Fate Therapeutics Reports Second Quarter 2018 Financial Results and Highlights Operational Progress
Treated 20th Subject in Phase 2 PROTECT Study of ProTmune
Opened Second Site for Enrollment of FATE-NK100 DIMENSION Study
Submitted First-of-Kind IND to
Licensed Novel CAR Constructs from
“Our submission to the
Clinical Programs
- Treated 20th Subject in Phase 2 PROTECT Study of ProTmune™. During the second quarter of 2018, 14 subjects were treated in the randomized, controlled and double-blinded Phase 2 PROTECT study, which is intended to enroll a total of 60 adult subjects with hematologic malignancies undergoing allogeneic hematopoietic cell transplantation (HCT). Subjects in the Phase 2 PROTECT study are being randomized, in a 1:1 ratio, to receive either ProTmune, the Company’s next-generation hematopoietic cell graft, or a conventional matched unrelated donor cell graft. The Company has submitted an abstract to present clinical data from the seven subjects that were administered ProTmune in the Phase 1 stage of PROTECT, including data on a key secondary endpoint assessing freedom from chronic graft-versus-host disease (GvHD), cancer relapse and death at 1-year following HCT, at the 2018 ASH Annual Meeting.
- Expanded Enrollment of FATE-NK100 Dimension Study to
Baylor University Medical Center . The Company has now enrolled subjects in the Phase 1 DIMENSION study at two of the nation’s leading cancer research centers,Baylor Charles A. Sammons Cancer Center inDallas and theMasonic Cancer Center ,University of Minnesota . The DIMENSION study is assessing the safety and efficacy of NK100 when administered as a monotherapy and in combination with trastuzumab or cetuximab, twoFDA -approved monoclonal antibodies that are widely used today to treat various solid tumor malignancies. Three Phase 1 clinical trials of NK100 are currently being conducted in subjects with advanced liquid and solid tumors, and the Company plans to present additional clinical data for NK100 in the second half of 2018.
Universal Off-the-Shelf Cancer Immunotherapy Preclinical Pipeline
- Submitted First-of-Kind IND Application to
FDA for FT500. Within the last thirty days, the Company submitted an Investigational New Drug (IND) application to theU.S. Food and Drug Administration (FDA ) for FT500, a universal, off-the-shelf NK cell product. FT500 is the first product candidate emerging from the Company’s industry-leading induced pluripotent stem cell (iPSC) product platform, which uses clonal master iPSC lines as a renewable source for producing off-the-shelf cellular immunotherapies. The Company plans to clinically investigate FT500 in combination withFDA -approved checkpoint inhibitors as a rescue therapy. - Gained Rights to Novel CAR Constructs and CRISPR Gene-Editing from MSK. In May, the Company expanded its existing license agreement with
Memorial Sloan Kettering Cancer Center (MSK) to further enable the development of off-the-shelf CAR T-cell immunotherapies, including the Company’s universal, off-the-shelf CAR19 T-cell product candidate FT819. The newly-licensed portfolio of intellectual property covers certain patents and patent applications relating to novel chimeric antigen receptor (CAR) constructs and off-the-shelf CAR T cells, including the use of CRISPR and other innovative technologies for their production. In connection with amending the license agreement,Fate Therapeutics paid an upfront fee of$500,000 and issued 500,000 shares of the Company’s common stock valued at$4.8 million to MSK, and MSK returned its entire interest inTfinity Therapeutics, Inc. to the Company.
Organization
- Promoted Bob Valamehr, Ph.D. to Chief Development Officer. Dr. Valamehr joined
Fate Therapeutics in 2009 and oversees the Company’s iPSC product platform, including the development of the Company’s off-the-shelf NK cell and T-cell cancer immunotherapy pipeline. He is first author on the Company’s 2014 seminal publication in Stem Cell Reports describing the Company’s ground-breaking approach to the footprint-free generation, clonal selection and master cell banking of human iPSCs (https://doi.org/10.1016/j.stemcr.2014.01.014). - Appointed
Michael Lee to Board of Directors. Mr. Lee is co-founder of and has served as a portfolio manager atRedmile Group, LLC , a health care-focused investment firm based inSan Francisco andNew York , since 2007.
