Theriva™ Biologics Reports Full-Year 2023 Operational Highlights and Financial Results
- Positive progress in VIRAGE Phase 2b clinical trial for PDAC
- No safety concerns raised by the IDMC
- Expected completion of enrollment by H1 2024
- Theriva Biologics reports $23.2 million in cash as of December 31, 2023
- Financial runway into Q1 2025
- Company aims to achieve important milestones in 2024
- None.
Insights
The recommendation by the IDMC to continue the VIRAGE Phase 2b clinical trial without modifications is a positive development for Theriva Biologics. This suggests that the trial is proceeding as expected, which could be a precursor to a successful outcome. The ability to maintain the current protocol without safety concerns can be seen as a validation of the company's research direction and risk assessment capabilities. Moreover, with a cash runway extending into the first quarter of 2025, Theriva appears to have sufficient funding to complete its near-term clinical objectives, mitigating immediate financial risk for investors.
However, it's important to note that the company's cash position has decreased significantly from $41.8 million at the end of 2022 to $23.2 million at the end of 2023. This burn rate, while not uncommon for clinical-stage biotech companies, will likely necessitate additional capital raising in the future, possibly diluting current shareholders or incurring debt. Investors should monitor the company's cash management and potential financing activities as they could have significant implications for the stock's valuation.
The progression of the VIRAGE trial is a critical step for Theriva Biologics as it explores the efficacy of VCN-01 in treating metastatic PDAC, a cancer with historically poor outcomes and limited treatment options. The trial's focus on a combination therapy approach, leveraging VCN-01 with standard chemotherapy, aligns with current trends in oncology aiming to enhance treatment effectiveness. The absence of new safety concerns post the administration of a second dose of VCN-01 is particularly noteworthy, as it suggests the potential for repeat dosing which could be important for long-term treatment strategies.
Additionally, the completion of patient treatment in the Phase 1 trial for refractory retinoblastoma with VCN-01 and the upcoming design of a Phase 2 trial indicate progress in a pediatric indication. This could open a new therapeutic area for the company, diversifying its portfolio and potentially addressing a rare but impactful pediatric cancer. The collaboration with Sant Joan de Déu-Barcelona Children’s Hospital and the focus on combining VCN-01 with topoisomerase I inhibitors could further enhance the company's standing in the field of oncology research.
Theriva Biologics operates within the highly competitive and innovation-driven biopharmaceutical industry. The company's focus on addressing high unmet medical needs positions it in a niche market segment that could offer significant rewards if its clinical trials result in marketable treatments. The strategic partnership with key opinion leaders and regulatory agencies, as highlighted in the update, is a savvy move to bolster its clinical strategy and potentially expedite the path to market.
From a market perspective, the successful development of treatments for PDAC and retinoblastoma may allow Theriva to capture a share of the oncology therapeutics market, which is expected to grow substantially. However, the market is also sensitive to clinical trial outcomes and any future setbacks could adversely affect investor sentiment and the company's market value. It is therefore essential for investors to track the company's clinical progress alongside financial health to gauge the potential market impact of its research and development efforts.
– 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
- Conference call and webcast to be held on Monday, March 25 at 8:30 a.m. ET -
ROCKVILLE, Md., March 25, 2024 (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 full-year ended December 31, 2023, and provided a corporate update.
“With continued advancement of our clinical programs, we have the opportunity to achieve several important milestones this year,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. “VIRAGE, our Phase 2b trial of VCN-01 in newly-diagnosed metastatic PDAC remains on track to complete enrollment in the first half of 2024. We completed the first safety review with the IDMC, and with a positive recommendation, VIRAGE will continue to enroll patients as planned with no modifications to the protocol. Our clinical data has demonstrated that repeated systemic dosing of VCN-01 is feasible from a safety perspective, and will now focus on determining whether the repeated-dose regimen of VCN-01 may lead to improved clinical outcomes for patients with PDAC and other solid cancers. In addition to advancing the VIRAGE PDAC trial, we continue to work closely with key opinion leaders, and regulatory agencies to refine our protocol and clinical strategy for VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma. In parallel, our investigator sponsored Phase 1 trial evaluating the safety and activity of intravitreal VCN-01 in pediatric patients with refractory retinoblastoma continues to progress and will further inform our clinical development pathway in this area of high unmet need.”
Recent Program Highlights and Anticipated Milestones:
VCN-01:
- Pancreatic Ductal Adenocarcinoma (PDAC): 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 bmetastatic PDAC patients. The trial is expected to enroll 92 evaluable patients and remains on track to complete enrollment in H1 2024.
