Anophthalmia With Pulmonary Hypoplasia

CARLSBAD, Calif., Aug. 17, 2023 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (Nasdaq: QLGN), a clinical-stage therapeutics company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, announced today it is partnering with Translational Drug Development (TD2) as the contract research organization (CRO) to conduct the Phase 1 clinical development of lead drug candidate QN-302. Qualigen received US FDA IND clearance earlier this month to initiate a Phase 1 clinical trial of QN-302, a small molecule G-Quadruplex (G4)-selective transcription inhibitor, for the treatment of advanced or metastatic solid tumors. Tariq Arshad, M.D., M.B.A., Chief Medical Officer, stated: “I am delighted that the FDA has cleared QN-302 to enter the clinic for the proposed Phase 1 clinical trial in patients with advanced or metastatic patients with solid tumors. This furthers our ongoing investigation of a potentially exciting new therapeutic approach for this group of cancer patients with high unmet medical need along with our assessment of corresponding biomarkers relevant to G4 expression. TD2, our CRO partner, has been instrumental in bringing us to this point. Their demonstrated ability to meet critical timelines within budget reinforces its status as an industry leader in preclinical and clinical oncology drug development, maximizing the opportunity for QN-302 to reach the patients who need it the most.” TD2 is a precision oncology drug development organization integrating preclinical, clinical, and regulatory expertise and providing expert drug development services, including the design and execution of oncology clinical trials. TD2 has a proven track record of obtaining IND clearances and managing complex trial designs, including recruitment for Orphan diseases, to accomplish first patient dosing as quickly as possible. “The successful IND filing of QN-302 is the result of a strong partnership and shared dedication between Qualigen and TD2 to advance cancer therapeutics into patients who may have run out of options," said Stephen Gately, Ph.D., President and CEO of TD2. "We appreciate the chance to work with Qualigen on this exciting development program and look forward to the upcoming clinical data.” Qualigen Therapeutics secured exclusive worldwide rights to QN-302 in January 2022 from University College London (UCL). QN-302 was invented and developed by Professor Stephen Neidle and his team from the UCL School of Pharmacy, one of the top ten pharmacy and pharmacology research institutions in the world. Professor Neidle has a distinguished 30+ year history in nucleic acid research and drug design with over 500 published papers and 14 patents and has been a member of Qualigen’s QN-302 Scientific Advisory Board since February 2022. Professor Neidle stated, “I’m delighted that our novel experimental drug QN-302 is at this very exciting stage of now having FDA clearance for clinical evaluation. We are so pleased that Qualigen has not only shared our vision but has taken QN-302 with remarkable skill and speed to this important milestone. I am proud that we have long been a pioneer of the quadruplex targeting concept and now look forward to the clinical development of QN-302.” Qualigen plans to initiate activation of the first Phase 1 clinical trial site and enroll the first patient in the Phase 1 dose escalation clinical study later this year. Qualigen will enroll patients with advanced or metastatic solid tumors who have failed prior therapy. About QN-302 QN-302 is a small molecule G-Quadruplex (G4)-selective transcription inhibitor in Phase 1 clinical development for the treatment of G4-expressing solid tumors, such as pancreatic cancer (PDAC), prostate cancer, sarcomas, and others. QN-302 stabilizes G4 complexes prevalent in the promoter region of oncogenes in many tumor types, impeding transcription of G4-containing cancer genes and may potentially offer a tumor-agnostic clinical approach to treatment. Orphan Drug Designation (ODD) was granted by the FDA in January of this year for QN-302 for the intended indication of pancreatic cancer. About Qualigen Therapeutics, Inc. Qualigen Therapeutics, Inc. is a clinical-stage therapeutics company focused on developing treatments for adult and pediatric cancer. Our investigational QN-302 compound is a small molecule selective transcription inhibitor with strong binding affinity to G4s prevalent in cancer cells; such binding could, by stabilizing the G4s against “unwinding,” help inhibit cancer cell proliferation. The investigational compounds within Qualigen’s family of Pan-RAS oncogene protein-protein interaction inhibitor small molecules are believed to inhibit or block the binding of mutated RAS genes’ proteins to their effector proteins, thereby leaving the proteins from the mutated RAS unable to cause further harm. In theory, such mechanism of action may be effective in the treatment of about one quarter of all cancers, including certain forms of pancreatic, colorectal, and lung cancers. About Translational Drug Development (TD2) TD2 is a leader in precision oncology, providing innovative services for improved drug development. Using a dedicated, expert team with broad experience and understanding in cancer medicine, TD2 is uniquely positioned to support accelerated development of novel therapeutics. Rigorous and high-throughput translational preclinical development services, combined with regulatory affairs expertise, enables customized clinical trial design and execution. Our broad suite of capabilities encourages the timely selection of patient populations who are most likely to benefit from a new agent, and the rapid identification of clinically significant endpoints. TD2 is committed to reducing the risks and uncertainty inherent in the drug development process with the ultimate goal of accelerating patient access to promising treatments. For more information, visit www.TD2inc.com. Forward-Looking Statements This news release contains forward-looking statements by Qualigen that involve risks and uncertainties and reflect the Company's judgment as of the date of this release. These statements include those related to the Company's prospects and strategy for development of its therapeutic drug candidates, including the anticipated timeline for initiating the Company’s Phase 1 clinical trial and enrolling and dosing of patients and the identification of a late in vivo candidate. Actual events or results may differ from the Company's expectations. There can be no assurance that the Company will be able to successfully develop any drugs (including QN-302, Pan-RAS and QN-247); that preclinical development of the Company's drugs (including Pan-RAS and QN-247) will be completed on any projected timeline or will be successful; that any clinical trials will be approved to begin by or will proceed as contemplated by any projected timeline, or at all; that any future clinical trial data will be favorable or that such trials will confirm any improvements over other products or lack negative impacts; that any drugs will receive required regulatory approvals (or Fast Track designation or Orphan Drug status) or that they will be commercially successful; that patents will issue on the Company's owned and in-licensed patent applications; that such patents, if any, and the Company's currently owned and in-licensed patents would prevent competition; or that the Company will be able to procure or earn sufficient working capital to complete the development, testing and launch of the Company's prospective therapeutic products (including QN-302, Pan-RAS and QN-247). The Company's stock price could be harmed if any of the events or trends contemplated by the forward-looking statements fail to occur or is delayed or if any actual future event otherwise differs from expectations. Additional information concerning these and other risk factors affecting the Company's business can be found in the Company's prior filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K, all of which are available at www.sec.gov. The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this news release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. For more information about Qualigen Therapeutics, Inc., please visit www.qlgntx.com. Contact:Investor Relations760-530-6487ir@qlgntx.com. Source: Qualigen Therapeutics, Inc.

Phase 2 data from randomized BRACELET-1 trial in HR+/HER2- metastatic breast cancer showed a near tripling of confirmed ORR, >50% improvement in PFS, and 71% reduction in risk of disease progression Pelareorep selected for inclusion in the Precision PromiseSM phase 3 platform trial in pancreatic cancer, designed to accelerate registration path and reduce by ~50% phase 3 costs compared to traditional trial $24.4 million in cash, cash equivalents and marketable securities as of June 30, 2023 provides projected runway into H2 2024 Strengthened financial position with a successful US$15 million public offering on August 8, 2023 Management hosting conference call and webcast today at 8:30 a.m. ET SAN DIEGO and CALGARY, AB, Aug. 14, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced recent operational highlights and financial results for the second quarter ended June 30, 2023. All dollar amounts are expressed in Canadian currency unless otherwise noted. "Our core programs in pancreatic and breast cancer are both progressing rapidly towards registrational studies on the back of the impressive clinical data showing the potential of pelareorep as a backbone immunotherapy," said Dr. Matt Coffey, President and Chief Executive Officer. "Data reported at the American Society of Clinical Oncology (ASCO) Annual Meeting from our BRACELET-1 randomized phase 2 trial demonstrated robust improvements in objective response rate (ORR) and progression-free survival (PFS) with a hazard ratio of 0.29 (95% CI: 0.09, 0.98). This has unlocked the potential for including PFS as a dual endpoint in our registrational trial, which could considerably reduce the time to a pivotal readout. At the same time, pelareorep was selected for inclusion in the ongoing Precision