Annuncio • Jul 28
Hamlet Biopharma Announces Grant and Impending Grant of New Patents in the Us and Japan Hamlet BioPharma announced the grant and impending grant of new patents in the US and Japan. The 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 Interleukin-1 (IL-1)-related technology for the treatment of bladder pain. The new addition to the cancer patent portfolio offers technical solutions to the production of Alpha1H, with relevance to larger scale production for future markets. The new addition to the company's IL-1-related technology for covers the bladder pain syndrome, essential for the development of new treatments against this debilitating disorder. Our molecular and clinical studies have identified IL-1 as a key driver of acute cystitis and pain and the IL-1 receptor antagonist anakinra as a successful treatment, when used off label in this patient group, with acute response rates of >50% and extended effects with continued clinical use. With these latest additions, Hamlet BioPharma now holds over 150 active patents and over 30 pending patent applications across numerous countries, showcasing a robust innovation strategy designed to fuel long-term growth, protect proprietary technologies, and drive value for partners and customers alike. The company plans to integrate these patented technologies with clinical trial activities and ongoing product development. Annuncio • Jun 30
Hamlet BioPharma Receives European Regulatory Approval For Phase III Study of Alpha1H In Bladder Cancer Hamlet BioPharma announced 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 Control (SÚKL) during the Phase II program and further refined in close collaboration with the U.S. Food and Drug Administration (FDA), supported by regulatory experts at InClino in Europe and Target Health in the USA. The European Phase III study will be conducted in partnership with the group of Professor Marek Babjuk at the Second Faculty of Medicine, Charles University in Prague. The same team recently completed the successful Phase II study of Alpha1H in patients with non-muscle invasive bladder cancer (NMIBC), which demonstrated promising anti-tumor activity and a favorable safety profile. As a result of this approval, patients with low- to intermediate-risk NMIBC will now have access to Alpha1H treatment within the framework of the clinical study. Annuncio • Jun 19
Hamlet BioPharma Conducts Pre-Initiation Visit For Phase III Trial Of Alpha1H In Bladder Cancer Hamlet BioPharma AB conducted a pre-initiation visit at the Department of Urology at Charles University, Prague, for the Phase III trial of Alpha1H in bladder cancer. 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 the commercial potential of Alpha1H and the future market opportunities for the drug. Bladder cancer is a significant unmet medical need and the costliest cancer form in the USA, due to high recurrence rates and cancer progression. Despite available treatments, patient remain at risk of recurrence, creating a need for less toxic therapies. The Phase III study is based on an extensive scientific and clinical evaluation of Alpha1H by the FDA (Food and Drug Administration, USA), including reviews of published clinical data and the mechanism of action described in peer-reviewed publications. Annuncio • May 20
Hamlet Biopharma Secures New Patents and Allowances Hamlet Biopharma, a company innovating the treatment of cancer and infections, 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 bacterial infections, including cystitis. With these latest additions, Hamlet BioPharma now holds about 150 active patents and over 30 pending patent applications across numerous countries, showcasing a robust innovation strategy designed to fuel long-term growth, protect proprietary technologies, and drive value for partners and customers alike. The company plans to integrate these patented technologies with Phase III clinical trial activities and ongoing product development. Annuncio • Nov 10
Hamlet BioPharma Receives FDA Pivotal- Study Feedback for Novel Neoadjuvant Therapy in Non-Muscle Invasive Bladder Cancer Hamlet BioPharma 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). This latest interaction with the US FDA follows the previous successful face-to-face interaction with the Agency last June 2025. FDA's letter, specific and helpful, evidenced both serious and enthusiastic support for the program. Alpha1H has so far exhibited little to no toxicity in the clinic and offers low-risk NMIBC patients treatment in the neoadjuvant phase of disease, for which currently there are no therapy options available. Helpful in advancing Hamlet's marketing objectives for Alpha1H, the FDA's comments focused on a pivotal clinical design. Next steps for Hamlet BioPharma and their partners will be to put these collaborative fruits to good use with the full protocol development. Highlights from the FDA Interaction: The FDA's written feedback supports the overall pivotal study design framework proposed by Hamlet BioPharma, including patient population, key efficacy endpoints, and statistical approach. The Agency provided guidance on primary and key secondary