Year-end Report (Q4) July 2023 – June 2024

OPENING REMARKS

The fiscal year 2023-2024 has been very productive, eventful and successful for Hamlet Biopharma, addressing the need for new treatment options in patients with cancer or severe bacterial infections. Financing was secured for the continued development of the company’s rich project portfolio. Progress in the cancer therapeutics area is shown by strong clinical data on the tumor response, FDA approval of the company’s IND and Fast Track status for Alpha1H. Significant clinical progress was made in the immuno-therapeutic Phase II studies, reported in patients with the bladder pain syndrome, and the company is finalizing the analytical part of the recurrent acute cystitis study. New drugs in the company’s pipeline have made exciting progress, providing a high level of confidence for their continued development towards clinical trials.

Bladder Cancer

Alpha1H shows strong, dose-dependent effects in patients with bladder cancer, resulting in a partial or complete response in 82% of the treated tumors, at the higher concentration of Alpha1H.

Further clinical analysis identified a potent immune response to Alpha1H in treated patients, showing that Alpha1H also acts as an immunotherapeutic agent, which strengthens the potential of Alpha1H as a new investigational drug for the treatment of bladder cancer. This is of significant interest, as immune responses with an anti-tumor profile can be highly protective.

To advance the project towards Phase III studies, the company has secured large-scale production of the Alpha1 peptide and the Alpha1H complex.

Immunotherapy – a new approach to treating infections and pain using the IL-1 receptor antagonist anakinra

Results from the ongoing phase II trial on Bladder Pain Syndrome has shown promising results, supporting the effect of anakinra in this patient group. 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. The study is continuing, to define the therapeutic potential of anakinra in this patient group.

The analysis of data from the study of anakinra treatment in recurrent acute cystitis is ongoing and will be communicated, once the study is unblinded.

Our immunotherapy project portfolio shows great promise

The immuno-therapy portfolio contains several important projects with the potential to treat bacterial infections, hyper-inflammatory conditions, tuberculosis and uro-sepsis, as well as population-based studies to define important patient groups and especially, who should receive the new therapies.  

Strategic Alliances and Commercial Collaborations

Hamlet BioPharma has initiated strategic collaborations with top international advisory firms, primarily to identify partners for the Alpha1H asset. The commercial collaborations may also include the immunotherapy projects. These partnership strategies aim to broaden networking within the industry, to find new partnerships and to strengthen the existing ones.

Next steps

The progress made with Alpha1H and IL1-RA underscores the competence of our organization and our dedication to developing treatments that address significant unmet medical needs and improve patient outcomes. As we move into the next year, Hamlet BioPharma remains committed to advancing the clinical programs with the goal of bringing these innovative therapies to market. The strategic alliances and commercial collaborations with international advisory firms for our primary assets within cancer and infections, continues to be a major focus area for the company, as we move into the new fiscal year.

We thank our shareholders, for their commitment to the company and trust in our vision. We also thank our competent, multinational team and our external partners and experts for their invaluable contributions.

Catharina Svanborg      Martin Erixon

Chairman of the Board     Chief Executive Officer

SIGNIFICANT EVENTS DURING THE FISCAL YEAR

FDA-IND clearance & Fast-track designation for Alpha1H

On July 1st, 2023, the U.S. Food and Drug Administration (FDA) cleared Hamlet BioPharma’s Investigational New Drug (IND) application for Alpha1H, a highly selective synthetic peptide for treatment of non-muscle invasive bladder cancer. Studies with Alpha1H show a combination of high tumor selectivity and a lack of toxicity for cancer cells, resulting in cell death, massive cell shedding from solid tumors and a reduction in tumor size. The FDA’s ‘Study May Proceed’ letter begins a new chapter for the treatment of NMIBC patients globally.

On November 29, 2023, Hamlet BioPharma received U.S. FDA Fast Track designation for Alpha 1H for the treatment of non-muscle invasive bladder cancer. Fast-track status provides the company with a number of strategic advantages, including more intensive guidance from the FDA during the clinical development phase of Alpha1H and a stronger position for discussions with commercial partners.

Merger between Hamlet pharma and Selectimmune Pharma creates Hamlet Biopharma, with an extensive project portfolio

On July 11th, 2023, the shareholders of Hamlet Pharma were invited to an extraordinary general meeting in Hamlet Pharma AB to be held on August 11th, 2023 in Malmö.

On August 4th, 2023, the Swedish Companies Registration Office (Bolagsverket) issued a permission for the merger between Hamlet Pharma AB (publ) and SelectImmune Pharma AB (publ).

