antibodies and other protein therapeutic product candidates. CAB product candidates are designed to have more selective targeting, greater efficacy with lower toxicity, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has extensive and worldwide patent coverage for its CAB platform technology and products with greater than 780 active patent matters, more than 500 of which are issued patents. Broad patent coverage in all major markets include methods of making, screening and manufacturing CAB product candidates in a wide range of formats and composition of matter coverage for specific products. To learn more about BioAtla, Inc., visit www.bioatla.com.

About Ozuriftamab Vedotin (Oz-V)
Ozuriftamab vedotin (Oz-V), CAB-Platform-ROR2-ADC, is a conditionally and reversibly active antibody drug conjugate directed against ROR2, a transmembrane receptor tyrosine kinase that is present across many different solid tumors including head and neck, lung, triple-negative breast cancer and melanoma. Overexpression of ROR2, a noncanonical wnt5A signaling receptor, is driven by oncoproteins associated with HPV infection and forms a cancer axis that is associated with poor prognosis and resistance to chemo- and immunotherapies. This Phase 3 ready clinical asset is targeting multiple solid tumor indications, including the treatment of patients with OPSCC who have previously experienced progression on PD-1/L1 therapies and platinum chemotherapy. The FDA granted Fast Track Designation to ozuriftamab vedotin for the treatment of patients with recurrent or metastatic SCCHN.

About CAB-EpCAM x CAB-CD3 Bispecific T-cell Engager Antibody
BioAtla is developing BA3182 as a potential anticancer therapy for patients with advanced adenocarcinoma. BA3182 is a (CAB) EpCAM x (CAB) CD3 bispecific T cell engager antibody that contains two binding sites for EpCAM and two binding sites for CD3ε. The binding sites for EpCAM and CD3ε have been designed to bind their respective targets specifically and reversibly under the conditions found in the TME and to have reduced binding outside of the TME. The CAB selective binding to both the CAB EpCAM and CAB CD3ε arms are required to activate the T cell engagement against the tumor, thus enabling the combined selectivity of each CAB binding arm in the bispecific antibody. BioAtla continues to advance the ongoing Phase 1 study to evaluate the safety, pharmacokinetics, and efficacy of BA3182 in advanced adenocarcinoma patients.

Forward-looking Statements
Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “expect,” “believe,” “will,” “may,” “should,” “estimate,” “project,” “outlook,” “forecast” or other similar words. Examples of forward-looking statements include, among others, statements we make regarding BioAtla’s business plans and prospects; and the expected timing, benefits and outcomes of our strategic partnerships and transactions. Forward-looking statements are based on BioAtla’s current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: factors that raise substantial doubt about our ability to continue as a going concern and that we will need additional funding to continue development of our CAB technology platform and our CAB product candidates; the risk that preliminary or interim clinical results may not be indicative of results from later cohorts or larger populations; potential delays in clinical and preclinical trials; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, or regulatory approval dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; whether regulatory authorities will be satisfied with the design of and results from the clinical studies or take favorable regulatory actions based on results from the clinical studies; our dependence on the success of our CAB technology platform; our ability to enroll patients in our ongoing and future clinical trials; the successful selection and prioritization of assets to focus development on selected product candidates and indications; our ability to form collaborations and partnerships with third parties and the success of such collaborations and partnerships; our reliance on third parties for the manufacture and supply of our product candidates for clinical trials; our reliance on third parties to conduct our clinical trials and some aspects of our research and preclinical testing; potential adverse impacts due to geopolitical or macroeconomic events outside of our control, including health epidemics or pandemics; and those other risks and uncertainties described in the section titled “Risk Factors” in our Annual Report on Form 10-K filed with the SEC on March 27, 2025, our Quarterly Reports on Form 10-Q filed with the SEC on May 6, 2025, August 7, 2025 and November 13, 2025 and our subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and BioAtla undertakes no duty to update such information except as required under applicable laws. 

Internal Contact: 
Richard Waldron 
Chief Financial Officer 
BioAtla, Inc. 
rwaldron@bioatla.com
858.356.8945 

External Contact: 
Joyce Allaire
LifeSci Advisors, LLC 
jallaire@lifesciadvisors.com

Inhibikase Therapeutics Announces Pricing of $100 Million Public Offering of Common Stock and Pre-Funded Warrants




Inhibikase Therapeutics Announces Pricing of $100 Million Public Offering of Common Stock and Pre-Funded Warrants

WILMINGTON, Del., Nov. 20, 2025 (GLOBE NEWSWIRE) — Inhibikase Therapeutics, Inc. (NASDAQ: IKT) (“Inhibikase” or “Company”), a clinical-stage pharmaceutical company developing therapeutics to modify the course of pulmonary arterial hypertension (“PAH”), today announced the pricing of its underwritten public offering of 46,091,739 shares of common stock and pre-funded warrants to purchase 22,873,779 shares of common stock. The shares of common stock are being sold at an offering price of $1.45 per share, and the pre-funded warrants are being sold at an offering price of $1.449 per pre-funded warrant, which represents the per share offering price for the common stock less the $0.001 per share exercise price for each such pre-funded warrant. In addition, Inhibikase has granted the underwriters a 30-day option to purchase up to an additional 10,344,827 shares of its common stock at the public offering price, less underwriting discounts and commissions. The aggregate gross proceeds to Inhibikase from this offering are expected to be approximately $100.0 million, before deducting underwriting discounts and commissions and other offering expenses, excluding the exercise of any pre-funded warrants. All of the securities being sold in the offering are being offered by Inhibikase. The offering is expected to close on November 24, 2025, subject to the satisfaction of customary closing conditions.