Second Quarter 2018 Financial Results
- Cash & Short-term Investment Position: Cash, cash equivalents and short-term investments as of
June 30, 2018 were$78.0 million compared to$100.9 million as ofDecember 31, 2017 . The decrease was primarily driven by the Company’s use of cash to fund operating activities. - Total Revenue: Revenue was
$1.0 million for the second quarter of 2018 as well as for the same period in 2017. All revenue was derived from the Company’s research collaboration and license agreement with Juno Therapeutics. - R&D Expenses: Research and development expenses were
$16.8 million for the second quarter of 2018, compared to$7.9 million for the same period in 2017. In the second quarter of 2018, the Company incurred a one-time$5.3 million expense associated with the in-license of additional intellectual property from MSK. The remaining increase in R&D expenses was primarily attributable to an increase in expenses associated with the clinical development of FATE-NK100 and with regulatory and manufacturing activities to support the submission of the FT500 IND application. - G&A Expenses: General and administrative expenses were
$3.8 million for the second quarter of 2018, compared to$2.7 million for the same period in 2017. The increase in G&A expenses was primarily attributable to an increase in employee compensation associated with growth in headcount and in intellectual property-related expenses. - Shares Outstanding: Common shares outstanding were 53.4 million as of
June 30, 2018 and 52.6 million as ofDecember 31, 2017 . Preferred shares outstanding as ofJune 30, 2018 andDecember 31, 2017 were 2.8 million, each of which is convertible into five shares of common stock. All preferred shares outstanding are from the Company’s sale and issuance of non-voting Class A convertible preferred stock toRedmile Group, LLC inNovember 2016 .
Today's Conference Call and Webcast
The Company will conduct a conference call today,
About FATE-NK100
FATE-NK100 is an investigational, first-in-class, allogeneic donor-derived natural killer (NK) cell cancer immunotherapy comprised of adaptive memory NK cells, a highly specialized and functionally distinct subset of activated NK cells expressing the maturation marker CD57. Higher frequencies of CD57+ NK cells in the peripheral blood or tumor microenvironment in cancer patients have been linked to better clinical outcomes. In
About ProTmune™
ProTmune™ is an investigational next-generation hematopoietic cell graft for the prevention of acute graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic cell transplantation (HCT). ProTmune is manufactured by pharmacologically modulating a donor-sourced, mobilized peripheral blood graft ex vivo with two small molecules (FT1050 and FT4145) to decrease the incidence and severity of acute GvHD while maintaining the anti-leukemia activity of the graft. ProTmune has been granted Orphan Drug and Fast Track Designations by the
About Fate Therapeutics’ iPSC Product Platform
The Company’s proprietary iPSC product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered in repeat doses to mediate more effective pharmacologic activity, including in combination with cycles of other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event, and selecting a single iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for consistently and repeatedly manufacturing homogeneous cell products in quantities that support the treatment of patients in an off-the-shelf manner. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 100 issued patents and 100 pending patent applications.
