Form 8-K - Current report

 

 

 

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): May 7, 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)

 

[phone]

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 May 7, 2024, Theriva Biologics, Inc., a Nevada corporation (the “Registrant”) issued a press release that included financial information for its quarter ended March 31, 2024. 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 May 7, 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: May 7, 2024	THERIVA BIOLOGICS, INC.
	By:	/s/ Steven A. Shallcross
		Name:	Steven A. Shallcross
		Title:	Chief Executive Officer and Chief Financial Officer

  

 

 

Exhibit 99.1

 

 

Theriva™ Biologics Reports First Quarter 2024 Operational Highlights and Financial Results

 

- Reported topline data from the investigator sponsored Phase 1 trial of intravitreal VCN-01 in pediatric patients with refractory retinoblastoma; trial results were determined to be positive by the study Monitoring Committee-

 

-Presented preclinical data demonstrating the potential synergy between VCN-01 and liposomal irinotecan in a human pancreatic mouse xenograft at the ASGCT Annual Meeting; emphasizes VCN-01’s potential in diverse chemotherapy combinations for improved efficacy in pancreatic cancer-

 

- VIRAGE, the Phase 2b clinical trial of VCN-01 in combination with chemotherapy for metastatic Pancreatic Ductal Adenocarcinoma (PDAC), is expected to complete enrollment in the third quarter of 2024-

 

- As of March 31, 2024, Theriva Biologics reports $18.3 million in cash, which is expected to provide runway into the first quarter of 2025-

  

Rockville, MD, May 7, 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 first quarter ended March 31, 2024, and provided a corporate update.

 

“In the first quarter we reported positive topline data from the investigator sponsored Phase 1 trial in patients with refractory retinoblastoma, further validating VCN-01’s unique mechanism of action and therapeutic potential to improve treatment outcomes as an adjunct to chemotherapy in this area of high unmet need,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. “In parallel, we continue to build a portfolio of potentially improved therapeutic combinations for PDAC patients. VIRAGE, our Phase 2b trial evaluating VCN-01 in metastatic PDAC is progressing and enrolling patients across sites in the U.S. and Spain. Further, the recently presented preclinical data at ASGCT support the potential antitumor synergy of VCN-01 with topoisomerase 1 inhibitors, an important class of chemotherapeutic agents used in a number of different cancers. We look forward to identifying opportunities to evaluate the combination of VCN-01 with additional first-line pancreatic cancer chemotherapy regimens (FOLFIRINOX or NALIRIFOX) that incorporate the topoisomerase 1 inhibitor irinotecan. Building on this momentum, we are well positioned to achieve several important milestones that will continue to drive forward our clinical development program.”

 

Recent Program Highlights and Anticipated Milestones:

 

VCN-01:

·       Pancreatic Ductal Adenocarcinoma (PDAC):

o

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. The trial is expected to enroll 92 evaluable patients and is expected to complete enrollment in the third quarter of 2024.

§

The ongoing Phase 2b trial continues to enroll patients across seven sites in the U.S. and ten sites in Spain. 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.

 

 

 

 

 

o

Presented preclinical data demonstrating enhanced anti-tumor effects in human pancreatic cancer xenograft-bearing mice treated with lead product candidate VCN-01 and liposomal irinotecan. These data support the potential synergy of VCN-01 and additional first-line pancreatic cancer chemotherapy regimens and were presented at the American Society for Cell and Gene Therapy (ASGCT) 27th Annual Meeting in Baltimore from May 7-11, 2024.

·       Retinoblastoma:

o

The investigator sponsored Phase 1 trial evaluating the safety and activity of intravitreal VCN-01 in pediatric patients with refractory retinoblastoma completed patient treatment and the trial results were determined to be positive by the study Monitoring Committee.

§

In the Phase 1 trial in collaboration with Sant Joan de Déu-Barcelona Children’s Hospital (SJD), patients received two intravitreal injections of VCN-01, 14 days apart, at a dose of either 2 x 109 vp/eye (n=1) or 2 x 1010 vp/eye (n=8). The safety and clinical outcomes support the therapeutic potential of VCN-01 in retinoblastoma and emphasize VCN-01’s potential for use in diverse cancer indications. Results will help inform the planned Phase 2 trial design.

·       Additional Updates:

o

The trial design for VIRAGE will be discussed at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago, IL, from May 31-June 4.

§

Based on the strength of the science and its relevance, VIRAGE has been accepted for presentation as a trial-in-progress poster (abstract: TPS4210).

  

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).

o

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.

o

The trial has completed enrollment into the second cohort and a data readout are expected in the third quarter of 2024. If the Data Safety and Monitoring Committee recommends continuation of the trial , enrollment into the third cohort could commence in the second half of 2024.

 

Business Updates

 

·

Theriva is actively pursuing licensing discussions for our SYN-020 intestinal alkaline phosphatase asset.

 

First Quarter Ended March 31, 2024 Financial Results

 

General and administrative expenses decreased to $1.9 million for the three months ended March 31, 2024, from $2.2 million for the three months ended March 31, 2023. This decrease of 12% is primarily comprised of the decrease in salary costs, consulting, legal fees, and lower director and officer insurance, offset by an increase in fair value of the contingent consideration adjustment. The charge related to stock-based compensation expense was $101,000 for the three months ended March 31, 2024, compared to $87,000 for the three months ended March 31, 2023.

