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

 

November 20, 2019

Date of Report

 

Q BioMed Inc.

(Exact name of registrant as specified in its charter)

 

Nevada 333-193328 46-4013793
(State or other jurisdiction of incorporation) (Commission File Number) (IRS Employer Identification No.)

 

c/o Ortoli Rosenstadt LLP

366 Madison Avenue

New York, NY 10017

  10022
(Address of principal executive offices)   (Zip Code)

 

(212) 588-0022

Registrant’s telephone number, including area code

 

Check the appropriate box below if the Form 8-K 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:
None   None   None

 

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 7.01 Regulation FD Disclosure

 

On November 20, 2019, we issued a press release announcing that the U.S. Food and Drug Administration (the “FDA”) approved our contract manufacturer, IsoTherapeutics Group LLC (“ITG”). ITG is now cleared to manufacture our FDA approved non-opioid cancer bone pain drug Strontium-89 Chloride USP. A copy of the press release is furnished herewith as Exhibit 99.1. On November 14, 2019, the Department of Health and Human Services notified the Company that its supplemental abbreviated new drug application for a new drug product manufacturing site, IsoTherapeutics Group, LLC, has been approved as of November 4, 2019.

 

The information in this Item 7.01 of this Form 8-K is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liabilities of that section. The information in this Item 7.01 of this Form 8-K also shall not be deemed to be incorporated by reference into any filing under the Act or the Securities Exchange Act of 1934, except to the extent that we specifically incorporate it by reference.

 

Item 9.01 Financial Statements and Exhibits.

 

Exhibits.

 

99.1 Press Release entitled “Q BioMed Announces FDA Approval. Company Gets Green Light for Manufacturing FDA Approved Non-Opioid Cancer Palliation Drug”, dated November 20, 2019.

 

 

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.

 

 

Q BioMed Inc. 

   
Date: November 20, 2019 By: /s/ Denis Corin
 

Name: Denis Corin

Title:  President

 

 

 

 

 

 

Exhibit 99.1

 

Q BioMed Announces FDA Approval

 

Company Gets Green Light for Manufacturing FDA Approved Non-Opioid Cancer Palliation Drug

 

NEW YORK, Nov. 20, 2019 /PRNewswire/ -- Q BioMed Inc. (QBIO),  announces FDA approval of its contract manufacturer IsoTherapeutics Group LLC (ITG). ITG is now cleared to manufacture the Company's FDA approved non-opioid cancer bone pain drug Strontium-89 Chloride USP.

 

The long-awaited approval of the facility means that this important oncologic pain drug will soon be available to patients in the US and the rest of the world. Q BioMed is now the only FDA-approved source for this drug in the western world. The Company is activating its planned commercial operations to support marketing, sales, and distribution in the US and, soon, in the rest of the world.

 

Strontium-89 is an FDA-approved non-opioid radiopharmaceutical indicated for the treatment of painful skeletal metastases caused by cancer. The product is administered intravenously once every three months as an alternative to opioid analgesics and plays a critical role in the treatment of metastatic bone pain. The product has a long history of providing well-documented and significant pain relief for patients suffering from the excruciating pain associated with primary cancers that have spread to the bone, including breast, prostate, lung and others. This is the ideal time to be launching Strontium-89 given the current concerns with the over-use of opioid drugs. In addition, as more therapies come to market for the treatment of primary cancers, more people are living longer with metastatic disease. It is estimated that approximately two million patients experience debilitating bone pain from metastatic disease. The opportunity to provide significant pain relief to this group is substantial.

 

QBioMed CEO Denis Corin said, "We have been anticipating this critical regulatory step  for a long time, certainly longer than we hoped, but we are thrilled that we can now move forward with certainty. This is the start of a new chapter in the evolution of our company, and we are looking forward to serving the needs of thousands of patients suffering from metastatic bone pain, providing them the chance to minimize their pain and positively impact life with metastatic disease. With millions of potential patients around the world, this is a major market opportunity for our company. In addition, we are investigating and planning expansion trials to provide additional indications for the drug and entry into an even larger therapeutic market."

 

We look forward to updating our shareholders and those awaiting the drug availability in the next 60 days.

 

About Q BioMed Inc.

 

Q BioMed Inc. is a biotech acceleration and commercial stage company. We are focused on licensing and acquiring undervalued biomedical assets in the healthcare sector. Q BioMed is dedicated to providing these target assets with strategic resources, developmental support, and expansion capital to ensure they meet their developmental potential, enabling them to provide products to patients in need‏.

 

Please visit http://www.QBioMed.com and sign up for regular updates.

 

Media Contact Q BioMed:
Denis Corin
CEO
+1(404) 995-6671
ir@qbiomed.com