Selecta Biosciences Reports Third Quarter 2022 Financial Results and Provides Business Update
– DISSOLVE I & II studies of SEL-212 in Chronic Refractory Gout remain on track for joint topline data readout in Q1 2023 –
– SEL-302, Selecta’s wholly owned gene therapy in combination with ImmTOR for the treatment of Methylmalonic Acidemia (MMA), remains on track to begin a Phase 1 trial in Q4 2022 –
– As of
– Candidate selection for an IL-2 and IgA protease expected by year-end 2022 –
“We are pleased with the steady progress seen across our clinical and pre-clinical pipelines. With expected financial runway into mid-2024 we believe we are well-positioned to execute on our key priorities and achieve multiple near-term value driving inflection points,” said
Recent Program Highlights and Anticipated Upcoming Milestones:
Tolerogenic Therapies for Autoimmune Disease:
- ImmTOR-IL: Preclinically,
Selectahas observed synergistic activity when ImmTOR is combined with engineered IL-2 molecules that are selective for Tregs (ImmTOR-IL™). Furthermore, when ImmTOR-IL was co-administered with an antigen of interest, the resulting data suggested that ImmTOR-IL may have profound synergistic effects in expanding antigen-specific Tregs when compared to ImmTOR alone, positioning ImmTOR-IL as a potential first-in-class antigen-specific therapy for the treatment of autoimmune disease. Selectacontinues to work with its partners to develop a next generation IL-2 molecule to combine with ImmTOR and still anticipates selecting an IL-2 candidate by year-end 2022. Selectacontinues internal work on identifying additional target indications in autoimmune disease. Selectaplans to adopt a staged development approach, starting first with diseases driven by a single pathogenic antigen, such as Primary Biliary Cholangitis (PBC), then accelerating development across related indications.
- Primary biliary cholangitis (PBC):
Selectaintends to co-administer ImmTOR-IL with PDC-E2, the autoantigen implicated in PBC and continues IND-enabling work for this combination.
- SEL-302 for MMA:
Selectaremains on track to initiate a Phase 1/2 clinical trial of SEL-302, an AAV gene therapy combined with ImmTOR for the treatment of MMA, in the fourth quarter of 2022.
- SEL-018 IgG Protease (Xork): In collaboration with Genovis,
Selectacontinues to advance Xork, a next-generation IgG protease, to help address disease in patients who are ineligible for gene therapies due to pre-existing anti-AAV antibodies. Selectabelieves the novel combination of Xork and ImmTOR has the potential to address two of the key hurdles in gene therapy today: pre-existing immunity to AAVs and the inability to re-dose AAV gene therapies due to the immune response to AAV capsids.
- IND-enabling studies and manufacturing scale-up activities are ongoing.
- ImmTOR-IL: In
October 2022, we presented preclinical data at the 29th Annual European Society of Geneand Cell Therapy(ESGCT) Conference further supporting the potential therapeutic utility of ImmTOR in enabling safe repeated vector dosing and mitigating unwanted immune responses. Additionally, we presented data in which we observed the potential of ImmTOR-IL in driving antigen-specific Treg expansion while synergistically inhibiting formation of anti-AAV antibodies at high vector doses.
- SEL-212 for chronic refractory gout: Selecta continues to advance DISSOLVE, the Phase 3 development program of SEL-212, which has been licensed to Sobi.
- In Q3 2022,
Selectareceived a $10 millionmilestone payment from Sobi following the completion of enrollment of DISSOLVE II in June 2022.
- DISSOLVE I & II trials are on track for completion in Q1 2023 with joint topline readout expected in Q1 2023.
- In Q3 2022,
- ImmTOR with IgA protease for IgA nephropathy:
Selectacontinues to work with its partners to identify and develop a next generation IgA protease to combine with ImmTOR, and consistent with prior guidance anticipates selecting an enzyme candidate by year-end 2022.
Further Corporate and Partnership Updates:
- In Q3 2022, and as previously disclosed,
Selectareceived a $2 millionpayment from Sarepta relating to the extension of its Research License and Option Agreement for ImmTOR in Duchenne Muscular Dystrophy (DMD) and certain Limb-Girdle Muscular Dystrophies (LGMD) for an additional nine months to Q1 2023, and an additional $4 millionpayment from Sarepta for achievement of certain preclinical milestones.
