Allena Pharmaceuticals Reports Second Quarter 2019 Financial Results and Provides Business Update
-- Interim Data from Study 206 Demonstrated Substantial Treatment Effect in Patients with Enteric Hyperoxaluria and Advanced Chronic Kidney Disease, Including Robust Reductions in Both Urine and Plasma Oxalate --
-- Topline Data from Phase 3 URIROX-1 Trial and Study 206 On Track for the Second Half of 2019 --
“At Allena, we are committed to providing a first-in-class treatment for the full spectrum of patients with enteric hyperoxaluria (EH),” 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.
The URIROX program consists of two pivotal Phase 3 clinical trials, URIROX-1 and URIROX-2, which are designed to evaluate the safety and efficacy of reloxaliase in patients with EH. The primary efficacy endpoint for both trials is the percent change from baseline in 24-hour urinary oxalate (UOx) excretion measured during Weeks 1-4, comparing reloxaliase to placebo. The primary long-term efficacy endpoint to confirm clinical benefit in URIROX-2 is the proportion of patients with kidney stone disease progression, defined as a composite of either symptomatic kidney stones or finding of new or enlarged kidney stones using imaging, over a minimum treatment period of two years. Allena expects to report topline data from URIROX-1 in the second half of 2019, and from URIROX-2 in the second half of 2021.
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 EH or primary hyperoxaluria (PH) with advanced chronic kidney disease (CKD) and elevated plasma oxalate. Patients orally administer 7,500 units of reloxaliase with each meal or snack five times a day, for 12 consecutive weeks. Allena expects to report topline data from Study 206 in the second half of 2019.
June 2019, Allena announced interim data from Study 206. EH patients treated with reloxaliase in Study 206 demonstrated a substantial treatment effect. This includes EH patients with advanced CKD, a patient population not previously treated with reloxaliase, who showed reductions in UOx and plasma oxalate (POx). Treatment with reloxaliase was well-tolerated in all patient populations, with no reported treatment-related serious adverse events over the 12-week study, which is the longest duration of treatment to date.
- All four patients with EH experienced a reduction in POx, with an average reduction of 35% compared to baseline (range 16% to 49%). The two patients not on dialysis also experienced reductions in UOx of 29% and 42%, respectively.
June 2019, Allena presented on its reloxaliase development program and the unmet need in patients with EH in four sessions at the Oxalosis & Hyperoxaluria Foundation (OHF) International Hyperoxaluria Workshopin Boston, MA.
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 file an Investigational New Drug (IND) application with the
June 2019, Allena announced a $10.0 millionregistered direct offering of common stock.
Second Quarter 2019 Financial Results:
- Cash Position: As of June 30, 2019, cash and cash equivalents were $48.5 million, as compared to $61.6 million as of December 31, 2018. This decrease was primary due to cash used in operating activities, partially offset by aggregate gross proceeds of approximately
$10 millionfrom the Company’s registered direct offering of common stock, which closed in June 2019.
- R&D Expenses: R&D expenses were $8.6 million for the second quarter of 2019, as compared to $5.9 million for the second 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, and an increase of formulation and development costs incurred advancing ALLN-346.
- G&A Expenses: G&A expenses were $2.7 million for the second quarter of 2019, as compared to $2.3 million for the second quarter of 2018. The increase was primarily due to increases in professional services costs, including public relations, legal, and recruiting activities.
- Net Loss: Net loss was $11.3 million for the second quarter of 2019, or a net loss per basic and diluted share of $0.54, as compared to a net loss of $8.6 million for the second quarter of 2018, or a net loss per basic and diluted share of $0.42.
Based on its current plans, Allena expects that its existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2020.
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding Allena’s URIROX clinical program and alignment with the
|Allena Pharmaceuticals, Inc.|
|Selected Condensed Consolidated Balance Sheet Data|
|As of June 30,
|As of December 31,
|Cash and cash equivalents||$||48,523||$||61,643|
|Working capital (1)||44,565||58,706|
|Loan payable, net of current portion and discount||7,984||9,980|
|Total stockholders' equity||37,673||49,456|
|(1) The Company defines working capital as current assets less current liabilities. See the Company's condensed consolidated financial statements for further detail regarding its current assets and current liabilities.|
|Allena Pharmaceuticals, Inc.|
|Condensed Consolidated Statements of Operations|
|(in thousands, except share and per share data)|
|For the Three Months Ended
|For the Six Months Ended
|Research and development||$||8,589||$||5,860||$||17,717||$||11,791|
|General and administrative||2,746||2,275||5,177||4,317|
|Total operating expenses||11,335||8,135||22,894||16,108|
|Other income (expense), net||62||(512||)||202||(419||)|
|Net loss per share attributable to common stockholders—basic and diluted||$||(0.54||)||$||(0.42||)||$||(1.09||)||$||(0.80||)|
|Weighted-average common shares outstanding—basic and diluted||20,903,298||20,733,043||20,859,251||20,714,319|
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Source: Allena Pharmaceuticals, Inc.