Jefferies, BofA Securities and Cantor are acting as joint book-running managers for the offering. LifeSci Capital and Oppenheimer & Co. are acting as co-lead managers for the offering. H.C. Wainwright & Co. and Ladenburg Thalmann & Co. Inc. are acting as co-managers for the offering.

The securities described above are being offered by Inhibikase pursuant to a shelf registration statement on Form S-3 (No. 333-288213) that was previously filed with the Securities and Exchange Commission (“SEC”) and declared effective on June 27, 2025. This offering is being made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement and accompanying prospectus related to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov.   Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may also be obtained, when available, by contacting: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at prospectus_department@jefferies.com; BofA Securities, Inc., Attention: Prospectus Department, 201 North Tryon Street, NC1-022-02-25 Charlotte, NC 28255- 0001, or by email at dg.prospectus_requests@bofa.com; or Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, NY 10022, or by email at prospectus@cantor.com.

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

About Inhibikase Therapeutics

Inhibikase Therapeutics, Inc. (Nasdaq: IKT) is a clinical-stage pharmaceutical company developing therapeutics to modify the course of cardiopulmonary diseases namely, Pulmonary Arterial Hypertension (“PAH”), that arise from aberrant signaling through the Abelson Tyrosine Kinase, and type III receptor tyrosine kinases including platelet derived growth factor receptors and c-KIT. Our lead product candidate is IKT-001, a prodrug of imatinib mesylate, for PAH which is an orphan indication. PAH is a progressive, life-threatening disease characterized by pulmonary vascular remodeling and elevated pulmonary vascular resistance that affects approximately 50,000 Americans.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking terminology such as “believes,” “expects,” “may,” “will,” “should,” “anticipates,” “plans,” or similar expressions or the negative of these terms and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, uncertainties related to market conditions and statements regarding the timing, size and expected proceeds of the offering, the satisfaction of customary closing conditions related to the offering and sale of securities, and Inhibikase’s ability to complete the offering. These forward-looking statements are based on Inhibikase’s current expectations and assumptions. Such statements are subject to certain risks and uncertainties, which could cause Inhibikase’s actual results to differ materially from those anticipated by the forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include our ability to execute clinical trials, including to evaluate IKT-001 as a treatment for PAH, as well as such other factors that are included in our periodic reports on Form 10-K and Form 10-Q that we file with the SEC. Any forward-looking statement in this release speaks only as of the date of this release. Inhibikase undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.

Contacts:
Investor Relations:
Michael Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com

Seren Advanced Dentistry Oxnard Announces Implementation of Biomimetic Conservative Dentistry Led by Dr. Ette Ntekim




Seren Advanced Dentistry Oxnard Announces Implementation of Biomimetic Conservative Dentistry Led by Dr. Ette Ntekim

Oxnard, CA, Nov. 20, 2025 (GLOBE NEWSWIRE) — Seren Advanced Dentistry Oxnard today formally announced the introduction of biomimetic conservative dentistry as part of its restorative care offerings. The announcement marks a structured update to the practice’s clinical direction, led by Dr. Ette Ntekim, who has overseen the implementation of the approach following a series of internal protocol evaluations and training initiatives. This development expands treatment pathways available to individuals seeking a dentist in Oxnard, CA, and reflects the clinic’s continued effort to align with evolving methodologies in contemporary dental care.

Biomimetic conservative dentistry is an evidence-based philosophy focused on preserving natural tooth structure whenever feasible while reconstructing teeth using materials and techniques designed to mimic natural biomechanics. The approach centers on layered adhesive restorations, stress-reduction strategies, and diagnostic assessments aimed at minimizing unnecessary removal of healthy tooth material. With its adoption, Seren Advanced Dentistry Oxnard is making available a practice framework supported by established scientific literature and increasingly recognized across restorative disciplines.

Dr. Ntekim stated that the integration resulted from ongoing evaluation of advancements in minimally invasive dentistry. “Biomimetic conservative dentistry provides a structured method for approaching restorations to maintain as much of the natural tooth as possible,” Dr. Ntekim said. “Our team has dedicated substantial time to training and refining protocols so that the philosophy is applied consistently and responsibly. The intention behind this update is to offer a scientifically grounded treatment option to patients while adhering to standards that support long-term tooth integrity.”

According to the practice, the decision to formally adopt the biomimetic framework followed several months of preparation involving the selection of appropriate materials, the calibration of adhesive workflows, and the implementation of diagnostic procedures that support conservative treatment planning. The clinic noted that the update does not represent a replacement of existing restorative services but rather an additional pathway made available to patients seeking care aligned with conservation-oriented principles.

In explaining the rationale behind the transition, Seren Advanced Dentistry Oxnard highlighted an interest among patients in options that maintain natural tooth structure when possible. Although the clinic emphasized that treatment decisions continue to be guided by clinical assessment rather than preference alone, the inclusion of biomimetic practices allows for an alternative aligned with minimally invasive philosophies when appropriate. The practice clarified that the announcement is intended to inform the public about an expanded methodology rather than imply specific outcomes or advantages.

The adoption of biomimetic conservative dentistry also includes modifications to internal workflows. These changes involve stepwise reinforcement processes, updated adhesive strategies, and criteria-based selection of restorations that follow recognized stages of biomimetic classification. The practice indicated that its team has taken steps to ensure that integration remains consistent with credentialed research and accepted educational practices within the field.

