Genmab Announces EPKINLY® (epcoritamab-bysp) in Combination with Rituximab and Lenalidomide Approved by the U.S. Food and Drug Administration for the Treatment of Relapsed or Refractory Follicular Lymphoma




Genmab Announces EPKINLY® (epcoritamab-bysp) in Combination with Rituximab and Lenalidomide Approved by the U.S. Food and Drug Administration for the Treatment of Relapsed or Refractory Follicular Lymphoma

Company Announcement

• EPKINLY plus rituximab and lenalidomide (EPKINLY + R²) is the first and only bispecific-based therapy approved by the FDA for follicular lymphoma in the second-line setting
• In the Phase 3 EPCORE^® FL-1 trial, fixed duration EPKINLY + R² demonstrated significantly superior progression-free survival and overall response rates compared to standard of care R², with approximately three out of four patients achieving a complete response
• This approval marks the third indication for EPKINLY and the first-ever FDA approval for a bispecific combination therapy in the lymphoma space

COPENHAGEN, Denmark; November 18, 2025 – Genmab A/S (Nasdaq: GMAB) announced today that EPKINLY^® (epcoritamab-bysp) in combination with rituximab and lenalidomide (EPKINLY + R²) was approved by the U.S. Food and Drug Administration (FDA) for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). The approval is based on results from the pivotal Phase 3 EPCORE^® FL-1 study that evaluated fixed duration EPKINLY + R² compared to standard of care R².ⁱ

In the study, treatment with fixed duration EPKINLY + R² reduced the risk of disease progression or death by 79% (HR 0.21, 95% CI: 0.13-0.33, p<0.0001) compared to R². Median progression-free survival (PFS) was not reached (NR) among patients treated with EPKINLY + R² (95% CI: 21.9-NR) compared to 11.2 months for patients treated with R² (95% CI: 10.5-NR). Among patients who were treated with EPKINLY + R², 89% responded to treatment (n=216/243, 95% CI: 84-93, p<0.0001) and 74% achieved a complete response (CR) (n=181/243, 95% CI: 69-80). This is compared to a 74% overall response rate (n=181/245, 95% CI: 68-79) and 43% CR rate among patients treated with R² (n=106/245, 95% CI: 37-50).ⁱ The Phase 3 EPCORE FL-1 study included patients with relapsed or recurrent FL following at least one prior line of treatment across a broad range of patient characteristics and disease risk factors.

The safety profile of EPKINLY + R² in the EPCORE FL-1 study was generally consistent with the known safety profiles of the individual regimens (epcoritamab and R²). The most common (≥ 20%) adverse reactions in patients who received EPKINLY + R² were rash, upper respiratory tract infections, fatigue, injection site reactions, constipation, diarrhea, cytokine release syndrome (CRS), pneumonia, COVID-19, and fever. The most common Grade 3 to 4 laboratory abnormalities (≥ 10%) were decreased neutrophil count, lymphocyte count, and platelets. CRS occurred in 24% of patients at the recommended 3 step-up dosing schedule, and was primarily low grade (19% Grade 1, 5% Grade 2). A single event of immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in one patient, grade 1 (0.8%). The prescribing information has a Boxed Warning for serious or fatal CRS and ICANS. Warnings and precautions include infections, cytopenias, and embryo-fetal toxicity. Please see additional Important Safety Information below.ⁱ

“Recurrent follicular lymphoma can be an incurable, complex, and persistent disease, creating a clear need for additional treatments that can change its course earlier in the treatment journey,” said Lorenzo Falchi, M.D., Lymphoma Specialist, Department of Medicine, Memorial Sloan Kettering Cancer Center. “The results shown with EPKINLY + R² in the EPCORE FL-1 study are incredibly meaningful, demonstrating durable responses compared to patients treated with R² alone. These data, delivered by a regimen that’s chemotherapy-free and can be administered in the outpatient setting, suggest that EPKINLY + R² could potentially become a new standard of care.”
  
FL is typically a slow-growing form of non-Hodgkin lymphoma (NHL) that impacts approximately 15,000 new patients per year in the U.S..^ii,iii The disease is considered incurable with current standard of care therapies.^iv Patients with FL often relapse, and in some cases, the disease can transform into a more aggressive form of NHL called diffuse large B-cell lymphoma (DLBCL).^v

“Today’s milestone marks meaningful progress for people living with follicular lymphoma. With a bispecific-based therapy that can be administered in a variety of medical settings, patients have the possibility of accessing this treatment at sites of care closer to where they live,” said Meghan Gutierrez, Chief Executive Officer, Lymphoma Research Foundation.

EPKINLY + R² was previously granted Breakthrough Therapy Designation (BTD) by the FDA for the treatment of R/R FL. This designation is granted to investigational medicines for serious or life-threatening diseases in cases where preliminary clinical evidence shows that the therapy may provide substantial improvements over available therapies.

“The FDA approval of EPKINLY + R² is an important advancement for patients with follicular lymphoma, enabling treatment at initial recurrence when more effective intervention is needed,” said Judith Klimovsky, M.D., Executive Vice President & Chief Development Officer, Genmab. “This milestone also underscores EPKINLY’s potential as the core therapy for B-cell malignancies, demonstrating benefit in combination and earlier disease, and building on its established role as a single agent option in later lines of treatment.”

