Selecta Biosciences Reports First Quarter 2021 Financial Results and Provides Business Update
- SEL-399 (empty AAV8 capsid with ImmTOR) study on track with topline data expected in the fourth quarter of 2021
- SEL-212 enrollment on track with topline data from DISSOLVE phase 3 program expected in second half of 2022
- IND filing for IgA nephropathy program expected by the end of 2021
- IND filing for wholly-owned gene therapy program in MMA expected by the end of 2021; IND in OTC deficiency gene therapy program expected in 2022
- As of
March 31, 2021, Selectahad approximately $149.2 millionin cash, cash equivalents, and marketable securities which is expected to provide runway into the second quarter of 2023
“We are very pleased about the continued progress across all aspects of the company,” said
Recent Highlights and Anticipated Upcoming Milestones:
- SEL-212 for chronic refractory gout: Enrollment for the Phase 3 DISSOLVE clinical program for SEL-212 for the treatment of chronic refractory gout, which was licensed to Sobi, is progressing as planned with topline data expected in the second half of 2022.
- Leveraging the success of SEL-212,
Selectaexpects to file an Investigational New Drug, or IND, application by the end of 2021 for a novel therapeutic approach that combines ImmTOR with an enzyme, IgA1 protease for the treatment of IgA nephropathy.
- First-in-human trial of SEL-399: In collaboration with AskBio,
Selectainitiated the first-in-human, dose-escalation trial of SEL-399, an adeno-associated viral serotype 8 (AAV8) empty vector capsid ( EMC-101) containing no DNA combined with ImmTOR. The trial aims to determine the optimal dose of ImmTOR to mitigate the formation of antibodies to AAV8 capsids used in gene therapies. Selectaand AskBio expect to report topline data in the fourth quarter of 2021.
- MMA-101 for methylmalonic acidemia (MMA):
Selectaregained exclusive rights to its lead gene therapy program in MMA from AskBio and expects to file an IND in MMA-101, in combination with ImmTOR, by the end of 2021. The phase 1/2 MMA-101 program, which is expected to commence in 2022, will evaluate biomarkers of efficacy, neutralizing antibodies and safety and tolerability.
- SEL-313 for ornithine transcarbamylase deficiency (OTC deficiency): Selecta’s proprietary gene therapy product candidate, SEL-313, is being developed to treat OTC deficiency, a rare genetic urea cycle disorder that causes ammonia to accumulate in the blood due to mutations in the OTC gene. SEL-313 is currently in preclinical development and a clinical trial application, or CTA and/or IND filing are expected in 2022. A Pediatric Investigation Plan (PIP) for SEL-313 was submitted to the
European Medicines Agency(EMA) pediatric committee in February 2021.
- Sarepta Therapeutics program in Duchenne Muscular Dystrophy (DMD) and certain Limb-Girdle Muscular Dystrophies (LGMD) subtypes:
Selectahas achieved a $3 millionmilestone payment related to the completion of a preclinical study under the Research License and Option Agreement.
Restoring Self-Tolerance in Autoimmune Diseases:
Selectacontinues IND-enabling work on an ImmTOR-based approach to treating primary biliary cholangitis (PBC), a chronic, progressive autoimmune liver disorder that leads to inflammation, damage and scarring of the small bile ducts. Selectaexpects to file an IND in PBC in the second half of 2022.
Kristen Baldwinwas appointed Chief People Officer. She brings 20 years of Human Resources and Consulting experience to the company. Most recently Ms. Baldwinserved in dual capacity as the Chief People Officer for the LIVEKINDLY Collective, a high growth plant-based foods company, and as a Senior Partner at CEO.works. Ms. Baldwinhas also held senior HR roles at Bayerand Otsuka Pharmaceuticals. Satish Tripathi, Ph.D., was appointed Vice President of Global Regulatory Affairs. Dr. Tripathihas over 25 years of combined R&D, business, and global regulatory strategy experience. Dr. Tripathimost recently served as VP of Global Regulatory Affairs for AveXiswhich became Novartis Gene Therapies, where he led the regulatory strategy and implementation for the gene therapy product AVXS-101 for Spinal Muscular Atrophy. AVXS-101 is recognized as only one of the 3 drugs in the world to receive Breakthrough ( US FDA), PRIME (EMA) and Sakigake (MHLW/PMDA) designations. Dr. Tripathiled the simultaneous submission of AVXS-101 in 2018 for global registration, which has been approved as Zolgensma for SMA in US, Europe, Japan, Canada, and Brazil. Brad Dahmswill be stepping down as Chief Financial Officer effective May 21st, 2021to pursue another opportunity. Mr. Dahms’ departure is not related to Selecta’s operations, financial reporting, or controls. A search is currently underway for a successor. Ann Donohuewill be promoted to Vice President Finance, effective immediately, after having served as Controller of Selectasince December 2017.
First Quarter 2021 Financial Results:
- Net cash used in operating activities was
$12.1 millionfor the first quarter of 2021, as compared to $11.7 millionfor the same period in 2020.
Revenue: Revenue recognition for the first quarter of 2021 was
Research and Development Expenses: Research and development expenses for the first quarter 2021 were
General and Administrative Expenses: General and administrative expenses for the first quarter 2021 were
Net Loss: For the first quarter 2021,
Conference Call and Webcast Reminder:
Selecta Forward-Looking Statements
Any statements in this press release about the future expectations, plans and prospects of
Consolidated Balance Sheets
(Amounts in thousands, except share data and par value)
|Cash and cash equivalents||$||125,407||$||138,685|
|Prepaid expenses and other current assets||6,971||5,434|
|Total current assets||163,125||151,343|
|Property and equipment, net||1,301||1,395|
|Right-of-use asset, net||10,676||10,948|
|Long-term restricted cash||1,379||1,379|
|Liabilities and stockholders’ (deficit) equity|
|Total current liabilities||84,607||81,547|
|Loan payable, net of current portion||24,551||24,793|
|Stockholders’ (deficit) equity:|
|Additional paid-in capital||414,214||391,175|
|Accumulated other comprehensive loss||(4,570||)||(4,563||)|
|Total stockholders’ (deficit) equity||(19,571||)||(18,006||)|
|Total liabilities and stockholders’ (deficit) equity||$||176,746||$||165,435|
Consolidated Statements of Operations and Comprehensive Loss
(Amounts in thousands, except share data and per share data)
|Three Months Ended
|Grant and collaboration revenue||$||11,050||$||—|
|Research and development||13,004||14,724|
|General and administrative||5,204||4,098|
|Total operating expenses||18,208||18,822|
|Loss from operations||(7,158||)||(18,822||)|
|Foreign currency transaction gain, net||7||82|
|Change in fair value of warrant liabilities||(16,747||)||(846||)|
|Other income (expense), net||—||(1||)|
|Other comprehensive loss:|
|Foreign currency translation adjustment||(6||)||(60||)|
|Unrealized (losses) on marketable securities||(1||)||—|
|Total comprehensive loss||$||(24,604||)||$||(19,680||)|
|Net loss per share:|
|Basic and diluted||$||(0.22||)||$||(0.21||)|
|Weighted average common shares outstanding:|
|Basic and diluted||110,742,150||94,723,513|
Source: Selecta Biosciences, Inc.