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 5, 2018

 

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, MD 20850

(Address of principal executive offices and zip code)

 

Registrant’s telephone number, including area code: (301) 417-4364

 

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:

 

¨ 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))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§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 1.01. Entry into a Material Definitive Agreement.

 

On September 5, 2018, Synthetic Biologics, Inc. (the “Company”), entered into an agreement with Cedars-Sinai Medical Center (CSMC) for an investigator-sponsored Phase 2 clinical study of SYN-010 to be co-funded by the Company and CSMC (the “Study”). The Study will provide further evaluation of the efficacy and safety of SYN-010, the Company’s modified-release reformulation of lovastatin lactone, which is exclusively licensed to the Company by CSMC. SYN-010 is designed to reduce methane production by certain microorganisms ( M. smithii ) in the gut to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C).

 

In consideration of the support provided by CSMC for the Study, the Company entered into a Stock Purchase Agreement with CSMC pursuant to which the Company has agreed upon the approval of the Study protocol by the Institutional Review Board to: (i) issue to CSMC Fifty Thousand (50,000) shares of common stock of the Company; and (ii) transfer to CSMC an additional Two Million Four Hundred Twenty Thousand (2,420,000) shares of common stock of its subsidiary Synthetic Biomics, Inc. (“Synbiomics”) owned by the Company, such that after such issuance CSMC will own an aggregate of Seven Million Four Hundred Eighty Thousand (7,480,000) shares of common stock of Synbiomics, representing seventeen percent (17%) of the issued and outstanding shares of Synbiomics’ common stock. 

 

The Stock Purchase Agreement also provides CSMC with a right, commencing on the six month anniversary of issuance of the stock under certain circumstances in the event that the shares of stock of Synbiomics are not then freely tradeable, and subject to NYSE American, LLC approval, to exchange its Synbiomics shares for unregistered shares of the Company’s common stock, with the rate of exchange based upon the relative contribution of the valuation of Synbiomics to the public market valuation of the Company at the time of each exchange. The Stock Purchase Agreement also provides for tag-along rights in the event of the sale by the Company of its shares of Synbiomics.

 

On September 6, 2018, the Company issued the press release attached hereto as Exhibit 99.1 regarding the agreements described herein.

 

Item 3.02. Unregistered Sales of Equity Securities.

 

The information regarding the shares of Company set forth under Item 1.01 of this Current Report on Form 8-K is incorporated by reference in this Item 3.02. The Company issued to CSMC the shares of the Company’s common stock in reliance on the exemption from registration provided for under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). The Company relied on this exemption from registration for private placements based in part on the representations made by CSMC, including the representations with respect to CSMC’s status as an “accredited investor,” as such term is defined in Rule 501(a) of the Securities Act, and CSMC’s investment intent.

 

Item 8.01 Other Events

 

The Company today issued a press release announcing that the Company has entered into an agreement with Cedars-Sinai Medical Center for an investigator-sponsored Phase 2 clinical study of SYN-010. The study will provide further evaluation of the efficacy and safety of SYN-010, the Company’s modified-release reformulation of lovastatin lactone, which is exclusively licensed to the Company by Cedars-Sinai Medical Center. SYN-010 is designed to reduce methane production by certain microorganisms ( M. smithii ) in the gut to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C).

 

The Phase 2 study will be conducted out of the Pimentel Laboratory at Cedars-Sinai Medical Center and is expected to be comprised of a 12-week, placebo-controlled, double-blind, randomized clinical trial to evaluate two dose strengths of oral SYN-010 (21 mg and 42 mg) in approximately 150 patients diagnosed with IBS-C. The investigator-sponsored Phase 2 clinical study will be led by the gastrointestinal microbiota researcher Ruchi Mathur, M.D., director of Metabolism, Clinical Research and Administrative Operations at the Medically Associated Science and Technology (MAST) Program at CSMC. The Phase 2 study, which will be co-funded by the Company and CSMC, is expected to begin enrollment during the fourth quarter of 2018, contingent upon approval of the clinical study protocol by CSMC’s Institutional Review Board. Both CSMC and Dr. Pimentel have a financial interest in the Company.

 

 

 

 

The primary objective for the study will be to determine the efficacy of SYN-010, measured as an improvement from baseline in the weekly average number of complete spontaneous bowel movements (CSBMs) during the 12-week treatment period for SYN-010 21 mg and 42 mg daily doses relative to placebo. Secondary efficacy endpoints for both dose strengths of SYN-010 are expected to measure changes from baseline in abdominal pain, bloating, stool frequency as well as the use of rescue medication relative to placebo. Exploratory outcomes include Adequate Relief and quality of life measures using the well-validated EQ-5D-5L and PAC-SYM patient questionnaires.

 

Item 9.01.   Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit

No.

  Description
     
10.1   Stock Purchase Agreement between Synthetic Biologics, Inc., and Cedars-Sinai Medical Center dated September 5, 2018
99.1   Synthetic Biologics, Inc. press release dated September 6, 2018

 

 

 

 

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: September 6, 2018 SYNTHETIC BIOLOGICS, INC.
  (Registrant)
     
  By: /s/ Steven Shallcross
    Name: Steven Shallcross
    Title: Interim Chief Executive Officer and Chief Financial Officer

 

 

 

Exhibit 10.1

 

STOCK PURCHASE AGREEMENT

 

THIS STOCK PURCHASE AGREEMENT (this “ Agreement ”) is made and entered into as of September 5, 2018 (the “ Effective Date ”), by and among Synthetic Biologics, Inc., a Nevada corporation (the “ Company ”), Synthetic Biomics, Inc., a Nevada corporation and wholly-owned subsidiary of the Company (“ Synbiomics ”), and Cedars-Sinai Medical Center, a California nonprofit public benefit corporation (“ CSMC ”).