In a statement included with the announcement, practice representative Amin Nassiri commented on the organizational significance of the update. “This initiative reflects our ongoing efforts to align our clinical environment with developments supported by research in restorative dentistry,” Nassiri said. “Introducing biomimetic conservative dentistry required coordinated planning, and our team approached the process with a focus on accuracy, training, and clarity. The announcement is intended to communicate a formal update to the services now available at the practice.”

Seren Advanced Dentistry Oxnard noted that additional information on the biomimetic principles now in use has been made available through the practice’s website, where patients can review general descriptions of the approach and its placement within standard restorative options. The practice further emphasized that biomimetic conservative dentistry is now fully integrated into its active clinical structure and will continue to be evaluated as new research and guidelines emerge.

The clinic reiterated that this announcement is not intended as promotional content but as a corporate update communicating an expansion in treatment methodologies recognized within the field of dentistry. All treatment decisions will continue to be determined through individual clinical evaluation performed by licensed professionals.

Individuals seeking further details may visit the practice’s official website at Dentist in Oxnard | Seren Advanced Dentistry Oxnard.

About Seren Advanced Dentistry Oxnard

Seren Advanced Dentistry in Oxnard is a dental practice offering a range of general and restorative services in Oxnard, CA. The practice maintains a commitment to aligning its care standards with widely accepted research-based methodologies. Additional information can be found on the clinic’s website.

Media Contact
Company Name: Seren Advanced Dentistry Oxnard
Contact Person: Amin Nassiri
Email: amin@dentistnerds.com
Phone: 310-592-6293
Country: United States
Website: https://serendentaloxnard.com/

CONTACT: Media Contact
Company Name: Seren Advanced Dentistry Oxnard
Contact Person: Amin Nassiri
Email: amin@dentistnerds.com
Phone: 310-592-6293
Country: United States
Website: https://serendentaloxnard.com/

NovaBridge’s Visara Subsidiary Appoints Distinguished Ophthalmology Leaders as Chief Medical Officer and Scientific Advisory Board Chair to Drive VIS-101 Forward




NovaBridge’s Visara Subsidiary Appoints Distinguished Ophthalmology Leaders as Chief Medical Officer and Scientific Advisory Board Chair to Drive VIS-101 Forward

• Cadmus C. Rich, MD, MBA, as Chief Medical Officer, and Carlos Quezada-Ruiz, MD, FASRS, as Chair of the Scientific Advisory Board, bring invaluable clinical development expertise to VIS-101 Program
• The ability to attract seasoned ophthalmology leaders highlights the compelling opportunity for VIS-101, and underscores our commitment to assembling a world-class team
• VIS-101, a novel bifunctional biologic targeting VEGF-A/ANG2, has the potential to become the current standard for wet AMD, DME and RVO, and is expected to be Phase-3-ready in 2026

ROCKVILLE, Md., Nov. 20, 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 its subsidiary Visara, Inc. (Visara) has appointed Cadmus C. Rich, MD, MBA, as its Chief Medical Officer (CMO), and Carlos Quezada-Ruiz MD, FASRS, as Chairman of its Scientific Advisory Board (SAB). As CMO, Dr. Rich will be responsible for overseeing all of the clinical functions and programs for Visara. Dr. Quezada-Ruiz will chair Visara’s newly formed SAB.

“Dr. Rich and Dr. Quezada-Ruiz are each exceptional ophthalmologists and drug development leaders across global markets. Their appointments validate the exciting opportunity for VIS-101 and demonstrate Visara’s commitment to building a world class organization. Dr. Rich is a skilled ophthalmology professional and accomplished drug development executive with proven expertise in pioneering cutting-edge programs across the R&D and regulatory landscapes,” said Emmett T. Cunningham, Jr., MD, PhD, MPH, Co-Founder and Executive Chairman of Visara. “Dr. Quezada-Ruiz is an internationally recognized retina specialist and clinical scientist who has played a pivotal role in the development of novel technologies and therapies for retinal disease, including the development, global regulatory filings, and approvals of VABYSMO® for wet AMD. I am thrilled to welcome Dr. Rich and Dr. Quezada-Ruiz to Visara and believe they will each make invaluable contributions to our success.”

“I am passionate about accelerating the development of innovative new ophthalmology treatments by defining effective clinical and regulatory strategies to streamline their path to patients as quickly as possible,” said Dr. Rich, Chief Medical Officer of Visara. “VIS-101’s dual targeting of VEGF-A and ANG-2, with the potential for more durable efficacy, could make it the class leading therapy for patients with wet AMD. I am excited to work with the Visara team to complete the Phase 2 study and advance the VIS-101 program into registrational development.”

“I have had the privilege of contributing to the development and global approval of transformative retinal therapies that I now use in the clinic. Despite tremendous progress, there remains a significant unmet need for more durable and highly effective options,” said Dr. Quezada-Ruiz. “I am excited to work with the Visara team to complete the Phase 2 study and advance the VIS-101 program into registrational development. Dual Ang-2 and VEGF-A inhibition is a proven strategy to enhance disease control, maximize vision, and extend durability for patients with neovascular retinal disease. I am genuinely excited by the potential for VIS-101 to deliver a safe, more durable, best-in-class therapy for patients worldwide. I am eager to collaborate with Dr. Cunningham, Dr. Rich and the Visara team to cultivate strong relationships in the retinal disease community and help accelerate development,” said Dr. Quezada-Ruiz.

