8-K
Oncotelic Therapeutics, Inc. (OTLC)
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)
March23, 2025
ONCOTELIC THERAPEUTICS, INC.
(Exactname of registrant as specified in its charter)
| Delaware | 000-21990 | 13-3679168 |
|---|---|---|
| (State or other jurisdiction<br><br> <br>of incorporation) | (Commission<br><br> <br>File Number) | (IRS Employer<br><br> <br>Identification No.) |
29397 Agoura Road, Suite 107
Agoura Hills, CA 91301
(Addressof principal executive offices and Zip Code)
Registrant’s
telephone number, including area code
(650)635-7000
Not
applicable.
(Formername 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<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement<br> 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<br> of class | Trading<br> Symbols | Name<br> 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. ☐
Item8.01 Other Events.
On March 23, 2025, Oncotelic Therapeutics, Inc. (the “Company”) announced that Dr. Vuong Trieu, CEO of the Company presented a talk titled “Transforming Growth Factor Beta 2 in Aging, Cancer, Lupus, and Immuno-Oncology: A Convergence of Disease Pathways and Therapeutic Potential” at the 5th Symposium on World Cancer Research (SWCR) 2025. A copy of the presentation is attached as Exhibit 99.1 to this Current Report on Form 8-K.
Further, on March 25, 2025, the Company issued a press release announcing the presentation, as well as the successful results of a Phase 1 clinical trial of OT-101 and recombinant IL-2 (aldesleukin), a copy of the press release is attached as Exhibit 99.2 to this Current Report on Form 8-K.
Forward-LookingStatements
This document contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by 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. In addition, when or if used in this communication, the words “will,” “may,” “would,” “approximate,” “expect,” “intend,” and similar expressions and their variants, as they relate to the Company, identify forward-looking statements. Examples of forward-looking statements include, but are not limited to, statements relating to the expected start and the success of the subsequent planned clinical trials for OT-101 and IL2. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including the risk factors included in the Company’s most recent Annual Report on Form 10-K and other periodic reports filed with the Securities and Exchange Commission. Except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.
Disclaimer.
The information in Section 8.01 of this Current Report on Form 8-K, including the information set forth in Exhibit 10.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “ExchangeAct”), 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.
Item9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description |
|---|---|
| 99.1 | Presentation |
| 99.2 | Press Release dated March 25, 2025 |
| 104 | Cover<br> Page Interactive Data File (embedded within the Inline XBRL document) |
| -2- |
| --- |
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<br> Therapeutics, Inc. | ||
|---|---|---|
| Date:<br> March 25, 2025 | By: | /s/ Vuong Trieu |
| Vuong<br> Trieu |
| -3- |
| --- |
Exhibit 99.1
Exhibit 99.2
OncotelicTherapeutics Announces Successful Completion of Phase 1 Trial of OT-101 and IL-2, Highlights Findings at SWCR 2025 Conference
AGOURA HILLS, Calif., March x, 2025 (GLOBE NEWSWIRE) – Oncotelic Therapeutics, Inc (OTCQB:OTLC) (“Oncotelic”, the “Company” or “We” or “Our”), “), a leader in RNA-based therapeutics, announced today the successful completion of a Phase 1 clinical trial evaluating OT-101, in combination with IL-2 for advanced or metastatic solid tumors. These results set the stage for new studies that combine OT-101,an antisense therapeutic targeting Transforming Growth Factor Beta 2 (TGFβ2), with checkpoint inhibitors (“CKIs”) and recombinant IL-2 (aldesleukin) (“IL-2”).
The announcement coincides with a presentation delivered by Vuong Trieu, Ph.D., Chairman & CEO of Oncotelic, at the 5th Symposiumon World Cancer Research (SWCR) 2025. In his talk, titled “Transforming Growth Factor Beta 2 in Aging, Cancer, Lupus, andImmuno-Oncology: A Convergence of Disease Pathways and Therapeutic Potential,” Dr. Trieu described the central role of TGFβ2 in immune suppression across multiple diseases, and outlined the ongoing development of OT-101 in pancreatic cancer (Phase 3 STOP-PC study), gliomas, and combination regimens with immunotherapies.
