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Last10K.com | 10-Q Quarterly Report Thu May 05 2022
Exhibit 99.1
Aeglea BioTherapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Program Updates
Pegzilarginase BLA preparation on track to enable a second quarter 2022 submission to the FDA
Accelerating Phase 1/2 trial of AGLE-177 for Homocystinuria; clinical data announcement expected in the second half of 2022
$95 million of cash as of December 31, 2021, which is expected to fund operations into the first quarter of 2023
Austin, Texas, March 8, 2022 -
Aeglea BioTherapeutics, Inc. (Nasdaq:AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as innovative solutions for rare metabolic diseases, today announced financial results for the fourth quarter and full year 2021, and provided program updates.“2021 moved us closer to our goal of delivering life-changing medicines to people with rare metabolic diseases with positive topline data from our pivotal Phase 3 trial of pegzilarginase for Arginase 1 Deficiency and the dosing of the first patients in our Phase 1/2 trial of AGLE-177 for Homocystinuria. We enter 2022 well positioned to capitalize on the momentum we’ve built,” said Anthony Quinn, M.B., Ch.B., Ph. D., president and chief executive officer of Aeglea. “We are excited about the opportunities in 2022 for a transformative year. With a strong portfolio of human enzyme therapies for rare metabolic diseases, we are looking forward to advancing all our programs, including sharing clinical data from our AGLE-177 program, progressing AGLE-325 for Cystinuria through IND-enabling studies and working with the FDA throughout the regulatory process for pegzilarginase.”
Program Updates
Pegzilarginase in Arginase 1 Deficiency
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Announced the PEACE Phase 3 clinical trial met its primary endpoint with an 80% plasma arginine reduction, and an accompanying positive trend in a secondary endpoint assessing mobility. Additionally, 90.5% of patients achieved normal plasma arginine levels. Pegzilarginase was well-tolerated, and no patients discontinued the trial due to adverse events. |
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Highlighted 104-week data from the GMFM-E and 6-Minute Walk Test assessments from the Phase 1/2 open-label extension, which underscores the sustained, long-term impact of pegzilarginase treatment on mobility. |
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Plan to present additional data from PEACE Phase 3 clinical trial at the Society for Inherited Metabolic Disorders (SIMD) Annual Meeting in April 2022. |
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Hosted a Key Opinion Leader and Patient Caregiver event to provide insights and perspectives on treating and living with Arginase 1 Deficiency. |
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Met with U.S. Food and Drug Administration (FDA) in late February to discuss data from the pegzilarginase program and the path towards Biologic License Application (BLA) submission. |
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BLA preparation on track to enable a second quarter 2022 submission. |
AGLE-177 in Homocystinuria
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Completed dosing in the 0.15 mg/kg intravenous cohort in the Phase 1/2 clinical trial. AGLE-177 was well tolerated with no safety concerns and data from this first cohort showed reductions in total homocysteine in all patients. |
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The encouraging results from the first cohort allowed the Company to advance directly to the 0.45 mg/kg subcutaneous dose, accelerating the generation of dose response data. This second cohort is currently being dosed. |
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Filed an Investigational New Drug (IND) application with the FDA. Acceptance of the IND would allow the Company to open clinical trial sites in the U.S. for the Phase 1/2 clinical trial and a potential pivotal Phase 3 trial. |
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Expect to announce Phase 1/2 clinical data in the second half of 2022. |
AGLE-325 in Cystinuria
The following information was filed by Aeglea Biotherapeutics, Inc. (AGLE) on Tuesday, March 8, 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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Aeglea Biotherapeutics, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2022 10-K Annual Report includes:
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Revenue - Product Highlight
In July 2020, we filed and the SEC declared effective a shelf registration statement on Form S-3 for the potential offering, issuance and sale by us of up to $400.0 million of our common stock, preferred stock, debt securities, warrants to purchase common stock, preferred stock and debt securities, subscription rights to purchase common stock and units consisting of all or some of these securities.
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The shares of common stock and pre-funded warrants sold in the 2020 Public Offering were offered pursuant to a shelf registration statement on Form S-3, or the 2019 Registration Statement, declared effective in February 2019 by the SEC for the potential offering, issuance and sale by us of up to $200.0 million of our common stock, warrants to purchase common stock, and other security types and subscription rights.
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Pegzilarginase treated patients also showed statistically significant biochemical improvements in measures of ornithine and guanidino compounds compared to the placebo arm, consistent with the pegzilarginase mechanism of action.
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These increases will likely include higher costs related to the hiring of additional personnel and fees to outside consultants, lawyers and accountants, among other expenses.
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We sold 15,442,303 shares of common stock and pre-funded warrants to purchase up to 13,610,328 shares of common stock in an underwritten public offering, or the 2020 Public Offering, for gross proceeds of $138.0 million, resulting in net proceeds of $129.0 million after deducting underwriting discounts, commissions, and offering costs.
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Aeglea Biotherapeutics, Inc. provided additional information to their SEC Filing as exhibits
Ticker: AGLE
CIK: 1636282
Form Type: 10-Q Quarterly Report
Accession Number: 0001564590-22-018006
Submitted to the SEC: Thu May 05 2022 6:40:52 AM EST
Accepted by the SEC: Thu May 05 2022
Period: Thursday, March 31, 2022
Industry: Pharmaceutical Preparations
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