“The appointment of Dr. Rich as CMO and Dr. Quezada-Ruiz as SAB Chair highlights the successful execution of NovaBridge’s strategic transformation to a global biotech platform and the growing momentum behind our innovative “hub-and-spoke” strategy. The ability to attract distinguished international leaders demonstrates our commitment to Visara’s mission and to delivering value to our shareholders,” said Sean Fu, PhD, Chief Executive Officer of NovaBridge.

About Cadmus C. Rich, MD, MBA

Dr. Rich is the Chief Medical Officer for Visara and is responsible for all the clinical functions and clinical programs for the company. Prior to joining Visara, Dr. Rich was the Chief Medical Officer at Lassen Therapeutics, LLC leading the thyroid eye disease, oncology, and idiopathic pulmonary fibrosis clinical programs. Prior to Lassen he served as Chief Medical Officer and Head of R&D for Aura Biosciences, Inc. (Nasdaq: AURA) an oncology company developing first in class oncology treatments for primary tumors to reduce the incidence of metastatic cancer, starting with the lead indication in choroidal melanoma and a secondary indication in non-muscle invasive bladder cancer. Prior to Aura, Dr. Rich has held progressive positions in Ophthalmology R&D including Medical Director/Senior Director at IQVIA, Inc. (Quintiles), Head of Clinical Trial Management at Alcon, Therapeutic Unit Head for Intraocular Lens R&D at Alcon and VP, Clinical Development and Medical Affairs for Inotek Pharmaceuticals. In these roles he actively participated in the product development of over 40 Drugs/Device programs (including the approval of 5 drugs and 5 devices in the US and other global regions) and has led or participated in over 125 clinical trials. He has also served on the Board of Directors for Sustained Nano Systems, Inc., Prevent Blindness (where he also served as Treasurer), and the North Carolina Specialty Hospital.

Dr. Rich received his MD and Ophthalmology training at UNC/Chapel Hill Medical School/UNC Hospitals, his BA in Psychology from Case Western Reserve University, and his MBA in Health Care Administration from Regis University. Prior to joining the biopharmaceutical industry, Dr. Rich practiced cataract/refractive surgery and comprehensive ophthalmology and served as a Principal Investigator in multiple clinical trials. His passion is to combine his experience in ophthalmology, leadership, business and research and development to meet unmet medical needs for patients and coaching and mentoring professionals.

About Carlos Quezada-Ruiz, MD, FASRS

Dr. Carlos Quezada-Ruiz currently serves as Assistant Professor of Ophthalmology at the Instituto de Oftalmología Fundación Conde de Valenciana in Mexico City, and as Chairman of the Scientific Committee of the Mexican Retina Society. Dr. Quezada-Ruiz also serves as a scientific and drug development advisor to preclinical and clinical-stage biotechnology companies advancing novel therapies and technologies for retinal diseases.

Dr. Quezada-Ruiz has held senior leadership roles at Genentech Inc./Roche Group and most recently served as Senior Vice President and Ophthalmology Therapeutic Area Head at 4D Molecular Therapeutics (Nasdaq: FDMT). His expertise encompasses biologics, devices, and AAV-based gene therapies, as well as the application of artificial intelligence and machine learning to accelerate innovation in retinal drug development.

At Genentech, Dr. Quezada-Ruiz played a pivotal role in the global development and approvals of VABYSMO® and SUSIVMO™, leading design, execution, readouts, fillings and launch of registrational Phase 3 programs in wet AMD, DME, and diabetic retinopathy (DR), and label-expansion strategies for Lucentis®. At 4DMT, he directed early- and late-stage gene-therapy programs for retinal diseases and led trial design and global regulatory alignment for the company’s lead candidate 4D-150 in neovascular AMD. His strategic leadership delivered accelerated timelines, reduced program risk, and enabled alignment with both the FDA and EMA, establishing that a single Phase 3 clinical trial could be acceptable for regulatory submission for 4D-150 in DME.

Dr. Quezada-Ruiz has authored more than 40 scientific publications, served on the scientific committee of the Mexican Retina Society, the editorial board of the Mexican Journal of Ophthalmology. He is a Fellow of the American Society of Retina Specialists (ASRS) and a member of multiple international societies, including AAO, ARVO, EURETINA, PAAO, AMR, SMO, and ACOREV. His contributions have been recognized with several honors, including the ASRS Senior Honor Award, the Roche Award of Excellence, and Genentech’s Medical Excellence Award, among others.

About VIS-101

VIS-101 is a novel bifunctional biologic targeting VEGF-A and ANG-2, and a more potent molecule that could potentially provide more durable treatment benefits for patients with wet age-related macular degeneration (wet AMD), diabetic macular edema (DME) and retinal vein occlusion (RVO) than current standard of care. VIS-101 has completed initial safety and dose-escalation studies in both the US and China, and is currently completing a randomized, dose-ranging Phase 2 study in China. VIS-101 is anticipated to be Phase 3-ready in 2026.

About Visara, Inc.

Visara is a clinical-stage biopharmaceutical company focusing on the development of best-in-class ophthalmic therapeutics. The Company is led by Co-Founder and Executive Chairman Emmett T. Cunningham, Jr., MD, PhD, MPH, a physician, innovator, entrepreneur, and investor and internationally recognized specialist in infectious and inflammatory eye disease. NovaBridge is the majority shareholder of Visara, and Visara controls global rights to VIS-101, outside of Greater China and certain countries in Asia.

