On May 13, 2021 Biogen Inc. (Nasdaq: BIIB) and Envisagenics reported a new collaboration to advance ribonucleic acid (RNA) splicing research within central nervous system (CNS) diseases (Press release, Biogen, MAY 13, 2021, View Source [SID1234580040]). As part of the collaboration, Biogen will leverage Envisagenics’ proprietary artificial intelligence (AI)-driven RNA splicing platform, SpliceCore, to define and understand the regulation of different RNA isoforms in CNS cell types.

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Genetic information encoded in the human chromosome is converted into RNA molecules which is then used as the template to make proteins. RNA splicing is the process that trims out extra information embedded in the intermediate RNA molecules, and this trimmed RNA is what is then used to produce functional proteins.

"Since Biogen’s earliest days, RNA splicing has been an integral part of our history and mission dating back to co-founder Phillip Sharp’s discovery of the process in 1977," said Alfred Sandrock, Jr., M.D., Ph.D., head of research and development at Biogen. "By combining Envisagenics’ SpliceCore platform with our deep expertise in this scientific approach, we believe that Biogen will be able to advance our understanding of RNA splicing and potentially identify new drug targets for CNS diseases."

"Envisagenics is thrilled to work with Biogen because we share a commitment to identifying potential treatments for CNS diseases through innovative AI technology like the SpliceCore platform. Envisagenics and Biogen recognize the power of RNA splicing to aid in the discovery of potential therapeutics," said Maria Luisa Pineda, Ph.D., chief executive officer of Envisagenics. Envisagenics’ Chief Technology Officer, Martin Akerman, Ph.D., added, "scientists have only recently been able to uncover disease-causing novel isoforms at scale, thanks to improvements in the speed and sensitivity of bioinformatics software like SpliceCore."

Traditionally, the process of detecting, cataloging and interpreting RNA splicing errors has been laborious, slow and costly. However, by tapping into Envisagenics’ machine learning algorithms and high-performance computing, Biogen may now be able to identify, test and validate splicing errors at scale. Through this collaboration, Biogen will gain access to SpliceCore’s database of approximately seven million potential RNA splicing errors, which is the largest database of splicing errors in the world. This will provide Biogen with a broader lens to evaluate splicing events that may be targeted for therapeutic gain. In addition, collaboration aligns to Biogen’s broader objective of identifying and validating genetic targets of disease to increase the probability of success in CNS drug discovery.

On May 13, 2021 Southern Research reported that Two prominent Birmingham leaders have been named to leadership – the scientific discovery and research institution headquartered on Birmingham’s Southside (Press release, Southern Research Institute, MAY 13, 2021, View Source [SID1234579905]).

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Josh Carpenter has been named president and CEO, and Allen Bolton has been named executive vice president for strategy and finance. They begin the new roles on June 1.

They’ll be taking the reins at an organization with vast potential for shaping the future of Birmingham’s economy and its innovation ecosystem.

Carpenter, a Rhodes Scholar, most recently served as director of innovation and economic opportunity for the city of Birmingham. He previously worked at UAB.

Bolton most recently was senior vice president for finance and administration at UAB where he also served on the board of Southern Research.

"I couldn’t be more enthusiastic about what’s in front of us because of the people who are there," Carpenter said.

In addition to the expertise of the people and the legacy of Southern Research, Carpenter said he was attracted to the role because of the organization’s potential to transform the region’s economy.

Historically, he said Birmingham has been home to many islands of innovation. One of his goals is to create a better through-line to connect those pockets of R&D excellence in the community and raise their collective impact.

"Southern Research, perhaps better than any other organization, is specifically geared toward playing the role of that translational bridge – translating ideas to innovation and economic opportunity," Carpenter said. "If we can create the storefront to access those immense capabilities, we can present ourselves as the next frontier market in biotech."

Carpenter said Birmingham is well-positioned for growth in life sciences, precision medicine and related fields, and he said Southern Research, with expertise in those fields and others, can play a critical role in that innovation economy.

