UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 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): June 25, 2021

 

SCOPUS BIOPHARMA INC.

(Exact name of registrant as specified in its charter)

 

Delaware   001-39788   82-1248020

(State or other jurisdiction of

incorporation or organization)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

420 Lexington Avenue, Suite 300

New York, New York 10170

(Address of principal executive offices)

 

(212) 479-2513

(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:

 

¨ 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, $0.001 par value   SCPS   The Nasdaq Stock Market LLC (Nasdaq Global Market)

 

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 x

 

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.

 

Stock Exchange Agreement

 

On June 25, 2021 (the “Effective Date”), Scopus BioPharma Inc., a Delaware corporation (the “Company”), entered into a Stock Exchange Agreement (the “Stock Exchange Agreement”) with the stockholders of Olimmune, Inc., a Delaware corporation (“Olimmune”). Pursuant to the Stock Exchange Agreement, the Company acquired all of the issued and outstanding shares of Olimmune, a developer of groundbreaking oligonucleotide immunotherapies for treatment-resistant and metastatic cancers. The acquisition was undertaken in connection with Olimmune’s entry into two license agreements with City of Hope (“COH”), both of which are described below. Olimmune’s lead drug candidate, OLIM-01, is being developed for genitourinary and head and neck cancers. The acquisition of Olimmune expands the Company’s reach in immuno-oncology. In connection with the Stock Exchange Agreement, the Company issued to Olimmune stockholders 1,000,000 shares of common stock of the Company. We also issued 100,000 shares of common stock of the Company to COH as additional consideration for the two license agreements.

 

The foregoing description of the Stock Exchange Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Stock Exchange Agreement which will be filed with the Securities and Exchange Commission (“SEC”) as an exhibit to the Company’s next periodic report.

 

On June 30, 2021, the Company issued a press release announcing the acquisition of Olimmune. A copy of the press release is filed as Exhibit 99.1 hereto and is incorporated herein by reference.

 

ASO Exclusive License Agreement

 

On the Effective Date, Olimmune entered into an exclusive license agreement (the “ASO Exclusive License Agreement”) with COH pursuant to which Olimmune acquired from COH an exclusive license to ASO Patent Rights, which include: (i) PCT Application, Serial No. PCT/US2016/040361, filed June 30, 2016; (ii) patents, patent applications, continuations, divisional applications, and foreign equivalents that claim the same invention(s) and priority date as the foregoing; (iii) continuation-in-part applications that repeat a substantial portion of any of the foregoing applications; (iv) letters patent or the equivalent issued on any of the foregoing applications throughout the world; and (v) amendments, extensions, renewals, reissues, supplementary protection certificates, substitutions and re-examinations of any of the foregoing. Subject to the terms and conditions of the ASO Exclusive License Agreement, COH granted Olimmune an exclusive royalty-bearing right and license to commercially exploit the licensed rights in the field of therapeutics.

 

In connection with the ASO Exclusive License Agreement, Olimmune agreed to pay COH an upfront one-time non-refundable license fee and an additional one-time non-refundable license fee no later than five days after the six-month anniversary of the Effective Date. On or before the tenth business day after the beginning of each license year (excluding the first license year ending December 31, 2021), Olimmune agreed to pay to COH a non-refundable license maintenance fee. Over the course of the ASO Exclusive License Agreement, Olimmune is required to attain certain diligence milestones. Upon any change of control of Olimmune or an affiliate of Olimmune that controls Olimmune, we agreed to pay COH a non-refundable fee. We are also required to make development milestone payments for each indication. These development milestone payments are tied to achieving certain clinical milestones and obtaining marketing approvals. In addition to the development milestone payments, sales milestone payments are payable to COH tied to achieving certain levels of annual net sales. In addition, base royalties are payable on sales subject to minimum annual royalties, including an annual license maintenance fee. Concurrently with the execution of the ASO Exclusive License Agreement, we issued shares of the Company’s common stock to COH or its designees as described above.

