Infinity Pharmaceuticals Provides 2019 Goals and Financial Guidance
"In the year ahead, we are excited to be moving into earlier lines of therapy, new indications, and novel, potentially transformative immuno-oncology combinations to execute on our strategy to expand the depth and breadth of the development of IPI-549," said
"The IPI-549 safety and clinical activity from the MARIO-1 Phase 1b study continues to inform our strategy to expand the depth and breadth of IPI-549 development for cancer patients," said Dr.
Infinity plans to initiate MARIO-275, a combination study of IPI-549 with Opdivo® in I/O naïve urothelial cancer (UC) patients, in the first half of 2019. Opdivo was approved for use by the
Infinity will also be advancing novel triple combination therapies with Arcus, initially evaluating IPI-549 in combination with AB928, Arcus's dual adenosine receptor antagonist, and chemotherapy in patients with previously treated, advanced triple negative breast cancer, or TNBC. As both macrophages and high adenosine levels are believed to play critical roles in creating a highly immune-suppressive tumor microenvironment in cancer after chemotherapy, the novel immuno-oncology combination being evaluated in this setting represent a potentially promising approach to treating TNBC.
Infinity's chair and chief executive officer,
Anticipated Milestones in 2019: Expanding Depth and Breadth of
- Advance into Immuno-Oncology (I/O) Naïve Indications in Combination with Opdivo: Initiate MARIO-275 in I/O naïve UC patients with BMS
- Advance into Novel Triple Combinations Beyond CPIs: Initiate Triple Therapy Combination (IPI-549+AB928+Chemo) in previously treated advanced TNBC with Arcus
- Initiate the first IPI-549 combination study in front-line advanced cancer patients
- Complete enrollment of MARIO-1 seven combination expansion cohorts including:
- Augmented melanoma expansion cohort (n=40)
- TNBC expansion cohort (n=29)
2019 Financial Guidance
Infinity ended 2018 with approximately
- Net loss:
$30 million to $40 million
- Year-end cash:
$20 million to $30 million
- Cash runway: Into 2H 2020
Infinity's 2019 financial guidance is based on its current operating plans, excludes additional financing or business development activities, and includes a
IPI-549 is an investigational compound, and its safety and efficacy have not been evaluated by the
Infinity is an innovative biopharmaceutical company dedicated to advancing novel medicines for people with cancer. Infinity is advancing IPI-549, an oral immuno-oncology development candidate that selectively inhibits PI3K-gamma. A Phase 1/1b study in approximately 200 patients with advanced solid tumors is ongoing. 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 PI3K-gamma selective inhibition and IPI-549, alone and in combination with checkpoint inhibitors, including Opdivo, adenosine receptor antagonists, including AB928, and chemotherapies; timing of company presentations; clinical trial plans regarding IPI-549; 2019 financial guidance; 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 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: Infinity's results of clinical trials and preclinical studies; 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 and to enroll patients in its clinical trials; unplanned cash requirements and expenditures; development of agents by Infinity's competitors for diseases in which Infinity is currently developing or intends to develop IPI-549; and Infinity's ability to obtain, maintain and enforce patent and other intellectual property protection for IPI-549. These and other risks which may impact management's expectations are described in greater detail under the caption "Risk Factors" included in Infinity's quarterly report on Form 10-Q filed with the Securities and Exchange Commission (
OPDIVO® is a registered trademark of Bristol-Myers Squibb.
212-362-1200 or Stephanie@sternir.com
2 Sharma et al. AACR Annual Meeting 2018
3 www.clinicaltrials.gov, NCT02637531.
4 Hong et al,
5 Sullivan et al.,
6 Chmielowski et al,