SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported)
December 14, 2020
MATEON THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction
29397 Agoura Road Suite 107
Agoura Hills, CA 91301
(Address of principal executive offices and Zip Code)
Registrant’s telephone number, including area code
(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|
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. [ ]
Regulation FD Disclosure.
On December 14, 2020, management of Mateon Therapeutics, Inc. met with investors and potential partners to discuss ARTIVedaTM, and shared the Corporate Presentation attached hereto as Exhibit 99.1.
The information in this Current Report on Form 8-K, including the information set forth in Exhibit 99.1, 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 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.
The information is filed herewith.
|Item 9.01||Financial Statements and Exhibits.|
See Exhibit Index.
|Exhibit No.||Description||Incorporation by reference|
|99.1||ARTIVedaTM Product Information||Filed herewith.|
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: December 15, 2020||/s/ Vuong Trieu|
|Chief Executive Officer|
ARTIVedaTM positioned to address the COVID-19 pandemic in India.
Introduction: Mateon Therapeutics, Inc. is a US oncology company focusing on TGF-β inhibitors as therapies against cancers and infectious diseases. Mateon will launch an Ayurvedic therapeutic for COVID-19, with its India partner Windlas Biotech Private Ltd., in late-December 2020. The product, ARTIVedaTM, is a formulated plant extract of the indigenous plant Artemisia, known in Sanskrit texts as Damanaka and Davana. ARTIVedaTM is the first Ayurvedic drug against COVID-19 through TGF-β inhibition. It is broadly active against diseases of aging and infectious diseases including COVID-19.
ARTIVedaTM is expected to be effective through the entire infection cycle of COVID-19.
1. Prevention of COVID-19: Inhibition of viral binding to ACE2 receptor and inhibition of viral replication make this a prophylactic agent for prevention of COVID-19 [1-6].
2. Treatment of COVID-19: Clinical data demonstrated improvement in COVID-19 symptoms following treatment with ARTIVeda .
3. Recovery enhancer: Inhibition of TGF-β reduces scarring and reduces post-COVID-19 symptoms. Liver, lung, renal, and other organs fibrosis are inhibited 
|4.||Treatment of respiratory diseases in general. Inhibition of TGF-β has been shown to be effective against multiple viruses including influenza  and respiratory disorders such as allergic rhinitis .|
Manufacturing: The active component of ARTIVeda™ has been identified as artemisinin. Through proprietary GMP quality extraction and manufacturing processes, the Artemisia extract was rendered active against SARS-CoV-2 with robust Safety Index (SI) greater than 100 (ratio of nonspecific cell kill versus viral kill). Other extracts have SI <10. Testing was performed at the US NIAID core viral laboratory. The product is protected by a patent portfolio of over 15 international patents by Mateon’s R&D. The mechanism of action against COVID-19 has been confirmed in numerous international scientific/medical publications as listed below.
|Preliminary Data Clinical Study: ARTI-19: Mateon and Windlas have initiated a clinical trial scaling to 300 patients at 6 sites in India (including the prestigious AIIMS) with CTRI. Early read from ARTI-19 clinical trial suggests potent efficacy against COVID-19. The clinical study uses WHO scale from 1-asymptomatic to 8-death. In the treatment arm, 75% of patients who were moderate (WHO-scale-4) exhibited a drop to WHO-scale-3 by day “two” which discharged them from hospital. Majority (>80%) patients dropped to asymptomatic WHO-scale-1 by completion of one cycle of treatment (5 days-on, 5 days-off). Overall, the temporal sequence of the treatment demonstrated linear progression to asymptotic stage versus the control arm which exhibited high degree of randomness. The randomness can be explained by non-specific cocktail of anti-inflammatory and antibiotic drugs, many proven to be ineffective, including Remdesivir and Hydrochloroquinine . This trial is supported by a recent independent study published in the International Journal of Antimicrobial Agents, which showed that the combination of Artemisinin + Quinoline (Piperaquine) versus Quinoline (Hydroxychloroquine or HCQ) cut the time to virus-free by 50% and time to hospital discharge by 40%.|
Bottomline: Deployed broadly ARTIVedaTM has the ability to stop the pandemic in India by cutting infectivity rate (R0) by at least 50%.
|1.||Sehailia M, Chemat S. In-silico Studies of Antimalarial-agent Artemisinin and Derivatives Portray More Potent Binding to Lys353 and Lys31-Binding Hotspots of SARS-CoV-2 Spike Protein than Hydroxychloroquine: Potential Repurposing of Artenimol for COVID-19. ChemRxiv. 2020. Preprint. https://doi.org/10.26434/chemrxiv.12098652.v1.|
|2.||Alazmi M, Motwalli O. Molecular basis for drug repurposing to study the interface of the S protein in SARS-CoV-2 and human ACE2 through docking, characterization, and molecular dynamics for natural drug candidates. J Mol Model. 2020;26:338.|
|3.||Cao Y, Feng YH, Gao LW, et al. Artemisinin enhances the anti-tumor immune response in 4T1 breast cancer cells in vitro and in vivo. Int Immunopharmacol. 2019;70:110-116.|
|4.||Wang M, Cao R, Zhang L, et al. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res. 2020;30(3):269-271.|
|5.||Cao R, Hu H, Li Y, et al. Anti-SARS-CoV-2 Potential of Artemisinins In Vitro. ACS Infect Dis. 2020;6(9):2524-2531.|
|6.||Gilmore K, Zhou Y, Ramirez S, et al. In vitro efficacy of Artemisinin-based treatments against SARS-CoV-2. bioRxiv. 2020. 10.05.326637; doi: https://doi.org/10.1101/2020.10.05.326637.|
|7.||Li G, Yuan M, Li H, et al. Safety and efficacy of artemisinin-piperaquine for treatment of COVID-19: an open-label, non-randomised and controlled trial. Int J Antimicrob Agents. 2020;106216.|
|8.||Dolivo David et al., Artemisinin and artemisinin derivatives as anti-fibrotic therapeutics, Acta Pharmaceutica Sinica B, https://doi.org/10.1016/j.apsb.2020.09.001|
|9.||Denney L, Branchett W, Gregory LG, Oliver RA, Lloyd CM. Epithelial-derived TGF-β1 acts as a pro-viral factor in the lung during influenza A infection. Mucosal Immunology. 2018;11(2):523-535.|
|10.||J. Li, et al., Effect of artemisinin and neurectomy of pterygoid canal in ovalbumin-induced allergic rhinitis mouse model, Allergy Asthma Clin. Immunol. 14 (2018) 22.|