SYN - SYN STOCK NEWS

Synthetic Biologics (NYSE American: SYN) announced on November 23, 2020, that it received an extension until May 25, 2021, from NYSE American to regain compliance with certain listing standards. This extension follows prior notices indicating non-compliance due to the company reporting stockholder's equity of $6 million or less as of September 30, 2019, and ongoing losses. The company previously proposed a compliance plan accepted in February 2020. Failure to meet compliance by the new deadline could lead to delisting.

Synthetic Biologics, Inc. (NYSE American: SYN) has engaged A.G.P./Alliance Global Partners to explore strategic options aimed at maximizing growth and shareholder value. This move, approved by the Board of Directors, reflects the company's proactive approach to enhancing its portfolio. Currently developing SYN-004 (ribaxamase) for preventing gastrointestinal diseases in hematopoietic cell transplant recipients, the firm plans to initiate a Phase 1b/2a clinical program in early 2021, pending pandemic conditions. The timeline for evaluating strategic alternatives remains undefined, with no guarantee of outcomes.

Synthetic Biologics, Inc. (NYSE American: SYN) has appointed John Monahan, PhD, to its Board of Directors, effective immediately, replacing Scott L. Tarriff. Dr. Monahan brings over 45 years of experience in the biotech sector, having co-founded Avigen Inc. and raised over $235 million during his tenure there. His expertise in drug development and regulatory strategies is expected to bolster the company's clinical programs, particularly for SYN-004 and SYN-020, which target significant unmet medical needs in gastrointestinal diseases. The company aims to leverage Dr. Monahan's industry relationships to expand its pipeline.

Synthetic Biologics (NYSE American: SYN) provided a Q3 2020 update, highlighting significant developments in its clinical programs amid the COVID-19 pandemic. The FDA has approved the Phase 1b/2a clinical study of SYN-004 in adult HCT recipients, set to commence in Q1 2021. Additionally, progress was made on the SYN-020 program with the completion of drug supply for its Phase 1 SAD study. However, the company announced the discontinuation of the SYN-010 trial due to interim analysis results that suggested it would not meet its primary objective. Financially, cash reserves have decreased to $6.0 million, down $9.0 million since 2019.

Synthetic Biologics, Inc. (NYSE American: SYN) is set to announce its operational highlights and financial results for Q3 2020 on November 10, 2020, during a conference call at 4:30 p.m. ET. The company focuses on developing therapeutics for gastrointestinal diseases through microbiome leveraging. Its lead candidates include SYN-004, aimed at preventing microbiome damage from IV antibiotics, and SYN-010, targeting IBS-C by reducing methane-producing organisms. An archived call replay will be accessible post-event.

Synthetic Biologics (NYSE American: SYN) announced that the Phase 2b clinical trial of SYN-010 for irritable bowel syndrome with constipation (IBS-C) will be discontinued due to an interim futility analysis conducted by Cedars-Sinai Medical Center. Although SYN-010 was well-tolerated, it is unlikely to meet its primary efficacy objective. The trial aimed to assess improvements in complete spontaneous bowel movements (CSBMs) over a 12-week period for two dosage strengths. The company remains committed to advancing its other candidates, SYN-004 and SYN-020.

Synthetic Biologics (NYSE American: SYN) announced its Q2 2020 clinical program updates and financial results on August 6, 2020. The FDA granted a study-may-proceed letter for the Phase 1 trial of SYN-020, targeting radiation enteropathy. Enrollment for SYN-010's Phase 2b trial resumed after COVID-19 delays, with interim data expected in Q3. Despite increased general and administrative expenses (up 23% to $1.3M), R&D expenses decreased by 38% to $1.6M. Cash reserves stood at $8.1M, down $7M from the previous year.

Synthetic Biologics (NYSE American: SYN) announced it received a study-may-proceed letter from the FDA for its first clinical study of SYN-020, an oral formulation of recombinant intestinal alkaline phosphatase (IAP). This Phase 1 study will assess safety, tolerability, and pharmacokinetics in healthy volunteers and is set to commence in Q1 2021. The program aims to evaluate SYN-020's potential to mitigate intestinal damage caused by pelvic cancer radiation therapy. Additionally, Synthetic Biologics has an option to license technology from Massachusetts General Hospital to advance SYN-020's clinical applications.

Synthetic Biologics, Inc. (NYSE American: SYN) will release its operational highlights and financial results for the quarter ended June 30, 2020 on August 6, 2020, followed by a conference call at 4:30 p.m. ET. The company focuses on developing therapeutics leveraging the microbiome to address gastrointestinal diseases. Key candidates include SYN-004, aimed at preventing microbiome damage from antibiotics, SYN-010 for irritable bowel syndrome with constipation, and SYN-020 to treat GI and systemic diseases. More details are available on their website.