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 September 30, 2022 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 THERIVA BIOLOGICS, INC. (Exact name of Registrant as Specified in Its Charter) Nevad ...

Synthetic Biologics, Inc. (SYN) Q2 2022 Earnings Conference Call August 11, 2022 8:30 AM ET Company Participants Chris Calabrese - Investor Relations Steven Shallcross - Chief Executive & Chief Financial Officer Manel Cascallo - General Director of VCN & European Operations Conference Call Participants Laura Suriel - Alliance Global Partners Michael Okunewitch - Maxim Group Operator Good day, and welcome to the Synthetic Biologics' Second Quarter 2022 Earnings Call. Today's conference is being recorded. And ...

Part I [Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The company reported a **net loss of $5.0 million** for Q2 2022, with cash decreasing to **$52.3 million** due to the VCN acquisition and operations, and a 1-for-10 reverse stock split effective July 25, 2022 Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2022 | December 31, 2021 | Change | | :--- | :--- | :--- | :--- | | Cash and cash equivalents | $52,266 | $67,325 | ($15,059) | | In-process research and development | $20,562 | $0 | +$20,562 | | Goodwill | $5,185 | $0 | +$5,185 | | Total Assets | $82,331 | $70,365 | +$11,966 | | Total Liabilities | $20,657 | $4,957 | +$15,700 | | Total Stockholders' Equity | $61,674 | $65,408 | ($3,734) | Condensed Consolidated Statements of Operations (in thousands, except per share data) | Metric | Q2 2022 | Q2 2021 | H1 2022 | H1 2021 | | :--- | :--- | :--- | :--- | :--- | | General and administrative | $1,500 | $1,265 | $3,155 | $2,685 | | Research and development | $3,485 | $1,932 | $6,082 | $3,049 | | Loss from Operations | ($4,985) | ($3,197) | ($9,237) | ($5,734) | | Net Loss Attributable to Common Stockholders | ($4,968) | ($3,195) | ($9,241) | ($14,654) | | Net Loss Per Share | ($0.31) | ($0.24) | ($0.62) | ($1.31) | Condensed Consolidated Statements of Cash Flows Highlights (Six Months Ended June 30, in thousands) | Cash Flow Activity | 2022 | 2021 | | :--- | :--- | :--- | | Net Cash Used In Operating Activities | ($9,258) | ($5,924) | | Net Cash Used in Investing Activities | ($4,294) | ($14) | | Net Cash Provided (used in) by Financing Activities | ($1,376) | $74,002 | | Net (decrease) increase in cash | ($14,963) | $68,064 | - On March 10, 2022, the company acquired VCN Biosciences for total consideration of approximately **$23.9 million**, consisting of **$4.7 million** in cash, **$6.6 million** in common stock, and **$12.2 million** in fair value of contingent consideration[46](index=46&type=chunk)[48](index=48&type=chunk) - A 1-for-10 reverse stock split was effective on July 25, 2022, reducing outstanding shares from **158.4 million** to **15.8 million**, with all share and per-share amounts in the financial statements retrospectively adjusted[29](index=29&type=chunk)[30](index=30&type=chunk)[31](index=31&type=chunk) - Subsequent to the quarter end, in July 2022, the company closed a private placement of Series C and D Preferred Stock for gross proceeds of approximately **$3.0 million**[142](index=142&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company is transitioning its strategic focus to oncology post-VCN acquisition, with **R&D expenses increasing 80%** and a **net loss of $5.0 million** for Q2 2022, while management believes its **$52.3 million cash position** is sufficient for the next twelve months - The company is shifting its strategic focus to oncology following the acquisition of VCN Biosciences and is exploring value creation options for its legacy GI assets, SYN-004 and SYN-020[147](index=147&type=chunk)[148](index=148&type=chunk) Product Pipeline Status | Candidate | Target Indication | Status* | | :--- | :--- | :--- | | **VCN-01** | Pancreatic Cancer (IV) | Protocol submitted for regulatory review | | | Retinoblastoma (IVit) | Developing Ph 2/3 Protocol (ODD US & EU) | | | HNSCC (IV) + CPI | Treatment Complete, in Follow-up Period | | **SYN-004** | Prevention of aGVHD in allo-HCT | Cohort 1 Topline Data expected Q4'22 | | **SYN-020** | Celiac, NAFLD/NASH, etc. | MAD Study Topline Data reported Q2'22 | | **VCN-11** | Solid tumors (IV) | Preclinical studies ongoing | *Based on management's current beliefs and expectations Comparison of Operating Expenses (Three Months Ended June 30, in thousands) | Expense Category | 2022 | 2021 | % Change | | :--- | :--- | :--- | :--- | | General and administrative | $1,500 | $1,265 | 19% | | Research and development | $3,485 | $1,932 | 80% | Comparison of Operating Expenses (Six Months Ended June 30, in thousands) | Expense Category | 2022 | 2021 | % Change | | :--- | :--- | :--- | :--- | | General and administrative | $3,155 | $2,685 | 18% | | Research and development | $6,082 | $3,049 | 99% | - The company believes its cash and cash equivalents of **$52.3 million** as of June 30, 2022, are sufficient to fund operations through the