Replimune to Host Virtual Investor Event on March 30, 2022

On March 21, 2022 Replimune Group Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel class of tumor-directed oncolytic immunotherapies, reported that members of its executive team and Key Opinion Leaders will host an investor event to present updated data from the completed cohorts of the Phase 2 IGNYTE clinical trial in non-melanoma skin cancer ("NMSC") and melanoma (Press release, Replimune, MAR 21, 2022, View Source [SID1234610459]). Additionally, the Company will present new data from the ongoing clinical trial in anti-PD1 failed NMSC and from the ARTACUS clinical trial, a Phase 1b/2 clinical trial of RP1 as monotherapy in solid organ transplant recipients with skin cancer. The Company will also provide an overview of the Phase 1 data and details of the intended Phase 2 clinical development plan for its RP2/3 program.

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The event will begin at 8:00 a.m. Eastern Time on Wednesday, March 30, 2022. The webcast and slides will be accessible live under "Events & Presentations" on the Investors page of the Company’s website at www.replimune.com or by clicking here. A replay of the event will be available on Replimune’s website.

Opdivo (nivolumab) is a registered trademark of Bristol-Myers Squibb Company.

PokeAcell receives large grant to develop ImmPACT cell therapy

On March 21, 2022 PokeAcell reported that Innovation Fund Denmark invests DKK 25 million in an innovation project developing it’s ImmPACT cell therapy for IND submission and clinical testing in Merkel Cell Carcinoma (Press release, PokeAcell, MAR 21, 2022, View Source [SID1234610458]).

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The project is an example of increasing innovation and expertise in cell therapy in Denmark and the great therapeutic potential that cell therapy is expected to have in the long term. The project has brought together an International partnership supporting the development of the technology and clinical testing at University of Washington and Fred Hutch Cancer Center.

"With the ImmPACT technology we can stimulate personally selected T cells from patient’s blood that we know is critical to tumor killing in Merkel Cell Carcinoma. With the ImmPACT activation the T cells will expand and be optimally profiled to kill the tumor. The patients then received their own personalized T cell product as treatment", Anne Reker Cordt, CEO at PokeAcell, explains.

DTU has invented the ImmPACT technology and together with leading doctors in the USA identified the T cells that are particularly crucial in connection with Merkel Celle Carcinoma.

PokeAcell has exclusive rights and expertise in developing cell products with ImmPACT and will in the project work with CBIO around the production of T cells.

University of Washington and its collaboration partner Fred Hutch Cancer Center are experts at Merkel Cell Carcinoma and sees great potential in the multitargeted T cell therapy. They will conduct the clinical trial in the project, where the goal is to show that the treatment is safe and effective.

Oncorus to Present at the Maxim Group 2022 Virtual Growth Conference

On March 21, 2022 Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, reported that President and Chief Executive Officer, Theodore (Ted) Ashburn, M.D., Ph.D., will participate in a fireside chat at the Maxim Group 2022 Virtual Growth Conference on Monday, March 28, 2022 at 12:30 p.m. ET (Press release, Oncorus, MAR 21, 2022, View Source [SID1234610457]). Dr. Ashburn will also present a corporate overview, which will become available for on-demand viewing on Monday, March 28, 2022 at 9:00 a.m. ET.

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A live webcast of the fireside chat, as well as the on-demand corporate presentation, will be available to conference attendees from Monday, March 28 to Wednesday, March 30. Both presentations can be accessed by visiting the Investors & Media section of Oncorus’ website at View Source

VOLASTRA THERAPEUTICS ANNOUNCES DRUG DISCOVERY COLLABORATION WITH BRISTOL MYERS SQUIBB

On March 21, 2022 Volastra Therapeutics, an oncology company focused on exploiting chromosomal instability (CIN) as a vulnerability for cancer cells, reported a collaboration with Bristol Myers Squibb to discover, develop and commercialize new medicines (Press release, Volastra Therapeutics, MAR 21, 2022, View Source [SID1234610456]).

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The multi-year collaboration will leverage Volastra’s proprietary CINtech platform, to identify CIN-related, synthetic lethal targets as drug candidates. Synthetic lethality is a well-established genetic approach of target discovery that involves exploiting vulnerabilities in tumor cells to induce tumor cell death while sparing normal cells. In pre-clinical models, Volastra has demonstrated that synthetical lethal approaches can be particularly effective in tumors with high levels of CIN.

