On March 20, 2023 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported its preliminary financial results for 2022 on Tuesday, 28 March 2023 (Press release, Evotec, MAR 20, 2023, View Source [SID1234629096]).

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The Company is going to hold a conference call to discuss the results as well as provide an update on its performance. The conference call will be held in English.

Conference call details

Date: Tuesday, 28 March 2023

Time: 02.00 pm CEST (08.00 am EDT, 01.00 pm BST)

To join via phone, please pre-register via the following link: View Source;linkSecurityString=94e63fcfc

You will then receive a confirmation email with dedicated dial-in details such as telephone number, access code and PIN to access the call.

A simultaneous slide presentation for participants dialling in via phone is available at View Source

Webcast details

To join the audio webcast and to access the presentation slides you will find a link on our homepage www.evotec.com shortly before the event.

The on-demand version of the webcast will be available on our website: View Source

On March 20, 2023 Eterna Therapeutics Inc. (Nasdaq: ERNA) ("Eterna" or the "Company"), a life science company committed to realizing the potential of mRNA cell engineering to provide patients with transformational new medicines, reported financial results for the quarter and year ended December 31, 2022 and provided a business update (Press release, Eterna Therapeutics, MAR 20, 2023, View Source [SID1234629092]).

"2022 was a transformational year for Eterna, and we believe that we made significant progress executing on our core strategy of unlocking the potential of mRNA cell engineering through strategic collaboration," said Matt Angel, Ph.D., Chief Executive Officer of Eterna. "We remained focused on expanding our capabilities to support the development of next-generation mRNA-based therapeutic products, and deploying our extensive portfolio of in-licensed mRNA cell engineering patents through strategic partnerships. We believe that our accomplishments have positioned us to drive value for shareholders, partners, and patients, and for continued growth across our business."

Significant milestones in 2022 and year-to-date 2023 include:

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In February 2023, Eterna entered into an income generating, exclusive cell line customization and license agreement with Lineage Cell Therapeutics, Inc. ("Lineage") under which Eterna has agreed to develop novel gene-edited pluripotent stem cell (iPSC) lines, which Lineage may evaluate for development into cell transplant therapies for the treatment of certain central nervous system (CNS) disorders and other neurology indications. Eterna is the exclusive licensee of the key intellectual property underlying this partnership. This is Eterna’s first income generating agreement, leveraging its extensive patent portfolio in-licensed from its partner, Factor Bioscience Limited ("Factor").

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In January 2023, Eterna appointed Matt Angel, Ph.D. as CEO and President of Eterna. Dr. Angel had previously served as Interim CEO and President of Eterna since May 2022, and he has continued to serve on the Company’s Board of Directors.

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In November 2022, Eterna entered into an amended license agreement with Factor under which Eterna obtained expanded rights to sublicense Factor’s entire portfolio of more than 100 patents related to mRNA-based cell engineering technologies to third parties.

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In October 2022, Eterna entered into a sublease agreement with Bristol Myers Squibb ("BMS") for the entire top floor (approximately 45,000 square feet) of 250 Water Street, a new approximately 450,000 square feet building located at the new Cambridge Crossing development in the heart of the greater Boston biotech community. BMS has agreed to provide $8.6 million for Eterna to build out the space into a state-of-the-art lab and office.

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In October 2022, the Company completed its name change from Brooklyn ImmunoTherapeutics, Inc. to Eterna Therapeutics Inc. to reflect the Company’s focus on deploying its extensively patented in-licensed mRNA cell engineering technologies.

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In September 2022, Eterna entered into a Master Services Agreement ("MSA") and first work order under the MSA with Factor, giving Eterna access to Factor’s research laboratory facilities, scientific equipment, training in mRNA, iPSC and gene-editing technology, protocols related to the development of mRNA cell engineering products, and in vitro transcription templates, mRNA constructs, and iPS cells.

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In August 2022, Eterna entered into a sponsored research agreement with Michael Andreeff, M.D., Ph.D., Professor of Leukemia at The University of Texas MD Anderson Cancer Center. Under the agreement, Dr. Andreeff will evaluate the capacity of Eterna’s gene-edited iPSC-derived therapeutic candidates to stimulate enhanced immune responses, including their effects on various aspects of T-cell mediated immunity, and to promote multilineage differentiation and hematopoietic regeneration in vivo.

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In March and December 2022, Eterna announced the completion of two private placements yielding combined gross proceeds of approximately $20 million.

