Selecta Biosciences, Inc.

Good morning, everyone, and thank you for joining the Selecta Biosciences Q2 2023 earnings call. At this time, all participants are in a listen-only mode. Following management's remarks, we will hold a question and answer session. At that time, lines will be open for you. If anyone should require operator assistance, please press star and zero on your touch-tone telephones. At this time, I'd like to turn the floor over to Blaine Davis, Chief Financial Officer at Selecta. Please go ahead.

Blaine Davis Good morning, everyone, and thank you for joining our second quarter 2023 financial results and business update conference call. The press release reporting our financial results is available in the investors and media section of Selecta's website at www.selectabio.com. and in our quarterly report on Form 10-Q for the quarter ended June 30, 2023, which was filed earlier this morning with the Securities and Exchange Commission. Joining me on today's call are selected President and Chief Executive Officer Dr. Kirsten Brunn and Peter Traver, our Chief Medical Officer. During today's call, we will be making certain forward-looking statements, including, without limitation, statements about the potential safety, efficacy, and regulatory and clinical progress of our product candidates, our financial projections, and our future expectations, plans, partnerships, and prospects. These statements are subject to various risks that are described in the filings made with the SEC, including our most recent report on Form 10-K and quarterly report on Form 10-Q. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today, August 17, 2023. and selected as claims any obligation to update such statements, except as required by law, even if management's views change. With that, I'd now like to turn the call over to Karsten.

Good morning, and thank you, everyone, for taking the time to join us. Thus far, 2023 has proven to be an important year for mTOR, our Physician Immune Tolerance Platform, which we're leveraging to develop colorigenic therapies that selectively mitigate unwanted immune responses. In March, we were thrilled to share positive data on both Phase III trials of SAL-212 in patients with chronic refractory gout. As a reminder, SAL-212 consists of two components. First, the gasocase, a potent enzyme that has been observed to reduce serum urate in refractory gout patients who continue to have serious disease symptoms, such as debilitating joint pain and disfiguring tissue deposits of urate called TOSI. And second, IMTOR, which is our nanoencapsulated formulation, rapamycin, that is designed to condition the immune system to reduce antibody formation to drugs that are administered at the same time. The proposed mechanism of IMTOR action is the induction of immune tolerance rather than immune suppression, as with other commonly used drugs. In May, we had the opportunity to showcase this positive data during a late-breaking session at the European Alliance of Associations for Rheumatology, or EULAR Congress. This was the first scientific presentation of our data to the key opinion leaders and physicians who treat patients with gout and who are well aware of the limitations of current treatment options. We were extremely encouraged by the response to the data, which reinforces our belief that SEL212 could potentially serve as a once-monthly safe and effective Eurocase-based intervention for refractory chronic gout without the need for separate oral traditional immunosuppressants. We're currently focused on working with SOVI, our SEL212 development partner, to prepare for biologic license application or BLA filing in the US. The filing remains on track for the first half of 2024. As a reminder, under our agreement, SOBI is responsible for regulatory and commercial activities in all markets outside of China, while Selecta is responsible for indoor manufacturing. Selecta is entitled to receive up to $615 million in remaining milestone payments from SOBI, as well as tiered doubles and royalties on net sales. With the potential for peak sales of SEL-212 for the treatment of chronic factory gout to exceed $700 million, we believe that SEL 212 has the potential to deliver significant and meaningful long-term stockholder values. Importantly, the SEL 212 program serves as a validation for our entire platform, which represents the only mean tolerance platform with positive phase 3 data. While we firmly believe that the balance of our pipeline beyond SEL 212 has the potential to generate meaningful returns for our stockholders, we recognize that significant capital and time would be required to advance these assets to value creating reflection points on our own. As such, we've undertaken the decision to suspend further investments in all programs beyond SEL 212, and instead plan to pursue potential licensing and corporate development initiatives for these assets. These include INTOR, which can be combined with a variety of therapeutic approaches, to reduce immunogenicity across a range of indications, IMTOR-L, which combines our proprietary T-cell selective IL-2 candidate with IMTOR, SEL302 and AV gene therapy combined with IMTOR for the treatment of MMA, ZORC and next-generation IgG protease for the mitigation of preexisting anti-AV antibodies, and our next-generation IgA protease for IgA necropathy. For note, we will continue to work with our partner, Astellas, to advance the development of Zork in combination with AT845, Astellas' AAV-based therapy for the treatment of late-onset Pompe disease in adults. As a reminder, we have observed a unique low cross-reactivity profile in Zork that may provide therapeutic benefit to patients with pre-existing immunity to AAV. We believe our actions today will enable us to preserve capital and ultimately maintain stockholder interest in SEL 212 without a dilution that would have been necessary to support the continued development of the balance of our pipeline assets over the long term. With that, I'll now turn the call over to Blayne to review second quarter financial results.