Infinity Pharmaceuticals Provides 2020 Goals and Financial Guidance
- Recent Non-Dilutive Financing Extends Cash Runway into 2H 2021 and Fully Funds All Ongoing IPI-549 Clinical Trials Through Key Data Readouts -
- MARIO-275 Global, Randomized, Controlled Phase 2 Study in Urothelial Cancer Enrollment Completion Expected in 2020 with Data Expected in Mid-2021 -
- MARIO-3 Phase 2 Study in TNBC and RCC Enrollment Completion and Initial Data Expected in 2020 –
- Additional MARIO-1 Data Expected in 2020 -
- Company to Present at 38th Annual
“Our recently announced non-dilutive financing with
Infinity’s Chair and Chief Executive Officer,
Recent Financial and Corporate Highlights
$20 millionnon-dilutive asset-backed financing with BVF Partners L.P.with sole recourse in potential royalty payments due on future sales of patidegib, a hedgehog pathway inhibitor discovered by Infinity and licensed to PellePharm in 2013. Infinity is eligible to receive from BVF an additional $5 millionpayment upon positive data from PellePharm’s Phase 3 trial in patients with Gorlin Syndrome.
$60 millioncash on hand to fund all current IPI-549 trials to key data readouts throughout 2020 and into mid-2021.
Executive Leadership Promotions of
Jeffery Kutok, M.D., Ph.D., Chief Scientific Officer, from Senior Vice President to Executive Vice President, and Seth Tasker, J.D. from General Counsel to Chief Business Officer.
2020 IPI-549 Development Guidance
MARIO-275 enrollment completion. MARIO-275 is the company’s ongoing global, randomized, controlled Phase 2 study in collaboration with
Bristol-Myers Squibb, to evaluate IPI-549 in combination with Opdivo® in platinum-refractory, I/O naïve patients with advanced urothelial cancer. Data is expected in mid-2021.
MARIO-3 enrollment completion and initial data. MARIO-3 is the company’s ongoing Phase 2 study in collaboration with
Roche/Genentech to evaluate IPI-549 in novel triple combination front-line therapies with Tecentriq® and Abraxane® in triple negative breast cancer (TNBC) and with Tecentriq and Avastin® in renal cell cancer (RCC).
- Arcus Biosciences Collaboration Study expansion cohort enrolling. This ongoing Phase 1/1b trial, being conducted by Arcus, is evaluating a checkpoint inhibitor-free, novel triple-combination regimen of IPI-549 + AB928 (dual adenosine receptor antagonist) + Doxil® in advanced TNBC patients. The trial has been initiated with a goal of enrollment of up to 40 patients in an expansion cohort.
- Additional MARIO-1 data. MARIO-1 is the company’s ongoing Phase 1/1b study of IPI-549 as a monotherapy and in combination with Opdivo® in patients with advanced solid tumors.
2020 Financial Guidance
Infinity ended 2019 with approximately
Cash as of
January 8, 2020: ~$62 million(including $20 millionnon-dilutive financing)
$40 million to $50 million
$15 million to $25 million
- Cash Runway: Into 2H 2021
Infinity’s 2020 financial guidance is based on its current operating plans, excludes additional financing or business development activities, and excludes a potential
About Infinity and IPI-549
Infinity is an innovative biopharmaceutical company dedicated to advancing novel medicines for people with cancer. Infinity is advancing IPI-549, 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 IPI-549 combined with Opdivo in I/O naïve urothelial cancer patients for which enrollment is expected to be completed in 2020 with data by mid-2021. MARIO-3 is the first IPI-549 combination study in front-line advanced cancer patients and is evaluating IPI-549 in combination with Tecentriq and Abraxane in front-line TNBC and in combination with Tecentriq and Avastin in front-line RCC and is also expected to complete enrollment in 2020 with initial data expected in 2020. In collaboration with
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 expected benefits from the financing, Infinity’s expectation that its cash on hand will be sufficient to fund its operations into 2H 2021, the therapeutic potential of PI3K-gamma selective inhibition and IPI-549, alone and in combination with other cancer therapies; clinical trial enrollment and data presentation timelines; financial guidance; and Infinity’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 IPI-549 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: whether any milestones or royalties will become payable or paid by PellePharm under the license agreement; Infinity's results of clinical trials and preclinical studies; the content and timing of decisions made by the U.S.
Opdivo® is a registered trademark of
Tecentriq® and Avastin® are registered trademarks of
Abraxane® is a registered trademark of Celgene.
Doxil® is a registered trademark of Janssen Products.
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