In June 2024, EPKINLY monotherapy was granted accelerated approval by the FDA for the treatment of R/R FL following two or more lines of systemic therapy. With the results from the confirmatory Phase 3 EPCORE FL-1 study, the FDA has also converted the accelerated approval into a full approval.

Data from the Phase 3 EPCORE FL-1 study will be presented at the Annual Meeting and Exposition of the American Society of Hematology in December.

About the EPCORE FL-1 Trial
EPCORE FL-1 (NCT05409066) is a Phase 3 open-label interventional trial to evaluate the safety and efficacy of epcoritamab plus rituximab and lenalidomide (R²) versus R² alone in patients with relapsed/refractory (R/R) follicular lymphoma (FL). Patients were randomized to receive EPKINLY in combination with rituximab and lenalidomide (n=243) or rituximab and lenalidomide alone (n=245). Patients received EPKINLY in 28-day cycles for a total of 12 cycles or until disease progression or unacceptable toxicity, whichever occurred first. Efficacy was established based on the dual primary endpoints of progression free survival (PFS) and overall response rate (ORR) determined by Lugano 2014 criteria as assessed by Independent Review Committee (IRC). Additional efficacy outcome measures include complete response (CR) and duration of response (DOR).

EPKINLY^® (epcoritamab-bysp) U.S. INDICATIONS AND IMPORTANT SAFETY INFORMATION

What is EPKINLY?
EPKINLY is a prescription medicine used to treat adults with:

• certain types of diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma that has come back (relapsed) or that did not respond (refractory), after 2 or more treatments.
  • EPKINLY for the treatment of DLBCL is approved based on patient response data. Studies are ongoing to confirm the clinical benefit of EPKINLY.
• follicular lymphoma (FL) that has come back or that did not respond to previous treatment, together with lenalidomide and rituximab
• follicular lymphoma (FL) that has come back or that did not respond after receiving 2 or more treatments.

It is not known if EPKINLY is safe and effective in children.

Important Warnings—EPKINLY can cause serious side effects, including:

• Cytokine release syndrome (CRS), which is common during treatment with EPKINLY and can be serious or lead to death. To help reduce your risk of CRS, you will receive EPKINLY on a step-up dosing schedule (when you receive 2 or 3 smaller step-up doses of EPKINLY before your first full dose during your first cycle of treatment), and you may also receive other medicines before and for 3 days after receiving EPKINLY. If your dose of EPKINLY is delayed for any reason, you may need to repeat the step-up dosing schedule.
• Neurologic problems that can be serious, and can be life-threatening, and lead to death. Neurologic problems may happen days or weeks after you receive EPKINLY.

People with DLBCL or high-grade B-cell lymphoma should be hospitalized for 24 hours after receiving their first full dose of EPKINLY on Day 15 of Cycle 1 due to the risk of CRS and neurologic problems.

People with follicular lymphoma (FL) may need to be hospitalized after receiving their first full dose of EPKINLY on Day 22 of Cycle 1 due to the risk of CRS.

Tell your healthcare provider or get medical help right away if you develop a fever of 100.4°F (38°C) or higher; dizziness or lightheadedness; trouble breathing; chills; fast heartbeat; feeling anxious; headache; confusion; shaking (tremors); problems with balance and movement, such as trouble walking; trouble speaking or writing; confusion and disorientation; drowsiness, tiredness or lack of energy; muscle weakness; seizures; or memory loss. These may be symptoms of CRS or neurologic problems. If you have any symptoms that impair consciousness, do not drive or use heavy machinery or do other dangerous activities until your symptoms go away.

EPKINLY can cause other serious side effects, including:

• Infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment and treat you as needed if you develop an infection. You should receive medicines from your healthcare provider before you start treatment to help prevent infection. Tell your healthcare provider right away if you develop any symptoms of infection during treatment, including fever of 100.4°F (38°C) or higher, cough, chest pain, tiredness, shortness of breath, painful rash, sore throat, pain during urination, feeling weak or generally unwell, or confusion.
• Low blood cell counts, which can be serious or severe. Your healthcare provider will check your blood cell counts during treatment. EPKINLY may cause low blood cell counts, including low white blood cells (neutropenia and lymphopenia), which can increase your risk for infection; low red blood cells (anemia), which can cause tiredness and shortness of breath; and low platelets (thrombocytopenia), which can cause bruising or bleeding problems.

Your healthcare provider will monitor you for symptoms of CRS, neurologic problems, infections, and low blood cell counts during treatment with EPKINLY. Your healthcare provider may temporarily stop or completely stop treatment with EPKINLY if you develop certain side effects.

Before you receive EPKINLY, tell your healthcare provider about all your medical conditions, including if you have an infection, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. If you receive EPKINLY while pregnant, it may harm your unborn baby. If you are a female who can become pregnant, your healthcare provider should do a pregnancy test before you start treatment with EPKINLY and you should use effective birth control (contraception) during treatment and for 4 months after your last dose of EPKINLY. Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EPKINLY. Do not breastfeed during treatment with EPKINLY and for 4 months after your last dose of EPKINLY.

The most common side effects of EPKINLY when used alone in DLBCL or high-grade B-cell lymphoma or FL include CRS, injection site reactions, tiredness, muscle and bone pain, fever, diarrhea, COVID-19, rash, and stomach-area (abdominal) pain. The most common severe abnormal laboratory test results with EPKINLY when used alone include decreased white blood cells, decreased red blood cells, and decreased platelets.