- The Independent Data Monitoring Committee (IDMC) recommended the continuation of enrollment as planned into the VIRAGE study. According to the IDMC's expert assessment of clinical data from patients enrolled at six sites open in the U.S. and nine sites in Spain, the ongoing Phase 2b trial will continue without any changes to the protocol. No safety concerns were raised based on the evaluation of data presented at the IDMC meeting. Intravenous VCN-01 has been well tolerated and demonstrated a safety profile consistent with prior clinical trials. Importantly, no additional toxicities were observed in patients receiving a second dose of VCN-01.
- The Independent Data Monitoring Committee (IDMC) recommended the continuation of enrollment as planned into the VIRAGE study. According to the IDMC's expert assessment of clinical data from patients enrolled at six sites open in the U.S. and nine sites in Spain, the ongoing Phase 2b trial will continue without any changes to the protocol. No safety concerns were raised based on the evaluation of data presented at the IDMC meeting. Intravenous VCN-01 has been well tolerated and demonstrated a safety profile consistent with prior clinical trials. Importantly, no additional toxicities were observed in patients receiving a second dose of VCN-01.
- Retinoblastoma: The investigator sponsored Phase 1 trial evaluating the safety and activity of intravitreal VCN-01 in pediatric patients with refractory retinoblastoma has completed patient treatment. The trial is designed to evaluate escalating doses of VCN-01 administered by two intravitreal injections separated by 14 days. The investigator sponsored Phase 1 trial, which will complete patient follow-up in H1 2024, will help inform the planned Phase 2 trial design.
- This builds on positive preclinical results presented by collaborators at Fundació Sant Joan de Déu demonstrating that administration of VCN-01 in combination with topotecan chemotherapy may improve VCN-01 activity against 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 enrollment into the second cohort in Q2 2024.
Business Updates
- On November 2, 2023, Theriva signed an exclusive option to license intellectual property from Sant Joan de Déu-Barcelona Children’s Hospital (SJD) to explore the therapeutic potential of VCN-01 in combination with topoisomerase I inhibitors. This strengthens a long-term research collaboration with SJD and builds on ongoing trial evaluating VCN-01 in pediatric cancers.
- Theriva is actively pursuing licensing discussions for our SYN-020 intestinal alkaline phosphatase asset.
Full-Year Ended December 31, 2023 Financial Results
General and administrative expenses decreased to
Research and development expenses increased to
Other income was
Cash and cash equivalents totaled
The audited financial statements for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K contain an unqualified audit opinion from the Company’s independent registered public accounting firm that includes an explanatory paragraph related to the Company's ability to continue as a going concern.
Conference Call
Theriva Biologics will host a conference call on Monday, March 25, 2024 at 8:30 a.m. ET to discuss its financial results for the full-year ended December 31, 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: 13744453. 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, https://www.therivabio.com, 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 www.therivabio.com.
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 half of 2024, cash being expected to provide runway into the first quarter of 2025, continued advancement of the Company’s clinical programs providing the opportunity to achieve several important milestones this year, VIRAGE remaining on track to complete enrollment in the first half of 2024, VIRAGE continuing to enroll patients as planned with no modifications to the protocol, determining whether the repeated-dose regimen of VCN-01 may lead to improved clinical outcomes for patients with PDAC and other solid cancers, continuing to work closely with key opinion leaders, and regulatory agencies to refine our protocol and clinical strategy for VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma, the Company investigator sponsored Phase 1 trial evaluating the safety and activity of intravitreal VCN-01 in pediatric patients with refractory retinoblastoma further informing the Company’s clinical development pathway in this area of high unmet need, the VIRAGE trial enrolling 92 evaluable patients, completing patient follow-up in Q1 2024 in the investigator sponsored Phase 1 trial evaluating VCN-01 in pediatric patients with refractory retinoblastoma, the SYN-004 trial being on track to complete enrollment in the second cohort in Q2 2024 and expected increases in research and development expenses as the Company incurs higher clinical program costs for its VCN product candidates. 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 the ability to continue to enroll patients as planned and the completion of enrollment in Virage in the first half of 2024, completion of patient follow- up in Q1 2024 in the investigator sponsored Phase 1 trial patient evaluating VCN-01 in pediatric patients with refractory retinoblastoma, and completing enrollment in the SYN-004 second cohort in Q2 of 2024, generating clinical data that establishes VCN-01 may lead to improved clinical outcomes for patients with PDAC and other solid cancers; 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,; 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 first quarter of 2025, and other factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 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.
