October 2023
Forward Looking Statements
This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, 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, and TeraImmune or its management, are intended to identify such forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Baudax Bio's current beliefs, expectations and assumptions regarding the future of its business, future plans and strategies, clinical results and other future conditions. There are a number of important factors that could cause Baudax Bio's actual results to differ materially from those indicated or implied by such forward-looking statements including, without limitation: whether Baudax Bio will be able to successfully integrate the TeraImmune operations and realize the anticipated benefits of the acquisition of TeraImmune; whether Baudax Bio's shareholders approve the conversion of the Series X Preferred Stock and the required cash payment of the then-current fair value of the Series X Preferred Stock if such approval is not provided; whether Baudax Bio's cash resources will be sufficient to fund Baudax Bio's continuing operations and the newly acquired TeraImmune operations, including the liabilities of TeraImmune incurred in connection with the completion of the Merger; whether Baudax Bio's collaborations will be successful; whether Baudax Bio will be able 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 clinical trials, that earlier-stage trials may not be indicative of later-stage trials, the approvability of product candidates; whether Baudax Bio will be able to comply with the financial and other covenants under its credit facility; and whether Baudax Bio will be able to maintain its listing on the Nasdaq Capital Market. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks anduncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Baudax Bio may not actually achieve the forecasts disclosed in such forward-looking statements, and you should not place undue reliance on such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption "Risk Factors" in Baudax Bio's most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in its subsequent filings with the SEC. Any forward- looking statement speaks only as of the date on which it was made. Neither Baudax Bio, nor any of its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing Baudax Bio's views as of any date subsequent to the date hereof.
2
Highlights
Powerful Combined Team
Baudax Bio: Development and Commercialization
Teraimmune: Discovery Platform and Research
- IND cleared for TCR Treg, expected "once and done" treatment to eradicate "inhibitors/auto-antibodies" interfering with Factor VIII therapy for Hemophilia A.
- Q1 '24 target for first ever human TCR Treg study for any product - will be an open Phase 1/2a study of TI-168 in Hemophilia A with inhibitors. Results for early patients could confirm early tolerability and efficacy.
3
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)
Yong Chan Kim, PhD - CSO
Former President & CEO, TeraImmune
Res Assis Prof., Uniformed Services University
Post-Doctoral Fellow, NIAID, NIH
Stewart Mc Callum, MD - Consulting CMO
EVP Medical Affairs, Baudax, Recro
Medical Director, GSK
Assistant Professor of Urology Stanford University
Staff Surgeon, Stanford University & Palo Alto VA
Medical Center
Natalie McAndrews, CPA - PT CFO/PFO
Past Senior Finance roles with Tmunity, Spark Therapeutics (startup through merger) Renmatrix, Tengion
4
What is the opportunity?
Commercial opportunity could produce peak year sales of $50-100 Million, assuming TPP met.
- Expected Q1 '24 open and begin enrollment of Phase 1/2a TI 168 trial in Hemophilia A patients with inhibitors.
- Clinical trial for an orphan drug complication. Treatment expected to be "once and done" administration of patient's own targeted Tregs (modified to block production of Factor VIII inhibitors in Hemophilia A).
- We believe a TCR Treg autologous product for elimination of the Factor VIII inhibitor in Hemophilia A patients can be developed and commercialized in a timely and cost- efficient manner.
5
Attachments
- Original Link
- Original Document
- Permalink
Disclaimer
Baudax Bio Inc. published this content on 06 October 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 06 October 2023 12:37:20 UTC.