endpoints appropriate for low-risk NMIBC, including complete response (CR) rate and duration of response and event-free survival, along with the safety database size. FDA aligned on Hamlet's plan to utilize central pathology review, blinded independent review (as applicable), and standardized cystoscopic assessment intervals. Hamlet intends to incorporate the Agency's recommendations and initiate enrollment in the next stage of the clinical program pending completion of routine CMC activities and institutional review board (IRB) approvals. Next Milestones: Finalize protocols and engage first study sites First Quarter - Second Quarter 2026. Complete CMC readiness packages, including process and formulation optimization, stability testing, and pharmaceutical development plans. Evaluate potential expedited-program designations with FDA. Annuncio • Sep 24
Hamlet BioPharma Prepares for Next Steps and Secures Drug Manufacturing of Alpha1h At Phase III Quality Hamlet BioPharma announced the successful production of a first batch of Alpha1H, the drug candidate targeting Bladder Cancer, at Phase III quality. The batch is now undergoing final evaluation steps, before release for clinical use. The clinical trial program in patients with bladder cancer has proceeded successfully, showing significant treatment effects and low toxicity in treated patients. Large-scale manufacturing of Alpha1H at Good Manufacturing Practice (GMP) quality has been established since the start of the clinical program, with an increase in volumes and technical adjustments during successive phases of the program. A Phase III trial requires increased production capacity, and advanced technical and drug quality control programs must be in place. Drug production at Phase III quality is therefore costly and extremely demanding. Hamlet BioPharma has completed the production of a first batch ofAlpha1H at Phase III quality. The batches is now undergoing final evaluation steps., before release for clinical use. To meet the increased demand for Phase III-grade material, Hamlet BioPharma is expanding its production of the Alpha1 peptide, which is the first step in the production process. The company has indentified Porton Pharmaceutical Chemicals GmbH as an advanced and cost effective pharmaceutical manufacturing infrastructure. The Alpha1 peptide production technology has been adjusted by Porton to meet the requirements of a Phase III trial and the production site has been extensively audited for alignment with international market requirements. To manufacture the final product, Hamlet BioPharma collaborates with Rechon Life Science AB - a manufacturer approved for pharmaceutical supply worldwide, including the US. Rechon are responsible for the final formulation and release of Alpha1H and have already established large scale processes for Alpha1H production and distribution to clinical trial sites. The timing of Phase III adjusted manufacturing is essential to secure a rapid and robust supply of Alpha1H to the clinic, which benefits Hamlet BioPharma's shareholders and patients, who will receive Alpha1H treatment. Annuncio • Aug 24
Hamlet BioPharma Announces the Completion of the Alpha1H Phase II Study in Non-Muscle Invasive Bladder Cancer Hamlet BioPharma announced the completion of the successful Phase II clinical trial of the company's drug candidate Alpha1H in patients with cancer in the urinary bladder. The final clinical study report based on extensive analyses of clinical and laboratory data highlights the potent treatment effects. All primary and secondary endpoints of safety and efficacy were reached. The final clinical report has been completed and submitted to the FDA (Food and Drug Administration, USA). Summary from the Clinical Study Report: Efficacy was formally confirmed - 80% of tumors responded to Alpha1H, with 59% average tumor size reduction in the high-dose group. Molecular and cellular secondary endpoints. Alpha1H reaches tumor tissue, triggers tumor cell apoptosis, and causes rapid shedding of tumor cells into the urine. Durable effect shown across repeated treatment cycles. Patients who received a second round of instillations maintained clinical benefit, showing continued tumor cell death and reduction -- demonstrating the treatment's lasting efficacy, even with repeated dosing. BCG-like immune activation confirmed - but faster. Cytokine profiling shows Alpha1H activates a broad immune response overlapping with BCG, the current standard of care. However, Alpha1H triggers this response more rapidly and without lasting side effects. Suppression of cancer genes and pathways. Advanced RNA sequencing revealed Alpha1H downregulated over 700 of ~800 cancer-related genes, including key oncogenes like RAS and GJA1. This provides a mechanistic explanation for its unique tumor-killing profile. Strong safety profile confirmed over longer follow-up - no serious side effects. No drug-related serious adverse events occurred, even after higher or repeated dosing. Mild local side effects were comparable to placebo, and no systemic effects were observed, consistent with Alpha1H's local mechanism of action. Annuncio • Jul 29