On August 11th, 2023, an extraordinary general meeting of Hamlet Pharma AB was held in Malmö, approving the board’s proposal for: • Amendment of the company’s articles of association, included a proposal to change the company´s name from Hamlet Pharma AB to Hamlet BioPharma AB • Determination of the number of board members, board deputies and their fees. • Election of the board members. • Authorization for the board to make decisions on issue. More details to be found on our website: http://www.hamletpharma.com.

On August 18th, 2023, the Swedish Companies Registration Office approved the company’s application of changing the company name from Hamlet Pharma AB (publ) to Hamlet BioPharma AB (publ). The share name is Hamlet BioPharma B, short name (Hamlet B) and ISIN are unchanged. The FISN code is changed to HAMLETBIOP/SH B. The company’s share is traded under the new name from August 24th, 2023.

Clinical Program

• Alpha1H treatment of bladder cancer

On October 16, 2023, Hamlet BioPharma published new strong anti-tumor effects in Alpha1H treated patients, for a combination of clinical and molecular endpoints. The company announced positive results of treatment with the investigational new drug Alpha1H in patients with bladder cancer. The analysis of the combined data set from two clinical study parts was completed and submitted for publication. Treatment resulted in a significant reduction in tumor size in 82% of tumors treated with the higher dose and 45% of tumors treated with the lower dose of Alpha1H. Hamlet BioPharma is now proceeding with the third part of the clinical trial to optimize the design of further clinical trials in dialogue with the FDA.

On January 25, 2024, Hamlet BioPharma published new clinical data in patients with bladder cancer treated with Alpha1H. Alpha1H treatment was shown to activate a broad immune response, with a strong protective potential against cancer. The immune response profile was similar to that in patients treated with BCG; a current standard of care.

On April 18, 2024, Hamlet BioPharma secured continued large-scale Alpha1 peptide production in an agreement with Polypeptide Group. The new production, at a larger scale, will be essential for the clinical trial program in bladder cancer, currently advancing towards Phase III.

• Immunotherapy against infections

IL1-RA treatment of acute cystitis

On January 9, 2024, Hamlet BioPharma announced progress for immunotherapy as a new approach to treating bacterial infections, including antibiotic resistant strains.  The published paper clearly shows that treatment with the drug anakinra (IL-1RA) prevents severe infections of the urinary tract in a murine model relevant to human disease, including kidney infections that may cause sepsis. The treatment was efficient also against infections caused by antibiotic resistant bacteria, defining this therapy as an alternative or complement to antibiotics.

IL1-RA treatment of bladder pain syndrome

On May 6, 2024, Hamlet BioPharma published clinical data from patients with bladder pain syndrome supporting anakinra (IL1-RA) as a new, successful treatment option. The company announced that a significant proportion of the patients with bladder pain syndrome (severe pain in the urinary bladder), treated with anakinra in a placebo-controlled study, have responded positively to the treatment.

• Additional cancer indications

On December 6, 2023, Hamlet BioPharma announced its continued development of Alpha1H as brain tumor therapy. The collaboration with Neurochase Limited in the UK continues, to develop technology for delivery of Alpha1H into the brain.

• Tuberculosis

On December 20, 2023, the company announced progress for the antimicrobial peptide therapy for tuberculosis infections from the group of Professor G. Godaly. A PhD thesis entitled ‘’Antimicrobial peptide therapy for tuberculosis infections’’, was successfully defended by Komal Umashankar Rao.

A successful round of financing

On November 27, 2023, Hamlet BioPharma AB proposed a rights issue of B shares with the possibility to secure approximately 40 MSEK. Approximately 13 MSEK had been subscribed in advance through subscription commitments. Technically, the issue amounted to 80 MSEK.

On November 27, 2023, Hamlet BioPharma called for an Extraordinary General Meeting in Hamlet BioPharma AB on December 14th 2023.

On January 22, 2024, Hamlet BioPharma AB published a prospectus in connection with the rights issue, which had been approved and registered by the Financial Supervisory Authority in Sweden.

On February 9, 2024, Hamlet BioPharma AB announced that the company receives a total of approximately MSEK 46.7 through the rights issue, before deduction of issue costs. Hence, the Company achieved the goal of the issue and was provided with the capital needed for continued development.

Commercial collaborations

On February 14, 2024, Hamlet BioPharma Entered into Commercial Collaborations with Top International Advisory Firms to Enhance Partnering and Strategic Alliances. The advisory firms will offer expert support to Hamlet BioPharma, leveraging their global networks and deep industry knowledge to identify and negotiate potential partnerships for commercial opportunities and strategic alliances.

