 -- Expanding URIROX-2 Trial Sites; Interim Analysis on Track for the First Quarter of 2022 - -- Initiated Phase 1 Clinical Trial of ALLN-346; Initial Data Expected in the Fourth Quarter of 2020 --- Raised Gross Proceeds of 22.7M Through Two Public Offerings, Extending Cash Runway Beyond the Second Quarter of 2021 -NEWTON, Mass., Aug. 05, 2020 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 Companys credit facility, partially offset by gross proceeds of approximately 15.0 million received from the companys 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 companys bought deal offering, which closed in July 2020. RD Expenses: RD 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. GA Expenses: GA 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 PharmaceuticalsAllena 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. Allenas 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.Forward-Looking StatementsThis release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding the statements regarding implementation of the amended trial design for URIROX-2 , the timing of sample size reassessments and interim analyses during the URIROX-2 trial, Allenas ability to utilize the accelerated approval regulatory pathway for reloxaliase, statements concerning the future clinical, regulatory and commercial potential of reloxaliase, statements regarding the Allenas development of ALLN-346, statements regarding Allenas financial position and need for capital. In addition, it should be noted that additional capital will be required to complete the planned URIROX-2 clinical trial, including the planned interim analysis at the first sample size reassessment, which capital may not be available to Allena on terms that are acceptable to it, if at all. If adequate funds are not available on a timely basis, Allena may be required to delay, limit, reduce or terminate its clinical development of reloxaliase. The impact of the COVID-19 coronavirus on Allenas business, the biotech sector generally and the broader macroeconomic environment is uncertain and could harm Allenas business by delaying regulatory review timelines, clinical development plans and our ability to raise necessary capital. Furthermore, Allena does not have sufficient cash to operate its business for the next 12 months, which raises substantial doubt about its ability to continue as a going concern. Allena will require additional capital to fund its planned operations, which may not be available to it on attractive terms or at all. If the company is unable to secure additional capital, it will be forced to delay, limit, reduce or terminate its development of reloxaliase and may not be able to continue as a going concern. Any forward-looking statements in this press release are based on managements current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. 