Opelkibart elmanitin

HDP-101 clinical trial in Europe and US continues with adjusted protocol and larger number of study sites in Europe; fifth patient cohort initiated at 100 µg/kg dosing Patient from third cohort continues to be dosed and shows stable disease Divestment of minority stake in Emergence leads to higher other income and additional cash inflows Sales and other income above plan, other financials in line with plan Ladenburg, Germany, 12 October 2023 – Heidelberg Pharma AG (FSE: HPHA) reported today on its course of business as well as on the Group's financial figures for the first nine months of fiscal year 2023 (1 December 2022 – 31 August 2023). Dr. Jan Schmidt-Brand, CEO of Heidelberg Pharma AG, commented: “After a turbulent start to the year at former partner Magenta and their strategic realignment, we were able to clarify issues regarding the ATAC technology platform and continue our study with HDP-101. Based on the experience at Magenta, additional safety measures were included in the study protocol. The good safety profile to date and the increase in the number of study sites have led to an accelerated recruitment of study participants, so that the fourth dose cohort has now been completed. The Safety Review Committee confirmed in early September that HDP-101 is safe and well tolerated at 80 ug/kg. The Committee recommended to escalate the dose for the next cohort. Our financials performed in line with plan, with an exceptional income recorded. As part of the acquisition by an US pharmaceutical company, we sold our minority stake in Emergence Therapeutics. As a result of the transaction, we recorded a cash inflow of USD 7.4 million, which we mainly used for a partial loan repayment of EUR 5 million to the shareholder loan extended by dievini." HDP-101 development program: HDP-101, an Antibody Targeted Amanitin Conjugate directed against the antigen BCMA, is being tested in a Phase I/IIa open-label, multicenter study for the treatment of relapsed or refractory multiple myeloma, a cancer of the bone marrow. The first part of the study is a Phase I dose escalation study to find the safe and optimal dosing of HDP-101 for the Phase IIa portion of the study. The first four patient cohorts and dose levels were completed with no evidence of dose limiting toxicities. Heidelberg Pharma had added additional safety measures to the clinical trial as a precautionary measure following the events at former partner Magenta. In order to accelerate the recruitment of the study, Heidelberg Pharma opened additional study centers, mainly in Poland and Hungary. This enabled rapid patient recruitment and the opening of the fourth cohort as early as June 2023, following adjustment of the study's protocol and receipt of all regulatory approvals. Further information can be found under "Events after the end of the reporting period". In the Phase IIa dose expansion portion, the recommended dose of HDP-101 will be administered to at least 30 patients. The primary objective of this second phase of the study is to provide an initial assessment of the anti-tumor activity of HDP-101 and to further evaluate the safety of the therapy. Developments at partner Magenta: Magenta reported earlier this year that a serious adverse event of grade 5 occurred that deemed to be possibly related to MGTA-117. For safety reasons, Magenta subsequently paused dosing in the clinical trial until further notice. Shortly thereafter, Magenta announced a change in strategy combined with the discontinuation of all current development programs and supply contracts. This resulted in Heidelberg Pharma losing sales revenue in the low single-digit million range for the financial year 2023. In April 2023, Heidelberg Pharma signed a termination agreement with Magenta under which all licensed ATAC rights and some MGTA patents were taken over by Heidelberg Pharma. New preclinical data from ATAC technology platform presented at AACR Annual Meeting 2023: At the American Association for Cancer Research (AACR) 2023 Annual Meeting in April, Heidelberg Pharma presented preclinical results from its ATAC technology. The first poster showed that in preclinical models, subcutaneous dosing of the ATACs used resulted in prolonged half-life and lower maximum serum levels compared with intravenous administration. This resulted in better tolerability while maintaining antitumor efficacy. Based on these preclinical models, subcutaneous