UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): August 8, 2019
AERPIO PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-38560 | 61-1547850 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) | ||
| 9987 Carver Road Cincinnati, OH |
45242 | |||
| (Address of principal executive offices) | (Zip Code) | |||
Registrant’s telephone number, including area code (513) 985-1920
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
| Common stock, $0.0001 par value per share | ARPO | Nasdaq Capital Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
| Item 2.02 | Results of Operations and Financial Condition |
On August 8, 2019, Aerpio Pharmaceuticals, Inc. announced its financial results for the quarter ended June 30, 2019. A copy of the press release is being furnished as Exhibit 99.1 to this Report on Form 8-K.
The information in this Report on Form 8-K and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | Press release issued by Aerpio Pharmaceuticals, Inc. on August 8, 2019 furnished herewith. | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: August 8, 2019 | AERPIO PHARMACEUTICALS, INC. | |||||
| By: | /s/ Stephen Hoffman | |||||
| Stephen Hoffman | ||||||
| Chief Executive Officer | ||||||
Exhibit 99.1
Aerpio Reports Second Quarter 2019 Financial Results and Provides Business Update
CINCINNATI—(BUSINESS WIRE)— Aerpio Pharmaceuticals, Inc. (Nasdaq: ARPO), a biopharmaceutical company focused on developing compounds that activate Tie2 to treat ocular diseases and diabetic complications, today reported financial results for the second quarter ended June 30, 2019, and provided a business update.
“We remain committed to rapidly advancing our topical ocular formulation of AKB-9778 for primary open-angle glaucoma (POAG),” said Stephen Hoffman, M.D., Ph.D., Chief Executive Officer of Aerpio. “Following the completion of our Phase 2b study in diabetic retinopathy, we took important steps to realign the Company. This realignment is designed to enable us to realize cost savings and efficiently utilize our resources as we direct our efforts toward advancing our clinical development program for glaucoma. Based on AKB-9778’s differentiated mechanism of action, as well as the consistent intraocular pressure (IOP) reduction observed in our previous TIME-2 and TIME-2b studies, we believe that AKB-9778 has the potential to provide a novel and differentiated approach to treating POAG. We look forward to announcing top-line results from the ongoing Phase 1b clinical trial later this year.”
Recent Company Highlights and Upcoming Milestones
| • | Initiated 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. |
| • | Completed realignment plan to reduce costs and right size the Company for the future development of its product candidates. |
Second Quarter 2019 Financial Highlights
As of June 30, 2019, cash and cash equivalents totaled $48.2 million. Total shares outstanding, as of June 30, 2019, were 40.6 million.
For the three months ended June 30, 2019, operating expenses totaled $6.0 million, including $0.9 million in restructuring expense, $0.6 million in non-cash stock compensation expense, compared to $7.4 million, including $0.9 million in non-cash stock compensation expense, for the same period in 2018.
Research and development expenses for the three months ended June 30, 2019, decreased $2.0 million, or 46.5%, compared to the same period in 2018. This decrease was primarily the result of decreased expenses associated with the TIME-2b clinical trial of AKB-9778.
General and administrative expenses for the three months ended June 30, 2019, decreased $0.3 million, or 10.8%, compared to the same period in 2018. This decrease was primarily attributable to decreased non-cash stock compensation expense.
Net loss attributable to common shareholders for the three months ended June 30, 2019 was $5.7 million, or $0.14 per share, compared to a net loss attributable to common shareholders of $6.0 million, or $0.22 net loss per share, for the same period in 2018.
