Oncolytics Biotech® Reschedules Special Meeting of Shareholders to Change Jurisdiction of Incorporation to Nevada




Oncolytics Biotech® Reschedules Special Meeting of Shareholders to Change Jurisdiction of Incorporation to Nevada

SAN DIEGO–(BUSINESS WIRE)–Oncolytics Biotech^® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced it has filed an amended registration statement on Form F-4 (the “Registration Statement”) with the Securities and Exchange Commission (the “SEC”) that includes a management circular/prospectus and other relevant documents related to various proposals contained therein, and that the Registration Statement has been declared effective by the SEC. The Company has rescheduled its special meeting of shareholders (the “Special Meeting”), as described in previous news releases, to January 15, 2026 at 10:00 a.m. (Eastern Time). The record date for shareholders entitled to attend and vote at the Special Meeting is December 9, 2025.

The Special Meeting will be held to vote on, among other things, a series of transactions that will change the jurisdiction of Oncolytics from the Province of Alberta in Canada to the State of Nevada in the United States of America (the “Domestication”). In order to facilitate the Domestication, the Company expects to, prior to the Domestication, continue its existence from the Province of Alberta to the Province of British Columbia (the “Continuance”). The Continuance and the Domestication require approval by the affirmative vote of not less than two-thirds of the votes cast at the Special Meeting by proxy or in person. If approved, the Domestication is expected to occur on or around April 1, 2026. There are not expected to be any material changes to the Company’s operations or financial results as a result of the Continuance or Domestication. The Company will continue to be subject to SEC reporting requirements and, as applicable, Canadian securities laws, and its common equity securities will continue to trade on the Nasdaq Capital Market under the symbol “ONCY.” In connection with the Domestication, shareholders will also be asked to vote on a proposal approving a new incentive award plan.

The Domestication is intended to reduce the regulatory burden and cost of being subject to the laws and regulations of both the United States and Canada and to facilitate shareholder value creation over the long term by, among other things, reducing operating costs and enabling the Company to compete effectively in raising the capital necessary to continue to implement the strategic plan. In addition, most of the Company’s operations are located in the United States, and a large percentage of shareholders are located in the United States. Oncolytics chose the State of Nevada to be the proposed domicile because of its favorable corporate environment and because the Nevada Revised Statutes expressly accommodate a continuance authorized by the Business Corporations Act (British Columbia). Canadian income tax liability considerations were taken into account as well.

Additional details about the Special Meeting and proposals are included in the Registration Statement and in the definitive management circular/prospectus filed with the SEC, as well the Company’s other definitive meeting materials, each of which will be distributed to shareholders eligible to vote at the Special Meeting and in relevant regulatory filings. The Company encourages all shareholders to review this information when it is available.

About Oncolytics Biotech Inc.

Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically “cold” tumors “hot” through the activation of innate and adaptive immune responses.

The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic pancreatic and breast cancers, of which both development programs have received Fast Track designation from the FDA, and other gastrointestinal tumors. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: www.oncolyticsbiotech.com or follow the Company on social media on LinkedIn and on X @oncolytics.

Additional Information and Where to Find It

The Company has filed the Registration Statement, a definitive management circular/prospectus and other relevant documents in connection with the proposed Continuance and Domestication. ONCOLYTICS SHAREHOLDERS ARE URGED TO READ CAREFULLY THESE DOCUMENTS, WHEN FILED AND MAILED, BECAUSE THEY CONTAIN AND WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED CONTINUANCE AND DOMESTICATION. Investors may obtain a free copy of the management circular/prospectus and other filings containing information about Oncolytics and the proposed Continuance and Domestication from the SEC at the SEC’s website at http://www.sec.gov. In addition, copies of the management circular/prospectus and other filings containing information about Oncolytics and the proposed Continuance and Domestication can be obtained without charge by directing a request to Oncolytics Biotech Inc., Suite 804, 322 11th Avenue SW, Calgary, Alberta T2R 0C5 (telephone (403) 670-7377) or accessing them on the Company’s corporate website at www.oncolyticsbiotech.com.

Oncolytics, its directors, executive officers, certain other members of management and employees may be deemed to be participants in the solicitation of proxies from the shareholders of Oncolytics in favor of the proposed Continuance and Domestication. In addition, Oncolytics has engaged Laurel Hill Advisory Group to aid in the solicitation of proxies for the Special Meeting, and Laurel Hill Advisory Group may solicit proxies by personal interview, mail, telephone, facsimile, email or otherwise. Oncolytics will pay Laurel Hill Advisory Group approximately CAD $35,000 for its proxy solicitation services, plus reasonable out-of-pocket expenses incurred in the process of soliciting proxies. Solicitations also may be made by mail, email, personal interview, telephone or other electronic transmission by directors, officers and other employees of Oncolytics without additional compensation.

Additional information regarding the interests of potential participants in the proxy solicitation is included in the management circular/prospectus and other relevant documents that the Company has filed and intends to file with the SEC in connection with the Special Meeting.

Forward-looking statements

This press release contains forward-looking statements, within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding the Company’s intention to hold a special meeting of shareholders to vote on, among other things, the Continuance, Domestication, and new incentive award plan, including the timing of the special meeting; the timing, implementation and adoption of the Continuance, Domestication, and new incentive award plan; the anticipated benefits of the Continuance and the Domestication; beliefs as to the potential, registration, mechanism of action and benefits of pelareorep as a cancer therapeutic; Oncolytics’ plan to continue actively pursuing strategic partnerships; its goals, strategies and objectives; and its belief in the clinical promise of pelareorep in metastatic pancreatic and other gastrointestinal cancers. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, access to capital markets, market dynamics and the impact of any prolonged shutdown of the U.S. government. Please refer to Oncolytics’ public filings with securities regulators in the United States and Canada for more information. The Company assumes no obligation to update forward-looking statements, except as required by law.

