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)

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 ...

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 ...

Financial Data and Key Metrics Changes - General and administrative expenses decreased to $1.1 million for Q1 2019 from $1.6 million in Q1 2018, a reduction of 30% primarily due to decreased stock-based compensation and lower investor relations costs [34] - Research and development expenses decreased to $2.4 million for Q1 2019 from $3.4 million in Q1 2018, a decrease of 28% attributed to lower program costs and no ongoing clinical trial activity for SYN-004 [35] - Cash and cash equivalents totaled $24.7 million as of March 31, 2019, a decrease of $4.2 million from December 31, 2018, providing sufficient runway to continue operations through Q2 2020 [38] Business Line Data and Key Metrics Changes - The primary focus for the first quarter was on the SYN-010 program, with the commencement of enrollment in a Phase 2b clinical study, which is expected to provide important data for future Phase 3 trials [14][15] - SYN-004, designed to protect the gut microbiome, is being positioned for a specific patient population, particularly allogeneic HCT recipients, with ongoing discussions for a Phase 1/2 clinical trial [21][25] - SYN-020, an oral form of intestinal alkaline phosphatase, is being developed to mitigate intestinal damage, with a pre-IND meeting request submitted to the FDA [30] Market Data and Key Metrics Changes - The company is targeting critical unmet needs in the prevention of gut microbiome infections and GI disorders, indicating a strategic focus on addressing significant market gaps [8] - The development of SYN-020 is expected to significantly reduce manufacturing costs, potentially making it a competitive product in the market [27] Company Strategy and Development Direction - The company is focused on realigning clinical programs to clear regulatory pathways while reducing cash burn through workforce streamlining and operational efficiency [7][33] - The strategy includes advancing clinical programs targeting specific patient populations, such as cancer patients undergoing allogeneic HCT, to enhance the therapeutic benefit of SYN-004 [21][24] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of prudent cash management and financial stewardship to extend the cash runway through at least Q2 2020 [11][33] - The company is optimistic about the potential of its clinical assets and is focused on executing clear milestones to drive value for shareholders [31][40] Other Important Information - The company has made significant progress in establishing infrastructure for clinical studies and is actively engaged with research institutions for protocol development [25][42] - Management highlighted the importance of ongoing discussions with potential partners to fund clinical trials, particularly for SYN-004 [19][20] Q&A Session Summary Question: No questions were posed during the Q&A session - The conference concluded without any participant questions [45]

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, 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 ...

Call Start: 16:30 January 1, 0000 5:14 PM ET Synthetic Biologics Inc. (SYN) Q4 2018 Earnings Conference Call February 27, 2019 16:30 ET Company Participants Vincent Perrone - Director, Corporate Communications Steven Shallcross - CEO & CFO Vince Wacher - Head, Product & Corporate Development Conference Call Participants Katherine Xu - William Blair Jim Molloy - Alliance Global Partners Operator Good afternoon and welcome to the Synthetic Biologics 2018 Year End Investor Conference Call. All participants wil ...

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, 2018 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: 1-12584 SYNTHETIC BIOLOGICS, INC. (Exact Name of Registrant as Specified in Its Charter) Nevada 13-3808303 (State or Other Jurisdiction of Incorporation or Or ...