ERPY - ERPY STOCK NEWS

ERYTECH Pharma reported significant developments in its Q1 2021 business update. The pivotal Phase 3 TRYbeCA-1 trial for second-line pancreatic cancer is fully enrolled, with final results expected in Q4 2021. A pre-BLA meeting with the FDA has been requested for eryaspase in hypersensitive ALL, aiming for BLA submission in H2 2021. The company ended Q1 with €37.4 million in cash, following a successful $30 million financing round. The net loss for Q1 2021 decreased by 32% year-over-year to €11.9 million, reflecting reduced operating costs as enrollment in clinical trials was completed.

ERYTECH Pharma announced a registered direct offering of $30 million on April 29, 2021. The offering consists of 1,034,483 Units, each containing four ordinary shares in the form of American Depositary Shares (ADS) and three warrants. The subscription price is set at $29.00 per Unit, translating to $7.25 per ADS. The proceeds are intended for further development of product candidates, including the Phase 3 TRYbeCA-1 trial, regulatory filings, and general corporate purposes. Closing is anticipated around May 4, 2021.

ERYTECH Pharma announced its cash position for Q1 2021, reporting €37.4 million (approximately $43.9 million), down from €44.4 million at the end of 2020. The €7.0 million decrease mainly resulted from €16.3 million in operating cash utilization. The company expects this cash will cover operational expenses into Q4 2021 and possibly into Q1 2022, along with funds from convertible bonds. A conference call to discuss these results is scheduled for May 5, 2021, at 2:30 PM CEST/8:30 AM EST.

ERYTECH Pharma has initiated the process to seek marketing approval from the FDA for its lead product eryaspase, targeting hypersensitive acute lymphoblastic leukemia (ALL) patients. This follows positive results from a NOPHO-sponsored Phase 2 clinical trial. The FDA acknowledged the unmet medical need and invited ERYTECH to request a pre-BLA meeting to discuss potential approvals. Pending feedback, ERYTECH plans to submit a Biologics License Application in the second half of 2021.

ERYTECH has completed the first cohort of its Phase 1 trial, rESPECT, for eryaspase in first-line pancreatic cancer. Conducted at Georgetown University, the trial showed no dose-limiting toxicity in three patients treated with 75 U/kg of eryaspase. Notably, two patients exhibited partial response and decreased CA19-9 levels, while one maintained stable disease. The next dose escalation to 100 U/kg will test the presumed maximum tolerated dose. As ERYTECH aims to determine efficacy in larger trials, top-line results from the TRYbeCA-1 Phase 3 trial are anticipated in Q4 2021.

ERYTECH Pharma announced its participation in two upcoming virtual investor conferences in April 2021. CEO Gil Beyen will engage in one-on-one meetings during the SMALLCAP EVENT on April 14-15 and the Kempen & Co. Life Sciences Conference on April 28. The company is focused on developing innovative therapies encapsulating drug substances in red blood cells, with its lead candidate, eryaspase, in clinical trials for pancreatic and triple-negative breast cancers. ERYTECH is listed on Nasdaq and Euronext under the ticker ERYP.

The press release provides monthly updates on the total number of voting rights and shares of ERYP as of March 31, 2021. The total shares composing the share capital stood at 21,619,894, marking an increase from 21,139,668 in February. The gross voting rights rose to 23,149,446 from 22,668,705, while the net voting rights increased to 23,146,946, up from 22,666,205. The report is in compliance with the French financial authority regulations, ensuring transparency regarding the company's shares and voting rights.

ERYTECH Pharma (Nasdaq & Euronext: ERYP) filed its 2020 Universal Registration Document and Annual Report on Form 20-F on March 9, 2021. The reports encompass management and financial details for the year ending December 31, 2020, and are accessible on their corporate website, as well as through regulatory authorities like the AMF and SEC. ERYTECH specializes in red blood cell-based therapeutics aimed at treating severe cancers and orphan diseases, with its lead product, eryaspase, currently in Phase 3 and Phase 2 clinical trials for pancreatic and breast cancers, respectively.

ERYTECH Pharma has provided a business update and financial results for the full year 2020, highlighting strong progress despite challenges from the COVID-19 pandemic. The company reported a net loss of €73.3 million, up 17% year-over-year, with cash and equivalents at €44.4 million as of December 31, 2020. Key clinical milestones are anticipated in 2021, including results from the pivotal Phase 3 TRYbeCA-1 trial in pancreatic cancer and updates on the potential regulatory pathway for eryaspase in acute lymphoblastic leukemia. The company aims to file a BLA in the second half of 2021.