AcelRx Pharmaceuticals, Inc.

Welcome to the AccelerEx third quarter 2023 financial results conference call. This call is being webcasted live via the events page of the investor section of AccelerEx's website at www.accelerx.com. This call is property of AccelerEx, and any recording, reproduction, or transmission of this call without the expressed written consent of AccelerEx is strictly prohibited. As a reminder, this webcast is being recorded. you may listen to a replay of this webcast by going to the investor section of AccelerEx's website. And now I would like to turn the call over to Rafi Asadorian, AccelerEx Pharmaceuticals Chief Financial Officer.

Thank you for joining us on the call today. This afternoon, we announced our third quarter 2023 financial results and associated business updates in a press release. This press release can be found within the investors section of our website. With me today are Vince Angotti, our chief executive officer, and Dr. Pam Palmer, Accelerex's founder and chief medical officer. Before we begin, I want to remind listeners that during this call, we will make forward-looking statements within the meaning of the federal securities laws. These forward-looking statements involve risks and uncertainties regarding the operations and future results of Accelerex. Please refer to our press release in addition to the company's periodic, current, and annual reports filed with the Securities and Exchange Commission for a discussion of the risks associated with such forward-looking statements. These documents can be found on our website within the Investors section. I will now hand the call over to Vince.

Thank you, Rafi, and good afternoon, everyone. Today, we look forward to updating you on NIAID, Accelerex's lead Nefamistat program, as well as other highlights of our business. For those of you who have followed Accelerex over time, you know that our focus on product candidates for use in the medically supervised setting has greatly evolved from acute pain. We're now at a stage where we're focusing our expertise in drug development on a very different area of unmet medical need, specifically dialysis. Our lead product candidate, NIAID, is a novel anticoagulant for use during dialysis and has received breakthrough device designation from the FDA. At the close of the third quarter, we were pleased to receive approval for our NIAID IDE, allowing us to proceed with the registrational study for what could potentially become the first FDA-approved regional anticoagulant for the dialysis circuit. We recently completed our investigators' meeting where the participants expressed excitement at the prospect of the near-term availability of an ultra-short-acting anticoagulant for use in CRRT. We'll now proceed with our registrational study known as the NEFRO CRRT study, the Nephamostat Efficacy in Phase 3 Registrational Continuous Renal Replacement Therapy Study. This 166-patient study will evaluate NIAID versus placebo, measuring clinical endpoints that have been agreed upon with the FDA. Based on the results from this study, we plan to submit a premarket approval, or PMA, application in the second half of 2024. In terms of market opportunity, we estimate NIAID to have a peak annual sales potential of over $200 million in the U.S., And this is attributed to just the inpatient and outpatient dialysis markets, excluding use in any other extracorporeal circuits. Note that our estimate and peak sales potential assumes modest penetration into these markets, specifically attaining only about a 20% share of the current in-hospital CRRT market and 6% of the dialysis market outside of the hospital. Our interactions with leaders in the field of nephrology have reinforced the urgent medical need for an alternative anticoagulant for use during CRRT. And this, combined with our recently conducted U.S. quantitative research, reaffirms the market potential for NIAID. In fact, as announced yesterday, we're hosting a key opinion leader panel discussion on December 6th with thought leaders in nephrology and critical care to discuss the use of anticoagulation in dialysis circuits and the nephro study protocol. At this point, I'd like to turn it over to Dr. Palmer to briefly expand on this.