On October 30, 2019 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported its third quarter 2019 financial results and provided an update on the company, including its progress with 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 (Press release, Infinity Pharmaceuticals, OCT 30, 2019, View Source [SID1234550039]).

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"It is an exciting and important time for Infinity as we anticipate completing enrollment in MARIO-1 by the end of this year and presenting data from our MARIO-1 and MARIO-3 trials in 2020. During 2020 we also expect to complete enrollment in MARIO-275, our randomized, controlled Phase 2 trial in patients with bladder cancer," said Adelene Perkins, Chief Executive Officer and Chair of Infinity Pharmaceuticals. "As we advance multiple studies designed to produce compelling data across a wide range of indications in innovative combinations, we are witnessing surging recognition of the importance of tumor macrophage-directed immuno-oncology therapies among the medical and scientific communities. With additional clinical and translational data expected from IPI-549 studies starting in 2020, Infinity is positioned to become the leader in macrophage-targeted immunotherapy."

Updated IPI-549 Clinical Program Guidance

MARIO-1 enrollment completion expected by year end with data presentation expected in 2020. 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.
MARIO-3 enrollment completion and data presentation expected in 2020. 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).
MARIO-275 enrollment completion expected during 2020. MARIO-275 is the company’s global, randomized 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 (bladder) cancer.
Arcus Biosciences Collaboration Study Initiated: This Phase 1 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.
Third Quarter 2019 Financial Results

At September 30, 2019, Infinity had total cash, cash equivalents and available-for-sale securities of $52.0 million, compared to $63.0 million at June 30, 2019.
Research and development expense for the third quarter of 2019 was $7.1 million, compared to $5.4 million for the same period in 2018. The increase in R&D expense was primarily due to an increase in clinical and development activities for IPI-549.
General and administrative expense was $3.6 million for the third quarter of 2019, compared to $3.4 million for the same period in 2018.
Net loss for the third quarter of 2019 was $11.4 million, or a basic and diluted loss per common share of $0.20, compared to net income of $13.4 million, or a basic and diluted earnings per common share of $0.23 for the same period in 2018. In the third quarter of 2018, we recognized $22.0 million in revenue related to a one-time payment due from Verastem for the approval by the U.S. Food and Drug Administration of Copiktra, which Infinity licensed to Verastem in 2016.
2019 Financial Guidance

Net Loss: Infinity expects net loss for 2019 to range from $40 million to $50 million.
Cash and Investments: Infinity expects to end 2019 with a year-end cash, cash equivalents and available-for-sale securities balance ranging from $40 million to $50 million.
Cash Runway: Based on its current operational plans, Infinity expects that its existing cash, cash equivalents and available-for-sale securities will be adequate to satisfy the company’s capital needs for at least the next 12 months. Infinity’s financial guidance excludes additional funding or business development activities.
Conference Call Information

Infinity will host a conference call today, October 30, 2019, at 4:30 p.m. ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the "Investors/Media" section of Infinity’s website at www.infi.com. To participate in the conference call, please dial 1-877-316-5293 (domestic) and 1-631-291-4526 (international) five minutes prior to start time. The conference ID number is 2612978. An archived version of the webcast will be available on Infinity’s website for 30 days.