Press Release
Recent Operational Highlights
● | ArtiShield™ (outside of |
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o | Signed an agreement with |
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o | ArtiShield™ /ARTIVeda™ approved for manufacture and marketing by the |
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o | Dr. |
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o | Dr. |
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o | Commenced patient enrollment for its ARTI-19 Phase IV multi-center interventional study to evaluate the safety and efficacy of ArtiShield™ in the treatment of adults with COVID-19 in |
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● | OT-101/COVID-19 program | ||
o | Received clearance from regulatory authorities in |
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o | Continuing our partnership with |
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● | Oxi4503/ Melanoma | ||
o | Announced that the |
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● | Strengthened our scientific and management teams with the appointments of |
“We are very encouraged by the progress being made at Mateon through the first nine months of 2020,” said Dr.
“We are excited about the commercialization of ARTIVeda™ in
Q3 2020 Financial Results Overview –
CONSOLIDATED STATEMENTS OF OPERATIONS FOR THE THREE MONTHS ENDED
(UNAUDITED)
2020 | 2019 | Variance | ||||||||||
Operating expense: | ||||||||||||
Research and development | 936,196 | 343,789 | 592,407 | |||||||||
General and administrative | 680,077 | 586,924 | 93,153 | |||||||||
Total operating expense | 1,616,273 | 930,713 | 685,560 | |||||||||
Loss from operations | (1,616,273 | ) | (930,713 | ) | (685,560 | ) | ||||||
Loss on conversion of debt | (88,817 | ) | - | (88,817 | ) | |||||||
Change in the value of derivatives on debt | 49,992 | - | 49,992 | |||||||||
Interest expense, net | (331,459 | ) | (60,413 | ) | (271,046 | ) | ||||||
Net Loss | $ | (1,986,557 | ) | (991,126 | ) | (995,431 | ) |
Total operating expenses for Q3 2020 rose to
Net loss attributable to common stockholders for Q3 2020 was
Cash and cash equivalents were
“During Q3 2020 we raised proceeds of
Additional information is included in the Company’s Form 10-Q for the period ended
ARTIShield ™/ARTIVedaTM- an Ethnobiology Drug
Mateon is pursuing several avenues with respect to the development and commercialization of ARTIShield™ in the treatment of COVID-19. ARTIShield™ is Ayurveda - Dvipaantara Damanaka - and is labeled as a capsule containing Artemisia Powder 500mg. It is a demonstration of how Ethnobiology can be used to drive drug development against emerging pandemics.
The classical pharmaceutical regulatory pathways have failed to provide fast-track to treatment and vaccines. Government resources have concentrated on a few candidates most of which have failed. The Ayurvedic medicine route is proving to be an accelerated pathway to deploy a well-known, abundantly available and cost effective Ayurvedic medicine that is safe and being proven in-vitro and large-scale clinical trial to be effective.
ARTIShield ™/ARTIVeda™ - Commercialization in
Mateon announced that ARTIShield ™/ARTIVeda™ has been approved for manufacture and marketing by the
ARTI-19 Multi-national Phase IV Trial, Currently in
Mateon announced the enrollment of its first patient in a Phase IV study ARTI-19, “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 trial will compare the efficacy of oral doses with standard-of-care (SOC) versus SOC alone. This is a global study with
About OT-101
OT-101 is an antisense against the host TGF-β protein required for viral replication and its overexpression likely to cause the wide range of clinical symptoms associated with COVID-19 including
TGF-β is elevated in COVID-19 (Xiong Y. et al. Transcriptomic characteristics of bronchoalveolar lavage fluid and peripheral blood mononuclear cells in COVID-19 patients. Emerging Microbes & infections 2020; 9:1, 761-770, DOI: 10.1080/22221751.2020.1747363. Agrati C. et al. Expansion of myeloid-derived suppressor cells in patients with severe coronavirus disease (COVID-19). Cell Death & Differentiation 2020; https://doi.org/10.1038/s41418-020-0572-6.).
OT-101 is also being developed as an adjuvant for second generation COVID-19 vaccine. To avoid the two potential issues with 1st generation vaccine against COVID-19, we will be combining the 1st generation COVID-19 DNA vaccine with a TGF-β inhibitor (OT-101) to stimulate a strong immune response while suppressing the IgA class switching that could aggravate the disease through
The development of OT-101 is important given the failure of other drugs leaving dexamethasone as the only clinically proven effective drug against COVID-19.
About
Mateon was created by the recent reverse merger with Oncotelic, 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 Mateon/Oncotelic, is a first-in-class anti-TGF-βRNA therapeutic that exhibited single agent activity in some relapsed/refractory cancer patients in clinical trial settings. OT-101 also has activity against SARS-CoV-2. 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 rare pediatric cancers. Mateon has rare pediatric designation for DIPG (OT-101), melanoma (CA4P), and AML (OXi4503).
For more information, please visit www.oncotelic.com and www.mateon.com.
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”, “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
Contact Information:
For
ashah@oncotelic.com
Source: Mateon Therapeutics, Inc.