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CRISPR Therapeutics Provides Business Update and Reports Third Quarter 2018 Financial Results

-Initiated Phase 1/2 Clinical Trial of CTX001 in β-thalassemia-
 -Targeting Initiation of Clinical Trial for CTX110, Targeting CD19+ Malignancies, in 1H 2019-
-$487.3 Million in Cash as of September 30, 2018-

ZUG, Switzerland and CAMBRIDGE, Mass., Nov. 07, 2018 (GLOBE NEWSWIRE) — CRISPR Therapeutics (NASDAQ: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, today reported financial results for the third quarter ended September 30, 2018 and commented on recent accomplishments and clinical development plans.

“As we enter the fourth quarter, we are actively moving our programs forward and expanding our clinical development activities in sickle cell disease, β-thalassemia and immuno-oncology,” said Samarth Kulkarni, Ph.D., Chief Executive Officer of CRISPR Therapeutics. “Importantly, enrollment for a Phase 1/2 trial of CTX001 for β-thalassemia is currently open at multiple clinical trial sites in Europe, and the first patient has been enrolled in the trial. We remain focused on our strategy to deliver on the potential of transformative gene editing therapies to change the lives of patients across a broad array of disease areas.”

Recent Highlights and Outlook

Third 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. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic collaborations with leading companies including Bayer AG, Vertex Pharmaceuticals and ViaCyte, Inc. 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
This press release may contain a number of “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding CRISPR Therapeutics’ expectations about any or all of the following:  (i) clinical trials (including, without limitation, the timing of filing of clinical trial applications and INDs, any approvals thereof and the timing of commencement of clinical trials), development timelines and discussions with regulatory authorities related to product candidates under development by CRISPR Therapeutics and its collaborators; (ii) the number of patients that will be evaluated, the anticipated date by which enrollment will be completed and the data that will be generated by ongoing and planned clinical trials, and the ability to use that data for the design and initiation of further clinical trials; (iii) the scope and timing of ongoing and potential future clinical trials; (iv) the intellectual property coverage and positions of CRISPR Therapeutics, its licensors and third parties; (v) the sufficiency of CRISPR Therapeutics’ cash resources; and (vi) the therapeutic value, development, and commercial potential of CRISPR/Cas9 gene editing technologies and therapies.  Without limiting the foregoing, the words “believes,” “anticipates,” “plans,” “expects” and similar expressions are intended to identify forward-looking statements.  You are cautioned that forward-looking statements are inherently uncertain. Although CRISPR Therapeutics believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, 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:  the outcomes for each CRISPR Therapeutics’ planned clinical trials and studies may not be favorable; that one or more of CRISPR Therapeutics’ internal or external product candidate programs will not proceed as planned for technical, scientific or commercial reasons; that future competitive or other market factors may adversely affect the commercial potential for CRISPR Therapeutics’ product candidates; uncertainties inherent in the initiation and completion of preclinical studies for CRISPR Therapeutics’ 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; uncertainties about regulatory approvals to conduct trials or to market products; uncertainties regarding the intellectual property protection for CRISPR Therapeutics’ technology and intellectual property belonging to third parties; and those risks and uncertainties described under the heading “Risk Factors” in CRISPR Therapeutics’ most recent annual report on Form 10-K, and in any other subsequent filings made by CRISPR Therapeutics with the U.S. Securities and Exchange Commission, 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. CRISPR Therapeutics 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
September 30,
    Nine Months Ended
September 30,
 
    2018     2017     2018     2017  
Collaboration revenue   $ 563     $ 2,387     $ 3,009     $ 8,672  
Operating expenses:                                
Research and development     39,820       17,845       84,972       49,770  
General and administrative     10,175       8,112       31,752       24,522  
Total operating expenses     49,995       25,957       116,724       74,292  
Loss from operations     (49,432 )     (23,570 )     (113,715 )     (65,620 )
Total other (expense) income, net     (1,142 )     (430 )     (3,357 )     (1,548 )
Net loss before income taxes     (50,574 )     (24,000 )     (117,072 )     (67,168 )
Provision for income taxes     (137 )     (707 )     (319 )     (1,330 )
Net loss     (50,711 )     (24,707 )     (117,391 )     (68,498 )
Foreign currency translation adjustment     (6 )     8       (15 )     38  
Comprehensive Loss   $ (50,717 )   $ (24,699 )   $ (117,406 )   $ (68,460 )
Reconciliation of net loss to net loss attributable to common shareholders:                                
Net loss   $ (50,711 )   $ (24,707 )   $ (117,391 )   $ (68,498 )
Net loss per share attributable to common
  shareholders – basic and diluted
  $ (1.07 )   $ (0.62 )   $ (2.51 )   $ (1.72 )
Weighted-average common shares outstanding used in calculating net loss per share attributable to common shareholders – basic and diluted     47,391,988       40,088,718       46,709,388       39,904,863  



CRISPR Therapeutics AG
Condensed Consolidated Balance Sheets Data
(Unaudited, in thousands)

  As of
  September 30, 2018   December 31, 2017
Cash $ 487,295   $ 239,758
Working capital   464,410     233,874
Total assets   518,903     271,346
Total shareholders’ equity   417,314     187,832
           

Investor Contact:
Susan Kim
susan.kim@crisprtx.com

Media Contact:
Jennifer Paganelli
WCG on behalf of CRISPR
347-658-8290
jpaganelli@wcgworld.com