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): July 30, 2020

 

 

 

Cleveland BioLabs, Inc.

(Exact Name of Registrant as Specified in Charter)

 

 

 

 

DELAWARE

001-32954

20-0077155

(State or Other Jurisdiction of Incorporation)

(Commission File Number)

(I.R.S. Employer Identification Number)

 

73 High Street

Buffalo, NY 14203

 

(Address of Principal Executive Offices and zip code)

     
 

(716) 849-6810

 

(Registrant's Telephone Number, Including Area Code)

 

 

Securities registered or to be 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 $0.005

CBLI

NASDAQ Capital Market

 

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 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 check mark 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 July 30, 2020, Cleveland BioLabs, Inc. (the “Company”) and the United States Department of Defense, office of Congressionally Directed Medical Research Programs (“DoD”), entered into a modification (the “Modification”) to the Award/Contract W81XWH-15-C-0101, dated September 1, 2015, issued by USA Med Research ACQ Activity (Joint Warfighter Medical Research Program), as amended to date (the “JWMRP Contract”). Under the JWMRP Contract, the DoD has provided funding support to further the development of the Company’s principal drug candidate, entolimod, as a medical radiation countermeasure. As previously disclosed, in October 2016, the DoD modified the original statement of work under the JWMRP Contract by eliminating certain tasks no longer deemed critical for the preparation of a biologics license application (“BLA”) for entolimod and established new tasks to address the formulation questions raised by the Food and Drug Administration (the “FDA”) during the review of the pre-Emergency Use Authorization dossier. Also as previously disclosed, (i) in September 2017, the DoD further modified the contract by extending its term to 2019 on a no-cost basis, (ii) in February 2019, the DoD further modified the contract by extending its term to April 2020 on a no-cost basis and (iii) in March 2020, the DoD further modified the contract by extending its term to September 2020 on a no-cost basis.

 

               Signed on July 30, 2020 with an effective date of July 31, 2020, the Modification accelerates the date by which performance of the remaining study tasks under the JWMRP Contract must be completed from September 30, 2020 to August 31, 2020. Additionally, the Modification effects an adjustment to the previous budget approved for certain tasks completed by the Company under the JWMRP Contract. The Company experienced cost overruns in connection with its completion of certain of these tasks, for which the DoD reimbursed the Company. The Modification allows the application of the reimbursed funds with respect to the overrun tasks against cost under-spending on other tasks under the JWMRP Contract. Accordingly, the Company will not be responsible for repaying any of the reimbursed amounts of approximately $472,310 back to the DoD. Finally, the Modification revises the approved statement of work and de-obligates funding on the JWMRP Contract by $5,063,589 for tasks that have been de-scoped from the contract. The DoD determined to de-scope these tasks because the length of time expended in obtaining concurrence from the FDA with the biocomparability study and the new required study design made it unlikely that such tasks could be completed before the expiration of the JWMRP Contract.

 

The Modification is filed as Exhibit 10.1 to this Current Report on Form 8-K. The foregoing summary of the terms of the Modification is subject to, and qualified in its entirety by, the Modification, which is incorporated herein by reference.

 

               Also effective July 31, 2020, the DoD modified the terms of the Company’s previously disclosed Award/Contract W81XWH-15-1-0570, dated September 30, 2015 by issued by USA Med Research ACQ Activity to the Company (the “PRMRP Grant”). Under the PRMRP Grant, the DoD has provided funding support for the clinical studies of entolimod needed for a BLA. Under the terms of the PRMRP Grant, the DoD was to have made approximately $6,573,992 available to reimburse the Company for the performance of the clinical studies. However, given the length of time expended in obtaining concurrence from the FDA with the biocomparability study and the new study design required to remove the clinical hold currently in place, the DoD has determined that there is not enough time left before the expiration of the PRMRP Grant to complete all of the studies for which funding was potentially available. Accordingly, the DoD, by notification to the Company, has modified the PRMRP Grant by reducing the funds available for reimbursement to the Company by approximately $6,350,306.

 

Item 9.01. Financial Statements and Exhibits.

 

(d)     Exhibits

 

Exhibit No.

