Heidelberg Pharma will Present at German Equity Forum and Provides Update on Partner Activities for its Legacy Assets

DGAP-News: Heidelberg Pharma AG / Key word(s): Conference
12.11.2020 / 15:01
The issuer is solely responsible for the content of this announcement.

PRESS RELEASE

Heidelberg Pharma will Present at German Equity Forum and Provides Update on Partner Activities for its Legacy Assets

- RedHill Biopharma plans Phase II/III trial with upamostat in COVID-19

- Telix Pharmaceuticals enters into strategic license and commercial partnership for China with radio-labelled antibody girentuximab

Ladenburg, Germany, 12 November 2020 - Heidelberg Pharma AG (FSE: HPHA) today announced that it will give a presentation at the German Equity Forum (Eigenkapitalforum, EKF) and provided an update on recent news from its licensing partners.

Presentation at EKF

The EKF will virtually take place from 16^th - 18^th November 2020. Dr. Jan Schmidt-Brand, CEO/CFO of Heidelberg Pharma AG will hold a company presentation on Wednesday, 18^th November at 10:00 am CET. Heidelberg Pharma's management will be available for one-on-one meetings.

Dr. Jan Schmidt-Brand said: "We are pleased that our partners are making significant progress with our out-licensed product candidates. Both, RedHill and Telix are continuing to develop our former clinical candidates in a promising and energetic manner, so that we will benefit from successful development and commercialization in the future. We support our partners where we can."

Update on partnering programs

Partnered program, RHB-107, making progress in COVID-19 and cancer

Licensing partner RedHill Biopharma Ltd. (RedHill, Nasdaq: RDHL) continues to develop RHB-107 (upamostat) in COVID-19 and has indicated that the company plans to initiate a Phase II/III study with outpatients in the USA early in 2021. This is further supported by promising results showing that RHB-107 strongly inhibited SARS-CoV-2 replication in an in vitro model of human bronchial tissue.

RedHill also recently announced the receipt of a Notice of U.S. Patent Allowance for the combination of opaganib and RHB-107 for the oral treatment of solid tumors. RedHill is developing opaganib for the treatment of cholangiocarcinoma (bile duct cancer). Based on preclinical results showing a potent anti-tumor effect of the combination of RHB-107 with opaganib, RedHill is now planning to add a third cohort to its ongoing Phase IIa study in cholangiocarcinoma to evaluate the combination therapy of RHB-107 with opaganib. For further information please see RedHill's press release: RedHill Biopharma Receives U.S. Patent Allowance Covering Opaganib and RHB-107 Combination.

Telix advances TLX250-CDx, signs commercial partnership for Greater China

Licensing partner Telix Pharmaceuticals Limited (Telix, ASX: TLX) announced that they have entered into a strategic license and commercial partnership with China Grand Pharmaceutical and Healthcare Holdings Limited (CGP) for several Telix product candidates for Greater China (Mainland China, Hong Kong SAR, Macau SAR, Taiwan). This includes TLX250-CDx, the radiolabeled antibody ⁸⁹Zirconium-girentuximab, which Telix in-licensed from Heidelberg Pharma. TLX250-CDx is in Phase III development for the imaging-based diagnosis of renal cancer. Under the terms of the agreement, CGP will be the exclusive distribution partner for TLX250-CDx in the Greater China market. Furthermore, CGP will develop TLX250, the ¹⁷⁷Lutetium-labeled antibody girentuximab, for the treatment of renal cancer patients in Greater China to align with Telix's global clinical development programs. CGP has committed to program-related investments for the clinical development of TLX250 among other additional investments in Telix. Heidelberg Pharma's licensing agreement with Telix is not directly affected by this agreement, but the Company is entitled to future royalties on sales of TLX250-CDx and TLX250 in Greater China. Further information on the deal was published in Telix's press release: Telix Pharmaceuticals Limited and China Grand Pharma Announce Strategic Licence and Commercial Partnership for Greater China Market.

Telix also recently announced a collaboration with Eczacıbaşı-Monrol Nuclear Products Co. for the manufacturing of TLX250-CDx in Turkey. The first Turkish patients in the Phase III ZIRCON trial have been dosed. Telix plans to enroll a total of approximately 250 patients in the global trial to determine the sensitivity and specificity of TLX250-CDx PET imaging compared to histology in clear cell renal cell cancer (ccRCC). Corresponding press release: First Patients Dosed in Phase III ZIRCON Trial of Renal Cancer Imaging Product in Turkey

Additionally, Telix has completed Phase I enrollment for its Phase I/II ZIRDAC-JP study in Japan evaluating TLX250-CDx for imaging renal cancer. The goal of this study is to confirm dosing and pharmacology in Japanese patients. Corresponding press release: Completion of Phase I Enrolment of Japanese Renal Cancer Study

About Heidelberg Pharma's proprietary ATAC technology
Antibody drug conjugates (ADCs) combine the high affinity and specificity of antibodies with the potency of cytotoxic small molecules for the treatment of cancer. Antibody Targeted Amanitin Conjugates (ATACs) are ADCs whose active ingredient is made up of amatoxin molecules. Amatoxins are small bicyclic peptides naturally occurring in the death cap mushroom. They inhibit mRNA transcription by binding to RNA polymerase II, a mechanism that is crucial for the survival of eukaryotic cells. In preclinical testing, ATACs have been shown to be highly efficacious, overcoming frequently encountered resistance mechanisms and combating even quiescent tumor cells.

About Heidelberg Pharma
Heidelberg Pharma AG is a biopharmaceutical company based in Ladenburg, Germany. Heidelberg Pharma is an oncology specialist and the first company to develop the toxin Amanitin into cancer therapies using its proprietary Antibody Targeted Amanitin Conjugate (ATAC) technology and to advance the biological mode of action of the toxin as a novel therapeutic principle. This proprietary technology platform is being applied to develop the Company's proprietary therapeutic ATACs, as well as in third-party collaborations, to create a variety of ATAC candidates. The proprietary lead candidate is HDP-101, a BCMA ATAC for multiple myeloma.

The Company has entered into partnerships to further develop and commercialize its clinical assets upamostat (formerly MESUPRON^(R)) and TLX250-CDx (formerly REDECTANE^(R)). Heidelberg Pharma AG is listed on the Frankfurt Stock Exchange: ISIN DE000A11QVV0 / WKN A11QVV / Symbol HPHA. More information is available at www.heidelberg-pharma.com.

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, or 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.

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