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To be labeled exceptional by the European Commission is a great honor and an acknowledgement of the quality of the drug development process in Hamlet Pharma
Catharina Svanborg, Founder and Chairman of the Board.
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Hamlet BioPharma Receives European Regulatory Approval for Phase III Study of Alpha1H in Bladder Cancer

Hamlet BioPharma, a pharmaceutical company specializing in the development of novel treatments for cancer and infectious diseases, today announces regulatory approval from the European Medicines Agency (EMA) for its Phase III clinical study of Alpha1H in bladder cancer. The approval represents a milestone crucial for the clinical development of Alpha1H and provides a clear regulatory path toward a potential future marketing application in Europe.The submission documents including the study protocol were based on the prior scientific dialogue with the Czech State Institute for Drug

Briefglance Highlights Hamlet BioPharma's Collaboration with the University of Iowa and the Potential for Advanced Bladder Cancer Therapy

The digital analytics platform Briefglance has highlighted Hamlet BioPharma's collaboration with the University of Iowa regarding the development of Alpha1H treatment for patients with severe bladder cancer. The article outlines the advanced scientific and clinical background, the importance of the collaboration and its significance for Hamlet BioPharma. Among other observations, Briefglance describes Alpha1H as a promising treatment candidate for patients who do not respond to BCG therapy; a patient population for whom treatment options remain limited. Briefglance is a U.S.

Hamlet BioPharma secures drug manufacturing at Phase III quality and release of Alpha1H for distribution to clinical trial sites

Hamlet BioPharma today announces the successful release of the Phase III quality batch of Alpha1H for use in clinical trials of bladder cancer in Europe and the US. Large-scale manufacturing of Alpha1H has been established since the start of the clinical program, with an increase in volumes and technical adjustments during successive phases of the program. The production at Phase III quality requires an extensive and complex development process, which now has been completed.  A Phase III trial requires increased production capacity, and advanced technical and drug quality control

Hamlet BioPharma’s monthly digital investors’ meeting on June 30th

Hamlet BioPharma invites you to our monthly investors’ meeting to be held on the 30th of June 2026, at 12:00. Please click on the link below to participate in the meeting https://us06web.zoom.us/j/83747321138?pwd=PIw6kh3f0CY20DAbrtYx3fbzQMCBco.1   For further information, please contact Jakob Testad, CFO, Hamlet BioPharma AB, +46 708 48 42 10, jakob.testad@hamletbiopharma.com   Catharina Svanborg, CEO, Hamlet BioPharma AB, +46 709 42 65 49, catharina.svanborg@hamletpharma.com

Clinical trial expansion in the US, in collaboration with the University of Iowa, to treat high-risk, resistant, non-muscle-invasive bladder cancer (NMIBC)

Hamlet BioPharma AB (publ) today announced the signing of a clinical trial agreement with the University of Iowa, one of the leading U.S. centers for bladder cancer research and therapy. The new study advances the clinical development of Alpha1H, a human breast milk derived treatment for bladder cancer, to include Carcinoma In Situ (CIS); a severe surface-spreading and therapy-resistant form of bladder cancer where patients may need to remove their bladders to avoid systemic disease. Professor O’Donnell, a key opinion leader and driver of the international bladder cancer therapy

Pre-initiation visit in Prague, for the Phase III trial of Alpha1H in bladder cancer

Hamlet BioPharma AB (publ) today conducted a pre-initiation visit at the Department of Urology at Charles University, Prague, led by Professor Marek Babjuk, a key international opinion leader in bladder cancer therapy. Prague is an important center for bladder cancer research and trials of novel therapies, and the trial technology and collaboration with Hamlet BioPharma and Lund University is established. Professor Babjuk’s group conducted the recently completed, successful Phase II study of Alpha1H in patients with non-muscle invasive bladder cancer (NMIBC). The Phase III study strengthens

Continued success for the new anti-infective therapies developed by Hamlet BioPharma

The Journal of Infectious Diseases publishes the paper “Targeting the disease response with NlpD and LytM for effective non-antibiotic treatment of urinary tract infections.” This study demonstrates that inhibiting the disease response of the host offers an efficient alternative to antibiotics for the treatment of bacterial infections. By inhibiting the disease response to infection and accelerating bacterial clearance, the drug candidates protect infected tissues from disease, with similar efficacy as antibiotics.  doi.org/10.1093/infdis/jiag243. The paper reveals a promising

Q3 INTERIMREPORTJANUARY–MARCH 2026

The third quarter of 2025-2026 has been extremely productive for Hamlet BioPharma, with high-profile Phase II trial publications, establishment of clinical Phase III trial infrastructure, drug production and partnering of the tuberculosis project with a Korean drug formulation specialist company. Ongoing, positive partnering discussions with a major player in the bladder cancer field, under a letter of intent, specifically address the commercialization of the bladder cancer asset Alpha1H. In parallel, we are securing and extending the IP portfolio. Hamlet BioPharma is driving a shift in

Monthly investor meeting on the 22nd of May when Hamlet BioPharma is releasing it’s Q3 report

