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Plan to advance AKB-9778 topical formulation into a Phase 2 trial in open angle glaucoma with top line results expected during the first quarter of 2021
Conference Call and Webcast Today,
“We ended the year with a strong cash position,
2019 Company Highlights
- Completed a Phase 1b clinical trial designed to assess the safety of the Company’s lead candidate, AKB-9778 in the form of topical ocular drops, for patients with OAG and OH.
- Presented promising IOP lowering data from the Company’s Phase 1b clinical trial of topical ocular formulation of AKB-9778 in patients with OAG and OH in
February 2020at the Glaucoma 360 conference in San Francisco. The IOP lowering activity observed in the Phase 1b trial when AKB-9778 was combined with a prostaglandin appeared comparable to or better than published Phase 3 data for marketed adjuvant therapies.
- Restructured the Company to preserve cash and provide flexibility to explore potential strategic alternatives.
- Completed a Phase 2b study in diabetic retinopathy that demonstrated activity in prespecified secondary diabetic endpoints, most notably a urinary albumin creatine ratio (UACR) signal for diabetic nephropathy.
Fourth Quarter and Full Year 2019 Financial Highlights
As of December 31, 2019, cash and cash equivalents totaled $38.5 million.
Revenue for the full year ended December 31, 2019, was
For the three months ended December 31, 2019, operating expenses totaled $4.7 million, compared to $8.9 million for the same period in 2018. Operating expenses for the full year ended December 31, 2019, was $24.4 million compared to $31.3 million for the full year ended December 31, 2018.
Research and development expenses for the three months ended December 31, 2019, decreased approximately $3.1 million, or 59.4%, to $2.1 million from $5.2 million in the three months ended December 31, 2018. Research and development expenses for the full year ended December 31, 2019, decreased approximately $5.0 million, or 28.2%, to $12.8 million from $17.8 million in the full year ended December 31, 2018. This decrease was primarily the result of decreased expenses associated with our clinical programs.
General and administrative expenses for the three months ended December 31, 2019, decreased approximately $2.1 million, or 57.4%, to $1.5 million from $3.6 million, in the three months ended
Restructuring expense for the year ended
Net loss attributable to common stockholders for the three months ended December 31, 2019, was $4.4 million, or $0.11 per share, compared to a net loss attributable to common stockholders of $8.5 million, or $0.21 per share, for the three months ended
Conference Call and Webcast
Aerpio management will host a live conference call and webcast at
The live webcast and a replay may be accessed by visiting Aerpio's website at http://ir.aerpio.com/. Please connect to the Company's website at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call 877-407-9716 (
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 and more recently has been shown to contribute to the development of increased IOP and glaucoma. 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. Aerpio is studying a topical ocular formulation of AKB-9778 in open angle glaucoma and exploring the utility of subcutaneous AKB-9778 for diabetic complications, including diabetic nephropathy.
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, the Company’s product candidates, including AKB-9778, ARP-1536 and the bispecific antibody asset, the clinical development plan therefor and the therapeutic potential thereof, the Company’s strategic alternatives review process and the potential transactions that may be identified and explored as a result of that process, and the intended benefits from its 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
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||38,525||$||62,614|
|Prepaid research and development contracts||311||754|
|Other current assets||735||616|
|Total current assets||39,571||63,984|
|Furniture and equipment, net||164||99|
|Operating lease right-of-use assets, net||162||-|
|Liabilities and shareholders' equity|
|Accounts payable and accrued expenses||$||3,232||$||5,457|
|Current portion of operating lease liability||103||-|
|Total current liabilities||3,335||5,457|
|Operating lease liability, net of current portion||67||-|
|Total stockholders' equity||36,535||58,667|
|Total liabilities and stockholders' equity||$||39,937||$||64,124|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(In thousands, except per share amounts)|
|Three months ended||Year Ended|
|License revenue, and other||$||-||$||2||$||-||$||20,157|
|Research and development||2,129||5,249||12,824||17,853|
|General and administrative||1,541||3,619||9,756||13,486|
|Total operating expenses||4,657||8,868||24,444||31,339|
|Loss from operations||(4,657||)||(8,866||)||(24,444||)||(11,182||)|
|Interest and other income||211||348||1,173||785|
|Net and comprehensive loss||$||(4,446||)||$||(8,518||)||$||(23,271||)||(10,397||)|
|Net loss per common share basic and diluted||$||(0.11||)||$||(0.21||)||$||(0.57||)||$||(0.31||)|
|Weighted average common shares outstanding|
|Basic and diluted||40,588||40,588||40,588||33,931|
Source: Aerpio Pharmaceuticals, Inc.