Synthetic Biologics, Inc. (SYN) Q4 2021 Earnings Conference Call March 16, 2022 4:30 PM ET CompanyParticipants Chris Calabrese - LifeSci Advisors, IR Steven Shallcross - Chief Executive Officer & Chief Financial Officer Manel Cascallo - General Director of VCN & European Operations Frank Tufaro - Head of Operations of VCN Conference Call Participants Jim Molloy - Alliance Global Partners Jason McCarthy - Maxim Group Michael Okunewitch - Maxim Group Operator Greetings and welcome to the Synthetic Biologics F ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 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 ...

Synthetic Biologics, Inc. (SYN) Q3 2021 Earnings Conference Call November 3, 2021 4:30 PM ET Company Participants Vincent Perrone - Director, Corporate Communications Steven Shallcross - Chief Executive and Financial Officer Michael Kaleko - Senior Vice President-Research and Development Vince Wacher - Head of Corporate and Product Development Conference Call Participants James Molloy - Alliance Global Partners Michael Okunewitch - Maxim Group Operator Good afternoon, and welcome to Synthetic Biologics’ 202 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 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) For the quarterly period ended September 30, 2021 Nev ...

Financial Data and Key Metrics Changes - The company reported approximately $74.3 million in cash on hand at the end of Q2 2021, indicating a strong balance sheet to support clinical programs through 2023 [7][33] - General and administrative expenses decreased by 2% to approximately $1.26 million compared to $1.29 million in Q2 2020 [35] - Research and development expenses increased by 21% to approximately $1.9 million from approximately $1.6 million in Q2 2020, primarily due to increased clinical trial expenses [36] Business Line Data and Key Metrics Changes - The SYN-020 program completed patient enrollment, dosing, and evaluation in its Phase 1 open label, single ascending dose clinical trial, demonstrating a favorable safety profile [10][27] - The SYN-004 program is currently in a Phase 1b/2a clinical trial for allogeneic hematopoietic cell transplant recipients, with data readout expected in Q4 2021 [12][19] Market Data and Key Metrics Changes - The company is targeting sizable and underserved markets with SYN-004 and SYN-020, which are expected to be foundational long-term value drivers [13][32] - Celiac disease, targeted by SYN-020, affects approximately 1% of the U.S. population, indicating a significant market opportunity [23] Company Strategy and Development Direction - The company aims to advance its GI and microbiome-focused clinical development programs, with a focus on SYN-004 and SYN-020 [6][9] - The strategy includes pursuing clinical trials for SYN-020 in celiac disease and potentially for non-alcoholic fatty liver disease and metabolic disorders [31][32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress of clinical programs and the financial strength to unlock long-term growth for shareholders [66] - The company remains focused on executing its strategy and is optimistic about upcoming catalysts that could enhance shareholder value [8][66] Other Important Information - The company regained listing compliance with the New York Stock Exchange during Q2 2021 [8] - The second Phase 1 multiple ascending dose clinical trial of SYN-020 is expected to commence in Q3 2021, with top-line data anticipated in Q2 2022 [9][28] Q&A Session Summary Question: Status of SYN-006 IND for CRE - SYN-006 is still in the preclinical stage, with a focus on advancing SYN-004 and SYN-020 in the clinic [42][43] Question: Partnerships for SYN-004 for C.diff - No current partnerships for SYN-004, with a strategy to develop additional clinical data before seeking partners [47] Question: Timeline for Phase 1 cohort data for SYN-004 - The total trial is expected to take about 18 months, with data evaluation at the end of the year [49] Question: Phase 1b/2a data readout and its implications - The study is designed to assess absorption data, which could be a derisking event for future trials [55] Question: Impact of COVID-19 on ongoing studies - No increased risk of delay has been reported for ongoing studies, with safety measures in place at Washington University [61]

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934 For the transition period from ____________ to ____________ Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 OR Commission File Number: 001-12584 SYNTHETIC BIOLOGICS, INC. (Exact name of Registrant as Specified in Its Charter) Nevada 1 ...