Hamlet BioPharma invites you to the investors’ meeting to be held on the 22nd of May 2026, at 12:00. Please click on the link below to participate in the meeting https://youtube.com/live/3TgHDRRadfk?feature=share     For further information, please contact Catharina Svanborg, Chairman of the Board, Hamlet BioPharma AB, +46 709 42 65 49, catharina.svanborg@hamletpharma.com Jakob Testad, CEO, Hamlet BioPharma AB, +46 708 48 42 10, jakob.testad@hamletbiopharma.com

Hamlet Biopharma Secures New Patents and Allowances, Going from Strength to Strength in Innovation and Technology

Hamlet Biopharma, a company innovating the treatment of cancer and infections, today announced the successful granting of new patents in Japan and India and a further patent allowance in Japan. The continued strengthening of Hamlet BioPharma’s intellectual property portfolio reaffirms its position at the forefront of technological innovation. The new patents and allowances cover breakthroughs in the HAMLET family of drug candidates, which effectively kill cancer cells and growing tumor tissue with high precision, as well as the company’s technology relating to the treatment of

Monthly investor meeting on the 29th of April

  Hamlet BioPharma invites you to the monthly digital investors’ meeting to be held on the 29th of April 2026, at 12:00. Please click on the link below to participate in the meeting https://us06web.zoom.us/j/83764124805?pwd=0dWpwsLs7u5I4YqQJJN0p3MuXLS6ay.1     For further information, please contact Catharina Svanborg, Chairman of the Board, Hamlet BioPharma AB, +46 709 42 65 49, catharina.svanborg@hamletpharma.com Jakob Testad, CEO, Hamlet BioPharma AB, +46 708 48 42 10, jakob.testad@hamletbiopharma.com

Hamlet BioPharma presented at the Financial Stockholm event on March 26, 2026

  Hamlet BioPharma AB, an innovative pharmaceutical company developing new therapies for cancer and infections, announces that the company presented its latest advances at the Financial Stockholm event on March 26, 2026.   Financial Stockholm is a central meeting place for companies and investors who want to stay up to date on the latest trends in the stock market. The event attracts both professional players and private investors from all over Sweden.   Please see the presentation at: https://www.youtube.com/watch?v=5VLDg_2kfD8       For more information

Hamlet BioPharmas digital monthly investor meeting on the 18th of March

Hamlet BioPharma invites you to our monthly investors’ meeting to be held on the 18th of March 2026, at 12:00. Please click on the link below to participate in the meeting https://us06web.zoom.us/j/87443477663?pwd=3QfpaU8RvYGIxlqF2o8uDEmIpX2mwM.1   For further information, please contact Catharina Svanborg, Chairman of the Board, Hamlet BioPharma AB, +46 709 42 65 49, catharina.svanborg@hamletpharma.com Jakob Testad, CEO, Hamlet BioPharma AB, +46 708 48 42 10, jakob.testad@hamletbiopharma.com

Hamlet BioPharma signed a Letter of Intent to outline terms of a potential collaboration and a commercial agreement concerning Alpha 1H.

  Hamlet BioPharma AB (Hamlet), a clinical‑stage biopharmaceutical company advancing targeted oncological and other therapies, today announces that its wholly owned subsidiary Alpha1H BC AB (A1HB) its collaborator Linnane Pharma AB (Linnane) and Hamlet have signed a non-binding Letter of Intent (LoI) with an undisclosed company specializing in uro-oncology based in northern Germany. The purpose is to outline terms and conditions for the completion of development and for global commercialization of Alpha 1H in the field of bladder cancer. Alpha 1H is being developed by Hamlet

Q2 INTERIM REPORT OCT – DEC 2025

OPENING REMARKS Hamlet BioPharma is identified as a mature pharmaceutical company, having reached major milestones, based on achievements of individual projects and of the company, as a whole paving the way for commercialization and efficient continued development of its rich project portfolio of promising new drug candidates. The company has successfully completed Phase II studies of cancer, infection and chronic pain, secured drug production for Phase III studies, expanded the patent portfolio and ensured a productive partnering process. The share issue, in August 11, 2025 initially

Nature Microbiology publishes the paper ‘’Targeted innate immune inhibition therapy compared with antibiotics for recurrent acute cystitis: a randomized, open-label phase 2 trial.’’