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.

Third-party products mentioned herein are the trademarks of their respective owners.

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; the strategic and clinical development of NovaBridge’s drug candidates, including givastomig 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

Mesoblast and BMT CTN to Initiate Pivotal Trial of Ryoncil® as Part of First-Line Regimen in Adults with Severe Acute GVHD Refractory to Steroids




Mesoblast and BMT CTN to Initiate Pivotal Trial of Ryoncil® as Part of First-Line Regimen in Adults with Severe Acute GVHD Refractory to Steroids

NEW YORK, Nov. 20, 2025 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that given the high rate of non-responsiveness to therapies in adults with severe acute graft versus host disease (aGvHD) who fail corticosteroids, and the high mortality in these patients, Mesoblast and the United States National Institutes of Health (NIH)-funded Blood and Marrow Transplant Clinical Trials Network (BMT CTN) will collaborate on a pivotal trial of Ryoncil^® (remestemcel-L-rknd) as part of first-line regimen in adults with severe aGvHD refractory to corticosteroids (SR-aGvHD). The BMT CTN is a body representing U.S. centers responsible for performing approximately 80% of all U.S. allogeneic BMTs.

Dr John Levine, Chair of the BMT CTN Steering Committee and Professor of Internal Medicine and Pediatrics, Icahn School of Medicine at Mount Sinai, New York said: “We are delighted to be partnering with Mesoblast in this pivotal Phase 3 trial of Ryoncil^®. We are aiming to extend the use of this potentially life-saving treatment, already approved by FDA in children and adolescents, to adults with severe SR-aGvHD.”

In Grade III/IV SR-aGvHD 44-58% of adults treated with ruxolitinib did not achieve response at Day 28 in two studies that supported FDA approval. In patients who fail ruxolitinib survival remains as low as 20-30% by 100 days.^1-3 Notably, use of Ryoncil^® in Mesoblast’s Expanded Access program in patients aged 12 and older with SR-aGvHD who failed ruxolitinib or other second-line agents was associated with 76% survival at Day 100.⁴

Mesoblast recently met with FDA to discuss the most appropriate patient population and timing of treatment in a pivotal trial of Ryoncil^® for adults with severe SR-aGvHD. In order to give adult patients with severe SR-aGvHD the best chance of survival, patients will be randomized in the trial as early as possible after corticosteroid refractoriness to receive ruxolitinib alone or combined with Ryoncil^®. The trial protocol will be provided to FDA in order to initiate enrollment in the first quarter of 2026.

Mesoblast Chief Executive Silviu Itescu said, “We are pleased to be partnering with the BMT CTN to expand the availability of Ryoncil^® to adult patients with severe SR-aGvHD given the poor outcome with existing therapies. This clearly remains a major unmet need and a market opportunity 3-4 times larger than the pediatric market.”

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

About the Blood and Marrow Transplant Clinical Trials Network (BMT CTN)
The BMT CTN conducts rigorous multi-institutional clinical trials of high scientific merit, focused on improving survival for patients undergoing hematopoietic cell transplantation and/or receiving cellular therapies. The BMT CTN has completed accrual to 52 Phase II and III trials at more than 125 transplant centers and enrolled over 16,600 study participants. BMT CTN is funded by the National Heart, Lung and Blood Institute and the National Cancer Institute, both parts of the National Institutes of Health, and is a collaborative effort of 19 Core Transplant Centers/Consortia, The Center for International Blood and Marrow Transplant Research (CIBMTR), the National Marrow Donor Program (NMDP) and the Emmes Company, LLC, a clinical research organization. CIBMTR is a research collaboration between the NMDP and the Medical College of Wisconsin (MCW). Together, MCW, NMDP and Emmes have been providing research support to the BMT CTN since 2001, as the Network’s data and coordinating center. More information about the BMT CTN can be found at www.bmtctn.net

About NMDP^®
At NMDP^SM, we believe each of us holds the key to curing blood cancers and disorders. As a global nonprofit leader in cell therapy, NMDP creates essential connections between researchers and supporters to inspire action and accelerate innovation to find life-saving cures. With the help of blood stem cell donors from the world’s most diverse registry and our extensive network of transplant partners, physicians and caregivers, we’re expanding access to treatment so that every patient can receive their life-saving cell therapy. NMDP. Find cures. Save lives. Learn more at nmdp.org.

About the Medical College of Wisconsin (MCW)
With a history dating back to 1893, the MCW is dedicated to leadership and excellence in education, patient care, research, and community engagement. More than 1,500 students are enrolled in MCW’s medical school and graduate school programs in Milwaukee, Green Bay, and Central Wisconsin. MCW’s School of Pharmacy opened in 2017. A major national research center, MCW is the largest research institution in the Milwaukee metro area and second largest in Wisconsin. In the last 10 years, faculty received more than $1.5 billion in external support for research, teaching, training, and related purposes. This total includes highly competitive research and training awards from the National Institutes of Health (NIH). Annually, MCW faculty direct or collaborate on more than 3,100 research studies, including clinical trials. Additionally, more than 1,800 physicians provide care in virtually every specialty of medicine for more than 2.8 million patients annually. It has a long history in hematopoietic transplantation and cellular therapy, including operating an outcomes registry of transplantation and cellular therapy outcomes and facilitating related research since 1972.

