Full Press Release Details
Fate Therapeutics Reports Fourth Quarter and Full Year 2015 Financial Results
ProTmune Investigational New Drug Application for Prevention of Acute GvHD and CMV Infection
Cleared by FDA in January 2016
Phase 1/2 Clinical Trial of ProTmune to Commence Enrollment in mid-2016
Data Updates for All Preclinical Adoptive Immunotherapy Programs Expected in 1H16
San Diego, CA March 3, 2016 Fate Therapeutics, Inc. (NASDAQ: FATE), a biopharmaceutical company dedicated to the development
of programmed cellular immunotherapies for cancer and immune disorders, today reported business highlights and financial results for the fourth quarter and full year ended December 31, 2015.
During this past year, we significantly advanced our long-term corporate strategy, successfully building a ground-breaking preclinical pipeline of
programmed adoptive immunotherapies, including a NK-cell therapy for solid tumors, a CD34+ cell therapy for autoimmune diseases and off-the-shelf cancer therapies derived from engineered pluripotent cell lines. We also formed a strategic research
collaboration with Juno Therapeutics, leveraging our expertise in hematopoietic cell biology and ex vivo cell programming, to enhance the therapeutic function of Juno s engineered T-cell immunotherapies, said Scott Wolchko,
President and Chief Executive Officer of Fate Therapeutics. We have continued this momentum into 2016, having secured FDA clearance to conduct a Phase 1/2 clinical trial of ProTmune, and we look forward to safety and efficacy data from this
trial during 2016. Finally, we will begin sharing data across our entire preclinical pipeline at industry-leading scientific conferences during the first half of 2016.
Upcoming Anticipated Milestones
Financial Results & Guidance
Today s Conference Call and Webcast
will conduct a conference call on Thursday, March 3, 2016 at 5:00 p.m. ET to review financial and operating results for the quarter and full year ended December 31, 2015. 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 58417776. 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.
ProTmune is an investigational programmed cellular immunotherapy undergoing clinical development for use as an allogeneic HCT cell source in adult
patients with hematologic malignancies. The cell therapy is produced by modulating donor-sourced, human mobilized peripheral blood (mPB) ex vivo with two small molecules (FT1050 and FT4145) to enhance the biological properties and therapeutic
function of the hematopoietic cells. The programmed mPB cells are adoptively transferred and administered to a patient as a one-time intravenous infusion.
About Fate Therapeutics, Inc.
Fate Therapeutics is a
biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders. The Company s cell therapy pipeline is comprised of immuno-oncology programs, including off-the-shelf NK- and T-cell
cancer immunotherapies derived from engineered induced pluripotent cells, and immuno-regulatory programs, including hematopoietic cell immunotherapies for protecting the immune system of patients undergoing hematopoietic cell transplantation and for
suppressing autoimmunity. 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.
Forward-Looking Statements
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 anticipated development and regulatory milestones and plans related to, the Company s product candidates, clinical studies and partnerships as well as the Company s 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 , will not be observed in ongoing or future studies involving these product candidates, the risk that 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 requirements that may be imposed by regulatory authorities and requirements for regulatory approval, 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), the risk that the Company s research collaborations, including with Juno Therapeutics, may not be successful or may be terminated 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 quarterly 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 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 December 31, | Years Ended December 31, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| (unaudited) | ||||||||||||||||
| Collaboration revenue | $ | 1,076 | $ | $ | 2,431 | $ | ||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 5,433 | 3,865 | 19,861 | 16,435 | ||||||||||||
| General and administrative | 2,555 | 2,078 | 10,352 | 8,469 | ||||||||||||
| Total operating expenses | 7,988 | 5,943 | 30,213 | 24,904 | ||||||||||||
| Loss from operations | (6,912 | ) | (5,943 | ) | (27,782 | ) | (24,904 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 3 | 1 | 10 | 2 | ||||||||||||
| Interest expense | (537 | ) | (291 | ) | (2,220 | ) | (549 | ) | ||||||||
| Loss on extinguishment of debt | (432 | ) | ||||||||||||||
| Total other expense, net | (534 | ) | (290 | ) | (2,210 | ) | (979 | ) | ||||||||
| Net loss and comprehensive loss | $ | (7,446 | ) | $ | (6,233 | ) | $ | (29,992 | ) | $ | (25,883 | ) | ||||
| Net loss per common share, basic and diluted | $ | (0.26 | ) | $ | (0.30 | ) | $ | (1.18 | ) | $ | (1.27 | ) | ||||
| Weighted-average common shares used to compute basic and diluted net loss per share | 28,687,797 | 20,501,713 | 25,484,262 | 20,451,840 |
Condensed Consolidated Balance Sheets
| December 31, 2015 | December 31, 2014 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 64,809 | $ | 49,101 | ||||
| Prepaid expenses and other assets | 843 | 760 | ||||||
| Total current assets | 65,652 | 49,861 | ||||||
| Long-term assets | 2,306 | 1,322 | ||||||
| Total assets | $ | 67,958 | $ | 51,183 | ||||
| Liabilities and Stockholders Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 3,435 | $ | 2,905 | ||||
| Long-term debt, current portion | 7,550 | 1,535 | ||||||
| Deferred revenue, current portion | 2,401 | |||||||
| Other current liabilities | 55 | 130 | ||||||
| Total current liabilities | 13,441 | 4,570 | ||||||
| Long-term debt, less current portion | 10,688 | 18,073 | ||||||
| Deferred revenue | 4,934 | |||||||
| Other long-term liabilities | 857 | 200 | ||||||
| Stockholders equity | 38,038 | 28,340 | ||||||
| Total liabilities and stockholders equity | $ | 67,958 | $ | 51,183 |
Baumgartner, Stern Investor Relations, Inc.
212.362.1200, jesse@sternir.com