0001104659-22-089034.txt : 20220811 0001104659-22-089034.hdr.sgml : 20220811 20220811081550 ACCESSION NUMBER: 0001104659-22-089034 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20220811 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20220811 DATE AS OF CHANGE: 20220811 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: 221153806 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 tm2223026d1_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): August 11, 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 2.02. Results of Operations and Financial Condition.

 

On August 11, 2022, Synthetic Biologics, Inc., a Nevada corporation (the “Registrant”) issued a press release that included financial information for its quarter ended June 30, 2022. A copy of the press release is attached as Exhibit 99.1 to this Report on Form 8-K. The information contained in the press release is being furnished to the Securities and Exchange Commission (the “Commission”) and shall not be deemed incorporated by reference into any of the Registrant’s registration statements or other filings with the Commission.

 

Item 9.01.Financial Statements and Exhibits.

 

(d)   Exhibits.

 

Exhibit
Number		   Description
99.1   Press Release issued by Synthetic Biologics, Inc., dated August 11, 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: August 11, 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 tm2223026d1_ex99-1.htm EXHIBIT 99.1

Exhibit 99.1

 

 

 

 

Synthetic Biologics Reports Second Quarter 2022 Operational Highlights and Financial Results

 

-Prioritizing the advancement of novel oncolytic adenovirus (OV) platform-

 

-Cash balance as of August 1, 2022 of $53.5 million, including the additional $3 million in gross proceeds from convertible preferred financing extends funding for business operations into Q1 2024-

 

-Conference call and webcast to be held today at 8:30 a.m. ET-

 

Rockville, MD, August 11, 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 reported financial results for the second quarter ended June 30, 2022, and provided a corporate update.

 

“We are pleased with the steady progress that continues to support the advancement of our novel OV platform and further underscores the potential value of our lead candidate, VCN-01, designed to address devastating cancers with high unmet need through a differentiated and potentially transformative mechanism of action,” said Steven A. Shallcross, Chief Executive Officer of Synthetic Biologics. “We have made the strategic decision to rationalize our spend and prioritize our oncology program, which is expected to extend cash runway into the first quarter of 2024. We believe this sharpened approach has the potential to drive near-term value for our shareholders and propel us forward to key milestones, including the initiation of our Phase 2 study in patients with metastatic pancreatic adenocarcinoma in the fourth quarter of 2022 and our Phase 2/3 study in retinoblastoma in the second half of 2023.”

  

Recent Program Developments:

 

·The acquisition of VCN Biosciences transformed Synthetic Biologics’ pipeline with the addition of VCN's lead clinical-stage drug candidate, VCN-01, an intravenous oncolytic adenovirus (OV), as well as preclinical stage VCN-11, which incorporates a proprietary albumin binding domain in the virus shell which is intended to improve systemic delivery by enabling the virus to coat itself in albumin and thereby evade neutralizing antibodies (NAbs).
·Initiated the investigator sponsored Phase 1, open-label, non-randomized clinical trial evaluating VCN-01 in combination with mesothelin-directed lentiviral transduced human chimeric antigen receptor modified T cells (huCART-meso) for patients with pancreatic and serous epithelial ovarian cancers (NCT05057715).

 

Corporate Update:

 

·On July 25, 2022, the Company’s common stock began trading on a split-adjusted basis. The Company’s common stock continues to trade on the NYSE American under the stock ticker “SYN” but under the new CUSIP number 87164U409.

 

   

 

 

 

Anticipated Milestones:

VCN-01

 

·Initiation of VCN-01 dosing in an investigator sponsored study of brain tumors at the University of Leeds (H2 2022).

·Data from the VCN-01 Phase 1 investigator sponsored study in and head and neck cancer to be presented at a major medical meeting (Q3 2022)  
·Initiation of 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 Phase 2/3 study of VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma (H2 2023).

 

SYN-004

 

·Topline data read out from the first cohort of the SYN-004 study in allo-HCT patients (H2 2022) followed by initiation of the second cohort (Q4 2022).

   

Quarter Ended June 30, 2022 Financial Results

 

General and administrative expenses increased to $1.5 million for the three months ended June 30, 2022, from $1.3 million for the three months ended June 30, 2021. This increase of 19% primarily comprised of increased consulting and legal costs related to the VCN acquisition, higher insurance costs, audit fees, and public relations expenses and VCN administrative expenses not included in prior year. The charge related to stock-based compensation expense was $86,000 for the three months ended June 30, 2022, compared to $83,000 the three months ended June 30, 2021.

  

Research and development expenses increased to $3.5 million for the three months ended June 30, 2022, from approximately $1.9 million for the three months ended June 30, 2021. This increase of 80% 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 expense for SYN-020, costs incurred related to our Phase 1a clinical trial of SYN-020 and expenses related to our Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients. We anticipate research and development expense to increase as we plan for and initiate enrollment for our phase 2 clinical trial for VCN-01 in PDAC, phase 2/3 clinical trial in retinoblastoma, expand GMP manufacturing activities for VCN-01, and continue with supporting our VCN-11 and other preclinical and discovery initiatives. The charge related to stock-based compensation expense was $27,000 for the three months ended June 30, 2022, compared to $19,000 related to stock-based compensation expense for the three months ended June 30, 2021.

 

Other income was $17,000 for the three months ended June 30, 2022 compared to other income of $2,000 for the three months ended June 30, 2021. Other income for the three months ended June 30, 2022 is primarily comprised of interest income of $26,000 offset by an exchange loss of $9,000. Other income for the three months ended June 30, 2021 is primarily comprised of interest income.

 

Cash and cash equivalents totaled $52.3 million as of June 30, 2022, compared to $67.3 million as of December 31, 2021. Cash and cash equivalents totaled approximately $53.5 million as of August 1, 2022.

 

On July 29, the company closed a private placement of Series C and Series D convertible preferred stock with MSD Credit Opportunity Master Fund, L.P. Total gross proceeds from the offerings, before deducting discounts, financial advisor fees and other estimated offering expenses, were $3 million.

 

   

 

 

 

 

Conference Call

 

Synthetic Biologics will host a conference call at 8:30 a.m. ET today to review second quarter 2022 operational highlights and financial results. Investors may participate in the live call via telephone by dialing (800) 289-0571 (domestic) or (929) 477-0324 (international) and using the conference ID: 7145566. 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.syntheticbiologics.com, under “Events” or by clicking here, for 90 days after the call.

 

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 recently consummated the acquisition of VCN Biosciences, S.L. (VCN), which is developing a new oncolytic adenovirus (OV) 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 initiation of VCN-01 dosing in an investigator sponsored study of brain tumors at the University of Leeds (H2 2022), initiation of 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 Phase 2/3 study of VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma (H2 2023), topline data read out from the first cohort of the SYN-004 study in allo-HCT patients followed by initiation of the second cohort (H2 2022), the potential value of VCN-01, designed to address devastating cancers with high unmet need through a differentiated and potentially transformative mechanism of action, extending the cash runway into the first quarter of 2024 and the potential to drive near-term value for shareholders and propel Synthetic Biologics forward to key milestones, including the initiation of a Phase 2 study in patients with metastatic pancreatic adenocarcinoma in the fourth quarter of 2022 and a Phase 2/3 study in retinoblastoma in late 2023 and research and development expense increasing as Synthetic Biologics plans for and initiates enrollment for its phase 2 clinical trial for VCN-01 in PDAC, phase 2/3 clinical trial in retinoblastoma, expands GMP manufacturing activities for VCN-01, and continues with supporting our VCN-11 and other preclinical and discovery initiatives. 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, Synthetic Biologics' ability to reach clinical milestones when anticipated, 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

 

   

 

 

 

 

Synthetic Biologics, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

(In thousands except share and par value amounts)

 

   June 30, 2022   December 31, 2021 
Assets          
           
Current Assets          
Cash and cash equivalents  $52,266   $67,325 
Prepaid expenses and other current assets   2,622    1,533 
Total Current Assets   54,888    68,858 
           
Non-Current Assets          
Property and equipment, net   285    101 
Restricted cash   96    — 
Right of use asset   1,292    1,383 
In-process research and development   20,562    — 
Goodwill   5,185    — 
Deposits and other assets   23    23 
           
Total Assets  $82,331   $70,365 
           
Liabilities and Stockholders' Equity          
           
Current Liabilities:          
Accounts payable  $1,003   $524 
Accrued expenses   1,987    1,928 
Accrued employee benefits   788    978 
Contingent consideration, current portion   9,302    — 
Loans Payable-current   56    — 
Operating lease liability   128    124 
Total Current Liabilities   13,264    3,554 
           
Non-current Liabilities          
Non-current contingent consideration   2,374    — 
Loan Payable - Long term   216    — 
Deferred tax liabilities, net   3,505    — 
Lease liability - Long term   1,298    1,403 
Total Liabilities   20,657    4,957 
           
Commitments and Contingencies          
Stockholders' Equity (Deficit):          
Common stock, $0.001 par value; 20,000,000 shares authorized, 15,844,294 issued and 15,844,061 outstanding at June 30, 2022 and 13,204,487 issued and 13,204,254 outstanding at December 31, 2021   16    13 
Additional paid-in capital   343,500    336,679 
Accumulated other comprehensive loss   (1,317)   — 
Accumulated deficit   (280,525)   (271,284)
Total Stockholders' Equity   61,674    65,408 
           
Total Liabilities and Stockholders' Equity  $82,331   $70,365 

  

   

 

 

 

  

Synthetic Biologics, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations

(In thousands except share and par value amounts)

 

   For the three months ended June 30,   For the six months ended June 30, 
   2022   2021   2022   2021 
Operating Costs and Expenses:                    
General and administrative  $1,500   $1,265   $3,155   $2,685 
Research and development   3,485    1,932    6,082    3,049 
Total Operating Costs and Expenses   4,985    3,197    9,237    5,734 
                     
Loss from Operations   (4,985)   (3,197)   (9,237)   (5,734)
                     
Other Expense:                    
Exchange loss   (9)   —    (31)   — 
Interest income   26    2    27    2 
Total Other Income(Expense)   17    2    (4)   2 
                     
Net Loss   (4,968)   (3,195)   (9,241)   (5,732)
                     
Net Loss Attributable to Non-controlling Interest   —    —    —    (1)
                     
Net Loss Attributable to Synthetic Biologics, Inc. and Subsidiaries  $(4,968)  $(3,195)  $(9,241)  $(5,731)
                     
Series A Preferred Stock Dividends   —    —    —    (24)
Effect of Series A Preferred Stock price adjustment   —    —    —    (7,402)
Series B Preferred Stock Dividends   —    —    —    (1,497)
                     
Net Loss Attributable to Common Stockholders  $(4,968)  $(3,195)  $(9,241)  $(14,654)
                     
Net Loss Per Share - Basic and Dilutive  $(0.31)  $(0.24)  $(0.62)  $(1.31)
                     
Weighted average number of shares outstanding during the period - Basic and Dilutive   15,844,016    13,204,254    14,837,832    11,153,902 
                     
Net Loss   (4,968)   (3,195)   (9,241)   (5,732)
Loss on foreign currency translation   (1,497)   —    (1,317)   — 
Total comprehensive loss   (6,465)   (3,195)   (10,558)   (5,732)
Comprehensive loss attributable to non-controlling interest   —    —    —    (1)
Comprehensive loss attributable to Synthetic Biologics, Inc. and Subsidiaries   (6,465)   (3,195)   (10,558)   (5,731)

 

   

 

 

 

 

 

 

 

 

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Cover
Aug. 11, 2022
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Aug. 11, 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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