Horizon Therapeutics plc to Release Fourth-Quarter and Full-Year 2022 Financial Results on March 1, 2023

On January 30, 2023 Horizon Therapeutics plc (Nasdaq: HZNP) reported that it will release its fourth-quarter and full-year 2022 financial results on Wednesday, March 1, 2023, prior to the open of U.S. financial markets (Press release, Horizon Therapeutics, JAN 30, 2023, View Source [SID1234626648]).

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In light of the recently announced agreement to be acquired by Amgen Inc. and applicable securities laws, Horizon will not be hosting a conference call to discuss its financial results. The earnings press release will be made available publicly on the Investor Relations page of its website at View Source

Beyond Cancer® Appoints Gavin Choy, PharmD as Chief Operating Officer

On January 30, 2023 Beyond Cancer, Ltd., an affiliate of Beyond Air, Inc. (NASDAQ: XAIR) that is developing ultra-high concentration nitric oxide (UNO) as an immunotherapeutic for solid tumors, reported the appointment of Gavin Choy, PharmD as Chief Operating Officer (Press release, Beyond Cancer, JAN 30, 2023, View Source;id=253141&p=2256311&I=1206939-c7Z3G6f3m8 [SID1234626647]). He brings more than 20 years of expertise to Beyond Cancer in the development of small molecules as well as immunotherapy in oncology with the successful management of multiple early first-in-human studies in the U.S. and Australia/New Zealand, and late-stage registrational clinical studies globally, as well as early access, and compassionate use programs.

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"Gavin’s extensive experience facilitating new drug products through the clinical trial process is a welcomed addition to the talented team at Beyond Cancer," commented Selena Chaisson, Chief Executive Officer of Beyond Cancer. "Gavin will be instrumental in our efforts to begin clinical trials in the U.S. and successfully develop UNO as a therapeutic option for patients with solid tumors."

"I am thrilled to partner with the talented and innovative Beyond Cancer team to advance UNO into additional clinical studies," remarked Dr. Choy. "Harnessing ultra-high concentration nitric oxide to engage the immune system with the aim of preventing metastatic disease and relapse across a variety of solid tumors can be a potentially viable treatment option added to the existing armamentarium of therapeutics for the treatment of solid tumors."

Dr. Choy has held various executive leadership roles in the pharmaceutical and biotechnology industry and has extensive experience leading cross-functional teams in early-, mid-, and late-stage clinical development programs. Dr. Choy successfully led or was an integral member of a team in four New Drug Applications (NDA) and seven Investigational New Drugs (IND) and has experience in achieving Fast Track and Orphan Drug Designations. He has also led a lead asset into a global Phase 2 program in fourteen countries with approximately 100 clinical investigative sites. He most recently served as Chief Clinical Development Officer at GT Biopharma where he authored an orphan drug application submission, co-authored an abbreviated clinical study report, and implemented their quality system. Prior to his role at GT Biopharma, he served as Chief Operating Officer at Apollomics, Inc. and was President at CG Pharmaceuticals, Inc. Dr. Choy is the co-founder and Chief Operating Officer of Adaptive Research, Inc., a healthcare ecosystem that enables physicians to participate in clinical trials and engages biotechnology and pharmaceutical sponsors to expand access to larger eligible and diverse patient pools in community settings.

Throughout Dr. Choy’s career, he has prolifically published manuscripts, abstracts and journal articles with over 75 peer-reviewed publications to his credit. Dr. Choy has 18 years of clinical experience in hematology/oncology/bone marrow transplantation and geriatrics at the Department of Veterans Affairs and Stanford University Hospital.

Dr. Choy received his Doctor of Pharmacy from the University of Southern California and completed residency training at the University of Southern California and at the U.S. Department of Veteran Affairs, Sepulveda Medical Center. He also holds a Master of Business Administration focused on Health Care from the University of California, Irvine, Paul Merage School of Business.

About Nitric Oxide
Nitric Oxide is a powerful molecule, naturally synthesized in the human body, proven to play a critical role in a broad array of biological functions. In the airways, NO targets the vascular smooth muscle cells that surround the small resistance arteries in the lungs. Currently, exogenous inhaled NO is used in adult respiratory distress syndrome, post certain cardiac surgeries and persistent pulmonary hypertension of the newborn to treat hypoxemia. Additionally, NO is believed to play a key role in the innate immune system and in vitro studies suggest that NO possesses anti-microbial activity not only against common bacteria, including both gram-positive and gram-negative, but also against other diverse pathogens, including mycobacteria, viruses, fungi, yeast and parasites, and has the potential to eliminate multi-drug resistant strains.

Scilex Holding Company Announces that its Majority Stockholder, Sorrento Therapeutics, Inc., has Issued an “FAQ” Regarding the Dividend of Scilex Holding Company Common Stock

On January 30, 2023 Scilex Holding Company (Nasdaq: SCLX) reported that its majority stockholder, Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today posted a "Frequently Asked Questions" document under the "Investors" section of its website at www.sorrentotherapeutics.com regarding its recent dividend to Sorrento stockholders of shares of common stock of Scilex Holding Company held by Sorrento (Press release, Sorrento Therapeutics, JAN 30, 2023, View Source [SID1234626646]).