administration could be a promising route of administration for ATACs in humans as well. A corresponding patent application for subcutaneous administration of ATACs has been filed by the company. A second poster presented preclinical data on ATACs targeting the protein GCC (Guanylyl Cyclase C). GCC is overexpressed in many gastrointestinal tumors, particularly in colorectal, esophageal, gastric and pancreatic cancers. In preclinical models, ATACs targeting GCC demonstrated high antitumor activity and inhibit tumor growth in preclinical models even at low concentrations after single or multiple dose treatment. These ATACs also showed a favorable safety profile and good tolerability and may represent a promising new therapeutic option against colorectal cancer. The posters are available on the website.[1] New CFO appointed: Walter Miller was appointed to the Executive Board with effect from 1 May 2023 and is responsible for the financial area as Chief Financial Officer. Dr. Jan Schmidt-Brand, who has served in a dual function since 2014, remains Spokesman of the Executive Board/CEO and handed over his duties as CFO to him. Walter Miller holds a degree in business administration and has many years of experience in corporate finance, M&A, strategic controlling as well as accounting and corporate development. He was most recently CFO of Optimapharm Group, headquartered in Zagreb, Croatia, a clinical research organisation (CRO), where he was responsible for finance, M&A and administration. Prior to that, Mr Miller was CFO at Mologen AG, Berlin and CFO at Nuvisan Group, headquartered in Neu-Ulm, Germany, and spent more than ten years in senior financial positions at Santhera Pharmaceuticals, Pratteln, Switzerland. Minority interest in Emergence sold: At the end of June, Heidelberg Pharma sold its minority stake in Emergence Therapeutics AG, Duisburg, (Emergence). The pharmaceutical company Eli Lilly and Company acquired all shares in Emergence. As a result of the transaction, Heidelberg Pharma received USD 7.4 million (EUR 6.8 million), the full amount of which was recognized in profit or loss. The cash was mainly used for a loan repayment of EUR 5 million on the shareholder loan extended by dievini. If defined guarantees are fulfilled and depending on clinical and regulatory milestones further inflows of up to USD 5 million (EUR 4.6 million) are possible. Partner Takeda reaches development milestone: Partner Takeda reached a development milestone in August for starting a GLP (Good Laboratory Practice) toxicology study for an Antibody Targeted Amanitin Conjugate. Upon achievement of the milestone, Heidelberg Pharma received a milestone payment. The payment was already budgeted for in Heidelberg Pharma's financial forecast for financial year 2023. Takeda exclusively licensed the worldwide development and commercialization rights for the use of the ATAC technology with an antibody directed against a defined target and the resulting product candidates in 2022. Expansion of ADC technology into a "toolbox": Heidelberg Pharma is expanding its own ADC technology to include suitable active substances in order to develop the best possible ADCs for further targets and areas of application. This includes an ADC technology for a topoisomerase inhibitor, immunostimulatory agents and other new approaches. The first ADC candidate HDP-201 with a new payload is in the early development phase. Progress with partner Telix: TLX250-CDx, the Zirconium-89 radiolabeled antibody girentuximab (89Zr-DFO-girentuximab), is a diagnostic imaging agent. It was developed at Heidelberg Pharma AG up to a first Phase III trial and out-licensed to the Australian company Telix Pharmaceuticals Limited, Melbourne, Australia, (Telix) in 2017. Accumulation of this antibody in tumor tissue can be visualized by positron emission tomography (PET) scans. This could fundamentally change therapy planning for renal cancer patients and avoid potentially unnecessary surgery. TLX250-CDx was tested in a phase III trial (ZIRCON) with 300 patients for imaging diagnosis of kidney cancer using PET. In November 2022, Telix reported positive data and plans to submit applications for marketing approval as a diagnostic in ccRCC with the FDA and other regulatory authorities worldwide. According to Telix the submission of the application is planned for the fourth quarter of 2023. Potential future benefits could include active surveillance, surgical staging and treatment response monitoring for renal cancer. Telix is conducting further clinical trials to expand the indication. The first patient in the Phase II STARBURST study with TLX250-CDx was dosed in June. STARBURST is a prospective, open-label Phase II "basket" study to investigate CAIX expression in patients across a broad range of solid tumors for potential diagnostic and therapeutic use. Tumor types being studied include breast, cervical, colorectal, gastric, and esophageal cancers.