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Data Reported by Can-Fite Veterinary Partner Vetbiolix who already exercised its option for a full license deal worth $325M Ramat Gan, Israel, Oct. 18, 2024 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced that its veterinary partner Vetbiolix reported positive final results from the osteoarthritis multicenter clinical study in dogs treated with Piclidenoson. Vetbiolix, Can-Fite’s veterinary commercialization partner, which is covering all costs associated with veterinary clinical development, successfully concluded the full study. Vetbiolix already exercised its option to enter into a full in-license agreement with Can-Fite and is obligated to pay Can-Fite an upfront payment, milestone payments and royalties on sales upon regulatory approval, summing up to projected income of $325M to Can-Fite over the next 10 years. The study looked at the effect of 90 days treatment with Piclidenoson at 100 μg/kg and 500 μg/kg twice daily orally in dog patients with osteoarthritis. Including all evaluable patients, the primary objective was the Liverpool OsteoArthritis in Dogs (LOAD) questionnaire for the assessment of symptoms severity evaluated on dog’s mobility. The secondary objectives included Visual Analog Scale (VAS) for pain assessment by pet parents and Numerical Rating Score (NRS) for (i) lameness and (ii) pain assessment by the veterinarian. The study reached the primary and secondary endpoints with a dose and time dependent inhibitory effect of Piclidenoson on LOAD and VAS, together with a favorable trend on NRS scores, demonstrating significant improvement in clinical status and decrease in pain utilizing the 500 µg/kg dose. The canine osteoarthritis market is projected to reach $3 billion by 2028. There is a clear need in the market for a safe and effective canine osteoarthritis drug. Current treatments for canine osteoarthritis include oral non-steroidal anti-inflammatory drugs (NSAIDs), which only treat symptoms and carry significant harmful side effects, and an injectable disease-modifying osteoarthritis drug (DMOAD) that targets the progression of the disease. “The final data from the osteoarthritis study are very encouraging and this veterinary indication offers Can-Fite the opportunity to get Piclidenoson onto the market faster to benefit canine, and potentially contribute to near-term revenues. We are very pleased to work productively with the team at Vetbiolix.” stated Can-Fite VP of business Development Dr. Sari Fishman. About Piclidenoson Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with an excellent safety and efficacy profile demonstrated in a Phase III clinical study in psoriasis. The drug’s mechanism of action entails inhibition of the inflammatory cytokines interleukin 17 and 23 (IL-17 and IL-23) and the induction of apoptosis of patients’ skin cell keratinocytes involved with the disease pathogenicity. About Can-Fite BioPharma Ltd. Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company’s lead drug candidate, Piclidenoson recently reported topline results in a Phase III trial for psoriasis. Can-Fite’s liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of NASH a Phase III trial for hepatocellular carcinoma (HCC), and the Company is planning a Phase IIa study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company’s third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,600 patients in clinical studies to date. For more information please visit: www.canfite.com. About VETBIOLIX SAS VETBIOLIX develops innovative products for the treatment and prevention of diseases affecting pets. VETBIOLIX has built a unique pipeline of First-in-class oral small molecules in-licensed (exclusive and worldwide license) from Human Biotech worldwide which will answer to veterinary unmet medical needs in periodontitis (VBX-1000; Cathepsin-K inhibitor), osteoarthritis (VBX-2000; Adenosin-A3 agonist) and gut motility disorders (VBX-3000; 5-HT4 agonist). VETBIOLIX focuses exclusively on clinical developments of its drug candidates: the company invests on (i) clinical proof of concept studies, (ii) CMC-Pharmaceutical developments, (iii) regulatory Pilot clinical studies and (iv) regulatory Pivotal clinical studies. Revenue generation of the company will be based on out-licensing and/or co-developments deals with the Veterinary Pharmaceutical Industry. For more information please visit: https://www.vetbiolix.com Contact: matthieu.dubruque@vetbiolix.com Forward-Looking StatementsThis press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, its product development efforts, business, financial condition, results of operations, strategies or prospects. All statements in this communication, other than those relating to historical facts, are “forward looking statements”. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause Can-Fite’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause actual results, performance or achievements to differ materially from those anticipated in these forward-looking statements include, among other things, our history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; risks related to any resurgence of the COVID-19 pandemic and the war between Israel and Hamas; risks related to not satisfying the continued listing requirements of NYSE American; and statements as to the impact of the political and security situation in Israel on our business. More information on these risks, uncertainties and other factors is included from time to time in the “Risk Factors” section of Can-Fite’s Annual Report on Form 20-F filed with the SEC on March 28, 2024 and other public reports filed with the SEC and in its periodic filings with the TASE. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Can-Fite undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. Contact Can-Fite BioPharmaMotti Farbsteininfo@canfite.com+972-3-9241114

