Aerpio Reports First Quarter 2019 Financial Results and Provides Business Update
On Track to Initiate Phase 1b Clinical Trial of Topical Drop Formulation of AKB-9778 for Primary Open-Angle Glaucoma (POAG) in the Second Quarter of 2019
“Although the TIME-2b study of the Tie2 activator, AKB-9778, did not meet its primary endpoint in non-proliferative diabetic retinopathy (NPDR), we continue to be encouraged by pre-specified secondary endpoint data that suggest the potential for AKB-9778 to treat primary open-angle glaucoma (POAG) and possibly diabetic nephropathy,” said
Recent Company Highlights and Upcoming Milestones
- Announced top-line results of the TIME-2b clinical trial designed to evaluate the safety and efficacy of AKB-9778, a Tie2 activator, in NPDR; the study did not meet its primary endpoint; however, the study generated encouraging data in a number of prespecified, key secondary endpoints, including reductions in urine albumin-to-creatinine ratio (UACR), a measure of kidney function, suggesting potential utility as a treatment for diabetic nephropathy, and reductions in intraocular pressure (IOP), suggesting potential utility in open-angle glaucoma;
- Presented encouraging preliminary IOP data from the Company’s TIME-2b study at the
Association for Research in Vision and Ophthalmology Annual Meeting 2019; and, - Anticipate initiating a Phase 1b clinical trial to evaluate the safety and pharmacokinetics of a topical drop formulation of AKB-9778 in healthy subjects in the second quarter of 2019, with results anticipated by the end of 2019.
First Quarter 2019 Financial Highlights
As of
For the three months ended
Research and development expenses for the three months ended
General and administrative expenses for the three months ended
Net loss attributable to common shareholders for the three months ended
About
About AKB-9778
AKB-9778 binds to and inhibits vascular endothelial protein tyrosine phosphatase (VE-PTP), an important negative regulator of Tie2. Decreased Tie2 activity contributes to vascular instability in many diseases including diabetes. AKB-9778 activates the Tie2 receptor irrespective of extracellular levels of its binding ligands, angiopoietin-1 (agonist) or angiopoietin-2 (antagonist) and may be the most efficient pharmacologic approach to maintain normal Tie2 activation.
Forward Looking Statements
This press release contains forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, projections regarding future revenue and financial performance, the Company’s long-term growth, the development of the Company’s product candidates, including AKB-9778, the Company’s plans for future development of its product candidates, including the timing and commencement of the Company’s planned clinical trials and expected results from such clinical trials, the therapeutic potential of the Company’s product candidates, and the Company’s collaboration with
These forward-looking statements are made as of the date of this press release, and the Company assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents the Company files with the
| AERPIO PHARMACEUTICALS, INC. | ||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| (In thousands) | ||||||||
| March 31, | December 31, | |||||||
| 2019 | 2018 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 53,423 | $ | 62,614 | ||||
| Prepaid research & development contracts | 340 | 754 | ||||||
| Other current assets | 536 | 616 | ||||||
| Total current assets | 54,299 | 63,984 | ||||||
| Furniture and equipment, net | 199 | 99 | ||||||
| Operating lease right-of-use asset | 518 | - | ||||||
| Deposits | 41 | 41 | ||||||
| Total assets | $ | 55,057 | $ | 64,124 | ||||
| Liabilities and shareholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 3,734 | $ | 5,457 | ||||
| Current portion of operating lease liability | 190 | - | ||||||
| Total current liabilities | 3,924 | 5,457 | ||||||
| Operating lease liability, net of current portion | 338 | - | ||||||
| Total liabilities | 4,262 | 5,457 | ||||||
| Stockholders' equity: | ||||||||
| Capital | 178,253 | 177,626 | ||||||
| Accumulated deficit | (127,458 | ) | (118,959 | ) | ||||
| Total stockholders' equity | 50,795 | 58,667 | ||||||
| Total liabilities and stockholders' equity | $ | 55,057 | $ | 64,124 | ||||
| AERPIO PHARMACEUTICALS, INC. | ||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
| (In thousands, except per share amounts) | ||||||||
| Three months ended | ||||||||
| March 31, | ||||||||
| 2019 | 2018 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 5,586 | $ | 4,029 | ||||
| General and administrative | 3,255 | 3,448 | ||||||
| Total operating expenses | 8,841 | 7,477 | ||||||
| Interest and other income | 348 | 51 | ||||||
| Net and comprehensive loss | $ | (8,493 | ) | $ | (7,426 | ) | ||
| Net and comprehensive loss per share basic and diluted | $ | (0.21 | ) | $ | (0.27 | ) | ||
| Weighted average number of common shares used in computing net and comprehensive loss per share, basic and diluted | 40,588 | 27,046 | ||||||
View source version on businesswire.com: https://www.businesswire.com/news/home/20190509005293/en/
Source:
Investor & Media:
Aerpio Pharmaceuticals, Inc.
Michael Rogers
Chief Financial Officer
mrogers@aerpio.com
or
Burns McClellan, on behalf of Aerpio Pharmaceuticals, Inc.
Media:
Nancie Steinberg / Robert Flamm, Ph.D.
nsteinberg@burnsmc.com / rflamm@burnsmc.com
or
Investors:
John Grimaldi
jgrimaldi@burnsmc.com