SOUTH SAN FRANCISCO, Calif., March 30, 2017 (GLOBE NEWSWIRE) -- Mateon Therapeutics, Inc. (OTCQX:MATN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of orphan oncology indications, today provided a corporate update and announced 2016 financial results.
Corporate Achievements During 2016
- Changed company’s name to Mateon Therapeutics, Inc. to reflect focus on combination vascular targeted therapy in orphan oncology indications
- Re-invigorated Board of Directors with complete changeover of independent members during 2016, adding three experienced biopharmaceutical industry leaders: Donald R. Reynolds, Bobby W. Sandage, Jr., Ph.D., and Simon C. Pedder, Ph.D.
"2016 was a key year for execution of the business plans that we developed in the months after I started as CEO in mid-2015, as we initiated our important FOCUS study, advanced the PAZOFOS study and moved our OXi4503 study in AML into its combination-treatment phase," stated William D. Schwieterman, M.D., Mateon's President and Chief Executive Officer. "We also rebranded the company and freshened our board, bringing in new outside board members with deep industry expertise as we made meaningful changes based on our new direction. Now, as the first quarter of 2017 nears completion, we are very encouraged by the early data in AML. We are also eagerly awaiting next month the first randomized clinical trial data from the company in years, as we conduct a scheduled interim analysis of FOCUS in platinum-resistant ovarian cancer.”
Key 2016 and Recent Developments
CA4P in combination with bevacizumab for Treatment of Ovarian Cancer
• Presented new data reflecting improved survival outcomes for CA4P-treated patients from Study GOG-0186I, an open-label randomized Phase 2 clinical trial in recurrent ovarian cancer
- Data demonstrated an improvement of 5.6 months in overall survival and 3.7 months in progression-free survival in patients with measurable disease
• Published positive results from Study GOG-0186I in Journal of Clinical Oncology, official journal of the American Society of Clinical Oncology. Study was funded by National Cancer Institute, conducted by Gynecologic Oncology Group (GOG).
• Initiated the FOCUS Study, a Phase 2/3 clinical trial of CA4P in combination with bevacizumab (Avastin®) and chemotherapy in platinum-resistant ovarian cancer
- Currently have 25 sites actively recruiting patients
CA4P in combination with pazopanib for Treatment of Recurrent Ovarian Cancer
• Initiated enrollment in Phase 2 portion of the PAZOFOS Study, a Phase 1b/2 clinical trial of CA4P in combination with pazopanib (Votrient®)
CA4P in combination with bevacizumab for Treatment of Glioblastoma Multiforme
• Received Orphan Drug Designation for CA4P for the treatment of glioma from U.S. Food and Drug Administration (FDA)
CA4P for Treatment of Neuroendocrine Tumors (NETs)
• Received Orphan Drug Designation for CA4P for the treatment of NETs from both the FDA and the European Commission
• Presented data from monotherapy study in NETs and announced an investigator-sponsored study in NETs using CA4P in combination with everolimus (AFINITOR®)
OXi4503 in combination with cytarabine for Treatment of Relapsed/Refractory Acute Myeloid Leukemia (AML)
• Completed enrollment of first three cohorts and initiated the fourth cohort of OX1222, an open-label Phase 1b dose-ranging study of OXi4503 in combination with cytarabine
• Presented data from OX1222 at 58th Annual Meeting of American Society of Hematology
• Presented updated data from OX1222 at the 29th Annual ROTH Conference
- Highlights include 3 patients, one from each dose cohort, experiencing complete remission
Additional Pipeline Developments
• Announced encouraging preliminary data from four syngeneic mouse models evaluating CA4P in combination with checkpoint inhibitors
- Most compelling results were found combining CA4P with an anti-CTLA4 antibody in an EMT-6 mammary model - 7 of 8 mice receiving combination were tumor free at study's completion, compared to 1 of 8 in CA4P monotherapy arm and 2 of 8 in anti-CTLA4 antibody monotherapy arm
Financial Results
For the year ended December 31, 2016, Mateon reported a net loss of $13.7 million, similar to the net loss for the year ended December 31, 2015. R&D expenses decreased to $8.8 million in 2016 compared to $9.1 million in 2015, while general and administrative expenses increased to $5.0 million in 2016 compared to $4.6 million in 2015.