Financial Data and Key Metrics Changes - The company reported a cash position of nearly $77 million at the end of Q1 2021, marking the strongest financial position in its history [6][24]. - General administrative expenses increased slightly to $1.42 million from $1.39 million year-over-year, primarily due to higher insurance costs and audit fees [26]. - Research and development expenses decreased to $1.1 million from $1.6 million year-over-year, attributed to lower indirect program costs and reduced manufacturing costs for SYN-020 [26][27]. Business Line Data and Key Metrics Changes - The company achieved significant milestones in its clinical pipeline, including the initiation of a Phase 1b/2a clinical trial of SYN-004 and a Phase 1a single ascending dose clinical trial of SYN-020 [8][20]. - Enrollment for the SYN-004 trial commenced, with the first patients dosed, and the company expects to report top line data from this cohort in Q4 2021 [12][14]. Market Data and Key Metrics Changes - The ongoing COVID-19 pandemic initially reduced the number of stem cell transplants, but recent management at Washington University has allowed for a recovery, with transplant numbers returning close to pre-pandemic levels [34][35]. Company Strategy and Development Direction - The company is focused on advancing its GI and microbiome-focused clinical development programs, with SYN-020 being prioritized for celiac disease and other systemic GI-related diseases [5][18]. - SYN-020 is viewed as a versatile multi-indication platform with potential applications in treating non-alcoholic fatty liver disease and metabolic disorders associated with aging [23]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the business outlook, citing significant progress in the clinical pipeline and a strong financial position to support operations through 2023 [6][29]. - The company anticipates reporting top line data from multiple clinical trials in the upcoming quarters, which are expected to enhance shareholder value [7][24]. Other Important Information - The company filed a Form S-3 to register the sale of up to $300 million worth of securities, providing flexibility for future financing opportunities [28]. - The company is keen on minimizing dilution while being funded to advance current clinical programs [28]. Q&A Session Summary Question: Impact of COVID-19 on stem cell transplants - Management noted that while there was a reduction in transplants during the height of the pandemic, systems are now in place to maintain transplant numbers close to pre-pandemic levels [34][35]. Question: Position of SYN-020 in the celiac disease market - Management clarified that SYN-020 has a different mechanism of action compared to other celiac drugs, allowing it to be used in combination with existing treatments [36][37]. Question: Expected costs for clinical studies - The first Phase 1a study for SYN-020 is estimated to cost around $1 million, while the second Phase 1a study may cost up to $1.4 million. The total cost for the SYN-004 trial is projected to be around $3 million over 18 months [38]. Question: Potential uses for cash reserves - Management indicated that they are exploring acquisition or licensing opportunities but did not provide specific details at this time [41][42].

