Current Report Filing (8-k)
13 November 2021 - 2:01AM
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2021-11-11
2021-11-11
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2021-11-12
2021-11-12
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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
Date
of Report (Date of earliest event reported): November 11, 2021
REGEN
BIOPHARMA, INC.
(Exact
name of small business issuer as specified in its charter)
Nevada
|
45-5192997
|
(State
or other jurisdiction of incorporation or organization)
|
(I.R.S.
Employer Identification No.)
|
Commission
File No. 333-191725
4700
Spring Street, St 304, La Mesa, California 91942
(Address
of Principal Executive Offices)
(619) 722
5505
(Issuer’s
telephone number)
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
|
|
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
8.01 Other Events.
On
November 11,2021 Regen Biopharma, Inc. (the “Company”) entered into a Letter of Intent ( “LOI”) with Canary Oncoceutics,
Inc (“Canary”) and Canary Oncoceutics Partners, LLC (“LLC”) whereby the Company shall acquire 95% of the share
capital and voting power of Canary ( “Canary Controlling Interest”) for consideration consisting of $1,000,000 and common
shares of the Company valued at the average share price of the common shares in the 2 weeks prior to the closing of a definitive agreement
between the parties (“RGBP Share Value”). The number of common shares to be issued shall be the number of common shares valued
at the RGBP share value which shall equal the value of the Canary Controlling Interest as determined by a mutually acceptable third-party
valuation expert.
No
definitive agreement between the parties for the acquisition by the Company of the Canary Controlling Interest shall close unless the
Company shall have raised the amount of $50,000,000 USD dedicated solely to the development and commercialization of Canary diagnostics
and products (“Canary Funds”).
It
is understood that the IP that will be licensed into Canary will originate from Cornell University. The final IP will be included in
the definitive agreement as an appendix. This IP allows for the creation of patient-derived tumor on vascular nets for in vitro testing
of therapeutic agents.
It
is contemplated by the parties that until the first commercial contract for use of the first Test Product, the Company shall pay to LLC
on each anniversary of the effective date of any definitive agreement the applicable fees listed below, with the last year pro-rated:
Date
|
PAYMENT
|
1st
- 3rd anniversary of Effective Date
|
$100,000
|
4th
anniversary of Effective Date
|
$150,000
|
5th
and each anniversary of Effective Date and each anniversary thereafter
|
$250,000
|
|
A.
Milestone Payments. The Company will pay LLC the following non-creditable milestone payments for each Test Product:
|
Milestone
|
AMOUNT
|
1.
Partnership with a genomics testing company
|
$1,000,000
|
2.
Partnership with a clinical laboratory equipment manufacturer
|
$1,000,000
|
3.
Submission to FDA of a Test Product Pre-Market Approval request
|
$500,000
|
4.
FDA (US) Approval of a Test Product
|
$3,000,000
|
5.
EMA (EU) Approval of a Test Product
|
$1,500,000
|
6.
PMDA (JPN) Approval of a Test Product
|
$1,000,000
|
7.
Cumulative Net Sales of Services for Test Products reach $100 Million
|
$2,000,000
|
|
|
|
Test
Product is defined within the LOI as a Patient-Derived Organoid on VascularNet (PDOV) for a specific tumor type. For example, a colon
tumor-derived PDOV is one Test Product, an ovarian tumor-derived PDOV is another Test Product.
It
is also contemplated that the Company shall pay LLC an earned royalty on Net Sales generated by use of the Test Products. Royalties are
payable on an annual worldwide Net Sales basis cumulative for each calendar year with an annual gross-up (if required) to reflect the
actual royalty tier achieved for the applicable calendar year.
|
CUMULATIVE
ANNUAL NET SALES
|
PERCENTAGE
|
|
Up
to $250 Million
|
2.5%
|
$250
Million to $500 Million
|
4%
|
Excess
above $500 Million
|
5%
|
It
is also contemplated that In the event of a Change in Control of Canary the Company shall pay to LLC a fee equal to 40% of the consideration
received by the Company as a result of the Change in Control net of expenses the Company has invested in Canary from date of acquisition,
including operational expenses and initial acquisition expenses. Change in Control is defined in the LOI as any transaction or series
of transactions, whether by merger or sale or transfer of more than fifty percent (50%) of the outstanding stock and voting power of
the relevant entity in which the members of the Board of Directors immediately preceding the closing of the Change of Control transaction
no longer constitute a majority of the Board of Directors of the surviving entity following the closing of such transaction.
Other
than as to confidentiality and goth faith provisions of the LOI the parties agree that the LOI does not constitute a binding commitment
by either party with respect to any transaction. The non-binding provisions of the LOI reflect only the parties’ current understanding
of the contemplated transaction, and a binding contract will not exist between the Parties unless and until they sign and deliver a mutually
acceptable definitive agreement. Other than to impose a duty to the parties to negotiate in good faith and to not disclose Confidential
Information, no obligations of one party to the other or liability of any kind shall arise from executing this Letter or its taking or
refraining from taking any actions relating to the proposed transaction.
The
management of the Company believes that the proposed acquisition of 95% of Canary would provide an opportunity for the Company to diversify
its intellectual property portfolio beyond the development of therapeutics into the development of in vitro diagnostics specifically
the development of complimentary functional precision medicine tests. In the event that intellectual property contemplated as being included
in any definitive agreement can be successfully developed cancer patients could receive both a genetic test and a functional test. This
combined test would provide their treating physician with information that will allow for the selection of the ideal drug/drug combination
for each patient.
The
transaction contemplated by the LOI is contingent upon the execution of one or more mutually acceptable definitive agreements between
the parties. No assurance can be given that any such agreements shall be executed or, if executed, shall not contain terms and conditions
materially different from the terms and conditions currently contemplated.
The
foregoing description of the abovementioned LOI is not complete and is qualified in its entirety by reference to the text of the abovementioned
LOI , which is attached to this Current Report on Form 8-K as Exhibit 99.1 and incorporated in this Item 8.01 by reference.
SIGNATURE
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.
|
REGEN BIOPHARMA, INC.
|
|
|
Dated: November 11, 2021
|
By: /s/ David Koos
|
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