CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov 14, 2022--
Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) (“Infinity” or the “Company”), a clinical-stage biotechnology company developing eganelisib, a first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic, today announced its third quarter 2022 financial results, provided a business update, and in a separate press release provided more mature data from the Phase 2 MARIO-3 1L TNBC clinical trial.
“Our top priority is entering into a strategic partnership to advance eganelisib development and pave the way to eventual approval. Current business development discussions are directed towards an initial, focused development plan in a randomized controlled setting. It is our goal to announce a partnership, and the focus of the next clinical study for eganelisib, in the first quarter of 2023,” said Adelene Perkins, Chief Executive Officer and Chair of Infinity. “We are encouraged by the long-term benefit seen in front-line TNBC patients reported earlier today from MARIO-3. These data are consistent with the long-term benefit seen in other indications in which eganelisib has been studied, giving us multiple potential paths forward to be prioritized with a prospective partner.”
MARIO-3 Clinical Update:
The Company reported today an update from its MARIO-3 study of eganelisib in combination with atezolizumab and nab-paclitaxel in front-line metastatic triple negative breast cancer (TNBC) patients: (Press release here )
Third Quarter 2022 Financial Results:
2022 Financial Outlook:
Infinity’s 2022 financial guidance remains as follows:
Conference Call Information
Infinity will host a conference call today, November 14, 2022, at 8:30 AM ET to discuss these financial results and business updates. To access the conference call, please register at https://register.vevent.com/register/BId44f86e6a2af42faadbb2844131346a8. Upon registering, each participant will be provided with call details and access codes. All participants are encouraged to join 10 minutes prior to the start time. A live webcast of the conference call can be accessed from the Events & Presentations page in the Investors/Media section of Infinity’s website at www.infi.com. An archived version of the webcast will be available on Infinity's website for 30 days following the event.
About Infinity and Eganelisib
Infinity Pharmaceuticals, Inc. (“Infinity” or the “Company”), is a clinical-stage biotechnology company developing eganelisib (IPI-549), a first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic which is designed to address a fundamental biologic mechanism of immune suppression in cancer in multiple clinical studies. 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. MARIO-275 is a randomized, controlled combination study of eganelisib combined with Opdivo ® 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 Company’s guidance with respect to net loss, cash and cash equivalents and cash runway; plans to evaluate and establish potential partnerships; 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 or will be successful in establishing a strategic partnership to further the development of eganelisib. 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.
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.
INFINITY PHARMACEUTICALS, INC. Condensed Consolidated Balance Sheets (in thousands) (unaudited) | ||||||
| September 30, 2022 |
| December 31, 2021 | |||
Cash and cash equivalents | $ | 47,182 |
|
| $ | 80,726 |
Other current assets |
| 2,168 |
|
|
| 1,542 |
Property and equipment, net |
| 906 |
|
|
| 1,241 |
Other long-term assets |
| 1,335 |
|
|
| 1,276 |
Total assets | $ | 51,591 |
|
| $ | 84,785 |
|
|
|
| |||
Accounts payable and accrued expenses | $ | 14,200 |
|
| $ | 13,300 |
Liabilities related to sale of future royalties, net 1 |
| 47,753 |
|
|
| 48,727 |
Operating lease liability, less current portion |
| 480 |
|
|
| 917 |
Long-term liabilities |
| 32 |
|
|
| 270 |
Total stockholders’ (deficit) equity |
| (10,874 | ) |
|
| 21,571 |
Total liabilities and stockholders’ (deficit) equity | $ | 51,591 |
|
| $ | 84,785 |
1 The company is not obligated to repay any of the liabilities related to sale of future royalties but these are recorded as a liability on the balance sheet in accordance with accounting guidance for royalty monetization. |
INFINITY PHARMACEUTICALS, INC. Condensed Consolidated Statements of Operations (in thousands, except share and per share amounts) (unaudited) | |||||||||||||||
| Three Months Ended September 30, |
| Nine Months Ended September 30, | ||||||||||||
| 2022 |
| 2021 |
| 2022 |
| 2021 | ||||||||
Royalty revenue | $ | 712 |
|
| $ | 428 |
|
| $ | 2,050 |
|
| $ | 1,407 |
|
Operating expenses: |
|
|
|
|
|
|
| ||||||||
Research and development |
| 7,663 |
|
|
| 7,073 |
|
|
| 25,448 |
|
|
| 23,231 |
|
General and administrative |
| 3,501 |
|
|
| 3,847 |
|
|
| 10,672 |
|
|
| 10,911 |
|
Royalty expense |
| 429 |
|
|
| 258 |
|
|
| 1,236 |
|
|
| 848 |
|
Total operating expenses |
| 11,593 |
|
|
| 11,178 |
|
|
| 37,356 |
|
|
| 34,990 |
|
Loss from operations |
| (10,881 | ) |
|
| (10,750 | ) |
|
| (35,306 | ) |
|
| (33,583 | ) |
Other income (expense): |
|
|
|
|
|
|
| ||||||||
Investment and other income |
| 209 |
|
|
| 82 |
|
|
| 302 |
|
|
| 107 |
|
Non-cash interest expense 1 |
| (45 | ) |
|
| (45 | ) |
|
| (135 | ) |
|
| (135 | ) |
Total other income (expense) |
| 164 |
|
|
| 37 |
|
|
| 167 |
|
|
| (28 | ) |
Net loss | $ | (10,717 | ) |
| $ | (10,713 | ) |
| $ | (35,139 | ) |
| $ | (33,611 | ) |
Basic and diluted loss per common share: | $ | (0.12 | ) |
| $ | (0.12 | ) |
| $ | (0.39 | ) |
| $ | (0.40 | ) |
Basic and diluted weighted average number of common shares outstanding: |
| 89,392,079 |
|
|
| 88,766,912 |
|
|
| 89,211,208 |
|
|
| 84,433,435 |
|
1 The liabilities related to sale of future royalties will be amortized using the effective interest method over the life of the arrangements. |
View source version on businesswire.com:https://www.businesswire.com/news/home/20221114005337/en/
CONTACT: Luke Heagle
Real Chemistry
lheagle@realchemistry.com
KEYWORD: MASSACHUSETTS UNITED STATES NORTH AMERICA
INDUSTRY KEYWORD: BIOTECHNOLOGY HEALTH PHARMACEUTICAL CLINICAL TRIALS ONCOLOGY
SOURCE: Infinity Pharmaceuticals, Inc.
Copyright Business Wire 2022.
PUB: 11/14/2022 07:07 AM/DISC: 11/14/2022 07:07 AM
http://www.businesswire.com/news/home/20221114005337/en