With the way the medical sector is trending, Carpenter sees a growing need for the type of capability expertise that can be found on the campus of Southern Research, which has 400 employees.

He’s also excited about the role the organization can play in building the local innovation ecosystem – an effort with vast implications for Birmingham’s economy.

There have been numerous examples of successful biotech companies that have originated from research conducted in Birmingham but ultimately moved elsewhere. One of his goals at Southern Research is to help build an environment that keeps those companies – and the jobs they create – in metro Birmingham.

"Southern Research is at it’s finest when the halls are brimming with first-rate intellect that come up with a novel discovery that becomes a commercial enterprise and creates jobs right here in Birmingham," he said.

Carpenter said there will be a focus on having a deeper and more profound relationship with UAB, which is located adjacent to Southern Research’s campus.

"We have not tapped the potential of working to integrate our approach," he said.

Carpenter also said a priority will be adapting Southern Research’s business model to capitalize on the opportunities at hand. What that will entail is likely to become more clear with a strategic plan that could be released later this year to coincide with Southern Research’s 80th anniversary.

He said he’s happy to have a veteran leader like Bolton joining him at Southern Research.

"No one has better experience navigating not just the UAB ecosystem, but a labyrinth of medical systems," Carpenter said. "He’s going to be a really effective arbiter of our strategic and financial interests."

On May 13, 2021 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported corporate updates and financial results for the first quarter ended March 31, 2021 (Press release, CymaBay Therapeutics, MAY 13, 2021, View Source [SID1234579921]).

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In May 2021, CymaBay strengthened its management team with the additions of Dr. Dennis Kim as Chief Medical Officer and Lewis Stuart as Chief Commercial Officer. CymaBay also continued to make significant progress conducting the development program for seladelpar in primary biliary cholangitis (PBC). With clinical sites activated in North America and Europe, patient recruitment is underway in RESPONSE, a global Phase 3 registrational study evaluating seladelpar in patients with PBC. In addition, CymaBay continued to conduct enrollment activities for ASSURE, an open-label, long-term study of seladelpar in patients with PBC intended to collect additional safety data to support registration.

Sujal Shah, President and CEO of CymaBay, stated, "I’m excited to announce the addition of two key executives to our management team, Dr. Dennis Kim as Chief Medical Officer and Lewis Stuart as Chief Commercial Officer. Dennis and Lewis are both experienced biopharma industry executives who will further complement our team and provide leadership in our growing clinical and commercial organizations. We also continued to make progress with RESPONSE, our registrational study designed to evaluate the efficacy and safety of seladelpar in patients with PBC. In addition to our core focus in PBC, we are excited about other early-stage pipeline candidates, with more updates to share in the coming months."

Recent Corporate Highlights

Hired Dr. Dennis Kim as Chief Medical Officer. Dr. Kim is a physician-scientist trained in endocrinology who brings significant clinical development and executive experience in emerging biotech environments from companies such as Amylin, Orexigen and Zafgen. Dr. Kim is well suited to articulate the science, medicine, and opportunities of our programs to broad audiences including medical experts, investigators, patient groups, investors, and analysts. Dr. Kim will lead all clinical-related functions including development, clinical operations, biometrics, and medical affairs.

