Baudax Bio Inc · OTC:BXRXQ
Baudax Bio — Investor Presentation (July 2023)
32 slides from Baudax Bio's investor presentation, Jul 17, 2023
Slide 1: Overview
4 aS 99.1 Overview eralmmune BauUDax BIO
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding: uses of proceeds; projected cash runways; future product development plans; and stockholde
Slide 3: Important Additional Information and Where to Find It
Important Additional Information and Where to Find It Baudax Bio, Inc., its directors and certain of its executive officers are deemed to be participants in the solicitation of proxies from Baudax Bio’s shareholders in connection with the matters to be considered at Baudax Bio’s 2023 Special Meeting
Slide 4: Baudax Bio + TeraImmune: Summary
Baudax Bio + TeraImmune : Summary Structured as a stock-for-stock transaction, signed/closed 6/29/23 Baudax equity holders owned ~18% (fully diluted) of combined company Balance of consideration in convertible-preferred, non-voting stock Baudax to seek stockholder approval of the conversion of the n
Slide 5: Senior Leadership Team
Senior Leadership Team Gerri Henwood - President & CEO Founder, President, CEO Baudax, Recro President of Malvern Consulting Group Founder, Pres., CEO Auxilium (NASDAQ: AUXL) Founder, CEO IBAH (NASDAQ: CRO) >10 years at SK&F (now GSK) Stewart Mc Callum, MD -Consulting CMO EVP Medical Affairs, Recro
Slide 6: R&D Leadership
R & D Leadership Significant discovery and drug development expertise Diane Myers, SVP Regulatory & Quality SVP Regulatory & Quality, Recro SVP Regulatory Affairs & Quality Assurance, MCG VP Regulatory Affairs & Quality, Auxilium >15 years at GSK Stewart Mc Callum, MD, PT-EVP, Medical Affairs EVP Me
Slide 7: TeraImmune Overview
$33 Immune OVERVIEW
Slide 8: About TeraImmune
Note: 1. Hemophilia A. 2. Myasthenia gravis. 3. Membranous nephropathy. 4. Pemphigus vulgaris. 5. Bullus Pemphigoid. 6.Neuromyelitis Optica. About TeraImmune Clinical stage company focused on autoantibody disorders by harnessing the power, innovation, and specificity of TCR Treg Cell therapies Regul
Slide 9: Unmet Treatment Needs
Unmet Treatment Needs Sources: 1Lusher J., Arkin S., Abildgaard C., Schwartz R. (1993) Recombinant factor VIII for the treatment of previously Ref: untreated patients with hemophilia A. Safety, efficacy, and development of inhibitors. Kogenate Previously Untreated Patient Study Group. N Engl J Med 3
Slide 10: Hemophilia A Market and TI-168 Positioning
Surgery / Refractory Standard of Care for HA with FVIII inhibitors ITI Emicizumab BPAs Hemophilia A – estimated to be a $9-10.5 Billion Market 100% of HA patients (~ 180,000 people in the world)* 30% of HA patients (~ 45,000 people in the world)* 10% of HA patients (~ 15,000 people in the world)* No
Slide 11: Platform for Autologous T Cell Therapy
Platform for Autologous T Cell Therapy Manufacturing optionality (Academic institutions /and TI facility– in process to be GMP ready) Foxp3+Helios+ Tregs, we believe “best-in-class” clinical-grade Treg cells Consistent Treg production without lot-to-lot variation Standard cGMP Treg production withou
Slide 12: TCR Treg Mechanism of Action in Autoimmune Disease
TCR Treg Mechanism of Action in Autoimmune Disease Autoimmune Disease Treatment with TCR Tregs Antigen recognition induces expression of effector molecules by T cells, activating B cells B cells proliferate and differentiate in Memory B cells and autoantibody- secreting cells TCR Tregs block patholo
Slide 13: TCR Treg Program Next Steps: Initiate TI-168 Clinical Program
TCR Treg Program NEXT STEPS: Initiate TI-168 Clinical Program TI-168 -Initiate clinical study process Study site selection (specially qualified sites) IRB approval process –at specialized sites can be extended, est. 6-12 months Open study sites and enrollment of first patient First cohort of 3 patie
Slide 14: Research Program Priorities for 2023/2024
Research Program Priorities for 2023/2024 Develop AChR TCR Treg Verify the TCR Treg as appropriate for the target Preclinical model development and qualification CMC and preclinical model studies preparatory work for IND IND filing target : late 2024/early 2025 Preclinical model development and qual
Slide 15: TCR Treg versus CAR-Treg in Autoimmune Disease
CAR-Treg – Engineering company in autoimmune disease TCR Treg cell therapy in autoimmune disease TCR Highly targeted and designed to minimize the risk for off target organ biodistribution. TeraImmune has the only cleared TCR Treg IND for use in Hemophilia A patients with inhibitors. TeraImmune is a
