On March 24, 2023 Oncorus, Inc. (Nasdaq: ONCR), an RNA medicines company focused on developing intravenously administered, self-amplifying RNA to transform outcomes for cancer patients, reported fourth quarter and full year 2022 financial results and provided an update on its business (Press release, Oncorus, MAR 24, 2023, View Source [SID1234629302]).

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"We are poised for a year of strong execution as we head further into 2023. Oncorus is pioneering a first-of-its-kind, self-amplifying RNA platform with an exciting lead program, ONCR-021, which is an intravenously (IV) administered viral RNA encoding an optimized genome of Coxsackievirus 21A. We plan to submit an IND with the FDA for ONCR-021 in mid-2023," said Theodore (Ted) Ashburn, M.D., Ph.D., President and Chief Executive Officer of Oncorus. "Our mission is to realize the full promise of IV-administered RNA medicines to transform outcomes for cancer patients. As leaders in the self-amplifying RNA and LNP delivery space, we continue to focus our development efforts on overcoming the challenges associated with today’s approved IV-administered, RNA-based therapeutics. I believe that our innovative science and our exceptional team position us to achieve our mission."

Business Highlights

Reprioritized portfolio to focus on IV-administered, self-amplifying RNA medicines. In November 2022, Oncorus announced a pipeline reprioritization to focus on ONCR-021, in addition to discontinuing its Phase 1 clinical trial of ONCR-177 and reducing its workforce and operating expenses. The company announced that further development of additional pipeline programs, including ONCR-788 and ONCR-719, will be dependent on the receipt of additional financing or support from strategic partnerships.
Self-amplifying RNA platform continues to progress. Oncorus remains on track to submit an IND for ONCR-021, the lead product candidate from its self-amplifying RNA platform, in mid-2023. The company plans to evaluate ONCR-021 in patients with non-small cell lung cancer, renal cell carcinoma, melanoma, hepatocellular carcinoma and anaplastic thyroid cancer.
Preclinical results featured in Nature Communications support IV-administered self-amplifying RNA/lipid nanoparticle (LNP) platform. In October 2022, Oncorus published preclinical data in Nature Communications highlighting the potential of its self-amplifying RNA platform as a novel approach to treating cancer by enabling tumor specific replication with systemic dosing. The data demonstrate that the delivery of RNA encoding for the genome of a replication competent virus encapsulated in an LNP enables selective replication, virus assembly and spread and lysis of tumor cells, leading to potent anti-tumor efficacy even in the presence of anti-viral neutralizing antibodies in the bloodstream. These results support the potential of this modality to safely and effectively kill tumor cells, while stimulating multiple arms of the immune system to better fight cancer.
Fourth Quarter 2022 Financial Results

Cash, cash equivalents and investments totaled $62.2 million as of December 31, 2022 compared to $123.9 million as of December 31, 2021.

Research and development expenses for the quarter ended December 31, 2022 were $15.7 million compared to $14.3 million for the corresponding quarter in 2021. The increase was primarily attributable to extensive pre-clinical work associated with our ONCR-021 program, as well as increased facility-related expenses to support our GMP manufacturing facility.

General and administrative expenses for the quarter ended December 31, 2022 were $5.1 million compared to $5.6 million for the corresponding quarter in 2021. The decrease was primarily attributable to savings from decreased annual insurance premiums, as well as decreased stock-based compensation due to our lower stock price in 2022.

Net loss for the quarter ended December 31, 2022 was $20.9 million, or $0.81 per share, as compared to a net loss of $19.8 million, or $0.77 per share for the corresponding quarter in 2021. The increase in net loss was due to higher research and development expenses as described above, as well as interest expense associated with our venture debt which was executed in April 2022.
Financial Guidance

Oncorus expects its cash, cash equivalents and investments to fund its capital expenditures and operating expenses into early 2024.

On March 24, 2023 NuCana plc (NASDAQ: NCNA) reported that, following a hearing on March 24, 2023, the Technical Board of Appeal (the "TBA") of the European Patent Office (the "EPO") issued an oral judgement that NuCana’s European Patent 2955190 (the "’190 patent") is not valid (Press release, Nucana BioPharmaceuticals, MAR 24, 2023, View Source [SID1234629300]).

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The TBA reversed the previous decisions of the EPO’s Examination Division which issued NuCana’s ‘190 patent and of the EPO’s Opposition Division which upheld this patent in 2021. In July 2022, the Regional Court of Dusseldorf issued a judgement that fully endorsed the decision of the EPO’s Opposition Division.

The TBA considered a part of Claim 1 of the ‘190 patent to lack an inventive step and did not allow NuCana to overcome this finding by an appropriate amendment of the claims in line with established case law of the EPO. "This aspect of the decision is particularly disappointing," said Dr. Thorsten Bausch, Senior Partner at Hoffmann Eitle, who represented NuCana at the hearing.