Contacts

Company Contact
Jon Patton

Director of IR & Communication

jpatton@oncolytics.ca

Investor Relations for Oncolytics
Mike Moyer

LifeSci Advisors

+1-617-308-4306

mmoyer@lifesciadvisors.com

Media Contact for Oncolytics
Owen Blaschak

LifeSci Communications

oblaschak@lifescicomms.com

Robert Stone Recognized as a Top Healthcare CEO in 2025




Robert Stone Recognized as a Top Healthcare CEO in 2025

City of Hope’s CEO was included in both Modern Healthcare’s 100 Most Influential People in Healthcare and Becker’s Hospital Review’s 61 CEO Influencers to Know list

LOS ANGELES–(BUSINESS WIRE)–City of Hope^® CEO Robert Stone, who leads one of the largest and most advanced cancer research and treatment organizations in the United States, has been recognized as one of the most influential leaders by two top health care trade publications: Modern Healthcare and Becker’s Hospital Review. Stone was honored for expanding access to advanced cancer care nationwide, advancing breakthrough cancer research, and developing a national network of lifesaving clinical trials, and advocating for more equitable cancer care, among other accomplishments.

Modern Healthcare’s 100 Most Influential People in Healthcare recognizes individuals who are shaping the future of healthcare through visionary leadership and industry-wide impact. Becker’s Hospital Review’s annual list of CEO Influencers to Know highlights chief executives who are driving transformation and influencing the direction of the healthcare industry. This marks the second consecutive year Stone has been included on Modern Healthcare’s list.

“It’s an honor to be recognized among so many visionary leaders who are transforming health care for the people who need us,” said Stone, chief executive officer and the Helen and Morgan Chu Chief Executive Officer Distinguished Chair at City of Hope. “This recognition represents the dedication of our more than 14,000 City of Hope employees who each day live out our values, advance our mission and change the lives of people with cancer. Our patients are the reason all of us at City of Hope continue to accelerate cancer treatment and discoveries.”

Amid a time of rapid innovation coupled with widening gaps in access to lifesaving research and care, City of Hope has transformed into a national organization that delivers cancer breakthroughs to patients across the country. Under Stone’s leadership, the organization has expanded beyond Los Angeles into Atlanta, Chicago, Phoenix and Orange County, Calif.; launched a groundbreaking national clinical trials network designed to make emerging treatments available more quickly at multiple care sites; and accelerated the development of advanced treatments, including immunotherapy and CAR-T, that can dramatically improve outcomes while being delivered closer to where patients live.

Stone has also emphasized a commitment to prioritizing patient survival, experience, and equitable access through policy changes. City of Hope has championed innovative reforms such as the California Cancer Care Equity Act and the Cancer Care is Different coalition, which aim to ensure vulnerable populations and Medicare Advantage seniors can access specialty oncology care.

A strong advocate for workforce development and culture, Stone has also championed talent retention, inclusion, and the cultivation of next-generation professionals, helping to build a diverse and resilient community of 2,000 leading physician-scientists and 14,000 health care professionals.

The complete Modern Healthcare ranking appears in the December issue of the magazine, with profiles of all honorees available online at https://www.modernhealthcare.com/100MostInfluential. Becker’s Hospital Review’s full list of CEO influencers to know, featuring individual profiles, can be found at: https://www.beckershospitalreview.com/hospital-management-administration/61-ceo-influencers-to-know-2025/.

About City of Hope

City of Hope’s mission is to make hope a reality for all touched by cancer and diabetes. Founded in 1913, City of Hope has grown into one of the largest and most advanced cancer research and treatment organizations in the United States, and one of the leading research centers for diabetes and other life-threatening illnesses. City of Hope research has been the basis for numerous breakthrough cancer medicines, as well as human synthetic insulin and monoclonal antibodies. With an independent, National Cancer Institute-designated comprehensive cancer center that is ranked among the nation’s top cancer centers by U.S. News & World Report at its core, City of Hope’s uniquely integrated model spans cancer care, research and development, academics and training, and a broad philanthropy program that powers its work. City of Hope’s growing national system includes its Los Angeles campus, Orange County, California, campus, a network of clinical care locations across Southern California and cancer treatment centers and outpatient facilities in the Atlanta, Chicago and Phoenix areas. City of Hope’s affiliated group of organizations includes Translational Genomics Research Institute and AccessHope^™. For more information about City of Hope, follow us on Facebook, X, YouTube, Instagram and LinkedIn.

Contacts

Samantha Paz

609-658-3290

sapaz@coh.org

Enveda Initiates Phase 2 Clinical Trials of ENV-294, a First-in-Class Oral Therapy in Atopic Dermatitis and Asthma




Enveda Initiates Phase 2 Clinical Trials of ENV-294, a First-in-Class Oral Therapy in Atopic Dermatitis and Asthma

Advancement to Phase 2 follows positive interim Phase 1b data in Atopic Dermatitis, demonstrating a robust efficacy and safety profile

Parallel Phase 2a initiated studies evaluating ENV-294, a first-in-class oral small molecule, in two distinct inflammatory indications

Parallel development strategy designed to accelerate assessment of ENV-294’s broad “pipeline-in-a-product” potential

Company planning initiation of Phase 2b dose-ranging study in 2026

BOULDER, Colo.–(BUSINESS WIRE)–Enveda, a clinical-stage biotech company pioneering the discovery and development of a new generation of small-molecule drugs derived from life’s chemistry, today announced that it has initiated two parallel Phase 2a clinical trials evaluating ENV-294, a first-in-class oral small molecule, for the treatment of moderate-to-severe Atopic Dermatitis (AD) and Asthma.

