On March 22, 2023 ArcticZymes Technologies ASA (OSE: AZT) reported that the Board of Directors has today accepted the voluntary resignation of Jethro Holter as Chief Executive Officer, due to personal reasons (Press release, ArcticZymes Technologies, MAR 22, 2023, View Source [SID1234629155]).

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The resignation will take effect on 30th September 2023 after the required 6 months notice period.

"On behalf of the Board, I want to thank Jethro very much for his outstanding contributions to ArcticZymes over the past 3 years that he has served as our CEO. During that time, Jethro has been instrumental in transforming ArcticZymes into a successful and highly profitable business," said Marie Roskrow. "All of the employees of ArcticZymes send their good wishes and thanks to Jethro."

The Board of Directors will immediately initiate a search for a new CEO. In the meantime, Chairman of the Board, Marie Roskrow, will act as Executive Chairman to lead and support the Company through this transition period.

ArcticZymes also anticipates expanding the Board of Directors in the near future.

On March 22, 2023 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a pre-commercial-stage biopharmaceutical company focused on oncology, reported its audited 2022 annual financial results for the year ended December 31, 2022, and provided recent corporate and portfolio updates (Press release, BioLineRx, MAR 22, 2023, https://ir.biolinerx.com/news-releases/news-release-details/biolinerx-reports-2022-financial-results-and-recent-corporate [SID1234629154]).

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"Over the last quarter and into this year, we continue to proceed with activities to advance the NDA review process of APHEXDA, while in parallel progressing with pre-launch activities in anticipation of potential approval later this year," said Philip Serlin, Chief Executive Officer of BioLineRx. "Importantly, we recently announced the appointment of our new chief medical officer and completed the formation of our U.S. commercialization team that includes industry veterans with significant and very relevant drug launch and sales experience. Additionally, we announced a new collaboration to evaluate motixafortide for stem cell mobilization for gene therapies in sickle cell disease, which continues our goal of fully maximizing its clinical potential for patients. This is an extremely exciting year for the Company, with the potential commercial approval of our first product, anticipated pancreatic cancer clinical trial data, as well as the planned initiation of two new clinical trials that may further our growth."

Recent Corporate Updates

Appointed Tami Rachmilewitz, M.D. as Chief Medical Officer
Finalized formation of the U.S. commercial leadership team, which collectively has significant drug launch and sales experience, with particular expertise in stem cell mobilization and transplantation
Portfolio Execution

Motixafortide (selective inhibitor of CXCR4 chemokine receptor)

Multiple Myeloma

Announced FDA acceptance of the APHEXDA (motixafortide) NDA in stem cell mobilization for autologous transplantation in multiple myeloma patients. PDUFA target action date set for September 9, 2023
Presented a cost-effectiveness analysis of APHEXDA (motixafortide) versus plerixafor in stem cell mobilization for autologous transplantation in patients with multiple myeloma at the American Society of Hematology (ASH) (Free ASH Whitepaper) 64th Annual Meeting, which was held December 10-13, 2022, in New Orleans, Louisiana. The analysis demonstrated significant net cost savings with APHEXADA (motixafortide)
Pancreatic Ductal Adenocarcinoma (PDAC)

Continued to advance preparation activities for a Phase 2b randomized clinical trial with 200 patients assessing motixafortide in combination with a PD-1 inhibitor and standard-of-care chemotherapy as a first line metastatic PDAC (mPDAC) therapy with collaboration partner GenFleet. Anticipate clinical trial initiation in 2023
Continued collaboration progress with Columbia University investigator-initiated Phase 2 study assessing motixafortide in combination with the PD-1 inhibitor cemiplimab and standard-of-care chemotherapy in first line mPDAC patients. Anticipate initial patient data in 2023
Sickle Cell Disease & Gene Therapy

Announced clinical trial collaboration with Washington University School of Medicine in St. Louis to evaluate motixafortide as monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell mobilization for gene therapies in sickle cell disease. Anticipate clinical trial initiation in 2023. Clinical trial design was presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 64th Annual Meeting, which was held December 10-13, 2022, in New Orleans, Louisiana
AGI-134 (synthetic alpha-Gal glycolipid)

Solid Tumor Immunotherapy

Announced results from Phase 1/2a study of investigational anti-tumor vaccine AGI-134 in metastatic solid tumors. First-in-human, single-agent study met primary endpoint for safety and tolerability and demonstrated immune activity across multiple biomarkers. The Company is evaluating potential development program pathways in consultation with its scientific advisory board
Financial Results for Year Ended December 31, 2022

