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10-Q – Quarterly report [Sections 13 or 15(d)]

Bristol-Myers Squibb has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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GENFIT Announces Publication of the 2021 Universal Registration Document; the 2021 Annual Report on Form 20-F and Availability of Preparatory Documents for the Annual Combined Shareholders Meeting on May 25, 2022

On April 29, 2022 GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with severe chronic liver diseases, reported the filing of its 2021 Universal Registration Document with the Autorité des marchés financiers (AMF) and its Annual Report on Form 20-F for the year ended December 31, 2021 with the U.S. Securities and Exchange Commission (SEC), as well as the availability of preparatory documents for its annual shareholders meeting on Wednesday May 25, 2022 (Press release, Genfit, APR 29, 2022, https://ir.genfit.com/news-releases/news-release-details/genfit-announces-publication-2021-universal-registration [SID1234613255]).

These annual reports are available to the public free of charge in accordance with applicable regulations and may be viewed at and downloaded from GENFIT’s website at ir.genfit.com. The 2021 Registration Document is also available on the AMF’s website: www.amf-france.org and the Annual Report on Form 20-F is available on the website of the SEC (www.sec.gov).

GENFIT’s 2021 Universal Registration Document includes, in particular, the annual financial report, the annual Board of Directors’ management report, the Board of Directors’ report on corporate governance, the Statutory Auditors’ reports on the annual and consolidated financial statements and related-party agreements, and the table summarizing the fees paid to the Statutory Auditors.

Documents for the Annual Combined Shareholders Meeting on May 25, 2022 are available to shareholders in accordance with existing regulations, and can be found on the Company’s website, in the Investors and Media section (https://ir.genfit.com/financial-information/shareholders-meeting).

10-Q – Quarterly report [Sections 13 or 15(d)]

Eli Lilly has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

Elicio Therapeutics Presents Preclinical Data on the AMP-Peptide Vaccine in Combination with TCR-T Cell Therapy for Solid Tumors at the 2022 Keystone Symposia: Emerging Cellular Therapies

On April 29, 2022 Elicio Therapeutics, a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer and other diseases, reported that it is presenting preclinical data demonstrating robust and durable anti-tumor responses by combining its Amphiphile (AMP) platform vaccine, carrying cognate peptide and adjuvant cargos, with T cell receptor T cell therapies (TCR-Ts) (Press release, Elicio Therapeutics, APR 29, 2022, View Source [SID1234613254]). AMP cognate peptides traffic to the lymph nodes and are presented by activated antigen-presenting cells to improve TCR-T cell persistence and anti-tumor function. The data is being presented at the 2022 Keystone Symposia on Emerging Cellular Therapies virtually and in-person in Keystone, CO from April 27-May 1, 2022. The electronic presentation is accessible here.

"The efficacy of TCR-Ts in solid tumors has been promising but limited by challenges related to suboptimal T cell expansion, persistence and function as well as poor tumor infiltration and antigen escape. These data are particularly exciting because we have shown that TCR-Ts in combination with our AMP-vaccination platform can address each of these issues," said Peter DeMuth, Ph.D., Chief Scientific Officer at Elicio Therapeutics. "By targeting AMP-peptide vaccination directly to the lymph nodes, we can promote antigen presentation alongside numerous complementary mechanisms critical for potent TCR-T cell enhancement and broad immune activation. We’ve seen that this potent activation in the lymph nodes results in TCR-T cell persistence and robust anti-tumor function."

Robert Connelly, Elicio’s Chief Executive Officer, added, "The ability to enhance TCR-T clinical responses in solid tumors using the AMP platform supports our existing data across other immunotherapy platforms and indications, reinforcing the untapped potential of our lymph node-targeting strategy."