 

A. The Company and Synbiomics have entered into an exclusive license agreement with CSMC dated December 5, 2013 (the “ License Agreement ”), in which CSMC has licensed the rights to certain technology to Synbiomics;

 

B. CSMC currently owns 5,060,000 shares of the common stock of Synbiomics, representing 11.5% of the issued and outstanding capital stock of Synbiomics (the “ Initial CSMC Shares ”);

 

C. Company and CSMC have entered into the Investigator-Initiated Trial Research Agreement dated September 5, 2018 to be conducted by CSMC (the “ Trial ”), the costs of which will be shared by the Company and CSMC; and

 

D. In consideration of the support to be provided by CSMC for the Trial as set forth in the Investigator-Initiated Trial Research Agreement dated September 5, 2018, the Company has agreed to (i) issue to CSMC Fifty Thousand (50,000) shares of common stock of the Company (the “ SYN Shares ”); and (ii) transfer to CSMC an additional Two Million Four Hundred Twenty Thousand (2,420,000) shares of common stock of Synbiomics owned by the Company (the “ New Shares ”), such that after such issuance CSMC shall own an aggregate of Seven Million Four Hundred Eighty Thousand (7,480,000) shares of common stock of Synbiomics, representing seventeen percent (17%) of the issued and outstanding shares of Synbiomics’ common stock (the New Shares together with the Initial CSMC Shares being referred to as the “ CSMC Shares ”).

 

AGREEMENT

 

In consideration of the mutual covenants contained in this Agreement and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties hereby agree as follows:

 

sECTION 1.     AUTHORIZATION OF SALE OF SYN SHARES AND TRANSFER OF NEW SHARES ; ANTI-DILUTION; EXCHANGE OF CSMC SHARES.

 

1.1               Authorization . Subject to the terms and conditions of this Agreement, the Company has duly authorized the issuance to CSMC, of the SYN Shares, and the transfer to CSMC, of the New Shares, in consideration of the support to be provided by CSMC for the Trial, which shares shall represent five and a half percent (5.5%) of Synbiomics’ issued and outstanding capital stock on a Fully-Diluted Basis on the Issue Date (as defined below). For purposes of this Agreement, the term “ Fully Diluted Basis ” shall include all of the issued and outstanding equity securities of Synbiomics (including, without limitation, all common stock, preferred stock and units of any kind) calculated on an “as-converted” basis plus all outstanding options, warrants and other securities exercisable or exchangeable for or convertible into equity securities of Synbiomics calculated on an “as-converted” basis plus any securities issued under any stock plan or other equity incentive plan or arrangement of Company then in effect or contemplated calculated on an “as-converted” basis.

 

 

 

 

1.2               Exchange of CSMC Shares .

 

(a)                Commencing on the six (6) month anniversary of the Issue Date, if the CSMC Shares are not then freely tradeable, CSMC shall have the right to exchange all or any portion of the CSMC Shares then held by CSMC (such shares, the “ Exchange Shares ”) for shares of common stock, $0.001 par value, of the Company (“ Company Stock ”) pursuant to the terms set forth in this Section 1.2 by delivering a written notice to the Company (the “ Exchange Notice ”) at least ninety (90) days prior to any such proposed exchange. The right of CSMC to exchange the Exchange Shares is referred to as the “ Exchange Right .” The number of shares of Company Stock for which the Exchange Shares may be exchanged shall equal the quotient obtained by dividing (i) the aggregate Fair Market Value of the Exchange Shares to be exchanged as determined in accordance with Section 1.2(c) below by (ii) the Current Market Price of a single share of Company Stock as determined in accordance with Section 1.2(d) below. The parties intend to allow CSMC to exercise the Exchange Right no more than two (2) times during any twelve month period.

 

(b)               Unless the parties involved mutually agree otherwise, delivery to the Company of the share certificates representing the Exchange Shares to be exchanged pursuant to this Section 1.2 shall take place at a closing (each, an “ Exchange Closing ”) to be held at the offices of Gracin & Marlow, LLP, The Chrysler Building, 405 Lexington Avenue, 26th Floor, New York, New York 10174 at 10:00 a.m. (Eastern Time)or at such other place as the Company and CSMC may agree at 10:00 a.m. within two (2) calendar days following approval of the NYSE American Stock Exchange LLC (the “ NYSE American ”) with respect to such issuance. The Company shall promptly apply to the NYSE American or any exchange upon which the Company’s shares are then listed for approval of the issuance of the Company Stock to CSMC after the determination of the applicable Fair Market Value for the Exchange Shares to be exchanged pursuant to this Section 1.2 and every exchange shall be subject to approval of the NYSE American or any exchange upon which the Company’s shares are then listed. Immediately prior to the transfer of title to the Exchange Shares, to be exchanged at an Exchange Closing and issuance of Company Stock, CSMC shall provide the representations and warranties set forth in this Agreement as well as representations and warranties as to CSMC’s good and marketable title to the Exchange Shares and the absence of any liens, security interests or adverse claims of any kind arising by, through or under CSMC, all as of a recent date. It shall be a condition to CSMC’s transfer of title to the Exchange Shares, to be exchanged at an Exchange Closing that each of the representations and warranties of the Company and Synbiomics in this Agreement shall be true and correct as of the date of the applicable Exchange Closing, except for representations and warranties that speak as of a particular date, which shall be true and correct as of such date, and the Company shall deliver to CSMC a certificate signed by its Chief Executive Officer on behalf of the Company, dated as of the applicable Exchange Closing, certifying that such condition has been satisfied. CSMC agrees that as a condition to its receipt of any Company Stock pursuant to the terms of this Section 1.2 that it will enter into a customary “lockup” or “market standoff” agreement with a term no longer than six (6) months in a form reasonably satisfactory to the Company, and such agreement shall include customary exceptions including for transfers to affiliates. No fractional shares or scrip representing fractional shares shall be issued upon the exchange of any Exchange Shares pursuant to this Section 1.2. As to any fraction of a share which CSMC would otherwise be entitled to purchase upon such exchange, the Company shall, at its election, either pay a cash adjustment in respect of such final fraction in an amount equal to such fraction multiplied by the Current Market Price of a share of Company Stock or round up to the next whole share.

