|Dosing of fourth cohort initiated according to plan in Phase I clinical trial of lead CARMA therapy candidate, MCY-M11|
Gaithersburg, MD – April 9, 2020: MaxCyte, the global cell-based therapies and life sciences company, provides today a business update regarding the potential impact of the COVID-19 pandemic. The Company also confirms that MCY M11 dosing commenced in March 2020, in the fourth cohort (at the next higher cell dose) of MaxCyte’s Phase I clinical trial.
“As the world continues to respond to the challenges of the COVID-19 global health pandemic, we wanted to share an update on our business and industry,” stated MaxCyte CEO Doug Doerfler. “There is currently significant uncertainty regarding the depth and duration of the economic impacts of the pandemic, generally, and on the biopharmaceutical industry, in particular. Our top priorities as a business are to ensure the health and safety of our employees first and foremost, to preserve jobs, and to enable our customers to bring new therapies and vaccines to market for many unmet health needs, including COVID-19. We are actively working to understand and respond to the economic impact of this public health crisis specific to MaxCyte as we continue to maintain our support for all MaxCyte customers.”
Life Sciences Business Progress
Due to the unprecedented restrictions put in place around COVID-19, including global lock-downs, MaxCyte has noted the potential negative impact on its Life Sciences business through slowdowns in customer operations, limiting of some clinical sites to studies related only to COVID-19, extension of sales cycles because of visitor restrictions at the operational sites of potential customers, shrinkage in customer capital budgets or delays in customers’ clinical trials. On the other hand, MaxCyte, its partners and its suppliers are generally considered “essential” businesses under shelter-in-place orders, and the Company continues to receive and fulfill orders from customers and interest from companies with new approaches related to COVID-19 that may be enabled by MaxCyte technology. The MaxCyte business remains resilient due to strong recurring revenues including from consumables and instruments in place under long-term leases with Cell Therapy partners and significant growth in this business segment is expected as compared to 2019. Importantly, MaxCyte announced its ninth cell therapy agreement in March 2020, with Allogene Therapeutics, bolstering the potential pre-commercial milestone payments potentially due to the Company.
CARMA™ Program Update
Maxcyte today announces that dosing has commenced, in March 2020 according to plan, in the fourth cohort of patients (at the next higher cell dose) for MCY-M11 in MaxCyte’s Phase I clinical trial. MCY-M11 is the Company’s wholly-owned, non-viral mRNA-based cell therapy candidate – a mesothelin-targeting chimeric antigen receptor (CAR) therapy that is being tested in patients with relapsed/refractory ovarian cancer and peritoneal mesothelioma.
At the start of 2020, MaxCyte established CARMA Cell Therapies as a wholly owned subsidiary to facilitate independent investment and new partnerships to advance the CARMA platform. The Company expects CARMA to be self-funded by 2021.
CARMA Cell Therapies remains fully committed to the MCY-M11 clinical development program, however timelines may be impacted due to the current deprioritization of non-COVID-19 clinical trials and restrictions on patient recruitment at the two clinical trial sites.
Status of Business Operations
As early as February, the Company began to encourage all field and office-based employees to commence working from home. MaxCyte continues its restricted travel and work-from-home policy wherever possible and has implemented an evergreen business continuity and facilities control plan for its corporate headquarters facilities in Maryland. To ensure business continuity, the Company is actively using technology to allow employees to work remotely and to replace all in-person meetings and field applications support. MaxCyte is considered an “essential business” in Maryland under state shelter-in-place orders, as are the Company’s customers and key suppliers. The Company is also maintaining constant vigilance in all countries where MaxCyte employees live and work. To protect the health and safety of employees, the Company has limited work at its labs and facilities to essential production and shipping activities to support customers. In addition, MaxCyte has taken measures such as splitting shifts and implementation of strict cleaning protocols and social distancing.
Mr. Doerfler added: “We are working diligently to keep our employees, their families, our partners and our vendors safe, while continuing to serve our customers and patients. With a resilient business model, we have every reason to remain highly optimistic for the future.”
MaxCyte, the clinical-stage global cell-based therapies and life sciences company, uses its proprietary next-generation cell and gene therapies to revolutionize medical treatments and ultimately save lives. The Company’s premier cell engineering enabling technology is currently being deployed by leading drug developers worldwide, including all of the top ten global biopharmaceutical companies. MaxCyte licenses have been granted to more than 100 cell therapy programmes, with more than 70 licensed for clinical use, and the Company has now entered into nine clinical/commercial license partnerships with leading cell therapy and gene editing developers. MaxCyte was founded in 1998 and is headquartered in Gaithersburg, Maryland. For more information, visit www.maxcyte.com
About MaxCyte’s Technology
MaxCyte’s Flow Electroporation® technology and next-generation ExPERT® platform enable our partners to accelerate, streamline and improve the drug development process from the early stages of research to commercialization. MaxCyte is also developing novel CARMA therapies, with its first wholly-owned drug candidate in a Phase I clinical trial. CARMA is MaxCyte’s mRNA-based proprietary therapeutic platform for autologous cell therapy for the treatment of solid cancers. In 2020, MaxCyte established CARMA Cell Therapies, a wholly owned subsidiary to facilitate independent investment and new partnerships to advance the CARMA platform.
For further information, please contact:
Doug Doerfler, Chief Executive Officer
Ron Holtz, Chief Financial Officer
US Media Relations
PressComm PR, LLC
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