Phase 2 PUMA Study of PROHEMA® Initiated - Interim Data Expected in 2H14
Clinical Trial of PROHEMA® in Lysosomal Storage Disorders to Begin in 2H14
Encouraging Clinical Data Published Highlighting the Potential of Ex Vivo T Cell Modulation
SAN DIEGO, March 17, 2014 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (Nasdaq:FATE), a biopharmaceutical company engaged in the discovery and development of adult stem cell modulators to treat orphan diseases, today reported therapeutic program updates and announced financial results for the fourth quarter and year ended December 31, 2013.
"Over the next twelve months, we are well-positioned to expand our ex vivo modulation platform through clinical studies involving patients with a range of rare, life-threatening malignant and non-malignant diseases and disorders. In the second half of this year, we look forward to sharing interim results from our recently-launched Phase 2 PUMA study of PROHEMA® in adult patients with hematologic malignancies and to initiating a clinical trial of PROHEMA® in pediatric patients with certain forms of lysosomal storage disorders," commented Christian Weyer, M.D., M.A.S., President and Chief Executive Officer of Fate Therapeutics. "Additionally, we remain on track for initial clinical assessment of our Wnt7a protein therapeutics program for muscle regeneration in 2015 – we have initiated production cell line development for two proprietary Wnt7a protein analogs, and expanded our preclinical pharmacology assessment of these IND candidates beyond muscular dystrophy and into other muscle disorders."
Recent Program Developments
Financial Results & Financial Guidance
Today's Conference Call and Webcast
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 11276251. 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 discovery and development of pharmacologic modulators of adult stem cells to treat orphan diseases. The Company utilizes established pharmacologic modalities, including small molecules and therapeutic proteins, and well-characterized biological mechanisms to enhance the therapeutic potential of adult stem cells. The Company has built two adult stem cell modulation platforms: a hematopoietic stem cell (HSC) modulation platform, which seeks to optimize the therapeutic potential of HSCs for treating patients with hematologic malignancies and rare genetic disorders, and a muscle satellite stem cell modulation platform, which seeks to activate the regenerative capacity of muscle for treating patients with degenerative muscle disorders. The Company is presently advancing its lead product candidate, PROHEMA®, a pharmacologically-modulated HSC therapeutic, in Phase 2 clinical development for hematologic malignancies. Fate Therapeutics is also advancing its proprietary Wnt7a protein analogs in preclinical development for the treatment of muscular dystrophies. 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 our programs for the modulation of adult stem cells to treat orphan diseases, and our preclinical and clinical development plans, including the timing of, and our ability to conduct safety reviews of subjects in the PUMA study, and the timing and availability of both interim and full data in the trial, our ability to advance and the timing for the development of PROHEMA® for the treatment of pediatric patients, the ability of PROHEMA® to enhance, and the potential therapeutic benefits of enhancing, the survival and immunological properties of T cells, the timing of and our ability to complete cell line development of our Wnt7a protein analogs and advance a Wnt7a protein analog into clinical trials, the therapeutic potential of a Wnt7a protein analog for the treatment of muscle damage and trauma, the impact of our hiPSC platform technology, and our projected cash runway. 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 observed in prior clinical development may not be replicated in our PUMA trial or other subsequent clinical trials of PROHEMA®, PROHEMA® may not produce the therapeutic benefits suggested by the results observed in our prior clinical development or may cause other unanticipated adverse effects in subsequent clinical trials, the risk of cessation or delay of any ongoing or planned preclinical or clinical development activities for a variety of reasons, including additional information that may be requested or additional obligations that may be imposed by the FDA as a condition to our initiation of new clinical trials or continuation of clinical trials with PROHEMA®, any delays in enrollment of clinical trials with PROHEMA®, any negative results following resumption of clinical trials with PROHEMA®, any inability to complete the cell-line development, in vivo studies, and pharmacokinetic and toxicology assessments necessary to advance our Wnt7a analog program into clinical development, and any inability to develop hiPSC-derived muscle or hematopoietic cells suitable for therapeutic applications. 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-K for the fourth quarter and year ended December 31, 2013, and from time to time the company's other investor communications. Fate Therapeutics is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
|Condensed Consolidated Statements of Operations and Comprehensive Loss|
|(in thousands, except share and per share data)|
Three Months Ended
For the Years Ended
|Collaboration revenue||$ —||$193||$626||$1,268|
|Research and development||3,031||3,403||12,007||11,999|
|General and administrative||1,871||1,284||6,639||4,228|
|Total operating expenses||4,902||4,687||18,646||16,227|
|Loss from operations||(4,902)||(4,044)||(17,675)||(13,557)|
|Other income (expense):|
|Loss on extinguishment of debt||—||—||—||(323)|
|Change in fair value of warrant liability||(29)||2||(8)||37|
|Change in fair value of exchangeable shares||(433)||—||(2,421)||90|
|Total other income (expense), net||(837)||(111)||(3,219)||(682)|
|Net loss and comprehensive loss||$ (5,739)||$ (4,155)||$ (20,894)||$ (14,239)|
|Net loss per common share, basic and diluted||$ (0.29)||$ (3.51)||$ (3.54)||$ (13.06)|
|Weighted-average common shares used to compute basic and diluted net loss per share||19,717,235||1,183,488||5,896,171||1,090,317|
|Condensed Consolidated Balance Sheets|
|December 31,||December 31,|
|Cash and cash equivalents||$54,036||$9,087|
|Prepaid expenses and other assets||615||706|
|Total current assets||54,651||9,793|
|Liabilities, Convertible Preferred Stock and Stockholders' Equity (Deficit)|
|Accounts payable and accrued expenses||$2,721||$2,268|
|Other current liabilities||1,879||2,582|
|Total current liabilities||4,600||4,850|
|Exchangeable share liability||--||551|
|Other long-term liabilities||135||1,974|
|Convertible Preferred Stock||--||56,526|
|Stockholders' equity (deficit)||50,848||$ (52,825)|
|Total liabilities, convertible preferred stock and stockholders' equity||$55,583||$11,076|
Paul Cox, Stern Investor Relations, Inc. 212.362.1200, firstname.lastname@example.org
Fate Therapeutics, Inc.
San Diego, California, UNITED STATES
Paul Cox, Stern Investor Relations, Inc. 212.362.1200, email@example.com
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