Selecta Biosciences Reports First Quarter 2022 Financial Results and Provides Business Update
– Phase 1 trial of SEL-302 remains on track to initiate in the second half of 2022 –
– DISSOLVE I & II studies on track for completion in Q4 2022 with joint topline readout in Q1 2023 –
– Completed underwritten offering, raising approximately
– As of
“In the first quarter of 2022, we executed across our pipeline and proactively took measures to extend our cash runway into mid-2024,” said
Recent Highlights and Anticipated Upcoming Milestones:
Tolerogenic Therapies for Autoimmune Disease
- ImmTOR with proprietary IL-2 protein agonist (ImmTOR-IL™): Pre-clinically,
Selectahas observed synergistic activity when ImmTOR is combined with engineered IL-2 molecules that are selective for Tregs. When ImmTOR-IL was co-administered with an antigen of interest in a preclinical study, the resulting preclinical data suggest that ImmTOR may have profound synergistic effects in further expanding antigen-specific Tregs when compared to ImmTOR alone, positioning it to be a potential first-in-class antigen-specific therapy for the treatment of autoimmune disease. Selectais working with its partner, Cyrus Biotechnology, to develop a next generation IL-2 molecule to combine with ImmTOR. Selectacontinues work toward identifying suitable target indications and accelerating the development of ImmTOR-IL to the clinic.
- Primary biliary cholangitis (PBC):
Selectacontinues IND-enabling work on an ImmTOR platform approach to treating PBC.
- SEL-302 for methylmalonic acidemia (MMA): On
March 9, 2022, the FDA removed the clinical hold on SEL-302 for the treatment of patients with MMA. Selectaexpects initiation of the Phase 1 clinical trial of SEL-302 in the second half 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 those 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 simultaneously address two of the key hurdles in gene therapy today: pre-existing immunity and the inability to re-dose AAV gene therapies.
- IND-enabling studies are expected to commence in 2022.
- SEL-212 for chronic refractory gout: Selecta continues to advance DISSOLVE, the Phase 3 development program of SEL-212, which has been licensed to Swedish Orphan Biovitrum AB (publ.) (“Sobi”).
December 1, 2021, Selectaannounced complete enrollment for DISSOLVE I, currently being run in the United States.
- DISSOLVE II continues to enroll, with trial sites in
the United Statesand four Eastern European countries. Screening and randomization in both Russiaand Ukrainehave been temporarily closed to preserve study supplies in these countries for those already enrolled. Moreover, 11 additional sites in the United Stateshave been activated to speed enrollment and help mitigate any potential disruptions from the closure of screening and randomization in Russiaand Ukraine, and DISSOLVE II enrollment has been increased to approximately 140 study participants.
- DISSOLVE I & II studies are on track for completion in Q4 2022 with joint topline readout expected in Q1 2023.
- ImmTOR with IgA1 protease for IgA nephropathy:
Selectais working with both Ginkgo Bioworks and IGAN Biosciences to identify and develop a next generation IgA protease to combine with ImmTOR. Selectaanticipates enzyme candidate selection to be completed in 2022.
- Completed underwritten offering of common stock and warrants, raising approximately
$38.7 millionin gross proceeds.
- Amended outstanding term loan to defer principal amortization period to
April 1, 2023.
- Performed strategic review and portfolio prioritization, pausing SEL-313, OTC-D gene therapy development and increasing focus on providing modality-enabling solutions to AAV gene therapy companies.
First Quarter 2022 Financial Results
Cash Position: Selecta had
Collaboration and License Revenue: Collaboration and license revenue for the first quarter of 2022 was
Research and Development Expenses: Research and development expenses for the first quarter of 2022 were
General and Administrative Expenses: General and administrative expenses for the first quarter of 2022 were
Net Income (loss): For the first quarter of 2022,
Conference Call and Webcast Reminder
About Selecta Biosciences, Inc.
Selecta Biosciences Inc. (NASDAQ: SELB) is a clinical stage biotechnology company leveraging its ImmTOR® platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses. With a proven ability to induce tolerance to highly immunogenic proteins, ImmTOR has the potential to amplify the efficacy of biologic therapies, including redosing of life-saving gene therapies, as well as restore the body’s natural self-tolerance in autoimmune diseases. Selecta has several proprietary and partnered programs in its pipeline focused on enzyme therapies, gene therapies, and autoimmune diseases. Selecta Biosciences is headquartered in the Greater Boston area. For more information, please visit www.selectabio.com.
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 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, enrollment in the Company's clinical trials and the Company's plans with respect to areas affected by geopolitical conflict 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 or 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 its 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 Quarterly Report on Form 10-Q to be filed after this release, 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.
Consolidated Balance Sheets
(Amounts in thousands, except share data and par value)
|Cash and cash equivalents||$||113,437||$||114,057|
|Prepaid expenses and other current assets||5,420||6,474|
|Total current assets||130,007||144,443|
|Property and equipment, net||2,689||2,142|
|Right-of-use asset, net||9,536||9,829|
|Long-term restricted cash||1,379||1,379|
|Liabilities and stockholders’ equity|
|Income taxes payable||320||601|
|Total current liabilities||39,246||72,251|
|Loan payable, net of current portion||25,042||19,673|
|Lease liability, net of current portion||8,316||8,598|
|Additional paid-in capital||461,888||457,391|
|Accumulated other comprehensive loss||(4,598||)||(4,566||)|
|Total stockholders’ equity||55,764||22,521|
|Total liabilities and stockholders’ equity||$||145,696||$||159,883|
Consolidated Statements of Operations and Comprehensive Income (Loss)
(Amounts in thousands, except share and per share data)
|Three Months Ended
|Collaboration and license revenue||$||33,999||$||11,050|
|Research and development||17,689||13,004|
|General and administrative||5,537||5,204|
|Total operating expenses||23,226||18,208|
|Operating income (loss)||10,773||(7,158||)|
|Foreign currency transaction, net||28||7|
|Change in fair value of warrant liabilities||18,515||(16,747||)|
|Other income, net||154||—|
|Net income (loss)||$||28,778||$||(24,597||)|
|Other comprehensive income (loss):|
|Foreign currency translation adjustment||(32||)||(6||)|
|Unrealized loss on marketable securities||—||(1||)|
|Total comprehensive income (loss)||$||28,746||$||(24,604||)|
|Net income (loss) per share:|
|Weighted average common shares outstanding:|
Source: Selecta Biosciences, Inc.