-Obtained Approvals of CTAs in Multiple Countries for CTX001 in β-thalassemia and SCD-
-Initiation of Clinical Trials for CTX001 in β-thalassemia and SCD on Track for 2018-
-Preclinical Studies for CTX110 Targeting CD19+ Malignancies Have Begun-
-Significantly Expanded Patent Portfolio with New Allowances-
-$319.7 million in cash as of June 30, 2018-
ZUG, Switzerland and CAMBRIDGE, Mass., Aug. 07, 2018 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (NASDAQ: CRSP), a biopharmaceutical company focused on developing transformative gene-based medicines for serious diseases, today reported financial results for the second quarter 2018 and commented on recent accomplishments and clinical development plans.
“In the first half of 2018, we continued to drive rapid and meaningful progress across our hemoglobinopathies program and our immuno-oncology platform,” commented Samarth Kulkarni, Ph.D., Chief Executive Officer of CRISPR Therapeutics. “We obtained approval of Clinical Trial Applications (CTA) in multiple countries for both β-thalassemia and sickle cell disease (SCD) and we continue to work closely with various clinical sites to initiate these trials. In parallel, we are working diligently with the FDA and have a clear path to resolve the current clinical hold of the Investigational New Drug application (IND) in the U.S. for SCD. In immuno-oncology, a key area of focus for us, preclinical studies have begun, and we look forward to initiating clinical trials early next year.”
Dr. Kulkarni continued, “As we move to the second half of the year, our focus remains on the execution of our development programs to bring us closer to our goal of providing transformational medicines to patients with significant unmet medical needs. We look forward to continuing our progress across key areas of our pipeline throughout the remainder of 2018.”
Recent Highlights and Outlook
Second Quarter 2018 Financial Results
About CRISPR Therapeutics
CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. The Company has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic collaborations with leading companies including Bayer AG and Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Cambridge, Massachusetts, and business offices in London, United Kingdom. For more information, please visit www.crisprtx.com.
CRISPR Forward-Looking Statement
Certain statements set forth in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the timing of filing of clinical trial applications and INDs, any approvals thereof and timing of commencement of clinical trials, the intellectual property coverage and positions of the Company, its licensors and third parties, the sufficiency of the Company’s cash resources and the therapeutic value, development, and commercial potential of CRISPR/Cas9 gene editing technologies and therapies. You are cautioned that forward-looking statements are inherently uncertain. Although the Company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those projected or suggested in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: uncertainties regarding the intellectual property protection for our technology and intellectual property belonging to third parties; uncertainties inherent in the initiation and completion of preclinical studies for the Company’s product candidates; availability and timing of results from preclinical studies; whether results from a preclinical trial will be predictive of future results of the future trials; expectations for regulatory approvals to conduct trials or to market products; and those risks and uncertainties described under the heading “Risk Factors” in the Company’s most recent annual report on Form 10-K, and in any other subsequent filings made by the Company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC’s website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.
CRISPR Therapeutics AG
Condensed Consolidated Statements of Operations
(Unaudited, In thousands except share data and per share data)
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||
Collaboration revenue | $ | 1,088 | $ | 3,582 | $ | 2,446 | $ | 6,285 | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | 25,633 | 17,120 | 45,152 | 31,925 | ||||||||||||
General and administrative | 12,741 | 7,768 | 21,577 | 16,410 | ||||||||||||
Total operating expenses | 38,374 | 24,888 | 66,729 | 48,335 | ||||||||||||
Loss from operations | (37,286 | ) | (21,306 | ) | (64,283 | ) | (42,050 | ) | ||||||||
Total other (expense) income, net | (998 | ) | (666 | ) | (2,215 | ) | (1,118 | ) | ||||||||
Net loss before income taxes | (38,284 | ) | (21,972 | ) | (66,498 | ) | (43,168 | ) | ||||||||
Provision for income taxes | (96 | ) | (343 | ) | (182 | ) | (622 | ) | ||||||||
Net loss | (38,380 | ) | (22,315 | ) | (66,680 | ) | (43,790 | ) | ||||||||
Foreign currency translation adjustment | (21 | ) | 6 | (9 | ) | 30 | ||||||||||
Comprehensive Loss | $ | (38,401 | ) | $ | (22,309 | ) | $ | (66,689 | ) | $ | (43,760 | ) | ||||
Reconciliation of net loss to net loss attributable to common shareholders: | ||||||||||||||||
Net loss | $ | (38,380 | ) | $ | (22,315 | ) | $ | (66,680 | ) | $ | (43,790 | ) | ||||
Net loss per share attributable to common shareholders - basic and diluted | $ | (0.82 | ) | $ | (0.56 | ) | $ | (1.44 | ) | $ | (1.10 | ) | ||||
Weighted-average common shares outstanding used in calculating net loss per share attributable to common shareholders - basic and diluted | 46,842,316 | 39,895,938 | 46,362,538 | 39,811,412 | ||||||||||||
CRISPR Therapeutics AG
Condensed Consolidated Balance Sheets Data
(Unaudited, in thousands)
As of | ||||||||
June 30, 2018 | December 31, 2017 | |||||||
Cash | $ | 319,737 | $ | 239,758 | ||||
Working capital | 312,068 | 233,874 | ||||||
Total assets | 353,130 | 271,346 | ||||||
Total shareholders' equity | 265,154 | 187,832 | ||||||
Media Contacts:
Jennifer Paganelli
WCG on behalf of CRISPR
347-658-8290
[email protected]
Investor Contacts:
Susan Kim
617-307-7503
[email protected]
Chris Brinzey
Westwicke Partners on behalf of CRISPR
339-970-2843
[email protected]
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