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Celcuity Licenses PI3K/mTOR Inhibitor from Pfizer, Enters $25M Debt Financing Agreement

NEW YORK – Celcuity said on Thursday after the close of the market that it has inked an exclusive license agreement with Pfizer to develop and commercialize its pan-PI3K/mTOR inhibitor gedatolisib, and entered into a $25 million debt financing agreement.

Celcuity paid Pfizer $5 million in cash and $5 million in common stock upfront for the exclusive worldwide license. Pfizer is also eligible to receive up to $330 million in development and sales-based milestone payments, as well as tiered royalties.

Gedatolisib is being studied in combination with CDK 4/6 inhibitor palbociclib (Pfizer's Ibrance) and endocrine therapy in a Phase Ib trial as a treatment for estrogen receptor-positive, HER2-negative advanced or metastatic breast cancer. Preliminary data from that study, also announced on Thursday, showed that 60 percent of evaluable patients had an objective response.

"The robust response rate and the observed tolerability profile are particularly compelling given the need for a therapeutic regimen that can address endocrine therapy resistance," Celcuity CEO and Co-founder Brian Sullivan said in a statement. "Developing a therapeutic such as gedatolisib allows us to more fully leverage our CELsignia cellular analysis platform."

The CELsignia test is designed to identify patients who don't have genomic or proteomic driver mutations but have disrupted oncogenic pathways driving their tumors. The company will share detailed data from the Phase Ib at a medical conference this year.

Based on the preliminary data and with feedback from the US Food and Drug Administration, Celcuity plans to begin a Phase II/III clinical trial of gedatolisib plus palbociclib and endocrine therapy in the same patient group in the first half of 2022.

"In light of the important role the PI3K/mTOR pathway plays in driving tumor growth when patients become resistant to endocrine therapies, we believe gedatolisib is a highly promising drug candidate to improve outcomes for patients with breast cancer," Sullivan added. "Supporting development of a potential first-in-class therapy for breast cancer, such as gedatolisib, with our CELsignia platform is a natural extension of our strategy to develop CELsignia CDx for other breast cancer therapies."

Earlier this year, Celcuity said it was collaborating with Pfizer to use its CELsignia Multi-Pathway Activity Test to select patients in a trial evaluating the combination of two Pfizer drugs, dacomitinib (Vizimpro) and crizotinib (Xalkori), in HER2-negative, metastatic breast cancer. The company has collaborations with other drugmakers and researchers to use CELsignia to identify best responders to cancer drugs.

Simultaneous with the gedatolisib licensing deal, the Minneapolis-based company also said it has entered into a $25 million debt financing agreement with Innovatus Capital Partners, of which the first $15 million tranche of funds will be available at closing. Celcuity can access two additional tranches of $5 million after it achieves certain clinical trial and financing milestones. The loan will mature on the fifth anniversary of the initial funding date and Innovatus can convert up to 20 percent of the outstanding principal amount into shares of Celcuity common stock until the third anniversary of the agreement. Armentum Partners advised Celcuity on this transaction.

On Friday morning, Celcuity's stock price had increased more than 50 percent on the Nasdaq and was trading at $19.37 on Friday afternoon.