MaxCyte Regulatory News (MXCT)

MaxCyte, Inc.

("MaxCyte")

CRISPR Therapeutics and MaxCyte Expand Clinical and Commercial License Agreement into Oncology

--CRISPR Therapeutics Gains Additional Rights to MaxCyte's Cell Engineering Technology to Develop CRISPR/Cas9-Based Cell Therapies in Immuno-Oncology--

ZUG, SWITZERLAND, CAMBRIDGE, MASS. and GAITHERSBURG, MD, November 9, 2018 - CRISPR Therapeutics (NASDAQ:CRSP) and MaxCyte (LSE: MXCT, MXCR) today announced the expansion of their existing relationship by entering into a non-exclusive commercial license agreement that will allow CRISPR Therapeutics to deploy MaxCyte's Flow Electroporation® Technology to develop CRISPR/Cas9-based therapies in immuno-oncology.

"As we advance our allogeneic CAR-T programs into the clinic, we are preparing for the future by securing our access to the leading ex vivo delivery platform for both clinical and commercial use, just as we previously did for our hemoglobinopathy developmental candidates," said Samarth Kulkarni, CEO of CRISPR Therapeutics.

The expanded relationship builds on an existing agreement announced in March 2017 which allowed for the development of commercial therapeutics for hemoglobin-related diseases. Under the terms of the new license agreement, CRISPR Therapeutics will obtain non-exclusive development and commercial-use rights to MaxCyte's cell engineering platform to develop immuno-oncology cell therapies. MaxCyte will supply its technology to CRISPR Therapeutics as part of the enabling technology license agreement and will receive milestone and sales-based payments in addition to other licensing fees.

"The expansion of our relationship with CRISPR Therapeutics signifies a key milestone for MaxCyte and our technology, providing further validation for the value and versatility of our technology as a leading enabler of next-generation cell-based therapies," said Doug Doerfler, President & CEO of MaxCyte, Inc. "CRISPR Therapeutics is a leader in gene editing, and we are very pleased to expand our collaboration into new therapeutic areas as we continue to explore the use of our technology to advance medicines to market that will make a difference for patients."

MaxCyte's Flow Electroporation® Technology enables the engineering of a broad range of therapeutically-relevant cell types at high efficiency while maintaining high viability and recovery. CRISPR Therapeutics' immuno-oncology cell therapy programs rely on ex vivo gene editing, where the CRISPR components are delivered into T-cells using the MaxCyte technology.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014.

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. 

About MaxCyte

MaxCyte is a global cell-based medicines and life sciences company applying its patented cell engineering technology to help patients with high unmet medical needs in a broad range of conditions. MaxCyte is developing novel CARMA therapies for its own pipeline. CARMA is MaxCyte's mRNA-based proprietary platform for autologous cell therapy. In addition, through its core business, the Company leverages its Flow Electroporation® Technology platform to enable its biopharmaceutical industry partners to advance the development of innovative, cutting-edge medicines, particularly in cell therapy, including the use of gene editing tools in the treatment of inherited genetic diseases and immuno-oncology approaches to treating cancer. The Company has placed its cutting-edge flow electroporation instruments worldwide, including with nine of the top ten global biopharmaceutical companies, and has more than 55 partnered programme licenses in cell therapy, including more than 25 licensed for clinical use. With its robust delivery technology, MaxCyte helps its partners to unlock the full potential of their products. For more information, visit www.maxcyte.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 Investor Contact:Susan Kimsusan.kim@crisprtx.com 

CRISPR Media Contact:Jennifer PaganelliWCG on behalf of CRISPR+1-347-658-8290jpaganelli@wcgworld.com

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