“The initiation of these Phase 2a trials is a major step in our strategy to unlock the full potential of ENV-294. With millions of patients still burdened by injectable biologics, there is a profound opportunity for an oral therapy that does not compromise on safety in AD,” said Viswa Colluru, Ph.D., Chief Executive Officer of Enveda.

“Building on the robust efficacy and safety profile from our analysis of the Phase 1b study in moderate-to-severe AD, we are moving with speed to evaluate ENV-294 in both skin and respiratory conditions simultaneously, accelerating our path to late-stage development,” said Jose Trevejo, M.D., Ph.D., Chief Medical Officer of Enveda.

Phase 1b Interim Analysis

In the interim analysis, ENV-294 demonstrated a rapid onset of action, with robust EASI improvements consistent with an anticipated JAK-inhibitor-like efficacy profile in patients with moderate-to-severe AD. Importantly, ENV-294 also maintained the expected biologic-like favorable safety profile consistent with earlier Phase 1a healthy volunteer studies and 3-month GLP toxicology studies.

About the Phase 2a Clinical Trials

The Phase 2a program is designed to evaluate the safety, tolerability, and efficacy of ENV-294 in two distinct patient populations, supporting the Company’s strategy to develop ENV-294 as a “pipeline-in-a-product” for inflammatory diseases.

• Atopic Dermatitis (AD): A randomized, double-blind, placebo-controlled study will evaluate ENV-294 in patients with moderate-to-severe AD. The study aims to characterize the efficacy of ENV-294 across key endpoints, including the Eczema Area and Severity Index (EASI) and Investigator’s Global Assessment (vIGA), as well as other endpoints, while further establishing its safety profile over a longer treatment duration.
• Asthma: A randomized, double-blind, placebo-controlled study has been initiated to evaluate ENV-294 in patients with moderate-to-severe asthma. This study will assess improvements in pulmonary function and safety, marking the first clinical evaluation of ENV-294 in a respiratory indication.

Phase 2b initiation in 2026

Based on the strength of the interim data in AD and the rapid enrollment anticipated for these studies, Enveda plans to initiate a Phase 2b study in 2026.

About ENV-294

ENV-294 is a novel, first-in-class, small molecule discovered using Enveda’s proprietary platform for the treatment of multiple inflammatory conditions. It targets a novel non-kinase inflammatory pathway distinct from current advanced therapies like JAK-STAT or cytokine signaling, aiming to deliver an oral agent with high efficacy and favorable safety.

About Enveda

Enveda is a biotechnology company that learns from life’s chemistry to create better medicines faster. Enveda uses AI-powered tools to identify and characterize a wide range of molecules produced by living organisms, the vast majority of which have never been explored by science, creating a database of chemical biodiversity: the library of life. By growing, organizing, translating, and searching this unique library, Enveda learns from life’s evolved solutions to address today’s most pressing medical needs. For more information, visit enveda.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the potential therapeutic benefits of ENV-294 and the anticipated initiation of Phase 2b studies in 2026. These statements are based on management’s current expectations and are subject to substantial risks and uncertainties that could cause actual results to differ materially. These risks include the inherent uncertainties of clinical development, the risk that Phase 1b data may not predict Phase 2 results, and regulatory review processes. ENV-294 is an investigational agent and is not approved for use by any regulatory authority. Enveda undertakes no obligation to update these statements.

Contacts

Enveda
Investor Contact:
Soumoditya Dey

soumoditya.dey@enveda.com

Media Contact:
KKH Advisors

Kimberly Ha

kimberly.ha@kkhadvisors.com
(917) 291-5744

Orca Bio Presents New Clinical Data on its Pipeline of High-Precision Cell Therapies including Orca-Q® Without GvHD Prophylaxis and Orca-T/CAR-T Combination Therapy at the 67th ASH Annual Meeting




Orca Bio Presents New Clinical Data on its Pipeline of High-Precision Cell Therapies including Orca-Q® Without GvHD Prophylaxis and Orca-T/CAR-T Combination Therapy at the 67th ASH Annual Meeting

Orca-Q, Orca Bio’s second investigational allogeneic T-cell immunotherapy, showed low rates of acute and chronic GvHD, infections and non-relapse mortality with and without GvHD prophylaxis

Orca-T plus CAR-T combination therapy, OrCAR-T™, showed improved relapse and overall survival rates compared to autologous CAR19/22 treatment in patients with B-ALL

MENLO PARK, Calif.–(BUSINESS WIRE)–Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced positive new data from its pipeline of allogeneic T-cell immunotherapies at the 67th American Society of Hematology (ASH) Annual Meeting.

Orca-Q with and Without the Use of GvHD Prophylaxis

A subset of the multi-center Phase 1 clinical trial evaluated Orca-Q, Orca Bio’s second-generation investigational allogeneic T-cell immunotherapy, in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML), myelofibrosis (MF), myelodysplastic syndrome (MDS) and mixed phenotype acute leukemia (MPAL) with HLA-matched related and unrelated donors. New data evaluating Orca-Q with and without the use of pharmacological graft versus host disease (GvHD) prophylaxis showed encouraging outcomes including rapid neutrophil recovery and low rates of acute and chronic GvHD, relapse and non-relapse mortality (NRM).

“Controlling alloreactivity and reducing GvHD following a conventional stem cell transplant typically requires multi-agent immunosuppression. However, this can impair immune reconstitution and increase the risk of organ toxicity, infection and relapse,” said presenting author Samer Srour, M.D., Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center. “In these new findings, Orca-Q demonstrated encouraging outcomes even without the use of any pharmacological GvHD prophylaxis. While ongoing enrollment is important to further validate these results, the data suggest that Orca-Q may be able to control alloreactivity and potentially offer a platform to improve transplant outcomes through controlling GvHD and infection and reducing non-relapse mortality without increasing the risk of relapse.”

