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Oncotelic (OTLC) highlights Sapu Nano Deciparticle platform, Phase 1 cancer trials

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8-K

Rhea-AI Filing Summary

Oncotelic Therapeutics, Inc. reported that its minority-owned company Sapu Nano will introduce its Deciparticle™ nanomedicine platform and present its clinical pipeline at BIO-Europe Spring 2026 on March 25, 2026. Sapu Nano has been selected as a Presenting Company at the conference.

The session will feature Deciparticle, a sub-20 nm drug delivery platform designed to optimize tissue distribution, improve pharmacokinetics, and reduce formulation-related toxicities for hydrophobic oncology drugs. Two lead candidates include an intravenous everolimus formulation in Phase 1 clinical trials and an advanced docetaxel formulation entering Phase 1.

The disclosure also reiterates Oncotelic’s broader oncology strategy, including rare pediatric cancer designations through its 45% joint venture GMP Bio and programs such as OT-101, CA4P, OXi 4503, and AL-101 for neurological and sexual health indications, while emphasizing extensive forward-looking statement cautions.

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Insights

Oncotelic highlights Sapu Nano’s Deciparticle platform entering early clinical stages.

Oncotelic uses this update to spotlight Sapu Nano’s Deciparticle™ nanomedicine platform and its selection as a Presenting Company at BIO-Europe Spring 2026 on March 25, 2026. The platform targets improved delivery of highly hydrophobic oncology agents via sub-20 nm particles.

Two assets anchor the story: an intravenous everolimus formulation already in Phase 1 clinical trials and a Deciparticle-based docetaxel formulation entering Phase 1. Both remain early-stage, so clinical risk is high and timelines are long, with no efficacy or safety data disclosed here.

The company also reminds readers of its broader oncology and neurology pipeline, rare pediatric designations and AI capabilities. Overall, this is a strategic and scientific positioning update rather than a financial event; its ultimate importance depends on future clinical results and partnering progress that are not detailed in this communication.

Item 8.01 Other Events Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
BIO-Europe Spring presentation date March 25, 2026 Date of Sapu Nano Presenting Company session
Deciparticle everolimus stage Phase 1 clinical trials Intravenous everolimus formulation using Deciparticle
Deciparticle docetaxel stage Entering Phase 1 Advanced docetaxel formulation leveraging Deciparticle
GMP Bio joint venture stake 45% Oncotelic interest in GMP Bio with OT-101 rare pediatric designation
2024 Form 10-K filing date April 15, 2025 Date referenced for 2024 Annual Report on Form 10-K
PointR Data acquisition year 2019 Oncotelic acquired PointR Data Inc. in November 2019
AL-101 acquisition period Q4 2021 Oncotelic acquired AL-101 during the fourth quarter of 2021
Deciparticle™ technical
"Sapu Nano will formally introduce its Deciparticle™ nanomedicine platform and present its advancing clinical pipeline"
nanomedicine technical
"its Deciparticle™ nanomedicine platform and present its advancing clinical pipeline at BIO-Europe Spring 2026"
Nanomedicine uses extremely tiny engineered materials and devices — often measured in billionths of a meter — to diagnose, monitor, or treat disease, for example by delivering drugs directly to specific cells or enhancing imaging. For investors it signals a high-tech approach with the potential for more effective therapies, smaller doses, and new product categories, but also brings specialized manufacturing, regulatory scrutiny, and research risk that can affect development timelines and returns.
therapeutic index medical
"engineered to optimize tissue distribution, enhance therapeutic index, and enable intravenous delivery"
The therapeutic index is a measure of a drug’s safety margin—the gap between the dose that produces a desired effect and the dose that causes harmful effects. For investors, a larger therapeutic index means a wider safety cushion, lower risk of dangerous side effects, smoother regulatory review and broader market acceptance, all of which can reduce clinical and commercial risk and affect a drug developer’s valuation.
Phase 1 clinical trials medical
"Intravenous formulation of everolimus ... Currently in Phase 1 clinical trials"
rare pediatric designation regulatory
"Oncotelic has rare pediatric designation for Diffuse Intrinsic Pontine Glioma"
forward-looking statements regulatory
"This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995"
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.
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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 24, 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 24, 2026, Oncotelic Therapeutics, Inc. (the “Company”) announced that Sapu Nano, in which the Company has a minority interest, will introduce its Deciparticle nanomedicine platform and its advancing clinical pipeline (“Press Release”) at the Bio-Europe Spring 2026 on March 25, 2026. A copy of the Press Release is attached as Exhibit 99.1 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
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 30, 2026 By: /s/ Vuong Trieu
    Vuong Trieu, Ph. D., CEO

 

 

 

 

 

 

Exhibit 99.1

 

 

Sapu Nano to Launch Deciparticle™ Platform and Present Clinical Pipeline at BIO-Europe Spring 2026

 

AGOURA HILLS, Calif., March 24, 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 formally introduce its Deciparticle™ nanomedicine platform and present its advancing clinical pipeline at BIO-Europe Spring 2026, where the company has been selected as a Presenting Company.

