On March 2, 2023 Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies for autoimmune diseases and gene therapies, reported financial results for the fourth quarter and full year ended December 31, 2022 and provided a business update (Press release, Selecta Biosciences, MAR 2, 2023, View Source [SID1234628074]).

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"2022 was a successful year for Selecta. We delivered on key milestones across our pipeline and established strategic collaborations that have allowed us to drive forward our development programs," said Carsten Brunn, Ph.D., President and Chief Executive Officer of Selecta. "The Phase 3 DISSOLVE I and II clinical trials investigating SEL-212 in chronic refractory gout remains on track, and we expect to deliver topline data later this quarter. We look forward to the potential for SEL-212 to address the unmet needs of patients suffering from chronic refractory gout. In addition, we are currently enrolling patients in ReiMMAgine, our Phase 1/2 clinical trial of SEL-302 for the treatment of MMA. We intend to continue to leverage learnings from our clinical experience and growing safety database to propel our next-generation programs toward multiple IND filings and advance our wholly owned pipeline using ImmTOR in combination with a proprietary IL-2 (ImmTOR-IL), which we believe has the potential to address the unmet need for precision immunotherapy for autoimmune diseases."

Recent Program Highlights and Anticipated Upcoming Milestones:

Tolerogenic Therapies for Autoimmune Disease:

ImmTOR-IL: In December 2022, the Company selected an identified IL-2 candidate.

The combination of ImmTOR and IL-2 (ImmTOR-IL) represents an evolution of the precision immune tolerance platform, and an opportunity to further advance and expand the Company’s wholly-owned pipeline.
The Company plans to initiate IND enabling studies in 2023, while also exploring multiple autoimmune indications that may be suitable for study with ImmTOR-IL, with an initial focus on diseases of the liver.
Gene Therapies:

SEL-302 for MMA: In December 2022, the Company initiated ReiMMAgine, the Phase 1/2 clinical trial of SEL-302, an adeno-associated virus (AAV) gene therapy combined with ImmTOR for the treatment of MMA.

The ReiMMAgine trial is now enrolling patients and aims to evaluate the safety, tolerability and efficacy of SEL-302.
SEL-018 IgG Protease (Xork) for Late-Onset Pompe Disease: In January 2023, the Company announced an exclusive licensing and development agreement for IdeXork (Xork), a next-generation immunoglobulin G (IgG) protease, to be developed for use with AT845, Astellas Pharma Inc.’s investigational AAV-based treatment for Late-Onset Pompe disease (LOPD) in adults.

Xork is differentiated by its low cross reactivity to pre-existing antibodies in human serum, which the Company believes has the potential to expand access of life-changing gene therapies to more patients.
Under the terms of the agreement, Selecta received a $10M upfront payment and is eligible to receive up to $340M upon the achievement of certain additional development and commercial milestones plus royalties on commercial sales. Selecta is responsible for the early development activities and manufacturing of Xork and will maintain rights to the development of additional indications beyond LOPD.
Biologic Therapies:

SEL-212 for chronic refractory gout: The DISSOLVE I & II Phase 3 clinical trials for SEL-212, which has been licensed to Swedish Orphan Biovitrum AB (publ.) (Sobi), are on track with topline data expected in Q1 2023.

Selecta has been responsible for executing the Phase 3 clinical trials, with reimbursement from Sobi, and Sobi will be responsible for biologics license application filing and commercialization.
ImmTOR with IgA Protease for IgA Nephropathy (IgAN): In December 2022, the Company selected a next generation Immunoglobulin A (IgA) protease from IGAN Biosciences, Inc. to develop in combination with ImmTOR for the treatment of IgAN.

ImmTOR in combination with this new class of IgA protease, which is derived from a commensal bacteria and has low levels of baseline anti-drug antibodies, is designed to address the underlying pathophysiology of IgAN.
The Company plans to initiate IND enabling studies in 2023.
Further Corporate and Partnership Updates:

In November 2022, Blaine Davis was appointed as Chief Financial Officer. Mr. Davis brings more than 25 years of experience in investor relations, business development, corporate affairs and sales and marketing at life sciences companies, with a particular focus on rare diseases.

Fourth Quarter and Full Year 2022 Financial Results:

Cash Position: Selecta had $136.2 million in cash, cash equivalents, marketable securities, and restricted cash as of December 31, 2022, as compared to cash, cash equivalents, marketable securities, and restricted cash of $129.4 million as of December 31, 2021. Selecta believes its available cash, cash equivalents, restricted cash, and marketable securities will be sufficient to meet its operating requirements into mid-2024.

Collaboration and License Revenue: Revenue for the fourth quarter and full year 2022 was $16.8 million and $110.8 million, respectively, as compared to $29.9 million and $85.1 million for the same periods in 2021. Revenue was primarily driven by the license agreement with Sobi resulting from the shipment of clinical supply and the reimbursement of costs incurred for the Phase 3 DISSOLVE clinical program.

Research and Development Expenses: Research and development expenses for the fourth quarter and full year 2022 were $19.0 million and $72.4 million, respectively, as compared to $20.3 million and $68.7 million for the same periods in 2021. The quarterly decrease was primarily driven by a decrease in expenses incurred for the SEL-212 clinical program. The annual increase was primarily driven by expenses incurred for preclinical programs, increased personnel expense and stock compensation expense.

General and Administrative Expenses: General and administrative expenses for the fourth quarter and full year 2022 were $6.3 million and $23.9 million, respectively, as compared to $5.5 million and $20.9 million for the same periods in 2021. The quarterly and annual increases were primarily driven by increases in stock compensation and personnel expenses.

Net Income (loss): For the fourth quarter and full year 2022, Selecta reported net income of $5.9 million, or basic net income per share of $0.04, and net income of $35.4 million, or basic net income per share of $0.24, respectively. For the fourth quarter and full year 2021, Selecta reported net income of $12.2 million, or $0.10 per share, and a net loss of $(25.7) million, or $(0.22) per share, respectively.

Conference Call and Webcast Reminder

Selecta’s management will host a conference call at 8:30 AM ET today to provide a corporate update and review the Company’s fourth quarter and full year 2022 financial results. Individuals may participate in the live call via telephone by dialing (844) 845-4170 (domestic) or (412) 717-9621 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 8768458. Investors and the public can access the live and archived webcast of this call and a copy of the presentation via the Investors & Media section of the Company’s website, www.selectabio.com.