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“2016 was a year of tremendous growth for
Recent Highlights and Outlook
- Significant progress on our lead program.
CRISPR Therapeutics is on track to file its clinical trial authorization (CTA) inEurope by year-end 2017 for its lead therapeutic product to treat beta-thalassemia. The preclinical program, including the manufacturing process, has been vetted and approved by thePaul-Ehrlich Institute inGermany , and by the United Kingdom’s health regulatory authority (MHRA). CRISPR’s gene editing approach is designed to re-create the genetic variants that are associated with hereditary persistence of fetal hemoglobin (HPFH), which has been shown to significantly reduce morbidity in patients with both beta-thalassemia and sickle cell disease. In two presentations at the 58thAmerican Society of Hematology (ASH) Annual Meeting in December, 2016, CRISPR demonstrated that CRISPR/Cas9 gene editing can re-create the genetics of naturally occurring HPFH with high efficiency and no detectable off target editing, in human hematopoietic stem cells, leading to high expression levels of protective fetal hemoglobin. - Expansion of ex vivo platform to other disease areas.
CRISPR Therapeutics is continuing to expand its ex vivo gene editing platform and manufacturing expertise to other diseases such as Hurler Syndrome and Severe Combined Immuno-deficiency Syndrome (SCID). A special focus is being given to immuno-oncology, where we have established a separate business unit with its own dedicated scientific leadership. We have established the ability to both disrupt and insert multiple genes in T-cells, enabling the generation of allogeneic products targeted to various tumor types, including solid tumors. - Platform improvement and delivery technologies to support in vivo applications. CRISPR Therapeutics together with Casebia Therapeutics (our joint venture with Bayer) is continuing to make substantial investments in technology improvements in support of our research and development programs, we are pursuing both viral and non-viral delivery technologies enabling in vivo applications of CRISPR/Cas9 technology. We have optimized lipid nanoparticle delivery to achieve high level of gene disruption and elimination of protein expression in animal models at therapeutically relevant doses.
- Successfully completed multiple financings. In
June 2016 ,CRISPR Therapeutics received$36.3 million of net proceeds from the issuance of Series B preferred stock bringing the total amount of net proceeds received from Series B financings to approximately$140.0 million , including amounts raised under convertible loans subsequently converted to Series B preferred stock. InOctober 2016 , CRISPR raised additional net proceeds of$54.1 million from an Initial Public Offering (IPO) of its common shares, and$35.0 million from a concurrent private placement with Bayer. - Entered into global agreement on foundational intellectual property for CRISPR/Cas9 gene editing technology. In
December 2016 ,CRISPR Therapeutics ,Intellia Therapeutics , Caribou Biosciences, ERS Genomics and their licensors entered into a global cross-consent and invention management agreement for the foundational intellectual property covering CRISPR/Cas9 gene editing technology. The agreement reflects our commitment to maintain and coordinate the prosecution, defense, and enforcement of the CRISPR/Cas9 foundational patent portfolio to protect the ongoing development efforts associated with CRISPR’s product candidates as well those being developed by our partners and licensees. - Continued organization build. In
January 2017 ,CRISPR Therapeutics opened its new office space inCambridge, MA , which will host employees of both CRISPR and Casebia Therapeutics, our joint venture with Bayer. CRISPR is continuing to attract key talent across all critical functions, including research and development, manufacturing, finance and legal. We have grown rapidly since the IPO and currently have greater than 100 full-time employees.
Fourth Quarter and Full Year 2016 Financial Results (U.S. GAAP)
As of
Three Months Ended
Research and development expenses were
General and administrative expenses were
The Year Ended
Research and development expenses for the year ended
General and administrative expenses were
About
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 therapeutic value, development, and commercial potential of CRISPR/Cas-9 gene editing technologies and therapies and the intellectual property protection of our technology 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 conduct of preclinical and clinical studies for the company’s product candidates; availability and timing of results from preclinical and clinical studies; whether results from a preclinical study or clinical trial will be predictive of future results in connection with future trials or use; 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 (
CRISPR Therapeutics AG | ||||||||||||||||||
Consolidated Statements of Operations | ||||||||||||||||||
In thousands except share data and per share data | ||||||||||||||||||
(Unaudited) | ||||||||||||||||||
Three Months Ended | Twelve Months Ended | |||||||||||||||||
December 31, | December 31, | |||||||||||||||||
2016 | 2015 | 2016 | 2015 | |||||||||||||||
Collaborative revenue | $ | 2,344 | $ | 247 | $ | 5,164 | $ | 247 | ||||||||||
Operating expenses: | ||||||||||||||||||
Research and development | 15,572 | 6,174 | 42,238 | 12,573 | ||||||||||||||
General and administrative | 12,082 | 6,239 | 31,056 | 13,403 | ||||||||||||||
Total operating expenses | 27,654 | 12,413 | 73,294 | 25,976 | ||||||||||||||
Loss from operations | (25,310 | ) | (12,166 | ) | (68,130 | ) | (25,729 | ) | ||||||||||
Other income (expense), net | 78,654 | (50 | ) | 70,462 | (92 | ) | ||||||||||||
Loss from equity method investment | (35,846 | ) | - | (36,532 | ) | - | ||||||||||||
Gain on extinguishment of convertible loan | - | - | 11,482 | - | ||||||||||||||
Net income (loss) before income taxes | 17,498 | (12,216 | ) | (22,718 | ) | (25,821 | ) | |||||||||||
Provision for income taxes | (400 | ) | (70 | ) | (484 | ) | (7 | ) | ||||||||||
Net income (loss) | 17,098 | (12,286 | ) | (23,202 | ) | (25,828 | ) | |||||||||||
Loss attributable to noncontrolling interest | 1 | 16 | 25 | 325 | ||||||||||||||
Dividends attributable to Redeemable Convertible Preferred Stock | (763 | ) | - | - | - | |||||||||||||
Net income allocated to participating securities | (2,299 | ) | - | - | - | |||||||||||||
Net income (loss) attributable to common stockholders | $ | 14,037 | $ | (12,270 | ) | $ | (23,177 | ) | $ | (25,503 | ) | |||||||
Net income (loss) per share attributable to common shareholders: | ||||||||||||||||||
Basic | $ | 0.43 | $ | (2.22 | ) | $ | (1.89 | ) | $ | (5.06 | ) | |||||||
Diluted | $ | 0.40 | $ | (2.22 | ) | $ | (1.89 | ) | $ | (5.06 | ) | |||||||
Weighted-average common shares outstanding used in net income (loss) per share attributable to common shareholders: | ||||||||||||||||||
Basic | 32,987,335 | 5,528,079 | 12,257,483 | 5,037,404 | ||||||||||||||
Diluted | 34,989,218 | 5,528,079 | 12,257,483 | 5,037,404 | ||||||||||||||
CRISPR Therapeutics AG | |||||||
Consolidated Balance Sheets Data | |||||||
in thousands | |||||||
(unaudited) | |||||||
As of December 31, | |||||||
2016 | 2015 | ||||||
Cash | $ | 315,520 | $ | 155,961 | |||
Working capital | 298,190 | 146,685 | |||||
Total assets | 344,962 | 159,423 | |||||
Redeemable convertible preferred shares | - | 64,521 | |||||
Total shareholders' equity (deficit) | 232,846 | (29,124 | ) |
MEDIA CONTACTS:Jennifer Paganelli W2O Group for CRISPR 347-658-8290 jpaganelli@w2ogroup.com INVESTOR CONTACT:Chris Brinzey Westwicke Partners for CRISPR 339-970-2843 chris.brinzey@westwicke.com