OTLC Oncotelic Therapeutics Inc (QB)

On January 26, 2021, Oncotelic Therapeutics, Inc. (the “Company”), began utilizing a new corporate presentation (the “Presentation”) regarding the Company’s biomarker program for OT-101 across multiple phase 2 trials in combination with pembrolizumab. Our phase 2 trials are designed to for the eventual approval of OT-101 against any solid tumors, with high-TGF signature, as determined by our companion diagnostic assay.

In June 2020, the Food and Drug Administration (the “FDA”) granted accelerated approval to pembrolizumab for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [ 10 mutations/megabase (mut/Mb)] solid tumors, as determined by a FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. We intend to utilize the same approval route for OT-101/ pembrolizumab combination.

A copy of the Presentation 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 may contain, among other things, certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, (i) statements with respect to the Company’s plans, objectives, expectations and intentions; and (ii) other statements identified by words such as “may”, “could”, “would”, should”, “believes”, “expects”, “anticipates”, “estimates”, “intends”, “plans” or similar expressions. Forward-looking statements in this document include, without limitation, statements regarding the Company’s expectations regarding the expectation and timing of AL-101’s approval through its proposed 505(b)(2) applications, whether the Company will complete development of AL-101, and the anticipated use of proceeds therefrom. These statements are based upon the current beliefs and expectations of the Company’s management and may be subject to significant risks and uncertainties; and that no assurances can be given that such expectations shall be fulfilled.