Allena Pharmaceuticals Reports First Quarter 2019 Financial Results and Provides Business Update
-- Entered into Agreement with
-- All Clinical Programs Progressing on Track; Expect to Report Initial Data from Study 206 in Second Quarter and Topline Data from Phase 3 URIROX-1™ Trial in Second Half of 2019 –
-- Multiple Catalysts Expected Across Broader Pipeline in 2019 --
“Our progress in the first quarter highlights our position as pioneers in the development of oral enzyme therapeutics for the treatment of rare and severe metabolic diseases,” 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 in two ongoing pivotal Phase 3 trials, URIROX-1 and URIROX-2, which are designed to evaluate the safety and efficacy of reloxaliase in patients with enteric hyperoxaluria. Allena plans to pursue a Biologics License Application (BLA) submission for reloxaliase using the accelerated approval regulatory pathway.
Allena is also evaluating reloxaliase in Study 206, a multi-center, open-label, single arm Phase 2 basket study of reloxaliase in adults and adolescents with primary hyperoxaluria or enteric hyperoxaluria with advanced chronic kidney disease (CKD) and elevated plasma oxalate.
March 2019, Allena announced an agreement with DCRI to support its URIROX-2 Phase 3 clinical trial. Under the terms of the collaboration, DCRI will establish and lead an Academic Coordinating Center (ACC), which, in addition to providing independent oversight and assisting with investigator engagement, will support Allena’s ongoing efforts to prepare for the potential launch of reloxaliase. The ACC will contribute scientific expertise and thought leadership to the data analysis and publication strategy, including research on the health economic impact of reducing oxalate burden in patients with enteric hyperoxaluria.
Allena expects to achieve the following key milestones for reloxaliase:
- Report preliminary findings from Study 206 in
- Report topline data from the URIROX-1 Phase 3 clinical trial in the second half of 2019; and
- Report topline data from Study 206 in the second half of 2019.
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. Allena is completing its preclinical development of ALLN-346 for the treatment of hyperuricemia in patients with gout in the setting of advanced CKD and also scaling its manufacturing processes to support clinical studies.
Allena expects to achieve the following key milestones for ALLN-346:
- File an IND application with the
FDAin the second half of 2019; and
- Initiate the first clinical trial in the first half of 2020.
April 2019, Allena announced the appointment of Allene Diazto its Board of Directors.
First Quarter 2019 Financial Results:
- Cash Position: As of March 31, 2019, cash and cash equivalents were $51.8 million, as compared to
$61.6 millionas of December 31, 2018. This decrease was primarily due to cash used in operating activities, including payment of the Company’s 2018 annual bonus.
- R&D Expenses: R&D expenses were $9.1 million for the first quarter of 2019 as compared to $5.9 million for the first quarter of 2018. The increase was primarily due to costs incurred for the URIROX-2 trial, which was initiated during the fourth quarter of 2018.
- G&A Expenses: G&A expenses were $2.4 million for the first quarter of 2019 as compared to $2.0 million for the first quarter of 2018. The increase was primarily due to disease awareness activities, consulting costs and accounting fees.
- Net Loss: Net loss was $11.4 million for the first quarter of 2019, or a net loss per basic and diluted share of $0.55, as compared to a net loss of $7.9 million for the first quarter of 2018, or a net loss per basic and diluted share of $0.38.
Based on its current plans, Allena expects that its existing cash and cash equivalents will be sufficient to fund its operating expenses and capital requirements through at least the first half of 2020.
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding Allena’s URIROX clinical program and alignment with the
|Allena Pharmaceuticals, Inc|
|Selected Condensed Consolidated Balance Sheet Data|
|As of March 31,
|As of December 31, 2018|
|Cash and cash equivalents||$||51,755||$||61,643|
|Working capital (1)||46,296||58,706|
|Loan payable, net of current portion and discount||8,962||9,980|
|Total stockholders' equity||38,679||49,456|
|(1) The Company defines working capital as current assets less current liabilities. See the Company's condensed consolidated financial statements for further detail regarding its current assets and current liabilities.|
|Allena Pharmaceuticals, Inc|
|Condensed Consolidated Statements of Operations|
|(in thousands, except share and per share data)|
|For the Three Months Ended
|Research and development||$||9,128||$||5,931|
|General and administrative||2,431||2,042|
|Total operating expenses||11,559||7,973|
|Other income (expense), net||140||93|
|Net loss per share attributable to common
stockholders—basic and diluted
|Weighted-average common shares
outstanding—basic and diluted
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Source: Allena Pharmaceuticals, Inc.