Patients on Arm A received Orca-Q and single-agent tacrolimus (tac, n=18) while patients on Arm C received Orca-Q and no immune suppression (n=26). Median time to neutrophil engraftment was 15 days for patients who received tac and 11 days for patients who did not. Orca-Q was well-tolerated with 94% overall survival (OS) at one year for patients with tac and 87% for patients without tac. At one year, GvHD-and-relapse-free survival (GRFS) was 77% with tac and 79% without tac, and NRM was 6% and 0% with tac and without tac, respectively. Relapse-free survival (RFS) at one year was 88% with tac and 87% without tac. At Day 180, moderate-to-severe chronic GvHD was 12% with tac and 0% without tac. Grade 3-4 acute GvHD was 8% and 6% with and without tac, respectively.

Importantly, Orca-Q patients treated without GvHD prophylaxis demonstrated more rapid immune reconstitution and improved control of infections. Specifically, BMT CTN Grade 2+ infections at one year were 33% with tac and 17% without tac.

Orca-T and CAR-T Combination Treatment Versus Autologous CAR-T

A second oral presentation compared the results from two separate Phase 1 trials in adults with high-risk relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL). The first trial evaluated OrCAR-T (n=16), a treatment that combines Orca-T and allogeneic CD19/CD22 CAR-T cells, and the second trial evaluated an autologous CD19/22 (n=17). At 18 months, progression-free survival (PFS) and OS were 100% and 100% with OrCAR-T, and 38.5% and 77% in the autologous cohort. Toxicities were mild across both cohorts, with no grade 3-4 CAR-related toxicities reported. At a median follow-up of 2.5 years, there were no relapses or patient deaths with OrCAR-T and seven deaths with autologous, six from refractory B-ALL.

“Among adults with B-ALL, CAR-T therapy is often followed by a consolidative allogeneic transplant to achieve long-term remission,” said Lori Muffly, M.D., associate professor in the Division of Blood and Marrow Transplantation-Cellular Therapies at Stanford Health Care. “Emerging data showing improved progression-free survival in patients with a prior transplant has prompted interest in exploring whether combining a high-precision allogeneic therapy like Orca-T with CAR-T cells could provide a feasible, all-in-one treatment. While these findings are early, they suggest this approach has the potential to benefit patients across a range of hematologic diseases.”

“Our team is encouraged by these new findings from our broader pipeline programs, including results that highlight the potential to eliminate the need for GvHD prophylaxis while preserving immune reconstitution with Orca-Q,” said Nate Fernhoff, Ph.D., co-founder and chief executive officer at Orca Bio. “The durability of Orca-T when combined with CAR-T therapy exemplifies how our high-precision approach may be applied to expand treatment options both within and beyond hematologic malignancies. Overall, these results reinforce our continued focus on advancing our pipeline to bring this high- precision platform to more patients who could potentially benefit.”

About Orca-Q

Orca-Q is Orca Bio’s second-generation investigational allogeneic T-cell immunotherapy under evaluation in clinical trials for the treatment of multiple hematologic malignancies, including in patients with haploidentical and mismatched donors. Orca-Q is a proprietary composition of stem cells combined with specific T-cell subsets derived from healthy donors and engineered by Orca Bio’s high-precision platform.

About Orca Bio

Orca Bio is a late-stage biotechnology company developing high-precision cell therapies for the treatment of blood cancer and autoimmune diseases. The company’s manufacturing platform uses single-cell precision to create personalized cell therapy products intended to replace a patient’s diseased blood and immune system with a healthy one. At Orca Bio, we are on a mission to redefine what’s possible for patients by transforming the field of curative allogeneic cell therapy. For more information, visit www.orcabio.com.

Trademarks or registered trademarks used in this press release are the property of their respective owners.

Contacts

Corporate Communications

Kelsey Grossman

media@orcabio.com

Investor Relations

Joshua Murray

ir@orcabio.com

Cellarity Presents on Cell State-Correcting Pipeline Programs for Sickle Cell Disease and Myelofibrosis at 2025 American Society of Hematology Annual Meeting




Cellarity Presents on Cell State-Correcting Pipeline Programs for Sickle Cell Disease and Myelofibrosis at 2025 American Society of Hematology Annual Meeting

• Preclinical data findings illustrate power of Cellarity’s discovery platform, which leverages transcriptomics and AI to discover previously unseen biological pathways to create novel cell state-correcting therapeutics
• Oral presentations highlight the promise of Cellarity’s small molecule therapies which may address significant unmet needs for people living with SCD and myelofibrosis

SOMERVILLE, Mass.–(BUSINESS WIRE)–Cellarity, a clinical-stage biotechnology company developing Cell State-Correcting therapies through integrated multi-omics and AI modeling, today announced the presentation of new preclinical data on investigational programs for sickle cell disease (SCD) and myelofibrosis (MF) during the American Society of Hematology (ASH) Annual Meeting.

Cellarity has created a novel approach to drug discovery that focuses on understanding the holistic cell state. The Company’s advanced platform leverages high-dimensional transcriptomics and AI predictive algorithms to discover new biological pathways and to create novel, oral therapeutics that can effectively and safely switch disease mechanisms to healthy cell function, termed as “Cell State-Correcting.” This has resulted in a growing pipeline of differentiated drug candidates, with the first now in clinical development for sickle cell disease.

“Cellarity’s novel platform is fueling meaningful progress, enabling us to explore a broad set of indications across several therapeutic areas. We are advancing our lead asset in sickle cell disease, CLY-124, currently in phase 1 clinical development, while also progressing a second hematology program focused on myelofibrosis in the preclinical stage,” said Ted Myles, Chief Executive Officer of Cellarity. “Together, these efforts reinforce the strength of our platform approach and commitment to delivering highly innovative, novel therapies to patients.”