next twelve months, including a commitment to fund VCN's R&D programs with approximately **$27.8 million** over the next three years[219](index=219&type=chunk)[238](index=238&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=45&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's market risk is limited to cash and cash equivalents held in low-risk money market instruments, with no significant impact expected from interest rate changes - The company's primary market risk is confined to its cash and cash equivalents, which consist mainly of money market instruments, and management does not expect significant effects from changes in market interest rates due to their short-term and low-risk nature[230](index=230&type=chunk) [Controls and Procedures](index=46&type=section&id=Item%204.%20Controls%20and%20Procedures) Management identified a material weakness in internal controls over financial reporting related to non-routine transactions, leading to the CEO's conclusion that disclosure controls were ineffective as of June 30, 2022 - A material weakness was identified in controls related to the accounting and disclosure for non-routine transactions, specifically concerning the review of reports and related income tax implications[233](index=233&type=chunk) - Due to the identified material weakness, the CEO concluded that disclosure controls and procedures were not effective as of June 30, 2022[232](index=232&type=chunk) - The company is integrating VCN's operations into its system of internal control but will exclude VCN from its assessment of internal control over financial reporting for the year ending December 31, 2022, as permitted by the SEC[234](index=234&type=chunk) Part II [Legal Proceedings](index=46&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings expected to have a material adverse effect on its business or financial condition - As of the report date, the company is not involved in any legal proceedings that would materially and adversely affect its business or financial condition[236](index=236&type=chunk) [Risk Factors](index=47&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including the need for additional capital, potential stockholder dilution due to limited authorized shares, and a previously disclosed material weakness in internal controls over financial reporting - The company will need to raise additional capital to fund its operations, including a commitment of approximately **$27.8 million** over three years for VCN's R&D programs, and failure to obtain funding could force delays or elimination of development programs[238](index=238&type=chunk) - A limited number of authorized and unissued shares of common stock (**2.9 million** available after accounting for outstanding convertible securities) may be insufficient for future equity financing or strategic transactions[240](index=240&type=chunk)[243](index=243&type=chunk) - A material weakness in internal controls over financial reporting related to non-routine transactions was identified, and there is no assurance it will be effectively remediated or that others will not occur[245](index=245&type=chunk)[246](index=246&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=49&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities occurred during the quarter ended June 30, 2022, beyond previously disclosed SEC filings [Defaults Upon Senior Securities](index=49&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section is not applicable [Mine Safety Disclosures](index=49&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable [Other Information](index=49&type=section&id=Item%205.%20Other%20Information) On August 9, 2022, the company amended its Securities Purchase Agreement for Series C and D preferred stock to limit voting rights, ensuring compliance with NYSE American rules - To comply with NYSE American rules, the company amended the SPA for its Series C and D preferred stock on August 9, 2022, to cap the number of votes the holder is entitled to cast[251](index=251&type=chunk) [Exhibits](index=49&type=section&id=Item%206.%20Exhibits) This section provides an index of exhibits filed or furnished as part of the Quarterly Report on Form 10-Q

Synthetic Biologics, Inc. (SYN) Q1 2022 Earnings Conference Call May 16, 2022 9:00 AM ET Company Participants Dean Schwartz - LifeSci Advisors, IR Steven Shallcross - CEO and CFO Manel Cascallo - General Director of VCN & European Operations Conference Call Participants Jim Molloy - Alliance Global Partners Leland Gershell - Oppenheimer Operator Greetings, and welcome to Synthetic Biologics' First Quarter 2022 Earnings Conference Call. At this time all participants are in a listen-only mode. A question-and- ...

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 March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934 Commission File Number: 001-12584 SYNTHETIC BIOLOGICS, INC. (Exact name of Registrant as Specified in Its Charter) Nevada ...

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]