Slide 16: Strong Interest in Treg Cell Therapies
2021 2022 Acquired by Merck for $1.85B Phase I Ulcerative Colitis $84M on Series A Preclinical Liver Transplantation $95M on Series A Preclinical MS, TTD $85M on Series A Preclinical Autoimmune $157M on Series A Preclinical T1D $265M on Series B Preclinical RA, T1D Collaboration with BMS for $1.9B P
Slide 17: NMB Portfolio
NMB Portfolio
Slide 18: NMB – Anesthesia Pipeline
NMB – Anesthesia Pipeline Continue at modest, sustainable pace Pre-clinical Phase 1 Phase 2 Phase 3 Milestones NEUROMUSCULAR BLOCKING AGENTS (NMBs) IV Intermediate-action (BX1000) Top-line data reported/Q2 2023 IV Ultra-short action (BX2000) Last patient dosed/end ‘24 NMB REVERSAL (ANESTHESIA) BX300
Slide 19: Baudax Bio Recent Financing
Baudax Bio Recent Financing Gross Proceeds from December 2022 Public Offering Raised in early January 2023 through warrant exercise $5 Million $4.3 Million Gross Proceeds from May 2023 Public Offering $4 Million
Slide 20: About TeraImmune
Note: 1. Hemophilia A. 2. Myasthenia gravis. 3. Membranous nephropathy. 4. Pemphigus vulgaris. 5. Bullus Pemphigoid. 6.Neuromyelitis Optica. About TeraImmune Clinical stage company focused on autoantibody disorders by harnessing the power, innovation, and specificity of TCR Treg Cell therapies Regul
Slide 21: Contact Information
Contact Information Mike Moyer LifeSci Advisors mmoyer@lifesciadvisors.com
Slide 22: Appendix
APPENDIX
Slide 23: Inhibitor Eradication Remains the Goal of Treatment for HA with Inhibitors
Inhibitor Eradication Remains The Goal of Treatment for HA with Inhibitors Inhibitor eradication remains the clinical goal ITI is the primary therapeutic strategy All patients should be offered at least one attempt at ITI Emicizumab monotherapy is an option for inhibitor patients who must delay or a
Slide 24: FVIII TCR-Tregs Suppress anti-FVIII Antibody Formation in HA Mice
Non-specific TCR Tregs FVIII TCR Tregs FVIII CAR Tregs Hemophilic mice were subcutaneously immunized with FVIII on day 0 4h after immunization, mice were infused with Control, TCR Tregs or CAR Tregs FVIII antibody levels were monitored weekly, and mice rechallenged with FVIII on day 56 FVIII Enginee
Slide 25: Limitations of Currently Available Therapies for HA with Inhibitors
TI-168 replaces ITI Limitations of Currently Available Therapies for HA with Inhibitors Limitations of Currently Available Therapies for HA with Inhibitors Immune Tolerance Induction (ITI) Products that Mimic Factor VIII (emicizumab) Bypassing Agents (BPAs) (Factor VIIa and aPCC) MoA Elimination of
Slide 26: Pressing Need for Novel Cost-Effective Therapies for HA Patients with Inhibitors
Pressing Need for Novel Cost-Effective Therapies for HA Patients with Inhibitors ~ $300-500k $800k+ Inhibitor management adds an average of $800k in healthcare costs, per year/patient BPAs such as FVIIa or FEIBA can cost up to $960k, per year/patient ITI consists of high doses of FVIII and can cost
Slide 27: TI-168 Readout Paves the Way for Follow-on Indications
Indications Discovery Preclinical Phase 1/2 Phase 3 TI-168 (Hemophilia A with Inhibitors) Myasthenia gravis Membranous nephropathy Neuromyelitis Optica Positive TI-168 Readout Paves the Way for Follow-on Indications with Well-Characterized Pathological Autoantibodies Mid -2024: FPI in hemophilia A w
Slide 28: Funding History
Funding History Pre-A: $10M Series A: $70M Series B: $265M Seed: $20M Series A: $157M Series A: $83.5M Series B: $156M Dev. Stage IND approved (2022) Pre-clinical Pre-clinical Phase 1/2 in UK Product TCR Treg Teff debulking biologics, CAR Treg CAR Treg, TCR Treg CAR Treg Virus 1 virus: TCR 1 virus:
Slide 29: Leadership Team with Significant Development Experience
Leadership Team with Significant Development experience Addressing High Unmet Need Orphan Conditions in Established Markets with Demonstrated Investor Interest Public company and recapitalized with investors Established GMP manufacturing (Academic and qualifying own venue) Compelling science with es
Slide 30: NMB portfolio offers potential to improve anesthesia patient management
NMB portfolio offers potential to improve anesthesia 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 of
Slide 31: Baudax NMB Portfolio
Baudax NMB Portfolio Added value at very modest, sustainable pace BX1000 BX2000 BX3000 Combination BX1000/ BX3000 Positive topline results reported Phase 2 in Q2 2023 Phase 1 Dose escalation in progress, completion expected late 2024 IND filing expected early Q4 2023 Small cohort study anticipated e
Slide 32: 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