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Last10K.com | 10-Q Quarterly Report Thu Nov 03 2022
Exhibit 99.1
Aeglea BioTherapeutics Reports Third Quarter 2022 Financial Results and Provides Program Updates
Interim Clinical Data from Phase 1/2 Trial of Pegtarviliase Expected in Fourth Quarter of 2022; Currently Dosing Cohort 3 at 1.35 mg/kg
MAA for Pegzilarginase for the Treatment of Arginase 1 Deficiency Accepted for Review by the EMA
$75.2 Million of Cash as of September 30, 2022; Runway into Fourth Quarter of 2023
Austin, Texas, November 3, 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 third quarter ended September 30, 2022 and provided program updates.
“With our recent corporate restructuring we have prioritized our pegtarviliase program to optimize our resources and maximize Aeglea’s success. We continue to advance our Phase 1/2 trial of pegtarviliase for Classical Homocystinuria with the ongoing enrollment of cohort 3 and look forward to sharing interim data from this trial before the end of the year,” said Jim Kastenmayer, Ph. D., J.D., interim chief executive officer and general counsel of Aeglea. “While our primary focus is pegtarviliase, we are a multi-program company and are pleased that the Marketing Authorization Application for pegzilarginase for Arginase 1 Deficiency submitted by our valued partner Immedica is currently under review by the EMA for a potential approval next year. We view the progress in our portfolio as validation of what can be accomplished through our innovative human enzyme engineering platform and its potential to transform the lives of patients and families living with rare metabolic diseases.”
Program and Corporate Updates
Pegtarviliase in Homocystinuria
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Currently dosing Classical Homocystinuria patients in cohort 3 at 1.35 mg/kg once weekly via subcutaneous injection in the Phase 1/2 clinical trial.
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Plan to announce interim Phase 1/2 clinical data, including data from cohort 3, in the fourth quarter of 2022.
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Received a letter from the U.S. Food and Drug Administration (FDA) responding to a protocol amendment stating that patients aged younger than 18 years cannot currently be enrolled in the Phase 1/2 trial. The company believes the letter will have no impact on the timeline for the trial.
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Hosted a Key Opinion Leader (KOL) webinar discussing Classical Homocystinuria and providing an overview of the pegtarviliase program.
Pegzilarginase in Arginase 1 Deficiency
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Marketing Authorization Application (MAA) was submitted by Immedica, Aeglea’s commercialization partner in Europe and certain countries in the Middle East, and validated by the European Medicines Agency (EMA). The MAA is currently under review by the EMA.
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Actively engaged with the FDA to identify a viable regulatory approach and path to the resubmission of the Biologics License Application (BLA).
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Presented efficacy and safety data from the PEACE Phase 3 clinical trial at the Society for the Study of Inborn
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Errors of Metabolism (SSIEM).
The following information was filed by Aeglea Biotherapeutics, Inc. (AGLE) on Thursday, November 3, 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, or the 2020 Registration Statement, 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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Financial - Shares Highlight
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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Other - Other Highlight
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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Revenue - Product Highlight
The net change in operating assets and liabilities of $3.3 million was primarily related to a $6.4 million increase in deferred revenue due to receiving a $21.5 million upfront payment under the Immedica Agreement offset by the recognition of revenue allocated to the license, PEACE Phase 3 trial and BLA filing.
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Financial - Shares Highlight
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: 0000950170-22-021529
Submitted to the SEC: Thu Nov 03 2022 7:05:08 AM EST
Accepted by the SEC: Thu Nov 03 2022
Period: Friday, September 30, 2022
Industry: Pharmaceutical Preparations
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