The most common side effects of EPKINLY when used together with lenalidomide and rituximab in FL include rash, upper respiratory tract infections, tiredness, injection site reactions, constipation, diarrhea, CRS, pneumonia, COVID-19, and fever. The most common severe abnormal laboratory test results with EPKINLY when used together with lenalidomide and rituximab include decreased white blood cells and decreased platelets.

These are not all of the possible side effects of EPKINLY. Call your doctor for medical advice about side effects.

You are encouraged to report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to Genmab US, Inc. at 1-855-4GENMAB (1-855-443-6622).

Please see Medication Guide, including Important Warnings.

Helping Patients Access Care
Genmab strives to positively impact patients’ lives, and we’re committed to helping ensure our medicines reach the people who need them. We understand the impact that cancer can have, and so we empower patients and their care partners to take ownership of their treatment journey, offering support every step of the way. MyNavCare Patient Support™ by Genmab offers resources and services, from financial information to ongoing support, to help eligible patients access their Genmab medication and navigate their treatment journey. MyNavCare is available now to patients who have been prescribed EPKINLY. Patients, care partners, and healthcare providers interested in learning more about MyNavCare can visit www.MyNavCare.com or call 1-866-NAV-CAR1 (1-866-628-2271).

About Follicular Lymphoma (FL)
Follicular lymphoma (FL) is typically an indolent, or slow-growing, form of non-Hodgkin lymphoma (NHL), that arises from B-lymphocytes. The second most common form of NHL, FL accounts for 20-30% of all NHL cases and is diagnosed in approximately 15,000 people in the U.S. every year.^ii,iii FL is considered incurable with current standard of care therapies.^iv Patients often relapse, and with each relapse the remission and time to next treatment shorten.^vi Over time, transformation to diffuse large B-cell lymphoma (DLBCL), an aggressive form of NHL associated with poor survival outcomes, can occur in more than 25% of FL patients.^v

About EPKINLY^® (epcoritamab-bysp)
EPKINLY^® (epcoritamab-bysp) is an IgG1-bispecific antibody created using Genmab’s proprietary DuoBody^® technology and administered subcutaneously. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.^vii 

Epcoritamab (approved under the brand name EPKINLY in countries including the U.S. and Japan, and as TEPKINLY^® in the European Union) has received regulatory approval in certain lymphoma indications in more than 65 countries. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ oncology collaboration. The companies will share commercialization responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the R/R FL indication and additional approvals for the R/R DLBCL indication. 

Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes four additional ongoing Phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL compared to investigators choice immunochemotherapy (NCT04628494), a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R²) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744), and a trial evaluating epcoritamab in combination with lenalidomide compared to chemotherapy infusion in patients with R/R DLBCL (NCT06508658). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information.

About Genmab
Genmab is an international biotechnology company with a core purpose of guiding its unstoppable team to strive toward improving the lives of patients with innovative and differentiated antibody therapeutics. For 25 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with knock-your-socks-off (KYSO) antibody medicines^®. 

Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.

Contact:        
Caitlin Craparo, Vice President, Global Communications & Corporate Affairs
T: +1 609 255 7397; E: cacr@genmab.com

Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com

This Company Announcement contains forward looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab^®; the Y-shaped Genmab logo^®; Genmab in combination with the Y-shaped Genmab logo^®; HuMax^®; DuoBody^®; HexaBody^®; DuoHexaBody^®, HexElect^® and KYSO^®.

ⁱ EPKINLY (epcoritamab-bysp) [package insert]. Copenhagen, Denmark: Genmab, 2025.
ⁱⁱ Lymphoma Research Foundation official website. https://lymphoma.org/aboutlymphoma/nhl/fl/. Accessed November 2025.
ⁱⁱⁱ Leukemia & Lymphoma Society. https://www.lls.org/research/follicular-lymphoma-fl. Accessed November 2025.
^iv Ghione P, Palomba ML, Ghesquieres H, et al. Treatment patterns and outcomes in relapsed/refractory follicular lymphoma: results from the international SCHOLAR-5 study. Haematologica. 2023;108(3):822-832. doi: 10.3324/haematol.2022.281421.
^v Al-Tourah AJ, Gill KK, Chhanabhai M, et al. Population-based analysis of incidence and outcome of transformed non-Hodgkin’s lymphoma. J Clin Oncol. 2008 Nov 10;26(32):5165-9. doi: 10.1200/JCO.2008.16.0283. Epub 2008 Oct 6. PMID: 18838711.
^vi Rivas-Delgado A, Magnano L, Moreno-Velázquez M, et al. Response duration and survival shorten after each relapse in patients with follicular lymphoma treated in the rituximab era. Br J Haematol. 2018;184(5):753-759. doi:10.1111/bjh.15708.
^vii Engelberts PJ, et al. DuoBody-CD3xCD20 Induces Potent T-Cell-Mediated Killing of Malignant B Cells in Preclinical Models and Provides Opportunities for Subcutaneous Dosing. EBioMedicine. 2020;52:102625. doi: 10.1016/j.ebiom.2019.102625.