For further information, please contact:
Investor Relations:
Chris Calabrese
LifeSci Advisors, LLC
ccalabrese@lifesciadvisors.com
917-680-5608
| Theriva Biologics, Inc. and Subsidiaries | ||||||||
| Consolidated Balance Sheets (In thousands except share and par value amounts) (Unaudited) | ||||||||
| December 31, | December 31, | |||||||
| 2023 | 2022 | |||||||
| Assets | ||||||||
| Current Assets | ||||||||
| Cash and cash equivalents | $ | 23,177 | $ | 41,786 | ||||
| Tax credit receivable | 1,812 | — | ||||||
| Prepaid expenses and other current assets | 2,414 | 3,734 | ||||||
| Total Current Assets | 27,403 | 45,520 | ||||||
| Non-Current Assets | ||||||||
| Property and equipment, net | 422 | 345 | ||||||
| Restricted cash | 102 | 99 | ||||||
| Right of use asset | 1,759 | 1,199 | ||||||
| In-process research and development | 19,755 | 19,150 | ||||||
| Goodwill | 5,700 | 5,525 | ||||||
| Deposits and other assets | 78 | 23 | ||||||
| Total Assets | $ | 55,219 | $ | 71,861 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 770 | $ | 915 | ||||
| Accrued expenses | 2,995 | 1,496 | ||||||
| Accrued employee benefits | 1,517 | 1,403 | ||||||
| Contingent consideration, current portion | — | 2,973 | ||||||
| Deferred research and development tax credit-current portion | 906 | — | ||||||
| Loans payable-current | 63 | 57 | ||||||
| Operating lease liability-current portion | 487 | 216 | ||||||
| Total Current Liabilities | 6,738 | 7,060 | ||||||
| Non-current Liabilities | ||||||||
| Non-current contingent consideration | 6,274 | 7,211 | ||||||
| Loan Payable - non-current | 162 | 221 | ||||||
| Deferred tax liabilities, net | — | 1,618 | ||||||
| Non-current deferred research and development tax credit | 906 | — | ||||||
| Non-current operating lease liability | 1,442 | 1,187 | ||||||
| Total Liabilities | 15,522 | 17,297 | ||||||
| Commitments and Contingencies | — | — | ||||||
| Temporary Equity | ||||||||
| Series C convertible preferred stock, | 2,006 | 2,006 | ||||||
| Series D convertible preferred stock, | 728 | 728 | ||||||
| Stockholders’ Equity: | ||||||||
| Common stock, | 18 | 16 | ||||||
| Additional paid-in capital | 346,519 | 343,750 | ||||||
| Treasury stock at cost, 720,233 shares at December 31, 2023 and at December 31, 2022 | (288 | ) | (288 | ) | ||||
| Accumulated other comprehensive income (loss) | 32 | (679 | ) | |||||
| Accumulated deficit | (309,318 | ) | (290,969 | ) | ||||
| Total Stockholders‘ Equity | 36,963 | 51,830 | ||||||
| Total Liabilities and Stockholders’ Equity | $ | 55,219 | $ | 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 year ended | ||||||||
| December 31, | ||||||||
| 2023 | 2022 | |||||||
| Operating Costs and Expenses: | ||||||||
| General and administrative | $ | 7,120 | $ | 9,858 | ||||
| Research and development | 14,311 | 11,723 | ||||||
| Total Operating Costs and Expenses | 21,431 | 21,581 | ||||||
| Loss from Operations | (21,431 | ) | (21,581 | ) | ||||
| Other Income: | ||||||||
| Foreign currency exchange gain (loss) | 3 | (41 | ) | |||||
| Interest income | 1,439 | 512 | ||||||
| Total Other Income | 1,442 | 471 | ||||||
| Net Loss before income taxes | (19,989 | ) | (21,110 | ) | ||||
| Income tax benefit | 1,640 | 1,425 | ||||||
| Net Loss Attributable to Theriva Biologics, Inc. and Subsidiaries | $ | (18,349 | ) | $ | (19,685 | ) | ||
| Effect of Warrant exercise price adjustment | — | (340 | ) | |||||
| Net Loss Attributable to Common Stockholders | $ | (18,349 | ) | $ | (20,025 | ) | ||
| Net Loss Per Share - Basic and Dilutive | $ | (1.14 | ) | $ | (1.31 | ) | ||
| Weighted average number of shares outstanding during the period - basic and dilutive | 16,107,014 | 15,327,328 | ||||||
| Net Loss | (18,349 | ) | (19,685 | ) | ||||
| Gain (loss) on foreign currency translation | 711 | (679 | ) | |||||
| Total comprehensive loss | (17,638 | ) | (20,364 | ) | ||||
FAQ
What is the status of the VIRAGE Phase 2b clinical trial for PDAC?
How much cash does Theriva Biologics have as of December 31, 2023?
When is the conference call scheduled for Theriva Biologics' financial results and corporate update?
How can individuals participate in the conference call?