Hamlet BioPharma AB (publ) to Report Fiscal Year 2025 Results on Aug 28, 2025 Hamlet BioPharma AB (publ) announced that they will report fiscal year 2025 results on Aug 28, 2025 Annuncio • Jun 19
Hamlet Biopharma Announces Progress in Tuberculosis Therapy Hamlet BioPharma announced progress in Tuberculosis therapy. The group led by Professor Gabriela Godaly, has conducted a study on the antimicrobial peptide NZ2114, which has been accepted for publication in Frontiers in Microbiology. The key findings are summarised below: The study highlights NZ2114, a plectasin variant, as a promising candidate therapeutic against Mycobacterium tuberculosis, capable of overcoming the bacterium's uniquely complex, lipid-rich, and low-permeability membrane. NZ2114 demonstrates potent antimycobacterial activity, synergizes with first-line TB drugs, remains stable in serum, and is non-toxic to human cells, making it a strong candidate for future TB treatment strategies. The antimicrobial effect was also observed against several clinical isolates of Gram-positive bacteria, including Enterococcus facadeecalis, Enterococcus facadeecium, and Methicillin-Resistant Staphylococcus aureus (MRSA). The peptide eliminated M. tuberculosis in a murine TB infection model with a log reduction of 81.14%) after three doses, compared to untreated controls. This study investigated another plectasin variant, NZ2114, known for its effectiveness against Gram-positive bacteria, as a potential anti-mycobacterial peptide both in cellsand disease models. NZ2114 effectively killed bacteria at a minimal inhibitory concentration (MIC99) of 6.1 mM, was non-toxic to primary human cells, and remained resistant to serum degradation while preserving its antimycobacterial capacity. In a checkerboard assay, NZ2114 demonstrated synergy with the first-line TB drugs isoniazid and ethambutol. Annuncio • Apr 08
Hamlet BioPharma Announces the Publication of New Scientific Advances Important for the Mechanism of Action of Alpha1H in the Treatment of Bladder Cancer Hamlet BioPharma announced the publication of new scientific advances important for the mechanism of action of Alpha1H in the treatment of bladder cancer, in collaboration with scientists at Lund University. The study shows that Alpha1H targets a major membrane system (ER) in tumor cells that stretches from the cell border all the way to the nuclei. This continuous membrane structure defines many aspects of cellular life. It is the largest membrane-bound organelle and accounts for more than 50% of the total membrane area in eukaryotic cells. Organized like a 'fishing net' the network plays a critical role as a scaffold for many different cellular functions, including cell death. The membrane structure is rigorously controlled to fulfil these different cellular needs. The scientists discovered that Alpha1H changes the structure of the network and triggers a process similar to the tightening of fishing nets around their content of fish. The paper proposes that this process allows dying cells to contain toxic components and avoid leakage to the surrounding tissue during the cell death process. This mechanism could be an essential explanation for the low toxicity of the Alpha1H complex, which has been seen in cells, animal models and patients. These insights into the mechanism of action of Alpha 1H were made possible by combining high resolution imaging technology with advanced microcopy, cellular and molecular techniques, available to Hamlet BioPharma through the collaboration with Lund University. Annuncio • Apr 07
Hamlet Biopharma's Drug Candidate Alpha1H Shows Potent Treatment Effects in Patients with Cancer of the Urinary Bladder Hamlet BioPharma announced that Hamlet BioPharma's drug candidate Alpha1H has shown potent treatment effects in patients with cancer of the urinary bladder. The final analysis of the placebo-controlled, dose-escalation and repeated treatment study parts, confirmed the strong treatment effects compared to placebo. The Clinical study report is being completed for submission to the FDA. Clinical effects: Clinical effects of alpha1-oleate were quantified in patients with non-muscle invasive bladder cancer, using a randomized, placebo-controlled study protocol. Patients were treated by six intra-vesical instillations of alpha1-oleate (Alpha1H) and the treatment response was defined relative to the placebo group. Responding patients were offered a second round of treatment, consisting of six intravesical instillations. A complete or partial tumor response was detected in >80% of the tumors in patients treated with 8.5 mM of Alpha1H. Intravesical Alpha1H administrations triggered rapid, dose-dependent tumor cell shedding and tumor fragmentation, consistent with the reduction in tumor size. Alpha1H was taken up by tumor tissue and treatment triggered rapid tumor cell apoptosis, during both treatment rounds. Immune response confirmed: Alpha1H treatment has previously been shown to activate an immune response with strong anti-tumor characteristics. This was confirmed in the study, with similar effects as BCG treatment, underlining the potential of Alpha1H as a broadly