Allena Pharmaceuticals Announces Third Quarter 2020 Financial Results and Provides Business Update
-- Presented Data at 53rd Annual Meeting of the
-- Completed Dosing of Subjects in Phase 1 Clinical Trial of ALLN-346; Initial Data Expected in the Fourth Quarter of 2020 –
-- Entered into
“In recent months, we have continued to make progress across our portfolio. We are actively enrolling URIROX-2, our pivotal trial of reloxaliase for patients with EH. We also recently completed dosing in our Phase 1 trial of ALLN-346 and we remain on track to achieve all our expected clinical milestones,” said
Recent Business Highlights and Upcoming Milestones:
Reloxaliase: Reloxaliase is a first-in-class, non-absorbed, orally administered enzyme for the treatment of severe hyperoxaluria. Allena is currently evaluating reloxaliase for patients with EH in URIROX-2, the second pivotal Phase 3 clinical trial in its URIROX program. Allena continues to expect the interim analysis from this trial in the first quarter of 2022 and to announce topline data, which are intended to support a potential Biologics License Application (BLA) submission, in the third quarter of 2022.
At the ASN meeting, held virtually in
ALLN-346: ALLN-346 is a first-in-class, orally administered, novel urate degrading enzyme that has been designed for activity and stability in the gastrointestinal tract for the treatment of hyperuricemia in patients with gout in the setting of advanced CKD.
September 2020, Allena entered into a $25 millionloan and security agreement with Pontifax Medison Finance, the healthcare-dedicated venture and debt fund of the Pontifax life sciences funds. Under the terms of the agreement, Allena will have access to up to $25 millionin convertible debt financing in three tranches; the Company drew the first tranche of $10 millionupon closing. Additionally, both Pontifax and Allena have the option to convert the loan drawn under the first two tranches into shares of Allena’s common stock at a price of $4.10per share, subject to certain conditions.
October 2020, Allena announced the appointment of Ann Miller, M.D., to its board of directors. Dr. Milleris an experienced industry executive, who has launched and grown multiple blockbuster products and built several leading franchises over the course of her career.
Third Quarter 2020 Financial Results:
- Cash Position: As of September 30, 2020, cash and cash equivalents were $30.1 million, as compared to $30.0 million as of December 31, 2019. The change in cash position was primarily due to gross proceeds of approximately
$15.0 millionreceived from the company’s June 2020registered direct offering and gross proceeds of approximately $7.7 millionreceived from the company’s July 2020public underwritten offering, offset by cash used in operating activities.
- R&D Expenses: R&D expenses were $5.0 million for the third quarter of 2020, as compared to $10.8 million for the third quarter of 2019. The decrease was primarily due to a reduction of costs incurred for the reloxaliase program, including costs for the URIROX-1 and Study 206 trials, both of which were completed in the fourth quarter of 2019, and a reduction of costs incurred for the ALLN-346 program, including costs for formulation and development relating to its investigational new drug (IND) application incurred in the third quarter of 2019. The Company filed an IND for ALLN-346 with the
U.S. Food and Drug Administration(FDA) in the fourth quarter of 2019.
- G&A Expenses: G&A expenses were $3.0 million for the third quarter of 2020, as compared to
$2.5 millionfor the third quarter of 2019. This increase was due primarily to increases in stock-based compensation and corporate directors and officers insurance costs.
- Net Loss: Net loss was $8.0 million for the third quarter of 2020, or a net loss per basic and diluted share of $0.22, as compared to a net loss of $13.3 million for the third quarter of 2019, or a net loss per basic and diluted share of $0.57. Contributing to the decrease in net loss per share was both a decrease in net loss for the quarter and an increase in the weighted average shares of common stock outstanding for the third quarter of 2020 compared to the weighted average shares outstanding for the third quarter of 2019, driven by the issuance of shares of common stock for the registered direct offering in
June 2020and the public underwritten offering in July 2020.
Based on its current plans, Allena expects that its existing cash and cash equivalents, together with the funds available under its agreement with Pontifax, will be sufficient to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2021.
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 including, without limitation, statements regarding the development and potential commercialization of reloxaliase, changes in Allena’s management, Allena’s pipeline of oral enzyme therapeutic candidates and Allena’s plans to build a commercial organization. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: market and other conditions, the timing for completion of Allena’s clinical trials of its product candidates, risks associated with obtaining, maintaining and protecting intellectual property; risks associated with Allena’s ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; the risk of competition from other companies developing products for similar uses; risk associated with Allena’s financial condition and its need to obtain additional funding to support its business activities, including the future clinical development of reloxaliase and its ability to continue as a going concern; risks associated with Allena’s dependence on third parties; and risks related to the COVID-19 coronavirus. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Allena’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Item 1A of Part I of Allena’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, as well as discussions of potential risks, uncertainties and other important factors in Allena’s subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Allena undertakes no duty to update this information unless required by law.
Stern Investor Relations, Inc.
Berry & Company Public Relations
|Selected Condensed Consolidated Balance Sheet Data|
|Cash and cash equivalents||$||30,136||$||30,007|
|Working capital (1)||27,400||22,127|
|Loan payable, net of current portion and discount||9,871||5,988|
|Total stockholders' equity||18,179||17,198|
|(1) The Company defines working capital as current assets less current liabilities. See the Company's condensed consolidated financial statements for further detail regarding its current assets and current liabilities.|
|Condensed Consolidated Statements of Operations|
|(in thousands, except share and per share data)|
|For the Three Months Ended
||For the Nine Months Ended
|Research and development||$||4,952||$||10,806||$||13,406||$||28,523|
|General and administrative||2,966||2,532||8,595||7,709|
|Total operating expenses||7,918||13,338||22,001||36,232|
|Other income (expense), net||(108||)||50||(586||)||252|
|Net loss per share attributable to common
stockholders—basic and diluted
|Weighted-average common shares
outstanding—basic and diluted
Source: Allena Pharmaceuticals, Inc.