 

The presentation will take place at:

 

  Event: BIO-Europe Spring 2026
  Session: Presenting Company
  Location: Theater A
  Date: March 25, 2026

 

During the session, Sapu Nano will unveil its proprietary Deciparticle™ platform, a next-generation drug delivery technology engineered to optimize tissue distribution, enhance therapeutic index, and enable intravenous delivery of highly hydrophobic oncology agents.

 

The company will highlight two lead clinical candidates:

 

  Sapu003 (Everolimus for Injection)

 

  Intravenous formulation of everolimus
  Designed to overcome limitations of oral exposure and tissue variability
  Currently in Phase 1 clinical trials

 

  Sapu006 (Docetaxel for Injection)

 

  Advanced formulation of docetaxel leveraging Deciparticle™ technology
  Aimed at improving safety and efficacy versus conventional docetaxel formulations
  Entering Phase 1 clinical trials

 

“Our Deciparticle™ platform represents a major step forward in controlling drug distribution at the tissue level,” said Dr. Vuong Trieu, Chief Executive Officer of Sapu Nano. “With Sapu003 and Sapu006 entering Phase 1, we are translating this platform into clinical-stage assets with the potential to significantly improve outcomes in oncology.”

 

The presentation will emphasize:

 

  Platform-level advantages of Deciparticle™ in sub-20 nm nanomedicine design
  Improved pharmacokinetics and tissue targeting capabilities
  Reduction of formulation-related toxicities associated with conventional excipients
  Broad applicability across multiple hydrophobic drug classes

 

BIO-Europe Spring is one of the premier global partnering conferences for the life sciences industry, bringing together biotechnology, pharmaceutical, and investment leaders to foster strategic collaborations and advance innovative therapeutics.

 

Sapu Nano is actively seeking strategic partnerships, co-development opportunities, and regional collaborations to accelerate the clinical development and commercialization of its Deciparticle™ pipeline.

 

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

 

 

 

 

FAQ

What did Oncotelic Therapeutics (OTLC) announce about Sapu Nano in this 8-K?

Oncotelic announced that Sapu Nano will introduce its Deciparticle™ nanomedicine platform and present its advancing clinical pipeline at BIO-Europe Spring 2026. Sapu Nano was selected as a Presenting Company, highlighting its early-stage oncology drug delivery programs and partnership ambitions.

What is Sapu Nano’s Deciparticle nanomedicine platform mentioned by Oncotelic (OTLC)?

Deciparticle™ is described as a next-generation nanomedicine platform designed to optimize tissue distribution and improve the therapeutic index for hydrophobic oncology drugs. It uses sub-20 nm particles to enhance pharmacokinetics, tissue targeting, and reduce formulation-related toxicities from conventional excipients.

Which clinical candidates using Deciparticle is Sapu Nano presenting for Oncotelic (OTLC)?

Sapu Nano will present two lead oncology candidates: an intravenous formulation of everolimus already in Phase 1 clinical trials and an advanced docetaxel formulation leveraging Deciparticle technology that is entering Phase 1. Both are aimed at improving safety, efficacy, and exposure consistency versus existing formulations.

When and where will Sapu Nano present its platform for Oncotelic (OTLC)?

Sapu Nano will present at BIO-Europe Spring 2026 as a Presenting Company. The session is scheduled for March 25, 2026 in Theater A, where the company will formally introduce the Deciparticle™ platform and outline its lead Phase 1 clinical programs.

How does this update relate to Oncotelic’s broader oncology strategy (OTLC)?

The update positions Sapu Nano’s Deciparticle™ platform within Oncotelic’s wider oncology focus, including rare pediatric designations via its 45% joint venture GMP Bio and assets like OT-101, CA4P, and OXi 4503. It underscores the company’s emphasis on innovative drug delivery and difficult cancer indications.

Is the Sapu Nano and Deciparticle information in this Oncotelic (OTLC) filing considered filed with the SEC?

The company states that information in Section 8.01, including the attached press release, is being furnished and not deemed filed under Section 18 of the Exchange Act. It is also not incorporated by reference into other securities filings unless specifically referenced there.

Filing Exhibits & Attachments

6 documents