[2] In parallel, Telix is preparing to launch an Expanded Access Program (EAP) in the US to provide patients with pre-approval access to TLX250-CDx. In Europe, the first study sites have been enrolled in the Early Access Program.[3] In addition to the development of the diagnostic antibody, Telix also plans to develop a therapeutic radioimmune conjugate (177Lu-DOTA-girentuximab, TLX250) program based on the lutetium-177-labeled girentuximab antibody. TLX250 will be tested in two Phase II combination studies (STARLITE 1 and 2) with immunotherapies. The first patients will be treated with TLX250 in combination with the anti-PD-1 immunotherapy Opdivo® in the STARLITE 2 trial at Memorial Sloan Kettering Cancer Center in New York. The STARLITE 1 study is testing TLX250 in combination with Cabometyx® and Opdivo® for the treatment of advanced renal cancer. Preparations are currently underway to enroll patients in the trial. In collaboration with Merck KGaA, Telix is also testing TLX250 in an open-label, single-arm, multicenter Phase Ib dose escalation and dose expansion study in combination with the DNA protein kinase inhibitor peposertib, a DNA damage response inhibitor (DDRi). The first patient in this STARSTRUCK study was dosed in July. Progress at partner RedHill: Redhill Biopharma Ltd (RedHill; NASDAQ: RDHL) is developing the out-licensed serine protease inhibitor upamostat (RHB-107 at RedHill) for the treatment of COVID-19, among other diseases. RHB-107 has shown both antiviral and potential tissue-protective activity, with RHB-107 strongly inhibiting SARS-CoV-2 replication in a preclinical human bronchial tissue study. At the end of July, the company announced that RHB-107 was included in the US government-supported “Austere environments Consortium for Enhanced Sepsis Outcomes” (ACESO) multinational PROTECT platform trial for early outpatient treatment of COVID-19, to be conducted in the US, Thailand, Ivory Coast and South Africa. In addition, it was announced that the Phase II study, predominantly funded by the US Government Department of Defense's Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), has received FDA clearance to start and is estimated to be completed by end of 2024. Events after the end of the reporting period Phase I/IIa clinical update with HDP-101: After the end of the reporting period, Heidelberg Pharma announced that recruitment of patients for the fifth patient cohort at a dose of 100 µg/kg has started. The evaluation of the patient data of the fourth cohort by the Safety Review Committee (SRC) showed that no dose-limiting toxicities have occurred to date. The first four dose levels have shown to be safe and well tolerated. So far 12 patients have been treated in the trial. Study participant with "stable disease": A study participant who received the first dose (60 µg/kg) of HDP-101 in January 2023 has shown no progression of the disease for nine months (stable disease). The patient receives monotherapy with HDP-101 and was treated so far with twelve doses. With the approval of the fourth cohort by the Safety Review Committee this patient is now being offered a higher dose of 80 µg/kg. The Heidelberg Pharma Group, consisting of Heidelberg Pharma AG and its subsidiary Heidelberg Pharma Research GmbH reports consolidated figures as at the balance sheet date. The reporting period referred to below relates to the period from 1 December 2022 to 31 August 2023 (9M 2023). In the first nine months of the 2023 business year, the Group generated sales revenues and income totaling EUR 13.9 million (previous year: EUR 16.8 million), which is above plan. The sales revenues included in this figure amounted to EUR 6.6 million, a significant decrease compared to the previous year's total of EUR 15.7 million, which was exceptionally high caused by a payment for a license taken by the partner Huadong. Due to the unplanned sale of the Emergence