"The combination of Bristol Myers Squibb’s expertise in oncology and Volastra’s deep understanding of chromosomal instability as cancer’s Achilles heel makes for an ideal partnership to advance novel therapies for patients," said Charles Hugh-Jones, M.D., FRCP, Chief Executive Officer at Volastra. "Through this collaboration, Volastra will apply our innovative platform towards the creation of effective CIN-targeted medicines. We look forward to working together with Bristol Myers Squibb to transform cancer treatment."

"We look forward to collaborating with Volastra and utilizing their chromosomal instability targeting platform to identify important drug discovery insights," said Rupert Vessey, M.A., B.M., B.Ch., FRCP, D.Phil., Executive Vice President, Research & Early Development, Bristol Myers Squibb. "New therapies targeting CIN have the potential to enhance treatment selectivity and improve patient outcomes."

Under the terms of the agreement, Volastra will be responsible for conducting various activities for undisclosed targets. For select targets, Volastra will conduct all research activities through development candidate selection and Bristol Myers Squibb may take on the responsibilities for all subsequent development, regulatory and commercialization activities of the development candidates under an exclusive worldwide license.

Volastra will receive $30 million in an upfront payment and will also be eligible to receive up to $1.1 billion in development, regulatory and commercial milestone payments. Additionally, Volastra is entitled to receive royalties on net global sales of any product commercialized by Bristol Myers Squibb resulting from the collaboration.

About Volastra’s CINtech Platform

Volastra’s CINtech platform harnesses a deep biological understanding of chromosomal instability (CIN) as cancer’s most targetable vulnerability to develop promising therapies for patients. CINtech integrates proprietary imaging technologies, model cell line systems and computational analytics to drive a broad and differentiated pipeline.

Genscript Biotech Reports 2021 Annual Results

On March 20, 2022 GenScript Biotech, the world’s leading biotech company, reported its annual results as of December 31, 2021 (Press release, GenScript, MAR 20, 2022, View Source [SID1234610393]).

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"2021 is a pivotal year for GenScript. Our continuous investments in innovation and optimization of current business portfolio over the past few years lead to encouraging results.", said Dr. Patrick Liu, Rotating CEO of GenScript. "In the life science segment, we are pushing forward our business through automation and industrial-scale production. In the emerging gene and cell therapy CDMO segment, GenScript ProBio achieved explosive revenue growth thanks to strategic investment, advanced platforms and high quality standards. Bestzyme reached breakeven, which is made possible by business optimization and product innovation. With continued investment in synthetic biology, Bestzyme will further unfold its potential in the future. In early 2022, our subsidiary Legend Biotech, an innovative cell therapy company, together with our partner J&J, successfully commercialized CarvyktiTM, which is a monumental event for the cell therapy industry and demonstrates innovation capabilities of China’s biopharmaceutical industry. Looking ahead, GenScript Group will continue investment in innovation capabilities to address challenges in the fields of gene and cell therapy and synthetic biology. We will stay committed to our mission to "make people and nature healthier through biotechnology" by accelerating innovation in the biotech industry, and continuously create value for our shareholders."

Results Analysis of the Four Business Segments

Life-science services and products

During the Reporting Period, revenue from life-science services and products was approximately US$315.8 million, representing an increase of 26.4% as compared with approximately US$249.8 million for the year ended December 31, 2020. During the Reporting Period, the gross profit was approximately US$183.3 million, representing an increase of 10.8% as compared with approximately US$165.4 million for the year ended December 31, 2020. During the Reporting Period, the operating profit of life-science services and products was approximately US$91.6 million, representing an increase of 6.5% from approximately US$86.0 million for the same period in 2020.

The growth of revenue and gross profit was mainly attributable to the (i) expanded capacity and productivity, (ii) successful commercial operation that focused on the novel products such as oligo synthesis and cPass services and kit, (iii) successful development of key accounts, and (iv) the improvement of online commercial platform and tools to attract new customers. The decrease in gross profit margin was primarily attributable to the (i) significant decrease of exchange rate of USD against RMB as compared to 2020 which caused an increase of converted cost as the majority of production cost occurred in Mainland China, (ii) increased freight and duty costs, and (iii) change of product portfolio strategy. The increase in operating profit was primarily attributable to the improved capacity utilization and operational efficiency, and was partially offset by increased investment in research and development.

Biologics development services

During the Reporting Period, revenue from biologics development services was approximately US$81.4 million, representing an increase of 101.5% as compared with approximately US$40.4 million for the year ended December 31, 2020. During the Reporting Period, the gross profit was approximately US$25.6 million, representing an increase of 158.6% as compared with approximately US$9.9 million for the year ended December 31, 2020. Total backlog for biologics development services increased by 108.4% from US$94.7 million as at December 31, 2020 to US$197.4 million as at December 31, 2021. The gross profit margin increased from 24.5% for the same period in 2020 to 31.4% this year. During the Reporting Period, the operating loss of biologics development services was approximately US$4.5 million, whilst the operating loss was approximately US$7.6 million for the same period in 2020.

