0001104659-22-104345.txt : 20220930 0001104659-22-104345.hdr.sgml : 20220930 20220930081026 ACCESSION NUMBER: 0001104659-22-104345 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20220930 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20220930 DATE AS OF CHANGE: 20220930 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Synthetic Biologics, Inc. CENTRAL INDEX KEY: 0000894158 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] 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: 221282339 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: ADEONA PHARMACEUTICALS, INC. DATE OF NAME CHANGE: 20081027 FORMER COMPANY: FORMER CONFORMED NAME: PIPEX PHARMACEUTICALS, INC. DATE OF NAME CHANGE: 20061214 FORMER COMPANY: FORMER CONFORMED NAME: SHEFFIELD PHARMACEUTICALS INC DATE OF NAME CHANGE: 19970730 8-K 1 tm2227075d1_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): September 30, 2022

 

SYNTHETIC 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 SYN 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 7.01.   Regulation FD Disclosure.

 

On September 30, 2022, Synthetic Biologics, Inc. (the “Company”) issued a press release announcing an oral presentation entitled “Topotecan enhances oncolytic adenovirus infection, replication and antitumor activity in retinoblastoma,” featuring Dr. Victor Burgueño, Professor at Fundació Sant Joan de Déu at the SIOP 2022 Congress of the International Society of Pediatric Oncology (the “SIOP”), being held in Barcelona, Spain from September 28-October 1, 2022. The new data further support evaluation of VCN-01, an oncolytic adenovirus expressing hyaluronidase, and topotecan for the treatment of refractory retinoblastoma.

 

The information in this Item 7.01 and in the press release furnished 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 and 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.

 

The press release furnished as Exhibit 99.1 to this Current Report on Form 8-K includes “safe harbor” language pursuant to the Private Securities Litigation Reform Act of 1995, as amended, indicating that certain statements contained therein are “forward-looking” rather than historical.

 

Item 8.01.   Other Events. 

 

On September 30, 2022, the Company issued a press release announcing an oral presentation entitled “Topotecan enhances oncolytic adenovirus infection, replication and antitumor activity in retinoblastoma,” featuring Dr. Victor Burgueño, Professor at Fundació Sant Joan de Déu at the SIOP 2022 Congress of the International Society of Pediatric Oncology, being held in Barcelona, Spain from September 28-October 1, 2022. The new data from the study for which Dr. Victor Burgueño is the lead investigator further support evaluation of VCN-01, an oncolytic adenovirus expressing hyaluronidase, and topotecan for the treatment of refractory retinoblastoma. Key data and conclusions showcased in the SIOP presentation include:

 

•VCN-01 treatment in combination with topotecan, but not with carboplatin or melphalan, significantly increased VCN-01 infection and replication in retinoblastoma cells (p=0.0007) in vitro.

•In athymic mice engrafted with human retinoblastomas, topotecan administered systemically after intratumoral VCN-01 increased viral genome replication and the number of VCN-01 infected cells when compared to administration of VCN-01 alone (p = 0.0002).

•Sequential administration of intratumoral VCN-01 followed by systemic topotecan significantly increased median ocular survival, compared to VCN-01 alone (p =0.0364).

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit
Number		   Description
99.1   Press Release issued by Synthetic Biologics, Inc., dated September 30, 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 Current Report on Form 8-K to be signed on its behalf by the undersigned hereunto duly authorized.

 

Dated: September 30, 2022 SYNTHETIC BIOLOGICS, INC.
       
  By: /s/ Steven A. Shallcross
    Name:  Steven A. Shallcross
    Title:

Chief Executive Officer and Chief Financial Officer

 

 

 

 EX-99.1 2 tm2227075d1_ex99-1.htm EXHIBIT 99.1

Exhibit 99.1

 

 

 

Synthetic Biologics Announces Presentation at SIOP International Society of Pediatric Oncology on New Preclinical Data Supporting Evaluation of VCN-01 and Topotecan for the Treatment of Refractory Retinoblastoma

 

- Preclinical results demonstrated that topotecan treatment enhanced VCN-01 oncolytic activity against retinoblastoma-

 

Rockville, MD, September 30, 2022 – Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need, today announced the presentation of new data from collaborators at Fundació Sant Joan de Déu that further support evaluation of VCN-01, an oncolytic adenovirus expressing hyaluronidase, and topotecan for the treatment of refractory retinoblastoma. Preclinical results were featured in an oral presentation at the SIOP 2022 Congress of the International Society of Pediatric Oncology, being held in Barcelona, Spain from September 28-October 1, 2022.