shares, other income increased to EUR 7.3 million and was thus significantly above the previous year's level of EUR 1.1 million. Operating expenses, including depreciation, amounted to EUR 30.0 million in the reporting period (previous year: EUR 27.6 million) and break down as follows: Cost of sales decreased significantly to EUR 3.1 million (previous year: EUR 5.2 million) and correspond to 10% of total costs. Research and development costs of EUR 22.1 million increased compared to the same period last year (EUR 17.7 million) due to the ongoing clinical trial with HDP-101 and the expansion of cost-intensive external manufacturing for the ATAC projects. R&D costs continue to be the largest cost block, accounting for 74% of operating expenses. Administrative costs, which include the costs of holding activities and the stock exchange listing, were lower at EUR 3.6 million compared to the same period last year (EUR 4.1 million), which showed increased legal and consulting costs due to the Huadong transaction. Other expenses for business development, marketing and commercial market supply activities, which mainly include personnel and travel expenses, increased year-on-year to EUR 1.2 million (previous year EUR 0.6 million) and represented 4% of operating expenses. The financial result, which mainly consists of net interest income amounts to EUR 0.5 million (previous year: EUR -0.6 million). The net loss for the first nine months of the financial year increased to EUR 15.8 million compared to the previous year's figure of EUR 13.2 million. The increase is due to lower sales revenues and higher expenses. Earnings per share improved from EUR 0.39 in the previous year to EUR 0.34, considering the significantly higher number of shares. Cash amounted to EUR 50.7 million at the end of the third quarter (30 November 2022: EUR 81.3 million; 31 August 2022: EUR 10.5 million). In the first nine months of the financial year, Heidelberg Pharma had an average cash outflow of EUR 2.3 million per month (previous year: EUR 0.1 million), excluding the loan repayment of EUR 10 million. If the one-time inflows from the sale of the Emergence investment are excluded, the monthly cash consumption without financing activities amounts to EUR 3.0 million. Total assets as of 31 August 2023 amounted to EUR 74.3 million and were thus below the value of the comparative reporting date of 30 November 2022 (EUR 100.6 million). Equity (EUR 51.5 million) also decreased as a result of the loss for the period compared to the end of the 2022 financial year (EUR 66.6 million). For the 2023 financial year, the Executive Board planned revenues and other income totaling between EUR 7.0 million and EUR 10.0 million (2022: EUR 19.9 million). Due to the emergence transaction, other income could be increased significantly; accordingly, the annual planning will be exceeded. Operating expenses will develop in line with the planning between EUR 37.0 million and EUR 41.0 million and thus at a comparable level to the 2022 financial year (EUR 37.0 million). For 2023, an operating result (EBIT) of between EUR -28.5 million and EUR -32.5 million is expected (2022: EUR -17.2 million), which should, however, improve due to the volume of the Emergence transaction. Cash consumption for the business operations of the Heidelberg Pharma Group will also increase in line with the operating business and range between EUR 32.5 million and EUR 36.5 million. This corresponds to an average cash consumption per month of EUR 2.7 million to EUR 3.1 million (2022: EUR 0.7 million). Based on the current planning, the Group is financed until mid-2025. The complete set of figures for the interim financial statements is available at http://www.heidelberg-pharma.com/ "Press & Investors > Announcements and Reports > Financial Reports > Interim announcement of 12 October 2023. A conference call on this interim announcement will not be offered. Key figures for the Heidelberg Pharma Group In EUR thsd. 9M 2023 1 EUR thsd. 9M 2022 1 EUR thsd. Earnings Sales revenue 6,635 15,695 Other income 7,259 1,149 Operating expenses (29,985) (27,611) of which research and development costs (22,065) (17,676) Operating result (16,091) (10,767) Earnings before tax (15,561) (11,347) Net loss for the period (15,838) (13,224) Basic earnings per share in EUR (0.34) (0.39) Balance sheet as of the end of the period Total assets 74,328 29,805 Cash 50,675 10,523 Equity 51,488 (6,073) Equity ratio2 in % 69.3 (20.4) Cash flow statement Cash flow from operating activities (26,494) (1,201) Cash flow from investing activities 5,871 (282) Cash flow from financing activities (10,024) 4,932 Employees (number) Employees as of the end of the period3 111 104 Full-time equivalents as of the end of the period3 101 97 1 The reporting period begins on 1 December and ends on 31 August. 