At December 31, 2016, Mateon had cash and short-term investments of $12.0 million.
About Mateon
Mateon Therapeutics, Inc. is a biopharmaceutical company seeking to realize the full potential of vascular targeted therapy (VTT) in oncology. VTT includes vascular disrupting agents (VDAs) such as the investigational drugs that Mateon is developing, and anti-angiogenic agents (AAs), a number of which are FDA-approved and widely used in cancer treatment. These two approaches have distinct yet complementary mechanisms of action.
At Mateon, we believe that we can significantly improve cancer therapy by employing these two complementary approaches simultaneously. When utilized this way, VDAs obstruct existing blood vessels in the tumor leading to significant central tumor cell death while AAs prevent the formation of new tumor blood vessels.
Mateon is committed to leveraging our intellectual property and the product development expertise of our highly skilled management team to enable VTT to realize its true potential and to bring much-needed new therapies to cancer patients worldwide.
Safe Harbor Statement
Certain statements in this news release, including, but not limited to, those concerning the advancement of CA4P and OXi4503, the results of clinical trials, the potential significance of this data and its relation to other clinical and pre-clinical studies are considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. They can be affected by inaccurate assumptions Mateon might make or by known or unknown risks and uncertainties, including, but not limited to: the uncertainties as to the future success of ongoing and planned clinical trials; the unproven safety and efficacy of products under development or that may be developed in the future; and the sufficiency of the Company’s cash resources to conduct and complete future clinical and pre-clinical trials. Consequently, no forward-looking statement can be guaranteed, and actual results may vary materially. Additional information concerning factors that could cause actual results to materially differ from those in the forward-looking statements is contained in Mateon’s reports to the Securities and Exchange Commission, including Mateon’s reports on Forms 10-Q, 8-K and 10-K. However, Mateon undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise.
| Balance Sheet Data | ||||||||
| December 31, | ||||||||
| 2016 | 2015 | |||||||
| (all amounts in thousands) | ||||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 3,535 | $ | 27,285 | ||||
| Short-term investments | 8,512 | - | ||||||
| Prepaid expenses and other current assets | 2,023 | 105 | ||||||
| Other assets | 44 | 63 | ||||||
| Total assets | $ | 14,114 | $ | 27,453 | ||||
| Liabilities and stockholders' equity | ||||||||
| Accounts payable and accrued liabilities | $ | 1,614 | $ | 2,103 | ||||
| Total stockholders' equity | 12,500 | 25,350 | ||||||
| Total liabilities and stockholders' equity | $ | 14,114 | $ | 27,453 | ||||
| Statement of Operations Data | |||||||||||
| 2016 | 2015 | ||||||||||
| (all amounts in thousands, except per share data) | |||||||||||
| Operating Expenses: | |||||||||||
| Research and development | $ | 8,764 | $ | 9,086 | |||||||
| General and administrative | 4,995 | 4,596 | |||||||||
| Total operating expenses | 13,759 | 13,682 | |||||||||
| Loss from Operations | (13,759 | ) | (13,682 | ) | |||||||
| Interest income | 106 | 27 | |||||||||
| Other income (expense) | (1 | ) | 1 | ||||||||
| Net loss and comprehensive loss | $ | (13,654 | ) | $ | (13,654 | ) | |||||
| Basic and diluted net loss per common share | |||||||||||
| attributable to common stock | $ | (0.51 | ) | $ | (0.54 | ) | |||||
| Weighted-average number of common shares | |||||||||||
| outstanding | 26,545 | 25,201 | |||||||||