 

“The exciting new data presented at SIOP demonstrate that administration of VCN-01 in combination with topotecan chemotherapy may improve VCN-01 activity against retinoblastoma, ” said Manel Cascallό, Ph.D., General Director of Synthetic Biologics’ European Subsidiary. “These results further underscore VCN-01’s therapeutic potential in chemo-refractory retinoblastoma and will inform our planned clinical study, which is expected to initiate in the second half of 2023. More broadly, these results support the development of our novel OV platform and demonstrate that VCN-01 holds tremendous promise as an adjunct to intravitreal chemotherapy in patients who fail currently available treatments. We remain encouraged by the potential of this novel combination approach to provide superior clinical benefits for devastating cancers with high unmet need.”

 

The oral presentation (#1380), entitled “Topotecan enhances oncolytic adenovirus infection, replication and antitumor activity in retinoblastoma,” featured Dr. Victor Burgueño, Professor at Fundació Sant Joan de Déu and lead investigator of the study. Key data and conclusions showcased in the SIOP presentation include:

 

•VCN-01 treatment in combination with topotecan, but not with carboplatin or melphalan, significantly increased VCN-01 infection and replication in retinoblastoma cells (p=0.0007) in vitro.

•In athymic mice engrafted with human retinoblastomas, topotecan administered systemically after intratumoral VCN-01 increased viral genome replication and the number of VCN-01 infected cells when compared to administration of VCN-01 alone (p = 0.0002).

•Sequential administration of intratumoral VCN-01 followed by systemic topotecan significantly increased median ocular survival, compared to VCN-01 alone (p =0.0364).

 

Details on the presentation can be found below.

 

•Session: (1460 - FPS 07) Retinoblastoma and Germ Cell Tumors

•Date and Time: Friday, September 30, 2022 at 10:40 a.m. CEST

•Location: Barcelona International Convention Center, Room 11

 

 

 

 

 

 

About Synthetic Biologics, Inc.

 

Synthetic Biologics, Inc. (NYSE American: SYN) is a diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need. The Company advanced into oncology through the acquisition of VCN Biosciences, S.L. (VCN), who have developed 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 (a) microbiome damage, (b) Clostridioides difficile infection (CDI), (c) overgrowth of pathogenic organisms, (d) the emergence of antimicrobial resistance (AMR), and (e) 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 Synthetic Biologics' website at www.syntheticbiologics.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 administration of VCN-01 in combination with topotecan chemotherapy improving VCN-01 activity against retinoblastoma, VCN-01’s therapeutic potential in chemo-refractory retinoblastoma, the planned clinical study in retinoblastoma initiating in the second half of 2023 and VCN-01 holding tremendous promise as an adjunct to intravitreal chemotherapy in patients who fail currently available treatments. 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 ability of VCN-01 in combination with topotecan chemotherapy to improve VCN-01 activity against retinoblastoma, the ability of VCN-01 to be an effective therapeutic in chemo-refractory retinoblastoma , Synthetic Biologics' and VCN’s ability to reach clinical milestones when anticipated including initiation of a Phase 2 study in patients with metastatic pancreatic adenocarcinoma in the fourth quarter of 2022 and a clinical study in retinoblastoma in the second half of 2023 , Synthetic Biologics' ability to successfully combine and operate the business of Synthetic Biologics and VCN, Synthetic Biologics' 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 Synthetic Biologics' 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 Synthetic Biologics' and VCN's products, developments by competitors that render such products obsolete or non-competitive, Synthetic Biologics' and VCN's ability to maintain license agreements, the continued maintenance and growth of Synthetic Biologics' and VCN's patent estate, the ability to continue to remain well financed, and other factors described in Synthetic Biologics' Annual Report on Form 10-K for the year ended December 31, 2021 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 Synthetic 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

 

 

 

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Cover
Sep. 30, 2022
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Sep. 30, 2022
Entity File Number 001-12584
Entity Registrant Name SYNTHETIC 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 SYN
Security Exchange Name NYSEAMER
Entity Emerging Growth Company false
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