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): March 15, 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)

 

 

(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 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

 

Dr. Raphael Hofstein became a member of the Audit Committee of the company, filling a vacancy created by the resignation of Dr. Lesley Russell, for reasons unrelated to the operations, policies, or practices of the company, accepted and/or ratified on March 15, 2021 and/or March 18, 2021, as the case may be. Dr. Hofstein assumes this position in addition to his role as a member of each of the Compensation Committee and Nominating Committee. In this connection, Dr. Hofstein also assumed the role of Chair of the Compensation Committee. Dr. Hofstein is considered to be an “independent director” under the rules of the Nasdaq Stock Market, which is defined generally as a person other than an officer or employee of the company or its subsidiaries or any other individual having a relationship, which, in the opinion of the company’s board of directors would interfere with the director’s exercise of independent judgment in carrying out the responsibilities of a director. In accordance with the rules of the Nasdaq Stock Market, the Audit Committee is required to be composed exclusively of independent directors who are “financially literate” as defined under the rules of the Nasdaq Stock Market. The Nasdaq Stock Market rules define “financially literate” as being able to read and understand fundamental financial statements, including a company’s balance sheet, income statement and cash flow statement. The Nasdaq Stock Market requires that the company’s Audit Committee have at least one member who has past employment experience in finance or accounting, requisite professional certification in accounting, or other comparable experience or background that results in the individual’s financial sophistication. Dr. Hofstein qualifies as an “audit committee financial expert,” as defined under rules and regulations of the United States Securities and Exchange Commission.

 

Item 8.01 Other Events.

 

On March 15, 2021, the company issued a press release announcing the finalization of arrangements for the completion of the investigational new drug package for the company’s lead drug candidate and its submission to the United States Food and Drug Administration. A copy of this press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit
Number 		  Description
99.1   Press Release dated March 15, 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: March 19, 2021 By: /s/ Joshua R. Lamstein
    Joshua R. Lamstein
    Chairman

 

 

 

Exhibit 99.1

 

 

 

Scopus BioPharma Finalizes Arrangements for Submission of IND Package

 

Submission to FDA Expected in Q2 2021

 

New York, New York, March 15, 2021 – Scopus BioPharma Inc. (Nasdaq: “SCPS”) today announced the finalization of arrangements for the completion of the investigational new drug (“IND”) package for the company’s lead drug candidate and its submission to the United States Food and Drug Administration (“FDA”). The IND submission is expected in Q2 2021.

 

Scopus is a biopharmaceutical company developing transformational therapeutics based on groundbreaking scientific and medical discoveries. The company’s lead drug candidate is a novel, targeted immuno-oncology gene therapy for the treatment of multiple cancers.

 

Joshua R. Lamstein, Chairman of Scopus BioPharma, stated, “We are extremely excited about the forthcoming submission of the IND for the Phase 1 clinical trial for our lead drug candidate. We believe investors will recognize this milestone as an important near-term driver of shareholder value.”

 

The company’s lead drug candidate is highly distinctive, encompassing both gene 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.

 

About Scopus BioPharma

 

Scopus BioPharma Inc. is a 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 gene therapy for the treatment of multiple cancers. This drug candidate is highly distinctive, encompassing both gene 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 offering circular filed with the U.S. Securities and Exchange Commission) 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.

 

Contact

 

Rodd Leeds/David Waldman

Crescendo Communications, LLC

Tel: (212) 671-1020

Email: SCPS@crescendo-ir.com