 

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(c)                The “ Fair Market Value ” of the Exchange Shares shall be determined based primarily upon the relative contribution of the valuation of Synbiomics to the public market capitalization of Company and as provided in this Section 1.2(c). Upon the Company’s receipt of an Exchange Notice, CSMC and the Company shall forthwith attempt to agree upon the Fair Market Value of the Exchange Shares. If CSMC and the Company cannot agree on the Fair Market Value of the Exchange Shares within ten (10) days of the Company’s receipt of the Exchange Notice then CSMC and the Company shall, within ten (10) days of the end of such initial 10-day period (such period, the “ Mutual Selection Period ”), choose one mutually acceptable qualified independent appraiser to determine the Fair Market Value of the Exchange Shares and such appraiser shall deliver its written appraisal within twenty (20) days of the date of its selection and the Fair Market Value of the Exchange Shares shall be as set forth in such appraisal. If CSMC and the Company cannot agree on a mutually acceptable qualified independent appraiser within the Mutual Selection Period, then CSMC and the Company shall select a qualified independent appraiser to determine the Fair Market Value of the Exchange Shares within five (5) days after the end of the Mutual Selection Period. The appraisers so selected shall attempt to agree to the Fair Market Value of the Exchange Shares. If they are unable to do so within twenty (20) days of the date of selection of the last of the appraisers selected, they shall furnish each party with their respective written appraisals within thirty (30) days of the date of selection of the last of the appraisers selected, which written appraisals shall set forth the Fair Market Value of the Exchange Shares. If each valuation is within ten percent (10%) of the other valuation, the Fair Market Value shall be the numerical average (mean) of both valuations. If each valuation is not within ten percent (10%) of the other valuation, then the two appraisers, within ten (10) days after submitting their respective valuations, shall mutually select and appoint a third appraiser, similarly qualified, and give written notice of that appointment to the Company and CSMC. Within thirty (30) days after the appointment of the third appraiser, the third appraiser shall submit in writing its determination of the Fair Market Value of the Exchange Shares. Thereafter, the Fair Market Value of the Exchange Shares shall be the numerical average (mean) of the two (2) valuations which are numerically closest together, unless one of the values is the numerical average (mean) of the three (3) values, in which case such value shall be the Fair Market Value. The Fair Market Value, as determined above, shall be conclusive, final and binding upon the Company and CSMC. If either the Company or CSMC shall fail to appoint an appraiser within five (5) days after the end of the Mutual Selection Period referred to above, then, the appraiser appointed by the party which does appoint an appraiser shall alone determine the Fair Market Value of the Exchange Shares, and such appraisal shall be binding. Any appraiser appointed in accordance with this Section 1.2(c) shall value Synbiomics as a going concern and shall not apply any illiquidity and minority discount to the Exchange Shares. Each party shall compensate the appraiser appointed by such party, and the compensation of the first, mutually acceptable appraiser and the third appraiser, if any, and the expenses of the related appraisal shall be borne equally by the Company and CSMC. Company shall have no lost opportunity liability to CSMC for CSMC’s decision to exchange or not exchange the Exchange Shares, or any delays or disputes associated with the valuation process and subsequent price fluctuations of the public market price of the Company Stock.

 

(d)               The “ Current Market Price ” of a share of Company Stock shall be determined as provided in this Section 1.2(d). If the Company Stock is traded regularly in a public market, the fair market value of a share of Company Stock shall be the average of the closing prices of the Company Stock over a five (5) trading day period ending three (3) days before the applicable Exchange Closing. If the Company Stock is not regularly traded in a public market, the Board of Directors of the Company shall determine fair market value in its reasonable good faith judgment.

 

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1.3               Tag Along Rights . CSMC shall have tag-along rights with respect to the CSMC Shares in the event that the Company proposes to sell, transfer or otherwise dispose of any of the Company’s shares of Synbiomics’ capital stock. If the Company proposes to engage, directly or indirectly, in a sale, transfer or other disposition (a “ Sale ”) of any shares of Synbiomics’ capital stock (the “ Offered Shares ”), and the Company receives a bona fide written offer (the “ Purchase Offer ”) from a person (the “ Offeror ”) to purchase the Offered Shares for a purchase price (the “ Offer Price ”) denominated and payable in United States dollars at closing or according to specified terms, with or without interest before making such a transfer, the Company shall, prior to consummating any Sale contemplated by this Section 1.3, immediately give to CSMC written notice (such notice being referred to herein as the “ Notice of Transfer ”) setting froth the price and the terms of payment, and any other material terms of such proposed Sale. The Notice of Transfer shall constitute an offer by the Company to CSMC to permit CSMC to sell its shares of Synbiomics in the proposed Sale, for the same price and form of consideration to be received by the Company and otherwise upon the terms and subject to the conditions set forth in the Notice of Transfer, on a pro rata basis with the Company (based on respective shares of Synbiomics capital stock). For a period of twenty (20) days following receipt of the Notice of Transfer, CSMC may, by delivering to the Company written notice of its election, elect irrevocably to participate as a seller in such proposed Sale on a pro rata basis with the Company. If CSMC fails to respond within such 20-day period, CSMC shall be deemed to have elected not to participate in the proposed Sale and shall have waived any and all rights under this Section with respect thereto. Within ten (10) days of the expiration of such 20-day period, the Company may consummate the transaction proposed in the applicable Purchase Offer and Notice of Transfer. Any such Synbiomics capital stock not so ttransferred during such 10-day period shall thereafter again be subject to the tag-along rights of CSMC set forth in this Section 1.3.

 

1.4               Exchange Approval . Subject to the provisions of Section 6.1 below, the parties acknowledge that any issuance of stock by the Company of its common stock, including with respect to the share exchanges referred to above, is subject to the prior approval of the NYSE American or any other exchange upon which the shares of the Company are listed and if required by such exchange or any other rule or regulation applicable to Synbiomics or the Company, shareholder approval.

