Synthetic Biologics(TOVX)

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Synthetic Biologics(TOVX) - 2024 Q1 - Quarterly Report
2024-05-07 11:10
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, 2024 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) Nevada 13 ...
Synthetic Biologics(TOVX) - 2024 Q1 - Quarterly Results
2024-05-07 11:05
Exhibit 99.1 Theriva™ Biologics Reports First Quarter 2024 Operational Highlights and Financial Results - Reported topline data from the investigator sponsored Phase 1 trial of intravitreal VCN-01 in pediatric patients with refractory retinoblastoma; trial results were determined to be positive by the study Monitoring Committee- -Presented preclinical data demonstrating the potential synergy between VCN-01 and liposomal irinotecan in a human pancreatic mouse xenograft at the ASGCT Annual Meeting; emphasizes ...
Synthetic Biologics(TOVX) - 2023 Q4 - Annual Report
2024-03-25 20:20
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, 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) Nevada 13-3808303 (State or other jurisdiction of i ...
Synthetic Biologics(TOVX) - 2023 Q4 - Earnings Call Transcript
2024-03-25 16:01
Theriva Biologics, Inc. (NYSE:TOVX) Q4 2023 Earnings Conference Call March 25, 2024 8:30 AM ET Company Participants Chris Calabrese - Investor Relations, LifeSci Advisors Steven Shallcross - Chief Executive Officer and Chief Financial Officer Manel Cascallo - General Director Vince Wacher - Head, Corporate and Product Development Conference Call Participants James Molloy - Alliance Global Partners Operator Greetings, and welcome to the Theriva Biologics Full-Year 2023 Investor Conference Call. At this time, ...
Synthetic Biologics(TOVX) - 2023 Q4 - Annual Results
2024-03-25 11:40
Exhibit 99.1 Theriva™ Biologics Reports Full-Year 2023 Operational Highlights and Financial Results – The independent data monitoring committee (IDMC) recommended the continuation of VIRAGE, the Phase 2b clinical trial of VCN- 01 in combination with chemotherapy for metastatic Pancreatic Ductal Adenocarcinoma (PDAC), with no safety concerns raised - - VIRAGE remains on track to complete enrollment in the first half of 2024- - As of December 31, 2023, Theriva Biologics reports $23.2 million in cash, which is ...
Synthetic Biologics(TOVX) - 2023 Q3 - Earnings Call Transcript
2023-11-17 17:51
Theriva Biologics, Inc. (NYSE:TOVX) Q3 2023 Results Conference Call November 13, 2023 8:30 AM ET Company Participants Steve Shallcross - Chief Executive and CFO Dr. Manel Cascalló - General Director, European Subsidiary Dr. Vince Wacher - Head, Corporate and Product Development Conference Call Participants James Molloy - Alliance Global Partners Operator Greetings, and welcome to the Theriva Biologics, Inc. 2023 Third Quarter Operational Highlights and Financial Results. [Operator Instructions] As a reminde ...
Synthetic Biologics(TOVX) - 2023 Q3 - Quarterly Report
2023-11-13 13:15
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 ...
Synthetic Biologics(TOVX) - 2023 Q2 - Earnings Call Transcript
2023-08-12 17:52
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]
Synthetic Biologics(TOVX) - 2023 Q2 - Quarterly Report
2023-08-08 13:03
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 ...
Synthetic Biologics(TOVX) - 2023 Q1 - Quarterly Report
2023-05-11 12:15
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 ...