Onconova Therapeutics Inc (NASDAQ:ONTX) Expects To Announce Topline Data Of Inspire Phase 3 Trial Soon: Plans To Seek Approval For Commercial Launch Of Rigosertib

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Onconova Therapeutics Inc (NASDAQ:ONTX) anticipates reporting topline data by the end of Q3 2020 following it’s INSPIRE clinical study achieving all the survival points.

IND application for rigosertib

CEO of Onconova, Steven M. Fruchtman, said the company expects to submit an IND application for Rigosertib for commercialization if the drug could improve patients’ survival with high-risk myelodysplastic syndromes (MDS).

Highlights

Onconova commenced Phase 1/ 2a clinical trial of rigosertib (oral administration) and nivolumab in patients with KRAUS+ lung cancer. It also enrolled the first patient for this clinical study.

Onconova applied to take part in the government-funded studies in humans to treat coronavirus using its rigosertib, which exhibited promising evidence in the preclinical study to inhibit replication of SARS-COV-2.

Onconova strengthened its board by adding Terri Shoemaker, an industry veteran. She will contribute over 30 years of experience in leadership and commercial fields to Onconova. Michael Hofman, Chairman of Onconova said Ms. Terri is a key executive in introducing azacitidine in myelodysplastic syndromes.

Michael further said Terri’s skills in managing and developing commercial life science organizations are instrumental in moving forward with the commercial introduction of azacitidine. Terri worked as President and CEO of Medexus Pharma for the last two years.

Rigosertib

The small molecule – Rigosertib prevents cellular signaling by working as a mimetic of Ras Protein. The activated Ras proteins will switch ON the genes responsible for cell growth, survival, and differentiation.

Financials

Onconova holds cash equivalents and a cash balance of $27.2 million by the end of Q2 2020. Its net loss widened to $7.4 million in Q2 2020 from $3.6 million in Q2 2019. The company strengthened its balance sheet by adding $9.8 million through exercising common stock warrants in December and November 2019. Its outstanding common warrants as of August 12, 2020, are 12.6 million.

Compliance with the minimum price requirement of NASDAQ

Onconova said it complies with NASDAQ’s minimum price requirement because the closing price of its common stock for the last 10 days is at least $1 as per the listing rule of 5550(a)(2). To this effect, the company received a letter of compliance from NASDAQ on August 3, 2020.