2 Equity / total assets 3 Including members of the Executive Management Board Rounding of exact figures may result in differences. [1] https://heidelberg-pharma.com/de/forschung-entwicklung/wissenschaftliche-poster [2] https://telixpharma.com/news-views/first-patient-dosed-in-phase-ii-starburst-study-of-tlx250-cdx-exploring-indication-expansion/ [3] https://telixpharma.com/wp-content/uploads/2023/08/20230823-H1-2023-Results-Deck-vFINAL.pdf

Clinical trial with HDP-101 continues with adjusted protocol and larger number of study sites in Europe Patient from 3rd cohort continues to be dosed and shows stable disease Partnership with Magenta terminated due to clinical events and strategy change at Magenta Walter Miller appointed Chief Financial Officer Financials in line with plan Divestment of minority stake in Emergence leads to higher cash inflows Ladenburg, Germany, 13 July 2023 - Heidelberg Pharma AG (FSE: HPHA) published today its financial report on the first six months of 2023 (1 December 2022 - 31 May 2023). Dr. Jan Schmidt-Brand, CEO of Heidelberg Pharma AG, commented: "After a turbulent start to the first half of 2023, marked by the events at Magenta and the impact on us, we can now look back on very positive developments. We are very pleased to have received full regulatory approvals for the precautionary amendment of our study protocol and some study sites are already enrolling patients in the fourth cohort of the study with our ATAC candidate HDP-101. We are now focused on successful patient enrollment and further data analysis in the fourth quarter of 2023. In May, we welcomed our new Chief Financial Officer, Walter Miller, to Heidelberg Pharma, and at the end of June, we announced an extraordinary cash inflow of USD 7 million from the sale of our company shares in ADC developer Emergence Therapeutics." HDP-101 (BCMA-ATAC) program: Heidelberg Pharma presented preliminary safety data from the clinical trial with HDP-101. The first three patient cohorts and dose levels were concluded and has so far been shown to be safe and well tolerated. Following completion of the third dose level, in March 2023, a data review was conducted by the Safety Review Committee (SRC). The SRC recommended to escalate the dose. The safety review of study data does not indicate that the side effects experienced at Magenta Therapeutics, Cambridge, MA, USA, (Magenta), could be a class effect of all Amanitin-based ADCs. Due to the events at Magenta, further safety measures were implemented for the patients as an extra precaution. The BCMA Antibody Amanitin Candidate HDP-101 is being evaluated in a Phase I/IIa clinical trial for treatment of relapsed or refractory multiple myeloma, a cancer affecting bone marrow. Partnership with Binghamton University: In December 2022, Heidelberg Pharma Research has entered into a research and exclusive option agreement with Binghamton University, State University of New York, Binghamton, NY, USA, related to a novel and proprietary immunostimulatory technology platform. The platform includes potent novel immunostimulatory compounds and Antibody Drug Conjugate (ADC) technology for the specific delivery of these compounds to tumor tissue. These immunostimulatory agents are synergistic with cytotoxic agents, including ADCs generated by Heidelberg Pharma’s ATAC technology. Development at the partner Magenta: Magenta announced in January 2023 that in the third dose level of the MGTA-117 clinical trial, a grade 5 serious adverse event occurred that deemed to be possibly related to MGTA-117. For safety reasons, Magenta subsequently paused dosing in the clinical trial until further notice and announced shortly thereafter, following an internal review, that further development of all programs including the ATACs would be halted. At the end of February 2023, the Amanitin linker supply contract was terminated by Magenta, followed by the signing of a termination agreement in April 2023. This resulted in Heidelberg Pharma losing sales revenue, which is reflected in