Fourth Quarter and Full Year 2022 Financial Results

Research and development expenses were $2.0 million for the fourth quarter of 2022, which included $0.2 million of non-cash stock-based compensation expense. For the full year of 2022, research and development expenses were $10.4 million, which included $1.2 million of non-cash stock-based compensation expense. General and administrative expenses were $2.8 million for the fourth quarter of 2022, which included $0.2 million of non-cash stock-based compensation expense. For the full year of 2022, general and administrative expenses were $16.8 million, which included $1.7 million of non-cash stock-based compensation expense. The impairment of in-process research and development was approximately $6.0 million for the full year of 2022 and related to the Company’s decision to not further develop the IRX-2 product candidate associated with its legacy immunotherapy business. There was no such charge in the fourth quarter of 2022. The change in the fair value of warrant liabilities was a credit of $0.3 million for the fourth quarter of 2022 and a credit of $10.8 million for the full year of 2022.

Net loss for the fourth quarter of 2022 was $4.5 million, or $1.24 per share. For the full year of 2022, net loss was $24.6 million, or $8.06 per share. As of December 31, 2022, Eterna had cash of approximately $15.5 million, of which approximately $4.1 million was restricted cash, collateralizing a letter of credit with respect to our BMS sublease.

Earlier today, Eterna filed its Annual Report on Form 10-K for the year ended December 31, 2022 with the Securities and Exchange Commission.

On March 20, 2023 CoImmune, Inc., a clinical stage immuno-oncology company working to redefine cancer treatment using best-in-class cellular immunotherapies, reported it has exercised its option to obtain an exclusive license in the CD19-targeted, allogeneic cell therapy field to IL-18 Armored Chimeric Antigen Receptor (CAR) technology under a prior agreement with Memorial Sloan Kettering Cancer Center (MSK) (Press release, CoImmune, MAR 20, 2023, View Source [SID1234629075]). The company plans to couple the technology with allogeneic Cytokine Induced Killer (CIK) cells to launch the clinical development of CMN-008 (Armored CAR-CIK cells) with CD19 as the initial target in B-cell malignancies.

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"We are pleased to obtain an exclusive license in the CD19-targeted, allogeneic cell therapy field to IL-18 Armored CAR technology developed by the renowned researchers at MSK that significantly strengthens our position as a leader in the field of immuno-oncology," said Charles Nicolette, Ph.D., Chief Executive Officer of CoImmune. "As we advance towards the clinical development of a new investigational product with this technology in combination with our proprietary CIK cells, it is important to note that this is not simply another CD19 program. We are preparing to launch the first corporate-sponsored Armored CAR-CIK trial for a B-cell malignancy, and we believe this is an opportunity to dramatically change the therapeutic model to a potential outpatient procedure."

CoImmune designed CMN-008 using a highly potent proprietary CAR-CD19/IL-18 construct co-developed with MSK scientists. The CIK cells are genetically modified using a non-viral bicistronic vector encoding both CAR-CD19 and IL-18 that ensures all CAR+ cells are IL-18+. CMN-008 is manufactured from healthy donor cells requiring minimal tissue match to the patient and is more cost effective to produce than autologous CAR-T therapies.

"Traditional CAR-T therapies require preconditioning lymphodepletion prior to administration which frequently results in infection complications requiring hospitalization," said Renier J. Brentjens, M.D., Ph.D., Deputy Director and Chair of Medicine, Roswell Park Comprehensive Cancer Center, who previously developed the IL-18 Armored CAR technology at MSK. "In animal models evaluating IL-18 Armored CAR technology, there was an increase in durability of responses and anti-tumor activity without requiring lymphodepletion, which could be a real game changer and warrants further evaluation."

CoImmune intends to file an Investigational New Drug (IND) application with the U.S. Food & Drug Administration (FDA) for CMN-008 in mid-2023 followed by the initiation of a Phase 1 clinical trial.

On March 20, 2023 Phanes Therapeutics, Inc. (Phanes), an emerging leader in innovative discovery research and clinical development in oncology, reported that the first patient has been dosed in the phase 1 clinical study (NCT05482893) of PT886, a first-in-class native IgG-like bispecific antibody (bsAb) targeting claudin 18.2 and CD47 for the treatment of gastric, gastroesophageal junction and pancreatic adenocarcinomas (Press release, Phanes Therapeutics, MAR 20, 2023, View Source [SID1234629074]). PT886 was assembled using Phanes’ proprietary bispecific antibody platforms PACbody and SPECpair and was granted orphan drug designation (ODD) for the treatment of pancreatic cancer by the FDA last year.