“The presentations at ASH underscore the power of Cellarity’s novel pipeline of potentially transformative programs in hematology, addressing significant unmet medical need in sickle cell disease and myelofibrosis. CLY-124 has the potential to transform the standard of care in sickle cell disease, as we believe it may induce fetal hemoglobin through a pathway that avoids cytotoxicity that limits other approaches,” said Cameron Trenor, M.D., Chief Medical Officer of Cellarity. “In myelofibrosis, we have identified new candidates that are highly selective in targeting pathways implicated in mutant JAK2 signaling, which may result in the avoidance of anemia that is a common side effect associated with other therapies.”

CLY-124: A first-in-class, oral globin-switching therapy for sickle cell disease

SCD is a devastating inherited disease involving sickle-shaped red blood cells that block blood vessels. Research has demonstrated that increasing fetal hemoglobin (HbF) reduces vaso-occlusive crises (VOCs), pain and organ damage, yet most compounds that increase HbF are limited by cytotoxicity and highly variable patient response. Using its integrated discovery platform, Cellarity evaluated hemoglobin regulation through erythropoiesis to predict chemical compounds that could enrich fetal hemoglobin, identifying high levels of HbF induction associated with neddylation inhibition. This led to the identification of Defective in Cullin Neddylation 1 (DCN1) – a previously unexplored target for globin gene switching. Knockout of DCN1 in vitro led to increased expression of gamma globin genes (HBG1/2) and a higher ratio of fetal vs total globin gene expression with no evidence of cytotoxicity, illustrating a potentially safer globin-switching mechanism.

CLY-124 is being developed as a potent DCN1 inhibitor with optimized pharmacology and pharmacokinetic properties. Preclinical evaluation of CLY-124 demonstrated superiority to hydroxyurea in both fetal hemoglobin protein and globin gene ratios (HBG1/2 over total beta-like globin transcripts), approaching levels reported for recent gene therapy programs. Further, pre-clinical combination studies demonstrated robust synergistic effects when combining CLY-124 with hydroxyurea and with no dose-limiting toxicities. CLY-124 is currently progressing through a phase 1 dose escalating study in healthy volunteers and adults with sickle cell disease.

Selective targeting of mutant JAK2 to address myelofibrosis

Myelofibrosis is a blood cancer caused by mutated gene called JAK2V617F (JAK2) in stem cells within the bone marrow, causing fibrosis, inflammation, and dysfunctional blood cells that lead to anemia, enlargement of the spleen and eventual bone marrow failure. Current JAK2 inhibitor therapies like ruxolitinib manage disease symptoms but are limited by dose because they inhibit both healthy and mutant JAK2 signaling resulting in cytopenias.

Cellarity leveraged high-dimensional transcriptomics from patient samples to map gene signatures uniquely associated with JAK2-mutant hematopoietic stem cells. Through its AI-powered, transcriptomic-driven discovery platform and iPSC (induced pluripotent stem cell)-based disease models, the company identified a novel, druggable biological target and small molecule interventions that selectively suppress the JAK2-mutant clone while sparing normal hematopoiesis.

About Cellarity

Founded by Flagship Pioneering in 2019, Cellarity is pioneering a fundamentally new approach to drug discovery that corrects whole cell-state dysfunction to solve complex diseases. The Company’s proprietary drug discovery platform leverages advanced transcriptomics to comprehensively understand gene networks and applies the power of dynamic AI modeling to predict and design oral Cell State-Correcting therapeutics that can precisely regulate genetic switch mechanisms to restore proper cell function. The Company’s lead asset, CLY-124, is designed to treat sickle cell disease through a novel globin-switching mechanism and is under evaluation in a Phase 1 clinical study. Additional candidates designed by the platform are advancing for indications in hematology and immunology, and Cellarity has an active collaboration with Novo Nordisk targeting metabolic dysfunction-associated steatohepatitis (MASH). For more information visit www.cellarity.com.

Contacts

Media Contact:
Rushmie Nofsinger

rnofsinger@cellarity.com

Anova Today Announced the Enrollment of 550+ Patients at 50+ Sites in Six Months for a Single Study




Anova Today Announced the Enrollment of 550+ Patients at 50+ Sites in Six Months for a Single Study

• Anova completed enrollment of 550+ patients for an intermediate-sized, treatment IND in just six months, significantly reducing traditional site activation and patient enrolment timelines, and provided safety and efficacy data to support its drug development efforts.
• Activated 50+ sites rapidly through digitized workflows and real-time performance oversight powered by AnovaOS™ further demonstrates operational efficiency at scale.
• AI-driven patient matching and centralized coordination improved data quality while reducing operational strain on sites and patients.

LONDON & CHICAGO–(BUSINESS WIRE)–#anova–Anova Enterprises, Inc. (Anova), a technology-enabled CRO dedicated to improving the conduct of clinical trials, today announced the completion of enrollment of 550+ patients at 50+ sites for a single study in just six months, using it’s proprietary AnovaOS™ Platform. The program provided cancer doctors and patients with a promising treatment that was otherwise unavailable. The sponsor was provided with safety and efficacy data to support its drug development efforts.

This was achieved through the company’s proprietary clinical operations platform, AnovaOS™, which has redefined the cost, speed and precision with which complex studies can be delivered.

The program, required coordinated site activation and patient screening, matching, and retention strategies and demonstrated the power of connected research systems. Through AnovaOS™, the study sponsor was provided with rapid execution that outperformed traditional industry timelines and at a lower cost.

“Enrolling 550+ patients to a study in just six months is a remarkable accomplishment,” said Chris Beardmore, CEO and Co-founder of Anove. “This demonstrates how AnovaOS™ eliminates bottlenecks, improves study visibility, and supports sites that may have a range of clinical trials experience as then enroll and treat the right patients faster — without compromising quality or compliance.”