acting anti-tumor molecule. Alpha1H treatment further inhibited the expression of cancer gene networks, including bladder cancer genes and became more similar to healthy tissue. Drug-related side effects were not recorded, except for local irritation at the site of instillation. Clinical study report is being completed for submission to the FDA: These anti-tumor effects strongly support Alpha1H's potential in patients, initially as a neoadjuvant, targeting newly diagnosed tumors or recurrences, acknowledged by the FDA (Food and Drug Administration, USA), by awarding Alpha1H Fast Track status as a neoadjuvant for the treatment of bladder cancer. The broad collaborative clinical network required for these studies is maintained through long-standing collegial interactions. Technology for genome-wide analyses of clinical samples is maintained by the scientists at Lund University. Annuncio • Feb 18
Hamlet BioPharma AB (publ) Announces CEO Changes The Board of Hamlet BioPharma has decided to appoint Catharina Svanborg as CEO. Catharina immediately assumes the CEO role and continues as a Board member. Martin Erixon leaves the CEO role and will be at the company's disposal during his notice period. New Risk • Feb 15
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr42m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr42m free cash flow). Earnings have declined by 21% per year over the past 5 years. Shareholders have been substantially diluted in the past year (41% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (9.7% average weekly change). Market cap is less than US$100m (kr666.3m market cap, or US$62.3m). New Risk • Jan 16
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 33% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 17% per year over the past 5 years. Shareholders have been substantially diluted in the past year (33% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (11% average weekly change). Market cap is less than US$100m (kr560.3m market cap, or US$50.2m). Annuncio • Dec 11
Hamlet BioPharma AB (publ) to Report Q1, 2026 Results on Nov 14, 2025 Hamlet BioPharma AB (publ) announced that they will report Q1, 2026 results on Nov 14, 2025 Annuncio • Dec 04
Hamlet BioPharma AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 26.790008 million. Hamlet BioPharma AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 26.790008 million.
Security Name: B Shares
Security Type: Common Stock
Securities Offered: 9,922,225
Price\Range: SEK 2.7
Transaction Features: Subsequent Direct Listing New Risk • Sep 11
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of Swedish stocks, typically moving 13% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr36m free cash flow). Share price has been highly volatile over the past 3 months (13% average weekly change). Earnings have declined by 13% per year over the past 5 years. Revenue is less than US$1m (kr30k revenue, or US$2.9k). Minor Risks Shareholders have been diluted in the past year (50% increase in shares outstanding). Market cap is less than US$100m (kr627.4m market cap, or US$60.4m). New Risk • May 26
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr39m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr39m free cash flow). Earnings have declined by 9.0% per year over the past 5 years. Shareholders have been substantially diluted in the past year (52% increase in shares outstanding). Revenue is less than US$1m (kr2.4m revenue, or US$222k). Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Market cap is less than US$100m (kr749.9m market cap, or US$70.3m). Annuncio • May 06
Hamlet BioPharma AB Completes the First Part of A Controlled Clinical Trial in Patients with Bladder Pain Syndrome (Severe Pain in the Urinary Bladder) Hamlet BioPharma AB has successfully completed the first part of a controlled clinical trial in patients with bladder pain syndrome (severe pain in the urinary bladder). The patients have been treated with anakinra, which is an Interleukin1 (IL-1) receptor antagonist (IL-1RA). The company can now announce that a significant proportion of the treated patients have responded positively to the treatment. Patients with bladder pain syndrome have severe pain, which is socially debilitating. Broadly used pain killers are not effective. Some patients are helped by morphine or surgery, but often without lasting effects. Hamlet BioPharma has patented the use of anakinra for bladder pain and is conducting a placebo-controlled study to evaluate the treatment effect in patients with bladder pain syndrome. The pro-inflammatory cytokine IL-1 increases pain in the bladder and blocking of the IL-1 effect with anakinra treatment reduces the pain response in animal models. Anakinra is an IL-1 receptor antagonist that neutralizes the biological activity of the two potent pro-inflammatory molecules IL-1a and IL-1b. In the initial part of the clinical study, the recruited patients were treated with anakinra to define the responder group for the later placebo-controlled part of the trial. Significant effects were detected in the majority of the treated patients. The pain score was reduced after treatment and the quality of life increased in this severely disabled patient group. In addition, laboratory tests showed a convincing reduction in pain molecules after treatment, suggesting a direct effect of treatment at the molecular level. Annuncio • Jan 25