The increase in revenue was primarily attributable to the (i) accumulated biologics development track records and expanded global customer base, (ii) expanded capacity and productivity of pre-clinical and clinical development, (iii) shorter delivery time for antibody and protein drug development, and (iv) significant increase in plasmid revenue from the boosting GCT market, including mRNA related applications. The increase in gross profit was primarily attributable to the (i) increased revenue, (ii) production cost reduction and quality improvement, and (iii) improved capacity utilization. The operating loss was primarily attributable to the (i) investment in selling and distribution, and (ii) investment in research and development activities.

Industrial synthetic biology products

During the Reporting Period, revenue from industrial synthetic biology products was approximately US$38.6 million, representing an increase of 33.6% as compared with approximately US$28.9 million for the year ended December 31, 2020. During the Reporting Period, the gross profit was approximately US$11.3 million, representing an increase of 31.4% as compared with US$8.6 million for the year ended December 31, 2020. During the Reporting Period, the industrial synthetic biology products segment has achieved operating break-even this Year, whilst the operating loss was approximately US$3.0 million for the same period in 2020.

The increase in revenue and gross profit was primarily attributable to the (i) launch of innovative products, (ii) increased penetration into big industrial customers, and (iii) business development in overseas markets. The gross profit margin remained stable during the Reporting Period.

Cell therapy

During the Reporting Period, revenue from cell therapy was approximately US$89.8 million, representing an increase of 18.6% as compared with approximately US$75.7 million for the year ended December 31, 2020. During the Reporting Period, gross profit was approximately US$89.8 million, representing an increase of 18.6% as compared with approximately US$75.7 million for the year ended December 31, 2020. During the Reporting Period, the operating loss of cell therapy was approximately US$373.9 million, whilst the operating loss was approximately US$233.4 million for the same period in 2020.

The increase in both revenue and gross profit was primarily attributable to additional milestones achieved in 2020 and 2021, and thus further recognition of contract revenue from the collaboration with Janssen on developing cilta-cel. The operating loss was primarily attributable to the (i) investment in clinical trials, higher patients enrollment and more pipelines, (ii) cost for commercial preparation activities for the launch of cilta-cel, and (iii) expansion of administrative functions.

Revenue

In 2021, the Group recorded revenue of approximately US$511.1 million, representing an increase of 30.8% from approximately US$390.8 million in 2020. This was primarily attributable to (i) the continued increase of non-cell therapy products and services from major strategic customers and new competitive services and products, and (ii) the increase of contract revenue derived from Legend’s collaboration with Janssen with new milestones achieved.

Gross Profit

In 2021, the Group’s gross profit increased 18.6% to approximately US$303.5 million from approximately US$255.9 million in 2020. The increase in gross profit was primarily attributable to the (i) rapid growth of revenue, and (ii) operational efficiency improvement. The increase in gross profit was partially offset by unfavorable exchange rate fluctuation and increased shipping costs.

Selling and distribution expenses

The selling and distribution expenses increased by 56.6% to approximately US$168.0 million in 2021 from approximately US$107.3 million in 2020. This was mainly attributable to the (i) recruiting of more experienced personnel and improved incentive packages to enhance the business development capability, and (ii) increased marketing and advertising expenses, primarily attributable to the global expansion of our business, including Legend’s collaboration with Janssen.

Administrative expenses

The administrative expenses increased by 48.9% to approximately US$134.5 million in 2021 from approximately US$90.3 million in 2020. This was mainly caused by (i) reinforcing key administrative functions such as information technology, supply chain and legal to support the Group’s overall business expansion and ensure compliance with certain updated requirements, (ii) one-time consultation expenses and other costs related to the Investigation, and (iii) the CARVYKTI application and the Follow-on Public Offering of Legend.

Research and development expenses

The research and development expenses increased by 36.1% to approximately US$358.4 million in 2021 from approximately US$263.4 million in 2020. This was mainly due to the (i) increase in clinical trial expenses and preclinical study costs in the cell therapy segment, (ii) investment in new research and development projects to strengthen our competitiveness in the GCT market and related supply chain, (iii) investment in development projects that improved our production efficiency, and (iv) increase in compensation package including equity-settled share-based compensation expense for research and development personnel.