Promise pancreatic cancer platform trial. Precision Promise, created by the Pancreatic Cancer Action Network, provides us with the opportunity to reduce the time and costs needed for a potential approval, and we are honored to have been selected for participation in this novel and exclusive trial." Second Quarter and Subsequent Highlights Breast Cancer Program BRACELET-1 data demonstrated a >50% improvement in progression-free survival and a nearly three-fold increase in confirmed overall response rate An oral presentation at the ASCO Annual Meeting featured results from a randomized trial of pelareorep in HR+/HER2- metastatic breast cancer. As of a March 3, 2023 cut-off date, BRACELET-1 data in the paclitaxel plus pelareorep cohort showed median PFS of 9.5 months, compared to 6.3 months in the paclitaxel monotherapy cohort. This resulted in a hazard ratio of 0.29 (95% CI: 0.09, 0.98), indicating the pelareorep-paclitaxel combination reduced the risk of disease progression by 71%. Confirmed ORR in these cohorts was 37.5% for paclitaxel plus pelareorep and 13.3% for paclitaxel. Overall survival data continues to mature as several patients are still on study. With these data, the HR+/HER2- metastatic breast cancer program is now phase 3-ready, and, with two randomized phase 2 trials showing meaningful benefits to patients, the focus is now on progressing to a registrational trial evaluating pelareorep-paclitaxel compared to paclitaxel alone. Oncolytics hosted a key opinion leader (KOL) webinar on June 5, 2023 where breast cancer experts and the management team discussed recent data from the BRACELET-1 study. A link to the replay is available by clicking here. Pancreatic Cancer Program Pelareorep selected for inclusion in Precision Promise Pivotal Phase 3 Platform Trial Pelareorep has been selected for inclusion as a new investigational treatment in Precision Promise. Created by the Pancreatic Cancer Action Network (PanCAN), Precision Promise is an innovative adaptive phase 3 clinical trial designed to streamline registration pathways for promising pancreatic cancer therapies. Inclusion is expected to accelerate the registrational pathway and reduce by half the phase 3 costs compared to a traditional trial. The study is designed to evaluate pelareorep in combination with a checkpoint inhibitor and the chemotherapeutic agents gemcitabine and nab-paclitaxel in comparison to gemcitabine and nab-paclitaxel standard of care therapy. This clinical study is expected to support the approval of the pelareorep combination therapy as a treatment for first-line metastatic pancreatic ductal adenocarcinoma. Additional Immunotherapeutic Opportunity Preclinical pelareorep-chimeric antigen receptor (CAR) T cell therapy combination program A poster presentation at ASCO showed preclinical results of pelareorep synergistically enhancing CAR T cell therapy efficacy in murine solid tumor models (link to the poster). The results suggest pelareorep could substantially expand the commercial potential of CAR T cell therapy beyond hematologic malignancies to include solid tumors, which represent the vast majority of cancer cases. Oncolytics is currently advancing preclinical research collaborations evaluating pelareorep-CAR T cell combination therapies. Financial Highlights As of June 30, 2023, the Company reported $24.4 million in cash, cash equivalents, and marketable securities, then successfully closed a US$15 million public offering on August 8, 2023. On a pro forma basis, including the estimated US$13.6 million in net proceeds from the public offering, the Company's cash, cash equivalents and marketable securities would have been approximately $42.7 million. The net loss for the second quarter of 2023 was $7.4 million, compared to a net loss of $5.1 million for the second quarter of 2022. The basic and diluted loss per share was $0.12 in the second quarter of 2023, compared to a basic and diluted loss per share of $0.09 in the second quarter of 2022. Net cash used in operating activities for the six months ended June 30, 2023 was $16.3 million, compared to $13.2 million for the six months ended June 30, 2022. The change reflected higher net operating activities and non-cash working capital changes. General and administrative expenses for the second quarter of 2023 were $3.5 million, compared to $2.8 million for the second quarter of 2022. The increase was primarily due to higher investor relations activities and annual general meeting of shareholders costs. Research and development expenses for the second quarter of 2023 were $3.7 million, compared to $3.2 million for the second quarter of 2022. The increase was primarily due to higher manufacturing expenses associated with an engineering production run along with process and analytical development activities and higher personnel-related expenses. The increase was partly offset by lower BRACELET-1 study costs. Anticipated Milestones and Catalysts Updated GOBLET study data in advanced/metastatic pancreatic ductal adenocarcinoma (PDAC): H2 2023 Update on GOBLET study's metastatic