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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Infinity Pharmaceuticals Inc | NASDAQ:INFI | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.0322 | 0.0321 | 0.0348 | 0 | 01:00:00 |
CAMBRIDGE, Mass., Aug. 3, 2017 /PRNewswire/ -- Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced its second quarter 2017 financial results and provided an update on the company, including its progress with IPI-549, an oral immuno-oncology product candidate that selectively inhibits phosphoinositide-3-kinase gamma (PI3K-gamma). Infinity is evaluating IPI-549 as a monotherapy and in combination with Opdivo® (nivolumab), a PD-1 immune checkpoint inhibitor, in a four-part Phase 1 study in patients with advanced solid tumors. Infinity announced today that it has completed an evaluation of escalating monotherapy doses of IPI-549 ranging from 10 mg once daily (QD) to 60 mg QD and has selected the 60 mg dose for evaluation in the monotherapy expansion component of the study. The selection of the 60 mg QD dose was based on pharmacokinetic and pharmacokinetic analyses, which showed that IPI-549 maintained full suppression of PI3K-gamma at this dose level. Data also showed that the IPI-549 dosed at 60 mg QD was well tolerated, and no dose-limiting toxicities were observed. The monotherapy expansion component of the study is now open for enrollment and will evaluate the safety and activity of IPI-549 dosed at 60 QD in approximately 25 patients.
Dose escalation evaluating IPI-549 in combination with Opdivo is ongoing, and Infinity expects to initiate the combination expansion component of the study in the second half of 2017. IPI-549 is believed to be the only selective PI3K-gamma inhibitor in clinical development.
"We have initiated the monotherapy expansion component of our Phase 1 study and are eager to also move forward with the combination expansion, allowing us to generate additional clinical and translational data from monotherapy treatment as well as from the combination of IPI-549 and Opdivo in specific types of solid tumors," stated Adelene Perkins, Infinity's chair and chief executive officer. "We also recently undertook an important strategic initiative and amended our license agreement with Takeda Oncology for IPI-549. We issued Takeda an unsecured $6.0 million convertible note in exchange for eliminating future royalty obligations on IPI-549. This amendment reflects our strong belief in the potential of IPI-549 to be a first-in-class, oral immuno-oncology therapy and reduces the total royalty burden on any future net sales of IPI-549 to four percent due to Mundipharma and Purdue from a previous agreement."
The ongoing Phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and activity of IPI-549 as a monotherapy and in combination with the approved dose of Opdivo in approximately 175 patients with advanced solid tumors. The study includes four parts: monotherapy dose escalation, combination therapy dose escalation, monotherapy expansion and combination therapy expansion. The combination expansion component of the study will include multiple cohorts designed to evaluate IPI-549 in patients with specific types of cancer, including patients with non-small cell lung cancer (NSCLC), melanoma and squamous cell carcinoma of the head and neck (SCCHN) whose tumors show initial resistance or subsequently develop resistance to immune checkpoint blockade therapy. There is a great need for additional treatment options for the growing number of patients living with these cancers, which account for more than 17 percent of all new cancer cases in the U.S.1,2
Recent Developments
Second Quarter 2017 Financial Results
Cash and Investments Outlook
Infinity's 2017 financial outlook remains as follows:
Based on its current operational plans, Infinity expects that its existing cash and cash equivalents at June 30, 2017, will be adequate to satisfy the company's capital needs into the first quarter of 2019. The company's financial outlook excludes additional funding or business development activities.
Conference Call Information
Infinity will host a conference call today, August 3, 2017, at 4:30 p.m. ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the "Investors/Media" section of Infinity's website at www.infi.com. To participate in the conference call, please dial 1-877-316-5293 (domestic) or 1-631-291-4526 (international) five minutes prior to start time. The conference ID number is 40376609. An archived version of the webcast will be available on Infinity's website for 60 days.
About the IPI-549 and the Ongoing Phase 1 Study
IPI-549 is an investigational, orally administered immuno-oncology development candidate that selectively inhibits PI3K-gamma. In preclinical studies, IPI-549 reprograms macrophages from a pro-tumor to an anti-tumor phenotype and is able to overcome resistance to checkpoint inhibition.3,4 As such, IPI-549 may have the potential to treat a broad range of solid tumors and represents a potentially complementary approach to restoring anti-tumor immunity in combination with other immunotherapies such as checkpoint inhibitors.
A Phase 1 study of IPI-549 in patients with advanced solid tumors is ongoing to explore the activity, safety, tolerability, pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy and in combination with Opdivo® (nivolumab), a PD-1 immune checkpoint inhibitor, in patients with advanced solid tumors.6 The four-part study includes monotherapy and combination dose-escalation components, in addition to monotherapy expansion and combination expansion components. The expansion component of the study evaluating IPI-549 plus Opdivo will include patients with non-small cell lung cancer (NSCLC), melanoma and squamous cell carcinoma of the head and neck (SCCHN). Patients enrolled in these combination expansion cohorts represent a difficult-to-treat population, as they must have demonstrated initial resistance or subsequently develop resistance to a PD-1 or PD-L1 therapy immediately prior to enrolling in the study. Overall, the study is expected to enroll approximately 175 patients.