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PT886 directly kills tumor cells via both the ADCP activity of macrophages and ADCC activity of NK cells, and by targeting both claudin 18.2 and CD47 overexpressed on the surface of tumor cells, it broadens the tumor killing spectrum. Additionally, PT886 is expected to induce the presentation of tumor neoantigens by channeling tumor cells into phagocytotic antigen presenting cells (APCs) and stimulate adaptive immune system by indirectly activating T cell killing of claudin 18.2 low or negative tumor cells through recognition of tumor neoantigens. The anti-CD47 arm of PT886 is highly differentiated and has demonstrated minimum binding to human red blood cells while maintains strong binding activity to CD47 on tumor cells. "PT886 targets a validated tumor associated antigen in claudin 18.2 with enhanced anti-tumor activity and broadened tumor killing spectrum through a best-in-class anti-CD47 arm. It is a product of Phanes’ ingenious innovation in creative design of both novel therapeutic approaches and practical technologies," said Dr. Ming Wang, Founder and CEO of Phanes Therapeutics.

The multi-center Phase I clinical trial of PT886 is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PT886 in patients with locally advanced or metastatic gastric, gastroesophageal junction and pancreatic cancers that have progressed after all available standard therapy or for which standard therapy has proven to be ineffective, intolerable, or is considered inappropriate. Enrollment in the trial is open to individuals aged 18 years and older who have measurable disease with at least 1 lesion amenable to response assessment per RECIST 1.1 criteria, adequate organ function, and an ECOG performance status of 0 to 1.

For more information on the study please visit ClinicalTrials.gov (NCT05482893).

On March 20, 2023 Oxford Nanopore Technologies plc (Oxford Nanopore) and 4bases, a Switzerland-based company, specialising in kits for sequencing and bioinformatic tools, reported a collaboration to make available 4bases kits with Oxford Nanopore sequencing technology (Press release, Oxford Nanopore, MAR 20, 2023, View Source [SID1234629072]). While appropriate for a broad range of human and cancer genomic analyses, a first target is to enable same day sample-to-answer results for the analysis of the BRCA1 and BRCA2 genes.

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BRCA1 and BRCA2 4bases kits are compatible with Oxford Nanopore’s devices, which start from $1000 for a MinION starter pack, expanding access to accurate, fast and affordable sequencing for any laboratory across Italy and Switzerland.

Internal studies using an extensive set of commercial samples have shown 100% concordance identifying the known genetic variants present within the BRCA1 and BRCA2 genes of these samples. These variants, which include single nucleotide variants and larger changes, are associated with increased cancer risk. . The performance of the kits is equivalent to that of existing gold-standard methods, such as short-read sequencing, MLPA and Sanger sequencing. Research studies using clinical samples are underway in multiple sites.

Sequencing BRCA1 and BRCA2

Mutations in BRCA1 and BRCA2 genes can significantly increase the risk of developing breast and ovarian cancers. Early identification of mutational carriers enables appropriate risk stratifications which can lead to important survival benefits. Additionally, highly effective treatment options such as PARPi (Poly(ADP-ribose) polymerase inhibition) have now been approved for certain cancer patients harbouring BRCA1 and 2 genetic mutations.

In healthcare, routine BRCA1 and BRCA2 genetic testing currently performed for both cancer prevention and treatment are highly centralised and can have a turnaround time ranging from a few weeks to months, depending on the need to batch multiple samples. In certain cases, the long turnaround time can lead to making clinical decisions (like surgical treatment decisions) without the result at hand which can later have strong implications for patients harbouring BRCA mutations.

To address an unmet need for workflows that can rapidly sequence BRCA1 and BRCA2, in matter of hours or day(s), Oxford Nanopore and 4bases will release an end-to-end research workflow using 4bases kits and Oxford Nanopore sequencing technology.

The 4bases kit targets the BRCA1 and BRCAC2 genes through PCR generating short amplicons compatible with Oxford Nanopore’s built-in short fragment mode (SFM) sequencing and, following nanopore library prep and sequencing, the software identifies variants present in these genes to provide a report listing the mutations to the end user.

Gordon Sanghera, CEO, Oxford Nanopore Technologies, commented:

"We are delighted to be working with 4bases on this important work to deliver distributed and accessible sequencing to scientists in Italy and Switzerland. In the first instance, we are excited to see how the combination of 4bases and nanopore sequencing will enable rapid characterisation of the BRCA1 and BRCA2 genes and significantly decrease the time to answer. As our collaboration develops we will see this expanded across the breadth of the 4bases portfolio and this will have a large impact on many research areas."

Fabio Grandi, CEO, 4bases, commented:

"With now over 10 years of activity in the field of next generation sequencing, we at 4bases have witnessed every step of what we can call a revolution, leading to an always faster and more comprehensive acquisition of genomic data to the increasing benefit of clinicians involved with precision medicine. Our solutions are now used on a worldwide basis with the main sequencing systems and are now specifically adapted to the new Oxford Nanopore sequencing technology. After the development of 4eVAR, our new bioinformatics tool, completed last year, this strategic collaboration represents a new and exciting milestone in the 4bases development."