the current guidance. New preclinical data from the ATAC technology platform presented at the AACR 2023 Annual Meeting: At the American Association for Cancer Research (AACR) 2023 Annual Meeting in April, Heidelberg Pharma presented preclinical data of its ATAC technology. The first poster showed that in preclinical models, subcutaneous dosing of the ATACs used resulted in prolonged half-life and lower maximum serum levels compared with intravenous administration. The second poster included preclinical data on ATACs targeting the protein GCC, including the candidate HDP-104. ATACs targeting GCC demonstrated high antitumor activity and inhibit tumor growth in preclinical models even at low concentrations. Chief Financial Officer appointed: Walter Miller has been appointed to the board effective 1st May 2023, and is responsible for the finance area as Chief Financial Officer. Dr. Jan Schmidt-Brand, who has served in a dual role since 2014, will remain Spokesman of the Management Board/CEO and handed over his duties as CFO to Walter Miller. Encouraging progress on out-licensed clinical project TLX250-CDx: Telix Pharmaceuticals Limited, Melbourne, Australia, (Telix) reported positive data in November 2022 and plans to submit applications for marketing approval as a diagnostic in clear cell renal cell carcinoma (ccRCC) to the FDA and other regulatory authorities worldwide. Furthermore, Telix is also preparing the launch of an Expanded Access Program (EAP) to provide patients with pre-approval access to TLX250-CDx. As part of its planned indication expansion, Telix announced in June that the first patient in the Phase II STARBURST study has been dosed with TLX250-CDx. STARBURST is a prospective, open-label Phase II "basket" study designed to evaluate CAIX expression in patients across a broad range of solid tumors for potential diagnostic and therapeutic use. Precautionary adjustment of the HDP-101 study plan and continuation of patient recruitment: Adaptations to the study protocol have been made in recent months, and initial study sites are continuing patient enrollment with the fourth cohort after receiving all regulatory approvals and the approval of the relevant ethics committees. Several centers are enrolling patients in the study since June. One of the study participants from the third cohort has so far shown no progression of the disease (stable disease). He has now been on monotherapy of HDP-101 for over six months and is in good condition. The patient has since been treated with seven doses of HDP-101. The data are not yet conclusive, but it is very encouraging for the patient with multiple myeloma and limited treatment options that he has been able to benefit from the therapy so far. Selling of minority shareholding in Emergence: After the end of the reporting period, Heidelberg Pharma sold its minority shareholding in Emergence Therapeutics AG, Duisburg, Germany, (Emergence) at the end of June. The US pharma company Eli Lilly and Company acquired all outstanding shares in Emergence. As a result of the transaction, Heidelberg Pharma expects a cash inflow in 2023 of about USD 7 million (EUR 6.4 million), which will mainly be used for a loan repayment of € 5 million on the shareholder loan extended by dievini. If defined guarantees are fulfilled and depending on clinical and regulatory milestones further inflows of up to USD 5 million (EUR 4.6 million) are possible. Financial results for the first six months of fiscal year 2023 The Heidelberg Pharma Group (Heidelberg Pharma) – comprising Heidelberg Pharma AG and its subsidiary Heidelberg Pharma Research GmbH – reports consolidated figures. In the first six months of the 2023 fiscal year, the Heidelberg Pharma Group generated sales revenue and income totaling EUR 4.7 million, thus significantly decreasing the previous year’s total of EUR 12.2 million, which was exceptionally high due to a payment for a license taken from the partner Huadong. Sales revenue totaling EUR 4.4 million comprises the group-wide collaboration agreements for ATAC technology (EUR 4.3 million) and the service business of Heidelberg Pharma Research (EUR 0.1 million). Other income of EUR 0.3 million was at the previous year’s figure and comprised income from the reversal of unused accrued liabilities (EUR 0.2 million) and other items (EUR 0.1 million). Operating expenses, including depreciation, amortization and impairment, amounted to EUR 20.7 