Company Announcement no. 49
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122

Genmab A/S
Carl Jacobsens Vej 30
2500 Valby
Denmark

Attachment

• 181125_CA49_Genmab EPKINLY R2 RR FL FDA Approval

NeuroSigma Launches Next-Generation Monarch Device for Pediatric ADHD After Successful Pilot Program




NeuroSigma Launches Next-Generation Monarch Device for Pediatric ADHD After Successful Pilot Program

Company dispensed over 1,000 FDA-cleared systems in pilot phase; unveils new website and second-generation device for early 2026 launch

LOS ANGELES, Nov. 18, 2025 (GLOBE NEWSWIRE) — NeuroSigma, Inc., a Los Angeles-based bioelectronics company, today announced the successful completion of its pilot commercialization program for the first-generation Monarch eTNS^® System and the launch of a new website in preparation for release of its second-generation Monarch device. The pilot program validated strong market demand, with over 1,000 Monarch eTNS Systems and 100,000 disposable patches dispensed since introducing the product in the United States.

New Website Supports Second-Generation Launch
NeuroSigma has launched a new website to support the commercialization of its second-generation Monarch device. The website provides product information and allows physicians, parents, and caregivers to join an advance reservation list for the upcoming launch. www.monarch-etns.com

Second-Generation Device Offers Improved Design
The first-generation Monarch eTNS System was the first-ever wearable medical device to receive FDA clearance as a drug-free treatment for pediatric attention-deficit/hyperactivity disorder (ADHD). The second-generation device treats pediatric ADHD with the same therapeutic trigeminal nerve stimulation as the first-generation device, but with an efficient, more modern design and a simplified user interface. The new device is scheduled for U.S. launch in the first quarter of 2026. The Monarch eTNS System is also the only eTNS-based neurostimulation device with peer-reviewed data from double-blinded, placebo-controlled studies. These studies were conducted at elite universities and institutions, using the FDA-cleared Monarch eTNS System, with results published in reputable academic journals.  

“NeuroSigma is proud to report the successful completion of our pilot commercial program. Our results confirmed a robust reception and strong satisfaction for the therapy from both patients and caregivers, as reflected by a significant number of repeat prescribers,” said Colin Kealey, M.D., President and CEO of NeuroSigma. “We are also excited by the early results from launch of the new website. It is already proving to be an effective online gateway for all parties interested in the Monarch eTNS System.”

“The results of our pilot commercial program, including substantial recurring revenue through the sale of daily disposable patches, demonstrated strong demand for this innovative product and validation for NeuroSigma’s business model,” added Tom Paschall, Director of NeuroSigma and CEO of Checkmate Capital. “2026 will be a transformative year for NeuroSigma as we launch the second-generation device and expand our commercial efforts to patients, caregivers, and physicians throughout the United States.”

About NeuroSigma
NeuroSigma is a Los Angeles, California-based bioelectronic medical device company developing technologies to transform medical practice and patients’ lives. The company’s lead product is the Monarch eTNS System, which is the first non-drug treatment for pediatric ADHD cleared by the FDA. Pipeline indications for the Monarch eTNS System include neurodevelopmental disorders such as autism spectrum disorder (ASD), learning disabilities, and epilepsy. NeuroSigma has received Breakthrough Device Designation for the Monarch eTNS System from the FDA in drug-resistant epilepsy. For more information about NeuroSigma, please visit www.neurosigma.com. For more information on the Monarch eTNS System, please visit www.monarch-etns.com.

Contact:
Colin Kealey, M.D., President of NeuroSigma at CKealey@neurosigma.com 

ALX Oncology to Present at Upcoming Investor Conferences




ALX Oncology to Present at Upcoming Investor Conferences

SOUTH SAN FRANCISCO, Calif., Nov. 18, 2025 (GLOBE NEWSWIRE) — ALX Oncology Holdings Inc., (“ALX Oncology” or the “Company”) (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, today announced that ALX Oncology leadership will participate in both the Jefferies Global Healthcare Conference in London and Piper Sandler 37^th Annual Global Healthcare Conference in New York.

The details of the meetings are as follows:

Jefferies Global Healthcare Conference in London

Format: Fireside Chat
Date: Wednesday, November 19, 2025
Time: 11:30 AM GMT / 6:30 AM EST
Location: London, UK
Webcast link: Available here

Piper Sandler 37^th Annual Global Healthcare Conference

Format: Fireside Chat
Date: Wednesday, December 3, 2025
Time: 9:30 AM EST
Location: New York, NY
Webcast link: Available here

The webcasts of the Jefferies London and Piper Sandler fireside chats can be accessed by visiting the Investors section of ALX Oncology’s website at www.alxoncology.com under the Events section of the Events and Presentations tab. Replays of the webcasts will be archived for up to 90 days following the fireside chat dates.

About ALX Oncology
ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives. ALX Oncology’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. ALX Oncology’s second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action and entered the clinic in a Phase 1 trial in August 2025. More information is available at www.alxoncology.com and on LinkedIn @ALX Oncology.

