Zacks Investment Research | May 07, 2019 09:33PM ET
Infinity Pharmaceuticals Inc. (NASDAQ:INFI) reported a loss of 24 cents in the first quarter of 2019, wider than a loss of 18 cents in the year-ago quarter. Loss was also wider than the Zacks Consensus Estimate of a loss of 5 cents.
Revenues in the first quarter were $2.1 million, which mainly relates to the achievement of a $2-million milestone from PellePharm for the initiation of a phase III study, investigating patidegib (a hedgehog pathway inhibitor) in patients with Gorlin Syndrome. The company did not realize any revenues in the year-ago quarter. Revenues missed the Zacks Consensus Estimate of $10 million.
Infinity recognized the $30-million gross proceeds from the Copiktra royalty monetization as a liability, net of transaction costs, as of Mar 31, 2019. The company is amortizing the liability to non-cash interest expenses, and will continue to recognize the royalty revenues that Verastem pays to HealthCare Royalty Partners III, L.P. (HCR) as non-cash royalty revenues.
Shares of Infinity have soared 44.1% year to date compared with the industry ’s growth of 8.5%.
2019 Outlook
The company expects net loss for 2019 to range from $40 million to $50 million, including the Copiktra royalty monetization updated from the previous guidance of $30-$40 million.
Infinity expects its existing cash, cash equivalents and available-for-sale securities to be adequate to satisfy the company's capital needs in the second half of 2020.
Pipeline Updates
The company announced that it will initiate MARIO-3, a phase II study of novel triple combination front-line therapy in clinical collaboration with Roche/Genentech (OTC:RHHBY) . Roche will supply Tecentriq (atezolizumab) to Infinity for use in MARIO-3. The study will evaluate the company’s lead immuno-oncology candidate, IPI-549, in combination with Tecentriq and Abraxane (nab-paclitaxel) in front-line triple negative breast cancer (TNBC), and IPI-549 in combination with Tecentriq and Avastin (bevacizumab) in front-line renal cell cancer (RCC). The study is anticipated to initiate in the second half of 2019.
The data that will be generated in the front line with MARIO-3 will complement the data that will be generated in the second line with MARIO-275. MARIO-275, being conducted in collaboration with Bristol-Myers Squibb (NYSE:BMY) , is a phase II study evaluating the combination of IPI-549 and Opdivo (nivolumab) in immuno-oncology naive patients with urothelial cancer. The study will be initiated in the second quarter of 2019.
The company expects to complete enrollment in MARIO-1 combination expansion cohorts, including augmented melanoma expansion cohort and TNBC expansion cohort, in the second half of 2019.
In the second half of 2019, the company will also initiate a study in collaboration with Arcus BioSceinecs Inc. (NYSE:RCUS) to evaluate IPI-549 combined with the latter’s adenosine inhibitor, AB928, and Abraxane in patients with previously-treated advanced TNBC.
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