Description

10.1

Award/Contract W81XWH-15-0101 modification dated July 31, 2020 issued by USA Med Research ACQ Activity

 

 

 

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.

 

 

 

Cleveland BioLabs, Inc.

 

 

 

 

 

 

 

 

 

Date: July 31, 2020 

By:

/s/ Christopher Zosh

 

 

Name: 

Christopher Zosh

 

 

Title: 

 Title: Vice President of Finance

 

 

 

 
ex_196483.htm

Exhibit 10.1

 

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

 

U

PAGE OF PAGES

 1    4

 2.  AMENDMENT/MODIFICATION NO.

 3.  EFFECTIVE DATE

31-Jul-2020

 4. REQUSITION/PURCHASE REQ. NO.

0010624278-0002

 5. PROJECT NO. (If applicable)

 6.  ISSUED BY                            CODE

W81XWH

7. ADMINISTERED BY (If other than Remo)        CODE           W81XWH

 

 

USA MED RESEARCH ACQ ACTIVITY

820 CHANDLER ST

    FORT DETRICK MD 21702-5014

USA MED RESEARCH ACO ACTIVITY

820 CHANDLER ST

FORT DETRICK MD 21702-5014

 8.  NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code)

 

CLEVELAND BIOLABS, INC.

CLEVELAND BIOLABS

73 HIGH ST STE 203A

BUFFALO NY14203-1149

 

9A. AMENDMENT OF SOLICITATION NO.

   

9B. DATED (SEE ITEM 11)

 

X

10A. MOD. OF CONTRACT/ORDER NO.

W81XWH-15-C-0101

 

X

10B. DATED (SEE ITEM 13)

17-Aug-2015

CODE 3MWX2

FACILITY CODE

   

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

 

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer ☒ is extended, ☐ is not extended.

 

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods: (a) By completing Items 8 and 15, and returning ___ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12.  ACCOUNTING AND APPROPRIATION DATA (If required)

  See Schedule

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACT/ORDERS.
IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

 

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE 1N THE CONTRACT ORDER NO. IN ITEM 10A.

 

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

x

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

FAR 52.243-2 - Changes Cost-Reimbursement

 

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor

☐ is not, ☒ is required to sign this document and return 1 copy to the issuing office.

 14.  DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

 

Modification Control Number: pmartha203261

The purpose of this modification is as follows:

 

Revise the current scope of work.

Re-budget CLIN 0001 funds for mouse model assay; as well as, biocomparability study.

De-obligate cancelling funds for return to the US Department of Treasury.

Revise the period of performance.

 

All other terms and conditions remain unchanged. Please see continuation page for further information.

 

 

 

 

 

Except as provided herein, all terms and conditions of the document referenced in Item9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

 

Christopher Zosh, VP of Finance

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

Medina.Wayn (Digitally signed by Medina.Wayn.A – E.A. 1376454181)

TEL EMAIL

15B. CONTRACTOR/OFFEROR

 

 

(Signature of person authorized to sign)

15C. DATE SIGNED

 

7/29/20

16B. UNITED STATES OF AMERICA

 

_____________________________________________

(Signature of Contracting Officer)

16C. DATE SIGNED

 

7/30/20

 

 

 

W8JXWH-15-C-0101

(pmartha20326 l)

 

Page 2 of 4

 

 

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

 

SUMMARY OF CHANGES

 

 

SECTION A- SO LICITATION/CONTRACT FORM

 

The total cost of this contract was decreased by $5,063,589.00 from $9,226,454.64 to $4,162,865.64.

 

 

SECTION B - SUPPLIES OR SERVICES AND PRICES

 

 

 

CLIN 0001

The estimated/max cost has decreased by $2,206,950.00 from $4,922,759.20 to $2,715,809.20. The unit price amount $3,299,215.00 has been added.

The total cost of this line item has decreased by $2,206,950.00 from $5,506,165.00 to $3,299,215.00.

 

 

 

CLIN0002

The estimated/max cost has decreased by $2,856,639.00 from $3,720,289.64 to $863,650.64. The unit price amount $863,650.64 has been added.