IPI-549 is an investigational compound and its safety and efficacy has not been evaluated by the U.S. Food and Drug Administration or any other health authority.
About Infinity
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 study in 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® (nivolumab); the company's expectations about the potential value of the buyout of future royalty obligations related to IPI-549; clinical trial plans regarding IPI-549; plans to report clinical data of IPI-549; plans regarding the company's office space; 2017 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 or that any positive developments in Infinity's product portfolio or other strategic options Infinity may pursue 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, including subsequent analysis of existing data and new data received from ongoing and future studies; a failure of Infinity and/or Verastem to fully perform under the license agreement; 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 (SEC) on August 3, 2017, and other filings filed by Infinity with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and Infinity 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.
INFINITY PHARMACEUTICALS, INC. | |||||||
Condensed Consolidated Balance Sheets (unaudited) (in thousands) | |||||||
June 30, 2017 |
December 31, 2016 | ||||||
Cash, cash equivalents and available-for-sale securities |
$ |
66,197 |
$ |
92,064 |
|||
Other current assets |
2,580 |
9,596 |
|||||
Property and equipment, net |
22,040 |
23,424 |
|||||
Other long-term assets |
28 |
571 |
|||||
Total assets |
$ |
90,845 |
$ |
125,655 |
|||
Current liabilities |
$ |
10,936 |
$ |
23,863 |
|||
Financing obligation, less current portion |
20,799 |
19,149 |
|||||
Other long-term liabilities |
208 |
189 |
|||||
Total stockholders' equity |
58,902 |
82,454 |
|||||
Total liabilities and stockholders' equity |
$ |
90,845 |
$ |
125,655 |
INFINITY PHARMACEUTICALS, INC. | |||||||||||||||
Condensed Consolidated Statements of Operations (unaudited) (in thousands, except share and per share amounts) | |||||||||||||||
Three Months Ended June 30, |
Six Months Ended June 30, | ||||||||||||||
2017 |
2016 |
2017 |
2016 | ||||||||||||
Collaboration revenue |
$ |
— |
$ |
9,467 |
$ |
— |
$ |
18,723 |
|||||||
Operating expenses: |
|||||||||||||||
Research and development |
3,901 |
52,947 |
7,940 |
92,135 |
|||||||||||
General and administrative |
6,205 |
15,692 |
12,642 |
26,528 |
|||||||||||
Total operating expenses |
10,106 |
68,639 |
20,582 |
118,663 |
|||||||||||
Gain on AbbVie Opt-Out |
— |
112,216 |
— |
112,216 |
|||||||||||
Income (loss) from operations |
(10,106) |
53,044 |
(20,582) |
12,276 |
|||||||||||
Other income (expense): |
|||||||||||||||
Interest expense |
(300) |
(307) |
(602) |
(616) |
|||||||||||
Other expense |
(6,882) |
— |
(6,882) |
— |
|||||||||||
Investment and other income |
334 |
254 |
637 |
667 |
|||||||||||
Total other income (expense) |
(6,848) |
(53) |
(6,847) |
51 |
|||||||||||
Net income (loss) |
$ |
(16,954) |
$ |
52,991 |
$ |
(27,429) |
$ |
12,327 |
|||||||
Earnings (loss) per common share: |
|||||||||||||||
Basic |
$ |
(0.34) |
$ |
1.05 |
$ |
(0.54) |
$ |
0.24 |
|||||||
Diluted |
$ |
(0.34) |
$ |
1.05 |
$ |
(0.54) |
$ |
0.24 |
|||||||
Weighted average number of |
|||||||||||||||
Basic |
50,455,832 |
49,437,062 |
50,439,682 |
49,388,475 |
|||||||||||
Diluted |
50,455,832 |
49,439,537 |
50,439,682 |
49,399,926 |
Contact:
Jaren Irene Madden, Senior Director,
Investor Relations and Corporate Communications
Jaren.Madden@infi.com
__________________________________
1 American Cancer Society, Cancer Facts and Statistics 2016, http://www.cancer.org/research/cancerfactsstatistics/cancerfactsfigures2016/index and http://www.cancer.org/cancer/skincancer-melanoma/detailedguide/melanoma-skin-cancer-key-statistics, Last Accessed April 27, 2017.
2 Conquer Cancer Foundation, Head and Neck Cancer Statistics, http://www.cancer.net/cancer-types/head-and-neck-cancer/statistics, Last Accessed April 27, 2017.
3 Kaneda, M., Messer, K., Ralainirina, N., Li, H., et al. PI3Kγ is a molecular switch that controls immune suppression. Nature, 2016 Nov;539:437–442.
4 De Henau, O., Rausch, M., Winkler, D., Campesato, L., et al. Overcoming resistance to checkpoint blockade therapy by targeting PI3Kγ in myeloid cells. Nature, 2016 Nov;539:443-447.
5 Tolcher, A., Hong, D., Sullivan, R., Chmielowski, B., et al. AACR Annual Meeting 2017.
6 www.clinicaltrials.gov, NCT02637531.
View original content:http://www.prnewswire.com/news-releases/infinity-provides-company-update-and-reports-second-quarter-2017-financial-results-300499252.html
SOURCE Infinity Pharmaceuticals, Inc.
Copyright 2017 PR Newswire
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