Exhibit 99.1

Allena Pharmaceuticals Reports Third Quarter 2017 Financial Results and Provides Business Update

— Successfully Completed Initial Public Offering, Raising $74.9 Million in Gross Proceeds

— Presented Final Results from Phase 2 Trials of ALLN-177 in Secondary Hyperoxaluria at ASN Kidney Week 2017

— Received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) and European Commission for ALLN-177 in Primary Hyperoxaluria

NEWTON, Mass., December 14, 2017 – Allena Pharmaceuticals, Inc., a late-stage clinical 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 and provided a business update for the third quarter ended September 30, 2017.

“Our third quarter and recent accomplishments represent significant progress across our business,” said Alexey Margolin, Ph.D., Chief Executive Officer of Allena Pharmaceuticals. “In November, we presented the final results from our Phase 2 trials of ALLN-177 in secondary hyperoxaluria at the Kidney Week Conference of the American Society of Nephrology (ASN), which suggest that ALLN-177 may offer patients with enteric hyperoxaluria the first potential therapy for reducing urinary oxalate levels and, we believe, support its advancement into pivotal Phase 3 studies. We also received orphan drug designation for ALLN-177 for primary hyperoxaluria in both the United States and Europe. We are committed to addressing the significant unmet need for patients with severe oxalate disorders, for which there are no FDA or European Commission approved therapies. Following the completion of our initial public offering, we are well-funded, with resources expected to be sufficient to advance our clinical, preclinical, and manufacturing development into 2020.”

Third Quarter and Recent Business Highlights:

Pipeline:

ALLN-177: ALLN-177, Allena’s lead product candidate, is a first-in-class, non-absorbed, orally-administered enzyme for the treatment of severe hyperoxaluria. Allena expects to initiate the first of two planned pivotal Phase 3 clinical trials for ALLN-177 in enteric hyperoxaluria in the first quarter of 2018 and to announce topline data in the second half of 2019. The Company also plans to initiate a Phase 2 clinical trial of ALLN-177 in adolescents and adults with primary hyperoxaluria or severe forms of secondary hyperoxaluria in the first quarter of 2018, with interim data expected in the second half of 2018.

 

    In 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 Week 2017 in New Orleans, LA. In patients with enteric hyperoxaluria, ALLN-177 substantially reduced urinary oxalate (UOx) excretion and was well-tolerated, with no drug-related serious or severe adverse events (SAEs) and no discontinuations of study drug due to SAE. Also at the ASN meeting, Allena presented preclinical data from a porcine dietary model of severe hyperoxaluria, which showed a significant reduction in both plasma oxalate and UOx excretion. This preclinical study supported the Company’s orphan drug designation in primary hyperoxaluria and demonstrated animal proof-of-concept for the upcoming Phase 2 clinical trial in patients with severe hyperoxaluria and hyperoxalemia (elevated plasma oxalate). Hyperoxalemia increases the risk of systemic oxalosis, which refers to the presence of excess oxalate throughout the body, including the blood, bones, joints, eyes and heart.

 

    In July 2017, Allena received orphan drug designation from both the FDA and the European Commission for ALLN-177 for the treatment of primary hyperoxaluria (PH). PH is a severe rare genetic disorder caused by endogenous overproduction of oxalate by the liver that can result in kidney stone disease, kidney damage, kidney failure, and systemic oxalosis, which may lead to death.


The following information was filed by Allena Pharmaceuticals, Inc. (ALNA) on Thursday, December 14, 2017 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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