Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) (“Infinity” or the “Company”), a clinical-stage biotechnology company developing eganelisib, a potential first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic, today announced upcoming presentations including data on eganelisib by Infinity’s collaborator, Professor Judith A. Varner of the UCSD Moores Cancer Center, La Jolla, California, at the 2023 Annual Meeting of the American Association of Cancer Research (AACR) to be held April 14 - 19, 2023 in Orlando, Florida.

Highlights of the presentations include preclinical and translational data further reinforcing the mechanism of action of PI3K-γ inhibition:

• Single cell transcriptomics data showing PI3K-γ knockout switches tumor associated macrophages in head and neck squamous cell carcinoma (HNSCC) and non small cell lung cancer (NSCLC) tumor models to activated, antigen-presenting, T cell-stimulating macrophages.
• Preclinical data supporting tumor growth delay of HNSCC tumor models in PI3K-γ knockout mice is mediated by intra-tumoral interleukin-12, interferon gamma and CD8+ T cells, key drivers of immune response to cancer.
• Translational data from the MARIO-275 clinical trial showing increased systemic immune activation in patients treated with nivolumab in combination with eganelisib over nivolumab alone, with enrichment of genes from interferon signaling, antigen presentation, and T cell receptor pathways.
• Translational data from the MARIO-3 clinical trial, showing immune activation within the tumor microenvironment in patients treated with eganelisib, nab-paclitaxel and atezolizumab, with up-regulation of interferon signaling, antigen presentation, and T cell receptor pathways.
• Following translational data from MARIO-1 indicating increased expression of the TGF-β activating integrin αVβ8 in HNSCC patients treated with combination of eganelisib and nivolumab, initial preclinical studies showing anti-αVβ8 monoclonal antibody treatment prevents growth of HNSCC tumor model in PI3K-γ knock-out mice.

“Our presentations describe exciting aspects of the role of PI3K-γ as a fundamental molecular switch controlling immune response by myeloid cells in the tumor microenvironment,” said Professor Varner. “Our preclinical data suggest key roles for antigen-presenting activated macrophages, intra-tumoral IL-12, IFN-γ release and activated CD8+ T cells in mediating the effect of PI3K-γ knockout or PI3K-γ inhibition in tumor models. In line with our preclinical studies, emerging translational data from the MARIO-275 and MARIO-3 clinical trials support the mechanism of action of eganelisib through reprogramming and activation of tumor associated macrophages to reshape the tumor microenvironment and favor anti-tumor activity. Altogether, these data continue to underscore the potential of eganelisib as a next generation macrophage reprogramming immunotherapeutic, in combination with checkpoint inhibitors or potentially new immuno-oncology agents like anti-αVβ8 monoclonal antibodies.”

Details of the presentations are as follows:

Presentation time: Saturday, April 15, 2023, 8:30am-8:50am EDT

Title: Macrophages rule in cancer

Session: ED034 - Antigen Presentation: The Macrophage-Dendritic Cell Debate

Presenter: Judith A. Varner

Presentation time: Tuesday, April 18, 2023, 10:20am-10:40am EDT

Title: Basic and clinical impacts of targeting myeloid cells in tumors

Session: Session SY14 - Next Generation of Myeloid Checkpoints in Cancer

Presenter: Judith A. Varner

About Infinity and Eganelisib

Infinity Pharmaceuticals, Inc. (“Infinity” or the “Company”), is a clinical-stage biotechnology company developing eganelisib (IPI-549), a potential first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic designed to address a fundamental biologic mechanism of immune suppression in cancer. MARIO-3 is a clinical study evaluating eganelisib in combination with atezolizumab and nab-paclitaxel in front-line triple negative breast cancer (TNBC) and in combination with atezolizumab and bevacizumab in front-line renal cell carcinoma (RCC). MARIO-275 is a randomized, controlled combination study of eganelisib combined with nivolumab in I/O naïve urothelial cancer. For more information on Infinity, please refer to Infinity's website at www.infi.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include the therapeutic potential of eganelisib including its potential as a first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company's current expectations. For example, there can be no guarantee that eganelisib will successfully complete necessary preclinical and clinical development phases. Further, there can be no guarantee that any positive developments in Infinity's product portfolio will result in stock price appreciation. Management's expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: the cost, timing and results of clinical trials and other development activities that may be delayed or disrupted by the COVID-19 pandemic or otherwise; the content and timing of decisions made by the U.S. FDA and other regulatory authorities; Infinity's ability to obtain and maintain requisite regulatory approvals; unplanned cash requirements and expenditures; development of agents by Infinity's competitors for diseases in which Infinity is currently developing or intends to develop eganelisib; and Infinity's ability to obtain, maintain and enforce patent and other intellectual property protection for eganelisib. These and other risks which may impact management's expectations are described in greater detail under the caption "Risk Factors" included in Infinity's annual report and quarterly reports filed with the Securities and Exchange Commission (SEC), and in other filings that Infinity makes with the SEC, available through the Company’s website at www.infi.com. Any forward-looking statements contained in this press release speak only as of the date hereof, and Infinity does not undertake and expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

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