On May 13, 2021 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) ("Infinity" or the "Company"), a clinical-stage biotechnology company developing eganelisib (IPI-549), a potentially first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic, reported its first quarter 2021 financial results and provided a corporate update (Press release, Infinity Pharmaceuticals, MAY 13, 2021, View Source [SID1234579916]).
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"2021 is poised to be a landmark year for Infinity with meaningful data updates, building on important data presentations over the last few months, which support the potential of eganelisib’s unique immune modulatory mechanism to improve outcomes across multiple solid tumor indications, lines of therapies and treatment combinations," said Adelene Perkins, Chief Executive Officer and Chair of Infinity Pharmaceuticals. "Our encouraging results from MARIO-3 in front-line TNBC show a patient benefit from the addition of eganelisib to the approved standard of care regimen, Tecentriq and Abraxane. We are very much looking forward to sharing updated data from the study across a substantially larger number of patients, with an initial analysis of durability of response, in both mid-year and in the fourth quarter of this year. In order to provide the most meaningful update to our MARIO-3 TNBC presentation from SABCS in December 2020 for our mid-year TNBC update, our goal is to maximize the amount – both in terms of the number of patients and time on study – of data available by planning for a June data cut to be discussed on a July 27th webcast."
Ms. Perkins continued, "Our most recent data from MARIO-275 demonstrate the benefit of adding eganelisib to nivolumab in the advanced second line bladder cancer patient population irrespective of their PD-L1 status and especially for patients who are PD-L1 low who represent the majority of these patients and are least likely to respond to checkpoint inhibitors alone. Based on these results, we are in the planning stages of a potentially registration-enabling study, and we look forward to providing an update on our path forward in bladder cancer on our July 27th webcast based on our interactions with regulatory authorities and in the context of the recent FDA Oncologic Drugs Advisory Committee, or ODAC, meeting in which accelerated approvals for two checkpoint inhibitors in bladder cancer were reviewed."
Recent Updates and Program Guidance:
MARIO-3 Triple Negative Breast Cancer Cohort
Additional data from the triple negative breast cancer (TNBC) cohort of MARIO-3, the company’s ongoing Phase 2 study in collaboration with Roche/Genentech to evaluate eganelisib in a novel triple combination in the 1L setting, adding to Tecentriq and Abraxane, which has received accelerated approval in PD-L1 high 1L TNBC patients, are expected on July 27th and in 4Q 2021. Presentations will include increased patient numbers and early durability data, building upon the positive data presented at the 2020 San Antonio Breast Cancer Symposium which included 100% of patients who had some reduction and 69.2% of patients who had a response per RECIST 1.1, irrespective of PD-L1 status.
Completion of enrollment is expected in 2H’21
MARIO-275 and Advanced Urothelial Cancer
Presented positive data from the MARIO-275 randomized, placebo-controlled Phase 2 study evaluating eganelisib in combination with Opdivo in platinum-refractory, I/O naïve patients with advanced urothelial cancer (aUC), in collaboration with Bristol Myers Squibb (BMS) at the 2021 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU)
Combination of eganelisib with nivolumab demonstrated improved overall response rate (ORR), disease control rate (DCR), and progression free survival (PFS) versus 2L standard of care nivolumab monotherapy
Eganelisib increased the patient benefit over nivolumab monotherapy, regardless of PD-L1 status. The greatest benefit of eganelisib and nivolumab combination therapy over nivolumab monotherapy was observed in the PD-L1 low patient population (n=23) with improvement over nivolumab monotherapy (n=7): ORR of 26% vs. 14%; DCR 57% vs. 14%; and best responses of complete response (CR) 9% vs. 0%, and stable disease (SD) 30% vs. 0%
PD-L1 low patients demonstrated an extended progression free survival (PFS) with a hazard ratio of 0.54 representing a 46% reduction in probability of progression with the addition of eganelisib
The combination of eganelisib and nivolumab was well tolerated at the 30mg once daily dose
Translational data support eganelisib’s immune modulatory mechanism of action
Infinity is in the process of planning a potential registration enabling study leveraging findings from MARIO-275 and incorporating feedback from the U.S. Food and Drug Administration (FDA) including their ultimate decision following the recent ODAC reviews of checkpoint inhibitor accelerated approvals in PD-L1 high metastatic urothelial cancer patients and plans to provide an update on July 27th.
Corporate Update
Closed a $92 million public offering in February 2021 to support execution on the next phase of eganelisib development.
First Quarter 2021 Financial Results:
At March 31, 2021, Infinity had total cash, cash equivalents and available-for-sale securities of $106.8 million, compared to $34.1 million at December 31, 2020.
Research and development expense for the first quarter of 2021 was $8.2 million, compared to $7.3 million in the same period in 2020. The increase is primarily related to clinical, development and consulting expenses to support continued development of eganelisib.
General and administrative expense was $3.6 million for the first quarter of 2021, compared to $3.3 million for the same period in 2020. The increase in G&A expense is primarily due to an increase in stock compensation.
Net loss for the first quarter of 2021 was $11.6 million, or a basic and diluted loss per common share of $0.15, compared to a net loss of $10.9 million, or a basic and diluted loss per common share of $0.19 in the same period in 2020.
Financial Outlook: Infinity’s 2021 financial guidance, following the closing in February 2021 of a $92 million public offering of Infinity’s common stock is as follows:
Net Loss: Infinity expects net loss for 2021 to range from $40 million to $50 million.
Cash and Investments: Infinity expects to end 2021 with a year-end-cash, cash equivalents and available for sale securities balance ranging from $70 million to $80 million. Infinity’s financial guidance does not include additional funding or business development activities.
Conference Call Information
Infinity will host a conference call today, May 13th, 2021, at 4:30PM 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 (877) 316-5293 (domestic) and (631) 291-4526 (international) five minutes prior to start time. The conference ID number is 9988449. An archived version of the webcast will be available on Infinity’s website for 30 days.