8-K
Theriva Biologics, Inc. (TOVX)
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest eventreported): November 10, 2022
THERIVA BIOLOGICS, INC.
(Exact name of registrant as specified in its charter)
| Nevada | 001-12584 | 13-3808303 |
|---|---|---|
| (State or other jurisdiction of<br><br> <br>incorporation) | (Commission File No.) | (IRS Employer Identification<br><br> <br>No.) |
9605 Medical Center Drive, Suite 270
Rockville, Maryland 20850
(Address of principal executive offices and zip code)
(301) 417-4364
Registrant’s telephone number, including area code
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| --- | --- |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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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, par value $0.001 per share | TOVX | NYSE American |
Indicate by check mark whether the registrant is an emerging growth company as defined in in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by checkmark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
| Item 2.02. | Results of Operations and Financial Condition. |
|---|
On November 10, 2022, Theriva Biologics, Inc., a Nevada corporation (the “Registrant”) issued a press release that included financial information for its quarter ended September 30, 2022. A copy of the press release is attached as Exhibit 99.1 to this Report on Form 8-K and is incorporated herein by reference.
The information in this Item 2.02 and in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 2.02 and in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
| Item 9.01. | Financial Statements and Exhibits. |
|---|---|
| (d) | Exhibits. |
| --- | --- |
| ExhibitNumber | Description |
| --- | --- |
| 99.1 | Press Release issued by Theriva Biologics, Inc., dated November 10, 2022 |
| 104 | Cover Page Interactive Data File (embedded within the XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: November 10, 2022 | THERIVA BIOLOGICS, INC. | ||
|---|---|---|---|
| By: | /s/ Steven A. Shallcross | ||
| Name: | Steven A. Shallcross | ||
| Title: | Chief Executive Officer and Chief Financial Officer |
Exhibit 99.1
Theriva BiologicsReports Third Quarter 2022 Operational Highlights and Financial Results
-Reported encouragingclinical data supporting the differentiated mode-of action of Theriva’s novel oncolytic adenovirus (OV) platform-
-Received clearancefrom the Federal Drug Administration (FDA) and Spanish Competent Authority (AEMPS) for the planned Phase 2 clinical trial of systemicallyadministered VCN-01 in Pancreatic Ductal Adenocarcinoma (PDAC) patients-
- Reported positivesafety and pharmacokinetic data from Cohort 1 of the Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic celltransplant recipients and dosed the first patient in Cohort 2-
-As of September 30,2022, Theriva Biologics reports $50.5 million in cash, which is expected to provide runway into the first quarter of 2024-
-Conference call and webcast to be held onFriday, November 11 at 8:30 a.m. ET-
Rockville, MD,November 10, 2022 – 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 quarter ended September 30, 2022, and provided a corporate update.
“We are encouraged by our clinical results demonstrating the therapeutic potential of Theriva’s oncology-focused platform,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. “Important clinical data for VCN-01, our lead oncolytic virus product candidate was presented at ESMO, further validating VCN-01’s differentiated mechanism of action and potential to provide meaningful clinical benefit across multiple solid tumor indications. With regulatory clearance from the FDA and Spanish Competent Authority (AEMPS), our near-term priority is the initiation of Theriva’s Phase 2 study of VCN-01 in combination with standard-of-care chemotherapy (gemcitabine/nab-paclitaxel) as a first line therapy for patients with newly-diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC). We will also seek to leverage our Orphan Drug Designation and engage with regulatory agencies to define the best path forward for VCN-01 in the treatment of advanced retinoblastoma. We look forward to providing updates on Theriva’s progress as we deliver on upcoming milestones and drive shareholder value.”
