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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)
March
23, 2026
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 |
|
|
|
|
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
March 23, 2026, Oncotelic Therapeutics, Inc. (the “Company”) announced that Sapu Nano, in which the Company has a minority
interest, will present new data on evorlimus toxicology (“Presentation”) at the Society of Toxicology (SOT) 2026 Annual
Meeting and ToxExpo in San Diego, California. A copy of the Press Release is attached as Exhibit 99.1 to this Current Report on Form
8-K. Also attached is a copy of the poster presentation and is attached as Exhibit 99.3 to this Current Report on Form 8-K.
Disclaimer.
The
information in Section 8.01 of this Current Report on Form 8-K, including the information set forth in 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 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 |
| 99.1 |
|
Press release |
| 99.2 |
|
Poster presentation |
| 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:
March 27, 2026 |
By: |
/s/
Vuong Trieu |
| |
|
Vuong
Trieu, Ph. D., CEO |
Exhibit
99.1

Sapu
Nano to Present Everolimus Toxicology Data at SOT 2026 Annual Meeting
AGOURA
HILLS, Calif., March 23, 2026 (GLOBE NEWSWIRE) – Oncotelic Therapeutics, Inc. (OTCQB:OTLC) (“Oncotelic”, the “Company”
or “We” or “Our”), a leader in RNA-based therapeutics, announced today that its subsidiary Sapu Nano will present
new data on everolimus toxicology, focusing on tissue concentration–driven effects, at the upcoming Society of Toxicology (SOT)
2026 Annual Meeting and ToxExpo, taking place March 22–25, 2026, in San Diego, California.
The
presentation will be featured during the Poster Session: ADME/Toxicokinetics I:
| ● | Date:
Monday, March 23, 2026 |
| ● | Time
(Author Attended): 1:45 PM – 4:15 PM |
| ● | Display
Time: 9:00 AM – 4:30 PM |
| ● | Location:
Exhibit Hall B, San Diego Convention Center |
| ● | Abstract
#: 3539 |
| ● | Poster
Board #: K692 |
Presentation
Title:
“Everolimus Toxicology: Tissue Concentration Effects”
Authors:
W. Chang, N. Chang, T. Hoque, and C. Lee
Sapu Nano, San Diego, CA
This
poster presents new findings that elucidate the relationship between tissue-level exposure of everolimus and organ-specific toxicological
outcomes, advancing understanding beyond traditional plasma pharmacokinetics.
“These
data underscore the importance of tissue pharmacokinetics in determining toxicity profiles for mTOR inhibitors such as everolimus,”
said Wen-Han Chang PhD, Sr. Manager Nanomedicine. “Our findings provide a foundation for developing improved delivery strategies,
including intravenous and nanoparticle-based formulations that better control biodistribution.”
The
SOT Annual Meeting and ToxExpo is the leading international forum for toxicology, bringing together scientists from academia,
industry, and regulatory agencies to present cutting-edge research in safety science and drug development.
Sapu
Nano’s participation highlights its continued leadership in nanomedicine and advanced drug delivery, with a focus on enhancing
therapeutic index through precise control of drug distribution at the tissue level.
For
more information about the meeting, visit:
www.toxicology.org/2026 | #2026SOT | #ToxExpo
About
Sapu Nano
Sapu
Nano is a biotechnology company developing next-generation nanomedicine platforms to improve drug delivery, enhance therapeutic index,
and unlock new clinical potential for established and novel therapeutics, with a primary focus in oncology.
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 Bio, melanoma (through CA4P) and its wholly owned subsidiary Sapu, 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 2024 Annual Report on form 10-K filed with the SEC on April 15, 2025.
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, the success of the launch of a company with a DAO infrastructure, the success
of the entity and the plans surrounding the pet and animal health, the ability for the Company to register the tokens of Pet2DAO, the
actual filing of a registration statement and approval of the PDAO, or any other tokens that we may launch, as registrable securities
with the SEC through a registration statement, the ability of the tokens to be tradable or any value such tokens may have if they become
tradable.. 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 2024 Annual Report on Form 10-K filed with the SEC on April 15, 2025 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
Exhibit
99.2
