EVX-01

New biomarker and immune data from the ongoing phase 2 trial with EVX-01 will be presented at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting The data will be the latest of many additions to EVX-01’s strong data packageTwo-year clinical efficacy data from the trial will be presented at the European Society for Medical Oncology (ESMO) 2025 congress on October 17, 2025 COPENHAGEN, Denmark, October 3, 2025 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, will present new data for its lead asset EVX-01 at a poster session at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting taking place in National Harbor November 5-9, 2025. Designed with Evaxion’s AI-Immunology™ platform, EVX-01 is a personalized cancer vaccine currently being evaluated as a treatment for advanced melanoma (skin cancer). Evaxion will present new biomarker and immune data stemming from the ongoing phase 2 trial with EVX-01. The two-year clinical efficacy data from the trial will, as earlier announced, be presented in an oral presentation at the ESMO 2025 congress on October 17, 2025. Both datasets will add to an already strong data package for EVX-01, which includes convincing one-year interim data from the phase 2 trial. The phase 2 trial investigates EVX-01 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with advanced melanoma (skin cancer). Each patient enrolled in the trial has received a unique vaccine designed and manufactured based on their individual biology. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. SITC presentation details: Abstract title: Immune correlates of clinical response following treatment with the personalized cancer vaccine EVX-01 and Pembrolizumab in advanced melanoma patientsAbstract#: 605Poster#: 605Session (category): Clinical trials in progress (subcategory: Skin cancers)Location: Lower Level Atrium - Prince George's ABCDate/Time: Friday, November 7, 2025, 5:10–6:35 p.m. ET/23.10-00.35 CET Presenter: Michail Angelos Pavlidis, Research Associate at Evaxion About EVX-01 EVX-01 is a personalized peptide-based cancer vaccine intended for first-line treatment of multiple advanced solid cancers. It is Evaxion’s lead clinical asset. EVX-01 is designed with our AI-Immunology™ platform and is tailored to target the unique tumor profile and immune characteristics of each patient. It engages the patient's immune system to fight off cancer by mounting a targeted response against tumors. In clinical trials, EVX-01 has demonstrated 69% and 67% Overall Response Rates in patients with advanced melanoma. Further, significant correlations between clinical responses and AI-Immunology™ predictions have been observed, underlining the predictive power of the platform. Contact information Evaxion A/SMads KronborgVice President, Investor Relations & Communication+45 53 54 82 96 mak@evaxion.ai About Evaxion Evaxion is a pioneering TechBio company based upon its AI platform, AI-Immunology™. Evaxion’s proprietary and scalable AI prediction models harness the power of artificial intelligence to decode the human immune system and develop novel immunotherapies for cancer, bacterial diseases, and viral infections. Based upon AI-Immunology™, Evaxion has developed a clinical-stage oncology pipeline of novel personalized vaccines and a preclinical infectious disease pipeline in bacterial and viral diseases with high unmet medical needs. Evaxion is committed to transforming patients’ lives by providing innovative and targeted treatment options. For more information about Evaxion and its groundbreaking AI-Immunology™ platform and vaccine pipeline, please visit our website. Forward-looking statement This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “target,” “believe,” “expect,” “hope,” “aim,” “intend,” “may,” “might,” “anticipate,” “contemplate,” “continue,” “estimate,” “plan,” “potential,” “predict,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could,” and other words and terms of similar meaning identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including, but not limited to, risks related to: our financial condition and need for additional capital; our development work; cost and success of our product development activities and preclinical and clinical trials; commercializing any approved pharmaceutical product developed using our AI platform technology, including the rate and degree of market acceptance of our product candidates; our dependence on third parties including for conduct of clinical testing and product manufacture; our inability to enter into partnerships; government regulation; protection of our intellectual property rights; employee matters and managing growth; our ADSs and ordinary shares, the impact of international economic, political, legal, compliance, social and business factors, including inflation, and the effects on our business from other significant geopolitical and macro-economic events; and other uncertainties affecting our business operations and financial condition. For a further discussion of these risks, please refer to the risk factors included in our most recent Annual Report on Form 20-F and other filings with the US Securities and Exchange Commission (SEC), which are available at www.sec.gov. We do not assume any obligation to update any forward-looking statements except as required by law.

Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, B.C., July 29, 2025 /PRNewswire/ -- Equity Insider News Commentary – The average age of cancer patients is getting younger, as experts are urgently examining the rise of early-onset incidence across several different cancer types. According to the Cancer Discovery study from the National Cancer Institute (NCI), the largest increases were seen in female breast, colorectal, kidney, uterine, and pancreatic cancers. Biotechs in the oncology space are responding with optimistic new treatments with potential milestones in the near future that may shift the tide in the sector, including Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Celcuity Inc. (NASDAQ: CELC), Evaxion A/S (NASDAQ: EVAX), Lyell Immunopharma, Inc. (NASDAQ: LYEL), and Agenus Inc. (NASDAQ: AGEN). Globally, the cancer‑drug sector is projected to surpass US$900billion in sales by 2034, according to Vision Research Reports. Next‑generation therapeutics (those powered by precision and personalized medicine) are pegged by Precedence Research to hit US$175.2billion during that same time period, growing at a 7.35% CAGR. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) has officially entered the most critical phase of its journey yet—pursuing a potential registration-enabled trial in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC), for its flagship asset, pelareorep. The company announced it has begun formal discussions with the U.S. Food and Drug Administration (FDA) aimed at finalizing a pivotal study design, with trial start-up activities expected to begin before the end of 2025. For investors and potential partners, this marks a clear shift from promising data to regulatory execution in one of the deadliest solid tumors in medicine. "We expect to move quickly and decisively down a clear regulatory path," said Jared Kelly, CEO of Oncolytics. "This is about execution and focus. Our goal is to win on survival—and this pivotal study is how we do it. We believe this program not only creates significant value for shareholders but also positions Oncolytics as a highly attractive partner for pharma companies seeking to break open the immunotherapy landscape in mPDAC and other GI tumors." The move comes as Oncolytics sharpens its focus on pelareorep, a systemically delivered oncolytic virus designed to convert so-called "cold" tumors—those that are typically invisible to the immune system—into "hot" tumors that can respond to immunotherapy. Pelareorep has been studied across over 1,100 patients and has demonstrated promising results in difficult cancers like mPDAC and HR+/HER2- breast cancer, particularly when used in combination with chemotherapy and immune checkpoint inhibitors. In first-line pancreatic cancer, pelareorep-based regimens have shown a notable 21.9% two-year overall survival rate, compared to a 9.2% historical benchmark. In a separate study pairing pelareorep with chemotherapy and a checkpoint inhibitor, researchers recorded a 62% objective response rate—remarkable given that checkpoint inhibitors are not currently approved for use in this indication. This robust efficacy signal, along with impressive translational data, helped lay the groundwork for this regulatory step. "This robust data set, amassed from several studies in cancers that have historically resisted immunotherapeutic approaches, provides definitive validation of pelareorep's immune-mediated mechanism of action," said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. "We observed tumor biopsy-confirmed virus replication, immune cell activation, and the recruitment of cytotoxic T cells into the TME – all consistent with the durable responses observed in patients with metastatic PDAC and HR+/HER2- breast cancer who were treated with pelareorep." Earlier this month, Oncolytics hosted a key opinion leader event featuring gastrointestinal cancer experts who reviewed survival outcomes, biomarker validation, and the drug's potential role in combination therapy. That expert panel helped reinforce the view that pelareorep's mechanism—activating innate and adaptive immune responses in patients—is both biologically sound and commercially relevant. Oncolytics' execution-focused strategy is being led by Jared Kelly and Andrew Aromando, who both played key roles in Ambrx Biopharma's US$2 billion acquisition by Johnson & Johnson. Kelly was appointed CEO earlier this year, while Aromando recently joined as Chief Business Officer. Together, along with Oncolytics' already-established team, they're guiding the company into late-stage development with a sharp focus on capital efficiency and strategic alignment. Regulatory designations are already in place to accelerate development. Pelareorep holds Fast Track and Orphan Drug designations for pancreatic cancer (and Fast Track for HR+/HER2‑ mBC breast cancer) from the FDA, meaning the agency has already recognized both the drug's potential and the serious unmet need in this patient population. These statuses not only streamline review processes but also increase the attractiveness of the program to potential pharmaceutical partners. For context, pancreatic cancer is one of the deadliest common cancers, with a five-year survival rate of less than 14%. Most patients are diagnosed at a