 

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sECTION 2.     CLOSING AND DELIVERY

 

2.1               Issuance of Shares . Subject to the terms and conditions of this Agreement and in reliance upon the representations, warranties and agreements contained herein, on the later of approval from the CSMC Institutional Review Board of the Trial and NYSE American approval of the issuance of the SYN Shares(the “Issue Date”) the Company will issue to CSMC the SYN Shares and will transfer to CSMC the New Shares, and CSMC will acquire from the Company, the SYN Shares and the New Shares.

 

2.2               Closing . The closing of the purchase and sale of the SYN Shares and New Shares to be issued pursuant to Section 2.1 of this Agreement shall be held at the offices of Gracin & Marlow, LLP, The Chrysler Building, 405 Lexington Avenue, 26 th Floor, New York, New York 10174 or at such other place as the Company and CSMC may mutually agree on simultaneously with the execution of this Agreement.

 

2.3               Delivery of the SYN Shares and New Shares . Promptly following the Issue Date the Company shall cause to be delivered to CSMC certificates representing the number of SYN Shares and New Shares purchased hereunder, registered in the name of CSMC.

 

sECTION 3.     REPRESENTATIONS AND WARRANTIES OF THE COMPANY AND SYNBIOMICS .

 

Subject to and except as set forth in the SEC Documents (as defined below), the Company and Synbiomic, jointly and severally, hereby represent and warrants to CSMC as of the date hereof as follows:

 

3.1               Organization, Good Standing and Power . The Company is a corporation duly incorporated, validly existing and in good standing under the laws of the State of Nevada and has the requisite corporate power to own, lease and operate its properties and assets and to conduct its business as it is now being conducted and as described in the reports filed by the Company with the Securities and Exchange Commission (the “ Commission ”) pursuant to the reporting requirements of the Securities Exchange Act of 1934, as amended (the “ Exchange Act ”), since the end of its most recently completed fiscal year through the date hereof, including, without limitation, its most recent Quarterly Report on Form 10-Q. Synbiomics is a corporation wholly owned by the Company and duly incorporated, validly existing and in good standing under the laws of the State of Nevada with the requisite corporate power to own, lease and operate its properties and assets and to conduct its business as it is now being conducted. Other than Synbiomics and those subsidiaries identified in its most recent Quarterly Report on Form 10-Q, the Company does not have any subsidiaries. Each of the Company and Synbiomics is qualified to do business as a foreign corporation and is in good standing in every jurisdiction in which the nature of the business conducted or property owned by it makes such qualification necessary, except for any jurisdiction(s) (alone or in the aggregate) in which the failure to be so qualified will not have a Material Adverse Effect. For the purposes of this Agreement, “ Material Adverse Effect ” means any effect on the business, operations, properties or financial condition of the Company or Synbiomics, as applicable, that is material and adverse to the Company or Synbiomics, as applicable, taken as a whole, and any condition, circumstance or situation that would prohibit the Company or Synbiomics, as applicable, from entering into and performing any of its obligations hereunder.

 

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3.2               Authorization; Enforcement . Each of the Company and Synbiomics has the requisite corporate power and authority to enter into and perform this Agreement and the Company has the requisite power and authority to issue and sell the SYN Shares and transfer the New Shares in accordance with the terms hereof. The execution, delivery and performance of this Agreement by the Company and Synbiomics and the consummation by each of the transactions contemplated hereby have been duly and validly authorized by all necessary corporate action, and no further consent or authorization of the Company, Synbiomics, either of its board of directors or stockholders is required for the issuance of the SYN Shares or the transfer of the New Shares, the issuance of the Company Stock or the consummation of the transactions contemplated hereby. When executed and delivered by the Company and Synbiomics, this Agreement shall constitute a valid and binding obligation of the Company and Synbiomics enforceable against each in accordance with its terms, except as such enforceability may be limited by applicable bankruptcy, reorganization, moratorium, liquidation, conservatorship, receivership or similar laws relating to, or affecting generally the enforcement of, creditor’s rights and remedies or by other equitable principles of general application.

 

3.3               Issuance/Transfer of SYN Shares, New Shares and Company Stock . The issuance of the SYN Shares and transfer of the New Shares have been duly authorized by all necessary corporate action and, when issued or transferred, as applicable, in accordance with the terms hereof, will be validly issued, fully paid and nonassessable. In addition, when issued the SYN Shares and the New Shares and Company Stock, as applicable, will be free and clear of all liens, claims, charges, security interests or agreements, pledges, assignments, covenants, restrictions or other encumbrances created by, or imposed by, Synbiomics or the Company and rights of first refusal of any kind imposed by Synbiomics or the Company, as applicable (other than restrictions on transfer under applicable securities laws) and the holder of the SYN Shares, New Shares or Company Stock, as applicable, shall be entitled to all rights accorded to a holder of common stock of Synbiomics or the Company, as applicable. As of the date hereof, the only shares of Synbiomics’ common stock that are issued and outstanding are forty-four million (44,000,000) shares of common stock. The New Shares represent five and one half percent (5.5%) of the outstanding shares of common stock of Synbiomics on a Fully Diluted Basis and the 7,480,000 CSMC Shares will represent seventeen percent (17%) of the outstanding shares of common stock of Synbiomics on a Fully Diluted Basis.