Phase1 Trial of OT-101 (TASO) and IL-2 Successfully Completed
| ● | The<br> Phase 1 trial (ClinicalTrials.gov ID: NCT04862767) investigated the safety and tolerability<br> of OT-101 in combination with recombinant IL-2 in patients with advanced or metastatic solid<br> tumors. |
|---|---|
| ● | The<br> combination showed a tolerable safety profile at the planned dosing schedule, with no unexpected<br> safety signals identified. |
| --- | --- |
| ● | Based<br> on the favorable safety data, Oncotelic plans to advance OT-101 plus IL-2 into further clinical<br> studies, exploring synergies with CKIs such as PD-1 blockers. |
| --- | --- |
KeyHighlights From the Kyoto 2025 Presentation
| 1. | TGFβ2’s Central Role in Cancer and Beyond: |
|---|---|
| o | Dr.<br> Trieu presented evidence that TGFβ2 is a critical driver of immunosuppression, fueling<br> tumor progression by promoting an M2-like macrophage phenotype and blunting antitumor immunity. |
| --- | --- |
| 2. | OT-101’s Clinical Progress and Versatility: |
| --- | --- |
| o | In<br> pancreatic ductal adenocarcinoma (PDAC), OT-101 is currently in a Phase 3 clinical trial<br> (the STOP-PC study) combined with mFOLFIRINOX. |
| --- | --- |
| o | OT-101<br> has shown encouraging activity in gliomas, where high intratumoral TGFβ2 expression<br> correlates with poor prognosis. |
| --- | --- |
| o | Combination<br> regimens with CKIs and IL-2 address multiple pathways of immune evasion, potentially amplifying<br> therapeutic benefits. |
| --- | --- |
| 3. | Next Studies Targeting TGF β2 and Beyond: |
| --- | --- |
| o | With<br> the newly completed OT-101 and IL-2 Phase 1 trial, Oncotelic is poised to begin further combination<br> trials to determine the added efficacy of OT-101, IL-2, and CKIs in solid tumors such as<br> lung cancer, melanoma, and colorectal cancer. |
| --- | --- |
| o | Next<br> wave of clinical trials aiming to knock down TGF β 2 (e.g., with OT-101) paired with<br> intervention with a complementary therapy, checkpoint blockade, IL-2, interferon-based regimens,<br> or standard-of-care chemo, depending on the tumor indication |
| --- | --- |
“We are thrilled to announce the completion of our Phase 1 study evaluating OT-101 with IL-2, a key milestone that sets the stage for next-generation immunotherapy combinations,” said Dr. Vuong Trieu, Chairman & CEO of Oncotelic. Our findings reinforce that OT-101’s specific inhibition of TGFβ2 can significantly enhance the immune response, and we are eager to test these synergies with checkpoint inhibitors and IL-2 to maximize therapeutic potential for patients with hard-to-treat cancers.”
The presentation, along with a chatbot powered by PDAOAI, can be accessed on our new PDAOAI public Discord: https://discord.gg/jz6Q7G2SBQ.
Our PDAOAI Discord server allows members of the public to view and download the presentation. In addition, by using “/query”, they can utilize our proprietary chatbot technology to ask questions related to the presentation. We highly recommend joining Discord. If you need any help, members of the PDAOAI team can assist. In addition, you can use “/help”. We intend to use this server for our PDAOAI platform. For those who are interested in joining our investor Discord, can do so here: https://discord.gg/hMDV397832
“We are excited to bring PDAOAI to the public and are excited for the user feedback. This presentation is a beginning to bringing our AI technology to the masses and not just our internal team,” said Scott Myers, Product Manager.
AboutOncotelic
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 2023 Annual Report on form 10-K filed with the SEC on April 12, 2024.
Oncotelic’sCautionary 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 annual report on Form 10-K filed with the SEC on April 12, 2024 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.
ContactInformation:
For Oncotelic Therapeutics, Inc.:
Investor Relations
ir@oncotelic.com