Key outcomes of the IND program included:

• Successful activation of 50+ clinical sites using standardized digital workflows and automated start-up tools
• Enrollment of 550+ patients in an oncology therapeutic area traditionally challenged by study complexity, patient enrolment and variable data collection quality
• Acceleration of overall study timelines, driven by AI-assisted patient matching, digital engagement, and coordinated site support
• Strengthened data quality and oversight through continuous monitoring and real-time platform analytics

“Intermediate-sized, treatment INDs, or compassionate use, can provide quality data to inform drug development,” noted Martin Walsh, President and Co-founder of Anova. “AnovaOS™ brings every workflow — from feasibility to FPI — into a single connected environment. That unified approach was decisive in reaching this milestone ahead of schedule.”

Anova continues to expand and deliver its technology-enabled solution to the biopharmaceutical community treating patients with cancer, neurodegenerative conditions and infectious disease to replicate this success at scale.

To find out more, contact info.us@anovaevidence.com.

About Anova

Anova Enterprises, Inc. (Anova) is technology enabled concierge research organization committed to accelerating clinical development for start-up biopharmaceutical companies utilizing the company’s proprietary technology platform (AnovaOS®). For more information, please visit www.anovaevidence.com.

Contacts

Chris Beardmore, Co-Founder and CEO
chris@anovaevidence.com

Martin Walsh, Co-Founder and President
Anova Enterprises, Inc.

martin@anovaevidence.com

www.anovaevidence.com
Twitter feed at @anovaevidence

Follow Anova at www.linkedin.com/company/anovaevidence

Anova Enterprises, Inc.
Woodfield Preserve, 10 N. Martingale Road, Suite 560

Schaumburg, IL 60173

(224) 218-2408

info.us@anovaevidence.com

Flashpoint Therapeutics’ Scientific Founder Chad A. Mirkin Awarded the Prestigious Harvey Prize




Flashpoint Therapeutics’ Scientific Founder Chad A. Mirkin Awarded the Prestigious Harvey Prize

Technion’s highest honor recognizes Mirkin for pioneering discoveries in nanoscience, including the Spherical Nucleic Acid (SNA) technology that forms the foundation of Flashpoint’s structural nanomedicine platform

EVANSTON, Ill.–(BUSINESS WIRE)–Flashpoint Therapeutics, a biotechnology company pioneering a new class of structural nanomedicines, today congratulates its scientific co-founder, Professor Chad A. Mirkin, on being awarded the Harvey Prize in Science and Technology. The prestigious international prize, awarded by the Technion, Israel Institute of Technology in Haifa, recognizes Professor Mirkin for groundbreaking discoveries that have fundamentally reshaped the fields of nanoscience and nanotechnology.

The Harvey Prize is the Technion’s most esteemed scientific honor, recognizing individuals for exceptional achievements in technology and human health and for significant contributions to humanity. Notably, more than 30% of Harvey Prize recipients have subsequently been awarded the Nobel Prize. The award specifically honors Mirkin for exceptional achievements in technology and human health and for his significant contributions to humanity. Mirkin invented and developed spherical nucleic acids (SNAs), the core technology underpinning Flashpoint’s therapeutic platform.

SNAs are a revolutionary class of nanomedicines, and their discovery established the field of structural nanomedicine, where the architecture of a therapeutic, not just its chemical composition, dictates its efficacy and safety. This is the guiding principle behind Flashpoint’s mission to develop a new generation of precision medicines. The Harvey Prize is a testament to the power and potential of this approach, which is being leveraged by Flashpoint to create novel therapies for cancer and other devastating diseases.

“We are immensely proud to see Professor Mirkin receive this well-deserved and distinguished honor,” said Barry Labinger, Chief Executive Officer of Flashpoint Therapeutics. “The Harvey Prize is a powerful, independent validation of the scientific foundation upon which Flashpoint is built. Chad’s visionary work in creating SNAs and establishing the principles of structural nanomedicine provides us with a unique and powerful platform to develop life-changing therapeutics. We celebrate this remarkable achievement and are more energized than ever to translate this transformative science into clinical reality for patients.”

Professor Mirkin is the George B. Rathmann Professor of Chemistry and the Director of the International Institute for Nanotechnology (IIN) at Northwestern University. His work has led to seven SNA-based therapeutics currently in human clinical trials and more than 1,800 commercial products used worldwide.

“The Harvey Prize is a career-defining milestone, and I am honored to be among the extraordinary list of previous winners,” said Professor Mirkin. “I am grateful for the recognition from the Technion and for the dedicated efforts of my colleagues and trainees who have made this progress possible. It is thrilling to see the foundational science of SNAs being advanced by Flashpoint Therapeutics to address significant unmet medical needs.”

About Flashpoint Therapeutics

Flashpoint Therapeutics is a clinical-stage biotechnology company developing a new class of precision-engineered structural nanomedicines. Our platform enables the creation of targeted therapies that co-deliver optimized combinations of therapeutic components directly to individual cells, enhancing drug delivery, stability, potency, and safety. This modular approach supports a broad range of therapies, encompassing modalities like mRNA, DNA, proteins, and CRISPR. The company’s proprietary discovery platform is founded on nanotechnology research developed over the past decade at the laboratory of Prof. Chad Mirkin, Director of the International Institute for Nanotechnology at Northwestern University. Through strategic licensing and acquisition transactions with Northwestern University, Holden Pharmaceuticals, and Exicure, Flashpoint has assembled more than 150 issued patents and patent applications covering nucleic acid, protein, and CRISPR gene editing therapeutics. The company is funded by key investors, including Beta Lab and CS Venture Opportunities Fund. The company has also established an important partnership with King Abdullah International Medical Research Center (KAIMRC), which will advance the technology platform via the Flashpoint-KAIMRC Center of Excellence in Structural Nanomedicine and clinical trials in Saudi research institutions.

