Item 5. Other Information
Item 5. Other Information
Related Party Loans
Over the period January 1, 2022 through September 30, 2022, certain of the Company’s directors and executive officers loaned the Company an aggregate of $5.8 million to augment the Company’s working capital as reflected in the following table (in thousands):
Principal
Amounts
Annual
Interest
Rate
Term
Soomi Niihara(1)
$
300
12%
Due on Demand
Yasushi Nagasaki(2)
$
50
10%
Due on Demand
Hope International Hospice, Inc.(1)
$
350
10%
Due on Demand
Hope International Hospice, Inc.(1)
$
210
10%
Due on Demand
Soomi Niihara(1)
$
100
10%
Due on Demand
George Sekulich(2)
$
26
10%
Due on Demand
Soomi Niihara(1)
$
200
10%
Due on Demand
Osato Medical Clinic.(3)
$
250
12%
Due on Demand
Alfred Lui(2)
$
50
12%
Due on Demand
Hope International Hospice, Inc.(1)
$
150
12%
Due on Demand
Hope International Hospice, Inc.(1)
$
150
12%
Due on Demand
Wei Pei Derek Zen(2)
$
200
10%
Due on Demand
Willis Lee(2)
$
45
10%
Due on Demand
Hope International Hospice, Inc.(1)
$
40
10%
Due on Demand
Yutaka and Soomi Niihara(1)
$
402
12%
5 years
Hope International Hospice, Inc.(1)
$
50
10%
Due on Demand
Yutaka and Soomi Niihara(1)
$
250
10%
5 years
Yutaka and Soomi Niihara(1)
$
1,669
10%
5 years
Hope International Hospice, Inc.(1)
$
50
10%
Due on Demand
Yutaka and Soomi Niihara(1)
$
60
10%
Due on Demand
Seah Lim(2)
$
1,200
6%
3 years
(1)
Soomi Niihara is Dr. Niihara’s wife. Dr. Niihara, a Director and the Chairman, and Chief Executive Officer of the Company, is also a director and the Chief Executive Officer of Hope International Hospice, Inc., which is wholly owned by him and his wife.
(2)
Officer or current or former director.
(3)
Dr. Osato, a former director of Emmaus, and his wife are the sole owners of Osato Medical Clinic.
Diverticulosis
As reported in the Annual Report, based upon data from the initial Pilot/Phase 1 study of the safety and efficacy of prescription grade L-glutamine oral powder (“PGLG”) in diverticulosis, in July 2021 we initiated a sub-study under an amendment to the original IND protocol. The purpose of the sub-study was to standardize data collection and recording using video capture to support the accurate assessment of any changes in the sigmoid colon, the most frequent site for diverticulosis, as well as diverticulitis, a more severe manifestation of diverticulosis. The sub-study objective was to provide additional safety and efficacy data to support further clinical development. For the sub-study, five patients were administered oral L-glutamine 15g BID over six months beginning early this year. Unfortunately, as the study was ending a patient in the sub-study experienced serious health complications unrelated to the sub-study which necessitated his withdrawal from the study before treatment could be completed, while other patients showed marginal improvement. As a result, we do not have definitive data to conclude the study.
At present, we have plan for further study of PGLG in diverticulosis but are considering a future study in diverticulitis patients in order to possibly increase measurable clinical endpoints from the treatment with PGLG.
29
Item 6. Exhibits
(a) Exhibits
Incorporated by Reference
Exhibit
Number
Exhibit Description
Form
File No.
Exhibit
Filing Date
Filed/
Furnished
4.1
Warrant to Purchase Shares of Common Stock dated as of August 9, 2022
*
10.1
Promissory Note dated July 27, 2022
*
10.2
Promissory Note dated August 15, 2022
*
10.3
Promissory Note dated August 16, 2022
*
10.4
Promissory Note dated August 16, 2022
*
10.5
Promissory Note dated August 17, 2022
*
10.6
Promissory Note dated August 17, 2022
*
10.7
Promissory Note dated September 16, 2022
*
31.1
Certification of Chief Executive Officer pursuant to Item 601(b)(31) of Regulation S-K, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
*
31.2
Certification of Chief Financial Officer pursuant of Item 601(b)(31) of Regulation S-K, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
*
32.1
Certification of Chief Executive Officer and Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
**
101.INS
Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document
101.SCH
Inline XBRL Taxonomy Extension Schema Document
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)
*
Filed herewith.
**
This exhibit shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934, whether made before or after the date hereof and irrespective of any general incorporation language in any filings.
30
EMMAUS LIFE SCIENCES, INC.
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, thereunto duly authorized.
Emmaus Life Sciences, Inc.
Dated: November 14, 2022
By:
/s/ Yutaka Niihara
Name:
Yutaka Niihara, M.D., M.P.H.
Its:
Chief Executive Officer
By:
/s/ Yasushi Nagasaki
Name:
Yasushi Nagasaki
Its:
Chief Financial Officer
31