Biopharma Makes ‘Solid Clinical Progress’ in Q2/21

Source: Streetwise Reports   08/04/2021

The highlights of Oryzon Genomics’ Q2/21 clinical advancements were recapped in a Roth Capital Partners report.

In a July 30 research note, Roth Capital Partners analyst Jonathan Aschoff provided an update on Oryzon Genomics S.A. (ORY.SM:Madrid), notable for significant clinical progress and a healthy ending cash balance.

Aschoff briefly addressed four developments related to Oryzon’s clinical programs that occurred during Q2/21.

1) The Spain-based biopharma released updated results, in a poster presentation at the annual European Hematology Association meeting, from its ongoing Phase 2a ALICE trial of iadademstat/azacitidine combination therapy for treatment-naive acute myelogenous leukemia (AML) patients.

These data were positive, showing an 83% overall survival rate compared with 28% with azacitidine alone, the standard of care. Oryzon’s study also showed a 67% rate of complete remission or complete remission with incomplete hematologic recovery; with standard of care treatment, it is 19%. A favorable safety profile was maintained throughout the study as well. Oryzon plans additional combination therapy trials of patients with AML and solid tumors.

2) Oryzon highlighted vafidemstat’s anti-inflammatory effect on hospitalized, severe COVID-19 patients via an e-poster presentation of data from the Phase 2 ESCAPE trial. The biopharma presented these results at the annual meeting of the European Congress of Clinical Microbiology and Infectious Diseases.

“We note that a vafidemstat dose of 2.4mg/day for five days durably and substantially occupied its target LSD1 and was well tolerated,” Aschoff wrote.

3) Also regarding vafidemstat, the U.S. Food and Drug Administration approved the Phase 2b investigational new drug trial PORTICO, testing this drug in borderline personality disorder (BPD). The aim is to show vafidemstat can decrease agitation and aggression, which has no current treatment, thereby helping BPD patients. The study will encompass 15–20 sites in the U.S. and Europe and about 156 patients. Enrollment has already started in Europe.

4) Spanish drug regulators approved Oryzon’s clinical trial application for EVOLUTION, a Phase 2b study testing vafidemstat in schizophrenia. Recruitment is expected to commence in the next couple of months.

Finally, Aschoff noted that the takeaway from Oryzon’s just-released Q2/21 financials is that the company had a cash balance of $40.1 million at the quarter’s end.

“That should fund operations into 1Q23, as per our projections,” he concluded.

Roth has a Buy rating on Oryzon and has a target price of €15 per share. The stock is currently trading at about €3.36 per share.

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Disclosures from ROTH Capital Partners, Oryzon Genomics SA, Company Note, July 30, 2021

Regulation Analyst Certification (“Reg AC”): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.

ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months.