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Baudax Bio to Host Key Opinion Leader Webinar to Discuss Results of Phase 2 BX1000 Trial

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Baudax Bio (Nasdaq: BXRX) announced a virtual webinar on April 25, 2023, featuring key opinion leaders discussing the Phase 2 trial results of BX1000, a neuromuscular blocking agent (NMB), for patients undergoing elective surgery. The trial is a randomized, double-blind, active-controlled study comparing BX1000 doses against a standard dose of rocuronium in 80 adult patients. The event aims to provide insights on BX1000's potential advantages in surgical settings. Baudax is developing two NMBs, BX1000 and BX2000, along with a proprietary reversal agent, BX3000, expected to advance to IND filing in 2023. These agents may improve surgical efficiency and reduce operating room time. The company is committed to enhancing hospital-related products and developing its clinical pipeline.

Positive
  • Successful Phase 2 trial for BX1000 indicates promising results in neuromuscular blockade.
  • BX1000, BX2000, and BX3000 have the potential to enhance surgical efficiency and reduce costs.
  • Expected IND filing for BX3000 in the summer of 2023 supports product pipeline advancement.
Negative
  • Dependence on successful trial results to secure future financing and market positioning.
  • High-risk factors related to regulatory approvals and market competition.

Virtual Webinar to be held April 25, 2023 at 10:00 AM Eastern Time

MALVERN, Pa., April 24, 2023 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (Nasdaq:BXRX) (the “Company”), a pharmaceutical company focused on innovative products for hospital and related settings, today announced the Company is hosting a virtual key opinion leader event Innovation in Anesthesia: BX1000 for Neuromuscular Blockade (NMB) featuring Dr. Todd M. Bertoch, Chief Executive Officer of JBR Clinical Research, and Dr. Harold S. Minkowitz, Associate Director for Clinical Research at The University of Texas MD Anderson Cancer Center Department of Anesthesiology and Perioperative Medicine, to discuss results from its Phase 2 trial of BX1000 for neuromuscular blockade (NMB) in patients undergoing elective surgery.

The BX1000 Phase 2 surgery trial is a randomized, double-blind, active-controlled clinical trial comparing three different doses of BX1000 to a standard dose of 0.6mg/kg rocuronium in a planned trial of 80 adult patients undergoing elective surgery utilizing total intravenous anesthesia. A live question and answer session will follow the formal presentations.

To register for the event, click here.

Speaker Bios

Todd M Bertoch, MD, is a diplomate of the American Board of Anesthesiology. He received a Doctor of Medicine degree from the Uniformed Services University of the Health Sciences in Bethesda, Maryland and completed an internship in Internal Medicine and Anesthesiology residency at Wilford Hall Medical Center in San Antonio, Texas. Dr. Bertoch served as an anesthesiologist in the United States Air Force until 2006 where he gained extensive experience in both trauma care and pain management. Since joining JBR Clinical research in 2017, he has served as Principal Investigator for over 100 clinical trials, defended development programs for sponsors before the FDA, been invited to present study results on behalf of clients at professional meetings, designed and authored numerous clinical trial protocols, and has helped author several industry-related articles and white papers.

Harold S Minkowitz, MD, is President of Analgesics, Perioperative & Hospital Based Research at Evolution Research Group and Associate Director for Clinical Research at The University of Texas MD Anderson Cancer Center Department of Anesthesiology and Perioperative Medicine.

Dr. Minkowitz completed his medical training at the University of the Witwatersrand, in Johannesburg. After receiving his Fellowship in the Faculty of Anesthesiologists in South Africa, he relocated to the Texas Medical Center in Houston.

About Baudax Bio’s Neuromuscular Blocking Agents (NMBs)

Baudax Bio holds exclusive global rights to two novel NMBs, BX1000, an intermediate duration, clinical stage blocking agent, and BX2000, an ultra-short duration, clinical stage blocking agent, as well as a proprietary chemical reversal agent, BX3000, undergoing nonclinical studies intended to support an IND filing in 2023. BX3000 is a specific reversal agent that may rapidly reverse BX1000 and BX2000. All three agents are licensed from Cornell University. We believe these agents will allow for a very rapid induction of neuromuscular blockade for surgical settings, a predictable offset of blockade after administration, enhanced by rapid reversal of the neuromuscular blockade when BX3000 is used with the NMB agent. These novel agents have the potential to meaningfully reduce the time to onset of blocking and of reversal of blockade, reducing overall time in operating rooms or post-acute care settings, resulting in potential clinical and cost advantages, as well as time-related valuable cost savings for hospitals and ambulatory surgical centers.

About Baudax Bio

Baudax Bio is a pharmaceutical company focused on innovative products for hospital and related settings. The Company has a pipeline of innovative pharmaceutical assets including two clinical-stage, novel neuromuscular blocking (NMBs) agents, one undergoing a Phase II clinical trial and an additional unique NMB undergoing a dose escalation Phase I clinical trial, as well as a proprietary chemical reversal agent specific to these NMBs, which is currently undergoing nonclinical and manufacturing studies to prepare for an expected IND filing in the summer of 2023. For more information, please visit www.baudaxbio.com.

Forward Looking Statements

This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio’s expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “may,” “upcoming,” “plan,” “target,” “goal,” “intend” and “expect” and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication of this press release and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio’s performance to differ materially from those expressed in, or implied by, these forward-looking statements. These risks and uncertainties include, among other things, risks related to market, economic and other conditions, the ongoing economic and social consequences of the COVID-19 pandemic, Baudax Bio’s ability to advance its current product candidate pipeline through pre-clinical studies and clinical trials, that interim results may not be indicative of final results in later clinical trials, Baudax Bio’s ability to raise future financing for continued development of its product candidates such as BX1000, BX2000 and BX3000, Baudax Bio’s ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio’s ability to comply with the financial and other covenants under its credit facility, Baudax Bio’s ability to manage costs and execute on its operational and budget plans, Baudax Bio’s ability to achieve its financial goals; Baudax Bio’s ability to maintain listing on the Nasdaq Capital Market; and Baudax Bio’s ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio’s business and future results included in Baudax Bio’s filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to Baudax Bio, and Baudax Bio assumes no obligation to update any forward-looking statements except as required by applicable law.

CONTACTS:

Investor Relations Contact:

Mike Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com


FAQ

What are the objectives of the BX1000 Phase 2 trial?

The BX1000 Phase 2 trial aims to evaluate the efficacy and safety of BX1000 compared to a standard dose of rocuronium in patients undergoing elective surgery.

When will the results of the BX1000 trial be discussed?

The results will be discussed in a virtual webinar on April 25, 2023, featuring experts from clinical research.

What is the significance of the BX3000 agent?

BX3000 is a proprietary reversal agent intended to rapidly reverse neuromuscular blockade caused by BX1000 and BX2000, enhancing surgical efficacy.

What updates are expected for Baudax Bio's product pipeline?

Baudax Bio plans to file for IND for BX3000 in the summer of 2023, advancing its innovative neuromuscular blocking agents in clinical development.

Baudax Bio, Inc.

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