0001104659-24-038166.txt : 20240325 0001104659-24-038166.hdr.sgml : 20240325 20240325074033 ACCESSION NUMBER: 0001104659-24-038166 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 20 CONFORMED PERIOD OF REPORT: 20240325 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20240325 DATE AS OF CHANGE: 20240325 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Theriva Biologics, Inc. CENTRAL INDEX KEY: 0000894158 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] ORGANIZATION NAME: 03 Life Sciences IRS NUMBER: 133808303 STATE OF INCORPORATION: NV FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-12584 FILM NUMBER: 24776903 BUSINESS ADDRESS: STREET 1: 9605 MEDICAL CENTER DRIVE STREET 2: SUITE 270 CITY: ROCKVILLE STATE: MD ZIP: 20850 BUSINESS PHONE: (734) 332-7800 MAIL ADDRESS: STREET 1: 9605 MEDICAL CENTER DRIVE STREET 2: SUITE 270 CITY: ROCKVILLE STATE: MD ZIP: 20850 FORMER COMPANY: FORMER CONFORMED NAME: Synthetic Biologics, Inc. DATE OF NAME CHANGE: 20120305 FORMER COMPANY: FORMER CONFORMED NAME: ADEONA PHARMACEUTICALS, INC. DATE OF NAME CHANGE: 20081027 FORMER COMPANY: FORMER CONFORMED NAME: PIPEX PHARMACEUTICALS, INC. DATE OF NAME CHANGE: 20061214 8-K 1 tm249466d1_8k.htm FORM 8-K
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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 event reported): March 25, 2024

 

THERIVA BIOLOGICS, INC.

(Exact name of registrant as specified in its charter)

 

Nevada   001-12584   13-3808303

(State or other jurisdiction of

incorporation)

   (Commission File No.)  

(IRS Employer Identification

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))

 

  ¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

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 March 25, 2024, Theriva Biologics, Inc., a Nevada corporation (the “Registrant”) issued a press release that included financial information for its fiscal year ended December 31, 2023. 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.

 

Exhibit
Number		   Description
99.1   Press Release issued by Theriva Biologics, Inc., dated March 25, 2024
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: March 25, 2024 THERIVA BIOLOGICS, INC.
       
  By: /s/ Steven A. Shallcross
    Name:  Steven A. Shallcross
    Title: Chief Executive Officer and Chief Financial Officer

  

 

 

 

 

 

 EX-99.1 2 tm249466d1_ex99-1.htm EXHIBIT 99.1

 

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 expected to provide runway into the first quarter of 2025 -

 

- Conference call and webcast to be held on Monday, March 25 at 8:30 a.m. ET -

 

Rockville, MD, March 25, 2024 – 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.
o

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.
oThis 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 $7.1 million for the year ended December 31, 2023, from $9.9 million for the year ended December 31, 2022. This decrease of 28% is primarily comprised of the decrease in the fair value of the contingent consideration of $2.8 million, along with lower salary, investor relations, legal costs, consulting fees related to the VCN acquisition, and director and officer insurance offset by higher audit fees, and other consulting fees. The charge relating to stock based compensation expense was $0.4 million for the year ended December 31, 2023, compared to $0.4 million for the year ended December 31, 2022.

 

Research and development expenses increased to $14.3 million for the year ended December 31, 2023, from $11.7 million for the year ended December 31, 2022. This increase of 22% is primarily the result of higher clinical trial expenses related to our VIRAGE Phase 2 clinical trial of VCN-01 in PDAC, offset by lower expenses related to our Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients, the completed Phase 1a clinical trial of SYN-020, decreased manufacturing expenses related to our Phase 1a clinical trial of SYN-020 and lower other indirect costs. 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. Research and development expenses also include a charge relating to non-cash stock-based compensation expense of $165,000 for the year ended December 31, 2023, compared to $112,000 for the year ended December 31, 2022. In addition, we expect research and development expenses to increase as we incur higher clinical program costs for our VCN product candidates.

 

 

 

 

 

Other income was $1,442,000 for the year ended December 31, 2023, compared to other income of $471,000 for the year ended December 31, 2022. Other income for the year ended December 31, 2023 is primarily comprised of interest income of $1,439,000 and an exchange gain of $3,000. Other income for the year ended December 31, 2022 is primarily comprised of interest income of $512,000 offset by an exchange loss of $41,000.

 

Cash and cash equivalents totaled $23.2 million as of December 31, 2023, compared to $41.8 million as of December 31, 2022.

 

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, $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, 17,868,282 issued and 17,148,049 outstanding at December 31, 2023 and 15,844,061 issued and 15,123,828 outstanding at December 31, 2022

      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 exhange 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)

 

 

 

 

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Cover
Mar. 25, 2024
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Mar. 25, 2024
Entity File Number 001-12584
Entity Registrant Name THERIVA BIOLOGICS, INC.
Entity Central Index Key 0000894158
Entity Tax Identification Number 13-3808303
Entity Incorporation, State or Country Code NV
Entity Address, Address Line One 9605 Medical Center Drive
Entity Address, Address Line Two Suite 270
Entity Address, City or Town Rockville
Entity Address, State or Province MD
Entity Address, Postal Zip Code 20850
City Area Code 301
Local Phone Number 417-4364
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common stock, par value $0.001 per share
Trading Symbol TOVX
Security Exchange Name NYSEAMER
Entity Emerging Growth Company false
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