Synthetic Biologics(TOVX)

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Synthetic Biologics(TOVX) - 2020 Q2 - Earnings Call Transcript
2020-08-07 02:35
Synthetic Biologics, Inc. (SYN) Q2 2020 Earnings Conference Call August 6, 2020 4:30 PM ET Company Participants Vincent Perrone - Director, Corporate Communication Steven Shallcross - CEO, CFO, Treasurer and Secretary, Director Michael Kaleko - SVP of R&D Conference Call Participants James Molloy - Alliance Global Partners Michael Okunewitch - Maxim Group Operator Good afternoon and welcome to the Synthetic Biologics' 2020 Second Quarter Investor Conference Call. All participants will be in listen-only mode ...
Synthetic Biologics(TOVX) - 2020 Q2 - Quarterly Report
2020-08-06 21:01
Clinical 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].
Synthetic Biologics(TOVX) - 2020 Q1 - Earnings Call Transcript
2020-05-06 01:58
Synthetic Biologics, Inc. (SYN) Q1 2020 Earnings Conference Call May 5, 2020 4:30 PM ET Company Participants Vincent Perrone – Director-Corporate Communication Steven Shallcross – Chief Executive and Financial Officer Vince Wacher – Head-Product and Corporate Development Conference Call Participants James Molloy – Alliance Global Partners Michael Okunewitch – Maxim Group Operator Good afternoon and welcome to the Synthetic Biologics' 2020 First Quarter Investor Conference Call. At this time, I would like to ...
Synthetic Biologics(TOVX) - 2020 Q1 - Quarterly Report
2020-05-05 20:37
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2020 OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934 For the transition period from ____________ to ____________ Commission File Number: 001-12584 SYNTHETIC BIOLOGICS, INC. (Exact name of Registrant as Specified in Its Charter) Nevada 13-3808303 (State ...
Synthetic Biologics(TOVX) - 2019 Q4 - Earnings Call Transcript
2020-02-21 03:25
Synthetic Biologics, Inc. (SYN) Q4 2019 Earnings Conference Call February 20, 2020 4:30 PM ET Company Participants Vincent Perrone - Director, Corporate Communications Steven Shallcross - Chief Executive Officer and Chief Financial Officer Vince Wacher - Head of Product and Corporate Development Conference Call Participants Michael Okunewitch - Maxim Group Operator Good afternoon and welcome to Synthetic Biologics' 2019 Year End Investor Conference Call. All participants will be in listen-only mode. [Operat ...
Synthetic Biologics(TOVX) - 2019 Q4 - Annual Report
2020-02-20 21:37
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-K x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934 For the transition period from to Commission File Number: 001-12584 SYNTHETIC BIOLOGICS, INC. (Exact Name of Registrant as Specified in Its Charter) Nevada 13-3808303 (State or Other Jurisdiction of Incorporation or ...
Synthetic Biologics(TOVX) - 2019 Q3 - Earnings Call Transcript
2019-11-05 01:53
Synthetic Biologics, Inc. (SYN) Q3 2019 Earnings Conference Call November 4, 2019 4:30 PM ET Company Participants Vincent Perrone - Director, Corporate Communications Steven Shallcross - CEO and CFO Michael Kaleko - SVP of Research and Development Vince Wacher - Head of Product and Corporate Development Conference Call Participants Jim Molloy - Alliance Global Partners Operator Good afternoon and welcome to Synthetic Biologics' 2019 Third Quarter Investor Conference Call. All participants will be in listen- ...
Synthetic Biologics(TOVX) - 2019 Q3 - Quarterly Report
2019-11-04 21:36
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2019 OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934 For the transition period from ____________ to ____________ Commission File Number: 001-12584 SYNTHETIC BIOLOGICS, INC. (Exact name of Registrant as Specified in Its Charter) (State or Other Juris ...
Synthetic Biologics(TOVX) - 2019 Q2 - Earnings Call Transcript
2019-08-09 05:18
Synthetic Biologics, Inc (SYN) Q2 2019 Earnings Conference Call August 8, 2019 4:30 PM ET Company Participants Vincent Perrone - Director, Corporate Communication Steven Shallcross - Chief Executive Officer & Chief Financial Officer Vince Wacher - Head of Product & Corporate Development Conference Call Participants Jim Molloy - Alliance Global Partners Operator Afternoon and welcome to Synthetic Biologics' 2019 Second Quarter Investor Conference Call. All participants will be in a listen-only mode. [Operato ...
Synthetic Biologics(TOVX) - 2019 Q2 - Quarterly Report
2019-08-08 20:36
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q Nevada 13-3808303 (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2019 OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934 For the transition period from ____________ to ____________ Commission File Number: 001-12584 SYNTHETIC BIOLOGICS, INC. (Exact name of Registrant as Specified in Its Charter) (State o ...