TCR-T therapies are similar to CAR-T therapies but differ in the types of receptors they use to recognize antigens. TCR-Ts utilize the intrinsic antigen recognition mechanisms of the T cell and can even recognize intracellular antigens which makes them a powerful tool to target solid tumors. While this unique mechanism has shown clinical anti-tumor efficacy, TCR-T cells still face challenges that Elicio hopes to address by boosting TCR-T cell therapy in the lymph nodes, the "brain center" of the immune system, with its AMP platform.

Presentation Details

Title: Lymph node-targeted boosting with cognate Amphiphile-peptide vaccines enhances TCR-T Cell therapy to eradicate solid tumors

Highlights from the Presentation:

AMP vaccination delivers cognate peptides and adjuvant to lymph nodes which induces dendritic cell activation and provides in vivo activation of tumor-specific TCR-T cells to amplify, both in quantity and function, the anti-tumor potency of adoptively transferred cells.
AMP vaccination significantly enhanced TCR-T cell anti-tumor response while also inducing epitope spread among endogenous T cell population, leading to durable cures of solid tumors in an established, syngeneic tumor model.
Vaccination with AMP-mKRAS peptides in mice expressing human leukocyte antigen A*11:01 (HLA A*11:01) significantly enhanced the activation, persistence and specific target lysis of murine mKRAS-specific TCR-T cells.
AMP-peptide pulsed autologous human dendritic cells enhanced the function of several clinically relevant tumor-targeted human TCR-modified T cells in vitro including those targeting mKRAS, HPV16 E7 and NY-ESO-1.
These studies provide direct rationale and evidence for the combination of AMP vaccination with TCR-T cell therapies to augment clinical responses.
About the Amphiphile Platform

Our proprietary Amphiphile, or AMP, platform delivers investigational immunotherapeutics directly to the "brain center" of the immune system – the lymph nodes. We believe this site-specific delivery of disease-specific antigens, adjuvants and other immunomodulators may efficiently educate, activate and amplify critical immune cells, potentially resulting in induction and persistence of potent adaptive immunity required to treat many diseases. In preclinical models, we have observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function and durability. We believe our AMP lymph node-targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes.

Our AMP platform, originally developed at the Massachusetts Institute of Technology, or MIT, has broad potential across cancers, infectious diseases and other disease indications to advance a number of development initiatives through internal activities, in-licensing arrangements or development collaborations and partnerships.

The Amphiphile platform has been shown to deliver immunotherapeutics directly to the lymph nodes by latching on to the protein albumin, found in the bloodstream, as it travels to lymphatic tissue. In preclinical models, we have observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function and durability.

IntegraGen reports 2021 annual results with a strong growth of 20% in revenue from current operations and a significant profitability improvement

On April 29, 2022 IntegraGen, a company specializing in the decryption of the human genome, which carries out interpretable genomic analyzes for academic and private laboratories and develops diagnostic tools in oncology and part of OncoDNA Group, reported its financial results for the year ending December 31, 2021 (Press release, Integragen, APR 29, 2022, View Source [SID1234613253]). The annual audited accounts were approved by the company’s Board of Directors which met on April 29th, 2022.

Bernard Courtieu, CEO IntegraGen, said: "The year 2021 has been outstanding in multiple ways for IntegraGen. First of all, it was the first full year after the friendly takeover bid by OncoDNA and the operational integration of the teams. Then, it was a pandemic year which had a material impact on the activity of the P2M platform of the Institut Pasteur which has been particularly requested for the sequencing of COVID viruses in addition to its usual activities. Finally, IntegraGen continued its streamlining efforts, which made it possible to achieve the break-even point: for the first time, the company achieved a positive EBITDA and net result.

Now part of the OncoDNA Group, IntegraGen can offer a wider range of services and rely on the international sales network, particularly in Belgium and Spain, which offers new growth outlook.

We would like to thank all our customers who have remained loyal during the pandemic period and also all the laboratory and R&D employees who, through their professionalism and commitment, have enabled IntegraGen to exceed its objectives and, above all, contribute to the improvement in patient care."

