0000908259
false
0000908259
2023-08-21
2023-08-21
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
21, 2023
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
7.01 |
Regulation
FD Disclosure. |
On
August 23, 2023, the Company issued a press release announcing that Sapu Biosciences, LLC, a wholly owned subsidiary of GMP Biotechnology
Ltd., a joint venture in which the Company is a 45% owner, entered into a master services agreement with Cromos Pharma, LLC, a leading
global clinical research organization to conduct a clinical trial for pancreatic cancer. 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.
Exhibit
No. |
|
Description |
|
Incorporation
by reference |
|
|
|
|
|
99.1 |
|
Press release dated August 23, 2023 |
|
Filed
herewith |
|
|
|
|
|
104 |
|
Cover
Page Interactive Data File (embedded within the Inline XBRL document) |
|
|
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:
August 23, 2023 |
|
/s/
Vuong Trieu |
|
By: |
Vuong
Trieu |
|
|
Chief
Executive Officer |
Exhibit
99.1
![](https://www.sec.gov/Archives/edgar/data/908259/000149315223029903/ex99-1_001.jpg)
Sapu
BioScience and Cromos Pharma initiating P201 – A Registrational trial for OT-101 in Pancreatic Cancer
AGOURA
HILLS, Calif., August 23, 2023 (GLOBE NEWSWIRE) – Oncotelic Therapeutics, Inc (OTCQB:OTLC) (“Oncotelic”, the “Company”
or “We” or “Our”), announced today its joint venture partner, GMP Biotechnology Limited’s wholly owned
subsidiary – Sapu Bioscience, LLC (“Sapu”), together with with Cromos Pharma, LLC (“Cromos”), a US-based
international contract research organization (“CRO”), to conduct Sapu’s registrational trial for OT-101 in Pancreatic
Cancer.
P201:
A Randomized Phase 2b/Phase 3 Study of the TGF-β2 Targeting Antisense Oligonucleotide OT-101 in Combination with FOLFIRINOX Compared
with FOLFIRINOX Alone in Patients with Advanced and Unresectable or Metastatic Pancreatic Cancer.
The
rates of pancreatic cancer are rising—and are rising faster among younger women, particularly Black women, than among men of the
same age. Pancreatic cancer has the highest mortality rate of all major cancers, accounting for 3% of all cancer deaths in the U.S.,
and is more common among men than women. Addressing this urgent medical need, Oncotelic, through Sapu, is launching a registrational
Phase 2b/Phase 3 trial with their TGF-β2 targeting therapy, OT-101 in combination with Standard of Care- (FOLFIRINOX) against pancreatic
cancer. This is a multinational trial with sites across the USA, EU, and China involving up to 500 patients. Sapu has engaged Cromos
Pharma, an international midsized CRO, to assist in the conduct of the trial. Leveraging Cromos Pharma’s distinguished oncological
expertise, this collaboration underscores the joint commitment to bring innovative treatments to cancer patients.
Cromos
Pharma’s renowned proficiency in site selection, and its vast global network for patient enrollment, stands as an invaluable asset
for this clinical trial venture. Handling complex trials with precision, Cromos Pharma’s unparalleled expertise should ensure efficient,
high-quality site choices and good global patient onboarding. For a trial of such magnitude and intricacy, Cromos Pharma’s involvement
is pivotal and will ensure streamlined operations and meticulous execution that can potentially hasten the time towards finding a solution
for this devastating cancer.
“Over
the past years we have been meticulously planning this trial to ensure its success. Spearheaded by our discovery that suppression of
TGFβ2 could more than double survival in pancreatic cancer, we have engineered the trial to deliver a decisive win against pancreatic
cancer. We look forward to engage physicians and patients in this critically important clinical trial,” expressed Dr. Vuong Trieu,
CEO of Sapu and Oncotelic.
“It’s
truly an honor for Cromos to collaborate with Sapu and Oncotelic, visionaries within the oncology space. With over 20 years in the drug
development cycle I have witnessed firsthand the monumental impact such partnerships can have on advancing medicine. Our expertise will
ensure that this clinical trial’s complexities are navigated with precision and efficiency. Together, we aim to break new ground
to bring a new therapy to those affected by pancreatic cancer,” said Dr. Vlad Bogin, MD, FACP, CEO & Founder of Cromos Pharma.
About
Cromos
Founded
in 2004 and headquartered in the United States, Cromos Pharma is an international CRO. Cromos offers comprehensive clinical research
solutions, covering all trial phases and a wide range of therapeutic areas. These areas include oncology, cardiovascular diseases, and
gastroenterology. Over its almost 20-year journey, Cromos Pharma has successfully completed more than 300 clinical trials, demonstrating
its commitment to excellence and precision. Its mission is to expedite the development of drugs and devices that save lives and enhance
its quality. Cromos Pharma achieves this by combining innovation with validated best practices, reducing drug development time and costs
while maintaining unparalleled quality standards. Cromos Pharma serves a diverse clientele, including Global Pharma, Biotechs, and other
notable CROs. It has a strong operational presence across the US, Central and Eastern Europe, and Central and Southwestern Asia. Their
country-specific operations cover Bulgaria, Croatia, Czech Republic, Estonia, Georgia, Hungary, Kazakhstan, Latvia, Lithuania, Moldova,
Poland, Romania, Serbia, Slovak Republic, Slovenia, Türkiye, and Ukraine. For collaborations or inquiries, please contact them at
inquiry@cromospharma.com.