colorectal and anal cancer cohorts: H2 2023 Guidance on both the HR+/HER2- metastatic breast cancer and advanced/metastatic PDAC registration paths: H2 2023 BRACELET-1 phase 2 metastatic breast cancer study overall survival data Webcast and Conference Call Management will host a conference call for analysts and investors at 8:30 a.m. ET today, August 14, 2023. To access the call, please dial (888) 664-6383 (North America) or (416) 764-8650 (International) and, if needed, provide confirmation number 5411-4798. To join the conference call without operator assistance, please click here. A live webcast of the call will also be available by clicking here or on the Investor Relations page of Oncolytics' website (LINK) and will be archived for three months. A dial-in replay will be available for one week and can be accessed by dialing (888) 390-0541 (North America) or (416) 764-8677 (International) and using replay code: 114-798#. ONCOLYTICS BIOTECH INC. CONDENSED INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION (unaudited) (in thousands of Canadian dollars, except share amounts) ONCOLYTICS BIOTECH INC. CONDENSED INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS (unaudited) (in thousands of Canadian dollars, except share amounts) ONCOLYTICS BIOTECH INC. CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY (unaudited) (in thousands of Canadian dollars) ONCOLYTICS BIOTECH INC. CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) (in thousands of Canadian dollars) About the Pancreatic Cancer Action Network The Pancreatic Cancer Action Network (PanCAN) leads the way in accelerating critical progress for pancreatic cancer patients. PanCAN takes bold action by funding life-saving research, providing personalized patient services and creating a community of supporters and volunteers who will stop at nothing to create a world in which all pancreatic cancer patients will thrive. For 18 years in a row, PanCAN has earned a Four-Star Rating from Charity Navigator – the highest rating an organization can receive. This rating designates PanCAN as an official "Give with Confidence" charity, indicating strong financial health, ongoing accountability and transparency. About Oncolytics Biotech Inc. Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: . This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential and benefits of pelareorep as a cancer therapeutic; our belief that our core programs in pancreatic and breast cancer are both progressing rapidly towards registrational studies; our belief that recent data has unlocked the potential for including PFS as a dual endpoint in our registrational trial, which could considerably reduce the time to a pivotal readout; our plans and expectations regarding the inclusion of pelareorep in the Precision Promise pancreatic cancer platform trial; our anticipated milestones and catalysts; our plans to advance towards a registrational study in metastatic breast cancer and pancreatic cancer; our belief that our combined cash resources provide a runway into H2 2024; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws. Logo: SOURCE Oncolytics Biotech® Inc.

- Initiated dosing at U.S. sites for VIRAGE, the Phase 2b clinical trial of VCN-01 in combination with chemotherapy for Pancreatic Ductal Adenocarcinoma -Second doses of intravenous VCN-01 administered to patients in Spain and were well tolerated with a safety pro with prior clinical trials - -VIRAGE remains on track to complete enrollment in the first quarter of 2024- - VCN-01 granted Orphan Drug Designation by the U.S. FDA for the treatment of pancreatic cancer – - Ramon Alemany, Ph.D., appointed as Senior Vice President of Discovery, strengthening the collaboration with the Institut Catala d’Oncologia (ICO) and the Biomedical Research Institute of Bellvitge (IDIBELL)- -As of June 30, 2023, Theriva Biologics reports $34.2 million in cash, which is expected to provide runway into the fourth quarter of 2024- -Conference call and webcast to be held on Tuesday, August 8th at 8:30 a.m. ET - ROCKVILLE, Md., Aug. 08, 2023 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today reported financial results for the second quarter ended June 30, 2023, and provided a corporate update. “We are pleased by the continued progress in the first half of 2023 and look forward to executing on key priorities for our a systemically administered oncolytic adenovirus and lead program, VCN-01, in key indications and therapeutic combinations,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. “Notably, we have initiated dosing at U.S. sites for VIRAGE, the Phase 2b trial of VCN-01 in patients with newly-diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC). Dosing in Spain initiated in January 2023 and the first patients have now received their second doses of intravenous VCN-01, which were well tolerated with safety pro with prior clinical trials. VIRAGE remains on track to complete enrollment in the first quarter of 2024. Reaching this critical milestone adds to the strong momentum for the trial and we are further