About Aerpio Pharmaceuticals
Aerpio Pharmaceuticals, Inc. is a biopharmaceutical company focused on advancing first-in-class compounds that activate Tie2 to treat ocular diseases and complications of diabetes. Tie2 is an important regulator of vascular stability and its down-regulation is found in patients with diabetes and other conditions. Down-regulation is caused by activation of two inhibitors of Tie2, VE-PTP and Ang-2. The Company’s lead compound, AKB-9778, is being investigated, in a topical drop formulation, for its potential as a treatment for open-angle glaucoma. For more information, please visit www.aerpio.com
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 the intended benefits of the Company’s realignment, 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 of the Company’s planned clinical trials and expected results from such clinical trials, and the therapeutic potential of the Company’s product candidates. Actual results could differ from those projected in any forward-looking statements due to several risk factors. Such factors include, among others, the ability to continue to develop AKB-9778 or other product candidates, the inherent uncertainties associated with the drug development process, including uncertainties in regulatory interactions, commencing clinical trials and enrollment of patients in clinical trials, our ability to realize the intended benefits of our realignment, and competition in the industry in which the Company operates and overall market conditions.
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.
AERPIO PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
| June 30, | December 31, | |||||||
| 2019 | 2018 | |||||||
| Assets |
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| Current assets: |
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| Cash and cash equivalents |
$ | 48,157 | $ | 62,614 | ||||
| Prepaid R&D contracts |
368 | 754 | ||||||
| Other current assets |
264 | 616 | ||||||
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| Total current assets |
48,789 | 63,984 | ||||||
| Furniture and equipment, net |
298 | 99 | ||||||
| Operating lease right-of-use asset |
472 | — | ||||||
| Deposits |
41 | 41 | ||||||
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| Total assets |
$ | 49,600 | $ | 64,124 | ||||
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| Liabilities and shareholders’ equity |
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| Current liabilities: |
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| Accounts payable and accrued expenses |
$ | 3,402 | $ | 5,457 | ||||
| Current portion of operating lease liability |
193 | — | ||||||
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| Total current liabilities |
3,595 | 5,457 | ||||||
| Operating lease liability, net of current portion |
288 | — | ||||||
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| Total liabilities |
3,883 | 5,457 | ||||||
| Stockholders’ equity: |
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| Capital |
178,858 | 177,626 | ||||||
| Accumulated deficit |
(133,141 | ) | (118,959 | ) | ||||
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| Total stockholders’ equity |
45,717 | 58,667 | ||||||
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| Total liabilities and stockholders’ equity |
$ | 49,600 | $ | 64,124 | ||||
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AERPIO PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except per share amounts)
| Three months ended | Six months ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| License revenue, and other |
$ | — | $ | 1,333 | $ | — | $ | 1,333 | ||||||||
| Operating expenses: |
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| Research and development |
2,264 | 4,229 | 7,850 | 8,258 | ||||||||||||
| General and administrative |
2,800 | 3,140 | 6,055 | 6,588 | ||||||||||||
| Restructuring expense |
915 | — | 915 | — | ||||||||||||
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| Total operating expenses |
5,979 | 7,369 | 14,820 | 14,846 | ||||||||||||
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| Loss from operations |
(5,979 | ) | (6,036 | ) | (14,820 | ) | (13,513 | ) | ||||||||
| Interest and other income |
295 | 46 | 644 | 97 | ||||||||||||
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| Net and comprehensive loss |
$ | (5,684 | ) | $ | (5,990 | ) | $ | (14,176 | ) | $ | (13,416 | ) | ||||
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| Net loss per common share basic and diluted |
$ | (0.14 | ) | $ | (0.22 | ) | $ | (0.35 | ) | $ | (0.49 | ) | ||||
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| Weighted average common shares outstanding basic and diluted |
40,588 | 27,341 | 40,588 | 27,194 | ||||||||||||
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Contacts
Investor & Media:
Aerpio Pharmaceuticals, Inc.
Michael Rogers
Chief Financial Officer
mrogers@aerpio.com
or
Burns McClellan, on behalf of Aerpio Pharmaceuticals, Inc.
Media:
Robert Flamm, Ph.D.
rflamm@burnsmc.com
or
Investors:
John Grimaldi
jgrimaldi@burnsmc.com
Source: Aerpio Pharmaceuticals, Inc.