 

The ASO Exclusive License Agreement includes customary representations, warranties and covenants. Subject to certain exceptions and limitations, each of Olimmune and the Company has agreed to indemnify COH for breaches of representations, warranties and covenants, and other specified matters. Unless terminated earlier, the ASO Exclusive License Agreement will remain in effect, on a country-by-country basis and licensed product-by-licensed product (licensed service-by-licensed service) basis, until the parties’ royalty obligations end. The ASO Exclusive License Agreement is subject to termination upon certain events, including an uncured material breach by either party. We have guaranteed Olimmune’s obligations under the two license agreements.

 

 

 

 

Decoy Exclusive License Agreement

 

On the Effective Date, Olimmune entered into an exclusive license agreement (the “Decoy Exclusive License Agreement”) with COH pursuant to which Olimmune acquired from COH an exclusive license to Decoy Patent Rights, which include: (i) United States Issued Patent Number 9,976,147, issued May 22, 2018, United States Issued Patent Number 10,829,765, issued November 10, 2020, and United States Patent Application Number 17/070,321, filed October 14, 2020; (ii) patents, patent applications, continuations, divisional applications, and foreign equivalents that claim the same invention(s) and priority date as the foregoing; (iii) continuation-in-part applications that repeat a substantial portion of any of the foregoing applications; (iv) letters patent or the equivalent issued on any of the foregoing applications throughout the world; and (v) amendments, extensions, renewals, reissues, supplementary protection certificates, substitutions and re-examinations of any of the foregoing.

 

The remainder of the terms and conditions of the Decoy Exclusive License Agreement are substantially the same as the ASO Exclusive License Agreement, except that the deadline dates for the diligence milestones and the date and amount to reimburse COH for patent expenses are different.

 

The foregoing descriptions of the terms of the ASO Exclusive License Agreement and the Decoy Exclusive License Agreement do not purport to be complete and are qualified in their entirety by reference to the full text of the form of ASO Exclusive License Agreement and the Decoy Exclusive License Agreement, in each case, to be filed with the SEC as exhibits to the Company’s next periodic report. Certain terms of the ASO Exclusive License Agreement and the Decoy Exclusive License Agreement have been omitted from this Current Report on Form 8-K (this “8-K”) and will be omitted from the versions of the ASO Exclusive License Agreement and the Decoy Exclusive License Agreement to be filed as exhibits to the Company’s next periodic report because such terms are (i) not material and/or (ii) would likely cause competitive harm to the Company if publicly disclosed.

 

Item 2.01 Completion of Acquisition or Disposition of Assets.

 

The applicable information set forth in Item 1.01 of this 8-K is incorporated by reference in this Item 2.01.

 

Financial statements are not included in this 8-K because the Company has determined, in accordance with the guidance set forth in Regulation S-X Rule 11-01(d), that it did not acquire a business.

 

Item 3.02 Unregistered Sales of Equity Securities.

 

The applicable information set forth in Item 1.01 of this 8-K is incorporated by reference in this Item 3.02. The shares issued in connection with the Stock Exchange Agreement and the two City of Hope license agreements, were exempt from the registration requirements of the Securities Act of 1933, as amended (the “Act”), under Section 4(a)(2) thereof. The limited number of recipients of the shares, the fact that each recipient has agreed that such shares have been acquired for investment and not for resale, and the facts and circumstances surrounding the transactions under which the shares were issued establish that the shares were not issued in a transaction involving a public offering within the meaning of Section 4(a)(2).

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit
Number 		  Description
99.1   Press Release dated June 30, 2021

 

 

 

 

 

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.

 

  SCOPUS BIOPHARMA INC.
   
Dated: July 1, 2021 By: /s/ Joshua R. Lamstein
    Joshua R. Lamstein
    Chairman

 

 

 

 

 

 

 

 

 

Exhibit 99.1

 

 

 

 

Scopus BioPharma Expands Immunotherapy Pipeline with Acquisition of Olimmune

 

Transaction Creates Global Leader in Oligonucleotide Cancer Therapeutics

 

Combined Assets Target Broad Range of Hematological Malignancies and Solid Tumors

 

 

New York, New York, June 30, 2021 – Scopus BioPharma Inc. (Nasdaq: “SCPS”), a clinical-stage biopharmaceutical company developing transformational therapeutics, today announced the acquisition of Los Angeles-based Olimmune Inc.