Hired Lewis Stuart as Chief Commercial Officer, an executive who brings a diverse set of experiences launching products in both the pharmaceutical and molecular diagnostics healthcare sectors. Mr. Stuart brings more than 25 years of experience leading the marketing, sales, market access, and other commercial functions at successful biotech companies and has launched new therapies in women’s health, oncology, metabolic, and rare diseases. Mr. Stuart will lead all aspects of CymaBay’s commercial operations, including marketing and sales.
Appointed Thomas Wiggans to the Board. Mr. Wiggans is a biopharma industry veteran, who brings extensive experience and insight having previously served as CEO and leading companies such as Dermira, Peplin, and Connectics from development through commercialization.
Appointed Janet Dorling to the Board. Ms. Dorling is a senior commercial executive at Gilead, who previously served as Chief Commercial Officer at CymaBay and Achaogen and held prior executive and senior leadership positions in the commercial organization at Roche/Genentech.
Conducted enrollment activities for RESPONSE, a 52-week, placebo-controlled, randomized, global, Phase 3 registrational study evaluating the safety and efficacy of seladelpar in patients with PBC. This study is targeting enrollment of 180 patients who have an inadequate response to, or intolerance to, ursodeoxycholic acid, in a 2:1 randomization to oral, once daily seladelpar 10 mg or placebo. The primary outcome measure is the responder rate at 52 weeks. A responder is defined as a patient who achieves an alkaline phosphatase level < 1.67 times the upper limit of normal with at least a 15% decrease from baseline and has a normal level of total bilirubin. Additional key outcomes of efficacy will compare the rate of normalization of alkaline phosphatase at 52 weeks and the level of pruritus at 6-months for patients with moderate to severe pruritus at baseline assessed by a numerical rating scale recorded with an electronic diary.
Conducted enrollment activities for ASSURE, an open-label, long-term study of seladelpar in patients with PBC intended to collect additional long-term safety data to support registration.
Initiated enrollment in a Phase 2a proof-of-pharmacology study to evaluate the potential for MBX-2982, a GPR119 agonist, to prevent hypoglycemia in patients with type 1 diabetes (T1D). The study is being conducted by the AdventHealth Translational Research Institute (TRI) in Orlando, Florida and fully funded by The Leona M. and Harry B. Helmsley Charitable Trust with CymaBay retaining full rights to MBX-2982.
Continued executing a single and multiple ascending dose pharmacokinetic study of CB-0406 in healthy subjects to establish its pharmacokinetics, safety, and maximum tolerated dose. CB-0406 is a non-agonist ligand of PPARg that attenuates the expression of inflammatory genes.

Held $125.5 million in cash, cash equivalents and short-term investments as of March 31, 2021. We believe that cash and investments are sufficient to fund CymaBay’s current operating plan into mid-2022.

Due to the ongoing effects of the global coronavirus pandemic, CymaBay continues to conduct its operations remotely for all employees, which has allowed business activities to continue as seamlessly as possible. CymaBay continues to closely monitor pandemic developments and their associated risks to the business, including the conduct of its clinical development of seladelpar, and will continue to take actions to mitigate them where possible. Further, all CymaBay’s actions will continue to be guided by a commitment to ensuring the health and safety of its employees as well as patients enrolled in its clinical studies.
First Quarter Ended March 31, 2021 Financial Results

Research and development expenses for the three months ended March 31, 2021 and 2020 were $12.4 million and $9.5 million, respectively. Research and development expenses in the three months ended March 31, 2021 were higher than the corresponding periods in 2020 primarily due to an increase in clinical trial activities following our resumption of clinical development of seladelpar in PBC in late 2020. In particular, cost increases were primarily driven by the enrollment activities associated with RESPONSE and ASSURE, our two new global late-stage clinical trials in PBC. In the three months ended March 31, 2020, costs incurred were primarily associated with the termination and shutdown of our Phase 3 PBC, Phase 2b NASH, and Phase 2 PSC clinical trials, and other studies, after the seladelpar development program was placed on hold from November 2019 through July 2020.

General and administrative expenses for the three months ended March 31, 2021 and 2020 were $5.2 million and $4.4 million, respectively. General and administrative expenses in the three months ended March 31, 2021 were higher than the corresponding period in 2020 due to higher employee compensation associated with the hiring of additional personnel upon resumption of development of seladelpar in the second half of 2020.

Net loss for the three months ended March 31, 2021 and 2020 was $17.6 million and $13.1 million, or ($0.25) and ($0.19) per diluted share, respectively. Net loss was higher largely due to increases in clinical operating expenses which were incurred following the resumption of our clinical development of seladelpar in PBC during the second half of 2020. We expect our operating expenses to increase in 2021 as we continue to execute on our clinical development plans.
Conference Call Details

CymaBay will host a conference call today at 4:30 p.m. ET to discuss first quarter 2021 financial results and provide a business update. To access the live conference call, please dial 877-407-0784 from the U.S. and Canada, or 201-689-8560 internationally, Conference ID# 13718350. To access the live and subsequently archived webcast of the conference call, go to the Investors section of the company’s website at View Source

On May 13, 2021 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics, reported financial results for the first quarter ended March 31, 2021 (Press release, Repare Therapeutics, MAY 13, 2021, View Source [SID1234579937]).