Investor Relations Contact:
Elhan Webb, CFA, IR Consultant
ewebb@alxoncology.com

Media Contact:
Audra Friis, Sam Brown Healthcare Communications
audrafriis@sambrown.com
(917) 519-9577

Sarah Scott Named to Business Insurance’s “Women to Watch” List for 2025




Sarah Scott Named to Business Insurance’s “Women to Watch” List for 2025

Scott recognized for improving patient care and advancing innovation in workers’ compensation at CorVel

FORT WORTH, Texas, Nov. 18, 2025 (GLOBE NEWSWIRE) — CorVel Corporation is proud to announce that Sarah Scott, Executive Vice President of Product and Corporate Services, has been named to Business Insurance’s prestigious “Women to Watch” list for 2025. Now celebrating its 20th year, the award honors women who have achieved extraordinary success in insurance and risk management through leadership, innovation, and mentorship.

A 26-year veteran of CorVel, Scott has played a pivotal role in advancing the Company’s product innovation, clinical integration, and digital transformation initiatives. In her current role, she oversees the development and evolution of CorVel’s entire product portfolio, ensuring the organization continues to deliver innovative solutions that create value and meet the evolving needs of its partners.

As a registered nurse, Sarah began her career as a nurse case manager. Her combination of clinical insight and business acumen has helped shape CorVel’s data-driven approach to improving patient outcomes and operational efficiency. Today, she is spearheading initiatives to integrate generative AI across CorVel’s product suite, enabling faster, smarter decision-making while enhancing results for injured workers and ensuring responsible innovation. She is modernizing services and leveraging data-driven insights to anticipate trends and proactively address emerging challenges.

“Sarah’s leadership style, focused on adding value and driving strong performance, motivates her teams to think creatively, execute with precision, and consistently deliver meaningful impact across the organization,” said Michael Combs, CorVel’s President and CEO. “Her work continues to strengthen CorVel’s position in the marketplace and enhance the support we provide for our partners and the people we serve.”

“This recognition is truly a reflection of the incredible team I work with every day,” Scott said. “Together, we’re advancing the future of our industry through technology that enhances—not replaces—the human connection at the heart of recovery.”

Business Insurance will honor all 2025 Women to Watch recipients in its December issue.

About CorVel
CorVel Corp. applies technology, including artificial intelligence, machine learning, and natural language processing, to enhance the management of episodes of care and related health care costs. We partner with employers, third-party administrators, insurance companies, and government agencies in managing workers’ compensation and health, auto, and liability services. Our diverse suite of solutions combines our integrated technologies with a human touch. CorVel’s customized services, delivered locally, are backed by a national team to support our partners and their customers and patients.

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995
All statements included in this press release, other than statements or characterizations of historical fact, are forward-looking statements. These forward-looking statements are based on the Company’s current expectations, estimates and projections about the Company, management’s beliefs, and certain assumptions made by the Company, and events beyond the Company’s control, all of which are subject to change Such forward-looking statements include, but are not limited to, statements relating to the Company’s services and the Company’s continued investment in these and other innovative technologies, and statements relating to the Company’s product offerings. These forward-looking statements are not guarantees of future results and are subject to risks, uncertainties and assumptions that could cause the Company’s actual results to differ materially and adversely from those expressed in any forward-looking statement results of operations and financial condition is greater than our initial assessment. The risks and uncertainties referred to above include but are not limited to factors described in this press release and the Company’s filings with the Securities and Exchange Commission, including but not limited to “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended March 31, 2025, and the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025. The forward-looking statements in this press release speak only as of the date they are made. The Company undertakes no obligation to revise or update publicly any forward-looking statement for any reason.

Contact: Melissa Storan
Phone: 949-851-1473
www.corvel.com

Catalyst Pharmaceuticals to Participate in Citi’s 2025 Global Healthcare Conference




Catalyst Pharmaceuticals to Participate in Citi’s 2025 Global Healthcare Conference

CORAL GABLES, Fla., Nov. 18, 2025 (GLOBE NEWSWIRE) — Catalyst Pharmaceuticals, Inc. (“Catalyst” or “Company”) (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare and difficult-to-treat diseases, today announced that Rich Daly, President and CEO, along with other members of Catalyst’s management team, will participate in Citi’s 2025 Global Healthcare Conference in Miami on Tuesday, December 2, 2025.

Date of Presentation: Tuesday, December 2, 2025
Time: 1:00pm ET
Webcast Link

The webcast will be available under the Investors section on the Company’s website, www.catalystpharma.com, and a replay will be available for at least 30 days.

About Catalyst Pharmaceuticals, Inc.

Catalyst Pharmaceuticals, Inc. (Nasdaq: CPRX), is a biopharmaceutical company committed to improving the lives of patients with rare diseases. With a proven track record of bringing life-changing treatments to the market, we focus on in-licensing, commercializing, and developing innovative therapies. Guided by our deep commitment to patient care, we prioritize accessibility, ensuring patients receive the care they need through a comprehensive suite of support services designed to provide seamless access and ongoing assistance. Catalyst maintains a well-established U.S. presence, which remains the cornerstone of our commercial strategy, while continuously evaluating strategic opportunities to expand our global footprint. Catalyst, headquartered in Coral Gables, Fla., was recognized on the Forbes 2025 list as one of America’s Most Successful Mid-Cap Companies and on the 2024 Deloitte Technology Fast 500™ list as one of North America’s Fastest-Growing Companies.

For more information, please visit Catalyst’s website at www.catalystpharma.com.

Forward-Looking Statements

This press release contains forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst’s actual results in future periods to differ materially from forecasted results. A number of factors, including those factors described in Catalyst’s Annual Report on Form 10-K for the fiscal year 2024 and its subsequent filings with the U.S. Securities and Exchange Commission (“SEC”), could adversely affect Catalyst. Copies of Catalyst’s filings with the SEC are available from the SEC, may be found on Catalyst’s website, or may be obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date.

