NorthWest Biotherapeutics Inc (NWBO)

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Cryoport and Cell and Gene Therapy Catapult Announce Strategic Collaboration at Stevenage Manufacturing Innovation Centre for Advancement of Cell and Gene Therapies

https://www.sec.gov/ix?doc=/Archives/edgar/data/1124524/000141057823001635/cyrx-20230630x10q.htm

https://nwbio.com/northwest-biotherapeutics-and-advent-bioservices-announce-receipt-of-license-for-commercial-manufacturing-at-sawston-u-k-facility/


"Under this commercial manufacturing license, cell therapy products manufactured in the Sawston facility may be exported globally. Products (e.g., immune cells) may also be imported into the U.K. for production or release of cell therapy products under the facility’s licenses."





NASHVILLE, Tenn. and STEVENAGE, United Kingdom, Oct. 10, 2023 /PRNewswire/ -- Cryoport, Inc. (NASDAQ: CYRX) ("Cryoport"), a leading global provider of innovative products and services to the fast-growing cell and gene therapy industry enabling the future of medicine for a new era of life sciences, and the Cell and Gene Therapy Catapult ("CGT Catapult"), an independent innovation and technology organisation specializing in the advancement of cell and gene therapies, today announced the organisations have entered into a new strategic partnership to support the advancement of cell and gene therapies.

Through this collaboration, Cryoport Systems will establish its first global supply chain logistics centre in the U.K., a Good Manufacturing Practice (GMP)-compliant facility located within the bioscience cluster in Stevenage, U.K., at the CGT Catapult's large-scale cell and gene therapy Stevenage Manufacturing Innovation Centre. The partnership will provide CGT Catapult collaborators, and the larger U.K. cell and gene therapy community, with access to Cryoport's integrated, end-to-end supply chain capabilities including risk mitigation services and logistics support. The collaboration between the partners will commence operations in early 2024.

"The cell and gene therapy industry has become an area of rapid growth in the U.K. with increasing governmental support, making now the prime opportunity to partner with CGT Catapult to offer advanced therapy manufacturers streamlined solutions for their cold chain logistics needs," said Jerrell Shelton, CEO of Cryoport. "This partnership provides a valuable step in the expansion of our global supply chain infrastructure buildout to help accelerate the process of clinical development and commercialization of cell and gene therapies in the U.K. It also expands Cryoport Systems' footprint and advances our longer-term plans in this region by starting with this initial foothold."

Matthew Durdy, Chief Executive of the Cell and Gene Therapy Catapult, added, "Cryoport's expertise in the logistics and supply chain needs of advanced therapy manufacturers is an invaluable addition to the life sciences ecosystem in Stevenage and the wider U.K. The services Cryoport offers will support the continued growth of the industry, by strengthening even further the established global supply chains from the U.K., and we look forward to the future success of Cryoport in the U.K."

About Cryoport, Inc
Cryoport, Inc. (Nasdaq: CYRX), is a global provider of innovative products and services to the fast-growing Cell & Gene Therapy industry - enabling the future of medicine for a new era of life sciences. With 48 strategic locations covering the Americas, EMEA (Europe, the Middle East and Africa) and APAC (Asia Pacific), Cryoport's global platform provides mission-critical bio-logistics, biostorage, bioprocessing, and cryogenic systems to the life sciences markets worldwide.

For more information, visit www.cryoport.com or follow @cryoport on X, formerly known as Twitter at www.twitter.com/cryoport for live updates.

About the Cell and Gene Therapy Catapult
The Cell and Gene Therapy Catapult is an independent innovation and technology organisation committed to the advancement of cell and gene therapies with a vision of a thriving industry delivering life changing advanced therapies to the world. Its aim is to create powerful collaborations which overcome challenges to the advancement of the sector. The Cell and Gene Therapy Catapult works with Innovate UK.

For more information, please visit https://ct.catapult.org.uk/ or https://www.ukri.org/councils/innovate-uk/.

Forward-Looking Statements
Statements in this press release which are not purely historical, including statements regarding the Company's intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, those related to the Company's industry, business, long-term growth prospects, including expected growth in all of the Company's markets, plans, strategies, acquisitions, future financial results and financial condition, such as the Company's outlook and guidance for full year 2023 revenue and the related assumptions and factors expected to drive revenue, projected growth trends in the markets in which the Company operates, the Company's plans and expectations regarding the launch of new products and services, such as the expected timing and benefits of such products and services launches, the Company's plans to further strengthen its business and continue to position itself for long-term and profitable growth in the cell and gene therapy industry, and anticipated regulatory filings or approvals with respect to the products of the Company's clients. It is important to note that the Company's actual results could differ materially from those in any such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, risks and uncertainties associated with the effect of changing economic conditions, including as a result of the COVID-19 pandemic and its variants, supply chain constraints, inflationary pressures, the ongoing war between Russia and Ukraine and the effects of foreign currency fluctuations, trends in the products markets, variations in the Company's cash flow, market acceptance risks, and technical development risks. The Company's business could be affected by a number of other factors discussed in the Company's SEC reports, including in the "Risk Factors" section of its most recently filed periodic reports on Form 10-K and Form 10-Q, as well as in its subsequent filings with the SEC. The forward-looking statements contained in this press release speak only as of the date hereof and the Company cautions investors not to place undue reliance on these forward-looking statements. Except as required by law, the Company disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release.