 

3.4               No Conflicts; Governmental Approvals . The execution, delivery and performance of the Agreement by the Company and Synbiomics and the consummation by the Company and Synbiomics of the transactions contemplated hereby do not and will not: (i) violate any provision of the Company’s or Synbiomics’ Articles of Incorporation or Bylaws, each as amended to date; (ii) conflict with, or constitute a default (or an event which with notice or lapse of time or both would become a default) under, or give to others any rights of termination, amendment, acceleration or cancellation of, any agreement, mortgage, deed of trust, indenture, note, bond, license, lease agreement, instrument or obligation to which the Company or Synbiomics is a party or by which the Company’s or Synbiomics’ properties or assets are bound; or (iii) result in a violation of any federal, state, local or foreign statute, rule, regulation, order, judgment or decree (including federal and state securities laws and regulations) applicable to the Company or Synbiomics or by which any property or asset of the Company or Synbiomics is bound or affected, except for such conflicts, defaults, terminations, amendments, acceleration, cancellations and violations as would not, individually or in the aggregate, have a Material Adverse Effect. Neither the Company nor Synbiomics is required under federal, state, foreign or local law, rule or regulation to obtain any consent, authorization or order of, or make any filing or registration with, any court or governmental agency in order for it to execute, deliver or perform any of its obligations under this Agreement or issue the SYN Shares or the New Shares in accordance with the terms hereof (other than any filings, consents and approvals required to be made by the Company or Synbiomics under applicable state and federal securities laws, securities and exchange commission rules or regulations, rules or regulations of any stock exchange upon which shares of common stock of the Company may be listed or rules or regulations prior to or subsequent to the date hereof).

 

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3.5               SEC Documents, Financial Statements . The Company’s common stock is registered pursuant to Section 12(b) of the Exchange Act. During the one year period preceding the execution of this Agreement, the Company has timely filed all reports, schedules, forms, statements and other documents required to be filed by it with the Commission pursuant to the reporting requirements of the Exchange Act (the “ SEC Documents ”). At the times of their respective filing, all such reports, schedules, forms, statements and other documents complied in all material respects with the requirements of the Exchange Act and the rules and regulations of the Commission promulgated thereunder. At the times of their respective filings, such reports, schedules, forms, statements and other documents did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. As of their respective dates, other than with respect to its Annual Report on Form 10-K for the year ended December 31, 2017 the financial statements of the Company included in the SEC Documents complied in all material respects with applicable accounting requirements and the published rules and regulations of the Commission or other applicable rules and regulations with respect thereto. Such financial statements have been prepared in accordance with generally accepted accounting principles applied on a consistent basis during the periods involved (except (i) as may be otherwise indicated in such financial statements or the notes thereto or (ii) in the case of unaudited interim statements, to the extent they may not include footnotes or may be condensed or summary statements), and fairly present in all material respects the consolidated financial position of the Company as of the dates thereof and the results of operations and cash flows for the periods then ended (subject, in the case of unaudited statements, to normal year-end audit adjustments).

 

3.6               Brokers . Neither the Company, Synbiomics nor any of the officers, directors or employees of the Company or Synbiomics has employed any broker or finder in connection with the transaction contemplated by this Agreement

 

sECTION 4.     REPRESENTATIONS, WARRANTIES AND COVENANTS OF CSMC .

 

4.1               Purchaser Sophistication . CSMC represents and warrants to, and covenants with, the Company and Synbiomics that CSMC: (a) is knowledgeable, sophisticated and experienced in making, and is qualified to make decisions with respect to, investments in shares presenting an investment decision like that involved in the purchase of the SYN Shares and New Shares, including investments in securities issued by Synbiomics and investments in comparable companies, and has requested, received, reviewed and considered all information it deemed relevant in making an informed decision to purchase the SYN Shares and New Shares; (b) CSMC, in connection with its decision to purchase the SYN Shares and New Shares, relied only upon the documents of the Company filed with the Commission, other publicly available information, and the representations and warranties of the Company and Synbiomics contained herein. CSMC is an “ accredited investor ” pursuant to Rule 501 of Regulation D under the Securities Act; (c) CSMC is acquiring the SYN Shares and New Shares for its own account for investment only and with no present intention of distributing any of the SYN Shares and New Shares or any arrangement or understanding with any other persons regarding the distribution of the Shares; (d) CSMC has not been organized, reorganized or recapitalized specifically for the purpose of investing in the SYN Shares and New Shares; (e) CSMC will not, directly or indirectly, offer, sell, pledge, transfer or otherwise dispose of (or solicit any offers to buy, purchase or otherwise acquire to take a pledge of) any of the SYN Shares and New Shares except in compliance with the Securities Act of 1933 and applicable state securities laws; (f) CSMC understands that the SYN Shares and New Shares are being offered and sold to it in reliance upon specific exemptions from the registration requirements of the Securities Act and state securities laws, and that the Company and Synbiomics are relying upon the truth and accuracy of, and CSMC’s compliance with, the representations, warranties, agreements, acknowledgments and understandings of CSMC set forth herein in order to determine the availability of such exemptions and the eligibility of CSMC to acquire the SYN Shares and New Shares; (g) CSMC understands that its investment in the SYN Shares and New Shares involves a significant degree of risk, including a risk of total loss of CSMC’s investment; and (h) CSMC understands that no United States federal or state agency or any other government or governmental agency has passed upon or made any recommendation or endorsement of the SYN Shares and New Shares.

 

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4.2               Authorization and Power . CSMC has the requisite power and authority to enter into and perform this Agreement and to purchase the SYN Shares and New Shares being sold to it hereunder. The execution, delivery and performance of this Agreement by CSMC and the consummation by it of the transactions contemplated hereby have been duly authorized by all necessary corporate action, and no further consent or authorization of CSMC or its board of directors or stockholders is required. When executed and delivered by CSMC, this Agreement shall constitute a valid and binding obligation of CSMC enforceable against CSMC in accordance with its terms, except as such enforceability may be limited by applicable bankruptcy, insolvency, reorganization, moratorium, liquidation, conservatorship, receivership or similar laws relating to, or affecting generally the enforcement of, creditor’s rights and remedies or by other equitable principles of general application.

 

4.3               No Conflict . The execution, delivery and performance of this Agreement by CSMC and the consummation by CSMC of the transactions contemplated hereby do not and will not: (i) violate any provision of CSMC’s agreements; (ii) conflict with, or constitute a default (or an event which with notice or lapse of time or both would become a default) under, or give to others any rights of termination, amendment, acceleration or cancellation of, any agreement, mortgage, deed of trust, indenture, note, bond, license, lease agreement, instrument or obligation to which CSMC is a party or by which CSMC’s properties or assets are bound; or (iii) result in a violation of any federal, state, local or foreign statute, rule, regulation, order, judgment or decree (including federal and state securities laws and regulations) applicable to CSMC or by which any property or asset of CSMC are bound or affected, except, in all cases, other than violations (with respect to federal and state securities laws) above, for such conflicts, defaults, terminations, amendments, acceleration, cancellations and violations as would not, individually or in the aggregate, materially and adversely affect CSMC’s ability to perform its obligations under the Agreement.