CONTACT: Investor Contact
Melissa Kendis, Catalyst Pharmaceuticals, Inc.
(305) 420-3200
IR@catalystpharma.com

Media Contact
David Schull or Olipriya Das, Russo Partners
(858) 717-2310, 646 942 5588
david.schull@russopartnersllc.com, Olipriya.das@russopartnersllc.com

Mainz Biomed and OncoVanguard8 Enter into Agreement to bring ColoAlert to South America




Mainz Biomed and OncoVanguard8 Enter into Agreement to bring ColoAlert to South America

OncoVanguard8 is a leading service provider for innovative healthcare products for insurance companies operating in Peru, Colombia and Ecuador

BERKELEY, Calif. and MAINZ, Germany, Nov. 18, 2025 (GLOBE NEWSWIRE) — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company“), a molecular genetics diagnostic company specializing in the early detection of cancer, today announced the signing of a Memorandum of Understanding (“MOU”) with OncoVanguard8, a distributor of oncological innovations. The collaboration aims to introduce ColoAlert®, a DNA-based colorectal cancer (CRC) screening test, to South America, starting with Peru.

Colorectal cancer continues to represent one of the most prevalent yet largely preventable cancer types on a global scale. In the three initial launch markets Peru, Colombia and Ecuador alone, approximately 17,000 new cases are diagnosed each year, highlighting the pressing demand for effective early detection and preventive strategies. The rollout of a DNA-based CRC screening solution presents a significant step forward, with the potential to markedly raise screening participation, facilitate timely diagnosis, and align seamlessly with national public health initiatives aimed at reducing CRC-related mortality and enhancing long-term population health outcomes.

In their common MOU, Mainz Biomed and OncoVanguard8 have outlined core commercial, legal and regulatory terms as well as the go-to-market strategy for the initial territory to be part of a final distribution agreement aimed to be signed within the next weeks.

Please visit Mainz Biomed’s official website for investors at mainzbiomed.com/investors/ for more information

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About Mainz Biomed NV

Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company’s flagship product is ColoAlert®, an accurate, non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer. ColoAlert® is marketed across Europe. The Company is currently running its eAArly DETECT 2 clinical study in preparation for its pivotal FDA study for US regulatory approval. Mainz Biomed’s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in blood and stool samples. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook..

About OncoVanguard8

OncoVanguard8 is a company focused on identifying and implementing innovative healthcare solutions for Latin America, with a mission to bridge the technological gap in cancer prevention and early detection. Based in Lima, Peru, the company develops strategic partnerships with insurers, hospitals, and healthcare networks to introduce advanced diagnostic technologies and promote equitable access to innovation. Operating across Peru, Colombia, and Ecuador, OncoVanguard8 serves as a regional catalyst for integrating global oncology advancements into local healthcare systems.

For media inquiries as to Mainz Biomed:
MC Services AG
Maximilian Schur / Simone Neeten
+49 211 529252 20
mainzbiomed@mc-services.eu

For investor inquiries, please contact ir@mainzbiomed.com 

Forward-Looking Statements

Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company’s expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the “SEC”) by the Company. Additional information concerning these and other factors that may impact the Company’s expectations and projections can be found in its initial filings with the SEC, including its annual report on Form 20-F filed on March 31, 2025 and its mid-year report on Form 6-K filed on September 26, 2025. The Company’s SEC filings are available publicly on the SEC’s website at www.sec.gov. Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.

Inspire Medical Systems, Inc. to Present at the Piper Sandler 37th Annual Healthcare Conference




Inspire Medical Systems, Inc. to Present at the Piper Sandler 37th Annual Healthcare Conference

MINNEAPOLIS, Nov. 18, 2025 (GLOBE NEWSWIRE) — Inspire Medical Systems, Inc. (NYSE: INSP) (Inspire), a medical technology company focused on the development and commercialization of innovative, minimally invasive solutions for patients with obstructive sleep apnea, announced today that its management team will present at the Piper Sandler 37^th Annual Healthcare Conference on Tuesday, December 2, 2025.

Inspire is scheduled to present at 11:30 a.m. Eastern Time. The presentation will be accessible via a live webcast here.

A webcast replay of the presentation will be available for two weeks following the presentation in the Event Archive section of Inspire’s Investor website at https://investors.inspiresleep.com.

About Inspire Medical Systems
Inspire is a medical technology company focused on the development and commercialization of innovative, minimally invasive solutions for patients with obstructive sleep apnea. Inspire’s proprietary Inspire therapy is the first and only FDA, EU MDR, and PDMA-approved neurostimulation technology that provides a safe and effective treatment for moderate to severe obstructive sleep apnea.

For additional information about Inspire, please visit www.inspiresleep.com.

Investor and Media Contact
Ezgi Yagci
Vice President, Investor Relations
ezgiyagci@inspiresleep.com
617-549-2443

Entera Bio to Participate in the 8th Annual Evercore ISI Healthcare Conference




Entera Bio to Participate in the 8th Annual Evercore ISI Healthcare Conference

JERUSALEM, Nov. 18, 2025 (GLOBE NEWSWIRE) — Entera Bio Ltd. (Nasdaq: ENTX), (“Entera” or the “Company”) a leader in the development of oral peptide and protein replacement therapies, today announced that the Company’s Chief Executive Officer, Miranda Toledano, will be participating in a fireside chat at the 8th Annual Evercore ISI Healthcare Conference, details as below.

