Theradiag announces its 2021 full-year results

On March 21, 2022 THERADIAG (ISIN: FR0004197747, Ticker: ALTER), a company specializing in in vitro diagnostics and theranostics, reported its annual results for the financial year to December 31, 2021, as approved by the Board of Directors on March 17, 2022 (Press release, Theradiag, MAR 21, 2022, View Source [SID1234610460]).

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Bertrand de Castelnau, CEO of Theradiag, commented: "The net result for the second half of 2021 was impacted by exceptional expenses associated with Covid test sales. Excluding the latter, Theradiag is continuing to close in on profitability thanks to its solid fundamentals and to good control over its operating costs on its core business. While the public health context remained difficult, these results emphasize the relevance of our strategic refocus, initiated in recent semesters, on innovation and the internationalization of our activities. Bolstered by an improved cost structure and a privileged positioning on the vast biotherapy market, we are today reaffirming our determination to accelerate Theradiag’s development on this market through the implementation of our new strategic plan that will enable us to improve all of our financial indicators."

"In 2021, despite the continuing uncertain economic and public health context, Theradiag was able to both maintain the commercial momentum and control the costs of its two historical activities. In 2022, we intend to accelerate our growth in order to reaffirm our leadership position on the biotherapy market and to develop new actives to support our expansion," added Pierre Morgon, Chairman of the Board of Directors.

Revenue up 6.8% despite a public health situation that remained delicate

Over the year to December 31, 2021, Theradiag recorded revenue of €11.1 million, versus €10.4 million in 2020, giving growth of 6.8% in line with the strategic priorities defined by the Company prior to November’s Rights Issue.

On the strength of the 21 i-Track10 or equivalent analyzers installed and active around the world, Theranostics activity recorded another excellent performance with growth of 12.7% in 2021, and now accounts for 52% of Theradiag’s business.

In Vitro Diagnostics (IVD) activity recorded a slight increase of 1.2% in revenue to €5.3 million.

Globally, Theradiag recorded solid performances in terms of exports and in the United States with growth of 25.9% and 17.0% respectively, reflecting the significant success of its overseas partnerships such as the one with Veracyte for the marketing of its tests in the United States.

Net result impacted, particularly in H2 2021, by exceptional expenses associated with its Covid activity; excluding exceptional items, Theradiag is continuing its progress towards profitability

In 2021, the decrease in Theradiag’s results was due to exceptional expenses associated with its Covid activity that was deployed in an opportunistic manner in 2020. As announced in its H1 2021 financial report, in the chapter on significant events after June 30, 2021, Theradiag decided to end its antigen activities. Following a number of appeals to the State’s highest authorities, Theradiag definitively cleared its stock of products. These expenses were assessed by the Company at approximately €500 thousand in 2021 and were primarily booked in the second half of 2021.

Excluding Covid, on its historical activities Theradiag was able to control its operating costs while maintaining its strategic investments in R&D and its commercial development in the United States, which drive its current and future growth. Hence, despite a 2021 operating loss of €879 thousand, excluding the losses associated with its Covid activity the operating momentum has been positive in recent years. Indeed, excluding these exceptional expenses, the operating loss was €383 thousand in 2021 compared with a loss of €596 thousand in 2020, with a significant improvement in profitability in the second half of 2021 with an operating loss excluding Covid sales expenses of just €58 thousand.

Overall, the net result excluding exceptional items and the net result totaled -€679 thousand and -€767 thousand respectively at December 31, 2021, versus -€181 thousand and -€231 thousand at December 31, 2020.

Comfortable cash position with the financing horizon ensured until end-2026

At December 31, 2021, Theradiag had a net cash position of €7.1 million, compared to €1.4 million at June 30, 2021; for the last year or so, the Company has been able to stabilize its cash position at around €2 million, excluding capital increase. Henceforth, following the Rights Issue carried out in November, the Company has a financing horizon through to 2026 and thus has medium-term financial autonomy.

Reminder of the Company’s 2021 highlights

CE marking for the new TRACKER range i-Tracker test kits: Vedolizumab and Ustekinumab kits on originator and biosimilar molecules;
Signing of a contract to supply quality control reagents to Orgentec, a specialist in in vitro diagnostics, notably in autoimmunity and infectious diseases;
Participation in Humabdiag, a large-scale research project undertake with the University of Tours and the University Hospital of Tours targeting the bioproduction of monoclonal antibodies notably for Theradiag and the entire biotherapy market;
€5.33 million Rights Issue;
Launch of four new i-Tracker kits and validation of a new parameter in the United States: Golimumab and Rituximab kits.
Significant event since the end of 2021

Signing of a distribution agreement with BIOSYNEX for their AMPLIQUICK SARS-CoV-2 PCR test in January 2022

An initial two-year distribution agreement was signed between THERADIAG and BIOSYNEX for the AMPLIQUICK SARS-CoV-2 PCR test from BIOSYNEX, which will be promoted in hospitals by THERADIAG, which enjoys a strong presence in hospitals, and notably in the vast majority of University Hospitals.

As an extension of this first contract, BIOSYNEX and THERADIAG intend to explore opportunities to develop joint projects.

Financial calendar:

Annual General Meeting, Thursday May 5, 2022
H1 2022 revenue, Monday July 18, 2022
H1 2022 results, Monday September 19, 2022

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.