Madrigal Pharmaceuticals Reports 2016 Fourth Quarter and Year-End Financial Results, Reviews Key Corporate Achievements and Provides Update on Lead Clinical-stage Compound, MGL-3196
- MGL-3196, a liver-directed thyroid hormone receptor (THR) beta selective agonist, has the potential to treat NASH (non-alcoholic steatohepatitis) and familial hypercholesterolemia (FH) -
- Madrigal is well positioned to complete Phase 2 proof-of-concept trials for MGL-3196 in NASH and HeFH -
“The completion of the merger with Synta has allowed us to rapidly advance MGL-3196 into two Phase 2 proof-of-concept clinical trials for patients with NASH and HeFH, while planning for a third Phase 2 trial in HoFH,” said
In 2016, Madrigal:
- Positioned the Company with sufficient capital to complete its NASH and HeFH Phase 2 trials and initiate the third Phase 2 trial in HoFH (more than
$40M atDecember 31, 2016 ); - Established an experienced management team with proven track records in drug discovery, development and commercialization and significant expertise in liver diseases;
- Executed an exclusive worldwide license agreement with Tarveda for products based on the HSP90 Drug Conjugate program, reflecting Madrigal’s strategy to create additional shareholder value by out-licensing its novel oncology assets; and
- Formed a strong Board of Directors with relevant expertise in drug development, strategic alliances and finance.
Clinical Program Updates for MGL-3196
NASH
NASH is a common liver disease in
“Because MGL-3196 selectively agonizes THR-β, it has the potential to safely address key pathological mechanisms responsible for the progression of liver injury in NASH,” said
HeFH
Heterozygous familial hypercholesterolemia (HeFH) is a severe genetic dyslipidemia, typically caused by an inactivating mutation in one copy of the LDL receptor gene that leads to early onset cardiovascular disease. With conventional therapy, including statins and ezetimibe, the majority of HeFH and virtually all HoFH patients fail to reach their cholesterol (LDL-C) reduction goals. Based on evidence of impressive LDL cholesterol lowering in Phase 1 and data suggesting that MGL-3196 has a mechanism of action that is different from and complementary to statins, Madrigal is conducting a Phase 2 trial in HeFH. The 12-week, randomized, double-blind, placebo-controlled, multi-center study will enroll up to 105 patients with HeFH randomized in a 2:1 ratio to receive either MGL-3196 or placebo, in addition to their current drug regimen (including high dose statins and ezetimibe). The primary endpoint of the study is reduction of LDL cholesterol, with secondary endpoints including reductions in triglycerides, Lp(a), and ApoB, as well as safety. Lp(a) is a severely atherogenic lipid particle, commonly elevated in familial hypercholesterolemia patients and poorly controlled by existing lipid lowering therapies. THR-β agonism is one of the few therapeutic approaches that can substantially lower Lp(a). As previously announced, the first patient in this study was dosed in
HoFH
Homozygous familial hypercholesterolemia (HoFH) is a much rarer form of severe genetic dyslipidemia, which results from inactivating mutations in both copies of the LDL receptor gene, and can produce cardiovascular disease before age 20. The protocol for a Phase 2, open-label study of MGL-3196 in HoFH is in development. The 12-week trial will have endpoints similar to the HeFH study and is expected to begin enrolling patients by the end of 2017.
Summary of 2016 Financial Results
Financial Results for the Three Months and Twelve Months Ended
Operating expenses were
Research and development expenses for the three month and twelve month periods ended
General and administrative expenses for the three month and twelve month periods ended
Interest income (expense), net, for the three month and twelve month periods ended
Forward-Looking Statements
This communication contains “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the company's clinical development of MGL-3196, the timing and outcomes of clinical studies of MGL-3196, and the uncertainties inherent in clinical testing. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Madrigal undertakes no obligation to update any forward looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Please refer to Madrigal's filings with the
(Tables Follow)
Madrigal Pharmaceuticals, Inc. | ||||||||||||||
Condensed Consolidated Statements of Operations | ||||||||||||||
(in thousands, except share and per share amounts) | ||||||||||||||
(unaudited) | ||||||||||||||
Three Months Ended | Twelve Months Ended | |||||||||||||
December 31, | December 31, | |||||||||||||
2016 | 2015 | 2016 | 2015 | |||||||||||
Revenues: | ||||||||||||||
Total revenues | $ | - | $ | - | $ | - | $ | - | ||||||
Operating expenses: | ||||||||||||||
Research and development | 5,524 | 773 | 15,934 | 2,427 | ||||||||||
General and administrative | 2,232 | 145 | 9,290 | 806 | ||||||||||
Total operating expenses | 7,756 | 918 | 25,224 | 3,233 | ||||||||||
Loss from operations | (7,756 | ) | (918 | ) | (25,224 | ) | (3,233 | ) | ||||||
Interest income (expense), net | 7 | (965 | ) | (1,164 | ) | (3,612 | ) | |||||||
Net loss | $ | (7,749 | ) | $ | (1,883 | ) | $ | (26,388 | ) | $ | (6,845 | ) | ||
Basic and diluted net loss per common share | $ | (0.67 | ) | $ | (10.86 | ) | $ | (5.07 | ) | $ | (40.03 | ) | ||
Basic and diluted weighted average number of common shares outstanding | 11,509,791 | 173,341 | 5,204,644 | 171,012 | ||||||||||
Madrigal Pharmaceuticals, Inc. | ||||||||||||||
Condensed Consolidated Balance Sheets | ||||||||||||||
(in thousands) | ||||||||||||||
December 31, | December 31, | |||||||||||||
2016 | 2015 | |||||||||||||
Assets | ||||||||||||||
Cash, cash equivalents and marketable securities | $ | 40,499 | $ | 306 | ||||||||||
Other current assets | 708 | 58 | ||||||||||||
Other non-current assets | 3 | - | ||||||||||||
Total assets | $ | 41,210 | $ | 364 | ||||||||||
Liabilities and Equity | ||||||||||||||
Current liabilities | $ | 4,800 | $ | 49,277 | ||||||||||
Long-term liabilities | - | - | ||||||||||||
Stockholders’ equity | 36,410 | (48,913 | ) | |||||||||||
Total liabilities and Stockholders’ equity | $ | 41,210 | $ | 364 | ||||||||||
Investor Contact:Marc Schneebaum ,Madrigal Pharmaceuticals, Inc. [email protected] Media Contact:Mike Beyer ,Sam Brown Inc. [email protected] 312-961-2502