For more information about Flashpoint Therapeutics, please visit www.flashpoint.bio.

Contacts

Media Relations:

Rosie Gonzalez

media@flashpoint.bio
847-922-9385

Morris & Dickson LLC Signs Letter of Intent to Acquire Prodigy Health




Morris & Dickson LLC Signs Letter of Intent to Acquire Prodigy Health

Expands Plasma and Specialty Drugs Inventory for Hospitals and Community Clinics

SHREVEPORT, La.–(BUSINESS WIRE)–Morris & Dickson, the nation’s largest independent wholesale and specialty distributor, today announced that it has signed a non-binding Letter of Intent (LOI) to acquire Prodigy Health, a privately held, national specialty distributor of plasma derivatives, specialty drugs and vaccines.

The proposed acquisition underscores Morris & Dickson’s accelerated growth in serving both inpatient and outpatient care settings for health systems, hospitals and provider-owned community clinics and infusion centers. With the acquisition, M&D will expand its product portfolio to include a comprehensive on-shelf inventory of plasma derivatives, coagulation products, immune globulin, recombinants and vaccines for both acute and non-acute care through one company and one ordering portal, supported by M&D’s trusted distribution services and hallmark personalized account support team.

Prodigy Health customers will also gain access to 30,000 SKUs of full-line and specialty products through the M&D portfolio, plus the strength of an independent organization with 180-plus years of serving pharmacies.

“Signing the LOI with Prodigy Health is another important step in our growth strategy as we continue to expand nationally in support of pharmacies across all sites of care,” says Morris & Dickson CEO, Jody Hatcher. “The Prodigy team has built extensive capabilities in the management of these high-cost drugs for bleeding disorders and immune deficiencies, and they are aligned to our goal of creating an alternative, more agile and responsive distribution solution for pharmacies. This acquisition underscores our ability to serve customers in a more meaningful way with our full focus on their pharmacy success.”

“At Prodigy Health, our mission has always been to revolutionize specialty pharmaceutical distribution,” said Ty Dishman, CEO of Prodigy Health. “Joining forces with Morris & Dickson will allow us to scale and jointly come together on a mission to deliver an alternative model that provides an unmatched, seamless experience for hospitals, specialty pharmacies and clinics. We’re excited about what this future holds.”

Transaction terms were not disclosed and deal close is anticipated in Q1 2026. Both organizations will operate independently at this time.

About Morris & Dickson

Morris & Dickson is the industry’s largest independent full-line and specialty pharmaceutical distributor with a singular focus on reliable, next-day delivery of drugs and related products to health systems, independent and specialty pharmacies, specialty clinics and infusion centers, and alternative care facilities. Serving pharmacies since 1841, Morris & Dickson continues to grow to meet customers’ needs with a comprehensive inventory of over 35,000 SKUs and a state-of-the-art, 12-acre automated distribution center, located in Louisiana. M&D plans to open a second distribution center designed to support its national and specialty growth in early 2026, located in Olive Branch, MS. www.morrisdickson.com

About Prodigy Health

Prodigy Health is a specialty pharmaceutical distributor established in 2001 in Austin, TX. Prodigy Health is an independent, privately held organization that delivers the right solutions for its customers, emphasizing personalized service, cutting-edge technology, and trusted partnerships. The company’s dedication to efficiency, reliability, and patient-centric values has led to exceptional growth and ongoing success in markets across the United States. www.prodigyhealth.com

Contacts

Media Contact:
Cassandra Johnson

SVP, Marketing

cjohnson@morrisdickson.com
214-288-5471

Abcuro Presents Interim Phase 1 Data Evaluating Ulviprubart in Patients with T Cell Large Granular Lymphocytic Leukemia at the 67th American Society of Hematology Annual Meeting




Abcuro Presents Interim Phase 1 Data Evaluating Ulviprubart in Patients with T Cell Large Granular Lymphocytic Leukemia at the 67th American Society of Hematology Annual Meeting

NEWTON, Mass.–(BUSINESS WIRE)–Abcuro, Inc., a late-stage clinical biotechnology company developing potentially first-in-class immunotherapies designed to benefit people living with debilitating and progressive rare autoimmune diseases and for other indications where certain cytotoxic T cells are pathogenic, today presented interim data from the ongoing Phase 1/2 clinical trial evaluating ulviprubart (ABC008) in patients with T cell large granular lymphocytic leukemia (T-LGLL) with anemia and/or neutropenia, in an oral presentation at the 67^th American Society of Hematology (ASH) Annual Meeting and Exposition, taking place December 6-9, 2025 in Orlando, Florida.

Ulviprubart is a potentially first-in-class, potent, monoclonal antibody targeting KLRG1, a novel mechanism of action to drive selective depletion of highly differentiated T cells and modify disease progression. Ulviprubart was designed to target KLRG1-expressing T cells while sparing B and regulatory T cells that are required to maintain normal immune system homeostasis.

“The data presented at ASH continue to support the potential of ulviprubart to selectively target and deplete highly differentiated T cells that drive debilitating diseases like T-LGLL. At the interim analysis, ulviprubart had an acceptable safety profile and was generally well tolerated across ascending doses, further supporting ulviprubart’s potential in treating patients with T-LGLL,” said H. Jeffrey Wilkins, MD, Chief Medical Officer of Abcuro.

T-LGLL is a hematological cancer driven by pathogenic expansion of immune cells that are frequently KLRG1+, resulting in neutropenia and anemia. Neutropenia can lead to frequent infections, a major cause of premature death in patients with T-LGLL, while anemia results in transfusion dependence in approximately one-third of patients.

Key Highlights from Oral Presentation:

The Phase 1/2 clinical trial (NCT05532722) is an open label, ascending dose study of ulviprubart patients with T-LGLL. The primary objective is to evaluate safety and tolerability. Secondary objectives include evaluating initial efficacy and pharmacokinetic/pharmacodynamic (PK/PD) profile of ulviprubart.