metastatic stage, and current treatment options provide limited benefit. Unlike other cancers where immunotherapies like checkpoint inhibitors have transformed care, mPDAC remains largely resistant to those approaches—making the promise of pelareorep especially notable. What distinguishes pelareorep is its dual capability: it acts as both a viral therapy that replicates in cancer cells and a biological agent that activates the body's own immune response. Tumor samples have shown increased PD-L1 expression, heightened interferon signaling, and infiltration of tumor-killing T cells—all hallmark indicators that the immune system is being mobilized against cancer. These features are seen as essential for the next generation of immuno-oncology approaches. With this latest milestone, Oncolytics is entering a phase where the outcomes of FDA interaction will shape not only clinical plans but also potential commercial partnerships. If the agency accepts the company's proposed trial framework and endpoints—centered around overall survival—the resulting study could become the definitive test for pelareorep's market potential in mPDAC. More details on the trial design and timing are expected once FDA feedback is received, but the goal is clear: initiate the pivotal trial start-up activities before the end of 2025 and establish pelareorep as a cornerstone immunotherapy in one of the most underserved cancer settings. In the meantime, the company remains active in its ongoing breast cancer program and is continuing to explore pelareorep's potential in other gastrointestinal cancers, including KRAS-mutated colorectal cancer. However, first-line pancreatic cancer has now emerged as the lead strategic focus. The transition from early-stage promise to registration-stage planning marks a decisive evolution in the Oncolytics story. With data in hand, regulatory engagement underway, and a seasoned leadership team at the helm, Oncolytics is advancing into its most consequential chapter yet. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Celcuity Inc. (NASDAQ: CELC) recently announced that its Phase 3 VIKTORIA-1 trial met both progression-free survival (PFS) primary endpoints in patients with HR+/HER2- breast cancer without PIK3CA mutations. Gedatolisib-based combinations showed significant PFS improvements compared to standard therapies, including a 7.3-month gain for the triplet arm (9.3 vs. 2.0 months for fulvestrant monotherapy) and a 5.4-month gain for the doublet (7.4 vs. 2.0 months for fulvestrant monotherapy). "The efficacy improvement relative to the control that each of the gedatolisib regimens demonstrated was historic for this patient population," said Brian Sullivan, Chairman, CEO and co-founder of Celcuity. "We are excited about the potential opportunity to provide a breakthrough therapeutic option for patients with HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer." The company plans to discuss a potential NDA submission with the FDA following a full data presentation later this year. Lyell Immunopharma, Inc. (NASDAQ: LYEL) announced impressive new data from its LYL314 trial in relapsed/refractory large B-cell lymphoma, showing an 88% overall response rate and 72% complete response rate in the 3L+ setting. Over 70% of complete responders remained disease-free at 6 months. "Based on these robust data, and our recent End-of-Phase 1 meeting with the FDA, we have initiated PiNACLE, a single-arm pivotal trial of LYL314 in patients with large B-cell lymphoma in the third- or later-line setting and remain on track to initiate a pivotal trial to evaluate LYL314 in the second-line setting by the beginning of 2026," said Lynn Seely, MD, President and CEO of Lyell. The pivotal PiNACLE trial is now underway to support potential approval of this next-generation dual-targeting CAR T therapy. Later this year in October, Evaxion A/S (NASDAQ: EVAX) shared it will be presenting two-year data at ESMO 2025 from its Phase 2 trial of EVX-01, an AI-designed personalized cancer vaccine, showing durable responses in advanced melanoma. Results included a 69% overall response rate and a strong correlation between AI predictions and immune activity. The study supports EVX-01's role as a first-line immunotherapy candidate when paired with checkpoint inhibitors like pembrolizumab. "We are delighted to have the two-year data from the EVX-01 phase 2 trial accepted for presentation at the ESMO Congress 2025," said Birgitte Rønø, CSO and interim CEO of Evaxion. "As one of the most important and prestigious medical oncology conferences in the world, the congress will be a great place for us to present the data to a large audience, including potential partners." Also at ESMO 2025, Agenus Inc. (NASDAQ: AGEN) will present survival data from its botensilimab/balstilimab program, including an oral session highlighting survival plateaus across five refractory tumor types. With over 1,200 patients treated, the agents are showing promising results in historically cold tumors like mCRC and non-melanoma skin cancer. These data continue to support botensilimab as a backbone immunotherapy candidate for solid tumors. Source: CONTACT: Equity Insider [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. 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