Item
7.01 Regulation FD Disclosure.
On
November 23, 2021, Oncotelic Therapeutics, Inc. (the “Company”) issued a press release announcing positive topline
results for its Phase 2 C001 COVID study “A Double-Blind, Randomized, Placebo Controlled, Multi-Center Study of OT-101 in Hospitalized
COVID-19 Subjects.” A copy of the press release is attached hereto as Exhibit 99.1.
Disclaimer.
The
information in 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.
Forward-Looking
Statements.
This
Current Report on Form 8-K, and the attacahed Exhibit 99.1, 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 Current Report on Form 8-K, and the attached 99.1, include, but are not limited
to, statements about future plans, the progress, timing, 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. Each of these forward-looking statements involves risks and uncertainties, and actual results may differ
materially from these forward-looking statements. 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. 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 15, 2021 and in the company’s other periodic filings. Forward-looking statements are based on expectations
and assumptions as of the date of this Current Report on Form 8-K. 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 as a result of new information future
events, or otherwise.