On April 11, 2024, Alpha1H was identified as the first asset for the international advisory firms. The commercial collaborations will start with the Alpha1H investigational new drug.

International development /communications

On December 13, 2023, Hamlet BioPharma announced the nomination of Elisabeth Parker to its Board of Directors. Dr. Parker’s nomination brings business development competence, international pharmaceutical industry networks and leadership excellence to the company and strengthens the continued growth of Hamlet BioPharma.

On January 10, 2024, Hamlet BioPharma featured in MSQ’s CEO Webinar series released during the JP Morgan Health Care Conference 2024. The company was presented to strategic partners and financial investors from the global-regional biopharma community. The video presentation is available at the company´s website: https://hamletbiopharma.com/news/media-archive/.

On March 6, 2024, Hamlet BioPharma announced that the company participated in the Swiss Nordic Bio 2024 conference set to take place in Zurich on March 7, 2024. The conference serves as a platform for collaboration and investment opportunities among Europe’s leading executives from the biotech and pharmaceutical sectors.

On March 26, 2024, Hamlet BioPharma presented at the Økonomisk Ugebrev’s Life Science Investor Conference. A video of the presentation on March 20th, 2024 is available at the company´s website:

https://hamletbiopharma.com/news/media-archive/.

On June 20, 2024, Hamlet BioPharma was featured in The Guardian as part of the Health Awareness campaign, BLADDER AND BOWEL HEALTH. The advertorial describes Hamlet BioPharma’s progress in key indications; bladder cancer, bladder pain and acute cystitis.

The publication is available at the company ‘s website

https://hamletbiopharma.com/wp-content/uploads/2024/06/Hamlet_Bladder-Bowel_Full-article.pdf

Media and communication/investor relations

Hamlet Pharma initiates quarterly report press briefings

On February 21, 2024, Hamlet BioPharma invited to a digital press briefing to be held on February 22, 2024 after the publication of the Q2 report. The video presentation is available at the company ́s website: https://hamletbiopharma.com/news/media-archive/

On May 22, 2024, Hamlet BioPharma invited to digital press briefing to be held on May 24, 2024 after the publication of the Q3 report. The video presentation is available at the company ́s website: https://hamletbiopharma.com/news/media-archive/

Hamlet BioPharma initiates a new series of digital meetings with the HAMLET TEAM

The first meeting was held on March 27, 2024, followed by three presentations held on April 9th, May 8th and June 12th.

Investor presentations, examples

On October 30, 2023, Hamlet BioPharma presented at the FS Market event on October 25th. A video presentation is available at: https://youtu.be/zkZsCx0y1Qw?si=bFGMAkwqGrkXLOd3

On December 11, 2023, Hamlet BioPharma invited interested parties to join a digital presentation at Invest Live, Tuesday December 12th at 12.00 CET. A video presentation is available at: https://www.youtube.com/watch?v=wjtkWLFwFuU

On May 27, 2024, Hamlet BioPharma announced that the company will participate in The Global Forum 2024 By BioStock, set to take place in Lund, Sweden, on May 29-30, 2024. The forum provides a unique platform for networking, knowledge exchange, and business development, with a focus on promoting global collaboration and investment in future medical solutions. A video presentation is available at: https://youtu.be/FiTlFO9BH4c?t=5505

View all investor presentations during 2023/2024 in our website media archive: https://hamletbiopharma.com/news/media-archive/

ABOUT HAMLET BIOPHARMA

Hamlet BioPharma is an innovative biotechnology company that develops scientific discoveries into drugs for the treatment of cancer and infections. The goal is to address unmet medical needs in large patient groups in need of improved cancer treatments or alternatives to antibiotics. The company is leveraging highly innovative scientific discoveries and an extensive IP portfolio, to take these innovative drugs through mechanistic and preclinical phases, through the development of drug production technology to the clinic. Three projects in clinical development are in Phase II trials.

Bladder cancer treatment. The investigational new drug Alpha1H has shown efficacy in the treatment of early bladder cancer and has potential as neoadjuvant for this and additional patient groups. The clinical program is progressing towards Phase III and the company is in a dialogue with the Food and Drug Administration (FDA) regarding the continued clinical program. Alpha1H was recently awarded Fast track status by FDA.

Immunotherapy against bacterial infections. Immunotherapy has great potential as a complement to antibiotics. Treatment of infections with the IL-1 receptor antagonist IL-1RA has shown potent effects in in animal models, proving that immunotherapy may protect against inflammation and symptoms. Surprisingly, the treatment also accelerates the clearance of bacteria with similar efficacy as antibiotics. The clinical program is progressing with two Phase II studies, where positive clinical effects were recently communicated in patients with bladder pain. The pipeline contains additional, highly competitive new molecules for future clinical development.