PART I. FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Unaudited Q1 2021 financials show significant cash and asset growth from financing, shifting equity to surplus [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) By March 31, 2021, the company's financial position significantly strengthened, with cash and assets increasing and equity shifting from deficit to surplus Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2021 | December 31, 2020 | Change | | :--- | :--- | :--- | :--- | | **Assets** | | | | | Cash and cash equivalents | $76,887 | $6,227 | +$70,660 | | Total Current Assets | $78,636 | $7,934 | +$70,702 | | Total Assets | $79,054 | $8,410 | +$70,644 | | **Liabilities & Stockholders' Equity** | | | | | Total Current Liabilities | $2,122 | $2,966 | -$844 | | Total Liabilities | $2,230 | $3,152 | -$922 | | Total Stockholders' Equity (Deficit) | $76,824 | $(7,540) | +$84,364 | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Q1 2021 net loss improved due to decreased R&D, but net loss attributable to common stockholders significantly increased from non-cash deemed dividends Condensed Consolidated Statements of Operations (in thousands, except per share data) | Account | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | Change | | :--- | :--- | :--- | :--- | | General and administrative | $1,419 | $1,393 | +1.9% | | Research and development | $1,118 | $1,635 | -31.6% | | Loss from Operations | $(2,537) | $(3,028) | +16.2% | | Net Loss | $(2,537) | $(2,990) | +15.2% | | Net Loss Attributable to Common Stockholders | $(11,459) | $(3,430) | -234.1% | | Net Loss Per Share - Basic and Dilutive | $(0.13) | $(0.20) | +35.0% | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Q1 2021 saw improved operating cash flow and substantial financing inflows from stock issuances and warrant exercises, significantly boosting cash Cash Flow Summary (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Net Cash Used In Operating Activities | $(3,328) | $(4,960) | | Net Cash Used in Investing Activities | $(14) | $0 | | Net Cash Provided by Financing Activities | $74,002 | $0 | | **Net increase (decrease) in cash** | **$70,660** | **$(4,960)** | | **Cash and cash equivalents at end of period** | **$76,887** | **$10,085** | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's clinical-stage business, significant Q1 financing, preferred stock conversions, and COVID-19 risks - The company's lead clinical candidates are **SYN-004 (ribaxamase)** for preventing GI damage from antibiotics and **SYN-020 (IAP)** for treating GI and systemic diseases[27](index=27&type=chunk) - During **Q1 2021**, all outstanding shares of Series A Convertible Preferred Stock were converted into approximately **9.0 million shares** of common stock following an amendment that lowered the conversion price to **$1.50** This induced conversion resulted in a **$7.4 million deemed dividend**[90](index=90&type=chunk) - All remaining shares of Series B Preferred Stock were converted to common stock in **Q1 2021**, resulting in a **deemed dividend of $1.5 million** for the amortization of the discount upon conversion[79](index=79&type=chunk) - In **Q1 2021**, the company sold approximately **78.7 million shares** of common stock through its At Market Issuance Sales Agreement, receiving net proceeds of approximately **$66.0 million**[93](index=93&type=chunk) - During **Q1 2021**, **11,655,747 warrants** were exercised for cash proceeds of **$8.0 million**[59](index=59&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses GI therapeutic development, Q1 2021 financial performance, and improved liquidity expected to fund operations through Q1 2023 [Overview and Clinical Programs](index=24&type=section&id=Overview%20and%20Clinical%20Programs) The company is advancing lead GI candidates SYN-004 and SYN-020, with ongoing Phase 1/2 trials and anticipated data readouts - The first patient was dosed in the Phase 1b/2a clinical trial of **SYN-004** in adult HCT recipients in **Q2 2021** A data readout for the first cohort is anticipated in **Q4 2021**[119](index=119&type=chunk)[127](index=127&type=chunk) - Enrollment commenced in the Phase 1a single-ascending-dose (SAD) study of **SYN-020**, with three of four cohorts dosed Topline data is expected in **Q3 2021**[120](index=120&type=chunk)[132](index=132&type=chunk) - A Phase 1 multiple-ascending-dose (MAD) study for **SYN-020** is planned to start in **Q3 2021**, with a topline data readout anticipated in **Q1 2022**[132](index=132&type=chunk) - The company is considering future trials for **SYN-020** in **celiac disease** and **non-alcoholic fatty liver disease (NAFLD)** following the completion of Phase 1 studies[130](index=130&type=chunk)[132](index=132&type=chunk) [Results of Operations](index=34&type=section&id=Results%20of%20Operations) Q1 2021 saw increased G&A and decreased R&D due to COVID-19 delays, resulting in a significantly higher net loss attributable to common stockholders from non-cash deemed dividends Expense Comparison (in millions) | Expense Category | Q1 2021 | Q1 2020 | Change | | :--- | :--- | :--- | :--- | | General and Administrative | $1.42 | $1.39 | +2% | | Research and Development | $1.1 | $1.6 | -32% | - The **decrease in R&D expenses** was primarily due to lower indirect program costs, reduced manufacturing costs for **SYN-020**, and clinical trial delays caused by the **COVID-19 pandemic**[139](index=139&type=chunk) - Net loss attributable to common stockholders for **Q1 2021** included a **$7.4 million deemed dividend** for a Series A preferred stock price adjustment and a **$1.5 million deemed dividend** for Series B preferred stock conversions[143](index=143&type=chunk) [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20Capital%20Resources) Cash significantly improved to $76.9 million by March 31, 2021, from Q1 financing, expected to fund operations through Q1 2023, but additional funding is needed for later-stage trials - Cash and cash equivalents increased to **$76.9 million** as of **March 31, 2021**[145](index=145&type=chunk) - In **Q1 2021**, the company raised approximately **$74.0 million** from the exercise of warrants and sales of common stock in "at the market offerings"[145](index=145&type=chunk) - The current cash position is believed to be **sufficient to fund operations through at least the end of Q1 2023**[145](index=145&type=chunk)[150](index=150&type=chunk) - Future clinical trials beyond the currently planned Phase 1 and 2 studies will require **additional funding**, which is not yet secured[151](index=151&type=chunk)[163](index=163&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Market risk is limited to short-term, low-risk cash and cash equivalents, with no significant impact expected from interest rate changes - The company's primary market risk exposure is limited to its cash and cash equivalents, which are invested in **short-term treasury securities**[156](index=156&type=chunk) - The company does not engage in hedging activities against interest rate changes and does not anticipate **significant impact** from sudden changes in market interest rates[156](index=156&type=chunk) [Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of March 31, 2021, with no material changes to internal controls during the quarter - Management concluded that as of **March 31, 2021**, the company's disclosure controls and procedures were **effective**[157](index=157&type=chunk) - **No material changes** were made to the company's internal control over financial reporting during the first quarter of **2021**[158](index=158&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any legal proceedings expected to have a material adverse effect on its business, financial condition, or operating results - As of the report date, the company is not involved in any **material legal proceedings**[160](index=160&type=chunk) [Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors) Key business risks include the need for additional capital for future trials, stock price volatility, and potential stockholder dilution - The company will need to raise **additional capital** for future clinical programs beyond the currently funded trials, and failure to do so could **negatively impact business plans**[162](index=162&type=chunk)[163](index=163&type=chunk) - The company's common stock price has been and may continue to be **highly volatile**, subject to fluctuations from market conditions, clinical trial results, and other factors, including the recent trend of "**short squeezes**" affecting certain stocks[164](index=164&type=chunk)[167](index=167&type=chunk) - Future capital raises through equity offerings will likely be **dilutive to existing stockholders** The company may need to increase its authorized shares to facilitate future financing and strategic transactions[168](index=168&type=chunk)[169](index=169&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=41&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The only unregistered equity sale was 531,614 common shares issued on February 9, 2021, from Series A Preferred Stock conversion, with no Series A shares remaining - On **February 9, 2021**, the company issued **531,614 shares** of common stock upon the conversion of **4,764 shares** of Series A Convertible Preferred Stock **All Series A shares have now been converted**[171](index=171&type=chunk)

Synthetic Biologics, Inc. (SYN) Q4 2020 Earnings Conference Call March 4, 2021 4:30 PM ET Company Participants Vincent Perrone - Director, Corporate Communication Steve Shallcross - Chief Executive Officer, Chief Financial Officer, Treasurer and Secretary, Director Mike Kaleko - Senior Vice President Research and Development Vince Wacher - Head, Product and Corporate Development Conference Call Participants Jim Molloy - Alliance Global Partners Michael Okunewitch - Maxim Group Operator Good afternoon, and w ...

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, 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 Jurisdiction of Incorporation or Organization) 9605 ...