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Aerpio Pharmaceuticals, Inc. (ARPO) SEC Filing 10-K Annual report for the fiscal year ending Monday, December 31, 2018

SEC Filings

Aerpio Pharmaceuticals, Inc.

CIK: 1607678 Ticker: ARPO

Exhibit 99.1

 

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Aerpio Reports Fourth Quarter and Full Year 2018 Financial Results

and Provides Business Update

Top-Line Results from the TIME-2b Clinical Trial Evaluating the Effect of AKB-9778 in

Patients with Non-Proliferative Diabetic Retinopathy (NPDR) Expected in March 2019

Conference Call and Webcast Today, March 5th at 8:30 a.m. EST

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 fourth quarter and full year ended December 31, 2018.

“We remain on track to report top-line data from our TIME-2b clinical trial before the end of March,” said Stephen Hoffman, M.D., Ph.D., Chief Executive Officer of Aerpio. “We view the study as an important inflection point for Aerpio and expect to use the results to direct the future development of AKB-9778 in non-proliferative diabetic retinopathy and possibly other conditions associated with diabetes. We look forward to sharing the results with you later this month. In parallel with our TIME-2b clinical trial, we continue to advance a topical ocular formulation of AKB-9778 in open angle glaucoma and expect to initiate a Phase 1b study in the second quarter of 2019.”

2018 Company Highlights

 

   

Completed dosing of the TIME-2b study, a Phase 2b clinical trial designed to assess the efficacy and safety of the Company’s lead candidate, AKB-9778, for patients with moderate-to-severe non-proliferative diabetic retinopathy (NPDR);

 

   

Presented promising preliminary renal function data from the Company’s TIME-2 Phase 2a clinical trial of AKB-9778 in diabetic retinopathy patients at the American Society of Nephrology Kidney Week 2018;

 

   

Announced, in June 2018, an exclusive global license agreement with a wholly-owned subsidiary of Gossamer Bio, Inc., GB004, Inc. (“Gossamer”), for the development and commercialization of Aerpio’s HIF-1 alpha stabilizer, AKB-4924 (renamed GB004 by Gossamer), along with other related compounds. Under the terms of the license agreement, Aerpio received a $20 million up front payment, and is eligible to receive potential development, regulatory, and sales milestones of up to $400 million, and royalties on worldwide net sales, which range from a high single digit to mid-teen percentage of net sales. Gossamer will be responsible for the remaining development, regulatory, and commercialization expenses for GB004;


The following information was filed by Aerpio Pharmaceuticals, Inc. (ARPO) on Tuesday, March 5, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Document And Entity Information
Consolidated Balance Sheets
Consolidated Balance Sheets (Parenthetical)
Consolidated Statements Of Cash Flows
Consolidated Statements Of Operations And Comprehensive Loss
Consolidated Statements Of Redeemable Convertible Preferred Stock And Stockholders' Equity (Deficit)
Consolidated Statements Of Redeemable Convertible Preferred Stock And Stockholders' Equity (Deficit) (Parenthetical)
Accounts Payable And Accrued Expenses
Accounts Payable And Accrued Expenses (Tables)
Accounts Payable And Accrued Expenses - Schedule Of Accounts Payable And Accrued Expenses (Details)
Commitments And Contingencies
Commitments And Contingencies (Tables)
Commitments And Contingencies - Additional Information (Detail)
Commitments And Contingencies - Schedule Of Non-Cancellable Future Minimum Lease Payments Related To Operating Leases (Detail)
Common Stock
Common Stock - Additional Information (Detail)
Employee Bonus Plan
Employee Bonus Plan - Additional Information (Detail)
Employee Retirement Plan
Employee Retirement Plan - Additional Information (Detail)
Employee Stock Purchase Plan
Employee Stock Purchase Plan - Additional Information (Detail)
Furniture And Equipment
Furniture And Equipment (Tables)
Furniture And Equipment - Summary Of Components Of Furniture And Equipment (Detail)
Income Taxes
Income Taxes (Tables)
Income Taxes - Additional Information (Detail)
Income Taxes - Schedule Of Reconciliation Of Statutory Federal Income Tax (Detail)
Income Taxes - Schedule Of Significant Components Of Deferred Tax Assets And Liabilities (Detail)
License Agreement
License Agreement - Additional Information (Detail)
Nature Of Organization And Operations
Nature Of Organization And Operations - Additional Information (Detail)
Net Loss Per Share Attributable To Common Stockholders
Net Loss Per Share Attributable To Common Stockholders (Tables)
Net Loss Per Share Attributable To Common Stockholders - Schedule Of Computation Of Basic And Diluted Net Loss Per Share (Detail)
Net Loss Per Share Attributable To Common Stockholders - Schedule Of Weighted Average Common Stock Equivalents Excluded From Calculation Of Diluted Net Loss Per Share (Detail)
Preferred Stock
Preferred Stock - Additional Information (Detail)
Quarterly Results (Unaudited)
Quarterly Results (Unaudited) (Tables)
Quarterly Results (Unaudited) - Additional Information (Detail)
Quarterly Results (Unaudited) - Summary Of Unaudited Quarterly Results (Detail)
Stock-Based Compensation
Stock-Based Compensation (Tables)
Stock-Based Compensation - Additional Information (Detail)
Stock-Based Compensation - Stock Options Valuation Assumptions (Detail)
Stock-Based Compensation - Summary Of Recognized Compensation Cost Related To Employee And Non-Employee Stock-Based Compensation Activity (Detail)
Stock-Based Compensation - Summary Of Restricted Stock Activity (Detail)
Stock-Based Compensation - Summary Of Stock Option Activity (Detail)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Policies)
Summary Of Significant Accounting Policies (Tables)
Summary Of Significant Accounting Policies - Additional Information (Detail)
Summary Of Significant Accounting Policies - Schedule Of Assets Measured On Recurring Basis (Detail)
Ticker: ARPO
CIK: 1422142
Form Type: 10-K Annual Report
Accession Number: 0001564590-19-006602
Submitted to the SEC: Thu Mar 07 2019 6:07:52 AM EST
Accepted by the SEC: Thu Mar 07 2019
Period: Monday, December 31, 2018
Industry: Pharmaceutical Preparations

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