This follows on from the judgement of the Patents Court of England and Wales handed down on March 21, 2023 which held that the ‘190 patent was invalid in the UK.

Neither of these decisions affect the patent protection on any of NuCana’s anti-cancer ProTides, which are covered by separate patents that were not involved in this litigation.

Hugh S. Griffith, NuCana’s Founder and CEO, said: "While we are disappointed by these decisions, they do not impact our core business of developing innovative new medicines for the treatment of patients with cancer. NuCana is well-capitalized, all of our clinical programs remain on track and we expect multiple data announcements in 2023."

On March 24, 2023 MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on developing and commercializing innovative antibody-based therapeutics for the treatment of cancer, reported that following the U.S. Food and Drug Administration’s (FDA) approval of Incyte’s Biologics License Application (BLA) for ZYNYZ (retifanlimab-dlwr), the Company will receive a $15 million milestone payment from Incyte (Press release, MacroGenics, MAR 24, 2023, View Source [SID1234629299]). ZYNYZ, a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), was previously developed by MacroGenics and licensed to Incyte pursuant to an exclusive global collaboration and license agreement in October 2017.

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"The FDA approval of ZYNYZ represents the third approval of a product originating from MacroGenics’ pipeline of proprietary or partnered product candidates," said Scott Koenig, M.D., Ph.D., President and Chief Executive Officer of MacroGenics. "We are delighted that with the approval of ZYNYZ, there is now an additional option for treating patients with Merkel cell carcinoma, a rare and aggressive type of skin cancer. We also look forward to Incyte’s continued progress in advancing their development of retifanlimab across additional indications and geographies."

On March 24, 2023 Celyad Oncology (Euronext & Nasdaq: CYAD) (the "Company"), a biotechnology company focused on innovative technologies for chimeric antigen receptor (CAR) T-cell therapies, reported Georges Rawadi as its new Chief Executive Officer (CEO), effective as of March 23, 2023, with starting date April 17, 2023 (Press release, Celyad, MAR 24, 2023, View Source [SID1234629294]). Michel Lussier will continue to serve as Interim CEO until April 17 to facilitate transition.

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Georges Rawadi is a seasoned executive with over 20 years of experience in pharma/biotech, as research director, business developer, CEO and board member. He spent four years at Celyad Oncology (2014-2018) as Vice-President Business Development & Intellectual Property ("BD & IP"), and has insightful knowledge of both the company and the CAR-T space. Georges Rawadi has a genuine passion for seeking and creating new business opportunities.

Georges Rawadi currently holds a number of Board positions and consultancy roles in the biotechnology industry. Recently, he has served as CEO and Board member of Ysopia Bioscience (France), Vice-President BD & IP of Celyad Oncology and Vice-President Business Development of Cellectis (France – Nasdaq listed company).

Georges Rawadi holds a Master Degree in Biochemistry, a Master Degree in Microanalysis, a Ph.D. in Microbiology and an Executive Master in Management and Strategy in the Health Industry.

Hilde Windels, Chair of the Board, commented: "It is with great enthusiasm that we announce that Georges has been appointed as our new CEO. His in-depth expertise in the CAR-T space and his significant BD and IP expertise are great assets that will help Celyad Oncology to excel in its next phase of growth. We congratulate Georges and wish him all the best in his new role."

Georges Rawadi added: "I am passionate about the space in which Celyad Oncology is operating and strongly believe in the value of its IP estate and efforts to overcome the current limitations of CAR-T approaches. As such, I am very pleased to be given the opportunity to join Celyad Oncology. I look forward to working with the team and the board, whose passion and vision I share."

Michel Lussier, Interim CEO and member of the Board, commented: "We are convinced that Georges’s solid business development track record and immuno-oncology in-depth knowledge will make Georges a great leader for Celyad Oncology. We look forward to work with Georges in monetizing our IP and research assets, ensuring that Celyad Oncology can make an impact on a global scale."

On March 24, 2023 bioAffinity Technologies, Inc. (NASDAQ: BIAF; BIAFW) reported it will report financial results for the three months ended December 31, 2022, on Friday, March 31, 2023, after the market close. The Company will host a conference call on Monday, April 3, 2023, at 9:00 a.m. Eastern time to discuss those results and answer questions (Press release, BioAffinity Technologies, MAR 24, 2023, View Source [SID1234629293]).

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Event: bioAffinity Technologies Fourth Quarter 2022 Financial Results
Date: Monday, April 3, 2023
Time: 9:00 a.m. EDT
Toll Free: 1-877-270-2148
International: 1-412-902-6510
Webcast: Webcast link

A replay of the event will be available for 90 days at the webcast link above, which can also be found in the Investor Relations section of bioAffinity’s website at www.ir.bioaffinitytech.com.