On May 12, 2022 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported a business and financial update at the end of March 2022 (Press release, ERYtech Pharma, MAY 12, 2022, View Source [SID1234614514]).
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"With the sale of our U.S. manufacturing facility to Catalent and the planned long-term supply agreement with Catalent, we managed to secure our potential long-term manufacturing needs in the United States while significantly extending our cash runway," said Gil Beyen, Chief Executive Officer of ERYTECH. "This brings us in a good position for the ongoing review of strategic options for the company, while we continue to focus on seeking an approval in the United States for our lead product candidate eryaspase (GRASPA) for the treatment of acute lymphoblastic leukemia patients who experienced hypersensitivities to pegylated asparaginase."
Business Highlights of the first quarter and April 2022
▪U.S. cell therapy manufacturing facility sold to Catalent for a total consideration of USD 44.5 million
Under the terms of an asset purchase agreement between ERYTECH and Catalent (the "APA"), Catalent acquired ERYTECH’s state-of-the-art commercial-scale cell therapy manufacturing facility in Princeton, New Jersey, for a total consideration of $44.5 million. ERYTECH’s staff at the site of approximately 40 people have been offered Catalent’s employment.
The parties also agreed on the terms of a long-term supply agreement, under which Catalent will manufacture ERYTECH’s lead product candidate eryaspase (GRASPA) for clinical and commercial supply in the United States.
The Princeton facility is a 30,900 square foot modern manufacturing facility, designed with the flexibility to expand to support various cell therapy production requirements and capacities. Catalent intends to expand the Princeton site and leverage the experienced staff previously employed by ERYTECH to manufacture a broader portfolio of cell therapies. ERYTECH retained its manufacturing site in Lyon, France and its expertise and capabilities in manufacturing process science to continue innovating in cell therapy manufacturing.
▪Path to BLA in hypersensitive ALL, based on results of NOPHO-sponsored Phase 2 trial
The NOPHO trial evaluated the safety and pharmacological profile of eryaspase in acute lymphoblastic leukemia (ALL) patients who had previously experienced hypersensitivity reactions to pegylated asparaginase therapy. In December 2020, positive trial results were presented at the 2020 American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting.
◦The Company pursues its interactions with the U.S. Food and Drug Administration (FDA) regarding a potential regulatory approval in this indication based on the NOPHO-sponsored trial. A pre-BLA meeting to discuss the submission of a Biologics License Application (BLA) took place in June 2021 after which the Company confirmed its intention to submit a BLA, subject to successful completion of remaining activities.
The BLA application is now almost completed, and the Company is planning for submission once the FDA has finalized its review of the remaining information requests.
▪rESPECT, Phase 1 investigator-sponsored trial (IST) in first-line pancreatic cancer
rESPECT is a Phase 1 trial, sponsored by the Georgetown Lombardi Comprehensive Cancer Center, evaluating the safety of eryaspase in combination with mFOLFIRINOX as a first-line treatment for locally advanced and metastatic pancreatic cancer in approximately 18 patients.
◦Interim data, presented at ASCO (Free ASCO Whitepaper) GI in January 2022, confirmed the acceptable safety profile in the trial and showed encouraging clinical activity. Out of the twelve patients enrolled, ten patients have been evaluated for response. They all achieved disease control; five patients had an objective response and five achieved stable disease.
The trial will continue enrolling up to approximately 18 patients. Reporting of data is expected in the third quarter of 2022.
▪ERYCEVTM, novel red blood cell vesiculation technology
ERYTECH presented its red blood cell vesiculation technology at the 24th Meeting of the European Red Cell Society (ERCS) in April 2022.
◦RBC-derived extracellular vesicles are formed naturally during senescence and storage of mature RBCs and are a potentially attractive drug delivery system. Vesiculation of RBCs that have already been loaded with active therapeutic compounds utilizing the ERYCAPS process, entails the potential of producing cargo-loaded RBC-derived extracellular vesicles for the development of novel therapeutic approaches.
▪Process to review strategic options and partnering alternatives
As announced on October 25th 2021, the Company has appointed a specialized advisor to evaluate its strategic and partnering options. After the transaction with Catalent, the Company continues to evaluate further strategic options to leverage its ERYCAPS platform with complementary assets and/or a broader corporate transaction.
Q1 2022 Financial Results
▪Key financial figures for the first quarter of 2022 compared with the same period of the previous year are summarized below:
▪Net loss for the first quarter of 2022 was €11.9 million, stable year-over-year, with a €0.7 million improvement (-5.5%) in operating loss and a €0.7 million decline in net financial income. The €0.7 million improvement in operating loss was attributable to the €2.4 million decrease in preclinical and clinical development expenses, offset in part by the €0.9 million decrease in other income from R&D tax credits, both reflecting the decrease in the Company’s clinical development activities, while general and administrative expenses increased by €0.8 million, mostly related to legal and due diligence expenses for partnering activities.
▪As of March 31, 2022, ERYTECH had cash and cash equivalents totaling €25.1 million (approximately $27.9 million), compared with €33.7 million as of December 31, 2021. The €8.6 million decrease in cash position during the first three months of 2022 was the result of a €10.7 million net cash utilization in operating activities and investing activities and €1.8 million generated in financing activities, including €2.3 million in pre-payment of a portion of the expected 2021 R&D tax credit, while the variation of the U.S. dollar against the euro led to a €0.3 million positive currency exchange impact.
▪The Company has not drawn any new tranche on the convertible note facility (OCABSA) since August 2021 and as of September 2021, there were no outstanding and unconverted notes. The company does not plan to draw any further OCABSA tranche until the expiration of the financing facility in June 2022.
▪The Company believes that its current cash position, including the $44.5 million gross proceeds received upon closing of the transaction with Catalent in April 2022, can fund its current development programs and planned operating expenses to mid-2024.
Key News Flow and Milestones Expected Over the Next 12 Months
▪Targeted BLA submission of eryaspase in hypersensitive ALL (Q3 2022)
▪Results from the Phase 1 rESPECT trial of eryaspase in combination with mFOLFIRINOX in first-line pancreatic cancer (Q3 2022)
▪Data from the randomized Phase 2 TRYbeCA-2 trial of eryaspase in TNBC (Q3 2022)
First Quarter 2022 Conference Call Details
ERYTECH management will hold a conference call and webcast on Friday, May 13, 2022, at 8:30am ET / 2:30 pm CEST on the business highlights and financial results for the quarter ended March 31, 2022. Gil Beyen, CEO, Eric Soyer, CFO/COO, and Iman El-Hariry, CMO, will deliver a brief presentation, followed by a Q&A session.
The audio call is accessible via the below registering link: View Source (Conference ID: 9535729)
Once registered, participants will receive a unique access code and the call number details to join the teleconference.
The webcast can be followed live online via the link:
View Source
An archived replay of the call will be available for 7 days by dialing + 1 855 859 2056, Conference ID: 9535729#.
An archive of the webcast will be available on ERYTECH’s website, under the "Investors" section at investors.erytech.com
ERYTECH plans on attending the following upcoming investor conferences:
▪H.C. Wainwright Global Investment Conference (Miami, USA) – May 23-26, 2022
▪Jefferies Global Healthcare Conference (New York, USA) – June 8-10, 2022
▪Spring Midcap Event (Paris, France) – June 23-24, 2022