 

4.4               Restricted Shares . CSMC acknowledges that the SYN Shares and New Shares are restricted securities and must be held indefinitely unless subsequently registered under the Securities Act of 1933 or Synbiomics receives an opinion of counsel reasonably satisfactory to Synbiomics that such registration is not required.

 

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4.5               Stock Legends . CSMC acknowledges that certificates evidencing the SYN Shares and New Shares shall bear a restrictive legend in substantially the following form (and including related stock transfer instructions and record notations):

 

THESE SECURITIES HAVE NOT BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE SECURITIES ACT OR PURSUANT TO AN AVAILABLE EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND IN ACCORDANCE WITH APPLICABLE STATE SECURITIES LAWS OR BLUE SKY LAWS AS EVIDENCED BY A LEGAL OPINION OF COUNSEL REASONABLY SATISFACTORY TO THE COMPANY.

 

sECTION 5.     SURVIVAL OF REPRESENTATIONS, WARRANTIES AND AGREEMENTS .

 

Notwithstanding any investigation made by any party to this Agreement, all representations and warranties made by the Company, Synbiomics and CSMC herein shall survive the execution of this Agreement and the issuance and sale to CSMC of the SYN Shares and the transfer of the New Shares.

 

sECTION 6.     COVENANTS.

 

6.1               Approval . In each case where the Company determines that the approval of the Company’s investors or any exchange or other listing upon which the Company Stock may be listed is required for the issuance of the CSMC Shares or Company Stock to CSMC, the Company shall use commercially reasonable efforts to secure such approval as promptly as possible. In the event, notwithstanding the foregoing obligation, the Company is unable to secure the approval with respect to the issuance of any Company Stock to be issued hereunder, then CSMC shall have a one-time demand registration right, at its own expense, to request that Synbiomics register the CSMC Shares held by CSMC with the Securities and Exchange Commission, subject to any Securities and Exchange Commission limitations; provided that such request is made within sixty (60) days of the date of notification from the Company to CSMC of the position of the NYSE American. If such registration is an underwritten public offering then it shall be subject to standard underwriter cut backs and lock ups. If the managing underwriter of an underwritten public offering determines and advises Synbiomics in writing that the inclusion of all securities proposed to be included by CSMC and Synbiomics and any other holders of Synbiomics securities requesting inclusion of their securities in the underwritten public offering would materially and adversely interfere with the successful marketing of the offering, then CSMC shall not be permitted to include any CSMC Shares in excess of the amount, if any, of securities which the managing underwriter of such underwritten public offering shall reasonably and in good faith agree in writing to include in such public offering.

 

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6.2        Upon request of CSMC, the Company agrees to provide an opinion of counsel to its transfer agent regarding the removal of the legend on the Company Stock issued to CSMC hereunder; provided that all legal requirements allowing for such legend removal and all applicable conditions under Rule 144 promulgated under the Securities Act are met.

 

sECTION 7.     NOTICES.

 

7.1               Any notice, request, instruction or other document required by this Agreement shall be in writing and shall be deemed to have been given (a) if mailed with the United States Postal Service by prepaid, first class, certified mail, return receipt requested, at the time of receipt by the intended recipient, (b) if sent by Federal Express or other overnight carrier, signature of delivery required, at the time of receipt by the intended recipient, or (c) if sent by facsimile transmission, when so sent and when receipt has been acknowledged by appropriate telephone or facsimile receipt, addressed as follows:

 

In the case of CSMC to:

 

8700 Beverly Boulevard

Los Angeles, California 90048-1865

Attention: Executive Vice President, Finance & CFO

With a copy to: Vice President, Technology & Business Affairs

 

 

or in the case of the Company or Synbiomics to:

 

9605 Medical Center Drive, Suite 270

Rockville, MD 20850

Attention: Steven A. Shallcross

Fax No.: (301) 417-4364

 

with a copy to:

 

Gracin & Marlow, LLP

The Chrysler Building

405 Lexington Avenue, 26th Floor

New York, New York 10174

Attn: Leslie Marlow, Esq.

 

or to such other address or to such other person(s) as may be given from time to time under the terms of this Section 7.1.

 

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sECTION 8.     MISCELLANEOUS .

 

8.1               Fees and Expenses . Each party shall pay the fees and expenses of its advisors, counsel, accountants and other experts, if any, and all other expenses, incurred by such party incident to the negotiation, preparation, execution, delivery and performance of this Agreement.

 

8.2               Waivers and Amendments . Neither this Agreement nor any provision hereof may be changed, waived, discharged, terminated, modified or amended except upon the written consent of the parties hereto.

 

8.3               Headings . The headings of the various sections of this Agreement have been inserted for convenience of reference only and shall not be deemed to be part of this Agreement.

 

8.4               Severability . If any provision hereof should be held invalid, illegal or unenforceable in any respect, then, to the fullest extent permitted by law: (a) all other provisions hereof shall remain in full force and effect and shall be liberally construed in order to carry out the intentions of the Parties as nearly as may be possible and (b) the parties shall use their best efforts to replace the invalid, illegal or unenforceable provision(s) with valid, legal and enforceable provision(s) which, insofar as practical, implement the purposes of such provision(s) in this Agreement.

 

8.5               Governing Law . This Agreement shall be governed by and construed in accordance with the laws of the State of Nevada as applied to contracts entered into and performed entirely in the State of Nevada, without regard to conflicts of law principles.

 

8.6               Counterparts . This Agreement may be executed in two or more counterparts, each of which shall constitute an original, but all of which, when taken together, shall constitute but one instrument, and shall become effective when one or more counterparts have been signed by each party hereto and delivered to the other parties.