"Our study shows a superior profile with the combination of fostrox and Lenvima in advanced liver cancer" STOCKHOLM, Aug. 22, 2024 /PRNewswire/ -- April – June Financial summary for the quarter Net turnover amounted to SEK 1.1 (2.0) million. The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -36.7 (-26.3) million. Basic and diluted earnings per share amounted to SEK -0.32 (-0.47). Cash flow from operating activities amounted to SEK -26.3 (-17.9) million. Cash and cash equivalents at the end of the period amounted to SEK 126.7 (82.8) million. Significant events during the quarter In April it was announced that Medivir's partner Vetbiolix, a veterinary biotechnology company based in France, reported positive results from a proof-of-concept clinical trial in canine periodontitis with its drug candidate VBX-1000, formerly known as MIV-701. In April it was announced that Medivir completed a so-called Type C meeting with the FDA and that the company's preparations for the planned phase 2b study in the fostrox program are progressing according to plan, with a few adjustments in study design that have limited impact on timeline and study size. In April, MIV-711 was granted Rare Pediatric Disease Designation (RPDD) as well as Orphan Drug Designation (ODD) from the FDA for the treatment of Legg-Calvé-Perthes Disease (LCPD), an unusual hip disease that affects children between the ages 2 and 12. The AGM in May re-elected board members Uli Hacksell, Lennart Hansson, Bengt Westermark and Yilmaz Mahshid, and elected Angelica Loskog and Anna Törner as new board members. Uli Hacksell was re-elected as Chairman of the Board. In June it was announced that Medivir has selected a global CRO partner for the planned phase 2b study evaluating fostrox+ Lenvima® compared to Lenvima alone in second-line liver cancer/hepatocellular cancer (HCC). On June 26 new positive data showing further improved effect with longer time to progression in Medivir's ongoing phase 1b/2a trial of fostrox + Lenvima in advanced HCC, were presented at the ESMO GI Cancer Congress in Munich. January – June Financial summary for the period Net turnover amounted to SEK 1.6 (2.4) million. The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -63.3 (-45.2) million. Basic and diluted earnings per share amounted to SEK -0.55 (-0.81). Cash flow from operating activities amounted to SEK -61.3 (-34.1) million. Cash and cash equivalents at the end of the period amounted to SEK 126.7 (82.8) million. Events after the end of the period In July it was announced that Medivir will present updated clinical data from the phase 1b/2a study with fostrox in advanced HCC, at the ESMO Cancer Congress in Barcelona in September Conference call for investors, analysts and the media The Interim Report January - June 2024 will be presented by Medivir's CEO, Jens Lindberg. Time: Thursday, August 22, 2024, at 14.00 (CET). To access the webcast and find information about the teleconference, please klick HERE! The conference call will also be streamed via a link on the website: . The presentation will be available on Medivir's website after completion of the conference. CEO's message Medivir is working decisively to ensure that the combination of fostrox and Lenvima® becomes the first approved treatment alternative after first line standard-of-care in advanced liver cancer. At the ESMO-GI congress in Munich in June, we presented new data from the ongoing phase 1b/2a study. These data indicate that fostrox + Lenvima provides a substantially better effect than previously shown in second-line liver cancer treatment, which generated significant positive attention, both from analysts and clinical experts. Our ongoing phase 1b/2a study with fostrox + Lenvima continues to show increasingly promising data and we see the opportunity to become the first approved medical treatment in a market worth ~$2.5 billion annually. The data presented at the ESMO-GI congress in Munich at the end of June showed good tolerability during longer treatment and that the clinical effect has continued to improve. The Objective Response Rate (ORR) was 24%, higher than the 5–10% ORR seen in other published studies in second-line HCC. The estimated median time to progression at the time of ESMO-GI was 10.8 months, which is substantially better than what's been shown in other studies in second-line HCC. It is tremendously encouraging that the patient in the study who has benefited the longest is still responding to treatment after 2 years. We now look forward to presenting detailed and mature data highlighting the combination's clinical value in second-line liver cancer at the ESMO Congress in Barcelona in mid-September. The strong and continuously improving data strengthen our belief in the combination's potential as the first approved treatment option in second-line liver cancer. Preparations for our planned phase 2b study continue based on the feedback we received at our Type C meeting with the FDA. For the phase 2b study, we have recently chosen a CRO partner with a global presence and a strong track record in oncology studies and in particular HCC studies. We are now initiating the next study phase to identify investigators and hospitals for the study and to complete the study protocol. This will lead us to opening an IND in the US, which is expected to take place in H2 2024. Regarding the projects out-licensed to collaborators, our partner Vetbiolix, a veterinary biotechnology company based in France, was in April able to report positive results from a clinical Proof-of-Concept study in periodontitis (tooth loss) in dogs with its candidate drug VBX-1000 (MIV-701), which was out-licensed to Vetbiolix in 2019. Vetbiolix is now preparing to evaluate VBX-1000 in a phase 2/3 study in dogs. Tooth loss is an immense problem for dogs and today there is no approved treatment. Vetbiolix estimates that the global market for oral care in pets amounts to approximately SEK 3 billion. Our project for partnership MIV-711 received Rare Pediatric Disease Designation and Orphan Drug Designation for the treatment of Legg-Calvé-Perthes Disease from the FDA. It creates new opportunities for collaborations and future income. At the annual general meeting, our board of directors was strengthened