encouraged by the FDA’s decision to grant orphan drug designation to VCN-01 for patients with pancreatic cancer, for which there is an urgent need for new treatment options.” Mr. Shallcross continued, “We are encouraged by the growing clinical data that underscores VCN-01’s multi-modal mechanism of action, alone or in combination with chemotherapy and immunotherapy products. At the upcoming annual ESMO Congress in Madrid, investigators will present survival data from the ongoing study of VCN-01 in combination with durvalumab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck, which will provide the first clinical insights into the feasibility of combining VCN-01 with an immune checkpoint inhibitor. These results build on the impressive safety, biochemical and mechanistic data presented last year, demonstrating that VCN-01 improved tumor immunogenicity in previously immunotherapy refractory patients. In parallel, we look forward to upcoming discussions with regulatory agencies planned in the second half of 2023 to discuss the development pathway for VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma. Further, as we continue to explore the potentially broad synergistic clinical benefit of VCN-01, we remain committed to pursuing new oncolytic virus candidates to leverage our novel Albumin Shield technology, which has tremendous potential for our pipeline.” Recent Program Highlights and Anticipated Milestones: VCN-01: Dosing is underway and enrollment continues to progress for VIRAGE, the randomized, controlled, multicenter, open-label Phase 2b trial of VCN-01 in combination with standard-of-care chemotherapy (gemcitabine/nab-paclitaxel) as a first line therapy in newly diagnosed metastatic PDAC patients. Initiated dosing at U.S sites following the initiation of dosing in Spain in January 2023. The first patients in Spain have now received their second doses of intravenous VCN-01, which were well tolerated with safety pro with prior clinical trials. The trial is expected to enroll 92 patients and, remains on track to complete enrollment (Q1 2024). The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to VCN-01 for the treatment of pancreatic cancer. Previously, the FDA granted orphan drug designation to VCN-01 for treatment of retinoblastoma. The University of Pennsylvania presented initial data from two ovarian cancer patients and one pancreatic cancer patient in their investigator sponsored study combining VCN-01 with huCART-meso cells. The presentation at the Cellicon Valley conference on Thursday 22 June 2023 demonstrated the feasibility of administering VCN-01 with huCART-meso cells and provided evidence of persistence for both VCN-01 and CAR T-cells, supporting the potential opportunity for VCN-01 in combination with immunotherapy products to treat solid tumors. Dosing is underway and screening is on-going for the investigator sponsored clinical trial of VCN-01 in patients with high-grade brain tumors who are scheduled for surgical resection. The first patient was dosed in January 2023 and the trial is being conducted at St. James’s University Hospital, United Kingdom, in collaboration with the University of Leeds. If the results show that intravenous VCN-01 gains entry to brain tumors that are otherwise only accessible through surgery, this could be transformative for patients by providing a potential systemic line of treatment. Additional anticipated milestones: Presentation of data from a Phase 1 investigator-sponsored study evaluating VCN-01 in combination with durvalumab for patients with recurrent/ metastatic squamous cell carcinoma of the head and neck (R/M HNSCC) at the ESMO Congress being held in Madrid, Spain from October 20-24, 2023. The Company intends to meet with the FDA (H2 2023) to discuss the clinical development and potential registration pathway for VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma. SYN-004 (ribaxamase): Dosing is underway for the ongoing Phase 1b/2a randomized, double-blinded, placebo-controlled clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients for the prevention of acute graft-versus-host-disease (aGVHD). SYN-004 appeared to be well tolerated in HCT patients treated with IV meropenem and SYN-004 was not detected in blood samples from the majority of the evaluable patients. The trial is on track to complete the second cohort (Q1 2024) Corporate Updates: In May 2023, appointed Ramon Alemany, Ph.D., to Senior Vice President of Discovery. In addition to overseeing Theriva’s discovery and development pipeline, Dr. Alemany continues to serve as Chair of the Scientific Advisory Board. Dr. Alemany is Head of the Immunotherapy and Virotherapy Group at the ProCURE Program of the Catalan Insitute of Oncology (ICO) and the Oncobell Program of the Biomedical Research Institute of Bellvitge (IDIBELL). Dr. Alemany’s laboratory has developed unique oncolytic adenoviruses that are highly selective for replication in tumor cells, with modifications for tumor-targeting, tumor stroma degradation, evasion of neutralizing antibodies, and promotion of tumor