Allena Pharmaceuticals Reports Fourth Quarter and Full Year 2017 Financial Results and Provides Business Update
-- Initiated URIROX-1™, First Phase 3 Trial of ALLN-177 in Enteric Hyperoxaluria; Topline Data Expected in Second Half of 2019 –
-- Initiated Phase 2 Trial of ALLN-177 for Patients with Primary Hyperoxaluria or Enteric Hyperoxaluria and Hyperoxalemia --
-- Initiated Preclinical Proof-of-Concept Study for ALLN-346 for Patients with Hyperuricemia and Chronic Kidney Disease –
-- Reiterates Guidance for Key Objectives --
“In recent months, we made tremendous progress across our business, maturing Allena into a Phase 3, publicly-traded company, and advancing our pipeline of oral enzyme therapeutics for patients with severe oxalate and urate disorders,” said
Fourth Quarter and Recent Business Highlights:
ALLN-177: ALLN-177 is a first-in-class, non-absorbed, orally-administered enzyme for the treatment of severe hyperoxaluria. Allena is currently evaluating ALLN-177 in URIROX-1™, the first of two anticipated Phase 3 clinical trials designed to support a planned Biologic License Application (BLA) for ALLN-177 in patients with enteric hyperoxaluria. The Company continues to engage with the
March 2018, Allena initiated URIROX-1™, a multi-center, global, randomized, double-blind, placebo-controlled Phase 3 trial to evaluate the safety and efficacy of ALLN-177 in patients with enteric hyperoxaluria. The primary endpoint of the study is percent change from baseline in 24-hour urinary oxalate (UOx) excretion averaged during Weeks 1-4, comparing ALLN-177 to placebo. Secondary endpoints include proportion of subjects with a ≥20% reduction from baseline in 24-hour UOx excretion averaged during Weeks 1-4. Allena expects to announce topline data in the second half of 2019.
- Also in
March 2018, Allena initiated Study 206, a Phase 2 basket trial to evaluate the safety and efficacy of ALLN-177 in adolescents and adults with primary hyperoxaluria or enteric hyperoxaluria and hyperoxalemia. ALLN-177 has been granted separate orphan designations for primary hyperoxaluria and pediatric hyperoxaluria by the FDA. Allena expects to announce interim data from Study 206 in the second half of 2018.
November 2017, Allena presented final results from its Phase 2 clinical trials of ALLN-177 in patients with secondary hyperoxaluria at the American Society of Nephrology (ASN) Kidney Week2017 in New Orleans, LA. In patients with enteric disease, ALLN-177 substantially reduced UOx and was well-tolerated. Also at ASN, Allena presented preclinical data from a porcine dietary model of severe hyperoxaluria, which showed a significant reduction in both plasma oxalate and UOx excretion.
ALLN-346: ALLN-346 is a first-in-class, orally-administered, non-absorbed, urate-degrading enzyme in preclinical development for patients with hyperuricemia and moderate to severe chronic kidney disease. These patients are challenging to manage due to limitations of existing therapies, such as poor tolerability, reduced efficacy, dose restriction or contraindications.
December 2017, Allena initiated a preclinical program for ALLN-346, including in vitro and animal proof-of-concept studies, designed to support an anticipated investigational new drug application in the first half of 2019.
November 2017, Allena completed its initial public offering of common stock at $14.00per share, raising gross proceeds of $74.9 million.
Fourth Quarter and Full Year 2017 Financial Results:
- Cash Position: As of
December 31, 2017, cash, cash equivalents and short-term investments were $94.5 million, as compared to $48.8 millionas of December 31, 2016. This includes $67.0 millionin net proceeds from Allena’s initial public offering of stock, which was completed in November 2017. The Company’s net cash used in operating activities in 2017 was approximately $21.1 million.
- R&D Expenses: R&D expenses were
$4.8 millionfor the fourth quarter of 2017 and $15.5 millionfor the year ended December 31, 2017, as compared to $4.8 millionfor the fourth quarter of 2016 and $20.1 millionfor the year ended December 31, 2016. The decrease for the full year 2017 as compared to the full year 2016 was primarily due to a decrease in clinical and manufacturing costs. In 2016, the Company incurred significant costs for its 713 and 649 studies for ALLN-177, both of which concluded during the first half of 2017. Also in 2016, the Company incurred significant set-up costs associated with a contract manufacturing organization, with whom it entered into a contract for the manufacture of ALLN-177 drug substance in 2015. Included in R&D expenses for the fourth quarter of 2017 were start-up expenses related to the URIROX-1™ trial.
- G&A Expenses: G&A expenses were
$1.8 millionfor the fourth quarter of 2017 and $5.4 millionfor the year ended December 31, 2017, as compared to $1.2 millionfor the fourth quarter of 2016 and $4.1 millionfor the year ended December 31, 2016. The increase for both fourth quarter 2017 and full year 2017 was primarily due to an increase in legal and consulting costs, an increase in the number of G&A employees, and an increase in costs attributable to operating as a public company during the fourth quarter of 2017.
- Net Loss: Net loss was
$6.7 millionfor 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 $0.48and $4.80, respectively, as compared to a net loss of $6.2 millionfor the fourth quarter of 2016 and $24.5 millionfor the year ended December 31, 2016, or a net loss per basic and diluted share of $4.65and $18.35, respectively.
Based on its current plans, Allena continues to expect that its existing cash, cash equivalents and short-term investments will be sufficient to fund its operating expenses and capital requirements into 2020.
Forward Looking Statements
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the duration of Allena’s URIROX-1 clinical trial and the announcement of topline data from such clinical trial, statements regarding Allena’s planned Phase 3 pivotal program for ALLN-177, including Allena’s planned URIROX-2 study, the resolution of the trial design for this study with the
|Allena Pharmaceuticals, Inc.|
|Selected Condensed Consolidated Balance Sheet Data|
|As of December 31,|
|Cash, cash equivalents and short-term investments||$||94,494||$||48,755|
|Working capital (1)||88,490||46,025|
|Loan payable, net of current portion and discount||5,516||9,409|
|Convertible preferred stock||—||95,727|
|Total stockholders' deficit||82,870||(59,277||)|
(1) The Company defines working capital as current assets less current liabilities. See the Company’s condensed consolidated financial statements for further detail regarding its current assets and current liabilities.
|Allena Pharmaceuticals, Inc.|
|Condensed Consolidated Statements of Operations|
|(in thousands, except share and per share data)|
|For the Three Months
Ended December 31,
|For the Year Ended
|Research and development||$||4,761||$||4,815||$||15,519||$||20,103|
|General and administrative||1,810||1,187||5,431||4,083|
|Total operating expenses||6,571||6,002||20,950||24,186|
|Other income (expense), net||(106||)||(217||)||(700||)||(321||)|
|Net loss per share attributable to common stockholders—basic and diluted||$||(0.48||)||$||(4.65||)||$||(4.80||)||$||(18.35||)|
|Weighted-average common shares outstanding—basic and diluted||13,949,046||1,341,385||4,520,337||1,339,254|
Stern Investor Relations, Inc.
Source: Allena Pharmaceuticals, Inc.