Hamlet Pharma : Q2 Interim report OCTOBER 2021-DECEMBER 2021

Q2

Interim report October - December 2021

The "Company" or "Hamlet Pharma" refers to Hamlet Pharma AB, corp. reg. no. 556568-8958

Opening remarks

The second quarter of the fiscal year 2021/2022 has been very productive ending on a high with the completion of the clinical part of the dose-escalation study in December. The positive outcome was communicated in January 2022, showing stronger effects on the tumors with higher doses of Alpha1H. No drug related side effects were detected, further strengthening the profile of Alpha1H as a drug candidate with a high level of tumor specificity. These findings inspire us to proceed with the drug development towards Phase III trials. The dialogue with our US partners Target Health has been reactivated to proceed with the FDA process.

We have secured the production of larger quantities of Alpha1H, in preparation for the next steps in the clinical trials programme using a stable, large scale manufacturing process. Hamlet Pharma is collaborating with Rechon Life Science who offers complete pharmaceutical services, including formulation, packaging, and distribution of clinical trial supplies. The synthetic peptide Alpha1 is provided by PolyPeptide Laboratories, who have provided excellent material throughout our clinical trial programme.

To proceed with the development of BAMLET for clinical use, we have also entered into an agreement with Galenica AB, exploring potential formulations for different clinical indications. Experimental studies of BAMLET in different cancer models have shown positive results.

Forming strong partnerships with market leaders is a company priority to complete drug development and commercialization of Alpha1H and BAMLET. Hamlet Pharma is attracting interest from leaders in the field of drug development and business development. Our Think Tank has been established as a forum to engage these experts in strategic discussions and benefit from their experience and advice.

Hamlet Pharma has updated the website to become more informative and interactive. The focus on communication is strengthened by the recruitment of a new media strategist, who will increase our visibility and provide information about Hamlet Pharma to shareholders and other interested parties.

Hamlet Pharma offers a cost-efficient solution for the development of new cancer drugs, aided by continued access to new technology through Linnane Pharma. The support from our share- holders, our team members, the clinic in Prague and all our external partners is very important and a prerequisite to the success of developing new treatment options for patients.

Catharina Svanborg and Mats Persson

Chairman of the Board/CMO and CEO of Hamlet Pharma AB

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Significant events during the second quarter

On October 28, 2021, the shareholders of Hamlet Pharma were summoned to the Annual General Meeting on November 25, 2021.

On October 29, 2021, we announced that Hamlet Pharma has secured the production of larger quantities of Alpha1H, using a stable, large scale manufacturing process. Larger amounts of drug will be needed for the continued clinical trial program, which involves larger study populations. Hamlet Pharma is collaborating with Rechon Life Science for the production and formulation of the drug candidate Alpha1H. Rechon is a well-recognized contract manufacturing organization based in Malmö and offers a complete pharmaceutical service including preparation, packaging, and distribution of Clinical Trial Supplies for clinical studies phases I-IV. Production is carried out in accordance with GMP and Rechon is approved for pharmaceutical supply worldwide (including the US).

On November 2, 2021, Hamlet Pharma's Board of Directors proposed two new members for election to the company's Board of Directors. Ulla Trägårdh is a lawyer with broad experience in the area of business law. She has been involved in the development of both a major Swedish law firm, as well as a local niche law firm that she established 2003. Lars Hedbys has many years of experience from the pharmaceutical industry and has founded and listed several life science companies.

On November 4, 2021, the annual report for the fiscal year 2020/2021 was published. It can be found on our website or on Spotlight Stock Market's webpage.

On November 11, 2021, Q1 for the fiscal year 2021/2022 was published. It can be found on our website or on Spotlight Stock Market's webpage.

On November 25, 2021, the Annual General Meeting was held. Due to the corona virus pandemic, the meeting was conducted by advance voting with the support of temporary statutory rules. It was decided to appoint Catharina Svanborg, Bengt Westermark, Bill Hansson, Ulla Trägårdh, Lars Hedbys and Helena Lomberg as board members for the period until the end of the next Annual General Meeting. The AGM resolved to approve the income statement and balance sheet as included in the annual report. The AGM resolved to dispose the company's results in accordance with the Board's proposal in the annual report. Furthermore, it was decided that no dividend will be paid for the financial year 2020/2021. It was also resolved to grant the members of the Board of Directors and the CEO discharge from liability for the period covered by the annual report presented at the meeting. The relevant members of the Board of Directors or the CEO did not participate in this decision.

On November 30, 2021, the company invited investors to an on-line meeting to summarize the information normally presented at the Annual General Meeting and to provide a forum for a dialogue with the shareholders. About 80 participants took part and the discussions were lively and constructive.

