Provention Bio, Inc.

Good morning. My name is Keith, and I will be your conference operator today. At this time, I would like to welcome everyone to the Prevention Bio call. There will be a question and answer session to follow. Please be advised that this call has been recorded at the company's request. And I would like to send a conference over to Mr. Robert Doody, Vice President of Investor Relations for Prevention Bio.

Thank you, Operator, and thank you all for joining us on Prevention Bio's second quarter 2022 financial results conference call. The agenda for today's call will start off with Thierry Chauchet, our Chief Financial Officer, providing an update on our Q2 financial results, as well as an update on our strategic financing efforts. Ashley will then join the call to review our 2022 progress to date and share some insights into what to expect going forward. Before turning the call over to Jason Hoyt, our Chief Commercial Officer, who will provide an overview of highlights from our recent Toplizumab Commercial Launch Planning Investor Event, as well as relevant updates. 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, clinical 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, as well as the planned delivery of significant catalysts over the next 24 months, the potential safety, efficacy, and commercial success of teplizumab and our other product candidates, the potential COVID-19 impact on our clinical studies and business plans, 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 these forward-looking statements as a result of various important factors, including those discussed in the risk factors section of our most recent quarterly report on Form 10-Q, which we filed with the SEC this morning, 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 date subsequent to today. There is more complete information regarding forward-looking statements, risks, and uncertainties in the reports prevention files with the SEC. These documents are available on prevention's website at www.preventionbio.com under the Investor section. We encourage you to review these documents carefully. With that, I will now turn the call over to Thierry.

Thank you, Bob. Before I begin discussing the financials for the second quarter, I would encourage you to read our 10-Q that was filed today. The 10-Q includes our financial statements, risk factors, as well as management's discussion and analysis of our financial conditions. I would also like to call your attention to the earnings press release, which was issued prior to this call. Let me start with our current cash position and cash projection. As of June 30, 2022, our cash, cash equivalents, and marketable securities position was $96.1 million. This includes net proceeds of $11.2 million. one million dollars generated through our at the market or ATM program during the second quarter of 2022. We have currently approximately 130 million dollars remaining capacity on our ATM and will continue to be opportunistic on the use of this program. Also, following the regulatory update we provided early July, we completed a private placement with two of our shareholders. The transaction brought in net proceeds of approximately $57.2 million, which will support our preparation towards the potential launch of Teplizumab, all bites in the same prudent manner in which we have been operating. This additional cash generated from the private placement is not included into the cash figure I cited for June 30th and will be reflected in the third quarter financial results. Our cash-based operating expenses for the first quarter ended June 30th, 2022, were $27.2 million, which excludes non-cash stock-based compensation of $3.2 million and depreciation expense of $0.2 million. This number came below the lower end of our guidance, driven by our prudent approach to expenses and cash management. We expect our cash-based operating expenses to be between $27 and $31 million in the third quarter of 2022, reflecting a slight increase in program spend and launch readiness activities as we prepare for the potential FDA approval of Teplizumab in Q4 2022. Based on our current business plans, we believe that our cash, cash equivalents, and marketable securities on hand, inclusive of the proceeds from the private placement, will be sufficient to fund the company's operating requirements for at least the next 12 months from the issuance of this financial statement. If the Teplizumab bill is approved, This guidance would be impacted by changes to estimated costs of commercialization and potential milestone payments. In a scenario where the approval for teplizumab is not obtained from the FDA in November, we estimate that our cash runway would extend through 2023, which is beyond the top-line data readout from the PROTECT Phase 3 trial in newly diagnosed T1D patients, currently expected in the second half of next year. We believe our momentum with a potential approval of Teplizumab later this year provides us with optionality to raise capital, and we will continue to be both strategic and opportunistic when evaluating potential financing alternatives, as evidenced by the most recent private placement. We will provide updates on our estimated cash-based expenses and cash runway as we progress towards the potential regulatory approval and commercial launch of Teplizumab and continue to position ourselves for long-term success. Moving to the P&L, we generated a net loss for the second quarter of 2022 of $29.7 million, or 46 cents per basic and diluted shares, compared to a net loss of $29.1 million, or 46 cents per basic and diluted share, for the second quarter of 2021. R&D expenses were $16.6 million for the second quarter of 2022, compared to $17 million during the same period in 2021. The decrease year-over-year was driven by lower costs for the company's Steplisma program, including the PROTECT study as target enrollment was reached in August of 2021, and lower regulatory costs compared to the prior year. R&D cost decreases were partially offset by increased costs associated with the enrollment of the proactive and prevailed 2A trials for odesicumab and PRV3279, respectively, as well as increased manufacturing costs for commercial batches of teplizumab. G&A expenses were $14 million for the second quarter of 2022, compared to $13.2 million in Q2 2021, driven by an increase in our pre-commercial activities. During the second quarter, we also recognized $0.7 million of collaboration revenue under our license agreement with Wadong. With that update, I will now turn the call over to Ashley.