The total cost of this line item has decreased by $2,856,639.00 from $3,720,289.64 to $863,650.64.

 

 

SECTION F - DELIVERIES OR PERFORMANCE

 

The following Delivery Schedule item for CLIN 0001 has been changed from:

 

DELIVERY DATE

QUANTITY

SHIP TO ADDRESS

DODAAC / CAGE

POP 01-SEP-2015 TO

NIA

FORT DETRICK - CDMRP

W91ZSQ

30-SEP-2020

 

FORT DETRICK - CDMRP

 
   

1120 FORT DETRICK

 
   

FREDERICK MD 21702

 
   

FOB: Destination

 

 

To:

     

DELIVERY DATE

QUANTITY

SHIP TO ADDRESS

DODAAC / CAGE

POP 01-SEP-2015 TO 31-AUG-2020

NIA

FORT DETRICK- CDMRP

FORT DETRICK - CDMRP 1120 FORT DETRICK

W91ZSQ

   

FREDERICK MD 21702

 
   

FOB: Destination

 

 

 

The following Delivery Schedule item for CLIN 0002 has been changed from:

 

 

 

W81XWH -15-C-0101

 

(pmartha203261)

 

Page 3 of 4

 

DELIVERY DATE     QUANTITY     SHIP TO ADDRESS          DODAAC/CAGE

CAG E

 

POP 01-SEP-2015 TO     N/A     FORT DETRICK - CDMRP     W91ZSQ 30-SEP-2020          FORT DETRICK - CDMRP

 

1120 FORT DETRICK

 

FREDERICK MD 21702

 

FOB: Destination

 

 

To :

 

 

DELIVERY DATE     QUANTITY     SHIP TO ADDRESS          DODAAC / CAGE

 

POP 01-SEP-2015 TO     N/A     FORT DETRICK - CDMRP     W9 1ZSQ 31-AUG-2020          FORT DETRICK - CDMRP

 

1120 FORT DETRICK

FREDERICK MD 21702

 

FOB: Destination

 

 

 

SECTION G - CONTRACT ADMINISTRATION DATA

 

Accounting and Appropriation Summary for the Payment Office

As a result of this modification, the total funded amount for this document was decreased by $5,063,589.00 from $9,226,454.64 to $4,162,865. 64.

 

CUN 0001:

 

AA: 09720142 01 501 3 000018310443439410     R.0012069.1.l     6100.9000021001 A7444 (CIN GFEBS00I062427800003) was decreased by $2,206,950 .00 from $5,506,165.00 to $3,299,215.00

 

CUN 0002:

 

AB: 097201420 15 013 00001831 044444141 0     R.00 12 070.1     6100.9000021001 A7444 (CIN GFEBS001062427800004) was decreased by $2,856,639.00 from $3,720,289.64 to $863,650.64

 

 

SECTION I - CONTRACT CLAUSES

 

 

 

The following have been added by reference:

 

52.232-22     Limitation Of Funds     APR 1984

 

 

 

SECTION J - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

 

 

 

 

W81XWH-15-C-0I0I

 

(pmartha203261)

 

Page 4 of 4

 

 

The Table of Contents has changed from:

 

Exhibit/Attachment Table of Contents

 

DOCUMENT TYPEDESCRIPTION

PAGES

DATE

Attachment IAttachment A: Revised

SOW 13 July 2016

 

28-SEP-2016

Attachment 2CDRLA00I

 

27-AUG-2015

Attachment 3CDRLA002

 

27-AUG-2015

Attachment 4CDRLA003

 

27-AUG-2015

Attachment 5CDRLA004

 

27-AUG-2015

 

to:

   

Exhibit/Attachment Table of Contents

   

DOCUMENT TYPEDESCRIPTION

PAGES

DATE

Attachment IRevised SOW

 

29-APR-2020

Attachment 2CDRLA00I

 

27-AUG-2015

Attachment 3CDRLA002

 

27-AUG-2015

Attachment 4CDRLA003

 

27-AUG-2015

Attachment 5CDRLA004

 

27-AUG-2015

 

 

(End of Summary of Changes)