This groundbreaking study introduces an entirely new approach to managing recurrent urinary tract infections. Instead of killing the bacteria, the treatment focuses on targeting and calming the disease response. Clinical efficacy of this approach is demonstrated in this study, showing effects comparable to standard antibiotic therapy. This discovery could also mark a major breakthrough in the fight against antibiotic resistance and the future treatment of infections. This non-antibiotic treatment approach is conceptually novel and the study is the first to demonstrate clinical

Monthly investor meeting on the 13th of February when Hamlet BioPharma is releasing it’s Q2 report

Hamlet BioPharma invites you to our February investors’ meeting to be held on the 13th of February 2026, at 12:00. Please click on the link below to participate in the meeting https://youtube.com/live/qstpMe2jhKI?feature=share     For further information, please contact Catharina Svanborg, Chairman of the Board, Hamlet BioPharma AB, +46 709 42 65 49, catharina.svanborg@hamletpharma.com Jakob Testad, CEO, Hamlet BioPharma AB, +46 708 48 42 10, jakob.testad@hamletbiopharma.com

Collaboration agreement between Hamlet BioPharma and Immunoforge in South Korea

Hamlet BioPharma has signed an agreement with the Korean biotech company ImmunoForge, to develop novel administration technology for the peptide drug NZX, for use in patients with tuberculosis. Tuberculosis is a major cause of mortality in all parts of the world and treatment options are becoming more limited, due to escalating antibiotic resistance. The antimicrobial peptide NZX is being developed as a drug candidate for pulmonary tuberculosis treatment, in collaboration with Hamlet BioPharma. The new, peptide-based drug has shown promising treatment effects against lung tuberculosis in

𝗦𝘆𝗺𝗽𝗼𝘀𝗶𝘂𝗺 𝗼𝗻 𝗡𝗼𝘃𝗲𝗹 𝗧𝗿𝗲𝗮𝘁𝗺𝗲𝗻𝘁𝘀 𝗳𝗼𝗿 𝗜𝗻𝗳𝗲𝗰𝘁𝗶𝗼𝗻𝘀 𝗮𝗻𝗱 𝗖𝗮𝗻𝗰𝗲𝗿

We warmly welcome you to the Symposium on “𝗡𝗼𝘃𝗲𝗹 𝗧𝗿𝗲𝗮𝘁𝗺𝗲𝗻𝘁𝘀 𝗳𝗼𝗿 𝗜𝗻𝗳𝗲𝗰𝘁𝗶𝗼𝗻𝘀 𝗮𝗻𝗱 𝗖𝗮𝗻𝗰𝗲𝗿.” The invited speakers are leading international scientists with a background in infection biology and scientists from Lund University, sharing cutting-edge research and future perspectives in therapeutic innovation.   𝗕𝗲𝗹𝗳𝗿𝗮𝗴𝗲𝘀𝗮𝗹𝗲𝗻, 𝗕𝗠𝗖 – 𝗕𝗶𝗼𝗺𝗲𝗱𝗶𝗰𝗶𝗻𝘀𝗸𝘁 𝗖𝗲𝗻𝘁𝗿𝘂𝗺 (𝗛𝗼𝘂𝘀𝗲 𝗗, 𝗙𝗹𝗼𝗼𝗿 𝟭𝟱), 𝗟𝘂𝗻𝗱   Join us for a day of scientific exchange, expert talks, and engaging panel discussions. Please see the formal

Invitation to digital meeting focusing on novel strategies for treating bacterial infections without antibiotics

Welcome to Hamlet BioPharma’s monthly digital meeting on January 21 at 12:00, held the same day as the Davos Summit discusses ‘’The Fragile Future of Antibiotics. ‘’ As stated in the Davos Summit Program: “Antimicrobial resistance (AMR) is already undermining modern medicine. As superbugs evolve faster than new treatments can be developed, once-manageable infections are becoming harder to cure, threatening everything from surgery to cancer care. How can we ensure global access to life-saving antibiotics while preserving their effectiveness for generations to come?” https://www.

The HAMLET project featured in Cancerfonden’s Christmas Campaign

The Swedish Cancer Society, Cancerfonden, is a powerful and important research support organization in Sweden. Based mainly on donations, Cancerfonden and its quality review system, has ensured that cancer research has an independent, quality-based funding source. This support from Cancerfonden has allowed a diverse flora of cancer research projects to thrive and develop scientifically and in some cases clinically. The Hamlet group at Lund University has received funding from Cancerfonden since the discovery of the HAMLET molecule and this continued support has been crucial for the

Q1 INTERIM REPORT JULY – SEPT 2025

OPENING REMARKS  The 2024-2025 financial year was extremely productive for Hamlet BioPharma and this trend continued into the first quarter of the financial year 2025-2026. The company has successfully completed Phase II studies of cancer and infection, secured production of drugs for Phase III studies, expanded the patent portfolio and secured financing, both short-term and long-term. These achievements identify the company as a mature pharmaceutical company and pave the way for commercialization and efficient development of the rich project portfolio of promising new drug candidates.

Hamlet BioPharma Receives FDA Pivotal-Study Feedback for Novel Neoadjuvant Therapy in Non–Muscle Invasive Bladder Cancer

HAMLET BioPharma, a clinical‑stage biopharmaceutical company advancing targeted oncological and other therapies, today announced it has received written feedback from the U.S. Food and Drug Administration (FDA) supporting a pivotal development path for Alpha1H, a first‑in‑class neoadjuvant therapy for patients with low‑risk non–muscle invasive bladder cancer (NMIBC).[En bild som visar text, skärmbild, Färggrann, grafisk design AI-genererat innehåll kan vara felaktigt.] This latest interaction with the US FDA follows the previous successful face-to-face interaction with the Agency last

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