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Interim Data From PROHEMA® PUMA Study Show Reduction in Severe Infections Across Multiple Pathogen Types
Strategic Research Collaboration Formed With Juno Therapeutics to Identify Small Molecule Modulators for Programming CAR T and TCR Immunotherapeutics
Two Natural Killer Cell-Based Programs Launched in Collaboration With University of Minnesota for Development of "Off-the-Shelf" Cancer Immunotherapeutics
SAN DIEGO, Aug. 5, 2015 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ:FATE), a biopharmaceutical company engaged in the development of programmed cellular immunotherapeutics for the treatment of severe, life-threatening diseases, today announced its financial results for the second quarter ended June 30, 2015, and recent corporate and clinical highlights.
"The interim data from our Phase 2 PUMA study indicate that the therapeutic value proposition of PROHEMA may include the prevention of severe life-threatening infections across a broad spectrum of bacterial, fungal and viral pathogens through a one-time administration at the time of hematopoietic cell transplantation (HCT). This would alleviate a significant cause of morbidity and mortality in patients undergoing HCT and also reduce the need for costly anti-infective treatment regimens following HCT," said Christian Weyer, M.D., M.A.S., President and Chief Executive Officer of Fate Therapeutics. "During the second half of 2015, we look forward to sharing additional clinical data from our adult and pediatric clinical development initiatives for PROHEMA. Additionally, we are aggressively moving to extend the promising observations from our PROHEMA clinical experience to other cell sources used in HCT including mobilized peripheral blood, where severe infections and graft-versus-host disease represent significant unmet medical needs. We remain on track to file an IND by the end of 2015 for PROTMUNE, a programmed mobilized peripheral blood immunotherapeutic designed to enhance the therapeutic properties of donor T cells."
Recent Corporate & Clinical Highlights
Today's Conference Call and Webcast
The Company will conduct a conference call on Wednesday, August 5th, 2015 at 5:00 p.m. ET to report on the Company's financial and operating results for the quarter ended June 30th, 2015 and provide a corporate update. In order to participate in the conference call, please dial 1-877-303-6235 (domestic) or 1-631-291-4837 (international) and refer to conference ID 93536859. The live webcast can be accessed under "Events & Presentations" in the Investors and 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 engaged in the development of programmed cellular immunotherapeutics for the treatment of severe, life-threatening diseases. The Company's lead product candidate, PROHEMA®, is a programmed hematopoietic cell-based immunotherapeutic, which is currently in clinical development in patients undergoing hematopoietic cell transplantation. The Company is also developing a PD-L1 programmed CD34+ cell immunotherapeutic for the treatment of autoimmune diseases and is leveraging its proprietary induced pluripotent stem cell platform to develop natural killer cell and T-cell cancer immunotherapeutics. 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 therapeutic potential of the Company's product candidates, including PROHEMA® and PROTMUNE™, and any product candidates that may arise from the Company's strategic collaborations with Juno Therapeutics, Inc. and the University of Minnesota, the Company's clinical development plans for PROHEMA and PROTMUNE, the timing of availability of data from the Company's ongoing Phase 2 PUMA study, the timing of the Company's filing of an IND and initiation of the clinical investigation for PROTMUNE, the success of the Company's collaborations with Juno and the University of Minnesota, and the amount and timing of potential milestone payments and royalties that the Company is eligible to receive under its strategic collaboration with Juno. 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 risks that: the results of PROHEMA observed in prior preclinical and clinical development may not be replicated in ongoing clinical trials, including the PUMA study and the PROVIDE study, or in subsequent clinical trials of PROHEMA, the results observed in the PUMA study to date represent only interim results for a limited number of patients and final results may differ materially, the Company may cease or delay preclinical or clinical development activities for any of its existing or future product candidates for a variety of reasons (including additional requirements that may be imposed by regulatory authorities, changes in regulatory approval pathways, difficulties or delays in patient enrollment in current and planned clinical trials, and any adverse events or other negative results that may be observed during preclinical or clinical development), or the Company's strategic collaborations with Juno and with the University of Minnesota may not be successful or may be terminated 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 Form 10-Q for the quarter ended June 30th, 2015, 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 we routinely communicate with our investors and the public using our company website (www.fatetherapeutics.com) and our investor relations website (ir.fatetherapeutics.com), including without limitation, through the posting of investor presentations, Securities and Exchange Commission filings, press releases, public conference calls and webcasts on our websites. The information that we post on these websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in Fate Therapeutics to review the information that we post on these websites on a regular basis. The contents of our website, or any other website that may be accessed from our 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|
|June 30,||June 30,|
|Collaboration revenue||$ 329||$ —||$ 329||$ —|
|Research and development||4,857||3,968||9,425||8,490|
|General and administrative||2,690||2,072||5,446||4,487|
|Total operating expenses||7,547||6,040||14,871||12,977|
|Loss from operations||(7,218)||(6,040)||(14,542)||(12,977)|
|Other income (expense):|
|Total other expense, net||(561)||(27)||(1,118)||(70)|
|Net loss and comprehensive loss||$ (7,779)||$ (6,067)||$ (15,660)||$ (13,047)|
|Net loss per common share, basic and diluted||$ (0.33)||$ (0.30)||$ (0.70)||$ (0.64)|
|Weighted-average common shares used to compute basic and diluted net loss per share||23,920,630||20,467,782||22,246,832||20,407,632|
|Condensed Consolidated Balance Sheets|
|June 30,||December 31,|
|Cash and cash equivalents||$ 81,176||$ 49,101|
|Prepaid expenses and other assets||395||760|
|Total current assets||81,571||49,861|
|Total assets||$ 83,483||$ 51,183|
|Liabilities and Stockholders' Equity|
|Accounts payable and accrued expenses||$ 3,998||$ 2,905|
|Long-term debt, current portion||5,156||1,535|
|Deferred revenue, current portion||2,105||—|
|Other current liabilities||56||130|
|Total current liabilities||11,315||4,570|
|Long-term debt, less current portion||14,539||18,073|
|Other long-term liabilities||569||200|
|Total liabilities and stockholders' equity||$ 83,483||$ 51,183|
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