For the three months ended
“I am excited about the growth potential for our newly combined company – we have a promising pipeline of next-generation immunotherapies targeting several significant cancer markets where there are significant unmet medical needs,” said
The company’s lead product candidate, OT-101, is being developed as a broad-spectrum anti-cancer drug that can also be used in combination with other standard cancer therapies to establish an effective multi-modality treatment strategy for difficult-to-treat cancers, including high-grade gliomas and pancreatic cancer. The company plans to initiate phase 3 clinical trials for OT-101 in both high-grade glioma and pancreatic cancer. During phase 2 clinical trials in pancreatic cancer, melanoma, and colorectal cancers (Study P001) and high-grade gliomas (Study G004), meaningful clinical benefits were observed and OT-101 exhibited a favorable safety profile. These clinical benefits included long term survival and meaningful tumor reduction. Both partial and complete responses have been observed in the G004 Phase 2 clinical trial of OT-101 as a single agent in patients with aggressive brain tumors and in patients with treatment failure pancreatic cancers.
About the company’s Self-Immunization Protocol (SIP©)
The company’s self-immunization protocol (SIP©) is based on novel and proprietary sequential treatment of cancers with OT-101 (an antisense against TGF-β2) and chemotherapies. This sequential treatment strategy is aimed at achieving effective self-immunization against a patients’ own cancer, resulting in robust therapeutic immune response and consequently better control of the cancer and improved survival. Prolonged states of being cancer-free have been observed in some patients with the most aggressive forms of cancer, raising a renewed hope for a potential cure. The use of OT-101 lifts the suppression of the patient’s immune cells around the cancer tissue, providing the foundation for an effective initial priming, which is critical for a successful immune response. The subsequent chemotherapy results in the release of neoantigens that result in a robust boost of the immune response. The company believes that a rational combination of the Oncotelic SIP platform with immune-modulatory drugs like interleukin 2 (IL-2) and/or immune checkpoint inhibitors has the potential to help achieve sustained and robust immune responses in patients with the most difficult-to-treat forms of cancer.
The mechanism of action of SIP© presentations at the AACR Annual Meeting are now available for viewing at www.oncotelic.com:
- Abstract Number: 3968 / 24: OT-101/Chemotherapy - A novel mechanism of action (MOA) in pancreatic cancer immunization therapy.
- Abstract Number: 5029 / 23: OT-101/Chemotherapy - A novel mechanism of action (MOA) in gliomas immunization therapy.
The company aims to translate its unique insights, which span more than three decades of original work using RNA therapeutics, into the deployment of antisense as an RNA therapeutic for diseases which are caused by TGF-beta overexpression, starting with cancer. Mateon’s current management was part of the team that developed Abraxane® as a chemotherapeutic agent for breast, lung, melanoma, and pancreatic cancer. Abraxane® was approved in 2005 and generates annual sales over
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" 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
Financial data appears below:
|Balance Sheet Data|
|(unaudited at March 31, 2019)||March 31, 2019||December 31, 2018|
|(all amounts in thousands)|
|Prepaid expenses and other current assets||140||170|
|Right of use operating assets||51||-|
|Liabilities and stockholders' deficit|
|Accounts payable and accrued liabilities||$||1,174||$||1,161|
|Total stockholders' deficit||(783||)||(362||)|
|Total liabilities and stockholders' equity/(deficit)||$||391||$||799|
|Statement of Operations Data|
|(unaudited)||Three months ended March 31,|
|(all amounts in thousands, except per share data)|
|Research and development||$||135||$||225|
|General and administrative||499||570|
|Total operating expenses||634||795|
|Loss from operations||(634||)||(795||)|
|Net loss and comprehensive loss||$||(633||)||$||(794||)|
|Basic and diluted net loss per common share|
|attributable to common stock||$||(0.02||)||$||(0.03||)|
|Weighted-average number of common shares|
Source: Mateon Therapeutics