Third Quarter 2022 Financial Results
Cash Position: Selecta had
Collaboration and License Revenue: Collaboration and license revenue for the third quarter of 2022 was
Research and Development Expenses: Research and development expenses for the third quarter of 2022 were
General and Administrative Expenses: General and administrative expenses for the third quarter of 2022 were
Net loss: For the third quarter of 2022,
Conference Call and Webcast Reminder
Selecta Forward-Looking Statements
Any statements in this press release about the future expectations, plans and prospects of Selecta Biosciences, Inc. (the “Company”), including without limitation, statements regarding the Company’s cash runway, the unique proprietary technology platform of the Company, and the unique proprietary platform of its partners, the potential of ImmTOR to enable re-dosing of AAV gene therapy and to mitigate immunogenicity, the potential of ImmTOR and the Company’s product pipeline to treat chronic refractory gout, MMA, IgAN, other autoimmune diseases, lysosomal storage disorders, or any other disease, the anticipated timing or the outcome of ongoing and planned clinical trials, studies and data readouts, the anticipated timing or the outcome of the FDA’s review of the Company’s regulatory filings, the Company’s and its partners’ ability to conduct its and their clinical trials and preclinical studies, the timing or making of any regulatory filings, the anticipated timing or outcome of selection of developmental product candidates, the potential treatment applications of product candidates utilizing the ImmTOR platform in areas such as gene therapy, gout and autoimmune disease, the ability of the Company and its partners where applicable to develop gene therapy products using ImmTOR, the novelty of treatment paradigms that the Company is able to develop, whether the observations made in non-human study subjects will translate to studies performed with human beings, the potential of any therapies developed by the Company to fulfill unmet medical needs, the Company’s plan to apply its ImmTOR technology platform to a range of biologics for rare and orphan genetic diseases, the potential of the Company’s technology to enable repeat administration in gene therapy product candidates and products, the ability to re-dose patients and the potential of ImmTOR to allow for re-dosing, the potential to safely re-dose AAV, the ability to restore transgene expression, the potential of the ImmTOR technology platform generally and the Company’s ability to grow its strategic partnerships and enrollment in the Company's clinical trials and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “hypothesize,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, but not limited to, the following: the uncertainties inherent in the initiation, completion and cost of clinical trials including proof of concept trials, including the uncertain outcomes, the availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a particular clinical trial will be predictive of the final results of that trial and whether results of early clinical trials will be indicative of the results of later clinical trials, the ability to predict results of studies performed on human beings based on results of studies performed on non-human subjects, the unproven approach of the Company’s ImmTOR technology, potential delays in enrollment of patients, undesirable side effects of the Company’s product candidates, its reliance on third parties to manufacture its product candidates and to conduct its clinical trials, the Company’s inability to maintain its existing or future collaborations, licenses or contractual relationships, its inability to protect its proprietary technology and intellectual property, potential delays in regulatory approvals, the availability of funding sufficient for its foreseeable and unforeseeable operating expenses and capital expenditure requirements, the Company’s recurring losses from operations and negative cash flows, substantial fluctuation in the price of the Company’s common stock, risks related to geopolitical conflicts and pandemics and other important factors discussed in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and in other filings that the Company makes with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of its publication and should not be relied upon as representing its views as of any subsequent date. The Company specifically disclaims any intention to update any forward-looking statements included in this press release, except as required by law.
Consolidated Balance Sheets
(Amounts in thousands, except share data and par value)
|Cash and cash equivalents||$||112,843||$||114,057|
|Prepaid expenses and other current assets||6,310||6,474|
|Total current assets||159,677||144,443|
|Property and equipment, net||2,904||2,142|
|Right-of-use asset, net||12,056||9,829|
|Long-term restricted cash||1,600||1,379|
|Liabilities and stockholders’ equity|
|Income taxes payable||—||601|
|Total current liabilities||23,728||72,251|
|Loan payable, net of current portion||20,215||19,673|
|Lease liability, net of current portion||10,506||8,598|
|Additional paid-in capital||490,252||457,391|
|Accumulated other comprehensive loss||(4,530||)||(4,566||)|
|Total stockholders’ equity||84,907||22,521|
|Total liabilities and stockholders’ equity||$||178,265||$||159,883|
Consolidated Statements of Operations and Comprehensive Income (Loss)
(Amounts in thousands, except share and per share data)
|Three Months Ended
||Nine Months Ended
|Collaboration and license revenue||$||20,710||$||24,427||$||93,982||$||55,140|
|Research and development||16,539||20,951||53,410||48,418|
|General and administrative||5,770||5,445||17,538||15,397|
|Total operating expenses||22,309||26,396||70,948||63,815|
|Operating income (loss)||(1,599||)||(1,969||)||23,034||(8,675||)|
|Foreign currency transaction, net||15||2||(61||)||(5||)|
|Change in fair value of warrant liabilities||(6,539||)||592||7,329||(11,335||)|
|Other income, net||1||9||155||15|
|Income (loss) before income taxes||(8,214||)||(2,066||)||29,165||(22,098||)|
|Income tax (expense) benefit||321||(15,828||)||321||(15,828||)|
|Net income (loss)||$||(7,893||)||$||(17,894||)||$||29,486||$||(37,926||)|
|Other comprehensive income (loss):|
|Foreign currency translation adjustment||(21||)||(1||)||65||5|
|Unrealized loss on marketable securities||(29||)||(1||)||(29||)||(1||)|
|Total comprehensive income (loss)||$||(7,943||)||$||(17,896||)||$||29,522||$||(37,922||)|
|Net income (loss) per share:|
|Weighted average common shares outstanding:|
Source: Selecta Biosciences, Inc.