As of the data cut-off date of November 15, 2025:

• 21 patients were enrolled and evaluable for safety. 95% (n=20) of patients had neutropenia and 57% (n=12) of patients had anemia at baseline.
• 62% (n=13) of patients achieved >12 weeks of Q4W dosing on ulviprubart.
  • Among evaluable patients, seven experienced sustained depletions of >50% of CD8⁺ CD57⁺ KLRG1⁺ T cells at two or more consecutive visits. Three patients experienced sustained depletions of >90% of both CD8⁺ CD57⁺ KLRG1⁺ T cells and the CD8⁺ CD57⁺ parent population.
  • Among evaluable patients, all had neutropenia and nine patients had anemia at baseline.
    • With treatment, seven patients had a neutropenia response, defined as an absolute neutrophil count (ANC) increase of ≥50% from baseline for ≥4 weeks or ANC levels ≥1000 cells/µL for ≥4 weeks.
    • With treatment, two patients had an anemia response, defined as hemoglobin increased ≥1 g/dL for ≥4 weeks and not attributable to transfusion or growth factor.

Overall, ulviprubart was well tolerated at increasing doses and had an acceptable safety profile. Most treatment-related treatment-emergent adverse events (TEAE) were mild or moderate in severity. One patient experienced a Grade 3 infusion-related reaction, the only serious treatment-related TEAE observed on therapy.

About Ulviprubart

Ulviprubart (ABC008) is potentially a first-in-class, potent, monoclonal antibody targeting KLRG1, a novel proposed mechanism of action to drive selective depletion of highly differentiated T cells and modify disease progression. KLRG1 is a cell surface receptor predominantly expressed on highly differentiated T cells, while moderately or minimally expressed on other immune cells. Ulviprubart was designed to selectively deplete KLRG1-expressing T cells while sparing B and regulatory T cells that are required to maintain normal immune system homeostasis.

About Abcuro

Abcuro is a late-stage clinical biotechnology company developing potentially first-in-class immunotherapies designed to benefit people living with debilitating and progressive rare autoimmune diseases and for other indications where certain cytotoxic T cells are pathogenic. Our product candidate, ulviprubart (formerly referred to as ABC008), is a humanized monoclonal antibody that targets pathogenic T cells that express killer cell lectin-like receptor G1 (“KLRG1”), referred to as KLRG1+ T cells. Ulviprubart is designed to selectively target and deplete well-differentiated cytotoxic KLRG1+ T cells where KLRG1 is highly expressed, while sparing other immune cells, which we believe will offer improvements in safety and tolerability as compared to other T cell depleting approaches. Ulviprubart is currently being evaluated in a registrational Phase 2/3 clinical trial in people with inclusion body myositis (IBM), and a Phase 1/2 clinical trial in people with T cell large granular lymphocytic leukemia (T-LGLL).

For more information, visit us on LinkedIn and at abcuro.com.

Contacts

Matthew DeYoung

Investor Relations and Media

Argot Partners

abcuro@argotpartners.com

PepGen Appoints Joseph Vittiglio, Esq., as Chief Business and Legal Officer




PepGen Appoints Joseph Vittiglio, Esq., as Chief Business and Legal Officer

BOSTON–(BUSINESS WIRE)–PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced the appointment of Joseph Vittiglio, Esq., as Chief Business and Legal Officer. Mr. Vittiglio brings more than two decades of executive leadership experience across legal, compliance, corporate development, and corporate governance within public biotechnology companies.

“Joe is a deeply experienced legal and business leader with a proven track record guiding companies through complex transactions, regulatory milestones, financings, product launches, and strategic partnerships,” said James McArthur, PhD, President and Chief Executive Officer of PepGen. “We are excited to welcome him to PepGen’s executive leadership team as we continue to make significant progress advancing our PGN-EDODM1 program and prepare for the anticipated 2026 readouts from the 5 mg/kg and 10 mg/kg cohorts in our FREEDOM2-EDODM1 multiple ascending dose study in DM1 patients.”

Mr. Vittiglio joins PepGen after providing extensive consulting support to the Company in 2025. He most recently served as Chief Business and Legal Officer and Corporate Secretary at bluebird bio, where he led global legal, compliance, and business development; supported the approval and launch of three U.S. gene therapy products; advanced ex-U.S. partnering; and completed more than $400 million in financings. Prior to bluebird, he served as Chief Business and Legal Officer at Finch Therapeutics, guiding the company’s IPO, building its public-company governance and compliance functions, and overseeing a global IP portfolio of more than 50 patent families. Previously, he was Chief Business Officer and General Counsel at AMAG Pharmaceuticals, supporting major corporate transactions, multiple product launches, significant financings, and all legal, compliance, and business development for a commercial organization generating over $400 million annually. Earlier in his career, he held senior legal roles at Flexion Therapeutics, AVEO Pharmaceuticals, and Oscient Pharmaceuticals, after beginning his legal career at Mintz. Mr. Vittiglio holds a J.D. from Northeastern University School of Law and a B.A. in International Relations from Tufts University.

About PepGen

PepGen Inc. is a clinical-stage biotechnology company developing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases. PepGen’s Enhanced Delivery Oligonucleotide (EDO) platform is founded on over a decade of research and development and leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics. Using these EDO peptides, the Company is generating a pipeline of oligonucleotide therapeutic candidates designed to target the root cause of serious diseases.

For more information, please visit PepGen.com. Follow PepGen on LinkedIn and X.

Contacts

Investor Contact
Laurence Watts

New Street Investor Relations

laurence@newstreetir.com

Media Contact
Julia Deutsch

Lyra Strategic Advisory

Jdeutsch@lyraadvisory.com