 

Olimmune is a developer of groundbreaking oligonucleotide immunotherapies for treatment-resistant and metastatic cancers. Olimmune’s lead drug candidate, OLIM-01, is being developed for genitourinary and head and neck cancers. It is anticipated that INDs for these indications will be submitted by Q1 2023.

 

Joshua R. Lamstein, Chairman of Scopus BioPharma, stated, “The acquisition of Olimmune dramatically expands our reach in immuno-oncology. Both companies have been pioneering proprietary technologies to address traditionally “undruggable” targets, such as STAT3. This combination positions Scopus as a global leader in bifunctional oligonucleotide cancer therapeutics.”

 

Olimmune was co-founded by Marcin Kortylewski, Ph.D., a leading immuno-oncologist and Professor in the Department of Immuno-Oncology at City of Hope. Dr. Kortylewski and his laboratory were instrumental in the seminal discovery that successful cancer immunotherapy needs to combine both TLR9 immunostimulation and STAT3 inhibition. This strategy underpins CpG-STAT3siRNA, Scopus’ lead drug candidate, which is covered by certain patents licensed from City of Hope. City of Hope is a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases near Los Angeles, California.

 

Dr. Kortylewski stated, “While it’s necessary to deliver STAT3 inhibitors to the proper cells, STAT3 inhibition, by itself, is not sufficient. You also need to stimulate immune activation. Fortunately, the short CpG sequence also serves as a TLR9 agonist, so you get release of immunosuppression by the STAT3 inhibitor and immune activation through TLR9 activation, both of which are necessary for a robust anti-cancer response.”

 

Dr. Kortylewski added, “City of Hope and Scopus are working closely to initiate a Phase 1 clinical trial evaluating CpG-STAT3siRNA for non-Hodgkin lymphoma. Now, we will work towards expanding our collaboration to other challenging cancer indications, such as head and neck, kidney, or prostate cancers using alternative STAT3 inhibitors.”

 

 

 

 

Alan Horsager, Ph.D., President and Chief Executive Officer of Olimmune, stated, “Scopus BioPharma is the ideal home for Olimmune. The combination of immuno-oncology assets creates a comprehensive portfolio of complementary cell-selective oligonucleotide therapeutics. Moreover, Scopus’ clinical development will provide us with invaluable insights, experience and expertise in bringing our drug candidates into the clinic.”

 

Olimmune has exclusive, worldwide licenses to certain patents from City of Hope to develop and commercialize CpG-STAT3ASO and CpG-STAT3decoy.

 

Terms of the acquisition have not been disclosed.

 

About Scopus BioPharma

 

Scopus BioPharma Inc. is a clinical-stage biopharmaceutical company developing transformational therapeutics capitalizing on groundbreaking scientific and medical discoveries from leading research and academic institutions. The company’s lead drug candidate is a novel, targeted immuno-oncology RNA therapy for the treatment of multiple cancers. This drug candidate is highly distinctive, encompassing both RNA therapy and immunotherapy by synthetically linking siRNA to an oligonucleotide TLR9 agonist, creating the potential for targeted gene silencing with simultaneous TLR stimulation and immune activation in the tumor microenvironment. The company is also developing additional new chemical entities to treat other serious diseases with significant unmet medical needs, including systemic sclerosis. Receive updates by following Scopus BioPharma on Twitter here.

 

Forward-Looking Statements

 

This press release may include forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to risks (including those set forth in the company’s Form 10-K for the fiscal year ended December 31, 2020, as amended, filed with the U.S. Securities and Exchange Commission (“SEC”)) and uncertainties which could cause actual results to differ from the forward-looking statements. The company expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the company’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based. Investors should realize that if our underlying assumptions for the projections contained herein prove inaccurate or that known or unknown risks or uncertainties materialize, actual results could vary materially from our expectations and projections.

 

Contacts

 

Rodd Leeds/David Waldman

Crescendo Communications, LLC

Tel: (212) 671-1020

Email: SCPS@crescendo-ir.com