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)
August24, 2021
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.) |
29397Agoura Road, Suite 107
AgouraHills, 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 | OTLC |
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 7.01 | Regulation FD Disclosure |
|---|
On August 24, 2021, Oncotelic Therapeutics, Inc. (the “Company”) issued a press release announcing that PulmoHeal^TM^and ArtiVeda^TM^ have proven to be effective against mild and moderate COVID-19 following the preplanned prospective analysis of the Company’s ARTI-19 clinical trial (NCT05004753 - A Prospective, Randomized, Multi-center, Open label, Interventional Study to Evaluate the Safety and Efficacy of Artemisinin 500 mg capsule in Treatment of Adult Subjects with COVID-19). As stated in the press release, the study report will serve as the basis for the Company’s regulatory submission for marketing approval of ArtiVeda^TM^. A copy of the press release is attached hereto as Exhibit 99.1.
Also on August 24, 2021, the Company began utilizing a new corporate presentation (the “Presentation”) regarding the clinical data from the ARTI-19 clinical trial. A copy of the Presentation is attached hereto as Exhibit 99.2.
Disclaimer.
The information in this Current Report on Form 8-K, including the information set forth in Exhibits 99.1 and 99.2, are 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 Exhibits 99.1 and 99.2 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.
| Item 9.01 | Financial Statements and Exhibits. |
|---|
(d) Exhibits.
| Exhibit No. | Description | Incorporation by reference |
|---|---|---|
| 99.1 | Press release dated August 24, 2021 | Filed<br> herewith. |
| 99.2 | PulmoHeal^TM^ Presentation dated August 24, 2021 | Filed<br> herewith |
| 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> August 26, 2021 | /s/ Vuong Trieu | |
| By: | Vuong<br> Trieu | |
| Chief<br> Executive Officer |
| -3- |
| --- |
Exhibit 99.1
PulmoHeal^TM^/ ArtiVeda^TM^ IS CLINICALLY ACTIVE AGAINST MILD AND MODERATE COVID-19.
AGOURAHILLS, Calif., August 24, 2021 - Oncotelic Therapeutics, Inc. (“Oncotelic” or the “Company”) (OTCQB:OTLC), a leading developer of TGF-β therapeutics for oncology and COVID-19, reported today that PulmoHeal^TM^/ ArtiVeda^TM^has proven active against mild and moderate COVID-19 following the preplanned prospective analysis of ARTI-19 clinical trial (NCT05004753- A Prospective, Randomized, Multi-center, Open label, Interventional Study to Evaluate the Safety and Efficacy of Artemisinin 500 mg capsule in Treatment of Adult Subjects with COVID-19). The study report will serve as the basis for Oncotelic’s regulatory submission for marketing approval of PulmoHeal^TM^/ ArtiVeda^TM^.
“The positive outcome of this well conducted clinical trial has validated our TGF-β platform against COVID-19. Targeting the immutable host protein, PulmoHeal^TM^/ ArtiVeda^TM^ is effective against COVID-19 variants. We look forward to continuing expansion of our marketing of PulmoHeal^TM^/ ArtiVeda^TM^ as phytomedicine and further clinical development of Artemisinin as a pharmaceutical.” said Dr. Vuong Trieu, CEO and Chairman of Oncotelic.
In summary, based on the study results, it was shown that Artemisinin 500 mg capsule administered once daily for 5 days:
| ● | was<br> effective in treating subjects with mild and moderate COVID-19, |
|---|---|
| ● | artemisinin+SOC<br> group showed significant improvement over SOC in WHO severity scale on Day 4 and Day 5 with p=0.0045 and p=0.0370, respectively. |
| ● | decline<br> in body temperature was faster and higher in Artemisnin+SOC group by day 2 in comparison to SOC arm, |
| ● | improvement<br> in respiratory rate was faster and higher in Artemisnin+SOC group by day 5 in comparison to SOC arm, |
| ● | improvement<br> in mean SpO2 level was significantly higher in Artemisnin+SOC group by day 28 (end of study) in comparison to SOC arm (p=0.029), |
| ● | no<br> clinically significant changes in biochemistry or hematology parameters, |
| ● | was<br> safe and well-tolerated by the study subjects. |
AboutARTI-19
NCT05004753- A Prospective, Randomized, Multi-center, Open label, Interventional Study to Evaluate the Safety and Efficacy of Artemisinin 500 mg capsule in Treatment of Adult Subjects with COVID-19. This was an open label, prospective, multicenter study. Subjects with a clinical diagnosis of mild to moderate COVID-19, subject to fulfilling other inclusion and exclusion criteria, were randomized to receive either SOC or test drug Artemisinin 500 mg capsule/day for 5 days + standard of care (SOC) per cycle with the option to repeat as needed until symptoms of the disease are resolved, up to a total of 3 cycles (“5 days treatment, 5 days off” comprise a cycle) or standard of care (SOC).
The subjects were randomly assigned and received treatment with either the test plus SOC (n=80) or the SOC (n=41). After having obtained signed, written Informed Consent, these subjects had undergone a screening examination. Provided all inclusion/exclusion criteria were fulfilled, the subjects were enrolled and randomized by block randomization to one of the two treatment arms on Day 1. All the subjects had received the usual treatment according to ICMR (Indian Council of Medical Research) and other Indian ministry of healthcare guidelines.
Assessments of safety and efficacy variables were performed as per the study protocol. The final visit end of study (EOS) was on Day 28. Serious AEs were followed-up until they resolve or get stabilized or until 30 days from the subject’s involvement in the study had ended, whichever occurred first, and it was documented according to ICH-GCP and Indian GCP guidelines
Over all 122 patients were screened. The subjects were randomly assigned to one of the two groups: Artemisinin 500 mg (BD) with SOC or SOC in a ratio of 2:1.
Subjects were initially hospitalized for 5 days of study treatment in both treatment arms. When necessary, subjects were permitted to remain for a few more additional days in the hospital for the second cycle or third cycle of treatment.
AboutOncotelic Therapeutics
Oncotelic Therapeutics, Inc. (f/k/a Mateon Therapeutics, Inc.) (“Oncotelic”), 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 was created by the 2019 merger with Oncotelic Inc., which became a wholly owned subsidiary of Mateon, thereby creating an immuno-oncology company dedicated to the development of first in class RNA therapeutics, as well as small molecule drugs against cancer and infectious diseases. OT-101, the lead immuno-oncology drug candidate of Oncotelic, is a first-in-class anti-TGF-β RNA therapeutic that exhibited single agent activity in some relapsed/refractory cancer patients in clinical trial settings. OT-101 also has shown activity against SARS-CoV-2. 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 also has rare pediatric designation for DIPG (OT-101), melanoma (CA4P), and AML (OXi 4503). The Company acquired PointR Data Inc. (“PointR”) in November 2019. The PointR Acquisition was intended to create a publicly traded artificial intelligence driven immuno-oncology company with a robust pipeline of first in class TGF-β immunotherapies for late-stage cancers such as gliomas, pancreatic cancer and melanoma.
For more information, please visit www.oncotelic.com
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, 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 May 20, 2020 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 as a result of new information future events, or otherwise.
ContactInformation:
For Oncotelic Therapeutics, Inc.:
Amit Shah
ashah@oncotelic.com
Exhibit99.2