immunogenicity. Second Quarter Ended June 30, 2023 Financial Results General and administrative expenses increased to $2.7 million for the three months ended June 30, 2023, from $1.5 million for the three months ended June 30, 2022. This increase of 80% is primarily comprised of increased expense related to the fair value of the contingent consideration adjustment of $0.9 million, along with higher audit fees, consulting fees, travel, and VCN administrative expenses not included in the prior year, offset by a decrease in legal costs related to the VCN acquisition. The charge related to stock-based compensation expense was $106,000 for the three months ended June 30,2023, compared to $86,000 for the three months ended June 30, 2022. Research and development expenses decreased to $3.1 million for the three months ended June 30, 2023, from approximately $3.5 million for the three months ended June 30, 2022. This decrease of 10% is primarily the result of lower expenses related to our Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients Phase 1a clinical trial of SYN-020, and decreased manufacturing expenses related to our Phase 1a clinical trial of SYN-020, offset by increased clinical trial expenses related to VCN-01. We anticipate research and development expense to increase as we continue enrollment in our VIRAGE Phase 2 clinical trial of VCN-01 in PDAC, and our ongoing Phase 1 clinical trial in retinoblastoma, expand GMP manufacturing activities for VCN-01, and continue supporting our VCN-11 and other preclinical and discovery initiatives. The charge related to stock-based compensation expense was $40,000 for the three months ended June 30, 2023, compared to $27,000 related to stock-based compensation expense for the three months ended June 30, 2022. Other income was $377,000 for the three months ended June 30, 2023 compared to other expense of $17,000 for the three months ended June 30, 2022. Other income for the three months ended June 30, 2023 is primarily comprised of interest income of $381,000 and exchange loss of $4,000. Other income for the three months ended June 30, 2022 is primarily comprised of interest income of $26,000 offset by an exchange loss of $9,000. Cash and cash equivalents totaled $34.2 million as of June 30, 2023, compared to $41.8 million as of December 31, 2022. Conference Call Theriva Biologics will host a conference call on Tuesday, August 8, 2023, at 8:30 a.m. ET to discuss its financial results for the quarter ended June 30, 2023 and provide a corporate update. Individuals may participate in the live call via telephone by dialing 1-877-451-6152 (domestic) or 1-201-389-0879 (international) and using the conference ID: 13739888. Participants are asked to dial in 15 minutes before the start of the call to register. Investors and the public can access the live and archived webcast of this call via the “News & Media” section of the company’s website, , under “Events” or by clicking here, up to 90 days after the call. About Theriva™ Biologics, Inc. Theriva™ Biologics (NYSE American: TOVX), is a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need. The Company is advancing a new oncolytic adenovirus platform designed for intravenous (IV), intravitreal and antitumoral delivery to trigger tumor cell death, improve access of co-administered cancer therapies to the tumor, and promote a robust and sustained anti-tumor response by the patient’s immune system. The Company’s lead candidates are: (1) VCN-01, an oncolytic adenovirus designed to replicate selectively and aggressively within tumor cells, and to degrade the tumor stroma barrier that serves as a significant physical and immunosuppressive barrier to cancer treatment; (2) SYN-004 (ribaxamase) which is designed to degrade certain commonly used IV beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent microbiome damage, thereby limiting overgrowth of pathogenic organisms such as VRE (vancomycin resistant Enterococci) and reducing the incidence and severity of acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients; and (3) SYN-020, a recombinant oral formulation of the enzyme intestinal alkaline phosphatase (IAP) produced under cGMP conditions and intended to treat both local GI and systemic diseases. For more information, please visit Theriva Biologics' website at . Forward-Looking Statement This release contains 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 VIRAGE remaining on track to complete enrollment in the first quarter of 2024, upcoming discussions with regulatory agencies planned in the second half of 2023 to discuss the development pathway for VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma, the broad synergistic clinical benefit of VCN-01, the expected enrollment of 92 patients in the VIRAGE trial, the opportunity for VCN-01 in combination with immunotherapy products to treat solid tumors, VCN-01 being transformative for patients by providing a potential systemic line of treatment, the SYN-004 trial being on track to complete the second cohort (Q1 2024). and cash being expected to provide runway into the fourth quarter of 2024,. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are subject to a number of risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s and VCN’s ability to reach clinical milestones when anticipated, including completion of enrollment in Virage in the first quarter of 2024 and completing the SYN-004 second cohort in the first quarter of 2024, generating clinical data that establishes VCN-01 being an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma and combining with immunotherapy products to treat solid tumors, the Company’s ability to successfully combine and operate the business of the Theriva Biologics and VCN, the Company’s and VCN’s product candidates demonstrating safety and effectiveness, as well as results that are consistent with prior results; the ability to complete clinical trials on time and achieve the desired results and benefits, continuing clinical trial enrollment as expected; the ability to obtain regulatory approval for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to the Company’s and VCN’s ability to promote or commercialize their product candidates for the specific indications, acceptance of product candidates in the marketplace and the successful development, marketing or sale of the Company’s and VCN’s products, developments by competitors that render such products obsolete or non-competitive, the Company’s and VCN’s ability to maintain license agreements, the continued maintenance and growth of the Company’s and VCN’s patent estate, the ability to continue to remain well financed and the cash providing a runway into the fourth quarter of 2024, and other factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 and its other filings with the SEC, including subsequent periodic reports on Forms 10-Q and current reports on Form 8-K. The information in this release is provided only as of the date of this release, and Theriva Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law. Theriva Biologics, Inc. and Subsidiaries Consolidated Balance Sheets (In thousands except share and par value amounts) (Unaudited) June 30, 2023 December 31, 2022 Assets Current Assets Cash and cash equivalents $ 34,248 $ 41,786 Prepaid expenses and other current assets 3,717 3,734 Total Current Assets 37,965 45,520 Non-Current Assets Property and equipment, net 301 345 Restricted cash 100 99 Right of use asset 1,956 1,199 In-process research and development 19,483 19,150 Goodwill 5,621 5,525 Deposits and other assets 23 23 Total Assets $ 65,449 $ 71,861 Liabilities and Stockholders‘ Equity Current Liabilities: Accounts payable $ 741 $ 915 Accrued expenses 1,826 1,496 Accrued employee benefits 1,070 1,403 Contingent consideration, current portion 4,978 2,973 Loans payable-current 67 57 Operating lease liability 452 216 Total Current Liabilities 9,134 7,060 Non-current Liabilities Non-current contingent consideration 5,773 7,211 Loan Payable - Long term 153 221 Deferred tax liabilities, net 952 1,618 Operating lease liability - Long term 1,684 1,187 Total Liabilities 17,696 17,297 Commitments and Contingencies Temporary Equity Series C convertible preferred stock, $0.001 par value; 10,000,000 authorized;275,000 issued and outstanding 2,006 2,006 Series D convertible preferred stock, $0.001 par value; 10,000,000 authorized;100,000 issued and outstanding 728 728 Stockholders’ Equity: Common stock, $0.001 par value; 350,000,000 shares authorized, 17,762,010 issued and 17,041,777 outstanding at June 30, 2023 and 15,844,294 issued and 15,124,061 outstanding at December 31, 2022 18 16 Additional paid-in capital 346,176 343,750 Treasury stock at cost, 720,233 shares at June 30, 2023 and at December 31, 2022 (288 ) (288 ) Accumulated other comprehensive loss (356 ) (679 ) Accumulated deficit (300,531 ) (290,969 ) Total Stockholders’ Equity 45,019 51,830 Total Liabilities Temporary Equity, and Stockholders’ Equity $ 65,449 $ 71,861 Theriva Biologics, Inc. and Subsidiaries Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share amounts) (Unaudited) For the three months ended June 30, For the six months ended June 30, 2023 2022 2023 2022 Operating Costs and Expenses: General and administrative 2,687 1,541 4,888 3,196 Research and development 3,133 3,485 6,110 6,082 Total Operating Costs and Expenses 5,820 5,026 10,998 9,278 Loss from Operations (5,820 ) (5,026 ) (10,998 ) (9,278 ) Other Expense: Exchange loss (4 ) (9 ) 1 (31 ) Interest income 381 26 745 27 Total Other Income (Expense) 377 17 746 (4 ) Net Loss (5,443 ) (5,009 ) (10,252 ) (9,282 ) Income tax benefit 359 532 689 532 Net Loss Attributable to Common Stockholders $ (5,084 ) $ (4,477 ) $ (9,563 ) $ (8,750 ) Net Loss Per Share - Basic and Dilutive $ (0.34 ) $ (0.28 ) $ (0.63 ) $ (0.59 ) Weighted average number of shares outstanding during the period - Basic and Dilutive 15,166,209 15,844,061 15,145,252 14,837,832 Net Loss (5,084 ) (4,477 ) (9,563 ) (8,750 ) Gain(Loss) on foreign currency translation (51 ) (1,442 ) 323 (1,261 ) Total comprehensive loss $ (5,135 ) $ (5,919 ) $ (9,240 ) $ (10,011 )