Recent ProgramHighlights and Anticipated Milestones:
VCN-01:
| • | In<br> September 2022, investigators from Hospital Sant Joan de Déu in Barcelona presented<br> new preclinical data at the SIOP 2022 Congress of the International Society of Pediatric<br> Oncology, demonstrating that administration of VCN-01 in combination with topotecan chemotherapy<br> may improve VCN-01 activity against retinoblastoma. |
|---|---|
| • | In<br> September 2022, announced a presentation at ESMO Congress 2022 describing initial data<br> from a Phase 1 investigator-sponsored study evaluating VCN-01 in combination with durvalumab<br> for patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M<br> HNSCC). The acceptable safety profile observed in the sequential arm of this study as well<br> as the biological activity observed in R/M HNSCC patients previously treated with anti-PD(L)-1<br> agents speak to the promise of VCN-01- as a potential<br> means of enhancing the efficacy of immunotherapeutic agents in patients who are unresponsive<br> to these cancer therapies. |
| --- | --- |
| • | In<br> September 2022, received clearance from the FDA and AEMPS for the planned Phase 2 clinical<br> trial of systemically administered VCN-01 in PDAC patients. |
| --- | --- |
| • | Anticipated<br> milestones: |
| --- | --- |
| o | Initiation<br> of VCN-01 dosing in an investigator sponsored study of brain tumors at the University of<br> Leeds (Q4 2022). |
| --- | --- |
| o | Initiation<br> of VIRAGE, a Phase 2 study of VCN-01 in combination with standard-of-care chemotherapy (gemcitabine/nab-paclitaxel)<br> as a first line therapy in newly diagnosed metastatic PDAC patients (Q4 2022). |
| --- | --- |
| o | Hold<br> a pre-IND meeting with the FDA (early 2023) prior to the initiation of a clinical study evaluating<br> VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma (H2<br> 2023). |
| --- | --- |
SYN-004 (ribaxamase):
| • | In<br> September 2022, announced a positive outcome from the Data and Safety Monitoring Committee<br> (DSMC) review of safety and pharmacokinetic data from the first Cohort of the Phase 1b/2a<br> randomized, double-blinded, placebo-controlled clinical trial of SYN-004 (ribaxamase) in<br> allogeneic hematopoietic cell transplant (HCT) recipients for the prevention of acute graft-versus-host-disease<br> (aGVHD). The DSMC recommended that the study may proceed to enroll Cohort 2 in which study<br> drug (SYN-004 or Placebo) will be administered in combination with the IV beta-lactam antibiotic<br> piperacillin/tazobactam. |
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| • | In<br> October 2022, announced the first patient was dosed in the second cohort of the SYN-004<br> study in allo-HCT patients. |
| --- | --- |
| • | Anticipated<br> milestones: |
| --- | --- |
| o | Complete<br> the second cohort of our Phase 1b/2a clinical study of SYN-004 for the prevention of acute<br> graft-versus-host-disease in bone marrow transplant patients (Q1 2024). |
| --- | --- |
CorporateUpdates
| • | In<br> October 2022, the Company rebranded as Theriva Biologics and began trading on NYSE American<br> under the new ticker symbol “TOVX.” The new name, logo, and branding elements<br> are a unifying identity for the Company that reflects our position as a leading multinational<br> developer of innovative, differentiated oncolytic virus therapies to treat devastating cancers<br> with high unmet need. |
|---|
Quarter EndedSeptember 30, 2022 Financial Results
General and administrative expenses
General and administrative expenses increased to $2.4 million for the three months ended September 30, 2022, from $1.3 million for the three months ended September 30, 2021. This increase of 88% was primarily comprised of increased consulting and legal costs related to the VCN acquisition, increase in the fair value of the contingent consideration, higher insurance costs, audit fees, and public relations expenses, and VCN administrative expenses not included in the prior year. The charge related to stock-based compensation expense was $93,000 for the three months ended September 30, 2022, compared to $83,000 for the three months ended September 30, 2021.
Research and development expenses
Research and development expenses increased to $2.6 million for the three months ended September 30, 2022, from approximately $2.0 million for the three months ended September 30, 2021. This increase of 30% is primarily the result of VCN research expenses related to VCN-01 not incurred in the prior year and, to a lesser extent, higher manufacturing expenses related to our Phase 1a clinical trial of SYN-020. We anticipate research and development expense to increase as we plan for and initiate enrollment for our VIRAGE phase 2 clinical trial for VCN-01 in PDAC and our proposed 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 $28,000 for the three months ended September 30, 2022, compared to $19,000 related to stock-based compensation expense for the three months ended September 30, 2021.
Other income/Expense
Other income was $161,000 for the three months ended September 30, 2022 compared to other income of $2,000 for the three months ended September 30, 2021. Other income for the three months ended September 30, 2022 is primarily comprised of interest income of $170,000 offset by an exchange loss of $9,000. Other income for the three months ended September 30, 2021 was primarily comprised of interest income.
Cash and cash equivalents totaled $50.5 million as of September 30, 2022, compared to $67.3 million as of December 31, 2021.
ConferenceCall
Theriva Biologics will host a conference call at 8:30 a.m. ET today to review the third quarter 2022 operational highlights and financial results. Individuals may participate in the live call via telephone by dialing (888) 254-3590 (domestic) or (929) 477-0402 (international) and using the conference ID: 5687287. 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 “Investors” section of the company’s website, https://www.therivabio.com, under “Events” or by clicking here, for 90 days after the call.