million in the reporting period (previous year: EUR 18.5 million). The net loss posted by the Heidelberg Pharma Group for the first six months of 2023 came to EUR 16.0 million (previous year: EUR 8.6 million). The significant increase is as planned and due to substantially lower income and higher expenses. Earnings per share amounted to EUR -0.34 and, taking into account the higher number of shares, developed positively compared with the previous year (EUR -0.42). At the end of the reporting period, Heidelberg Pharma had cash in the amount of EUR 57.4 million and were thus below the year-end figure of EUR 81.3 million and above the previous year's half-year figure as of 31 May 2022 (EUR 18.0 million). Excluding the financing effects, Heidelberg Pharma’s had an average cash requirement of EUR 3.2 million per month, compared with an average cash inflow of EUR 1.2 million per month in the same reporting period of the previous year. Total assets as of 31 May 2023 amounted to EUR 78.0 million, up from EUR 100.6 million as of the 30 November 2022 reporting date. Equity as of the end of the reporting period was EUR 50.9 million (30 November 2022: EUR 66.6 million). This corresponded to an equity ratio of 65.3% (30 November 2022: 66.3%). The full-year financial guidance issued on 24 March 2023 for the Heidelberg Pharma Group is confirmed at this time. Sales revenue and other income are in line with our planning as of the first six months of the fiscal year 2023. The majority of income will be generated in the second half of the year as other income will increase significantly due the Emergence transaction. Given that expenses might rise higher than the forecast, the operating result is expected to be unchanged as the higher income may be offset by higher expenses for new study centers in the trial with HDP-101.  Financial outlook H1 2023 EUR million Actual 2022 EUR million 2023 Plan EUR million Sales revenue and other income 4.7 19.9 7.0 – 10.0 Operating expenses (20.7) (37.0) 37.0 – 41.0 Operating result (16.0) (17.2) (28.5) – (32.5) Total funding requirement for operations and capex1 (18.9) (8.9) 32.5 – 36.5 Funds required per month 1 (3.2) (0.7) 2.7 – 3.1 1 Not including any corporate actions Invitation to the analyst and press conference call On Thursday, 13 July 2023, Heidelberg Pharma will hold a conference call for media, analysts, and investors in English at 3:00 pm CEST/9:00 am EDT. Please register at least 10 minutes in advance using the following link: https://us06web.zoom.us/webinar/register/WN_dQGJt0zKSv-GZCDY1la-xw You will receive an e-mail with your registration confirmation, which contains the link to participate in the audio webcast as well as dial-in numbers for participation by phone. Please note that asking oral or written questions is only possible for online participants. Key figures for the Heidelberg Pharma Group In EUR thsd. H1 2023 1 EUR thsd. H1 2022 1 EUR thsd. Earnings Sales revenue 4,391 11,935 Other income 277 235 Operating expenses (20,704) (18,517) of which research and development costs (14,772) (11,839) Operating result (16,036) (6,348) Earnings before tax (15,774) (6,736) Net loss for the period (15,951) (8,605) Earnings per share in EUR (0.34) (0.25) Balance sheet as of the end of the period Total assets 77,965 33,937 Cash and cash equivalents 57,379 18,017 Equity 50,891 (1,576) Equity ratio2 in % 65.3 (4.6) Cash flow statement Cash flow from operating activities (18,153) 7,063 Cash flow from investing activities (788) (135) Cash flow from financing activities (5,008) 4,953 Employees (number) Employees as of the end of the period3 113 102 Full-time equivalents as of the end of the period3 103 93 1 The reporting period begins on 1 December and ends on 31 May 2 Equity / total assets 3 Including members of the Executive Management Board Rounding of exact figures may result in differences. The full half-yearly financial report including the consolidated financial statements prepared in accordance with International Financial Reporting Standards (IFRS) was published at http://heidelberg-pharma.com/en/press-and-investors/announcements/financial-reports. Contact Heidelberg Pharma AG Corporate Communications Sylvia Wimmer Gregor-Mendel-Str. 22, 68526 Ladenburg Tel.: +49 89 41 31 3829 Email: investors@hdpharma.com IR/PR support MC Services AG Katja Arnold (CIRO) Managing Director & Partner Tel.: +49 89 210 22840 Email: katja.arnold@mc-services.eu