Increased sequencing for GCS SeqOIA

As a reminder, in 2018 the GCS SeqOIA (made up of Assistance Publique-Hôpitaux de Paris [AP-HP], the Institut Curie and the Gustave Roussy cancer center) accepted the offer of IntegraGen for the provision of an operating service for a high-throughput sequencing data production platform.

After the start of the platform’s operations in early 2019, the patients sequencing services have progressively increased with in particular the effect of the broadening of the indications. This shows a 24% increase in turnover to €3,341k during the financial year, compared to €2,687k in 2020.

Stability of genomic service activities

Genomic service activities, performed at our site in Evry, include services provided for research laboratories and teams in charge of clinical research. Despite a significant increase of orders received during the year (+22%), the annual turnover recognized during the 2021 financial year fell slightly by 2% to €4,742k. This order increase in 2021 has created a backlog for growth for 2022.

In total, the genomics teams have carried out more than 545 projects for 140 clients, academic and private entities.

Strong increase in services provided for the Institut Pasteur

IntegraGen continued its services for the shared microbiology (P2M) platform of the Institut Pasteur under the contract renewed in March 2020. The IntegraGen teams provided their support to the Institut Pasteur, which was in high demand as part of the Covid-19 virus pandemic and variant sequencing needs, leading to a significant increase in volumes. This contract generated €2,386k revenues, compared to €1,147k in 2020.

In 2021, the platform operated by IntegraGen for the Institut Pasteur carried out nearly 64,822 microbial sequencings, including 39,495 for SARS-Cov-2.

Increase in sales of genomic data interpretation solutions

The company offers three distinct software tools for interpreting genomic data which are available in the cloud as SaaS solutions. Mercury, which is utilized for the interpretation of data from patients with cancer; Sirius, for the analysis of research samples with a focus on research applications in constitutional genetics; and, Galileo, for RNA expression analysis. Sales increased modestly to €259k compared to €209k in 2020. Sales of analysis and consulting services (GeCo activity) fell to €95k.

2021 FINANCIAL RESULT

Continued improvement in operating income

Operating income continues to improve thanks to sales growth, the commercial and scientific development efforts carried out in recent years, as well as the rigorous management of resources.

2021 revenues amounted to €11,324k, up 26% compared to the previous year. Excluding recharge of personnel costs to the parent company (€546k), turnover amounted to €10,823k representing a growth of 20% compared to 2020 (€9,000k).

Operating expenses amounted to €11,589k, up 23% compared to 2020. This increase is explained by various factors including the increase in the cost of consumables, the recharge of personnel costs by the parent company (€512k), the increase in payroll costs following the recruitments made over the last twelve months. Over the period, the average workforce increased from 43 to 49 people. This increase also illustrates the investments in Quality in the scope of the certifications of our laboratory at Evry.

EBITDA was positive at €170k compared to a loss of €28k in 2020.

The financial result shows income of €126K, following the sale of securities compared to a loss of €2K in 2020.

The exceptional result is a net loss of 197 K€ which is mainly explained by restructuring costs.

Research & Development and innovation efforts have generated a tax credit of €130k compared to €92k in 2020.

The 2021 financial year ended with a positive net result of €15k in 2021 compared to a loss of €375k in the previous year.

The available cash amounts to €4,781k at the end of December 2021 compared to €5 124k one year before. This change was due to the flow of current transactions, change in working capital requirements and investments in quality systems. This cash position includes a State Guaranteed Loan (PGE) of €1,800k obtained last year in the context of the Covid-19 pandemic. The reimbursement over a period of 5 years will start in June this year.

OUTLOOK 2022: CONTINUED GROWTH EXPECTED

IntegraGen intends to pursue revenue growth in 2022 based on the order book to be delivered and the positive trend observed in the market with academic and private clients.

The completed integration within the OncoDNA group confirms IntegraGen’s commercial development perspectives outside of France.

The available cash will finance operational and investment needs.