About TherivaBiologics, 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’s subsidiary VCN Biosciences, S.L. (VCN), has been developing 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
Thisrelease contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some casesforward-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 cash being expected to provide runway into thefirst quarter of 2024, VCN-01 providing meaningful clinical benefit across multiple solid tumor indications, leveraging the Orphan DrugDesignation and engaging with regulatory agencies to define the best path forward for VCN-01 in the treatment of advanced retinoblastoma,providing updates on Theriva’s progress as Theriva delivers on upcoming milestones and driving shareholder value, VCN-01- asa potential means of enabling the use of immunotherapeutic agents in patientswho are unresponsive to these cancer therapies, initiation of VCN-01 dosing in an investigator sponsored study of brain tumors at theUniversity of Leeds (Q4 2022), initiation of VIRAGE, a Phase 2 study of VCN-01 in combination with standard-of-care chemotherapy (gemcitabine/nab-paclitaxel)as a first line therapy in newly diagnosed metastatic PDAC patients (Q4 2022), initiation of a clinical study evaluating VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma (H2 2023) and completing the second cohort of our Phase 1b/2a clinical study of SYN-004 for the prevention of acute graft-versus-host-disease in bone marrow transplant patients in the first quarter 2024*. These forward-looking statements are based on management’s expectationsand assumptions as of the date of this press release and are subject to a number of risks and uncertainties, many of which are difficultto predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or impliedby 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 initiation of VCN-01dosing in an investigator sponsored study of brain tumors at the University of Leeds (Q4 2022), initiation of VIRAGE, a Phase 2 studyof VCN-01 in combination with standard-of-care chemotherapy (gemcitabine/nab-paclitaxel) as a first line therapy in newly diagnosed metastaticPDAC patients (Q4 2022), initiation of a clinical study evaluating VCN-01 as an adjunct to chemotherapy in pediatric patients with advancedretinoblastoma (H2 2023), completing the second cohort of our Phase 1b/2a clinical study of SYN-004 for the prevention of acute graft-versus-host-diseasein bone marrow transplant patients in the first quarter 2024, the ability of VCN-01-* as a potentialmeans of enabling the use of immunotherapeutic agents in patients who are unresponsive to these cancer therapies, the Company’sability to successfully combine and operate the business of the Theriva Biologics and VCN, the Company’s and VCN’s productcandidates demonstrating safety and effectiveness, as well as results that are consistent with prior results; the ability to completeclinical trials on time and achieve the desired results and benefits, continuing clinical trial enrollment as expected; the ability toobtain regulatory approval for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatorylimitations relating to the Company’s and VCN’s ability to promote or commercialize their product candidates for the specificindications, acceptance of product candidates in the marketplace and the successful development, marketing or sale of the Company’sand VCN’s products, developments by competitors that render such products obsolete or non-competitive, the Company’s andVCN’s ability to maintain license agreements, the continued maintenance and growth of the Company’s and VCN’s patentestate, the ability to continue to remain well financed and the cash providing a runway into the first quarter of 2024, and other factorsdescribed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 and its other filings withthe SEC, including subsequent periodic reports on Forms 10-Q and current reports on Form 8-K. The information in this release isprovided only as of the date of this release, and Theriva Biologics undertakes no obligation to update any forward-looking statementscontained 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
TherivaBiologics, Inc. and Subsidiaries
Condensed ConsolidatedBalance Sheets
(In thousandsexcept share and par value amounts)
| December 31,<br><br> 2021 | |||||
|---|---|---|---|---|---|
| Assets | |||||
| Current<br> Assets | |||||
| Cash<br> and cash equivalents | 50,490 | $ | 67,325 | ||
| Prepaid<br> expenses and other current assets | 2,241 | 1,533 | |||
