Aerpio Reports Second Quarter 2020 Financial Results and Provides Business Update
- Initiated a Phase 2 Open Angle Glaucoma Trial; Recruiting Ahead of Schedule
Announced Partnershipwith I-SPY to Participate in a Clinical Trial to Treat ARDS in COVID-19 Patients
- Announced a Second Clinical Trial Funded in Part by the
U.S.Military to Prevent ARDS in COVID-19 Patients
- Ended Second Quarter 2020 with
$44.9 Millionin Cash
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Recent Company Highlights
June 2020, we initiated a Phase 2 clinical trial designed to assess the therapeutic potential of the Company’s lead candidate, razuprotafib (AKB-9778) in the form of topical ocular drops, for patients with Open Angle Glaucoma (OAG) and ocular hypertension (OH). Patients are being dosed for 28 days after a one month “wash-out” period from their current treatments with the goal to enroll 195 patients. To date, 189 patients have been screened with over 170 enrolled (either in “wash out” or being dosed). Based on current projections, the study may be fully enrolled by mid-October with top-line data available by the end of the year.
May 2020, we were selected by Quantum Leap Healthcare Collaborative to participate in the I-SPY COVID Trial (Investigation of Serial Studies to Predict Your COVID Therapeutic Response with biomarker Integration and Adaptive Learning) to evaluate razuprotafib for the treatment of COVID-19-related ARDS in adult patients with critical COVID-19. The I-SPY trial is a “platform study” currently planned to evaluate four drug candidates. The goal of the study is to identify agents with the potential to result in substantial improvements to the clinical condition of participants with critical COVID-19. Patients to be included in the study will be critical COVID-19 patients who are already intubated or receiving high flow oxygen. For more details about this trial, please click here.
August 4, 2020, we announced funding of up to $5.1 millionfrom MTEC ( Medical Technology Enterprise Consortium) to initiate a second clinical trial with razuprotafib, which is designed to assess its potential to prevent the ARDS in patients with moderate-to-severe COVID-19 infections. The MTEC trial is a stand-alone study managed by Aerpio that will evaluate earlier stage patients (moderate-to-severe COVID-19) prior to initiating high flow oxygen or intubation. Endpoints will include proportion of subjects alive and respiratory failure-free at Day 28; length of hospitalization from baseline to Day 7; and baseline to Day 28, or death. Trial start up activities are progressing rapidly.
May 2020, we received a one-time payment of $15.0 millionpursuant to an amendment to our license agreement with Gossamer Bio for GB004 resulting in a reduction in future potential milestone payments and tiered royalty rates over the life of the agreement.
“Our Phase 2 glaucoma study is recruiting ahead of schedule and remains on track to report top-line results in the fourth quarter of 2020,” said
Second Quarter 2020 Financial Highlights
As of June 30, 2020, cash and cash equivalents totaled $44.9 million, compared to
For the three months ended June 30, 2020, operating expenses totaled $5.7 million, a decrease of 4.0% compared to $6.0 million for the same period in 2019.
Research and development expenses for the three months ended June 30, 2020, increased approximately $1.3 million, or 56.7%, to $3.6 million from $2.3 million in the three months ended June 30, 2019. This increase was primarily the result of increased expenses associated with our clinical programs.
General and administrative expenses for the three months ended June 30, 2020, decreased approximately $0.6 million, or 21.6%, to $2.2 million from $2.8 million, in the three months ended
Net income attributable to common stockholders for the three months ended June 30, 2020, was $9.3 million, or $0.23 per share, compared to a net loss attributable to common stockholders of $5.7 million, or (
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About Razuprotafib (formerly known as AKB-9778)
Razuprotafib 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. Razuprotafib 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 razuprotafib in open angle glaucoma and exploring the utility of subcutaneous razuprotafib for diabetic complications, including diabetic nephropathy. In addition, a subcutaneous formulation of razuprotafib is being explored for its therapeutic potential in treating or preventing ARDS associated with COVID-19.
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 razuprotafib, ARP-1536 and the bispecific antibody asset, the clinical development plan therefor and the therapeutic potential thereof, the Company’s plans and expectations with respect to razuprotafib and the development therefor and therapeutic potential thereof in addressing COVID-19 and the intended benefits from the Company’s collaboration with Gossamer Bio for GB004, including the continued development of GB004 and the milestone and royalty payments related to the collaboration. Actual results could differ from those projected in any forward-looking statements due to several risk factors. Such factors include, among others, the continued development of GB004 and maintaining and deriving the intended benefits of the Company’s collaboration with Gossamer Bio; ability to continue to develop razuprotafib or other product candidates, including in indications related to COVID-19; the inherent uncertainties associated with the drug development process, including uncertainties in regulatory interactions, the design of planned or future clinical trials, commencing clinical trials and enrollment of patients in clinical trials; obtaining any necessary regulatory clearances in order to commence and conduct planned or future clinical trials; the impact of the ongoing COVID-19 pandemic on the Company’s business operations, including research and development efforts and the ability of the Company to commence, conduct and complete its planned clinical activities; and competition in the industry in which the Company operates and overall market conditions; and the additional factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2019, as updated by our subsequent Quarterly Reports on Form 10-Q and our other subsequent filings with the SEC.
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 SEC available at www.sec.gov.
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||44,864||$||38,525|
|Prepaid research and development contracts||307||311|
|Other current assets||264||735|
|Total current assets||45,435||39,571|
|Furniture and equipment, net||146||164|
|Operating lease right-of-use asset||115||162|
|Liabilities and shareholders' equity|
|Accounts payable and accrued expenses||$||2,994||$||3,232|
|Current portion of operating lease liability||111||103|
|Total current liabilities||3,105||3,335|
|Operating lease liability, net of current portion||10||67|
|Total stockholders' equity||42,601||36,535|
|Total liabilities and stockholders' equity||$||45,716||$||39,937|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)|
|(In thousands, except per share amounts)|
|Three months ended||Six months ended|
|License revenue, and other||$||15,000||$||—||$||15,000||$||—|
|Research and development||3,548||2,264||5,378||7,850|
|General and administrative||2,196||2,800||4,481||6,055|
|Total operating expenses||5,744||5,979||9,859||14,820|
|Income (loss) from operations||9,256||(5,979||)||5,141||(14,820||)|
|Interest and other income||20||295||216||644|
|Net and comprehensive income (loss)||$||9,276||$||(5,684||)||$||5,357||$||(14,176||)|
|Net income (loss) per common share basic and diluted||$||0.23||$||(0.14||)||$||0.13||$||(0.35||)|
|Weighted average common shares outstanding|
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Source: Aerpio Pharmaceuticals, Inc.