 

 

 

 

 

Research and development expenses increased to $3.5 million for the three months ended March 31, 2024, from approximately $3.0 million for the three months ended March 31, 2023. This increase of 16% is primarily the result of higher clinical trial expenses related to our VIRAGE Phase 2 clinical trial of VCN-01 in PDAC, increased expenses related to the Phase 1 Trial of intravitreal VCN-01 in patients with retinoblastoma, and increased expenses related to our Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients, offset by lower expenses related to our Phase 1a clinical trial of SYN-020. We anticipate research and development expense to increase as we continue enrollment in our VIRAGE Phase 2 clinical trial of VCN-01 in PDAC, advance our VCN-01 program 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 $58,000 for the three months ended March 31, 2024, compared to $39,000 related to stock-based compensation expense for the three months ended March 31, 2023.

 

Other income for the three months ended March 31, 2024 is primarily comprised of interest income of $228,000 and an exchange loss of $1,000. Other income for the three months ended March 31, 2023 is primarily comprised of interest income of $364,000 and exchange gain of $6,000.

 

Cash and cash equivalents totaled $18.3 million as of March 31, 2024, compared to $23.2 million as of December 31, 2023.

 

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 the potential synergy between VCN-01 and liposomal irinotecan in a human pancreatic mouse xenograft, VCN-01’s potential in diverse chemotherapy combinations for improved efficacy in pancreatic cancer VIRAGE expecting to complete enrollment in the the third quarter of 2024, enrolling 92 evaluable patients and continuing to enroll patients across seven sites in the U.S. and ten sites in Spain, cash being expected to provide runway into the first quarter of 2025, the therapeutic potential of VCN-01 in retinoblastoma and VCN-01’s potential for use in diverse cancer indications, the SYN-004 trial expecting to announce a data readout in the third quarter of 2024, the potential synergy of VCN-01 and additional first-line pancreatic cancer chemotherapy, continuing to build a portfolio of potentially improved therapeutic combinations for PDAC patients, identifying opportunities to evaluate the combination of VCN-01 with additional first-line pancreatic cancer chemotherapy regimens, being well positioned to achieve several important milestones that will continue to drive forward the clinical development program and anticipated research and development expense to increase . 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 third quarter of 2024, and announcing a data readout for the SYN-004 second cohort in the third quarter 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 

[e-mail] 

917-680-5608

 

 

 

 

 

Theriva Biologics, Inc. and Subsidiaries

 

Consolidated Balance Sheets 

(In thousands except share and par value amounts) 

(Unaudited)

 

		March 31, 2024				December 31, 2023
Assets
Current Assets
Cash and cash equivalents		$	18,261			$	23,177
Tax credit receivable			1,772				1,812
Prepaid expenses and other current assets			1,623				2,414
Total Current Assets			21,656				27,403
Non-Current Assets
Property and equipment, net			375				422
Restricted cash			99				102
Right of use asset			1,634				1,759
In-process research and development			19,316				19,755
Goodwill			5,573				5,700
Deposits and other assets			77				78
Total Assets		$	48,730			$	55,219
Liabilities and Stockholders‘ Equity
Current Liabilities:
Accounts payable		$	571			$	770
Accrued expenses			3,327				2,995
Accrued employee benefits			665				1,517
Deferred research and development tax credit-current portion			886				906
Loans payable-current			62				63
Operating lease liability-current portion			498				487
Total Current Liabilities			6,009				6,738
Non-current Liabilities
Non-current contingent consideration			6,476				6,274
Loan Payable - non-current			159				162
Non-current deferred research and development tax credit			664				906
Non-current operating lease liability			1,299				1,442
Total Liabilities			14,607				15,522
Commitments and Contingencies (Note 13)			—				—
Temporary Equity; 10,000,000 authorized
Series C convertible preferred stock, $0.001 par value; 275,000 issued and outstanding			2,006				2,006
Series D convertible preferred stock, $0.001 par value; 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 March  31, 2024 and 17,868,282 issued and 17,148,049 outstanding at December 31, 2023			18				18
Additional paid-in capital			346,679				346,519
Treasury stock at cost, 720,233 shares at March  31, 2024 and at December 31, 2023			(288	)			(288	)
Accumulated other comprehensive (loss) income			(537	)			32
Accumulated deficit			(314,483	)			(309,318	)
Total Stockholders’ Equity			31,389				36,963
Total Liabilities and Stockholders’ Equity		$	48,730			$	55,219

 

 

 

 

 

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 March 31,
		2024				2023
Operating Costs and Expenses:
General and administrative		$	1,933			$	2,201
Research and development			3,459				2,977
Total Operating Costs and Expenses			5,392				5,178
Loss from Operations			(5,392	)			(5,178	)
Other Income:
Foreign currency exchange (loss) gain			(1	)			6
Interest income			228				364
Total Other Income			227				370
Net Loss before income taxes			(5,165	)			(4,808	)
Income tax benefit			—				330
Net Loss Attributable to Common Stockholders		$	(5,165	)		$	(4,478	)
Net Loss Per Share - Basic and Dilutive		$	(0.30	)		$	(0.30	)
Weighted average number of shares outstanding during the period - basic and dilutive			17,148,049				15,124,061
Net Loss			(5,165	)			(4,478	)
(Loss) gain (loss) on foreign currency translation			(569	)			374
Total comprehensive loss			(5,734	)			(4,104	)

  

 

Cover	May 07, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	May 07, 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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