| Total<br> Current Assets | 52,731 | 68,858 | |||
| Non-Current<br> Assets | |||||
| Property<br> and equipment, net | 262 | 101 | |||
| Restricted<br> cash | 90 | — | |||
| Right<br> of use asset | 1,246 | 1,383 | |||
| In-process<br> research and development | 20,089 | — | |||
| Goodwill | 4,254 | — | |||
| Deposits<br> and other assets | 23 | 23 | |||
| Total<br> Assets | 78,695 | $ | 70,365 | ||
| Liabilities and Stockholders‘<br> Equity | |||||
| Current<br> Liabilities: | |||||
| Accounts<br> payable | 770 | $ | 524 | ||
| Accrued<br> expenses | 1,411 | 1,928 | |||
| Accrued<br> employee benefits | 1,319 | 978 | |||
| Contingent<br> consideration, current portion | 9,483 | — | |||
| Loans<br> Payable-current | 52 | — | |||
| Operating<br> lease liability | 157 | 124 | |||
| Total<br> Current Liabilities | 13,192 | 3,554 | |||
| Non-current<br> Liabilities | |||||
| Non-current<br> contingent consideration | 2,419 | — | |||
| Loan<br> Payable - Long term | 202 | — | |||
| Deferred<br> tax liabilities, net | 3,489 | — | |||
| Lease<br> liability - Long term | 1,244 | 1,403 | |||
| Total<br> Liabilities | 20,546 | 4,957 | |||
| Commitments<br> and Contingencies | |||||
| Series C<br> convertible preferred stock, 0.001 par value; 10,000,000;275,000 issued and outstanding | 2,006 | — | |||
| Series D<br> convertible preferred stock, 0.001 par value; 10,000,000;100,000 issued and outstanding | 728 | — | |||
| Stockholders’<br> Equity (Deficit): | |||||
| Common<br> stock, 0.001 par value; 20,000,000 shares authorized, 15,844,294 issued and 15,844,061 outstanding at September 30, 2022 and<br> 13,204,487 issued and 13,204,254 outstanding at December 31, 2021 | 16 | 13 | |||
| Additional<br> paid-in capital | 343,621 | 336,679 | |||
| Accumulated<br> other comprehensive loss | (2,844 | ) | — | ||
| Accumulated<br> deficit | (285,378 | ) | (271,284 | ) | |
| Total<br> Stockholders‘ Equity | 55,415 | 65,408 | |||
| Total<br> Liabilities and Stockholders‘ Equity | 78,695 | $ | 70,365 |
All values are in US Dollars.
Theriva Biologics, Inc.and Subsidiaries
Condensed ConsolidatedStatements of Operations and Comprehensive Loss
(In thousands,except share and per share amounts)
(Unaudited)
| For<br> the three months ended<br><br> September 30, | For<br> the nine months ended<br><br> September 30, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2022 | 2021 | 2022 | 2021 | |||||||||
| Operating<br> Costs and Expenses: | ||||||||||||
| General<br> and administrative | $ | 2,444 | $ | 1,303 | $ | 5,599 | $ | 3,988 | ||||
| Research<br> and development | 2,570 | 1,972 | 8,652 | 5,021 | ||||||||
| Total<br> Operating Costs and Expenses | 5,014 | 3,275 | 14,251 | 9,009 | ||||||||
| Loss<br> from Operations | (5,014 | ) | (3,275 | ) | (14,251 | ) | (9,009 | ) | ||||
| Other<br> Expense: | ||||||||||||
| Exchange<br> loss | (9 | ) | — | (40 | ) | — | ||||||
| Interest<br> income | 170 | 2 | 197 | 4 | ||||||||
| Total<br> Other Income(Expense) | 161 | 2 | 157 | 4 | ||||||||
| Net<br> Loss | (4,853 | ) | (3,273 | ) | (14,094 | ) | (9,005 | ) | ||||
| Net<br> Loss Attributable to Non-controlling Interest | — | — | — | (1 | ) | |||||||
| Net<br> Loss Attributable to Theriva Biologics, Inc. and Subsidiaries | $ | (4,853 | ) | $ | (3,273 | ) | $ | (14,094 | ) | $ | (9,004 | ) |
| Effect<br> of Warrant exercise price adjustment | (340 | ) | — | (340 | ) | — | ||||||
| Series A<br> Preferred Stock Dividends | — | — | — | (24 | ) | |||||||
| Effect<br> of Series A Preferred Stock price adjustment | — | — | — | (7,402 | ) | |||||||
| Series B<br> Preferred Stock Dividends | — | — | — | (1,497 | ) | |||||||
| Net<br> Loss Attributable to Common Stockholders | $ | (5,193 | ) | $ | (3,273 | ) | $ | (14,434 | ) | $ | (17,926 | ) |
| Net<br> Loss Per Share - Basic and Dilutive | $ | (0.33 | ) | $ | (0.25 | ) | $ | (0.95 | ) | $ | (1.51 | ) |
| Weighted<br> average number of shares outstanding during the period - Basic and Dilutive | 15,844,061 | 13,204,254 | 15,176,927 | 11,844,863 | ||||||||
| Net<br> Loss | (4,853 | ) | (3,273 | ) | (14,094 | ) | (9,005 | ) | ||||
| Loss<br> on foreign currency translation | (1,527 | ) | — | (2,844 | ) | — | ||||||
| Total<br> comprehensive loss | (6,380 | ) | (3,273 | ) | (16,938 | ) | (9,005 | ) | ||||
| Comprehensive<br> loss attributable to non-controlling interest | — | — | — | (1 | ) | |||||||
| Comprehensive<br> loss attributable to Theriva Biologics, Inc. and Subsidiaries | (6,380 | ) | (3,273 | ) | (16,938 | ) | (9,004 | ) |