Current Report Filing (8-k)
September 03 2021 - 07:01AM
Edgar (US Regulatory)
0000908259 false 0000908259 2021-08-31
2021-08-31 iso4217:USD xbrli:shares iso4217:USD xbrli:shares
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)
August 31, 2021
ONCOTELIC THERAPEUTICS, INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
000-21990 |
|
13-3679168 |
(State or
other jurisdiction
of
incorporation)
|
|
(Commission
File
Number)
|
|
(IRS
Employer
Identification
No.)
|
29397 Agoura Road,
Suite 107
Agoura Hills,
CA
91301
(Address
of principal executive offices and Zip Code)
Registrant’s
telephone number, including area code
(650)
635-7000
Not applicable.
(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 (see General Instruction A.2.
below):
☐ |
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
class |
|
Trading
Symbols |
|
Name of each
exchange on which registered |
N/A |
|
OTLC |
|
|
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
1.01 |
Entry
into a Material Definitive Agreement. |
On August
31, 2021, Oncotelic Therapeutics, Inc. (the “Company”)
entered into a binding term sheet (“Term Sheet”) with
Autotelic, Inc. (“Autotelic”) whereby the Company will
license AL-101, intranasal apomorphine, from Autotelic (the
“License”). Pursuant to the Term Sheet, the Company will
make payments to Autotelic, upon the achievement of certain
financial and regulatory milestones in the development of AL-101,
as shown below. The Term Sheet does not contemplate any upfront
payment and all payments are planned to be made upon the
achievement of the milestones. In addition, the payments of the
milestones are for 3 indications of AL-101, namely erectile
dysfunction (“ED”), Parkinson’s Disease (“PD”)
and female sexual dysfunction (“FSD”).
Milestones |
|
Transaction
Value |
|
|
Actions |
|
|
|
|
|
|
Tranche
1 |
|
$ |
1,000,000 |
|
|
Upon the
earlier to occur of: (i) the Company receiving an investment of at
least $20 million, and (ii) the uplisting of the Company’s common
stock to any NASDAQ market or the New York Stock
Exchange. |
|
|
|
|
|
|
|
Tranche
2 |
|
$ |
2,000,000 |
|
|
Upon
approval by the United States Food and Drug Administration of the
Company’s 505(b)2 application for purposes of treating
PD. |
|
|
|
|
|
|
|
Tranche
3 |
|
$ |
2,000,000 |
|
|
Upon first
patient in (“FPI”) for any clinical trial supporting the use
of AL-101 for the treatment of PD or ED. |
|
|
|
|
|
|
|
Tranche
4 |
|
$ |
2,500,000 |
|
|
Upon FPI for
phase 2 clinical trials supporting the use of AL-101 to treat
FSD. |
|
|
|
|
|
|
|
Tranche
5 |
|
$ |
2,500,000 |
|
|
Upon FPI for
phase 3 clinical trials supporting the use of AL-101 to treat
FSD |
|
|
|
|
|
|
|
Tranche
6 |
|
$ |
10,000,000 |
|
|
Upon
Marketing approval for the use of AL-101 to treat PD. |
|
|
|
|
|
|
|
Tranche
7 |
|
$ |
10,000,000 |
|
|
Upon
Marketing approval for the use of AL-101 to treat ED. |
|
|
|
|
|
|
|
Tranche
8 |
|
$ |
10,000,000 |
|
|
Upon
Marketing approval for the use of AL-101 to treat FSD |
|
|
|
|
|
|
|
Tranche
9 |
|
$ |
10,000,000 |
|
|
Upon the
earlier of: (i) the Company entering into a licensing agreement
with a third party for the use of AL-101 for the treatment of PD,
ED or FSD with an aggregate licensing value of at least $50
million; and (ii) the Company’s gross revenue derived from sales of
AL-101 for the treatment of PD, ED or FSD reaches at least $50.0
million. |
The Company
will also pay royalties to Autotelic, equal to an amount yet to be
agreed upon, but such amount to be not less than 15% of the
Company’s net sales of AL-101 once developed.
The Term
Sheet is subject to certain conditions including, without
limitation, the negotiation and approval of definitive
documentation regarding the License (the “Definitive
Agreement”), the Board of Directors of the Company approving
the Definitive Agreement, completion of due diligence, and receipt
of any necessary governmental approvals, if required. The Term
Sheet is subject to termination within 30 days of execution, unless
extended by mutual agreement of the Company and
Autotelic.
The
Company’s Chief Executive Officer, Mr. Vuong Trieu, is the majority
owner of Autotelic.
The
foregoing summary of the terms of the Term Sheet do not purport to
be complete and is qualified in its entirety by reference to the
Term Sheet, a copy of which is filed as Exhibit 10.1 to this Report
and is incorporated herein by reference.
Item
7.01 |
Regulation FD
Disclosure. |
On September
1, 2021, the Company issued a press release announcing the entry
into the Term Sheet with Autotelic. A copy of the press release is
attached hereto as Exhibit 99.1.
Disclaimer.
The
information in Section 7.01 of this Current Report on Form 8-K,
including the information set forth in Exhibit 99.1, is being
furnished and shall not be deemed “filed” for purposes of Section
18 of the Securities Exchange Act of 1934, as amended (the
“Exchange Act”), nor shall Exhibit 99.1 filed herewith be
deemed incorporated by reference in any filing under the Securities
Act of 1933, as amended, or the Exchange Act, except as shall be
expressly set forth by specific reference in such a
filing.
Item
9.01 |
Financial Statements
and Exhibits. |
(d)
Exhibits.
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.
|
Oncotelic Therapeutics,
Inc. |
|
|
|
Date:
September 3, 2021 |
|
/s/ Vuong
Trieu |
|
By: |
Vuong
Trieu |
|
|
Chief
Executive Officer |
Oncotelic Therapeutics (QB) (USOTC:OTLC)
Historical Stock Chart
From Apr 2022 to May 2022
Oncotelic Therapeutics (QB) (USOTC:OTLC)
Historical Stock Chart
From May 2021 to May 2022