Allena Pharmaceuticals Reports Fourth Quarter and Full Year 2018 Financial Results and Provides Business Update
-- Achieved Alignment with
-- Phase 3 URIROX-1 and URIROX-2 Trials Ongoing; URIROX-1 Topline Data Expected in Second Half of 2019 --
-- Multiple Catalysts Expected Across Pipeline in 2019 --
“We have made significant progress in our clinical development programs over the last few months, including securing alignment with the
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.
Allena expects to achieve the following key milestones for reloxaliase:
- Report initial data from Study 206 in the second quarter of 2019;
- 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 working to complete its preclinical development of ALLN-346 for the treatment of hyperuricemia in patients with gout in the setting of advanced CKD, and to scale its manufacturing processes to support clinical studies.
Allena expects to achieve the following key milestones for ALLN-346:
- File an Investigational New Drug application with the
FDAin the second half of 2019; and
- Initiate the first clinical trial in the first half of 2020.
January 2019, Allena announced the appointment of Louis Brenner, M.D. as Chief Executive Officer. Dr. Brenner previously served as President and Chief Operating Officer of Allena and succeeded Alexey Margolin, Ph.D., who transitioned to Chairman of the Board effective February 1, 2019.
Fourth Quarter and Full Year 2018 Financial Results:
- Cash Position: As of December 31, 2018, cash and cash equivalents were $61.6 million, as compared to $94.5 million as of December 31, 2017. This decrease was primarily due to cash used in operating activities.
- R&D Expenses: R&D expenses were $7.3 million for the fourth quarter of 2018 and
$26.4 millionfor the year ended December 31, 2018, as compared to $4.8 million for the fourth quarter of 2017 and $15.5 millionfor the year ended December 31, 2017. This increase was primarily due to costs incurred for URIROX-1 and Study 206, which were both initiated in the first quarter of 2018; start-up costs incurred for URIROX-2; production of engineering and clinical drug substance batches to support the URIROX Phase 3 program; and an increase in employee-related costs due to the hiring of additional clinical and technical operations personnel to support the URIROX Phase 3 program.
- G&A Expenses: G&A expenses were $2.5 million for the fourth quarter of 2018 and
$9.2 millionfor the year ended December 31, 2018, as compared to $1.8 million for the fourth quarter of 2017 and $5.4 millionfor the year ended December 31, 2017. This increase was primarily due to increases in compensation and benefit costs, including stock-based compensation, and costs attributable to operating as a public company during the full year of 2018, as compared to the full year of 2017.
- Net Loss: Net loss was $9.6 million for the fourth quarter of 2018 and
$35.6 millionfor the year ended December 31, 2018, or a net loss per basic and diluted share of $0.46 and $1.72, respectively, as compared to a net loss of $6.7 million for the fourth quarter of 2017 and $21.7 millionfor the year ended December 31, 2017, or a net loss per basic and diluted share of $0.48 and $4.80, respectively. The decrease in net loss per share for the fourth quarter and full year 2018 as compared to the fourth quarter and full year 2017 is primarily due to an increase in weighted average shares outstanding for the fourth quarter and full year 2018, following completion of the Company’s initial public offering and concurrent conversion of its preferred stock into common stock in November 2017.
Based on its current plans, Allena expects that its existing cash and cash equivalents will be sufficient to fund its operating expenses and capital requirements through at least the first half of 2020.
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding Allena’s URIROX clinical program and alignment with the
|Allena Pharmaceuticals, Inc|
|Selected Condensed Consolidated Balance Sheet Data|
|As of December 31,
|As of December 31,
|Cash and cash equivalents||$||61,643||$||94,494|
|Working capital (1)||58,706||88,490|
|Loan payable, net of current portion and discount||9,980||5,516|
|Total stockholders' equity||49,456||82,870|
|(1) The Company defines working capital as current assets less current liabilities. See the Company's condensed consolidated financial statements for further detail regarding its current assets and current liabilities.|
|Allena Pharmaceuticals, Inc|
|Condensed Consolidated Statements of Operations|
|(in thousands, except share and per share data)|
|For the Three Months Ended
|For the Year Ended
|Research and development||$||7,269||$||4,761||$||26,376||$||15,519|
|General and administrative||2,511||1,810||9,217||5,431|
|Total operating expenses||9,780||6,571||35,593||20,950|
|Other income (expense), net||169||(106)||(55)||(700)|
|Net loss per share attributable to common|
|stockholders—basic and diluted||$||(0.46)||$||(0.48)||$||(1.72)||$||(4.80)|
|Weighted-average common shares|
|outstanding—basic and diluted||20,782,177||13,949,046||20,741,226||4,520,337|
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Source: Allena Pharmaceuticals, Inc.