Oncotelic Therapeutics, Inc 8-K, filed Apr 7, 2020
Oncotelic Therapeutics, Inc. (OTLC)
About this 8-K
Oncotelic Therapeutics, Inc filed this 8-K on April 7, 2020, reporting on events of April 2, 2020.
Items reported
- Item 8.01: Other events
- Item 9.01: Financial statements and exhibits
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)
April 2, 2020
MATEON 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 | MATN | 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 April 2, 2020, Mateon Therapeutics, Inc. (the “Company”) issued a press release announcing the publication of a peer-reviewed research article co-authored by Fatih Uckun M.D. Ph.D., Sanjive Qazi Ph.D., and Vuong Trieu, Ph.D. in the oncology journal Cancer Reports and Reviews. A copy of that press release and peer reviewed research article are attached as Exhibit 99.1 and 99.2 to this Current Report on Form 8-K.
Forward-Looking Statements
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 may identify forward-looking statements. Examples of forward-looking statements include, but are not limited to, statements relating to the anticipated timing or results of the Company’s planned phase 3 trial for the OT101 product candidate, the Company’s ability to successfully secure any U.S. FDA priority review voucher, or the Company’s ability to sell and U.S. FDA priority review voucher or the terms of any such potential sale. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors that could cause actual events to differ from expectations, 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.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description | Incorporation by reference | ||
| 99.1 | Press Release | Filed herewith | ||
| 99.2 | Peer reviewed Research Article | Filed herewith |
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.
| Mateon Therapeutics, Inc. | ||
| Date: April 7, 2020 | /s/ Vuong Trieu | |
| By: | Vuong Trieu | |
| Chief Executive Officer | ||
Exhibit 99.1
MATEON THERAPEUTICS TEAM PUBLISHES A NEW PEER-REVIEWED ONCOLOGY ARTICLE ON THE POSITIVE CLINICAL STUDY RESULTS FOR OT-101 AGAINST RECALCITRANT RESISTANT ANAPLASTIC ASTROCYTOMA – A RARE FORM OF MALIGNANT BRAIN TUMOR
AGOURA HILLS, Calif., April 02, 2020 (GLOBE NEWSWIRE) — Mateon Therapeutics Inc. (OTCQB:MATN) today announced the publication of a peer-reviewed research article co-authored by Fatih Uckun MD PhD, Sanjive Qazi PhD, and Vuong Trieu, PhD in the oncology journal Cancer Reports and Reviews.
We previously reported the preliminary findings of a Phase II study (NCT00431561) confirmed its favorable safety profile and showed that OT101 can offer early disease control to R/R high-grade glioma patients at 6 months at a rate comparable to that achieved with the standard alkylating chemotherapy drug temozolomide. We are now reporting our analysis of the long-term follow-up data on the recalcitrant/resistant anaplastic astrocytoma (R/RR AA) patient subpopulation treated in the NCT00431561 study as proof of concept for the clinical utility of the Convection Enhanced Delivery of OT-101 platform (CEDOT). Notably, OT101 administered intratumorally via the CEDOT platform exhibited clinically meaningful single-agent activity and induced durable complete response (CR), partial response (PR) in more than half of the treated R/R AA patients. The median overall survival of patients receiving the CEDOT-delivered experimental therapy 1136 (95% CI:811 - 1743) days which was significantly better than the 590 (95% CI:287 - NA) days median OS (Log Rank χ2=6.5, P-value=0.011) of the TMZ-treated patient population.
“This work demonstrates superiority of OT-101 against an approved chemotherapeutic agent against AA and emphasizes our commitment to find effective new therapies for difficult-to-treat cancers,” stated Dr. Vuong Trieu, Chairman and Chief Executive Officer of Mateon Therapeutics.
OT-101 has received orphan drug designation for glioblastoma, melanoma, and pancreatic cancer. Furthermore, FDA recently granted Rare Pediatric Designation for OT-101 against diffuse intrinsic pontine glioma (DIPG). OT-101 is also effective against coronavirus including COVID-19 and being deployed against the COVID-19 epidemic.
About Mateon Therapeutics
Mateon was created by the recent reverse merger with Oncotelic which became a wholly owned subsidiary of Mateon Therapeutics Inc. (OTCQB:MATN) creating an immuno-oncology company dedicated to the development of first in class RNA therapeutics as well as small molecule drugs against cancer. The founding team members of Oncotelic were responsible for the development of Celgene’s Abraxane as a chemotherapeutic agent for breast, lung, melanoma, and pancreatic cancer. Abraxane was approved in 2005 and has more than $1B in sales annually. The same team was also responsible for the development of Cynviloq, a next generation Abraxane, which was acquired by NantPharma for $1.3B. Mateon/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 pediatric cancer patients. For more information, please visit www.oncotelic.com and www.mateon.com.
The Chief Executive Officer of Mateon, Dr. Vuong Trieu, PhD is a very experienced biotech executive and a KOL in the field of immunotherapy. He is best known for his seminal contributions to the development of Abraxane.
Mateon’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”, “innovative”, “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 April 10, 2019 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.
Contact Information:
For Mateon Therapeutics, Inc.:
Amit Shah
Email: ashah@oncotelic.com
Source: Mateon Therapeutics
Exhibit 99.2
