Provention Bio, Inc.

Good morning. My name is Raman, and I will be your conference operator for today. At this time, I would like to welcome everybody to the Prevention Value Third Quarter 2022 Financial Results Conference Call. All participants are in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the Start key followed by 0. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then 1 on your telephone keypad. To withdraw your question, please press star, then 2. Please be advised that this call is being recorded at the company's request. I would now like to turn the conference over to Heidi King-Jones, Chief Legal Officer of Prevention Bio. Please go ahead.

Thank you, Operator, and thank you all for joining us. Ashley Palmer, Chief Executive Officer and co-founder of Prevention Bio, will first provide an update on our third quarter regulatory interactions and corporate progress before turning the call over to Jason Hoyt, our Chief Commercial Officer, who will highlight the status of our preparations in anticipation of teplizumab potential commercial launch, as well as our co-promotion agreement with Sanofi. Gary Chauchet, our Chief Financial Officer, will then provide a summary of our third quarter financial results, as well as an update on our strategic financing activity. Before we begin, let me remind you that the various remarks we will make today constitute forward-looking statements. These include statements about our future plans and expectations in connection with the agreements we entered into with Sanofi and the potential commercialization of teplizumab, clinical study results, regulatory and other developments, and timelines related to our product candidates, including our plans to continue working with the FDA as they review our BLA resubmission and continuing our efforts towards securing a potential FDA approval for and commercialization of teplizumab for an at-risk indication. the potential safety, efficacy, and commercial success of teplizumab and our other product candidates, financial projections, including our anticipated use of cash and our cash runway, and our business plans and prospects and projected timing for the same. Actual results may differ materially from those indicated by forward-looking statements as a result of various important factors, including those discussed in the risk factor section of our most recently quarterly report on Form 10Q and in other filings that we may make with the SEC in the future. Any forward-looking statements represent our views as of today only. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our views change, except as required by law. Therefore, you should not rely on these forward-looking statements as representing our views as of any subsequent date to today. There is more complete information regarding forward-looking statements, risks and uncertainties in prevention reports we file with the SEC. These documents are available on prevention's website at www.preventionbio.com under the Investors section. We encourage you to review these documents carefully. With that, I will now turn the call over to Ashley.

Thank you, Heidi, and good morning, everyone. Throughout the third quarter, our team has continued to interact with the FDA in support of our resubmitted breakthrough therapy-designated teplizumab BLA for the delay of clinical type 1 diabetes, or stage 3 T1D, in at-risk or stage two individuals. In the major amendment notice we received at the end of June, the FDA informed us that if no major deficiencies were identified during its review, the agency planned to communicate proposed labeling and post-marketing requirements and commitments by October 17th, 2022. I am pleased to report that we have since received both the FDA's proposed labeling and the FDA's proposed post-marketing requirements and commitments and that these are generally consistent with our expectations and public market guidance to date. Our timely receipt of the FDA's proposed labeling and post-marketing requirements and commitments is encouraging. Nevertheless, we must caution that the FDA has yet to make its final decision regarding the BLA and there is always a possibility circumstances can change as the agency continues to review our application. In parallel with our ongoing FDA interactions, we have also been collaborating closely with our co-promotion partner Sanofi in preparing for the potential US commercialization of what might soon become, if approved, the first ever disease modifying therapy for at-risk T1D individuals with stage two disease to delay the onset of clinical stage three insulin dependency. Under our agreement with Sanofi, Prevention continues to maintain control over all aspects of regulatory and commercial strategy for the potential launch of teplizumab, including labeling negotiations, packaging, distribution, and pricing. Before handing the call over to Jason to further discuss our launch planning and preparations in anticipation of teplizumab's potential approval, Let me also mention that throughout the third quarter, our team has continued to make steady progress across all our autoimmune disease-focused clinical development programs. This includes our Phase 3 PROTECT trial, evaluating teplizumab for new onset T1D, our Phase 2a PREVAIL-2 trial, evaluating PRV-3279 for systemic lupus erythematosus, and in partnership with Amgen, our Phase IIb proactive trial, evaluating our anti-IL-15 monoclonal antibody, or disecumab, for non-responsive celiac disease. We are also in discussions with prospective partners regarding the next stages of development for our polyvalent Coxsackievirus B vaccine candidate, PRV101.