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Heidelberg PHARMA Focused Cancer Therapies Heidelberg Pharma AG : Interim Management Statement on the First Nine Months of 2021 Paul - Ehrlich - Institut follows the FDA in giving clearance to begin a Phase I / Ila trial of HDP - 101 ; first trial centers initiated in the USA Gross issue proceeds of over EUR 20 million generated from private placement in June Significant advances made in partner projects Guidance revised Ladenburg , Germany , 7 October 2021 Heidelberg Pharma AG ( FSE : HPHA ) today reported on the first nine months of fiscal year 2021 ( 1 December 2020 - 31 August 2021 ) and the Group's financial figures . - Dr. Jan Schmidt - Brand , CEO and CFO of Heidelberg Pharma AG , commented : “ We are delighted to have achieved important milestones in recent weeks and to have cleared several organizational hurdles for our initial clinical trial of HDP - 101 . The first two trial centers were initiated recently , and we are now eagerly awaiting the inclusion of the first patient . Our partners also reported encouraging regulatory developments . Magenta Therapeutics was cleared by the FDA to open a clinical trial to evaluate its MGTA - 117 ATACⓇ conditioning program . Our partner Telix announced that the FDA had accepted the IND application to undertake a clinical study of the radioimmunoconjugate TLX250 ( 177Lu - DOTA - girentuximab ) for treatment of advanced renal cancer . This means that the antibody girentuximab will be developed further for therapeutic purposes as well . RedHill , the partner for RHB - 107 ( upamostat ) , expanded the Phase II / III clinical trial in non - hospitalized COVID 19 patients from the US to South Africa . We are very pleased about these highly positive developments . We have adjusted our guidance due to delays in development programs , the associated lower expenses , and due to lower revenue from licensing agreements caused by postponements of milestones by our partners into the next fiscal year . Overall , the operating result will improve and funding requirements for fiscal year 2021 will decrease . " Important operational developments and achievements HDP - 101 ( BCMA ATAC ) development program : HDP - 101 is a BCMA ATAC that will be evaluated for the treatment of multiple myeloma . In the first quarter , the FDA approved the IND ( Investigational New Drug ) application to conduct a Phase I / Ila clinical trial . This paved the way for accelerating preparations at the trial centers , obtaining approval from the responsible ethics committees , and oplying the trial drug . Because HDP - 101 contains the toxin Amanitin , a special closed system transfer device ( CSTD ) must be used in the US to protect hospital staff from accidentally meeting the compound . In recent weeks , Heidelberg Pharma successfully performed the testing required to verify compatibility of HDP - 101 with the systems used by the trial centers . This means that the CSTD can be used for the infusion of HDP - 101 in the clinical trial . After a contract had been signed with MD Anderson in Houston , Texas , the trial drug had been shipped and medical staff had been trained , the first trial center was initiated at the end of September . At the beginning of October , the second center , the Winship Cancer Institute of Emory University in Atlanta , Georgia , was initiated . Heidelberg Pharma had also applied for a clinical trial to Germany's medical regulatory body , the Paul - Ehrlich - Institut , in March which was approved in July . Preparations were advanced in parallel , enabling the first trial center in Germany to be initiated in the next weeks . 1/7