Cryoport Reports Second Quarter 2023 Financial Results
Second quarter revenue of $57 million, in line with previously announced preliminary results
Clinical trials supported by Cryoport increased to a record 668 global clinical trials by quarter end; a net increase of 42 new trials added year-over-year
Strong balance sheet with over $500 million in cash and short-term investments
NASHVILLE, Tenn., Aug. 9, 2023 /PRNewswire/ -- Cryoport, Inc. (NASDAQ: CYRX) ("Cryoport" or the "Company"), a leading global provider of innovative products and services to the fast-growing cell & gene therapy industry enabling the future of medicine for a new era of life sciences, today announced financial results for the second quarter (Q2) and first half (H1) of 2023.


Jerrell Shelton, CEO of Cryoport, commented, "Today, we reported quarterly revenue results that were consistent with the preliminary results we previously provided, which reflected significantly weaker than expected demand for capital equipment from China and slower than expected ramps from certain clients during the second quarter.

"China's economic condition and a significant drop in orders caused a second quarter decline in MVE Biological Solutions' China derived revenue of 67% or $5.8 million year-over-year. For the previous two years the Chinese market has represented approximately 23% of MVE's total revenue and 10% of Cryoport's overall revenue. Our leadership team has recently been to China to meet with our MVE team based there, along with key clients, and distributors to reinforce our strengths and relationships. As a part of this effort, we have devised mitigation plans that we believe will help to build on MVE's long-term market leading position.

"We have confidence in our corporate strategy, and we remain steadfast that our long-term growth drivers are firmly intact, despite these short term-challenges. Our view is informed and reinforced by the more than 20% anticipated ten-year compound annual growth rate of the cell and gene therapy industry and the increasing number of clinical trials and commercial therapies now supported by Cryoport. In addition, a number of recent advancements by our cell and gene therapy clients fuel our optimism, such as the FDA's (U.S. Food and Drug Administration) approval for commercial production at Bristol Myers Squibb's new, state-of-the-art cell therapy manufacturing facility in Devens, Massachusetts, its acceptance of CRISPR Therapeutics/Vertex Pharmaceuticals' Biologics License Applications (BLAs) for exagamglogene autotemcel (exa-cel) for the treatment of severe sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT), and its approval of Sarepta Therapeutics' gene therapy ELEVIDYS, for the treatment of Duchenne Muscular Dystrophy.

"In addition to these client developments, we also continue to make strategic investments and form relationships to further enhance our growth prospects. These include the continued build-out of our Global Supply Chain Center Network, an expanded infrastructure we are creating that provides the life sciences industry with the most advanced solutions to ensure the safe and timely delivery of its extremely valuable, lifesaving cell and gene therapies. Our bioservices/biostorage network revenue grew 38% year-over-year to $3.2 million in the second quarter. We are also making further strides in the reproductive medicine industry, including recent agreements with Boston IVF and IVFAustralia as a supply chain solutions partner to support their global reproductive material shipments.

"With these recent client developments, new services and products and strategic relationships, we believe our future growth prospects are stronger than ever. We are committed to continue solidifying our leadership position in the cell and gene therapy industry, which is poised for significant expansion as it transforms the way medicine is practiced. By doing so, we will further strengthen our business and continue to position Cryoport for long-term and profitable growth," concluded Mr. Shelton.

In tabular form, revenue by market for Q2 2023 and H1 2023, as compared to the same periods in 2022 was as follows:

Cryoport, Inc. and Subsidiaries








Total revenues by market








(unaudited)








(in thousands)

Q2 2023

Q2 2022

% Change


H1 2023

H1 2022

% Change

Biopharma/Pharma

$ 46,533

$ 52,591

-12 %


$ 97,655

$ 95,601

2 %

Animal Health

7,873

9,285

-15 %


16,736

16,079

4 %

Reproductive Medicine

2,615

2,277

15 %


5,447

4,775

14 %

Total revenues

$ 57,021

$ 64,153

-11 %


$ 119,838

$ 116,455

3 %











As of June 30, 2023, the Company supported 12 commercial therapies and a net total of 668 global clinical trials, a net increase of 42 clinical trials over June 30, 2022 and a sequential increase of 16 clinical trials from Q1 2023. The number of trials in Phase 3 was 82 as of the end of the second quarter. The number of trials by phase and region are as follows: