0000894158 true As previously reported by Synthetic Biologics, Inc. the ("Company") in a Current Report on Form 8-K filed by the Company with the Securities and Exchange Commission (the "SEC") on March 11, 2022 (the "Initial Form 8-K"), the Company closed on March 10, 2022 the previously announced acquisiton (the "Acquisition") of all of the outstanding shares of VCN Biosciences, S.L., a corporation organized under the laws of Spain ("VCN"). On May 6, 2022, the Company filed Amendment No. 1 to the Initial From 8-K to provide the audited financial statements of VCN as of and for the fiscal year ended December 31, 2021 and unaudited pro forma condensed combined financial statements of the Company reflecting the Acquisiton of VCN as of and for the year ended December 31, 2021. This Amendment No. 2 is being filed to include unaudited pro forma condensed combined financial statements of the Company reflecting the Acquisition of VCN as of and for the six months ended June 30, 2022. 0000894158 2022-09-06 2022-09-06 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K/A

 

AMENDMENT NO. 2
TO
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 6, 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. ¨

 

 

 

 

  

Introductory Note

 

As previously reported by Synthetic Biologics, Inc. the (“Company”) in a Current Report on Form 8-K filed by the Company with the Securities and Exchange Commission (the “SEC”) on March 11, 2022 (the “Initial Form 8-K”), the Company closed on March 10, 2022 the previously announced acquisition (the “Acquisition”) of all of the outstanding shares of VCN Biosciences, S.L., a corporation organized under the laws of Spain (“VCN”).

 

On May 6, 2022, the Company filed Amendment No. 1 to the Initial From 8-K to provide the audited financial statements of VCN as of and for the fiscal year ended December 31, 2021 and unaudited pro forma condensed combined financial statements of the Company reflecting the Acquisiton of VCN as of and for the year ended December 31, 2021. This Amendment No. 2 is being filed to include unaudited pro forma condensed combined financial statements of the Company reflecting the Acquisition of VCN as of and for the six months ended June 30, 2022.

 

 

 

 

Item 9.01.   Financial Statements and Exhibits

 

(a) Financial Statements of Businesses Acquired

 

VCN’s audited financial statements as of and for the year ended December 31, 2021 required by Item 9.01(a) of Form 8-K are filed herewith as Exhibit 99.1 and incorporated by reference in this Item 9.01(a).

 

(b) Unaudited Pro Forma Financial Information

 

The pro forma condensed combined financial information of the Company as of and for the year ended December 31, 2021 required by Item 9.01(b) of Form 8-K is filed herewith as Exhibit 99.2 and incorporated by reference in this Item 9.01(b).

 

The pro forma condensed combined financial information of the Company as of and for the six months ended June 30, 2022 required by Item 9.01(b) of Form 8-K is filed herewith as Exhibit 99.3 and incorporated by reference in this Item 9.01(b).

 

(d) Exhibits.

 

The following exhibits are filed with this Amendment No. 2 to Current Report on Form 8-K/A.

 

Exhibit
Number
  Description
     
2.1*   Share Purchase Agreement, by and among Synthetic Biologics, Inc., VCN Biosciences, S.L. and the shareholders of VCN Biosciences, S.L., dated December 14, 2021 (incorporated by reference to the Form 8-K filed with the Securities and Exchange Commission on December 14, 2021 (File No. 001-12584)
     
2.2*   Amendment, dated March 9, 2022, to the Share Purchase Agreement, by and among Synthetic Biologics, Inc., VCN Biosciences, S.L. and the shareholders of VCN Biosciences, S.L., dated December 14, 2021 (incorporated by reference to the Form 8-K filed with the Securities and Exchange Commission on March 11, 2022 (File No. 001-12584)  
     
23.1*   Consent of of KPMG Auditores, S.L. independent auditor  (incorporated by reference to the Form 8-K filed with the Securities and Exchange Commission on May 6, 2022 (File No. 001-12584)
     
99.1*   VCN Biosciences, S.L. audited financial statements as of and for the year ended December 31, 2021 (incorporated by reference to the Form 8-K filed with the Securities and Exchange Commission on May 6, 2022 (File No. 001-12584)
     
99.2*   Synthetic Biologics, Inc. and Subsidiaries Unaudited Pro Forma Condensed Combined Financial Statements as of and for the year ended December 31, 2021 (incorporated by reference to the Form 8-K filed with the Securities and Exchange Commission on May 6, 2022 (File No. 001-12584)
     
99.3   Synthetic Biologics, Inc. and Subsidiaries Unaudited Pro Forma Condensed Combined Financial Statements for the six months ended June 30, 2022
     
104   Cover Page Interactive Data File (embedded within the XBRL document)

 

 * Previously filed.

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Amendment No. 2 to Current Report on Form 8-K/A to be signed on its behalf by the undersigned hereunto duly authorized.

 

Dated: September 6, 2022 SYNTHETIC BIOLOGICS, INC.
       