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"We have advanced the Phase 1/2 clinical development of our ATR inhibitor RP-3500, with initial results expected from the monotherapy arm of the trial in the second half of 2021. The PARP inhibitor and RP-3500 combination arm is now recruiting," said Lloyd M. Segal, President and Chief Executive Officer of Repare. "We are pleased that the first patient has been dosed in our Phase 1 clinical trial of RP-6306, materially ahead of the timeline we disclosed at the time of our IPO last June."

First Quarter 2021 Review and Operational Updates:

Highlighted program progress and introduced PKMYT1 as synthetic-lethal target to CCNE1 and FBXW7 at RP-6306 Virtual Investor Day Event.
In April 2021, the Company highlighted pre-clinical anti-tumor activity of RP-6306, a potential first-in-class small molecule product candidate targeting PKMYT1, which is synthetic lethal with CCNE1 amplification, FBXW7 loss, and potentially other genomic alterations.
Announced enrollment of first patient in RP-6306 Phase 1 clinical trial.
In April 2021, the Company dosed the first patient in its Phase 1 clinical trial of RP-6306.
The trial (NCT04855656) is expected to enroll approximately 60 patients with recurrent tumors characterized by genomic alterations predicted by the Company’s SNIPRx CRISPR-based platform to be sensitive to RP-6306.
The trial objectives include assessment of safety, tolerability, dose and schedule (including the establishment of a recommended Phase 2 dose).
Subject to completion and review of the Phase 1 clinical trial, the Company expects to advance RP-6306, both as monotherapy and in combination with chemotherapies and other agents, into proof-of-concept trials in 2022 targeting a variety of patient populations, including those with tumors with CCNE1 amplification, FBXW7 loss or other undisclosed alterations identified through its proprietary STEP2 screen.
Prospective enrichment of patient trial populations will be guided by the Company’s ongoing efforts to develop patient selection, target engagement and functional biomarkers.
Initiated patient recruitment of PARP-inhibitor combination arm of the RP-3500 TRESR Phase 1/2 clinical trial.
Repare has activated 10 clinical trial sites across North America and Europe, and is actively recruiting patients to evaluate RP-3500 in a combination arm with Pfizer’s PARP inhibitor, talazoparib, in addition to a monotherapy arm.
Initial results are expected to be reported from the monotherapy arm of the trial in the second half of 2021.
First Quarter 2021 Financial Results:

Cash and cash equivalents, restricted cash and marketable securities: Cash and cash equivalents, restricted cash and marketable securities as of March 31, 2021 were $319.1 million.
Research and development expenses, net of tax credits (Net R&D): Net R&D expenses were $16.5 million and $8.6 million for the quarters ended March 31, 2021 and 2020, respectively. The increase in R&D expenses year-over-year was primarily due to increases in development costs related to the Company’s RP-3500 and RP-6306 programs, as well as increases in personnel related expenses, including stock-based compensation, and certain other R&D expenses.
General and administrative (G&A) expenses: G&A expenses were $5.2 million and $2.2 million for the quarters ended March 31, 2021 and 2020, respectively. The increase in G&A expenses year-over-year was due to increases in personnel related costs, including stock-based compensation, and D&O insurance which increased as a result of the Company’s transition to a public company.
Net loss: Net loss was $21.4 million, or $0.58 per share in the quarter ended March 31, 2021 and $12.6 million, or $7.71 per share, in the quarter ended March 31, 2020.
About Repare Therapeutics’ SNIPRx Platform

Repare’s SNIPRx platform is a genome-wide CRISPR-based screening approach that utilizes proprietary isogenic cell lines to identify novel and known synthetic lethal gene pairs and the corresponding patients who are most likely to benefit from the Company’s therapies based on the genetic profile of their tumors. Repare’s platform enables the development of precision therapeutics in patients whose tumors contain one or more genomic alterations identified by SNIPRx screening, in order to selectively target those tumors in patients most likely to achieve clinical benefit from resulting product candidates.