On November 30, 2021, Hamlet Pharma signed a contract with Galenica AB. Hamlet Pharma is proceeding with the development of BAMLET for pharmaceutical use and a necessary first step is to establish technology for large-scale production of BAMLET. A new production method has been developed and patented and will be used as a basis for scaling up the production process together with Galenica AB. The parties have agreed on a development plan, including production technology transfer, testing of biological activity of the product and development of suitable formulations. Galenica AB is a contract research organisation (CRO) providing services in the field of pharmaceutical technology. The company has broad skills and experience in formulation, production and quality control of pharmaceuticals.

On December 7, 2022, Hamlet Pharma announced the new website and recruitment of a new media strategist. Hamlet Pharma increase focus on the company's digital channels to provide easier access for shareholders and the public. An updated website and digital meetings with shareholders are examples already implemented.

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Significant events after the end of the second quarter

On January 14, 2022, Strategic recruits to the Hamlet Pharma Think Tank were announced. The company has formed the Think Tank as a forum for strategic discussions important to the compa- ny's future. In addition to the competence that exists in the company, leading experts have been recruited in the areas of drug development, business development, finance and clinical strategy. The Think Tank will provide a forum for creative discussions and networking, a place where experience and expertise within the company's major strategic areas will be shared to reach innovative solutions.

On January 17, 2022, the successful completion of the dose-escalation extension of the Phase I/II study was announced. More potent effects of Alpha1H for key study parameters were seen for higher doses. The tumors were more strongly affected by Alpha1H at higher doses than in patients treated with the lower dose, as shown by more extensive shedding of tumor cells and tumor fragments into patient urine. As shown earlier, significant cell shedding or apoptosis did not occur in the placebo group, confirming the treatment effect. The results are very encouraging for our continued work towards Phase III trials.

On January 31, 2022, a newsletter was published to describe data from the dose-escalation study in greater detail. The correlation between dose and effect strongly indicate that Alpha1H shows characteristics indicative of its function as a drug against aggressive cancer, and that it may be possible in the future to administer Alpha 1H according to the special needs of the individual patient.

Important Milestones

Successful hearing with the EU

After the successful round of financing, the financial situation of Hamlet Pharma is stable. The EU grant further supports the company growth. During a recent 18 month follow up hearing with the EU, the company presented results showing successful completion of most of the milestones and work packages.

Clinical trial program

An extensive analysis of clinical and molecular data for the dose-escalation part of the clinical trial in bladder cancer is ongoing. The positive results from the first part were published in June 2021 in Nature Communications, a leading international journal. In January, we announced the positive data from the dose-escalation of Alpha1H. Patients were given Alpha1H or placebo directly into the bladder. By comparing urine samples from before and after the treatment, we detected a substantial increase in tumor cell shedding among the patients receiving active substance, along with an accumulation of cells containing Alpha1H. The purpose of a dose escalation study is to investigate if treatment with increased doses of Alpha1 results in increased effects in the patients with bladder cancer. The study showed that the tumors were more strongly affected with higher doses than in patients treated with the lower dose and those treated with placebo. The correlation between dose and efficacy strongly indicate that the substance elicits positive responses as can be expected from a functional drug showing dose response in terms of efficacy.

The patients were given Alpha1H or placebo directly into the bladder. By comparing urine samples from before and after the treatment, we detect a substantial increase in tumor cell shedding among the patients receiving active substance, along with an accumulation of cells containing Alpha1H.

BeforeAfter

Cancer cell shedding in urine samples taken after but not before the treatment with Alpha1H. Tumor cells and fragments are stained blue.

After just two hours, patients treated with the higher dose of Alpha1H started to shed large numbers of tumor cells into the urine and the shed cells contained large amounts of the Alpha1H drug candidate, suggesting that the tumor is fragmented and released into the urine. At the time of surgery, major changes were observed in the remaining tumor tissue, with a loss of viable tissue, areas of necrosis, evidence of tumor fragmentation and shedding of large fragments from the tumor surface.

BeforeAfter

Uptake of Alpha1H (red) in urine samples taken after treatment with Alpha1H. Tumor cells are shown to contain large amounts of Alpha1H after but not before treatment.

BeforeAfter

Tumor cell death induced by Alpa1H. Large numbers of green, dying cells are seen in urine samples taken from the patients after treatment with Alpha1H.

The higher dose was also shown to trigger a strong apoptosis response and to shut down the transcriptional machinery of the tumor, which translates RNA into new proteins. This means that Alpha1H does not just target one part of the tumor cell machinery but has a general effect on essential tumor cell functions, limiting their growth and inducing cell death.

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