On July 27, 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 second quarter 2021 financial results and provided a corporate update (Press release, Infinity Pharmaceuticals, JUL 27, 2021, View Source [SID1234585214]).
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Adelene Perkins, Chief Executive Officer and Chair, Infinity Pharmaceuticals, said, "Today we report data indicating that eganelisib re-programs macrophages in the tumor microenvironment, turning pro-tumor, M2, macrophages into anti-tumor, M1, macrophages and improves outcomes for patients in two distinct types of cancer. Specifically, when combined with current standard of care therapies, the data showed that eganelisib increased overall survival in patients with metastatic urothelial cancer and prolonged progression free survival in patients with TNBC. These data provide preliminary, but compelling evidence of eganelisib’s potential to improve outcomes for patients with these two types of cancer. Validation of the fundamental biologic hypothesis of eganelisib, and the resulting prospect of patient benefit, gives us great confidence in the future of eganelisib, Infinity and our ability to realize our vision of bringing better therapies to patients. In the months ahead, Infinity plans to work with investigators, key opinion leaders and regulatory authorities to carefully choose the most appropriate clinical paths forward and expects to provide an update by year end, together with an update on our maturing TNBC data."
Ms. Perkins continued, "We’re thrilled to have Dr. Peluso return to Infinity in the role of Chief Scientific Officer during this exciting time for Infinity. Stéphane served as a valued member of Infinity’s R&D Leadership Team during the discovery and preclinical development of eganelisib. His deep expertise will be incredibly valuable as we work to apply our clinical and translational learnings to maximize eganelisib’s unique role in re-programming macrophages and design the next set of clinical programs."
Dr. Peluso said, "I’m excited to return to Infinity to continue building on the extraordinary work of the Infinity team in the discovery and development of eganelisib. The translational and clinical data presented to date continue to support that eganelisib is working on-mechanism, as intended and described in Infinity’s earlier preclinical work, and I look forward to leveraging these data in helping select the best future development paths."
Corporate Update
Appointed Stéphane Peluso, Ph.D, as Chief Scientific Officer. Effective August 2, 2021, Dr. Peluso returns to Infinity from Ipsen Bioscience where he was most recently Vice President, Global Head of Oncology External Innovation. Prior to Ipsen, Dr. Peluso worked at Infinity where he held positions of increasing responsibility in medicinal chemistry and drug discovery ultimately leading Infinity’s early discovery and pipeline expansion efforts through both internal R&D and business development. Dr. Peluso started his career as a medicinal chemist at Millennium Pharmaceuticals. He graduated from the Ecole Supérieure de Chimie Industrielle de Lyon (ESCIL), France, obtained his Ph.D. from the University of Lausanne, Switzerland and completed postdoctoral studies at the Massachusetts Institute of Technology.
Recent Eganelisib Updates and Program Guidance – data updates from MARIO-275 and MARIO-3 during KOL event today at 8:00AM ET are summarized in a separate press release to be issued this morning.
Second Quarter 2021 Financial Results:
At June 30, 2021, Infinity had total cash, cash equivalents and available-for-sale securities of $97.3 million, compared to $106.8 million at March 31, 2021.
Research and development expense for the second quarter of 2021 was $8.0 million, compared to $6.1 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 $3.5 million for the second quarter of 2021, compared to $2.9 million for the same period in 2020. The increase in general and administrative expense is primarily due to an increase in consulting expenses and stock compensation.
Net loss for the second quarter of 2021 was $11.3 million, or a basic and diluted loss per common share of $0.13, compared to a net loss of $9.5 million, or a basic and diluted loss per common share of $0.16, 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 remains unchanged:
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 any potential additional funding or business development activities.
KOL Event Information
In lieu of an earnings conference call, Infinity will host a KOL event today, July 27, 2021, at 8:00AM ET to provide updates on the MARIO-3 TNBC and MARIO-275 UC clinical studies. Erika P. Hamilton, M.D. of Sarah Cannon Research Institute at Tennessee Oncology, and MARIO-3 lead investigator, and Brian Schwartz, M.D., Consulting Chief Physician of Infinity, will review the data for MARIO-3 and MARIO-275, respectively.