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The FAQs address questions regarding the details of the dividend, including the record date, payment date, dividend ratio, distribution of the shares of Scilex common stock, how Sorrento stockholders can obtain certain information regarding the dividend, CUSIP information for Scilex common stock, and transfer restrictions on the dividend stock as well as questions related to issues that may arise with respect to the dividend in connection with short positions in Sorrento common stock.

The FAQs and related annexes are included in this press release and can also be found on Scilex’s website View Source

Quince Therapeutics Provides Pipeline Update and Business Outlook for 2023

On January 30, 2023 Quince Therapeutics, Inc. (Nasdaq: QNCX), a biotechnology company focused on acquiring, developing, and commercializing innovative therapeutics that transform patients’ lives, reported an update on the company’s development pipeline and business outlook for 2023 (Press release, Quince Therapeutics, JAN 30, 2023, View Source [SID1234626645]). The company intends to prioritize capital resources toward the expansion of its development pipeline through opportunistic in-licensing and acquisition of clinical-stage assets targeting debilitating and rare diseases. Quince plans to out-license its bone-targeting drug platform and precision bone growth molecule NOV004 designed for accelerated fracture repair in patients with bone fractures and osteogenesis imperfecta.

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"We believe our optimal growth plan lies in dedicating our capital, drug development, and corporate resources toward the in-licensing and acquisition of clinical-stage assets. We are actively seeking partnership opportunities focused around clinical-stage assets in a broad variety of therapeutic areas," said Dirk Thye, M.D., Quince’s chief executive officer. "Supported by a strong balance sheet, optimized cash runway, and highly experienced development team, Quince is well-positioned to execute our plan as we diligently work to identify, assess, and complete the in-licensing and acquisition of commercially viable assets."

Key highlights of the company’s strategic growth plan include:

Prioritizing pipeline expansion through in-licensing and acquisition

Active diligence process to identify and evaluate actionable clinical-stage assets for in-licensing and acquisition.
Primarily seeking clinical-stage assets targeting debilitating and rare disease therapeutic areas.
Potential asset targets must have compelling data, a well-defined commercial opportunity, and efficient clinical and regulatory development pathway.
Ability to leverage management team’s collective prior experience in developing and commercializing more than 25 approved therapeutics.
Out-licensing of bone-targeting drug platform and precision bone growth molecule NOV004

Seeking to out-license bone-targeting drug platform and precision bone growth molecule NOV004.
Precision bone growth molecule NOV004 is an anabolic peptide engineered to precisely target and concentrate at the bone fracture site, resulting in rapid increases in bone density, strength, and expedited healing as demonstrated in extensive preclinical studies.
NOV004 has completed all IND-enabling studies, in addition to completion of a successful pre-IND meeting with the U.S. Food and Drug Administration.
Out-licensing effort to commence immediately with goal of identifying a partner and concluding the process by the end of 2023.
Competitively positioned with strong balance sheet

Strong cash position of approximately $94 million in cash, equivalents, and marketable securities as of December 31, 2022.
Significant cash runway to support pipeline expansion through in-licensing and acquisition, as well as fund capital and operating expenditures into at least 2028.
Expect annual capital and operating expenditures to approximate $11 million in 2023, excluding the impact of corporate restructuring and potential business development activities.
The company has not completed preparation of its financial statements for the fourth quarter or full year of 2022. The cash, cash equivalents, and investments presented as of December 31, 2022, are preliminary and unaudited and are thus inherently uncertain and subject to change as the company completes its financial results for 2022. Quince is in the process of completing the company’s customary year-end close and review procedures as of and for the year ended December 31, 2022, and there can be no assurance that final results for this period will not differ from these preliminary, unaudited amounts. The company’s independent registered public accounting firm has not audited, reviewed, compiled, or performed any procedures with respect to such preliminary data for the fourth quarter and year ended December 31, 2022.

Micronoma Receives FDA Breakthrough Device Designation for OncobiotaLUNG, A Novel Liquid Biopsy Assay for Lung Carcinoma Detection

On January 30, 2023 Micronoma, the first biotech company offering early cancer detection with a microbiome-driven liquid biopsy platform, reported that its OncobiotaLUNG assay received the Breakthrough Device Designation from the Food and Drug Administration (FDA) (Press release, Micronoma, JAN 30, 2023, View Source [SID1234626643]).

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As a result, Micronoma can expect continued guidance and prioritized reviews from the agency of its upcoming clinical trial and concomitant pre-market approval processes.

The FDA based its Breakthrough Device decision on the ability of Micronoma’s technology to categorize lung nodules into high-risk or low risk of malignancy through a simple blood draw, even in the earliest stages of the disease, compared to the current standard of care.