About
Oncotelic
Oncotelic
(f/k/a Mateon Therapeutics, Inc.), was formed in the State of New York in 1988 as OXiGENE, Inc., was reincorporated in the State of Delaware
in 1992, and changed its name to Mateon Therapeutics, Inc. in 2016, and Oncotelic Therapeutics, Inc. in November 2020. Oncotelic is seeking
to leverage its deep expertise in oncology drug development to improve treatment outcomes and survival of cancer patients with a special
emphasis on rare pediatric cancers. Oncotelic has rare pediatric designation for Diffuse Intrinsic Pontine Glioma (“DIPG”
through OT-101) through its 45% joint venture, GMP Biotechnology Limited, melanoma (through CA4P), and Acute Myeloid Leukemia (“AML”
through OXi 4503). Oncotelic also acquired PointR Data Inc. in November 2019 to build an AI driven biotechnology company. Further, Oncotelic
acquired AL-101, during the 4th quarter of 2021, for the intranasal delivery of apomorphine. We intend to develop AL-101 for the treatment
of Parkinson Disease, erectile dysfunction, female sexual disorder and hypoactive sexual desire disorder. All these ailments have a very
large population suffering from them and there is a need for treatments for each. For more information on AL-101, refer to our Annual
Report on Form 10-K/A filed with the SEC on April 19, 2023.
Oncotelic’s
Cautionary Note on Forward-Looking Statements
This
press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements,
other than statements of historical facts, included in this communication regarding strategy, future operations, future financial position,
prospects, plans and objectives of management are forward-looking statements. Words such as “may”, “expect”,
“anticipate” “hope”, “vision”, “optimism”, “design”, “exciting”,
“promising”, “will”, “conviction”, “estimate,” “intend,” “believe”,
“quest for a cure of cancer”, “innovation-driven”, “paradigm-shift”, “high scientific merit”,
“impact potential” and similar expressions are intended to identify forward-looking statements. Forward looking statements
contained in this press release include, but are not limited to, statements about future plans related to the operations of the JV, taking
the JV into an initial public offering or the success thereof, the progress, timing of clinical development, scope and success of future
clinical trials, the reporting of clinical data for the Company’s product candidates and the potential use of the Company’s
product candidates to treat various cancer indications as well as obtaining required regulatory approval to conduct clinical trials and
upon granting of approval by the regulatory agencies, the successful marketing of the products; building and the success of our nanoparticle
platform and the related success of launching the platform,. Each of these forward-looking statements involves risks and uncertainties,
and actual results may differ materially from these forward-looking statements or may not occur at all. Many factors may cause differences
between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical
studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition,
changes in the regulatory environment, failure of collaborators to support or advance collaborations or product candidates and unexpected
litigation or other disputes, taking the Company or its affiliates through initial public offerings. These risks are not exhaustive,
the company faces known and unknown risks, including the risk factors described in the Company’s Annual Report on Form 10-K/A filed
with the SEC on April 19, 2023 and in the company’s other periodic filings. Forward-looking statements are based on expectations
and assumptions as of the date of this press release. Except as required by law, the company does not assume any obligation to update
forward-looking statements contained herein to reflect any change in expectations, whether because of new information, future events,
or otherwise.
Contact
Information:
For
Oncotelic Therapeutics, Inc.:
Investor
Relations
ir@oncotelic.com
v3.23.2
X |
- DefinitionBoolean flag that is true when the XBRL content amends previously-filed or accepted submission.
+ References
+ Details
Name: |
dei_AmendmentFlag |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionFor the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.
+ References
+ Details
Name: |
dei_DocumentPeriodEndDate |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:dateItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.
+ References
+ Details
Name: |
dei_DocumentType |
Namespace Prefix: |
dei_ |
Data Type: |
dei:submissionTypeItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionAddress Line 1 such as Attn, Building Name, Street Name
+ References
+ Details
Name: |
dei_EntityAddressAddressLine1 |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionAddress Line 2 such as Street or Suite number
+ References
+ Details
Name: |
dei_EntityAddressAddressLine2 |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- Definition
+ References
+ Details
Name: |
dei_EntityAddressCityOrTown |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionCode for the postal or zip code
+ References
+ Details
Name: |
dei_EntityAddressPostalZipCode |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionName of the state or province.
+ References
+ Details
Name: |
dei_EntityAddressStateOrProvince |
Namespace Prefix: |
dei_ |
Data Type: |
dei:stateOrProvinceItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionA unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityCentralIndexKey |
Namespace Prefix: |
dei_ |
Data Type: |
dei:centralIndexKeyItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionIndicate if registrant meets the emerging growth company criteria.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityEmergingGrowthCompany |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionCommission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.
+ References
+ Details
Name: |
dei_EntityFileNumber |
Namespace Prefix: |
dei_ |
Data Type: |
dei:fileNumberItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTwo-character EDGAR code representing the state or country of incorporation.
+ References
+ Details
Name: |
dei_EntityIncorporationStateCountryCode |
Namespace Prefix: |
dei_ |
Data Type: |
dei:edgarStateCountryItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityRegistrantName |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityTaxIdentificationNumber |
Namespace Prefix: |
dei_ |
Data Type: |
dei:employerIdItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionLocal phone number for entity.
+ References
+ Details
Name: |
dei_LocalPhoneNumber |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 13e -Subsection 4c
+ Details
Name: |
dei_PreCommencementIssuerTenderOffer |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 14d -Subsection 2b
+ Details
Name: |
dei_PreCommencementTenderOffer |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Section 14a -Number 240 -Subsection 12
+ Details
Name: |
dei_SolicitingMaterial |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Securities Act -Number 230 -Section 425
+ Details
Name: |
dei_WrittenCommunications |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
Oncotelic Therapeutics (QB) (USOTC:OTLC)
Historical Stock Chart
From Jul 2024 to Aug 2024
Oncotelic Therapeutics (QB) (USOTC:OTLC)
Historical Stock Chart
From Aug 2023 to Aug 2024