Synthetic Biologics(US:TOVX)2020-08-06 21:01Clinical Development - The company is focused on developing therapeutics leveraging the microbiome to treat gastrointestinal diseases, with lead candidates SYN-004 and SYN-010 targeting specific conditions[112]. - SYN-004 (ribaxamase) aims to prevent microbiome damage and CDI in allogeneic HCT recipients, with a Phase 1b/2a clinical trial postponed to Q1 2021 due to COVID-19[113][126]. - Enrollment in the Phase 2b clinical study of SYN-010 was temporarily halted in Q1 and Q2 2020 but has since recommenced, contingent on patient recruitment capabilities[113][119]. - The company has received FDA feedback indicating that a single Phase 3 clinical trial may support marketing approval for SYN-004, pending additional funding[119]. - SYN-020, an early-stage oral formulation of intestinal alkaline phosphatase, is being developed to treat local GI and systemic diseases, with an IND application submitted to the FDA[120]. - SYN-006 and SYN-007 are additional products in preclinical stages, focusing on preventing aGVHD and antibiotic-associated diarrhea, respectively[117][121]. - The company has established a Clinical Trial Agreement with Washington University to conduct the Phase 1b/2a clinical trial for SYN-004, with safety and pharmacokinetic evaluations planned[125][127]. - The impact of COVID-19 on clinical trials has necessitated adjustments in timelines and patient recruitment strategies, affecting overall productivity[114]. - Clinical trial timelines for SYN-004 and SYN-010 are expected to be adversely impacted due to the COVID-19 pandemic, with anticipated delays in enrollment and trial commencement[154]. Financial Performance - General and administrative expenses increased by 23% to $1.3 million for the three months ended June 30, 2020, compared to $1.0 million for the same period in 2019[139]. - Research and development expenses decreased by 38% to $1.6 million for the three months ended June 30, 2020, down from $2.6 million for the same period in 2019[140]. - Net loss attributable to common stockholders was $3.3 million, or $0.18 per share for the three months ended June 30, 2020, compared to a net loss of $3.7 million, or $0.23 per share for the same period in 2019[144]. - Total research and development expenses for the three months ended June 30, 2020, were $1.6 million, with direct costs for SYN-010 at $94,000 and for ribaxamase at $40,000[142]. - General and administrative expenses increased by 22% to $2.7 million for the six months ended June 30, 2020, from $2.2 million for the same period in 2019[145]. - Research and development expenses decreased by 35% to $3.2 million for the six months ended June 30, 2020, down from $5.0 million for the same period in 2019[146]. - Net loss attributable to common stockholders for the six months ended June 30, 2020, was $6.8 million, or $0.38 per share, compared to a net loss of $7.7 million, or $0.48 per share for the same period in 2019, indicating an improvement of approximately 11.7%[150]. - Other income for the six months ended June 30, 2020, was $44,000, down from $125,000 in the same period of 2019, primarily due to reduced interest income[149]. Capital and Financing - Cash and cash equivalents totaled $8.1 million as of June 30, 2020, a decrease of $7.0 million from December 31, 2019, primarily due to operational cash flow needs[153]. - The accumulated deficit as of June 30, 2020, was $242.3 million, with expectations to continue incurring losses in the foreseeable future[151]. - The company does not have sufficient capital to fund operations beyond the next twelve months and is actively pursuing additional equity or debt financing[152]. - The company has not engaged in any financing activity during the six months ended June 30, 2020, as previous financings were sufficient to meet cash needs[157]. - Future clinical trials are expected to require larger cash expenditures than current studies, with no committed sources of financing available at this time[162]. - The company is currently limited by SEC rules regarding the number of shares of Common Stock that can be sold under the FBR Sales Agreement, impacting potential capital raising efforts[161]. - The company may require additional financing to fund future obligations, with no assurance on the terms of future financing sources[168]. Intellectual Property - The company is actively expanding its patent portfolio through new applications and licensing agreements to support its microbiome-focused pipeline[122]. - The company has over 110 U.S. and foreign patents and over 100 patents pending, supporting its various programs[136].