Hamlet Pharma : Successful review of HAMLET Pharma by the EU Horizon 2020 program

Hamlet Pharma has recently delivered its 18-month report to the Euro- pean Union's Horizon 2020 program. In their response, the EU states that the project has "fully achieved its objectives and milestones for the period" and "remains in line with the objectives".

The report summarizes the results in four parts.

1. The successful conclusion of the Phase I/II study. The report states that "the

results demonstrated good safety and efficacy, which is very encouraging and sup-

ports the continued development of Alpha1H towards a Phase III trial".

2. Transfer of the drug manufacturing methodology to a larger commercial fa-

cility. This challenging process has been achieved and the new product has been

tested and found to be fully active in cancer cells in the laboratory.

3. Initiation of contact with the FDA/EMA. Based on a positive gap analysis by

Target Health of the existing data, interactions have been initiated in order to start

to plan the presentation of the Phase III study design to the US FDA.

4. Marketing and risk analysis. A marketing and risk analysis plan for the bladder

cancer project has been presented. Options are to co-develop Alpha1H for this

indication together with Large Pharma partners through for example a licensing

deal, or with investor funding.

We greatly appreciate the continued support from the Horizon 2020 program (2.1 million Euro) which accelerates our development.

For more information, please contact

Catharina Svanborg, Chairman and founder of Hamlet Pharma, [phone] [e-mail]

Mats Persson, CEO Hamlet Pharma, [phone] [e-mail]

Lund March 4, 2022

About HAMLET Pharma

HAMLET Pharma, listed on Spotlight, develops drugs based on the unique tumoricidal protein- lipid complex, HAMLET, formed by two natural and harmless molecules found in breast milk. Development focuses primarily on drugs, for the treatment and prevention of cancer. HAMLET kills tumour cells and has proven safe in proof-of-concept studies in animal models. Alpha1H is the synthetic variant of HAMLET, which has enabled development of the agent for clinical trials. Alpha1H kills different types of tumour cells and has demonstrated therapeutic effects on bladder cancer in animal models. Hamlet Pharma has one ongoing Phase I/II clinical trial with Alpha1H in patients with bladder cancer, a costly form of cancer that is difficult to treat and intends to expand its activities into other types of cancer. The first results from the ongoing clinical Phase I/II study shows no side effects of Alpha1H, indicating that the treatment is safe and well tolerated. Alpha1H also demonstrated clinical efficacy compared with patients who received placebo. In addition, Hamlet Pharma develops BAMLET, which is a molecular com- plex formed by bovine α-lactalbumin and oleic acid. Data from animal models suggest that local BAMLET treatment may be effective against colon cancer.

This project is funded from the European Union's Horizon 2020 research and innovation program under grant agreement No 954360.