Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) a clinical-stage biotechnology company developing eganelisib, a potentially first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic which is designed to address a fundamental biologic mechanism of immune suppression in cancer, today announced the appointment of Robert Ilaria, Jr., M.D. as Chief Medical Officer. In addition, Brian Schwartz, M.D., will be transitioning from his role as Consulting Chief Physician to the Infinity Board of Directors.

“Robert’s deep expertise in oncology drug development, with a focus in immuno-oncology – most recently leading the Celgene/BeiGene PD-1 inhibitor collaboration and Bristol Myers Squibb’s CTLA-4 program, will be a tremendous asset to Infinity at this exciting point in the trajectory of eganelisib’s development,” said Adelene Perkins, Chief Executive Officer and Chair, Infinity Pharmaceuticals. “Robert’s extensive experience in drug development will be critically important as we build upon the compelling eganelisib data presented over the last year and initiate future studies to maximize eganelisib’s considerable potential.”

Dr. Ilaria said, “I’m thrilled to join Infinity at this important time in the development of eganelisib given the strength of the data generated to date across multiple indications and treatment settings which provide strong evidence that eganelisib has the potential to be a transformative therapy in immuno-oncology. These eganelisib data underscore the importance of reprogramming macrophages in the tumor microenvironment to improve outcomes for patients with some of the greatest unmet needs in solid tumors. I look forward to working to advance eganelisib in registration enabling studies to leverage the benefit shown for patients with urothelial cancer and triple negative breast cancer, including in patients who are PD-L1 negative for whom treatment options are limited.”

Dr. Schwartz said, “During my time leading eganelisib’s development, I have been extremely encouraged by the data generated from MARIO-275, MARIO-3 and MARIO-1, which demonstrate notable improvements in overall survival and progression free survival in bladder cancer and initial evidence of durable clinical activity in triple negative breast cancer. These data, along with the demonstrated ability to overcome resistance to checkpoint inhibition in patients with melanoma and squamous cell cancer of the head and neck cancer, show consistent patient benefit and on-mechanism immune modulation with eganelisib across some of the most challenging patient populations and clinical settings. I’m thrilled to continue contributing to the development of eganelisib in the capacity of a board member and look forward to working with Robert to ensure a seamless transition as he takes the helm of clinical development at Infinity.”

Ms. Perkins added, “We are tremendously grateful for Brian’s impactful contributions across our clinical programs through key data readouts that pave the way for future development and are delighted he will be joining the Infinity Board of Directors to provide continued strategic insight as we plan for a registration study in bladder cancer and determine the best path forward in triple negative breast cancer based on maturing data to be presented by year end.”

Dr. Ilaria joins Infinity from Bristol Myers Squibb where he was most recently the CTLA-4 Development Program Leader. He was previously Executive Medical Director, Global Clinical Research and Development at Celgene and Program Lead Physician for the PD-1 inhibitor tislelizumab partnership with BeiGene. Dr. Ilaria progressed through increasingly senior leadership roles in the global clinical development of over 20 drug candidates during 12 years at Eli Lilly and Company, resulting in Fast Track and Breakthrough Designations and accelerated approvals, and provided medical support for global regulatory submissions as well as launch and post-launch activities. Dr. Ilaria received his MD at University of Texas Southwestern Medical School, Dallas, Texas followed by internship/residency in internal medicine at Brigham and Women’s Hospital, a research post-doctoral fellowship at Harvard Medical School and a hematology and medical oncology fellowship at Brigham and Women’s Hospital and the Dana Farber Cancer Institute.

Dr. Schwartz has over 25 years of experience as a drug development expert in pharmaceutical and biotechnology industries and has served as Infinity’s consulting Chief Physician since early 2020. He was previously at ArQule for 10 years where he served as CMO prior to the acquisition by Merck & Co. of ArQule in late 2019. In senior leadership roles at ArQule, Ziopharm Oncology, Inc., Bayer AG, and LeoLabs, Inc., Dr. Schwartz has accumulated a number of successful new drug applications (NDAs), numerous investigational new drug (IND) applications, preclinical and clinical drug development programs. During his time in biotech, Dr. Schwartz acquired knowledge of investors relations, partnering and capital raising. Currently, in addition to the Infinity Board of Directors, Dr. Schwartz is a board member of Mereo Biopharma, Enlivex and Cyclacel pharmaceuticals and an advisor in different capacities to numerous biotech companies. Dr. Schwartz qualified as a medical doctor in South Africa followed by additional fellowship training in Canada.

Company Reports Inducement Grant to Chief Medical Officer under Nasdaq Listing Rule 5635(c)(4)

In accordance with Dr. Ilaria’s employment offer letter for the position of Chief Medical Officer, the Company further announces the grant of an inducement stock option award to Dr. Ilaria. This grant was approved by the Company’s Compensation Committee of the Board of Director’s and was made as a material inducement to Dr. Ilaria’s acceptance of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) as a component of his employment compensation. The inducement stock option award consists of an option to purchase a total of 300,000 shares of the Company’s common stock with an exercise price of $3.59, equal to the closing price of the Company’s common stock on September 1, 2021, the date of grant. The stock option has a 10-year term and vests over four years with 12/48 of the original number of shares vesting on the first anniversary of the date of grant and 1/48 of the original number of shares vesting monthly thereafter, subject to Dr. Ilaria’s continued service with the Company through the vesting dates. The inducement stock option award is subject to the terms and conditions of the inducement stock option award agreement covering the grant of the inducement stock options.

About Infinity and Eganelisib

Infinity is an innovative biopharmaceutical company dedicated to advancing novel medicines for people with cancer. Infinity is advancing eganelisib, a first-in-class, oral immuno-oncology development candidate that selectively inhibits PI3K-gamma, in multiple clinical studies. MARIO-275 is a global, randomized, controlled combination study of eganelisib combined with Opdivo® in I/O naïve urothelial cancer. MARIO-3 is the first eganelisib combination study in front-line advanced cancer patients and is evaluating eganelisib in combination with Tecentriq® and Abraxane® in front-line TNBC and in combination with Tecentriq and Avastin® in front-line RCC. In collaboration with Arcus Biosciences, Infinity is evaluating a checkpoint inhibitor-free, novel combination regimen of eganelisib plus AB928 (dual adenosine receptor antagonist) plus Doxil® in advanced TNBC patients. In 2019, Infinity completed enrollment in MARIO-1, a Phase 1/1b study evaluating eganelisib as a monotherapy and in combination with Opdivo (nivolumab) in patients with advanced solid tumors including patients refractory to checkpoint inhibitor therapy. With these studies Infinity is evaluating eganelisib in the anti-PD-1 refractory, I/O-naïve, and front-line settings. 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 those regarding: the therapeutic potential of eganelisib; plans to present data; plans to participate in scientific presentations; the timing of further clinical trial updates from the Company; and the Company's ability to execute on its strategic plans. 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 outcome of the Company’s risk/benefit review of its MARIO-275 clinical trial; the content and timing of decisions made by the U.S. Food and Drug Administration 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.

Opdivo® is a registered trademark of Bristol Myers Squibb.
Tecentriq® is a registered trademark of Genentech, Inc.
Abraxane® is a registered trademark of Abraxis BioScience, LLC., a wholly owned subsidiary of Bristol Myers Squibb Company.
Avastin® is a registered trademark of Genentech, Inc.
Doxil® is a registered trademark of Baxter Healthcare Corporation.

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