About CIBMTR^®
CIBMTR^® (Center for International Blood and Marrow Transplant Research^®) is a nonprofit research collaboration between NMDP^SM, in Minneapolis, and the Medical College of Wisconsin (MCW), in Milwaukee. CIBMTR collaborates with the global scientific community to increase survival and enrich quality of life for patients. CIBMTR facilitates critical observational and interventional research through scientific and statistical expertise, a large network of centers, and a unique database of long-term clinical data for more than 680,000 people who have received hematopoietic cell transplantation and other cellular therapies. Learn more at cibmtr.org. It is funded by the National Cancer Institute, the National Heart, Lung and Blood Institute and the National Institute for Allergy and Infectious Disease, the Health Resources and Services Administration, the Office of Naval Research, industry sponsors, MCW, and NMDP.

About Emmes
Emmes Group, a specialty, technology and AI enabled contract research organization (CRO), is advancing and modernizing clinical research to improve patient outcomes. Founded as Emmes more than 47 years ago, we became a trusted clinical research partner to the U.S. government. Today, Emmes Group is a global full-service CRO operating in 72 countries worldwide collaborating with government agencies, public-private partnerships, and biopharma innovators. Now wholly owned by New Mountain Capital, we are transforming the future of clinical research and bringing life-changing treatments closer to patients. Where human intelligence meets artificial intelligence. Learn more at www.theemmesgroup.com.

References / Footnotes

1. Jagasia M, et al. Ruxolitinib for the treatment of steroid-refractory acute GVHD (REACH1): a multicenter, open-label phase 2 trial. Blood. 2020 May 14; 135(20): 1739–1749
2. Abedin S, et al. Ruxolitinib resistance or intolerance in steroid-refractory acute graft versus-host disease — a real-world outcomes analysis. British Journal of Haematology, 2021;195:429–43
3. Zeiser R, et al. Ruxolitinib for Glucocorticoid-Refractory Acute Graft-versus-Host Disease. N Engl J Med 2020;382:1800-1810
4. Kurtzberg J, et al. Ryoncil (Remestemcel-L) for Third-Line Treatment of SR-aGvHD in Adolescents and Adults [Poster presentation]. 2025 Transplantation & Cellular Therapy Tandem Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for Blood and Marrow Transplant Research (CIBMTR).

Forward-Looking Statements
This press release includes forward-looking statements 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.

Release authorized by the Chief Executive.

For more information, please contact:

CHRISTUS Health recognized as ‘Most Wired’ health provider for digital transformation




CHRISTUS Health recognized as ‘Most Wired’ health provider for digital transformation

IRVING, Texas, Nov. 20, 2025 (GLOBE NEWSWIRE) — CHRISTUS Health has been recognized as a national 2025 “Most Wired” health provider for digital transformation that influences quality and accessibility of care for patients.

The honor from the College of Healthcare Information Management Executives (CHIME) places CHRISTUS among the top-performing health systems across the country. CHIME evaluates more than 50,000 facilities worldwide each year for its Digital Health Most Wired program.

“This award reflects our dedication to making health care more accessible,” said Jon Manis, CHRISTUS Health’s chief information officer. “Digital transformation is about ensuring our caregivers deliver exceptional and compassionate care supported by innovative tools and that our patients feel informed and empowered.”

CHRISTUS embarked on an enterprise-wide effort to standardize electronic health records through Epic across all facilities and clinics, unlocking tremendous potential to improve care delivery and harness AI for early detection and intervention.

CHIME recognized CHRISTUS with the Quality Award in both the Acute and Ambulatory categories of the 2025 Digital Health Most Wired program, with Quality Award designations reserved for organizations demonstrating strong, responsible adoption of digital tools.

Surveyed organizations were evaluated on key focus areas, including:

• Analytics and data management
• Clinical quality and safety
• Cybersecurity
• Infrastructure
• Innovation
• Patient engagement
• Population health

“As health care continues to evolve, CHRISTUS will keep investing in secure and advanced digital solutions that make a real difference in the lives of the people we are blessed to serve,” Manis said.

To learn more about CHRISTUS Health, visit our website.

###

About CHRISTUS Health
CHRISTUS Health is an international faith-based, not-for-profit health care system based in Irving, Texas, with more than 60 hospitals in Texas, Louisiana, New Mexico, Chile, Colombia and Mexico. CHRISTUS Health is made up of 50,000 Associates providing compassionate and individualized care at more than 600 centers, including community hospitals, clinics, long-term care facilities and health ministries. Sponsored by the Sisters of Charity of the Incarnate Word of Houston, the Sisters of Charity of the Incarnate Word of San Antonio and the Sisters of the Holy Family of Nazareth, our mission is to extend the healing ministry of Jesus Christ to every individual we serve. For more information, visit www.christushealth.org

Contact Info

Leigh Strope
Leigh.Strope@CHRISTUSHealth.org
+1 469-282-2563

BioSyent Releases Financial Results for Q3 and YTD 2025




BioSyent Releases Financial Results for Q3 and YTD 2025

MISSISSAUGA, Ontario, Nov. 20, 2025 (GLOBE NEWSWIRE) — BioSyent Inc. (“BioSyent”, TSX Venture: RX) released today its financial results for the three months (Q3) and nine months (YTD) ended September 30, 2025. Key highlights include:

• Return on Average Equity for TTM September 30, 2025 was 22% as compared to 20% for TTM September 30, 2024
• During YTD 2025, repurchased for cancellation a total of 19,500 common shares under a Normal Course Issuer Bid (NCIB)
• Paid quarterly cash dividends of $0.05 per common share on March 14, 2025, June 13, 2025, and September 15, 2025
• Declared subsequent cash dividend of $0.05 per common share to be paid on December 15, 2025

