DGAP-News: Heidelberg Pharma AG: Heidelberg Pharma Reports on First Half-Year 2022

PRESS RELEASE

Heidelberg Pharma Reports on First Half-Year 2022

• First clinical trial with HDP-101 in multiple myeloma on track, third cohort in preparation
• Signing of a strategic partnership with Huadong Medicine with an overall deal volume of up to one billion US dollars and an investment agreement of up to EUR 105 million; rights issue of up to EUR 80 million to be launched in August
• Significantly increased sales due to license payment from Huadong

Ladenburg, Germany, 12 July 2022 - Heidelberg Pharma AG (FSE: HPHA) published today its financial report on the first six months of 2022 (1 December 2021 - 31 May 2022).

Dr. Jan Schmidt-Brand, CEO and CFO of Heidelberg Pharma AG, commented: "We are looking back on an exceptionally successful first half of the year. A significant milestone was the dosing of the first patient with our lead ATAC^® project HDP-101 in February. The first cohort of patients, and thus the first dose level has been completed and the second cohort has already been treated. We hope to publish first safety data by the end of this year.

The signing of the partnership with the Chinese pharmaceutical company Huadong Medicine, which consists of a licensing and an investment agreement, was a landmark decision for us. Through this partnership, we gain an established licensing partner for our ATAC^® portfolio in Asia and another strategic investor supporting our strategy to become a major global ADC player. As a result of the license payment from Huadong, our sales developed very positively, which is encouraging. We will make an adjustment to our 2022 financial outlook after the planned capital increase has been completed."

Key events in the first six months of 2022

• HDP-101 program in multiple myeloma is progressing: Mid-February 2022, the first patient was dosed in the Phase I/IIa study with HDP-101, an BCMA antibody-Amanitin conjugate. The open-label, multi-center study is evaluating HDP-101 for the treatment of relapsed or refractory multiple myeloma, a bone marrow cancer. The first patient cohort and dose level has been completed and patients have already been treated in the second dose level.
• Financing commitment by main shareholder dievini: In order to support the financial reach and the negotiations with Huadong, which were ongoing at the beginning of the year, the main shareholder dievini Hopp BioTech holding GmbH & Co. KG, Walldorf, (dievini) made a financing commitment of up to EUR 36 million in February 2022. The funds pledged will be made available if and to the extent that this amount is not secured through alternative capital measures. This commitment replaces the not yet fully used financing commitment from March 2021.
• Signing of strategic partnership with Huadong: At the end of February, Heidelberg Pharma and Huadong Medicine Co., Ltd., Hangzhou, China, (Huadong) signed an exclusive licensing deal and investment agreement. This strategic partnership includes a licensing agreement for the development and commercialization of the ATAC^® candidates HDP-101 and HDP-103 as well as an exclusive option for the early candidates HDP-102 and HDP-104 for Asia.[1] In addition, Huadong intends to make an equity investment in Heidelberg Pharma totaling EUR 105 million, which will represent 35% of total shares outstanding after the transaction. The investment consists of a capital increase with rights issue (up to EUR 80 million) and a share transfer from the pool of the main shareholder dievini. By now, Huadong has obtained the exemption from the submission of a mandatory offer if the 30% shareholding is exceeded issued by the Federal Financial Supervisory Authority (BaFin) and received the certificate of no-objection to carry out the planned transaction from the Federal Ministry of Economic Affairs and Climate Action (BMWK).
• New preclinical data from the ATAC^® technology platform presented at the AACR 2022 Annual Meeting: At the American Association for Cancer Research (AACR) 2022 Annual Meeting in April, Heidelberg Pharma presented preclinical data on its ATAC^® technology. Data were shown on the synergy of ATACs^® together with immune checkpoint inhibitors, as well as data indicating that repeated treatment with ATACs^® in preclinical models results in better tolerability without compromising efficacy.
• Milestone reached in partner program: ATAC^®-Partner Magenta Therapeutics, Cambridge, MA, USA, (Magenta; NASDAQ: MGTA) dosed the first patient with MGTA-117 in a Phase I/II study in March. The achievement of this milestone triggered a payment to Heidelberg Pharma.
• Out-licensed clinical projects are on track at partners: Telix Pharmaceuticals Limited, Melbourne, Australia, (Telix) announced in July that the last patient had been dosed and that enrollment of the Phase III study (ZIRCON) for imaging diagnostics of renal cancer was now complete. Telix had expanded enrollment for this global study from 252 to 300 patients in March. Data are expected in the second half of 2022.
  RedHill Biopharma Ltd., Tel Aviv, Israel, (RedHill; NASDAQ: RDHL) announced that RHB-107 delivered positive efficacy results in a Phase II/III trial with COVID-19 non-hospitalized patients demonstrating a 100 % reduction in hospitalizations due to COVID-19 and an 87.8 % reduction in reported new severe COVID-19 symptoms. RedHill is currently in discussions with regulatory authorities regarding further development steps.

Financial results for the first six months of fiscal year 2022

The full half-yearly financial report including the consolidated financial statements prepared in accordance with International Financial Reporting Standards (IFRS) was published at https://heidelberg-pharma.com/en/press-and-investors/announcements/financial-reports.

About Heidelberg Pharma

Heidelberg Pharma is an oncology specialist and the first company to develop the toxin Amanitin into cancer therapies using its proprietary ATAC^® technology and to advance the biological mode of action of the toxin as a novel therapeutic principle. The proprietary technology platform is being applied to develop the Companys own therapeutic ATACs^® as well as in third-party collaborations. The lead candidate HDP-101 is a BCMA ATAC in clinical development for multiple myeloma. HDP-102, a CD37 ATAC for Non-Hodgkin lymphoma and HDP-103, a PSMA ATAC for metastatic castration-resistant prostate cancer, are in preclinical testing.

Heidelberg Pharma AG is based in Ladenburg, Germany, and is listed on the Frankfurt Stock Exchange: ISIN DE000A11QVV0 / WKN A11QVV / Symbol HPHA. More information is available at https://www.heidelberg-pharma.com/.

ATAC^® is a registered EU trademark of Heidelberg Pharma Research GmbH.

This communication contains certain forward-looking statements relating to the Company's business, which can be identified by the use of forward-looking terminology such as "estimates", "believes", "expects", "may", "will, "should, "future", "potential" or similar expressions or by a general discussion of the Company's strategy, plans or intentions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results of operations, financial condition, performance, achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Given these uncertainties, prospective investors and partners are cautioned not to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such forward-looking statements to reflect future events or developments.

^[1] Asia (excluding Japan, India, Pakistan, Sri Lanka): Peoples Republic of China, Hong Kong, Macao,
Taiwan, South Korea, Indonesia, Singapore, The Philippines, Thailand, Bangladesh, Bhutan,
Brunei, Myanmar, Cambodia, Laos, Malaysia, Maldives, Mongolia, Nepal and Vietnam