On May 14, 2021 Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses, reported financial results for the first quarter ended March 31, 2021 and provided a business update (Press release, Selecta Biosciences, MAY 13, 2021, View Source [SID1234579954]).

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"We are very pleased about the continued progress across all aspects of the company," said Carsten Brunn, Ph.D., president and chief executive officer of Selecta. "We regained exclusive rights to our MMA program and now have two proprietary gene therapy programs to rapidly follow our ongoing empty capsid study. Additionally, we continue to progress our enzyme program, with an expected IND filing by the end of 2021 in IgA nephropathy, and topline data from the Phase 3 DISSOLVE program for SEL-212 anticipated in the second half of 2022."

Recent Highlights and Anticipated Upcoming Milestones:

Enzyme Therapies:

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, Selecta expects 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.
Gene Therapies:

First-in-human trial of SEL-399: In collaboration with AskBio, Selecta initiated 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. Selecta and AskBio expect to report topline data in the fourth quarter of 2021.
MMA-101 for methylmalonic acidemia (MMA): Selecta regained 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: Selecta has achieved a $3 million milestone payment related to the completion of a preclinical study under the Research License and Option Agreement.
Restoring Self-Tolerance in Autoimmune Diseases:

Selecta continues 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. Selecta expects to file an IND in PBC in the second half of 2022.
Corporate Updates:

Kristen Baldwin was appointed Chief People Officer. She brings 20 years of Human Resources and Consulting experience to the company. Most recently Ms. Baldwin served 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. Baldwin has also held senior HR roles at Bayer and Otsuka Pharmaceuticals.

Satish Tripathi, Ph.D., was appointed Vice President of Global Regulatory Affairs. Dr. Tripathi has over 25 years of combined R&D, business, and global regulatory strategy experience. Dr. Tripathi most recently served as VP of Global Regulatory Affairs for AveXis which 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. Tripathi led 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 Dahms will be stepping down as Chief Financial Officer effective May 21st, 2021 to 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 Donohue will be promoted to Vice President Finance, effective immediately, after having served as Controller of Selecta since December 2017.
First Quarter 2021 Financial Results:

Cash Position: Selecta had $149.2 million in cash, cash equivalents, marketable securities, and restricted cash as of March 31, 2021, which compares to cash, cash equivalents, and restricted cash of $140.1 million as of December 31, 2020. Selecta believes its available cash, cash equivalents, marketable securities, and restricted cash will be sufficient to meet its operating requirements into the second quarter of 2023.

Net cash used in operating activities was $12.1 million for the first quarter of 2021, as compared to $11.7 million for the same period in 2020.
Revenue: Revenue recognition for the first quarter of 2021 was $11.1 million, compared to no revenue recognition for the same period in 2020. Revenue was recognized under the license agreement with Sobi which began in July 2020 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 first quarter 2021 were $13.0 million, which compares with $14.7 million for the same period in 2020. During the quarter ended March 31, 2021, there was a reduction in expenses for the SEL-212 clinical program and for the AskBio Collaboration, offset by an increase of expense for discovery and preclinical programs.

General and Administrative Expenses: General and administrative expenses for the first quarter 2021 were $5.2 million, which compares with $4.1 million for the same period in 2020. The quarterly increase in expense was the result of expenses for consulting and professional fees and salaries offset by reduced travel expenses.

Net Loss: For the first quarter 2021, Selecta reported a net loss of $24.6 million, or $0.22 per share, compared to a net loss of $19.6 million, or $0.21 per share for the same period in 2020.

Conference Call and Webcast Reminder:
Selecta management will host a conference call at 8:30 AM ET today to provide a corporate update and review the company’s first quarter 2021 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 10147801. 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.