“BioSyent delivered strong third quarter financial results,” commented Mr. René Goehrum, President and CEO of BioSyent. “Each of our three businesses performed well during the quarter, with total Company sales increasing by 28% overall. Though we experienced some gross margin compression on changes in sales mix, our overall EBITDA¹ margin in Q3 2025 remained consistent with the comparative period at 30% to sales as operating expenses were maintained in proportion to sales growth. On a year-to-date basis, total Company sales increased by 27% with an EBITDA¹ margin of 29% to sales. Our FeraMAX® and Tibella® / Tibelia® products continue to generate profitable sales growth, both in Canada and internationally. In just over one year since our September 2024 acquisition of the worldwide rights to Tibella® / Tibelia®, this product has generated incremental sales and profit growth in line with our initial expectations. As we enter the final weeks of the year, we remain focused on continued profitable growth and momentum in our businesses through the end of 2025 and into 2026.”

The CEO’s presentation on the Q3 and YTD 2025 Results is available at the following link: www.biosyent.com/investors/

The Company’s Interim Unaudited Condensed Consolidated Financial Statements and Management’s Discussion and Analysis for the three and nine months ended September 30, 2025 and 2024 will be posted on www.sedarplus.ca on November 20, 2025.

For a direct market quote for the TSX Venture Exchange and other Company financial information, please visit www.tmxmoney.com.

About BioSyent Inc.

Listed on the TSX Venture Exchange under the trading symbol “RX”, BioSyent is a profitable growth-oriented specialty pharmaceutical company focused on in-licensing or acquiring innovative pharmaceutical and other healthcare products that have been successfully developed, are safe and effective, and have a proven track record of improving the lives of patients. BioSyent supports the healthcare professionals that treat these patients by marketing its products through its community, specialty and international business units.

As of the date of this press release, the Company has 11,262,282 common shares outstanding.

1. EBITDA is a Non-IFRS Financial Measure. The term EBITDA does not have any standardized meaning under International Financial Reporting Standards (IFRS) and therefore may not be comparable to similar measures presented by other companies. The Company defines EBITDA as earnings before interest income or expense, income taxes, depreciation and amortization.

   A reconciliation of EBITDA to NIAT for the three months, nine months, and trailing twelve months ended September 30, 2025 and 2024 is provided in the table below:

For further information please contact:
Mr. René C. Goehrum
President and CEO
BioSyent Inc.
E-Mail: investors@biosyent.com
Phone: 905-206-0013
Web: www.biosyent.com

This press release may contain information or statements that are forward-looking. The contents herein represent our judgment, as at the release date, and are subject to risks and uncertainties that may cause actual results or outcomes to be materially different from the forward-looking information or statements. Potential risks may include, but are not limited to, those associated with clinical trials, product development, future revenue, operations, profitability and obtaining regulatory approvals. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.

BioSyent Declares Fourth Quarter 2025 Dividend




BioSyent Declares Fourth Quarter 2025 Dividend

MISSISSAUGA, Ontario, Nov. 20, 2025 (GLOBE NEWSWIRE) — BioSyent Inc. (“BioSyent”, “the Company”, TSX Venture: RX) is pleased to announce that its Board of Directors has declared a quarterly dividend of $0.05 per common share, payable in Canadian Dollars on December 15, 2025, to shareholders of record at the close of business on November 28, 2025. This fourth quarter 2025 dividend compares with the third quarter 2025 dividend of $0.05 per common share. This dividend qualifies as an ‘eligible dividend’ for Canadian income tax purposes. The declaration, timing, amount and payment of future dividends remain at the discretion of the Board of Directors.

About BioSyent Inc.

Listed on the TSX Venture Exchange under the trading symbol “RX”, BioSyent is a profitable growth-oriented specialty pharmaceutical company focused on in-licensing or acquiring innovative pharmaceutical and other healthcare products that have been successfully developed, are safe and effective, and have a proven track record of improving the lives of patients. BioSyent supports the healthcare professionals that treat these patients by marketing its products through its community, specialty and international business units.

As of the date of this press release, the Company has 11,262,282 common shares outstanding.

For a direct market quote for the TSX Venture Exchange and other Company financial information please visit www.tmxmoney.com.

For further information please contact:
Mr. René C. Goehrum
President and CEO
BioSyent Inc.
E-Mail: investors@biosyent.com
Phone: 905-206-0013
Web: www.biosyent.com

This press release may contain information or statements that are forward-looking. The contents herein represent our judgment, as at the release date, and are subject to risks and uncertainties that may cause actual results or outcomes to be materially different from the forward-looking information or statements. Potential risks may include, but are not limited to, those associated with clinical trials, product development, future revenue, operations, profitability and obtaining regulatory approvals.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.

Inhibikase Therapeutics Advancing IKT-001 to Global Phase 3 Study in Pulmonary Arterial Hypertension




Inhibikase Therapeutics Advancing IKT-001 to Global Phase 3 Study in Pulmonary Arterial Hypertension

Phase 3 Study initiating in First Quarter of 2026

Single Pivotal Study Accelerates Potential FDA Approval
Timeline by Approximately 3 Years

BOSTON and ATLANTA, Nov. 20, 2025 (GLOBE NEWSWIRE) — Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (“Inhibikase” or “Company”), a clinical-stage pharmaceutical company developing therapeutics to modify the course of cardiopulmonary diseases namely, Pulmonary Arterial Hypertension (“PAH”), today announced that it expects to advance IKT-001 to a global pivotal Phase 3 clinical study in PAH. The Phase 3 study, named IMPROVE-PAH (IKT-001 for Measuring Pulmonary Vascular Resistance and Outcome Variables in a Phase 3 Evaluation of PAH), is expected to be initiated in the first quarter of 2026.

