First Subject Treated with FATE-NK100 in VOYAGE for Acute Myelogenous Leukemia
FDA Clears Investigational New Drug Applications for FATE-NK100 in Recurrent Ovarian Cancer and in Advanced Solid Tumors with Monoclonal Antibody Therapy
Company Convenes PROTECT Data Monitoring Committee for ProTmune™ Phase 1 Review Following Treatment of First Six Subjects
SAN DIEGO, Aug. 14, 2017 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, today reported business highlights and financial results for the second quarter ended June 30, 2017.
"Clinical momentum across our first-in-class cellular immunotherapy programs continues to accelerate. The first subject was treated with FATE-NK100 in VOYAGE for AML, and we look forward to opening two additional clinical trials of FATE-NK100 for the treatment of multiple advanced solid tumor types including in combination with monoclonal antibody therapy," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "Our productive discussions with the FDA continue regarding the advancement of our proprietary iPSC-derived cancer immunotherapy pipeline toward first-in-human studies. We currently remain on-track to file, in the first quarter of 2018, an investigational new drug application with the FDA for FT500i, a first-of-kind natural killer cell product candidate derived from a master pluripotent cell line. We are also prepared to initiate enrollment in the Phase 2 efficacy stage of PROTECT next month. Six subjects received ProTmune and we have convened the study's data monitoring committee to review the Phase 1 data."
Recent Highlights & Program Updates
Second Quarter 2017 Financial Results
Today's Conference Call and Webcast
The Company will conduct a conference call today, Monday, August 14, 2017 at 5:00 p.m. ET to review financial and operating results for the quarter ended June 30, 2017. In order to participate in the conference call, please dial 877-303-6235 (domestic) or 631-291-4837 (international) and refer to conference ID 53251051. The live webcast can be accessed under "Events & Presentations" in the Investors & Media section of the Company's website at www.fatetherapeutics.com. The archived webcast will be available on the Company's website beginning approximately two hours after the event.
About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders. The Company's hematopoietic cell therapy pipeline is comprised of NK- and T-cell immuno-oncology programs, including off-the-shelf product candidates derived from engineered induced pluripotent cell lines, and immuno-regulatory programs, including product candidates to prevent life-threatening complications in patients undergoing hematopoietic cell transplantation and to promote immune tolerance in patients with autoimmune disease. Its adoptive cell therapy programs are based on the Company's novel ex vivo cell programming approach, which it applies to modulate the therapeutic function and direct the fate of immune cells. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.
This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company's advancement of and plans related to the Company's product candidates, clinical studies, research and development programs, the Company's progress and plans for its clinical investigation of ProTmune™ and of FATE-NK100, the Company's expected product development and regulatory strategy for its iPSC-derived product candidates, the timing for initiation of the Company's planned Phase 2 stage of PROTECT and for filing of an IND for FT500i, the therapeutic potential of ProTmune and FATE-NK100, and the Company's financial condition and projected cash expenditures. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that results observed in prior studies, including preclinical studies of ProTmune and FATE-NK100, will not be observed in ongoing or future studies involving these product candidates, the risk of a delay in the enrollment or evaluation of subjects in any ongoing clinical studies, the risk that the Company may cease or delay preclinical or clinical development for any of its existing or future product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities and requirements for regulatory approval, difficulties or delays in subject enrollment in current and planned clinical trials, difficulties in manufacturing and supplying the Company's product candidates for clinical testing, and any adverse events or other negative results that may be observed during preclinical or clinical development), and the risk that the Company's expenditures may exceed current expectations for a variety of reasons. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Company's periodic filings with the Securities and Exchange Commission, including but not limited to the Company's most recently filed periodic report, and from time to time the Company's other investor communications. Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.
Availability of Other Information about Fate Therapeutics, Inc.
Investors and others should note that the Company routinely communicates with investors and the public using its website (www.fatetherapeutics.com) and its investor relations website (ir.fatetherapeutics.com), including without limitation, through the posting of investor presentations, SEC filings, press releases, public conference calls and webcasts on these websites. The information posted on these websites could be deemed to be material information. As a result, investors, the media, and others interested in Fate Therapeutics are encouraged to review this information on a regular basis. The contents of the Company's website, or any other website that may be accessed from the Company's website, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.
|Condensed Consolidated Statements of Operations and Comprehensive Loss|
|(in thousands, except share and per share data)|
|Three Months Ended|
|Six Months Ended|
|Research and development||7,927||6,782||15,893||13,418|
|General and administrative||2,669||2,249||5,701||4,851|
|Total operating expenses||10,596||9,031||21,594||18,269|
|Loss from operations||(9,570||)||(8,004||)||(19,541||)||(15,920||)|
|Other income (expense):|
|Total other expense, net||(75||)||(404||)||(230||)||(865||)|
|Other comprehensive income (loss):|
|Unrealized gain (loss) on available-for-sale|
|Net loss per common share, basic and diluted||$||(0.23||)||$||(0.29||)||$||(0.48||)||$||(0.58||)|
|Weighted-average common shares used to compute|
|basic and diluted net loss per share||41,406,367||28,868,464||41,397,398||28,823,127|
|Condensed Consolidated Balance Sheets|
|June 30,||December 31,|
|Cash and cash equivalents||$||31,063||$||88,609|
|Prepaid expenses and other current assets||848||1,211|
|Total current assets||71,861||93,323|
|Liabilities and stockholders' equity|
|Accounts payable and accrued expenses||$||5,946||$||4,891|
|Long-term debt, current portion||—||8,187|
|Current portion of deferred revenue||2,105||2,105|
|Other current liabilities||1||4|
|Total current liabilities||8,052||15,187|
|Long-term debt, net of current portion||6,676||2,501|
|Other long-term liabilities||2,235||1,377|
|Total liabilities and stockholders' equity||$||73,952||$||95,048|
Contact: Christina Tartaglia Stern Investor Relations, Inc. 212.362.1200 email@example.com