Baudax Bio Inc · OTC:BXRXQ
Baudax Bio — Investor Presentation (May 2023)
21 slides from Baudax Bio's investor presentation, May 10, 2023
Slide 1: Corporate Presentation May 2023
BAUDAX BIO Corporate Presentation May 2023 Exhibit 99.1
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation 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,
Slide 3: Investor Highlights
Investor Highlights Addressing an estimated $4 billion global opportunity in growing acute care neuromuscular blocking agents (NMBs) segment Clinical stage NMB assets offer potential for improved patient management, cost reduction for procedures requiring NMBs BX1000 key data readouts reported in 1H
Slide 4: Our Team
Our Team Significant drug development and commercial assessment expertise Gerri Henwood President & CEO Founder, President, CEO Recro President of Malvern Consulting Group Founder, Pres., CEO Auxilium Founder, CEO IBAH (NASDAQ listed CRO) >10 years at SK&F (now GSK) Mike Choi Finance VP Finance, Rec
Slide 5: Neuromuscular Blockers and Reversal Agent
Neuromuscular Blockers and Reversal Agent
Slide 6: NMB Overview
NMB Overview Used to induce rapid total paralysis to permit intubation and muscle relaxation during surgery or in ventilated patients Used in the operating room/ASC to optimize surgical conditions Additional use in ICU to facilitate mechanical ventilation Procedural use increasing with growth of lap
Slide 7: Limitations of Current Standard of Care
Limitations of Current Standard of Care Agent Type Characteristics Products Limitations Depolarizing Open receptor channels similar to acetylcholine Succinylcholine Malignant hyperthermia Fasciculations – micro contractions Hyperkalemia – high potassium levels Anaphylaxis - Residual neuromuscular bl
Slide 8: Limitations of Current Standard of Care (continued)
Limitations of Current Standard of Care (continued) Agent Type Characteristics Products Limitations Reversal Agents Cyclodextrin which chelates the NMB The only selective relaxant binding agent in routine clinical use Sugammadex (Bridion® - Merck, $1.6B) Dose will vary by time of administration rela
Slide 9: Portfolio offers potential to improve patient management
Portfolio offers potential to improve patient management Rapid onset/offset may increase procedure capacity, reduce costs BX1000 BX2000 BX3000 AGENT Intermediate duration of action (est. 30-45 mins) Ultra short acting (est. 10-15 mins) Rapid offset (2-5 min) Rapid onset Predictable offset without re
Slide 10: BX1000 Phase 2 Study BDX-22-006
BX1000 Phase 2 Study BDX-22-006 A Phase 2, Randomized, Double-Blind, Active-Controlled, Evaluation of Intubation Conditions Following BX1000 or Rocuronium in Subjects Undergoing Surgery Primary Outcomes Assessment of Intubation Time Frame within 2 minutes after administration Conditions (Poor, Good,
Slide 11: Study BDX-22-006 - Objectives
Study BDX-22-006 - Objectives To evaluate the intubating conditions at 60, 90 or 120 seconds after administration of BX1000 or Rocuronium To evaluate the safety and tolerability of BX1000 To evaluate the neuromuscular blocking (NMB) profile of BX1000
Slide 12: Study BDX-22-006 – Design
Study BDX-22-006 – Design Phase 2 randomized, double blinded, active-controlled study 4 Treatment groups (n=20/group) - Single bolus dose of BX1000: - 0.15 mg/kg - 0.25 mg/kg - 0.35 mg/kg - Single bolus dose of Rocuronium: 0.6 mg/kg Patients undergoing hernia repair and other elective surgeries Effi
Slide 13: FDA Required Primary Efficacy Endpoint Criteria
FDA Required Primary Efficacy Endpoint Criteria Acceptable Unacceptable Excellent Good Poor Vocal cord position Adducted Intermediate Closed/Adducted Vocal cord movement None Moving Closing Ease of laryngoscopy* Easy Fair Difficult Airway reaction None Diaphragm Sustained>10s Limb movement None Slig
Slide 14: Study BDX-22-006 Demographics
Study BDX-22-006 Demographics Rocuronium BX1000 0.6 mg/kg 0.15 mg/kg 0.25 mg/kg 0.35 mg/kg Total (N=20) (N=20) (N=20) (N=20) (N=80) Subjects dosed n (%) 20 (100.0) 20 (100.0) 20 (100.0) 20 (100.0) 80 (100.0) Subjects in Efficacy Evaluation n (%) 19 (95.0* 20 (100.0) 20 (100.0) 20 (100.0) 79 (97.5) M
Slide 15: Study BDX-22-006 – Primary Endpoint
Study BDX-22-006 – Primary Endpoint Intubating Conditions at 60 seconds *1 Subject experienced a delay in intubating condition assessments at 60, 90, and 120 seconds after NMB administration due to issues with the endotracheal tube, and therefore not included in the efficacy analyses n (%) of Subjec
Slide 16: Study BDX-22-006 Adverse Events
Study BDX-22-006 Adverse Events - ≥5% of Total Population No SAEs have been reported for any treatment group at this time n (%) of Subjects Rocuronium BX1000 0.6 mg/kg 0.15 mg/kg 0.25 mg/kg 0.35 mg/kg Total Preferred Term (N=20) (N=20) (N=20) (N=20) (N=80) Subjects with >=1 TEAE 12 (60.0) 11 (55.0)
Slide 17: BX2000 Phase 1 Trial
Evaluate the safety and tolerability of single ascending doses of BX2000 Characterize the pharmacokinetics Evaluate the neuromuscular blocking profile Each cohort’s data reviewed by a safety committee (to confirm the decision to dose escalate to next highest dose) BX2000 Phase 1 Trial Phase 1, doubl
Slide 18: BX3000 IND Enabling Studies
BX3000 IND Enabling Studies GLP formulation production completed Available December 2022 Non-clinical Studies initiated December 2022 Dose finding studies Q1 GLP Studies initiate dosing in Q1 (US, Canada, UK & China) IND Filing Anticipated late Summer 2023
Slide 19: Pipeline: 2023 Catalysts
Pipeline 2023 Catalysts to inform development priorities Top-Line Data reported/Q2 2023 Last Patient Dosed/end ‘23/early ‘24 NEUROMUSCULAR BLOCKING AGENTS (NMBs) IV Intermediate-action (BX1000) IV Ultra-short action (BX2000) NMB REVERSAL (ANESTHESIA) BX3000 Pre-clinical Phase 1 Phase 2 Phase 2 Miles
Slide 20: Recent Financing
Recent Financing Cash & Cash Equivalent as of 12/31/22: $5.3 million Gross Proceeds from December 2022 Public Offering Proceeds to be used for working capital, pipeline development, general corporate purposes Raised in early January 2023 through warrant exercise $5 Million $4.3 Million Gross Proceed
Slide 21: Thank You!
THANK YOU! BauDax BIO