  By: /s/ Steven A. Shallcross
    Name:  Steven A. Shallcross
    Title:

Chief Executive Officer

and Chief Financial Officer

 

 

 

 

Exhibit 99.3

 

UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL INFORMATION

 

On December 14, 2021, Synthetic Biologics, Inc. (the “Company” or the “Buyer”) entered into a Share Purchase Agreement (the “Agreement” or “SPA”) with VCN Biosciences, S.L. (“VCN”) and each of VCN’s shareholders (the “Sellers ”) pursuant to which the Company would purchase 100% of VCN’s capital stock in exchange for total consideration consisting of $4.7 million (the “Closing Cash Consideration”), 2,639,531 of shares of the Company’s common stock (equal to 19.99% of outstanding shares of common stock on the Closing Date) (the “Closing Shares”) and certain contingent milestone payments of up to $70.25 million payable in cash (the “Milestone Payments” and, collectively with the Closing Cash Consideration and the Closing Shares, the “Total Consideration”). The transaction is hereinafter referred to as the “Acquisition.” The Acquisition closed on March 10, 2022 (the “Closing” or the “Closing Date”).

 

VCN is a private limited company founded in Spain in 2009 and is headquartered in Barcelona. VCN’s operations consist primarily of research and development activities with respect to certain biotechnologies and VCN is in its early stages of development. The Acquisition is legally structured pursuant to Spanish law to result in the tax-free purchase of shares. After the Closing (as defined below), VCN continued its current legal structure as a private limited company (sociedad limitada) formed under the laws of Spain and became a wholly owned subsidiary of Company.

 

The following unaudited pro forma condensed combined statement of operations for the six months ended June 30, 2022 are based on the historical audited financial statements of the Company and VCN. The unaudited pro forma condensed combined statement of operations for the six months ended June 30, 2022 gives effect to the Acquisition as if it had occurred on January 1, 2022. The unaudited pro forma condensed balance sheet as of June 30, 2022 is not required since VCN's results for that period are included in the Company's consolidated balance sheet as of that date. The unaudited pro forma statement of operations for the year ended December 31, 2021 was filed in the Company's Current Report on Form 8-K/A on May 6, 2022.

 

The unaudited pro forma combined financial statements do not necessarily reflect what the combined company’s financial condition or results of operations would have been had the Acquisition occurred on the dates indicated. They also may not be useful in predicting the future financial condition and results of operations of the combined company. The combined company’s actual financial condition and results of operations may differ significantly from the pro forma amounts reflected herein due to a variety of factors.

 

The unaudited pro forma combined financial information herein has been adjusted to depict the accounting of a business combination for the Acquisition (“Transaction Accounting Adjustments”), which reflect the application of the purchase accounting required by U.S. GAAP and SEC rules and regulations, linking the effects of the Acquisition to the historical consolidated financial statements. The unaudited pro forma combined financial information does not present any synergies and other transaction effects that have occurred or are expected to occur (“Management’s Adjustments”) and only presents Transaction Accounting Adjustments. The unaudited pro forma condensed combined financial statements reflect management’s preliminary and best estimate of the fair value of the tangible and intangible assets acquired and liabilities assumed in the Acquisition based on information currently available. Certain valuations and studies necessary to finalize the determination of estimated fair values and estimated useful lives, are incomplete as of the date of this filing. As final valuations are performed, increases or decreases in the unaudited pro forma condensed combined fair value of assets acquired and liabilities assumed may result in adjustments, which may be material, to the balance sheet and/or statements of operations.

 

Certain reclassifications and adjustments were made to VCN’s historical financial statements to conform them to generally accepted accounting principles in the U.S., reclassify VCN’s financial statement presentation to align them with the Company’s presentation, and to translate VCN’s reporting currency (the Euro) to the Company’s reporting currency (the U.S. dollar).

 

 

 

 

   Synthetic Biologics, Inc.
Unaudited Pro Forma Statement of Operations
For the year ended June 30, 2022
(Amounts in thousands)
     
                         
   Synthetic
Biologics, Inc.
Historical
   VCN Biosciences,
S.L. Historical
January 1, 2022 -
March 9, 2022
   Reclassifications
and Basis of Accounting
Adjustments (VCN)
Note 3
   Translation of VCN
Historical Financial
Statements to USD
Reporting Currency
   Transaction
Accounting
Adjustments
   Pro Forma
Combined
 
Operating expenses                              
General and administrative  $3,155   208   -   $235        $3,390 
Research and development   6,082    627    (378)(1)   281    -    6,363 
Total operating expenses   9,237    835    (378)   516    -    9,753 
                               
Operating loss   (9,237)   (835)   378    (516)   -    (9,753)
                               
Other income (expense)                              
Interest and other income   (31)   8    -    9         (22)
Interest and other expense   27    (15)   -    (17)        10 
Total other income (expense)   (4)   (7)   -    (8)   -    (12)
                               