About
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 results of operations, financial condition and sufficiency of its cash and cash equivalents to fund its operations, as well as statements regarding the advancement of and plans related to its product candidates, clinical studies and preclinical research and development programs, the Company’s progress, plans and timelines for its manufacture and clinical investigation of ProTmune™ and FATE-NK100 and its manufacture, preclinical development and intended clinical investigation of its iPSC-derived product candidates, including FT500, the timing for the Company’s receipt of data from its clinical trials and preclinical studies, the Company’s development and regulatory strategy, and the therapeutic and market potential of the Company’s product candidates. 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 of its product candidates, including preclinical studies and clinical trials 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 initiation of, or in the enrollment or evaluation of subjects in, any clinical studies, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials or to support regulatory approval, difficulties or delays in subject enrollment in current and planned clinical trials, difficulties in manufacturing or 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 the Company’s 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
Availability of Other Information about
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,
| Condensed Consolidated Statements of Operations and Comprehensive Loss |
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| (in thousands, except share and per share data) |
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| (unaudited) |
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| Three Months Ended | Six Months Ended | ||||||||||||||||||
| June 30, | June 30, | ||||||||||||||||||
| 2018 | 2017 | 2018 | 2017 | ||||||||||||||||
| Collaboration revenue | $ | 1,027 | $ | 1,026 | $ | 2,053 | $ | 2,053 | |||||||||||
| Operating expenses: | |||||||||||||||||||
| Research and development | 16,816 | 7,927 | 28,292 | 15,893 | |||||||||||||||
| General and administrative | 3,816 | 2,669 | 7,420 | 5,701 | |||||||||||||||
| Total operating expenses | 20,632 | 10,596 | 35,712 | 21,594 | |||||||||||||||
| Loss from operations | (19,605 | ) | (9,570 | ) | (33,659 | ) | (19,541 | ) | |||||||||||
| Other income (expense): | |||||||||||||||||||
| Interest income | 376 | 137 | 707 | 248 | |||||||||||||||
| Interest expense | (425 | ) | (212 | ) | (837 | ) | (478 | ) | |||||||||||
| Total other expense, net | (49 | ) | (75 | ) | (130 | ) | (230 | ) | |||||||||||
| Net loss | $ | (19,654 | ) | $ | (9,645 | ) | $ | (33,789 | ) | $ | (19,771 | ) | |||||||
| Other comprehensive loss: | |||||||||||||||||||
| Unrealized loss on available-for-sale securities, net | (2 | ) | (5 | ) | (12 | ) | (38 | ) | |||||||||||
| Comprehensive loss | $ | (19,656 | ) | $ | (9,650 | ) | $ | (33,801 | ) | $ | (19,809 | ) | |||||||
| Net loss per common share, basic and diluted | $ | (0.37 | ) | $ | (0.23 | ) | $ | (0.64 | ) | $ | (0.48 | ) | |||||||
| Weighted–average common shares used to compute basic and diluted net loss per share | 53,130,518 | 41,406,367 | 52,947,926 | 41,397,398 | |||||||||||||||
| Condensed Consolidated Balance Sheets | ||||||||
| (in thousands) | ||||||||
| (unaudited) | ||||||||
| June 30, | December 31, | |||||||
| 2018 | 2017 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 36,162 | $ | 88,952 | ||||
| Short-term investments and related maturity receivables | 41,857 | 11,997 | ||||||
| Prepaid expenses and other current assets | 2,015 | 1,647 | ||||||
| Total current assets | 80,034 | 102,596 | ||||||
| Long-term assets | 3,121 | 2,696 | ||||||
| Total assets | $ | 83,155 | $ | 105,292 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 11,886 | $ | 8,932 | ||||
| CIRM award liability | 600 | — | ||||||
| Long-term debt, current portion | 2,011 | — | ||||||
| Current portion of deferred revenue | 1,776 | 2,105 | ||||||
| Other current liabilities | — | 12 | ||||||
| Total current liabilities | 16,273 | 11,049 | ||||||
| Long-term debt, net of current portion | 12,835 | 14,808 | ||||||
| CIRM award liability | 400 | — | ||||||
| Deferred revenue | — | 724 | ||||||
| Other long-term liabilities | 1,822 | 1,522 | ||||||
| Stockholders’ equity | 51,825 | 77,189 | ||||||
| Total liabilities and stockholders’ equity | $ | 83,155 | $ | 105,292 | ||||
Contact:
Christina Tartaglia
Stern Investor Relations, Inc.
212.362.1200
christina@sternir.com
Source: Fate Therapeutics, Inc.