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- Ended fourth quarter 2020 with
$42.6 millionin cash and cash equivalents
- Aerpio is currently evaluating a range of strategic alternatives focused on maximizing stockholder value from existing clinical and preclinical assets and cash resources
- Aerpio discontinued RESCUE trial, prior to completion, due to challenges recruiting and monitoring COVID-19 patients in the current pandemic environment
- Aerpio’s participation in the I-SPY COVID trial has likewise been discontinued
Recent Updates to Company’s Business
December 2020, Aerpio reported top line results from its Phase 2 trial of razuprotafib in open angle glaucoma and ocular hypertension. While the trial met the primary efficacy endpoint at Day 28 with the twice-daily dosing group, the intraocular pressure (“IOP”) decrease was not at a level deemed sufficient to advance to Phase 3 development.
January 2021, the Company initiated a plan to reduce operating costs and better align its workforce with the needs of its ongoing business. The plan reduces its current workforce by 7 employees, representing approximately 58% of the Company’s workforce. The Company estimates it will incur a one-time employee-related severance charge of approximately $1.2 millionduring the first quarter of 2021 with the majority of severance-related payments being paid by the end of fiscal 2021.
February 2021, Aerpio discontinued its RESCUE trial for the prevention and treatment of acute respiratory distress syndrome (“ARDS”) in adult patients with moderate to severe COVID-19 sponsored by the Medical Technology Enterprise Organization(“MTEC”) after the first 31 patients based on challenges associated with recruiting and monitoring patients in the current pandemic environment. There were no apparent safety signals associated with dosing COVID-19 patients with razuprotafib. The Company expects to report top-line data from the enrolled patients during the second quarter of 2021.
March 2021, Aerpio and Quantum Leap Health Collaborative disclosed that the razuprotafib treatment arm has been discontinued from the I-SPY COVID-19 trial based on the complexity of monitoring patients during a pandemic surge in patients admitted to the intensive care unit. There were no apparent safety signals associated with razuprotafib.
The Company continues to explore strategic options for partnering its programs, as well as the potential for an acquisition, company sale, merger, business combination, asset sale, in-license, out-license or other strategic transaction.
Fourth Quarter and Full Year 2020 Financial Highlights
As of December 31, 2020, cash and cash equivalents totaled $42.6 million, compared to
For the three months ended December 31, 2020, operating expenses totaled $5.6 million, an increase of 21.0% compared to $4.7 million for the same period in 2019. Operating expenses for the full year ended December 31, 2020, was $21.4 million compared to $24.4 million for the full year ended December 31, 2019.
Research and development expenses for the three months ended December 31, 2020, increased approximately $1.1 million, or 51.8%, to $3.2 million from $2.1 million in the three months ended December 31, 2019. This increase was primarily the result of increased expenses associated with the Phase 2 clinical trials of razuprotafib. Research and development expenses for the full year ended December 31, 2020, decreased approximately $0.2 million, or 1.8% to $12.6 million from $12.8 million in the full year ended December 31, 2019. This decrease was primarily the result of a slight decrease in expenses associated with our clinical programs.
General and administrative expenses for the three months ended December 31, 2020, increased approximately $0.9 million, or 56.1%, to $2.4 million from $1.5 million, in the three months ended
Net loss attributable to common stockholders for the three months ended December 31, 2020, was $4.7 million, or $0.10 per share, compared to
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 strategic alternatives review process and the potential transactions that may be identified and explored as a result of that process, 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 ARDS related thereto 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 ability to identify and consummate strategic alternatives that yield additional value for shareholders; the timing, benefits and outcome of the Company's strategic alternatives review process, including the determination of whether or not to pursue or consummate any strategic alternative; the structure, terms and specific risks and uncertainties associated with any potential strategic transaction; potential disruptions in our business and the stock price as a result of our exploration, review and pursuit of strategic alternatives or the public announcement thereof and any decision or transaction resulting from such review; 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; our review and evaluation of strategic plans for our razuprotafib glaucoma program; 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, 2020, 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.
Investors & Media:
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||42,605||$||38,525|
|Prepaid research and development contracts||510||311|
|Other current assets||1,604||735|
|Total current assets||44,719||39,571|
|Furniture and equipment, net||122||164|
|Operating lease right-of-use assets, net||64||162|
|Liabilities and shareholders' equity|
|Accounts payable and accrued expenses||$||1,800||$||3,232|
|Current portion of operating lease liability||67||103|
|Total current liabilities||1,867||3,335|
|Operating lease liability, net of current portion||-||67|
|Total stockholders' equity||43,058||36,535|
|Total liabilities and stockholders' equity||$||44,925||$||39,937|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(In thousands, except per share amounts)|
|Three months ended||Year Ended|
|Research and development||3,231||2,129||12,595||12,824|
|General and administrative||2,405||1,541||8,762||9,756|
|Total operating expenses||5,636||4,657||21,357||24,444|
|Loss from operations||(5,636||)||(4,657||)||(6,357||)||(24,444||)|
|Interest and other income||919||211||2,042||1,173|
|Net and comprehensive loss||$||(4,717||)||$||(4,446||)||$||(4,315||)||(23,271||)|
|Net loss per common share basic and diluted||$||(0.10||)||$||(0.11||)||$||(0.10||)||$||(0.57||)|
|Weighted average common shares outstanding|
|Basic and diluted||47,137||40,588||42,624||40,588|
Source: Aerpio Pharmaceuticals, Inc.