CAMBRIDGE, Mass., Oct. 1, 2018 /PRNewswire/ -- Infinity
Pharmaceuticals, Inc. (NASDAQ: INFI) announced today that it earned
a $22 million payment from Verastem
Oncology under the license agreement between the Company and
Verastem for COPIKTRA (duvelisib). The payment was earned
upon the approval by the U.S. Food and Drug Administration (FDA) on
September 24, 2018 of duvelisib for
the treatment of adult patients with relapsed or refractory chronic
lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at
least two prior therapies, as well as accelerated approval for the
treatment of adult patients with relapsed or refractory follicular
lymphoma after at least two prior systemic therapies.
"We are really pleased that duvelisib is now available for
patients with CLL/SLL and follicular lymphoma and are proud of the
role Infinity played in its development," said Adelene Perkins, Chief Executive Officer and
Chair of Infinity. "This $22 million
FDA approval payment from Verastem supports Infinity's continued
expansion of the development of IPI-549, our first-in-class, oral,
immuno-oncology development candidate that selectively inhibits
phosphoinositide-3-kinase-gamma (PI3K-gamma), including in doublet
and triplet combination trials to identify the best combination
regimens to treat patients with specific types of cancer."
In 2016, Infinity entered into a license agreement granting
Verastem an exclusive worldwide license for the research,
development, commercialization, and manufacture of duvelisib and
products containing duvelisib in oncology. Pursuant to the terms of
the license agreement, Verastem has notified Infinity of its
election to make the $22 million
payment in cash, which Infinity expects to receive later this year.
Infinity also is eligible for royalties on worldwide net sales of
duvelisib ranging from the mid-to-high single digits, shared
equally with Takeda.
Infinity's updated 2018 financial guidance is:
- Net Loss: Infinity expects net loss for 2018 to range
from $10 million to $20 million.
- Cash and Investments: Infinity expects to end 2018 with
a year-end cash, cash equivalents and available-for-sale securities
balance ranging from $50 million to
$60 million.
- Cash Runway: Based on its current operational plans,
Infinity expects that its existing cash, cash equivalents and
available-for-sale securities will be adequate to satisfy the
company's capital needs into 2020. Infinity's financial guidance
excludes additional funding or business development activities and
does not include a potential $2
million payment from PellePharm, a private company, upon
initiation of a Phase 3 study for the hedgehog inhibitor program,
which Infinity licensed to PellePharm in 2013.
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 1/1b 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 other
treatment regimens; clinical trial plans regarding IPI-549; 2018
financial guidance and the company's ability to execute on its
strategic plans. Management's expectations and such forward-looking
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, including the
risks described 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 7,
2018, 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.
Contact:
Stephanie
Ascher, Stern Investor Relations, Inc.
212-362-1200 or stephanie@sternir.com
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SOURCE Infinity Pharmaceuticals, Inc.