7th Annual Evercore ISI HealthCONx Conference (Fireside Chat and 1×1 Meetings)

Date and Time: December 3 at 9:10-9:30AM in Sevilla A
Location: In person, December 3-5, 2024 Coral Gables, Florida

A live webcast of the discussion will be available at the link below. A replay will remain accessible for 90 days following the event.

Webcast Link: https://wsw.com/webcast/evercore52/entx/2393886

About Entera Bio
Entera is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N-Tab™) and its pipeline of first-in-class oral peptide programs targeting PTH(1-34), GLP-1 and GLP-2. The Company’s most advanced product candidate, EB613 (oral PTH(1-34)), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for post-menopausal women with low BMD and high-risk osteoporosis. A placebo-controlled, dose-ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). The EB612 program is being developed as the first oral PTH(1-34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity and metabolic syndromes; and first oral GLP-2 peptide as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com or follow us on LinkedIn, Twitter, and Facebook.

Cautionary Statement Regarding Forward Looking Statements
Various statements in this presentation are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this presentation regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward-looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. Important factors that could cause actual results to differ materially from those reflected in Entera’s forward-looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s ability to establish and maintain development and commercialization collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s competitive position with respect to other products on the market or in development for the treatment of osteoporosis, hypoparathyroidism, short bowel syndrome, obesity, metabolic conditions and other disease categories it pursues; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statement Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10-K filed with the SEC, as well as Entera’s subsequently filed Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward-looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward-looking statements Entera makes in this presentation. The information in this presentation is provided only as of the date of this presentation, and Entera undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

Company Contact:
Entera Bio: 
Ms. Miranda Toledano
Chief Executive Officer, Entera Bio
Email: miranda@enterabio.com

Nasus Pharma Announces Initiation of Phase 2 Clinical Study of NS002 with First Participant Dosed




Nasus Pharma Announces Initiation of Phase 2 Clinical Study of NS002 with First Participant Dosed

The Phase 2 study is designed to address regulatory approval considerations by comparing bioavailability and pharmacokinetics of NS002 against EpiPen

Previous clinical study demonstrated NS002 can achieve faster and higher absorption of epinephrine compared to an autoinjector

Dosing of the first participant in the Phase 2 study in Canada reflects the successful initiation of the Company’s needle-free epinephrine delivery program for anaphylaxis treatment

Interim results are expected in the first quarter of 2026

TEL AVIV, Nov. 18, 2025 (GLOBE NEWSWIRE) — Nasus Pharma Ltd. (NYSE: NSRX) (“Nasus Pharma” or the “Company”), a clinical-stage pharmaceutical company focused on the development of innovative intranasal products to treat emergency medical conditions, today announced the successful initiation of the Company’s Phase 2 clinical study with dosing of the first participant in Canada. The trial aims to evaluate NS002, the Company’s investigational intranasal epinephrine powder formulation, compared to EpiPen for the treatment of anaphylaxis. NS002 could potentially offer patients a needle-free alternative to traditional epinephrine autoinjectors.

The Phase 2 study is an open-label, fixed-sequence trial designed to evaluate the pharmacokinetic parameters and hemodynamic responses of NS002 compared to EpiPen in 50 healthy adults with a history of allergic rhinitis.  Interim results from this trial are expected in the first quarter of 2026.

“The dosing of the first participant in our Phase 2 study marks a significant milestone for our NS002 program and for patients with severe allergies who need more user-friendly treatment options to manage life-threatening anaphylaxis,” said Dan Teleman, Chief Executive Officer of Nasus Pharma. “We are moving forward at full speed, executing the NS002 development program as planned, and positioning the Company for its next stage of growth. For millions suffering from severe allergies, the fear of needles and the inconvenience of carrying cumbersome autoinjectors leads to poor compliance and potentially life-threatening outcomes in anaphylaxis management.”

About Nasus Pharma
Nasus Pharma is a clinical-stage pharmaceutical company developing a number of intranasal powder products addressing acute medical conditions in the community. NS002, Nasus’s intranasal powder Epinephrine product candidate is being developed as a needle-free alternative to Epinephrine autoinjectors for patients with anaphylaxis. Intranasal administration is most suitable for those situations in which rapid drug delivery is required and offers needle free, easy to use alternatives. Nasus proprietary powder-based intranasal (“PBI”) technology is designed for rapid and reliable drug delivery, leveraging the nasal cavity’s rich vascular network for quick absorption. The PBI formulation uses uniform spherical powder particles for broad dispersion and potentially faster, higher absorption compared to liquid-based nasal products. For further information about the Company, please visit www.nasuspharma.com or follow on Twitter (X) or LinkedIn.

Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and other U.S. federal securities laws. All statements, other than statements of historical fact, contained in this press release are forward-looking statements, including, among other things: statements regarding the initiation, progress, and potential outcomes of the Company’s Phase 2 clinical trial of NS002; the expected timing of interim results; the potential for NS002 to improve treatment accessibility and compliance compared to traditional autoinjectors and EpiPen; the ability of our proprietary powder-based intranasal technology to deliver epinephrine safely and effectively; the Company’s expectations for continued advancement of the NS002 development program as planned and its anticipated positioning for the next stage of corporate growth, and the advancement of NS002 as a needle-free alternative for the treatment of anaphylaxis. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on the Company’s current expectations and are subject to uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the Company’s prospectus filed with the U.S. Securities and Exchange Commission dated August 12, 2025. Forward-looking statements contained in this press release are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law.

Company Contact
Nasus Pharma Ltd.
info@nasuspharma.com

Investor Contact
Arx Investor Relations
North American Equities Desk
nasus@arxhq.com

Rakovina Therapeutics’ President & CSO to Present and Join Expert Panel at the 9th Annual DDR Inhibitors Summit




Rakovina Therapeutics’ President & CSO to Present and Join Expert Panel at the 9th Annual DDR Inhibitors Summit

VANCOUVER, British Columbia, Nov. 18, 2025 (GLOBE NEWSWIRE) — Rakovina Therapeutics Inc. (“Rakovina” or the “Company”) (TSX-V: RKV)(FSE: 7JO0) a biopharmaceutical company advancing cancer therapies through AI-enabled drug discovery, today announced that its President and Chief Scientific Officer, Prof. Mads Daugaard, has been invited to present and participate as a panelist at the 9th Annual DNA Damage Response (DDR) Inhibitors Summit, taking place January 27–29, 2026, in Boston, MA.

The DDR Inhibitors Summit is recognized as a premier global forum uniting translational scientists, clinicians, and biotechnology innovators working to advance next-generation DDR-targeted cancer therapies. The 2026 program will feature expert insights on synthetic lethality, emerging DDR drug targets, biomarkers, and AI-driven discovery, with a strong focus on translational strategies to accelerate clinical impact.

Prof. Daugaard will deliver a featured presentation titled:
“Harnessing AI-Driven Drug Discovery to Accelerate Next-Generation DDR Therapeutics”

His session will highlight Rakovina’s pivot to an AI-enabled drug discovery model and showcase studies of AI-designed DDR programs progressing through preclinical lead selection and toward development.

In addition to his presentation, Prof. Daugaard will participate in a fireside chat entitled “Empowering Academic Entrepreneurs to Translate DDR Discoveries Into Impactful Biotech Ventures” and a panel discussion on “Uniting Founders and Funders to Align Scientific Vision with Investment Strategy.” In these sessions, he will join a distinguished group of global oncology leaders to discuss evolving DDR biology, resistance mechanisms, and next-generation clinical strategies.

“The DDR field is undergoing a profound shift, driven by new discoveries in DNA damage response biology, smarter combination strategies, and the integration of AI into early discovery,” said Prof. Daugaard. “We are excited to contribute to the scientific dialogue shaping the future of targeted oncology, and to share how AI can accelerate the development of precisely engineered DDR therapeutics designed for clinical impact.”

As a co-founder of Rakovina and an Associate Professor at the University of British Columbia, Prof. Daugaard brings deep expertise in cancer biology and therapeutic resistance, with a research focus on uncovering vulnerabilities in tumor survival pathways and advancing them toward targeted drug discovery. His participation in the 9th DDR Inhibitors Summit reinforces the momentum behind Rakovina’s AI-accelerated DDR pipeline and highlights the Company’s role within a collaborative global effort to deliver new therapeutic options for patients with difficult-to-treat cancers.

About Rakovina Therapeutics Inc.
Rakovina Therapeutics is a biopharmaceutical research company focused on the development of innovative cancer treatments. Our work is based on unique technologies for targeting the DNA-damage response powered by Artificial Intelligence (AI) using the proprietary Deep-Docking™ and Enki™ platforms. By using AI, we can review and optimize drug candidates at a much greater pace than ever before.
The Company has established a pipeline of distinctive DNA-damage response inhibitors with the goal of advancing one or more drug candidates into human clinical trials in collaboration with pharmaceutical partners. Further information may be found at www.rakovinatherapeutics.com.

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

Notice Regarding Rakovina Therapeutics Forward-Looking Statements:
This release includes forward-looking statements regarding the company and its respective business, which may include, but is not limited to, statements with respect to the proposed business plan of the company and other statements. Often, but not always, forward-looking statements can be identified by the use of words such as “plans,” “is expected,” “expects,” “scheduled,” “intends,” “contemplates,” “anticipates,” “believes,” “proposes” or variations (including negative variations) of such words and phrases, or state that certain actions, events, or results “may,” “could,” “would,” “might,” or “will” be taken, occur, or be achieved. Such statements are based on the current expectations of the management of the company. The forward-looking events and circumstances discussed in this release may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the company, including risks regarding the biopharmaceutical industry, economic factors, regulatory factors, the equity markets generally, and risks associated with growth and competition.

Although the company has attempted to identify important factors that could cause actual actions, events, or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events, or results to differ from those anticipated, estimated, or intended. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made, and the company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. The reader is referred to the company’s most recent filings on SEDAR+ for a more complete discussion of all applicable risk factors and their potential effects, copies of which may be accessed through the company’s profile page at www.sedar.com.

For Further Information Contact:
Michelle Seltenrich, BSc MBA
Director, Corporate Development
IR@rakovinatherapeutics.com
778-773-5432