 

8.7               Successors and Assigns . Except as otherwise expressly provided herein, the provisions hereof shall inure to the benefit of, and be binding upon, the successors, assigns, heirs, executors and administrators of the parties hereto, provided that CSMC shall not assign its rights or obligations hereunder and Synbiomics shall only be able to assign its rights or obligations hereunder to an affiliated entity if the License Agreement is also assigned to such entity.

 

8.8               No Third Party Beneficiaries . This Agreement is intended for the benefit of the parties hereto and their respective permitted successors and assigns and is not for the benefit of, nor may any provision hereof be enforced by, any other person.

 

8.9               Expenses . Each party shall pay all costs and expenses that it incurs with respect to the negotiation, execution, delivery and performance of this Agreement.

 

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8.10           Entire Agreement . This Agreement (including the Schedule of Exceptions), License Agreement and other documents delivered pursuant hereto and thereto, including the exhibits, constitute the full and entire understanding and agreement between the parties with regard to the subjects hereof and thereof.

 

8.11           Publicity . Except as otherwise provided herein, no party shall issue any press releases or otherwise make any public statement with respect to the transactions contemplated by this Agreement without the prior written consent of the other party, except as may be required by applicable law or regulations, in which case such party shall provide the other parties with reasonable notice of such publicity and/or opportunity to review such disclosure.

 

8.12           Waiver of Rule of Construction . Each Party has had the opportunity to consult with counsel in connection with the review, drafting and negotiation of this Agreement. Accordingly, the rule of construction that any ambiguity in this Agreement shall be construed against the drafting Party shall not apply.

 

8.13           Further Assurances . From and after the date of this Agreement, upon the reasonable request of CSMC or the Company, the Company and CSMC shall execute and deliver such instruments, documents and other writings as may be reasonably necessary or desirable to confirm and carry out and to effectuate fully the intent and purposes of this Agreement.

   

 

 

[Signature Page Follows]

 

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IN WITNESS WHEREOF , the parties hereto have caused this Stock Purchase Agreement to be executed by their duly authorized representatives as of the day and year first above written.

 

 

 

SYNTHETIC BIOMICS, INC.

 

By: /s/ Steven A. Shallcross       

Name: Steven A. Shallcross

Title: Chief Executive Officer

 

   
 

SYNTHETIC BIOLOGICS, INC.

 

By: /s/ Steven A Shallcross           

Name: Steven A. Shallcross

Title: Interim Chief Executive Officer and

  Chief Financial Officer

 

 

CEDARS-SINAI MEDICAL CENTER

 

By: /s/ James D. Laur                                

Name: James D. Laur, JD

Title: Vice President, Technology & Business Affairs 

 

13  

 

Exhibit 99.1

 

 

 

Synthetic Biologics Announces Agreement with Cedars-Sinai Medical Center for an Investigator-

Sponsored Clinical Study of SYN-010, for the Treatment of IBS-C

 

-- Co-funded Research to be Led by Dr. Mark Pimentel’s Lab to Further Evaluate the Efficacy and

Safety of SYN-010 in a 12-Week, Placebo-Controlled, Phase 2 Clinical Study --

 

 

 

Rockville, MD, September 06, 2018 – Synthetic Biologics, Inc. (NYSE American: SYN), a late-stage clinical company developing therapeutics designed to preserve the microbiome to protect and restore the health of patients, today announced it has entered into an agreement with Cedars-Sinai Medical Center for an investigator-sponsored Phase 2 clinical study of SYN-010. The study will provide further evaluation of the efficacy and safety of SYN-010, the Company’s modified-release reformulation of lovastatin lactone, which is exclusively licensed to the Company by Cedars-Sinai Medical Center. SYN-010 is designed to reduce methane production by certain microorganisms ( M. smithii) in the gut to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C).

 

The Phase 2 study will be conducted out of the Pimentel Laboratory at Cedars-Sinai Medical Center and is expected to be comprised of a 12-week, placebo-controlled, double-blind, randomized clinical trial to evaluate two dose strengths of oral SYN-010 (21 mg and 42 mg) in approximately 150 patients diagnosed with IBS-C. The investigator-sponsored Phase 2 clinical study will be led by the gastrointestinal microbiota researcher Ruchi Mathur, M.D., director of Metabolism, Clinical Research and Administrative Operations at the Medically Associated Science and Technology (MAST) Program at Cedars-Sinai. The Phase 2 study, which will be co-funded by Synthetic Biologics and Cedars-Sinai Medical Center, is expected to begin enrollment during the fourth quarter of 2018, contingent upon approval of the clinical study protocol by the Cedars-Sinai Medical Center Institutional Review Board. Both Cedars-Sinai and Dr. Pimentel have a financial interest in Synthetic Biologics.

 

“This research collaboration is a further demonstration of Cedars-Sinai’s support for the advancement of promising therapies that harness the power of the microbiome to treat GI disorders such as IBS-C,” said Mark Pimentel, M.D., head of the Pimentel Laboratory and executive director of the MAST Program. “By targeting a major cause of IBS-C, SYN-010 has the potential to provide long-term, chronic relief to millions of patients who, to date, are forced to settle for therapies designed to treat the symptoms of IBS-C, but do little to treat the underlying problem.”

 

“We are delighted that Dr. Pimentel and Cedars-Sinai share our view on the potential of SYN-010 as a new and efficacious treatment option for IBS-C,” said Steven A. Shallcross, Interim Chief Executive Officer of Synthetic Biologics. “In addition to expanding and fortifying our well-established clinical dataset for SYN-010, the study is also intended to help determine the optimal dose strength of SYN-010 for potential future registration studies.”

