On January 13, 2020 Infinity Pharmaceuticals Inc. (NASDAQ: INFI) reported 2020 milestones for IPI-549, a first-in-class, oral, immuno-oncology product candidate targeting immune-suppressive tumor-associated myeloid cells through selective phosphoinositide-3-kinase-gamma (PI3K-gamma) inhibition and provided financial guidance for 2020 (Press release, Infinity Pharmaceuticals, JAN 13, 2020, View Source [SID1234553066]).

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"Our recently announced non-dilutive financing with BVF Partners has provided Infinity with the financial resources to fully fund all of our ongoing IPI-549 trials to key data readouts throughout 2020 and into 2H 2021," stated Adelene Perkins, Chief Executive Officer and Chair of Infinity Pharmaceuticals. "2020 will be a very exciting and important year for Infinity as we continue our efforts to expand the development of IPI-549 across earlier lines of therapy and broader indications, leveraging a safety profile that enables innovative combination therapy approaches. We continue to see growing recognition of the importance of MDSC-directed and tumor macrophage-directed immuno-oncology therapies among the medical and scientific communities, and we are well positioned to solidify our leadership in the field with expected clinical and translational data from IPI-549 studies in 2020 to mid-2021."

Infinity’s Chair and Chief Executive Officer, Adelene Perkins, will discuss the company’s continued execution on its corporate strategy and 2020 priorities as part of a podium presentation at the 38th Annual J.P. Morgan Healthcare Conference on January 16th, 2020 at 9 a.m. Pacific Time.

Recent Financial and Corporate Highlights

$20 million non-dilutive asset-backed financing with BVF Partners L.P. with sole recourse in potential royalty payments due on future sales of patidegib, a hedgehog pathway inhibitor discovered by Infinity and licensed to PellePharm in 2013. Infinity is eligible to receive from BVF an additional $5 million payment upon positive data from PellePharm’s Phase 3 trial in patients with Gorlin Syndrome.
Over $60 million cash on hand to fund all current IPI-549 trials to key data readouts throughout 2020 and into mid-2021.
Executive Leadership Promotions of Jeffery Kutok, M.D., Ph.D., Chief Scientific Officer, from Senior Vice President to Executive Vice President, and Seth Tasker, J.D. from General Counsel to Chief Business Officer.
2020 IPI-549 Development Guidance

MARIO-275 enrollment completion. MARIO-275 is the company’s ongoing global, randomized, controlled Phase 2 study in collaboration with Bristol-Myers Squibb, to evaluate IPI-549 in combination with Opdivo in platinum-refractory, I/O naïve patients with advanced urothelial cancer. Data is expected in mid-2021.
MARIO-3 enrollment completion and initial data. MARIO-3 is the company’s ongoing Phase 2 study in collaboration with Roche/Genentech to evaluate IPI-549 in novel triple combination front-line therapies with Tecentriq and Abraxane in triple negative breast cancer (TNBC) and with Tecentriq and Avastin in renal cell cancer (RCC).
Arcus Biosciences Collaboration Study expansion cohort enrolling. This ongoing Phase 1/1b trial, being conducted by Arcus, is evaluating a checkpoint inhibitor-free, novel triple-combination regimen of IPI-549 + AB928 (dual adenosine receptor antagonist) + Doxil in advanced TNBC patients. The trial has been initiated with a goal of enrollment of up to 40 patients in an expansion cohort.
Additional MARIO-1 data. MARIO-1 is the company’s ongoing Phase 1/1b study of IPI-549 as a monotherapy and in combination with Opdivo in patients with advanced solid tumors.
2020 Financial Guidance

Infinity ended 2019 with approximately $42.4 million in cash and investments (unaudited) and plans to report its fourth quarter and full-year 2019 financial results in March. The company is providing the following financial guidance today:

Cash as of January 8, 2020: ~$62 million (including $20 million non-dilutive financing)
Net Loss: $40 million to $50 million
Year-end Cash: $15 million to $25 million
Cash Runway: Into 2H 2021
Infinity’s 2020 financial guidance is based on its current operating plans, excludes additional financing or business development activities, and excludes a potential $5 million milestone payment from BVF for positive Phase 3 patidegib data and any milestones from, or the sale of the company’s equity interest in, PellePharm.