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, 2023 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 ...

Financial Data and Key Metrics Changes - General and administrative expenses increased to $2.7 million for Q2 2023, up 80% from $1.5 million in Q2 2022, primarily due to higher audit fees and consulting expenses [17] - Research and development expenses decreased to $3.1 million for Q2 2023, down from approximately $3.5 million in Q2 2022 [17] - Cash and cash equivalents totaled $34.2 million as of June 30, 2023, compared to $41.8 million as of December 31, 2022 [18] Business Line Data and Key Metrics Changes - The company is focused on its lead clinical candidate, VCN-01, which is being evaluated in multiple trials, including the VIRAGE trial for pancreatic ductal adenocarcinoma (PDAC) [4][11] - Enrollment is accelerating in the VIRAGE trial, which is evaluating VCN-01 in combination with standard chemotherapy [4][13] Market Data and Key Metrics Changes - The company is exploring the use of VCN-01 in various solid tumors, including ovarian cancer and head and neck cancer, with ongoing trials showing promising initial data [7][12] - The upcoming ESMO Congress will present survival data from the ongoing Phase I study, providing insights into the feasibility of combining VCN-01 with immune checkpoint inhibitors [7][34] Company Strategy and Development Direction - The strategic focus is on leveraging VCN-01's potential to enhance chemotherapy and immunotherapy outcomes in hard-to-treat cancers [4][11] - The company plans to meet with the FDA to discuss the development pathway for VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma [12][34] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical programs and the potential of VCN-01 to address urgent treatment needs in oncology [31][37] - The company remains committed to expanding its pipeline and enhancing shareholder value through strategic opportunities [50] Other Important Information - The company appointed Dr. Ramon Alemany as Senior Vice President of Discovery, enhancing its discovery and development pipeline [16] - The VIRAGE trial is expected to complete enrollment by the first quarter of 2024, with primary endpoints focused on overall survival and safety [34][37] Q&A Session Summary Question: When should we anticipate interim looks for the ongoing ISTs? - Management indicated that the UPenn study is ongoing without a set deadline, but they are encouraged by the data presented so far [20][21] Question: What is the timeline for the VIRAGE trial and when can we expect top-line data? - The primary endpoint is overall survival, with data expected to present itself in 2025, while secondary endpoints may provide indications as early as the end of this year [24][25] Question: Is the IND for VCN-11 on track for the third quarter? - Management confirmed that they are actively working on VCN-11 but do not have a formal deadline for this year [47] Question: What is the potential for partnerships regarding SYN-004 and SYN-020? - Management stated that there is a realistic expectation for potential partnerships, but discussions are ongoing without commitments yet [48][50]

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, 2023 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) Securities ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Nevada 13-3808303 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, 2023 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 ...

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, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934 For the transition period from to Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock TOVX NYSE A ...

Corporate Overview December 2022 Forward Looking Statements This presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward- looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions, and include statements regarding the potential of VCN-01 and its ability to overcome key oncolytic vi ...

Theriva Biologics (NYSE:TOVX) Q3 2022 Earnings Conference Call November 10, 2022 8:30 AM ET Company Participants Chris Calabrese - Investor Relations Steven Shallcross - Chief Executive and Chief Financial Officer Manel Cascalló - General Director, Theriva Biologics Europe Frank Tufaro - Chief Operating Officer Vince Wacher - Head, Corporate and Product Development Conference Call Participants Jim Molloy - Alliance Global Partners Operator Good day and welcome to the Theriva Biologics formerly Synthetic Bio ...

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