The need for novel therapies is significant and cancer and infection are major threats to health, worldwide. The high prevalence of bladder cancer illustrates the need for new treatments and the threat of antibiotic resistance is growing. The drug candidates developed by Hamlet BioPharma hold the promise of improving the health of large patient groups, by providing therapeutic alternatives or complements to more toxic cancer drugs and to antibiotics.

Hamlet BioPharma’s pipeline

Hamlet BioPharma - the pharmaceutical company with a strong portfolio of projects for the treatment of cancer and infections – has three projects in phase II clinical trials.

FINANCIAL OVERVIEW

The period in summary

FOURTH QUARTER, APR 1, 2024-JUN 30, 2024 (THE PARENT COMPANY)

– Net sales totaled KSEK 0 (0)

– Other operating income totaled KSEK 0 (2,421)

– Loss before tax amounted to KSEK -11,040 (-2,631)

– Loss after tax amounted to KSEK -11,040 (-2,631)

– Loss per share* was SEK -0.0658 (-0.0235)

FULL YEAR, JUL 1, 2023-JUN 30, 2024 (THE PARENT COMPANY)

– Net sales totaled KSEK 0 (0)

– Other operating income totaled KSEK 30 (2,421)

– Loss before tax amounted to KSEK -39,822 (-19,943)

– Loss after tax amounted to KSEK -39,822 (-19,943)

– Loss per share* was SEK -0.2374 (-0.1780)

– On June 30, 2024, the equity/assets ratio** was 94.2 (74.0) %

FOURTH QUARTER, APR 1, 2024-JUN 30, 2024 (THE GROUP)

– Net sales totaled KSEK 0 (0)

– Other operating income totaled KSEK 0 (2,421)

– Loss before tax amounted to KSEK -11,539 (-3,129)

– Loss after tax amounted to KSEK -11,539 (-3,129)

– Loss per share* was SEK -0.0688 (-0.0279)

FULL YEAR, JUL 1, 2023-JUN 30, 2024 (THE GROUP)

– Net sales totaled KSEK 0 (0)

– Other operating income totaled KSEK 30 (2,421)

– Loss before tax amounted to KSEK -41,817 (-20,441)

– Loss after tax amounted to KSEK -41,817 (-20,441)

– Loss per share* was SEK -0.2493 (-0.1824)

– On June 30, 2024, the equity/assets ratio** was 94.0 (73.5) %

Amounts in parentheses above and below indicate the corresponding value in the preceding year.

* Profit/loss after tax for the period divided by 167,762,902 (112,038,988), respectively, where 167,762,902 is the number of shares outstanding on June 30, 2024, The comparative figure in parentheses was the number of shares on June 30, 2023.

** Equity divided by total capital.

Revenues and earnings

The costs for the merged companies Hamlet BioPharma and SelectImmune Pharma reflect the larger project portfolio and the costs of the three clinical trials in Phase II. Hamlet BioPharma’s net sales amounted to KSEK 0 (0) during the fourth quarter, and to KSEK 0 (0) during the full year. Other operating income amounted to KSEK 0 (2,421) during the quarter, and to KSEK 30 (2,421) during the full year. The vast majority of the costs relate to the clinical trials, and especially the trial of Alpha1H in patients with bladder cancer. Costs were also related to manufacturing of the Alpha1H drug candidate, for use in ongoing and forthcoming clinical trials. Costs also include in the group accounting consists of depreciation of patent from the acquirement of Linnane Projects AB.

Loss before tax for the parent company for the fourth quarter was KSEK -11,040

(-2,631), and for the full year KSEK -39,822 (-19,943). Loss before tax for the group for the fourth quarter was KSEK -11,539 (-3,129), and for the full year KSEK -41,817 (-20,441).

Financial position

During the third quarter, the company carried out a very successful new share issue, which added KSEK 42,453 to the company after deducting issue costs of KSEK 4,314.

At the end of the fourth quarter, the equity/assets ratio was 94.2 (74.0) %, and the Company’s cash and cash equivalents were KSEK 23,076 (18,368). This includes a prepayment of Alpha1H production costs of approximately KSEK 3,000.

The company assesses that there will be a need to raise capital during the next financial year in order to secure continued operations.

Investments

The Company does not capitalize expenses for research and development as assets, since the Company is in an R&D stage. R&D costs are therefore recognized as operating expenses in the income statement.

