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Allena Pharmaceuticals, Inc. (ALNA) SEC Filing 10-Q Quarterly Report for the period ending Thursday, March 31, 2022

Allena Pharmaceuticals, Inc.

CIK: 1624658 Ticker: ALNA

Exhibit 99.1

Allena Pharmaceuticals Provides Clinical and Corporate Update

 

   

ALLN-346, an orally administered enzyme in development for the treatment of hyperuricemia and gout, demonstrates a statistically significant reduction in serum uric acid and a well-tolerated safety profile in first cohort of patients with hyperuricemia and chronic kidney disease in the Phase 2a Study 201

 

   

Allena to host webinar to discuss the initial Study 201 data with Key Opinion Leaders Robert Terkeltaub, M.D. and David S. Goldfarb, M.D. today at 8:00 am ET; log-in information below

 

   

ALLN-346 Phase 2a Study 202 is actively enrolling patients with gout and stages 2 and 3 chronic kidney disease in parallel cohorts; data from both cohorts expected in Q1 2022

 

   

Company currently evaluating potential modifications to the pivotal URIROX-2 Phase 3 trial of Reloxaliase in Enteric Hyperoxaluria in an effort to reduce the size and duration of the trial and plans to discuss such modifications with the FDA during Q1 2022

 

   

Company retains Stifel, Nicolaus & Company, Incorporated to assist in exploring strategic and financing alternatives

NEWTON, Mass., January 4, 2022 – Allena Pharmaceuticals, Inc. (NASDAQ: ALNA) (“Allena” or the “Company”), a late-stage biopharmaceutical company deploying its novel oral biologic platform to discover, develop and commercialize

first-in-class, oral enzyme therapeutics for difficult-to-treat metabolic diseases, today provided a clinical and corporate update.

ALLN-346 Program

ALLN-346 is a first-in-class, non-absorbed, orally administered enzyme in development for the treatment of hyperuricemia and gout in the setting of advanced chronic kidney disease (CKD). In November, ALLN-346 received Fast Track Designation from the U.S. Food and Drug Administration (FDA). The Company is conducting two Phase 2a trials of ALLN-346: Study 201, a one-week inpatient study being conducted at a clinical pharmacology unit, and Study 202, a two-week outpatient study being conducted at 20 sites across the U.S.

In Study 201, patients with hyperuricemia are being randomized (2:1) to receive either five capsules of ALLN-346 or matching placebo three times daily for one week. Planned enrollment in the trial consists of two cohorts, each with approximately 12 patients. Of the 11 patients in the first cohort, seven received ALLN-346 and four received placebo. The majority of these patients had Stage 2 CKD, including five of the seven subjects treated with ALLN-346. The second cohort is currently being enrolled with topline data expected in Q1 2022.


The following information was filed by Allena Pharmaceuticals, Inc. (ALNA) on Tuesday, January 4, 2022 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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Inside Allena Pharmaceuticals, Inc.'s 10-Q Quarterly Report:

Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Document And Entity Information
Condensed Consolidated Balance Sheets (Parenthetical) (Unaudited)
Condensed Consolidated Balance Sheets (Unaudited)
Condensed Consolidated Statements Of Cash Flows (Unaudited)
Condensed Consolidated Statements Of Operations And Comprehensive Loss (Unaudited)
Condensed Consolidated Statements Of Stockholders' Equity (Unaudited)
Accrued Expenses
Accrued Expenses (Tables)
Accrued Expenses - Schedule Of Accrued Expenses (Details)
Commitments And Contingencies
Commitments And Contingencies (Tables)
Commitments And Contingencies - Additional Information (Details)
Commitments And Contingencies - Schedule Of Maturities Of Operating Lease Liabilities (Details)
Convertible Debt Agreement
Convertible Debt Agreement (Tables)
Convertible Debt Agreement - Additional Information (Details)
Convertible Debt Agreement - Summary Of Minimum Aggregate Future Loan And Interest Payments (Details)
Fair Value Measurements
Fair Value Measurements (Tables)
Fair Value Measurements - Additional Information (Details)
Fair Value Measurements - Summary Of Financial Assets And Liabilities Measured At Fair Value (Details)
Nature Of Business
Nature Of Business - Additional Information (Details)
Net Loss Per Share
Net Loss Per Share (Tables)
Net Loss Per Share - Summary Of Anti-Dilutive Securities Excluded From Calculation Of Diluted Net Loss Per Share (Details)
Net Loss Per Share - Summary Of Basic And Diluted Net Loss Per Share Attributable To Common Stockholders (Details)
Stock Incentive Plan
Stock Incentive Plans (Tables)
Stock Incentive Plans - Additional Information (Details)
Stock Incentive Plans - Schedule Of Assumptions Used In Black-Scholes Option Pricing Model To Estimate Fair Value Of Stock Options (Details)
Stock Incentive Plans - Summary Of Nonvested Rsus (Details)
Stock Incentive Plans - Summary Of Stock Option Activity (Details)
Stock Incentive Plans - Summary Of Stock-Based Compensation Expense (Details)
Stockholders' Equity
Stockholders' Equity (Tables)
Stockholders' Equity - Additional Information (Details)
Stockholders' Equity - Summary Of Shares Of Common Stock Reserved (Details)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Policies)
Summary Of Significant Accounting Policies - Additional Information (Details)
Ticker: ALNA
CIK: 1624658
Form Type: 10-Q Quarterly Report
Accession Number: 0000950170-22-010077
Submitted to the SEC: Mon May 16 2022 4:12:13 PM EST
Accepted by the SEC: Mon May 16 2022
Period: Thursday, March 31, 2022
Industry: Biological Products No Disgnostic Substances

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