Hamlet Biopharma Announces New Analyses of Clinical Data from Alpha1h Treated Patients with Bladder Cancer Detect A Strong Immune Response with Known Anti-Tumor Effects Hamlet BioPharma's drug candidate Alpha1H has been shown to affect a majority of tumors in treated patients with cancer of the urinary bladder. A new analysis now provides a further explanation for this strong effect, based on an immune response in the treated patients with known anti-tumor effects. Thus, in addition to killing tumor cells and inducing tumor cell shedding, Alpha1H activates a broad immune response, which adds a strong protective potential against cancer. Alpha1H complex kills several types of cancer cells in vivo. In clinical studies, the complex has shown therapeutic effects in a randomized, placebo-controlled study of patients with non-muscle invasive bladder cancer and increased effects in patients treated with higher doses, with almost no toxicity. Alpha1H-instillations in the bladder of the patients triggered a rapid tumor response, quantified as the shedding of tumor cells into the urine within two hours of treatment. Tumor cell death was accompanied by a strong apoptosis-like response in the tumor and shed cells contained large amounts of Alpha1H, identifying potential effects of the peptide-lipid complexes on bladder cancer tissue. The new analysis detected an unexpected but very encouraging immune response in patients treated with Alpha1H, with strong anti-tumor potential. The company found that this immune response was activated by Alpha1H immediately after the first treatment, and was sustained during the treatment period of one month. The immune response also increased with the treatment dose. The activation of the immune system adds power to the anti-tumor effects of Alpha1H and an additional way in which the tumor can be attacked and neutralized, as Alpha1H creates a multifunctional therapeutic environment. Alpha1H treatment activates the immune response directly in the tumor area, resulting in a predominantly local effect. A further advantage of Alpha1H treatment is the lack of severe side effects in the treated patients, except for local irritation at the site of injection, which often accompanies local therapies. The new analysis further shows that the immune response profile in Alpha1H treated patients with early tumors is rapid and at least as strong as that reported in of patients treated with BCG, which is the drug of choice for many patients with more severe bladder cancer. Ongoing shortage of BCG supply in the USA and many countries, reported by the Food and Drug Administration, is expected to continue for years resulting in patients not getting full treatments, emphasizing the need for new alternative treatments. The publication will be evaluated during a review process before being considered for publication. Annuncio • Dec 20
Hamlet Biopharma AB (Publ) Announces Antimicrobial Peptide Therapy for Tuberculosis Infections Hamlet BioPharma announced the company currently advancing several phase II trials targeting infectious diseases and cancer, along with an extensive project and patent portfolio,is delighted to announce progress for the tuberculosis project. Tuberculosis is a major cause of mortality in all parts of the world, not least in patients whose immune system is compromised as in HIV infected individuals. The treatment options are becoming more limited, due to escalating antibiotic resistance. The group of Professor G. Godaly are developing a novel antimicrobial peptide, NZX, as a potential drug for pulmonary tuberculosis treatment, in collaboration with Hamlet BioPharma. The new, peptide-based drug has shown promising treatment effects against lung tuberculosis in animal models, both against antibiotic sensitive and antibiotic resistant bacteria. The bacteria causing tuberculosis, Mycobacterium tuberculosis, have a unique, thick cell wall, which is difficult for anti-bacterial compounds to penetrate. The effect of the peptide NZX on the bacterial cell was studied to understand NZX's membrane interaction in live bacteria. NZX displayed a pull-and-aggregate mechanism on the inner membrane of mycobacteria, disrupting cell integrity. In drug interaction studies, NZX showed an additive effect with traditional tuberculosis therapies such as isoniazid and ethambutol, which may be essential for defining future clinical protocols. In addition, the peptide NZX demonstrated broad-spectrum activity against non-tuberculosis mycobacteria and drug-resistant Staphylococcus aureus. These findings emphasize NZX's potent effects against mycobacteria, with a notable absence of antibiotic resistant mutants in resistance development studies. Annuncio • Dec 07