with two new members, Angelica Loskog and Anna Törner. Their competence and experience will contribute strongly to Medivir's success, where the clinical development of fostrox is our focus. We are convinced of the potential of fostrox to become a valuable treatment option that makes a real difference to patients with liver cancer. There is a clear need and an obvious place for fostrox in the treatment landscape. Our goal is to become the first approved treatment alternative in second-line for patients with primary liver cancer. I look forward to keeping you informed of Medivir's continued development. Jens Lindberg Chief Executive Officer For further information, please contact Magnus Christensen, CFO Phone: +46 (0)8 5468 3100 E-mail: [email protected] This report has not been subject to auditors' review. The information was submitted for publication at 08.30 CET on August 22, 2024. This information was brought to you by Cision The following files are available for download: SOURCE Medivir

STOCKHOLM, April 25, 2024 /PRNewswire/ -- Medivir AB (NASDAQ: MVIR) (STO: MVIR) , a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced today that its selective cathepsin K inhibitor, MIV-711, has been granted Rare Pediatric Disease Designation (RPDD) as well as Orphan Drug Designation (ODD) for the treatment of Legg-Calvé-Perthes Disease (LCPD). The FDA defines a rare pediatric disease as a serious or life-threatening disease in which the disease manifestations primarily affect individuals aged from birth to 18 years of age. Pediatric diseases recognized as "rare", affect fewer than 200,000 people in the United States. With a RPDD, MIV-711 qualifies to receive fast track review and upon marketing approval in LCPD, the Company may be eligible to receive a Priority Review Voucher from the FDA. The voucher can be redeemed to receive priority review for any subsequent marketing application or may be sold to another company for their use. - "LCPD is a disease, with a significant impact on daily life as well as risk for long-term sequalae, for which there are no available effective treatments. Children with LCPD are more likely to suffer from obesity and depression due to the forced immobility as a consequence of the disease. In more than half of the children, the affected leg becomes shorter than the healthy leg and about 50% end up with a deformed hip joint where ultimately osteoarthritis develops. We are delighted that MIV-711 has been granted RPDD by the FDA with the potential to become the first approved treatment option. We see partnership as an attractive way to move forward with MIV-711 to ensure speed of development," said Jens Lindberg, CEO of Medivir. To gain RPDD, there must be supportive data suggesting that the drug may be effective in the disease. MIV-711 has shown, in an LCPD-specific animal model, the ability to prevent femoral head deformity and positive impact on biomarker of bone degradation without negatively impacting normal bone formation. Similarly, clinical studies have shown that MIV-711 prevents bone degradation in patients with osteoarthritis, further supporting the potential clinical benefit in LCDP. Cathepsin K is the main cysteine protease involved in bone resorption and cartilage degradation by osteoclasts, through the breakdown of key bone matrix proteins. Cathepsin K inhibition protects the damaged bone by reducing bone resorption and promoting bone formation, thereby addressing the key mechanisms causing pathological changes in LCPD, with potential to minimize long-term negative effects. Selective inhibition of cathepsin K has the potential to provide clinical benefit in diseases characterized by excessive bone resorption, including additional pediatric bone disorders. For additional information, please contact: Magnus Christensen, CFO, Medivir AB Telephone: +46 8 5468 3100. E-mail: [email protected] About Legg-Calvé-Perthes Disease Legg-Calvé-Perthes disease (LCPD) is a childhood hip disorder initiated by a disruption of blood flow to the head of the femur. Due to the lack of blood flow, the bone dies (osteonecrosis or avascular necrosis) and stops growing. Over time, healing occurs by new blood vessels infiltrating the dead bone and removing the necrotic bone which leads to a loss of bone mass and a weakening of the femoral head. The condition is most commonly found in children between the ages of 4 and 8, but it can occur in children between the ages of 2 and 15. It is estimated to affect about 10 in 100.000 children per year in the USA. It results in permanent deformity of the femoral head in many children, which increases the risk of developing osteoarthritis in adults. About MIV-711 MIV-711 is a potent and selective inhibitor of cathepsin K, the principal protease involved in breaking down collagen in bone and cartilage. It has been shown to slow, stop or reverse the progressive degeneration of joints affected by osteoarthritis. By inhibiting cathepsin K and increased/excessive activity of osteoclasts, MIV-711 has the potential to prevent degradation of bone and cartilage and counteract the osteonecrosis induced by lack of blood flow, to prevent femoral head deformity and long-term negative effects as well as positively impact Quality of Life. About Medivir Medivir develops innovative drugs with a focus on cancer where the unmet medical needs are high. The drug candidates are directed toward indication areas where available therapies are limited or missing and there are great opportunities to offer significant improvements to patients. Medivir is focusing on the development of fostroxacitabine bralpamide (fostrox), a smart, targeted chemotherapy designed to selectively treat liver cancer cells and to minimize side effects. Collaborations and partnerships are important parts of Medivir's business model, and the drug development is conducted either by Medivir or in partnership. Medivir's share (ticker: MVIR) is listed on Nasdaq Stockholm's Small Cap list. . This information was brought to you by Cision The following files are available for download: SOURCE Medivir