Infinity Pharmaceuticals Inc. 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 (RHHBY - Free Report) . 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 (BMY - Free Report) , 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. (RCUS - Free Report) to evaluate IPI-549 combined with the latter’s adenosine inhibitor, AB928, and Abraxane in patients with previously-treated advanced TNBC.
Zacks Rank
Infinity currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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Infinity Pharmaceuticals Inc. 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 (RHHBY - Free Report) . 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 (BMY - Free Report) , 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. (RCUS - Free Report) to evaluate IPI-549 combined with the latter’s adenosine inhibitor, AB928, and Abraxane in patients with previously-treated advanced TNBC.
Zacks Rank
Infinity currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +98%, +119% and +164% in as little as 1 month. The stocks in this report could perform even better.
See these 7 breakthrough stocks now>>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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