Emmaus Life Sciences, Inc 8-K, filed Oct 12, 2021
Emmaus Life Sciences, Inc. (EMMA)
About this 8-K
Emmaus Life Sciences, Inc filed this 8-K on October 12, 2021, reporting on events of October 7, 2021.
Items reported
- Item 1.01: Entered into a material agreement
- Item 9.01: Financial statements and exhibits
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CURRENT REPORT
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Item 1.01. Entry into a Material Definitive Agreement
On October 7, 2021, Emmaus Life Sciences, Inc. (“we,” “us,” “our,” “Emmaus” or the “company”) entered into a License Agreement, effective as of October 6, 2021, with Kainos Medicine, Inc., a South Korean corporation (“Kainos”), under which Kainos has granted us an exclusive license in the territory encompassing the U.S., the U.K. and the EU to patent rights, know-how and other intellectual property relating to Kainos’s novel IRAK4 inhibitor, referred to as KM10544, for the treatment of cancers, including leukemia, lymphoma and solid tumor cancers. In consideration of the license, we have agreed in the License Agreement to pay Kainos a six-figure upfront fee in cash, cash payments upon the achievement of specified milestones totaling in the mid-eight figures, a single-digit percentage royalty based on net sales of the licensed products and a similar percentage of any sublicensing consideration.
The License Agreement will continue on a licensed product-by-licensed product and country-by-country basis until the last to expire valid claim of any licensed patent in such country.
On October 12, 2021, we issued a press release regarding the License Agreement, a copy of which is included as Exhibit 99.1 to this Current Report and incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
See the accompanying Index to Exhibits, which information is incorporated herein by reference.
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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.
| Date: October 12, 2021 | Emmaus Life Sciences, Inc. | |
| By: | /s/ YASUSHI NAGASAKI | |
| Name: Yasushi Nagasaki | ||
| Title: Chief Financial Officer | ||
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INDEX TO EXHIBITS
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Exhibit |
Description | |
| 99.1 | Press release dated October 12, 2021 |
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Exhibit 99.1
Emmaus Life Sciences Acquires Key Intellectual Property Rights to Novel IRAK4 Inhibitor From Kainos Medicine
Agreement Expands on the Companies’ Collaboration for the Preclinical Development of Potential Anti-Cancer Therapies
TORRANCE, Calif., October 12, 2021- Emmaus Life Sciences, Inc. (OTCQX: EMMA), a commercial-stage biopharmaceutical company and leader in the treatment of sickle cell disease, today announced the signing of an agreement with Kainos Medicine, Inc. (Kainos), granting Emmaus an exclusive license to patent rights, know-how and other intellectual property relating to Kainos’ novel IRAK4 inhibitor, referred to as KM10544, for the treatment of cancers including leukemia, lymphoma and solid tumors. The license agreement expands upon the existing research and development collaboration agreement between the parties. Financial details of the agreement were not disclosed.
Emmaus intends to advance the licensed technology to complete in-vivo studies to determine disease selection for KM10544 which, if successful, would be followed by Investigational New Drug enabling studies. Emmaus also plans to seek Orphan Drug Designation for relevant clinical indications.
“Obtaining the exclusive license to the intellectual property surrounding Kainos’ IRAK4 inhibitor is an important milestone as we expand our pipeline with a novel potential treatment option for some of the most resilient lymphomas in the world,” stated Yutaka Niihara, M.D., M.P.H., Chairman and Chief Executive Officer of Emmaus. “The KM10544 IRAK4 inhibitor has the potential to treat malignancies such as Waldenström’s Macroglobulinemia with MYD88 mutation and others. We look forward to furthering the development of this exciting compound and are grateful for our continuing collaboration with the Kainos team.”
Kisub Lee, Chairman and Chief Executive Officer of Kainos, added, “We have devoted significant efforts to bring KM10544 to its current stage and we are confident that Emmaus’ drug development expertise will allow the company to continue to progress this important program through the clinic.”
IRAK4 (interleukin-1 receptor-associated kinase 4) is a serine-threonine protein kinase made up of 460 amino acids that is a key messenger in signaling initiated by TLR/IL-1R (toll-like receptor/interleukin-1 receptor). It is known to be present and active in the occurrence of certain immunity responses, inflammation disorders and various cancers with myeloid differentiation factor 88 (MYD88) mutation.
About Kainos Medicine
Kainos Medicine, Inc., based in South Korea, is a clinical-stage company that specializes in the research and development of innovative medicines for brain diseases, cancers and infectious diseases, led by researchers who have years of experience and success in new drug discovery and development and an executive team that has experience with NASDAQ-listed companies. Kainos receives specialized counsel on product selection, evaluation and external licensing deals from advisory boards and business development consultants who have skills and significant experience in global drug development. For more information, please visit www.kainosmedicine.com.
About Emmaus Life Sciences
Emmaus Life Sciences, Inc. is a commercial-stage biopharmaceutical company and leader in the treatment of sickle cell disease. The company currently markets U.S. Food and Drug Administration approved ENDARI® (L-glutamine oral powder) indicated to reduce the acute complications of sickle cell disease in adults and children 5 years and older. The company is also engaged in the discovery and development of innovative treatments and therapies for certain rare and orphan diseases as well as those affecting larger populations, such as diverticulosis. For more information, please visit www.emmausmedical.com.
Forward-looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding the potential to advance early-stage studies of KM10544. These forward-looking statements are subject to numerous assumptions, risks and uncertainties which change over time, including uncertainties and risk factors disclosed in the company’s 2020 Annual Report on Form 10-K/A filed with the SEC on August 10, 2021, and actual results may differ materially. Such forward-looking statements speak only as of the date they are made, and Emmaus assumes no duty to update them, except as may be required by law.
Company Contact:
Emmaus Life Sciences, Inc.
Willis Lee
Chief Operating Officer
(310) 214-0065 x1130
wlee@emmauslifesciences.com
Investor Relations Contact:
Rx Communications Group
Michael Miller
(917)-633-6086
mmiller@rxir.com