On July 30, 2019 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported its second 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, JUL 30, 2019, View Source [SID1234537893]).

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"We are pleased to have initiated MARIO-275 and to begin the MARIO-3 study this quarter that will advance IPI-549 into novel combinations with best-in-class, emerging standards of care, while also expanding IPI-549 clinical development into new indications and earlier lines of therapy," said Adelene Perkins, Chief Executive Officer and Chair of Infinity Pharmaceuticals. "In January 2020, we will provide guidance on completion of enrollment in these Phase 2 trials in connection with our annual goals."

Recent developments include:

MARIO-275 Initiated: Today, Infinity announced the initiation of its global randomized Phase 2 study in collaboration with Bristol-Myers Squibb, which will evaluate IPI-549 in combination with Opdivo in second-line, I/O naïve patients with advanced urothelial cancer.

MARIO-3 Initiating in Q3: This Phase 2 study in collaboration with Roche/Genentech will evaluate IPI-549 in novel triple combination front-line therapies with Tecentriq and Abraxane in TNBC and with Tecentriq and Avastin in RCC.

Arcus Biosciences Collaboration Study Initiating in Q3: This Phase 1 trial, to be conducted by Arcus, will evaluate a checkpoint-inhibitor free, novel triple-combination regimen of IPI-549 + AB928 (dual adenosine receptor antagonist) + Doxil in advanced TNBC patients.

Completing MARIO-1 by year end: Infinity anticipates completing enrollment in the second half of 2019 in the expanded combination cohorts in MARIO-1, the company’s ongoing Phase 1/1b study of IPI-549 as a monotherapy and in combination with Opdivo in approximately 225 patients with advanced solid tumors.

Second Quarter 2019 Financial Results

At June 30, 2019, Infinity had total cash, cash equivalents and available-for-sale securities of $63.0 million, compared to $70.5 million at March 31, 2019.

R&D expense for the second quarter of 2019 was $6.1 million, compared to $3.7 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 $3.8 million for the second quarter of 2019, compared to $3.4 million for the same period in 2018.

In the first quarter of 2019, Infinity recognized $30.0 million in gross cash proceeds received from the Copiktra royalty monetization as a liability on the balance sheet in accordance with accounting guidance for royalty monetization. The company is amortizing the liability to non-cash interest expense on a quarterly basis. For the second quarter of 2019, non-cash interest expense was $1.1 million.

Net loss for the second quarter of 2019 was $10.5 million, or a basic and diluted loss per common share of $0.18, compared to a net loss of $7.0 million, or a basic and diluted loss per common share of $0.12 for the same period in 2018.

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 into 2H 2020. Infinity’s financial guidance excludes additional funding or business development activities.

Conference Call Information

Infinity will host a conference call today, July 30, 2019, at 8:00 a.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 3095248. An archived version of the webcast will be available on Infinity’s website for 30 days.