Provision (benefit) for income taxes   -    -    -    -         - 
                               
Net loss  $(9,241)  (842)  378   $(524)  $-   $(9,765)
                               
Net Loss Attributable to Non-controlling Interest   -              -         - 
Net Loss Attributable to Synthetic Biologics, Inc.   (9,241)   (842)   378    (524)   -    (9,765)
                               
Effect of Series A Preferred Stock Price Adjustment   -    -    -    -         - 
Series A and B Preferred Stock Dividends   -    -    -    -         - 
Net Loss Attributable to Common Stockholders  $(9,241)  $(842)  $378   $(524)  $-   $(9,765)
                               
Net loss per common share - basic and diluted  $0.62                       $(0.00)
Weighted average shares outstanding - basic and diluted   14,837,832                        14,837,832 
                               
Net Loss   (9,241)                       (9,765)
Loss on foreign currency translation   (1,317)                       (1,317)
Total comprehensive loss   (10,558)                       (11,082)
Comprehensive loss attributable to non-controlling interest   -                        - 
Comprehensive loss attributable to Synthetic Biologics, Inc. and Subsidiaries  $(10,558)                      $(11,082)

  

 

 

 

NOTES TO UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL STATEMENTS

 

1.Description of Transaction

 

On December 14, 2021, Synthetic Biologics, Inc. (the “Company” or the “Buyer”) entered into a Share Purchase Agreement (the “Agreement” or “SPA”) with VCN Biosciences, S.L. (“VCN”) and each of VCN’s shareholders (the “Sellers ”) pursuant to which the Company would purchase 100% of VCN’s capital stock in exchange for total consideration consisting of $4.7 million (the “Closing Cash Consideration”), 26,395,303 of shares of the Company’s common stock (equal to 19.99% of outstanding shares of common stock on the Closing Date) (the “Closing Shares”) and certain contingent milestone payments of up to $70.25 million payable in cash (the “Milestone Payments” and, collectively with the Closing Cash Consideration and the Closing Shares, the “Total Consideration”). The transaction is hereinafter referred to as the “Acquisition.” The Acquisition closed on March 10, 2022 (the “Closing” or the “Closing Date”).

 

VCN is a private limited company founded in Spain in 2009 and is headquartered in Barcelona. VCN’s operations consist primarily of research and development activities with respect to certain biotechnologies and VCN is in its early stages of development. The Acquisition is legally structured pursuant to Spanish law to result in the tax-free purchase of shares. After the Closing (as defined below), VCN continued its current legal structure as a private limited company (sociedad limitada) formed under the laws of Spain and became a wholly owned subsidiary of Company.

 

2.Basis of Presentation

 

The unaudited pro forma condensed combined financial statements were prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) and the regulations of the U.S. Securities and Exchange Commission (the “SEC”) and are intended to show how the Acquisition might have affected the historical financial statements if the Acquisition had been completed on January 1, 2022 for the purpose of the statement of operations for the six months ended June 30, 2022.

 

The Acquisition will be accounted for as a business combination, with the Company treated as the “acquirer” and VCN treated as the “acquired” company for financial reporting purposes. Under the acquisition method of accounting, the total estimated purchase price of an acquisition allocated to the net tangible and intangible assets is based on their estimated fair values. Such valuations are based on available information and certain assumptions that management believes are reasonable. The preliminary allocation of the purchase price to the tangible and intangible

assets acquired and liabilities assumed is based on various preliminary estimates. Accordingly, the pro forma adjustments are preliminary and have been made solely for the purpose of providing this unaudited pro forma combined financial information. Differences between these preliminary estimates and the final acquisition accounting may occur and these differences could be material. The differences, if any, could have a material impact on the accompanying unaudited pro forma condensed combined financial information and the Company’s future results of operations and financial position.

 

The unaudited pro forma condensed combined financial information includes certain reclassifications to conform the historical financial statement presentation of VCN to the Company. See “Note 3 – Reclassifications and Conforming Basis Adjustments” herein for additional information on the reclassifications.

 

Certain disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted in these unaudited pro forma condensed combined financial statements as permitted by SEC rules and regulations.

 

 

 

 

3.Reclassifications and Conforming Basis Adjustments

 

An adjustment is presented in the accompanying pro forma financial statements, as follows:

 

(1)To adjust research and development expense for the settlement of pre-existing loan expensed by Grifols which is accounted for as part of GAAP purchase consideration

 

All VCN statement of operations amounts have been translated into the Company’s U.S. dollar reporting currency using the average exchange rates for the six months ended June 30, 2022.

 

There are no Transaction Accounting Adjustments required for the six months ended June 30, 2022.

 

4.Net Loss Per Share

 

Pro forma net loss attributable to common stockholders as originally reported for the six month ended June 30,2022 is adjusted for the pro forma impacts of the Acquisition. Basic and diluted weighted average shares outstanding as originally reported are adjusted to reflect the effects of the issuance of 2,639,531 shares of common stock to the Sellers as of January 1, 2022.