AGOURA HILLS, Calif., Nov. 16, 2020 (GLOBE NEWSWIRE) -- Mateon Therapeutics, Inc. (“Mateon” or the “Company”) (OTCQB: MATN) today announced financial results for the third quarter ended September 30, 2020 (“Q3 2020”), as well as an update on its therapeutic development initiatives, including those related to COVID-19.
Recent Operational Highlights
| ● | ArtiShield™ (outside of India)/ARTIVeda™ (India) | ||
| o | Signed an agreement with Windlas Biotech Pvt. Ltd. of India to commercialize ArtiShield™ /ARTIVeda™, the Company’s lead ethnobiology dru,g designed to be a readily available and cost-effective agent to combat COVID-19; | ||
| o | ArtiShield™ /ARTIVeda™ approved for manufacture and marketing by the Ministry of AYUSH (Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy), license number UK.AY-401/2018, for the treatment of various symptoms like fever and inflammation frequently seen in COVID-19 patients; | ||
| o | Dr. Suhas Kshirsagar, B.A.M.S, M.D. (Ayurveda), a worldwide renowned ayurvedic expert, joined Mateon as an advisor for Mateon’s Ayurvedic product ARTIShield™ /ARTIVeda™ in its commercialization for COVID-19; | ||
| o | Dr. Suhas Kshirsagar led a successful symposium entitled: “Advancing Ayurveda Through Ethnobiology Drug Development.” Topics included Mateon’s ARTIShield™/ ARTIVeda™ for the Treatment of COVID-19 and COVID-19/Influenza Coinfection. Presentations can be viewed at https://www.youtube.com/watch?v=0agiVypL_LU&feature=youtu.be. | ||
| 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 India. This global study will evaluate the safety and efficacy of ArtiShield™ upto 3,000 total patients, 120 of whom are currently from India and further expandable to 300 patients from India. Top line data from ARTI-19 in India is expected between Q4 2020 and Q1 2021; | ||
| ● | OT-101/COVID-19 program | ||
| o | Received clearance from regulatory authorities in Argentina and Peru to initiate a Phase II clinical trial of OT-101, a TGF-β antisense, for the treatment of patients with mild to severe COVID-19 infection. Top line data from the study is currently expected during or before Q1 2021. If the outcome is positive, the data will form the basis for Emergency Use Approval (EUA) application to global regulatory bodies. Including the US Food and Drug Administration (FDA); | ||
| o | Continuing our partnership with Golden Mountain Partners (GMP) and/or their designee with drawdown of the $2.0 M debt financial instrument with GMP to conduct OT-101/COVID-19 clinical trial. | ||
| ● | Oxi4503/ Melanoma | ||
| o | Announced that the US FDA granted Rare Pediatric Disease (RPD) designation to OXi4503 (combretastatin A1-diphosphate; CA1P) for the treatment of acute myeloid leukemia due to genetic mutations that disproportionately affect pediatric patients. The FDA grants RPD designation for diseases with serious or life-threatening manifestations that primarily affect people aged from birth to 18 years, and that affect fewer than 200,000 people in the U.S.; and | ||
| ● | Strengthened our scientific and management teams with the appointments of Anthony Maida, III, Ph.D., MA, MBA as Chief Clinical Officer - Translational Medicine to drive the Company’s clinical development activity. | ||
“We are very encouraged by the progress being made at Mateon through the first nine months of 2020,” said Dr. Vuong Trieu, CEO of Mateon. “While our product portfolio addresses significant unmet needs with respect multiple disease states, including glioblastoma, melanoma, and pancreatic cancer, we are most excited by our strategy to focus on COVID-19 and COVID-19/influenza coinfection. We look forward to multiple clinical trial catalysts – notably top line data from our ARTI-19 Phase IV trial between Q4 2020 and Q2 2021 the end of this year - and are excited about the transformational opportunities that our therapies may provide.”
“We are excited about the commercialization of ARTIVeda™ in India. It is expected to be a cost-effective treatment and prophylactic for COVID-19. This is transformational for the Company, as we establish a consortium of manufacturers, distributors, and marketers for the equitable distribution of this COVID-19 therapy,” said Amit Shah, CFO of Mateon.
Q3 2020 Financial Results Overview –
MATEON THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS FOR THE THREE MONTHS ENDED SEPTEMBER 30
(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 $1.6 million from $0.9 million in Q3 2019, reflecting a $0.6 million increase in R&D expense and a $0.1 million increase in general & administrative expenses, both of which are to support ongoing clinical trial activity, including activity related to COVID-19.
Net loss attributable to common stockholders for Q3 2020 was $2.0 million, or ($0.02) per share, compared to a net loss of $1.0 million, or ($0.01) per share, for Q3 2019.
Cash and cash equivalents were $1.4 million as of September 30, 2020, compared to $0.6 million as of June 30, 2020, and $0.1 million as of December 31, 2019. Total assets increased from $23,684,781 to $24,628,545
“During Q3 2020 we raised proceeds of $2.3 million, net of costs, to help us advance our therapeutic development activities,” said Mr. Shah.“ Also, the Company has formally changed its name to Oncotelic Therapeutics, Inc. with the State of Delaware. We are working with the appropriate agencies to obtain approvals to change our name and establish our new ticker symbol.”
Additional information is included in the Company’s Form 10-Q for the period ended September 30, 2020, filed on November 16, 2020, a copy of which is available free of charge at http://investor.mateon.com/sec-filings.
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 India
Mateon announced that ARTIShield ™/ARTIVeda™ has been approved for manufacture and marketing by the Ministry of AYUSH (Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy) in India for the treatment of various symptoms including fever and inflammation, which can be associated with COVID-19. ARTIShield™ is in co-development with Windlas Biotech Pvt. Ltd., Mateon’s commercial partner for India and is designed to be a readily available and cost-effective agent to combat COVID-19. ARTIVeda™ is the tradename for India and ArtiShieldTM is the tradename for outside of India. Mateon expects sales will commence in India before year end.
ARTI-19 Multi-national Phase IV Trial, Currently in India
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 India to contribute at least 300 patients to the total aggregate of 3000 patients. We expect preliminary top-line data for ARTI-19 sometime between Q420 and Q121.
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 Kawasaki syndrome (Fatih M. Uckun, Vuong Trieu. Targeting Transforming Growth Factor-beta for Treatment of COVID-19-associated Kawasaki Disease in Children. Clin Res Pediatr 2020; 3(1): 1-3) and acute respiratory distress syndrome (ARDS) (Fatih M. Uckun, Larn Hwang, Vuong Trieu. Selectively targeting TGF-β with Trabedersen/OT-101 in treatment of evolving and mild ARDS in COVID-19. Clin. Invest. (Lond.) 2020; 10(2), 167-176. DOI: 10.4172/ Clinical-Investigation.1000166.).
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 Kawasaki reaction- IgA vasculitis. The company is aggressively pursuing the development of this 2nd generation COVID-19 vaccine expecting that the 1st generation vaccines would not be fully effective and may not be sufficiently protective to counter the current pandemic.
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 Therapeutics
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 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.
Contact Information:
For Mateon Therapeutics, Inc.:
Amit Shah
ashah@oncotelic.com