 

The primary objective for the study will be to determine the efficacy of SYN-010, measured as an improvement from baseline in the weekly average number of complete spontaneous bowel movements (CSBMs) during the 12-week treatment period for SYN-010 21 mg and 42 mg daily doses relative to placebo. Secondary efficacy endpoints for both dose strengths of SYN-010 are expected to measure changes from baseline in abdominal pain, bloating, stool frequency as well as the use of rescue medication relative to placebo. Exploratory outcomes include Adequate Relief and quality of life measures using the well-validated EQ-5D-5L and PAC-SYM patient questionnaires.

 

 

 

 

About Irritable Bowel Syndrome

 

IBS affects an estimated 10 to 15 percent of the population, or as many as 45 million people in North America. The illness affects both men and women; however, two-thirds of diagnosed sufferers are women. It has been reported that up to 20 percent of all IBS patients have IBS-C and current FDA-approved therapies for the treatment of IBS-C, which include prescription and over-the-counter laxatives, do little to treat the underlying cause of the disease. These products provide patients with temporary relief from the symptoms of constipation by elevating the amount of water which passes through the gastrointestinal tract, but tend to cause an IBS-C patient to swing from suffering from constipation, to suffering from diarrhea.

 

About SYN-010

 

SYN-010 is a proprietary, modified-release formulation of lovastatin lactone that is intended to reduce methane production by certain microorganisms ( M. smithii ) in the gut while minimizing disruption to the microbiome to treat an underlying cause of IBS-C. SYN-010 is intended to act primarily in the intestinal lumen while avoiding systemic absorption, thereby targeting a major cause of IBS-C, not just the symptoms. To learn more about SYN-010’s unique mechanism of action, please click here .

 

About Cedars-Sinai Medical Center

 

Cedars-Sinai is a national leader in providing high-quality, patient-centered healthcare encompassing primary care as well as specialized medicine and conducting research that leads to lifesaving discoveries and innovations. Since its beginning in 1902, Cedars-Sinai has evolved to meet the healthcare needs of one of the most diverse regions in the nation, continually setting new standards in quality and innovation in patient care, research, teaching and community service.

 

Today, Cedars-Sinai is widely known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare globally by developing new approaches to treatment and educating tomorrow's physicians and other health professionals. At the same time, Cedars-Sinai demonstrates a longstanding commitment to strengthening the Los Angeles community through wide-ranging programs that improve the health of its most vulnerable residents.

 

About Synthetic Biologics, Inc.

 

Synthetic Biologics, Inc. (NYSE American: SYN) is a late-stage clinical company developing therapeutics that preserve the microbiome to protect and restore the health of patients. The Company's lead candidates poised for Phase 3 development are: (1) SYN-004 (ribaxamase) which is designed to protect the gut microbiome from the effects of certain commonly used intravenous (IV) beta-lactam antibiotics for the prevention of C. difficile infection (CDI), overgrowth of pathogenic organisms and the emergence of antimicrobial resistance (AMR), and (2) SYN-010 which is intended to reduce the impact of methane producing organisms in the gut microbiome to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C). The Company’s preclinical pursuits include an oral formulation of the enzyme intestinal alkaline phosphatase (IAP) to treat both local GI and systemic diseases as well as monoclonal antibody therapies for the prevention and treatment of pertussis, and novel discovery stage biotherapeutics for the treatment of phenylketonuria (PKU). For more information, please visit Synthetic Biologics' website at www.syntheticbiologics.com .

 

 

 

 

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 includes statements regarding the planned design of the Phase 2 study, the expected commencement of enrollment of the Phase 2 trial during the fourth quarter of 2018, the potential of SYN-010 as a new and efficacious treatment option for IBS-C, the potential of SYN-010 to provide long-term, chronic relief to millions of patients who, to date, are forced to settle for therapies designed to treat the symptoms of IBS-C, but do little to treat the underlying problem, the study helping to determine the optimal dose strength of SYN-010 for potential future registration studies. 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 to received Institutional Board Approval of the Phase 2 trial protocol, the ability to commence the trial when anticipated, the results of the SYN-010 trial demonstrating support for the use of SYN-010 to treat symptoms of IBS-C, Synthetic Biologics' ability to regain compliance with the continued listing standards of the NYSE American by September 2, 2019, Synthetic Biologics' ability to comply with other continued listing requirements of the NYSE American, the ability of its product candidates to demonstrate safety and effectiveness, as well as results that are consistent with prior results, Synthetic Biologics' clinical trials continuing enrollment as expected, a failure to receive the necessary regulatory approvals for commercialization of Synthetic Biologics' therapeutics, including approval of proposed trial designs, a failure of Synthetic Biologics' clinical trials, and those conducted by investigators, for SYN-004 and SYN-010 to be commenced or completed on time or to achieve desired results and benefits, a failure of Synthetic Biologics' clinical trials to continue enrollment as expected or receive anticipated funding, a failure of Synthetic Biologics to successfully develop, market or sell its products, Synthetic Biologics' inability to maintain its material licensing agreements, or a failure by Synthetic Biologics or its strategic partners to successfully commercialize products, Synthetic Biologics’ ability to achieve acceptance of its product candidates in the marketplace and the successful development, marketing or sale of Synthetic Biologics' products by competitors that render Synthetic Biologics' products obsolete or non-competitive, the continued maintenance and growth of Synthetic Biologics' patent estate, Synthetic Biologics becoming and remaining profitable, Synthetic Biologics' ability to obtain or maintain the capital or grants necessary to fund its research and development activities, a loss of any of Synthetic Biologics' key scientists or management personnel and other factors described in Synthetic Biologics' Form 10-K for the year ended December 31, 2017 and its other filings with the SEC, including subsequent periodic reports on Forms 10-Q and 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:

 

Synthetic Biologics, Inc. (Corporate and Investors)

Vincent I. Perrone, Director, Corporate Communication, (240) 660-2000, info@syntheticbiologics.com

 

Cedars-Sinai

Jonathan Diamond, Senior Communications Specialist, (323) 866-8146, jonathan.diamond@cshs.org

 

Ogilvy (Media)

Gregory Kelley, Senior Vice President, (404) 836-2302, gregory.kelley@ogilvy.com

 

 

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