IKT-001 is an investigational novel pro-drug of imatinib mesylate (“imatinib”). Imatinib is an anti-proliferative tyrosine kinase inhibitor, TKI, with potential best-in-class improvements in pulmonary vascular resistance (“PVR”) and 6-minute walk distance (“6MWD”) of 45 meters⁽¹⁾ based on Phase 3 IMPRES and Phase 2 studies⁽²⁾. Despite the IMPRES Phase 3 study of imatinib demonstrating improved exercise capacity and hemodynamics in patients with advanced PAH, high discontinuations impacted the results. IKT-001 is a prodrug of imatinib which is engineered to realize the potential of imatinib in PAH and lower discontinuations in the forthcoming Phase 3 study.

The Company previously planned to initiate a Phase 2b study in 150 subjects in PAH prior to advancing to a pivotal Phase 3 study. However, the Company submitted a Type C Meeting request to the U.S. Food & Drug Administration (“FDA”) to, among other things, obtain feedback on an immediate transition to a pivotal Phase 3 study design. 

Following receipt from the FDA of the Written Response from the Type C interaction, the Company now plans to initiate a two-part adaptive Phase 3 study. We expect Part A of IMPROVE-PAH will be a double blind, placebo-controlled study in 140 patients with a primary endpoint of PVR at Week 24. We expect Part B will adopt an identical format to Part A except the primary endpoint will be 6MWD at Week 24 in 346 patients. We believe this adaptive Phase 3 study design has important advantages including; (1) permitting a 12-week dose-titration phase designed to get patients to the highest tolerable dose of IKT-001; (2) uninterrupted enrollment between Part A and Part B; and (3) the ability to, if necessary, undertake a sample size re-estimation for Part B based on Part A findings. Given the Company was well-advanced in initiating the previous Phase 2b study design, the Company expects to initiate IMPROVE-PAH in the first quarter of 2026, with this study expected to be conducted in up to approximately 180 sites around the world.

“Our revised study plan for IKT-001 in PAH permits a single pivotal study format and thereby has the potential to advance our timeline to Phase 3 topline data readout and a potential NDA filing by approximately three years. We are excited about the recent progress we have made,” said Mark Iwicki, Chief Executive Officer of Inhibikase. “Importantly, the written responses from FDA will allow the Company to adopt a 12-week dose-titration phase which we believe will potentially allow patients to get to the higher tolerable doses where imatinib has previously demonstrated the greatest benefit in exercise capacity and hemodynamics. With over two decades of imatinib clinical experience, together with IKT-001’s expected improved gastrointestinal tolerability profile and adaptive study design for IMPROVE-PAH, we believe this supports a potential higher probability of success and we are looking forward to study initiation next quarter.” 

About Inhibikase (www.inhibikase.com)

Inhibikase Therapeutics, Inc. (Nasdaq: IKT) is a clinical-stage pharmaceutical company developing therapeutics to modify the course of cardiopulmonary diseases namely, PAH, that arise from aberrant signaling through the Abelson Tyrosine Kinase, and type III receptor tyrosine kinases including platelet derived growth factor receptors and c-KIT. Our lead product candidate is IKT-001, a prodrug of imatinib mesylate, for PAH which is an orphan indication. PAH is a progressive, life-threatening disease characterized by pulmonary vascular remodeling and elevated pulmonary vascular resistance that affects approximately 50,000 Americans.

Social Media Disclaimer

Investors and others should note that the Company announces material financial information to investors using its investor relations website, press releases, SEC filings and public conference calls and webcasts. The Company intends to also use LinkedIn as a means of disclosing information about the Company, its services and other matters and for complying with its disclosure obligations under Regulation FD.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking terminology such as “believes,” “expects,” “may,” “will,” “should,” “anticipates,” “plans,” or similar expressions or the negative of these terms and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements that express the Company’s intentions, beliefs, expectations, strategies, predictions or any other statements related to the potential effects of IKT-001; expectations regarding the Company’s Phase 3 trial of IKT-001 in PAH, including design, timing of initiation and its impact on the Company’s timeline; and the Company’s future activities, or future events or conditions. These forward-looking statements are based on Inhibikase’s current expectations and assumptions. Such statements are subject to certain risks and uncertainties, which could cause Inhibikase’s actual results to differ materially from those anticipated by the forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include our ability to initiate and execute a global Phase 3 trial to evaluate IKT-001 as a treatment for PAH, as well as such other factors that are included in our periodic reports on Form 10-K and Form 10-Q that we file with the U.S. Securities and Exchange Commission. Any forward-looking statement in this release speaks only as of the date of this release. Inhibikase undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.

Contacts:
Investor Relations:
Michael Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com

(1) Placebo-adjusted 6MWD improvement of 45 meters at week 24 in patients at 400 mg for >50% of treatment. See Hoeper et al; Circulation 2013 Suppl. Appendix. (2) The referenced Phase 3 IMPRES and Phase 2 Studies were conducted by Novartis Pharmaceutical Corporation