Depreciation

Depreciation of equipment amounted to KSEK 113 (0) during the quarter and KSEK 394 (0) during the full year, and the depreciation of patents from the merger with SelectImmune Pharma AB amounted to KSEK 2,021 (0) during the quarter and KSEK 7,216 (0) during the full year.

In the group, depreciation of patents, including the acquisition of Linnane Projects AB, amounted to KSEK 2,520 (499) during the quarter and KSEK 9,212 (499) during the full year

Employees

The company had the equivalent of 7 (5) full-time employees during the quarter

The share

The Company’s shares have been traded on Spotlight Stock Market since October 23, 2015. The share is traded under the short name “HAMLET B” with ISIN code SE0015661152.

At the extraordinary general meeting in Hamlet Pharma AB on March 2, 2021, it was decided that the company’s common shares would undergo a split with relation 3:1 and would be reclassified as A- and B-shares. The B-shares will be traded on Spotlight Stock Market. The A-shares will not be listed. Each A-share entitles to ten votes and B-shares entitles to one vote. Furthermore, it is possible for shareholders to convert A-shares to B-shares, which can be traded on Spotlight Stock Market. This conversion program is ongoing with no current deadline. This means that the ratio between A- and B-shares will change over time.

As of August 27, 2024, the number of shares registered at the Swedish Companies Registration Office (Bolagsverket) totalled 167,762,902. As of August 27, 2024, the registered current ratio of shares was 39,985,034 A-shares and 127,777,868 B-shares.

Subscription warrants or guarantees

The company had no outstanding warrants or guarantees as of June 30, 2024.

Transactions with related parties

During the quarter, KSEK 1,370 (Hamlet Pharma: 630, SelecImmune Pharma: 495) was paid to Linnane Pharma AB, of which KSEK 0 (Hamlet Pharma: 105) refers to consulting fees, KSEK 0 (Hamlet Pharma: 525, SelectImmune Pharma: 375) refers to the old agreement about the technology platform, KSEK 1,250 (0) refers to the new co-operation agreement, KSEK 120 (Hamlet Pharma: 0, SelectImmune Pharma: 120) refers to patent license.

The consulting fees to Linnane Pharma refer to compensation for the collaboration agreement access to advanced science and cutting-edge technology for drug development. The collaboration means that Linnane Pharma's technology platform and other resources are available to Hamlet BioPharma. Hamlet BioPharma is a subsidiary company of Linnane Pharma AB, which owns 36.31% of the capital and 76.26% of the votes of Hamlet BioPharma.

Furthermore, salaries and allowances to board and management were paid during the period. Transactions with related parties are on market terms.

Significant risks and uncertainties

The Board's assessment of significant risks and uncertainties is unchanged compared to the most recent financial year and is described in the most recently published Annual report (2023-06-30).

Basis of preparation for the interim report

The Company prepares its accounts in accordance with the Swedish Annual Accounts Act (Årsredovisningslagen) and the K3 framework (BFNAR 2012:1) of the Swedish Accounting Standards Board (Bokföringsnämnden).

The company's accounting principles are unchanged compared with the most recent financial year and are described in the most recently published Annual report (2023-06-30).

On March 31st, 2023, Hamlet BioPharma acquired Linnane Projects AB from Linnane Pharma AB and the patents and know-how regarding a new peptide-based drug against tuberculosis as well as the know-how required to develop the project. In accordance with regulations at Spotlight and the Swedish Accounting Standards Board (Bokföringsnämnden), consolidated accounts of Linnane Projects and Hamlet BioPharma are drawn up.  The quarterly report is prepared with the parent company’s accounting in focus. In texts, the group is only commented on if anything differs significantly from the parent company.

Review

This interim report has not been audited.

Financial calendar

Annual Report for 2023/2024 October 31, 2024

Interim report for Q1, 2024/2025 November 15, 2024

Annual General Meeting for 2023/2024 November 21, 2024

Income Statement: The Parent Company

Balance Sheet : The Parent Company

Cash Flow Statement: The Parent Company

Equity : The Parent Company

Income Statement : The Group

Balance Sheet : The Group

Cash Flow Statement : The Group

Equity : The Group

The Board of Directors and the Chief Executive Officer assure that the interim report provides a true and fair view of the Company's operations, position, and results.

Malmö, August 28 , 2024

 Catharina Svanborg Martin Erixon

 Chairman of the Board CEO

 Bill Hansson Helena Lomberg

 Board member Board member

 Magnus Nylén Elisabeth Parker

 Board member Board member

 Ulla Trägårdh 

 Board member