Research and development expenses for the year ended December 31, 2022, were $17.6 million compared to $19.5 million for the year ended December 31, 2021. The decrease resulted primarily from lower expenses related to NDA supporting activities related to motixafortide, as well as lower expenses associated with the completed motixafortide GENESIS clinical trial, offset by an increase in expenses associated with the AGI-134 study and an increase in payroll and related expenses
Sales and marketing expenses for the year ended December 31, 2022, were $6.5 million compared to $1.0 million the year ended December 31, 2021. The increase resulted primarily from initiation of pre-commercialization activities related to motixafortide, as well as an increase in market research
General and administrative expenses for the year ended December 31, 2022, were $5.1 million compared to $4.3 million for the year ended December 31, 2021. The increase resulted primarily from an increase in share-based compensation and small increases in a number of general and administrative expenses
Net loss for the year ended December 31, 2022, was $25.0 million, compared to $27.1 million for the year ended December 31, 2021
As of December 31, 2022, the Company had cash, cash equivalents, and short-term bank deposits of $51.1 million and anticipates this will be sufficient to fund operations, as currently planned, into the first half of 2024
A copy of the Company’s annual report on Form 20-F for the year ended December 31, 2022 has been filed with the U.S. Securities and Exchange Commission at View Source and posted on the Company’s investor relations website at View Source Company will deliver a hard copy of its annual report, including its complete audited consolidated financial statements, free of charge, to its shareholders upon request at [email protected].

Conference Call and Webcast Information

BioLineRx will hold a conference call today, Wednesday, March 22 at 10:00 a.m. EDT.

To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until March 24, 2023; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.

On March 22, 2023 Applied DNA Sciences, Inc. (NASDAQ: APDN) (the "Company"), a leader in PCR-based DNA technologies, reported that its wholly-owned clinical laboratory subsidiary, Applied DNA Clinical Labs, LLC (ADCL), has submitted a validation package to the New York State Department of Health (NYSDOH) in support of approval for a pharmacogenomics (PGx) assay as a NYSDOH laboratory-developed test (LDT) (Press release, Applied DNA Sciences, MAR 22, 2023, View Source [SID1234629153]). If approved by NYSDOH, the LDT test will be used by ADCL to power its population-scale PGx testing services.

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ADCL’s PGx testing will focus on population-scale testing that is expected to be accretive to ADCL’s margin profile. ADCL’s commercial strategy is centered on the direct-to-enterprise and self-insured health markets that do not require ADCL to seek third-party reimbursement or engage in individual patient billing. In advance of initiating its PGx testing services, the Company’s sales outreach has targeted regional health systems and large, self-insured entities in its New York operating area and in States that recognize New York’s CLEP/CLIA certification.

PGx testing is a data-driven approach that relates an individual’s genetic factors to variable responses to prescription drugs. ADCL’s PGx assay interrogates 120 targets across 37 genes relevant to a broad range of common drugs, including cardiac, pain management, cancer, and mental health therapies. PGx testing yields actionable information to empower healthcare providers to deliver precision medicine to their patients through personalized drug prescribing and dosing.

Recently published studies have shown that population-scale PGx testing can significantly reduce overall population healthcare costs, reduce adverse drug events, and increase population wellbeing1,2. These benefits can result in significant cost savings to large entities and self-insured employers, the latter accounting for approximately 65% of all U.S. employers in 20223.

"PGx testing is a logical first step into the promising field of personalized medicine that brings together ADCL’s demonstrated capacity for population-scale testing and PGx’s proven benefits to the individual. When applied to large populations, we believe that the combination will generate significant healthcare cost reductions for enterprises and overall wellness benefits to employees," stated Dr. James A. Hayward, president and CEO of Applied DNA Sciences. "Given PGx testing’s attractive margin profile and ongoing conversations with prospective customers, we view this first genetic assay as the basis for a long-term, profitable testing service."

Footnotes:
1 Jarvis, J. P., Peter, A. P., Keogh, M., Baldasare, V., Beanland, G. M., Wilkerson, Z. T., Kradel, S., & Shaman, J. A. (2022). Real-world impact of a pharmacogenomics-enriched comprehensive medication management program. Journal of Personalized Medicine, 12(3), 421. View Source
2 Jesse J Swen, Cathelijne H van der Wouden, et al., A 12-gene pharmacogenetic panel to prevent adverse drug reactions: an open-label, multicentre, controlled, cluster-randomised crossover implementation study, The Lancet, Volume 401, Issue 10374, 2023, pages 247-356. View Source(22)01841-4. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)01841-4/fulltext
3 View Source

On March 22, 2023 Anocca reported that it will attend 6th Annual Neoantigen Summit Europe (Press release, Anocca, MAR 22, 2023, View Source [SID1234629152]).

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Reagan Jarvis, our CEO, is presenting ‘Showcasing Individualised Neoantigen Discovery Platform’ at the TCR-Based Therapies for Solid Tumours, where he talks about understanding HLA-restricted neoantigen target complexity with cell-based assays, validating neoantigen targets with T-cell Receptor reagents derived by rapid
multiplex discovery and considering TCR potency and safety trade-off for HLA-restricted neoantigens.

On March 22, 2023 Anocca reported it wil attend 2023 Cell & Gene Meeting on the Med (Press release, Anocca, MAR 22, 2023, View Source [SID1234629151]).

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We are delighted to be one of the sponsors of this year’s 2023 Cell & Gene Meeting on the Med, with Reagan Jarvis, our CEO and Brian McGee, our CBO presenting Anocca, our technology platforms and our pipeline of novel T-cell therapies.