Hamlet Biopharma's Continued Development of Brain Tumor Therapy Hamlet BioPharma AB (publ) update about the development of brain tumor therapy based on the investigational new drug Alpha1H. Hamlet BioPharma together with its partner Neurochase Ltd. are making progress with the early pre-clinical work for the treatment of brain tumors. Important milestones have been reached during the preclinical assessment. Hamlet BioPharma is developing a new class of anti-cancer therapeutics for multiple cancer indications based on the discovery of its proprietary drug complex HAMLET ('Human Alpha-lactalbumin Made Lethal to Tumor cells'). HAMLET has shown great promise for the treatment of brain tumors, killing brain tumor cells of different origins and significantly delaying brain tumor growth. The cellular effects are reproduced by Hamlet BioPharma's lead anti-cancer compound Alpha1H, which efficiently kills different brain tumor cells in the laboratory. The brain and spinal cord constitute the central nervous system (CNS), where vital functions are controlled. Due to a lack of efficient drugs that are suitable for delivery into the central nervous system, brain tumor treatment presents a significant challenge. Unlike other organs, the brain does not easily tolerate invasive procedures, making surgical removal of tumors particularly difficult. In many cases, the location of tumors within the brain may render them inoperable without causing severe damage to vital neural structures. New Risk • Sep 22
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 14% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr30m free cash flow). Share price has been highly volatile over the past 3 months (14% average weekly change). Earnings have declined by 2.3% per year over the past 5 years. Revenue is less than US$1m (kr2.4m revenue, or US$217k). Minor Risks Shareholders have been diluted in the past year (14% increase in shares outstanding). Market cap is less than US$100m (kr315.0m market cap, or US$28.2m). Annuncio • Jun 30
Hamlet Pharma Announces CEO Changes Hamlet Pharma announced the appointment of Petter Segelman Lindqvistas new CEO, starting October 1st 2023. The recruitment of Petter Segelman Lindqvist marks a new phase in the development of Hamlet BioPharma's groundbreaking technologies for cancer and infection therapy. Petter Segelman Lindqvist's extensive experience from the global pharmaceutical Industry will increase the emphasis on partnering, commercialization and future market approval. The board wishes to thank Martin Erixon, who will stay as CEO until Petter Segelman Lindqvist joins the company in the fall of 2023. Petter Segelman Lindqvist, with a background at pharmaceutical companies such as GlaxoSmithKline, Abbott and AbbVie, is currently holding a position as Portfolio Strategy Lead at Sobi (Swedish Orphan Biovitrum AB). He brings significant experience from the Global Strategy and Corporate Development functions, as well as from roles in global commercial operations and product strategy. Petter Segelman Lindqvist holds an MSc in Economics and Business Administration from the Stockholm School of Economics and EM Lyon, France. New Risk • Jun 16
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 3.0% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr23m free cash flow). Share price has been highly volatile over the past 3 months (13% average weekly change). Earnings have declined by 1.7% per year over the past 5 years. Revenue is less than US$1m (kr223k revenue, or US$21k). Minor Risks Shareholders have been diluted in the past year (3.0% increase in shares outstanding). Market cap is less than US$100m (kr299.1m market cap, or US$28.2m). Board Change • Nov 16
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 6 non-independent directors. Director Bill Hansson was the last director to join the board, commencing their role in 2021. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. Board Change • Apr 27
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 6 non-independent directors. Director Bill Hansson was the last director to join the board, commencing their role in 2021. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. Annuncio • Mar 19
Hamlet Pharma Announces New Treatment Advances in an Experimental Model of Bladder Cancer Hamlet Pharma announced new treatment advances in an experimental model of bladder cancer. A potent treatment effect of Alpha1H has previously been reported in mice with bladder cancer. The company now show that continued treatment can provide long-term protection as well. Repeated treatment prevented tumor growth and the bladders remained similar to the control group without tumors. In contrast, mice treated with placebo showed rapid tumor progression and severe disease after 12 days. The first round of Alpha1H treatment prevented tumor development for 4 weeks and long-term protection was achieved when treatment was repeated at 4-week intervals, as evidenced by marked differences in tumor size, pathology score, biomarkers and gene expression. Cancer is often a chronic condition and several rounds of treatment are usually necessary. The results presented here suggest that repeated Alpha1H treatment regimens may be beneficial to ensure long-term protection against bladder cancer. This needs further validation in future clinical trials. 
