Allena Pharmaceuticals Provides Business Update

8/9/20

NEWTON, Mass., (GLOBE NEWSWIRE) -- Allena Pharmaceuticals (NASDAQ:ALNA), a late-stage, biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders, today reported financial results for the second quarter ended June 30, 2020 and provided a business update.

“In concert with our recent financings, our team has moved quickly to implement planned activities across our portfolio, including the expansion of URIROX-2 clinical trial sites and the initiation of our Phase 1 study of ALLN-346. We are grateful for the effort and attention of our URIROX-2 trial investigators and business partners, which has enabled us to enroll patients in this second Phase 3 trial, even in the midst of the pandemic. This is the final study necessary for filing and approval of reloxaliase as a first-in-class therapy for patients with enteric hyperoxaluria,” said Louis Brenner, M.D., President and Chief Executive Officer of Allena Pharmaceuticals. “We are also excited to announce the initiation of our first-in-human study of ALLN-346, our second novel, oral enzyme therapeutic. We are initially developing ALLN-346 for the treatment of renally impaired patients with hyperuricemia and gout, for whom existing treatment options are inadequate due to safety and dosing limitations. As we look to the second half of 2020, we remain on track to achieve all of our clinical development milestones, with initial data for ALLN-346 expected by year end and the first interim analysis from URIROX-2 expected in the first quarter of 2022.”

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 enteric hyperoxaluria (EH) in URIROX-2, the second pivotal Phase 3 clinical trial in its URIROX program. Allena is actively expanding to new sites and new geographies in its ongoing URIROX-2 clinical trial. The Company continues to expect the interim analysis in the first quarter of 2022 and to announce topline data supporting a potential Biologics License Application (BLA) submission in the third quarter of 2022.

Allena continues to engage with the U.S. Food and Drug Administration (FDA) to explore potential expedited registration paths for reloxaliase in patients with EH and advanced chronic kidney disease (CKD).

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. In July 2020, Allena initiated a Phase 1 clinical trial of ALLN-346. Initial data is expected in the fourth quarter of 2020.

Corporate: In June 2020, Allena completed a registered direct offering of common stock and, in July 2020, an underwritten offering of common stock. Together, these transactions netted gross proceeds to Allena of $22.7 million.

Second Quarter 2020 Financial Results:

  • Cash Position: As of June 30, 2020, cash and cash equivalents were $26.5 million, as compared to $30.0 million as of December 31, 2019. This decrease was primarily due to cash used in operating activities and payments of principal and interest made on the Company’s credit facility, partially offset by gross proceeds of approximately $15.0 million received from the company’s June 2020 registered direct offering. Cash and cash equivalents as of June 30, 2020 do not include gross proceeds of approximately $7.7 million received from the company’s bought deal offering, which closed in July 2020.
  • R&D Expenses: R&D expenses were $3.8 million for the second quarter of 2020 as compared to $8.6 million for the second 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 URIROX-2 trials, 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. During the fourth quarter of 2019, the Company completed its URIROX-1 trial and filed an IND for ALLN-346 with the FDA.
  • G&A Expenses: G&A expenses were $2.8 million for the second quarter of 2020 as compared to $2.7 million for the second quarter of 2019. This increase was due to increases in compensation and benefit costs, the majority of which were related to stock-based compensation, partially offset by decreases in consulting and professional services costs.
  • Net Loss: Net loss was $7.0 million for the second quarter of 2020, or a net loss per basic and diluted share of $0.26, as compared to a net loss of $11.3 million for the second quarter of 2019, or a net loss per basic and diluted share of $0.54.

Financial Guidance:
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 beyond the second quarter of 2021.

About Allena Pharmaceuticals

Allena Pharmaceuticals, Inc. is a late-stage biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders. Allena’s lead product candidate, reloxaliase, is a first-in-class, oral enzyme therapeutic for the treatment of hyperoxaluria, a metabolic disorder characterized by markedly elevated urinary oxalate levels and commonly associated with kidney stones, chronic kidney disease and other serious kidney disorders.