Synthetic Biologics, Inc. (SYN) Q3 2020 Earnings Conference Call November 10, 2020 4:30 PM ET Company Participants Vincent Perrone - Director, Corporate Communication Steven Shallcross - Chief Executive Officer & Financial Officer Michael Kaleko - Senior Vice President, Research & Development Vince Wacher - Head-Product & Corporate Development Conference Call Participants Michael Okunewitch - Maxim Group Operator Good afternoon, and welcome to the Synthetic Biologics' 2020 Third Quarter Investor Conference ...

x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) For the quarterly period ended September 30, 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) (State or Other Juris ...

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 ...

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, 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 ...

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, 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 ...

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, 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- ...

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements for the period ended September 30, 2019, detailing the company's financial position, performance, and cash flows [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of September 30, 2019, shows a decrease in total assets to $20.7 million and a significant decline in stockholders' equity to $2.1 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | Sep 30, 2019 | Dec 31, 2018 | | :--- | :--- | :--- | | Cash and cash equivalents | $18,650 | $28,918 | | Total Assets | $20,742 | $30,141 | | Total Liabilities | $6,172 | $3,686 | | Total Stockholders' Equity | $2,089 | $14,159 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported a net loss attributable to common stockholders of $5.3 million for Q3 2019 and $12.9 million for the nine-month period, driven by increased R&D expenses Statement of Operations Highlights (in thousands, except per share data) | Metric | Q3 2019 | Q3 2018 | Nine Months 2019 | Nine Months 2018 | | :--- | :--- | :--- | :--- | :--- | | General and administrative | $1,098 | $1,474 | $3,297 | $4,525 | | Research and development | $4,144 | $2,846 | $9,156 | $9,788 | | Loss from Operations | $(5,242) | $(4,320) | $(12,453) | $(14,313) | | Net Loss Attributable to Common Stockholders | $(5,253) | $(3,741) | $(12,934) | $(10,375) | | Net Loss Per Share - Basic and Dilutive | $(0.31) | $(0.93) | $(0.79) | $(2.73) | [Condensed Consolidated Statements of Stockholders Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%20Equity) Stockholders' equity significantly declined from $14.2 million at year-end 2018 to $2.1 million as of September 30, 2019, primarily due to the net loss - Total stockholders' equity decreased from **$14,159 thousand** at December 31, 2018 to **$2,089 thousand** at September 30, 2019, mainly due to the net loss for the period[22](index=22&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was $10.3 million for the nine months ended September 30, 2019, with cash and cash equivalents decreasing to $18.7 million Cash Flow Summary (Nine Months Ended Sep 30, in thousands) | Metric | 2019 | 2018 | | :--- | :--- | :--- | | Net Cash Used In Operating Activities | $(10,268) | $(13,989) | | Net Cash Provided By Financing Activities | $0 | $6,422 | | Net decrease in cash | $(10,268) | $(7,567) | | Cash and cash equivalents at end of period | $18,650 | $9,549 | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes detail the company's business, accounting policies, clinical pipeline, liquidity, and significant financing events, highlighting the need for additional funding for future trials - The company is a clinical-stage company focused on GI diseases with lead candidates **SYN-004 (ribaxamase)**, **SYN-010**, and **SYN-020**[27](index=27&type=chunk) - As of September 30, 2019, the company had **$18.7 million** in cash, sufficient to fund operations through Q4 2020, but additional financing or a partnership is required for Phase 3 clinical trials[30](index=30&type=chunk)[31](index=31&type=chunk) - The company adopted ASC 842 on January 1, 2019, recording an ROU asset of approximately **$537,000** and a lease liability of approximately **$939,000**[39](index=39&type=chunk) - In October 2018, the company completed a public offering of Class A and Class B Units, raising gross proceeds of approximately **$18.6 million**[57](index=57&type=chunk)[69](index=69&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses clinical pipeline advancements, operational results, and liquidity, highlighting increased R&D expenses and the need for additional capital for late-stage trials despite current cash reserves - The company's lead candidates include **SYN-004 (ribaxamase)**, **SYN-010** for IBS-C, and **SYN-020** for local GI and systemic diseases[90](index=90&type=chunk) - Key milestones include a **SYN-010 Phase 2b data readout in 1H 2020**, **SYN-004 Phase 1b/2a enrollment in Q1 2020**, and **SYN-020 IND submission in Q1 2020**[91](index=91&type=chunk) Q3 2019 vs Q3 2018 Operating Expenses (in millions) | Expense Category | Q3 2019 | Q3 2018 | Change | | :--- | :--- | :--- | :--- | | General and administrative | $1.1 | $1.5 | -26% | | Research and development | $4.1 | $2.8 | +46% | - The company held **$18.7 million** in cash as of September 30, 2019, sufficient for operations through Q4 2020, but insufficient for planned Phase 3 trials without additional capital or a partner[127](index=127&type=chunk)[130](index=130&type=chunk)[131](index=131&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's market risk is limited to low-risk cash and cash equivalents, with no significant impact expected from interest rate changes - The company's primary market risk is confined to its cash and cash equivalents, consisting mainly of low-risk money market securities[137](index=137&type=chunk) - Due to the short-term, low-risk profile of its investments, the company does not anticipate a significant impact from changes in market interest rates[137](index=137&type=chunk) [Controls and Procedures](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2019, with no material changes to internal controls during the quarter - Management concluded that the company's disclosure controls and procedures were effective as of **September 30, 2019**[138](index=138&type=chunk) - There were no material changes in internal controls over financial reporting during the third quarter of 2019[139](index=139&type=chunk) [PART II. OTHER INFORMATION](index=30&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings that would materially adversely affect its business or financial condition - The company is not presently a party to any legal proceedings expected to have a material adverse effect on its business[141](index=141&type=chunk) [Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) This section updates risk factors, emphasizing the critical need for additional capital for future clinical trials, with fundraising limited by market capitalization - The company will need to raise additional capital to fund operations and its development programs[143](index=143&type=chunk) - Current cash is insufficient to complete planned Phase 3 clinical trials for **SYN-004** and **SYN-010** or late-stage trials for **SYN-020**, requiring significant expenditures or a strategic partnership[144](index=144&type=chunk) - The company's ability to raise capital through security sales is currently limited by SEC and NYSE American rules due to its market value[144](index=144&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=31&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company did not sell any unregistered equity securities during the third quarter of 2019 - No equity securities were sold in unregistered transactions during the quarter ended **September 30, 2019**[145](index=145&type=chunk) [Defaults Upon Senior Securities](index=31&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to the company - Not applicable[146](index=146&type=chunk) [Mine Safety Disclosures](index=31&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[147](index=147&type=chunk) [Other Information](index=31&type=section&id=Item%205.%20Other%20Information) This item is not applicable to the company - Not applicable[148](index=148&type=chunk) [Exhibits](index=31&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including a Clinical Trial Agreement, CEO/CFO certifications, and XBRL data files - Exhibits filed with the report include the Clinical Trial Agreement with Washington University School of Medicine, officer certifications, and XBRL data[155](index=155&type=chunk) [Signatures](index=32&type=section&id=SIGNATURES)