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Exhibit 99.1
Aeglea BioTherapeutics Provides Corporate Update and Reports Third Quarter 2017 Financial Results
Austin, Texas, November 7, 2017 -
Aeglea BioTherapeutics, Inc., (NASDAQ: AGLE) a biotechnology company committed to developing enzyme-based therapeutics in the field of amino acid metabolism to treat rare genetic diseases and cancer, today provided a corporate update and reported financial results for the third quarter ended September 30, 2017.“I am very pleased with the forward momentum and progress of the team at Aeglea over the last few months. Initiation of repeat dosing in Part 2 of our Phase 1/2 clinical trial for the treatment of Arginase 1 Deficiency is an important milestone and we look forward to the first insights on the effects of longer term dosing with AEB1102 in adults with Arginase 1 Deficiency,” said Anthony Quinn, M.B Ch.B, Ph.D., interim chief executive officer of Aeglea. “Additionally, our clinical collaboration with Merck on the effects of AEB1102 in combination with pembrolizumab in small cell lung cancer allows us to accelerate our profiling of the anti-cancer activity of AEB1102 beyond monotherapy in cancers with characteristics suggestive of arginine dependence.”
Corporate Update
Arginase 1 Deficiency:
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Dosed two adults in Part 2 (repeat dose) of our Phase 1/2 clinical trial of AEB1102 (pegzilarginase), which is designed to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of weekly treatment in patients with Arginase 1 Deficiency |
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Initiated site selection and regulatory activities in Europe and site readiness in Canada to support our ex-US strategy for completion of the Phase 1/2 clinical trial |
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Continued dialogue with FDA about the inclusion of pediatric patients in the Phase 1/2 clinical trial |
Cancer:
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Announced a clinical collaboration to evaluate the combination of AEB1102 with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), for the treatment of patients with small cell lung cancer. The multicenter Phase 1/2 trial will evaluate objective response rates in patients with extensive small cell lung cancer who have relapsed or progressed after receiving platinum-based chemotherapy. Enrollment is expected to begin in the first quarter of 2018. |
Upcoming Events
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Aeglea will deliver a poster presentation describing the effects of combining AEB1102 with anti-PD-L1 in a preclinical tumor model at the 2017 Society for Immunotherapy of Cancer Annual Meeting taking place November 8 – 12 in National Harbor, Maryland |
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Aeglea will present a corporate update at the BMO Capital Markets 2017 Prescription for Success Healthcare Conference on December 14 in New York |
Third Quarter 2017 Financial Results
On September 30, 2017, Aeglea had available cash, cash equivalents and marketable securities of $55.7 million. Based on Aeglea’s current operating plan, management believes that it has sufficient capital resources to fund anticipated operations through the third quarter of 2019.
Aeglea recognized grant revenues of $1.3 million in the third quarter of 2017, compared with $1.2 million in the third quarter of 2016. The grant revenues are the result of a $19.8 million research grant received from the Cancer Prevention and Research Institute of Texas (CPRIT). The increase was primarily due to additional qualifying expenditures associated with the clinical trials for AEB1102 in patients with advanced solid tumors and the hematological malignancies acute myeloid leukemia and myelodysplastic syndrome.
Research and development expenses totaled $6.2 million for the third quarter of 2017, compared with $5.4 million for the third quarter of 2016. The increase was primarily associated with hiring additional personnel to expand Aeglea’s internal regulatory, laboratory, and clinical development capabilities, as well as manufacturing activities for AEB1102 and other pipeline programs.
General and administrative expenses totaled $3.0 million for the third quarter of 2017, compared with $2.1 million for the third quarter of 2016. The increase was primarily due to an increase in employee compensation and facilities costs.
Net loss totaled $7.9 million and $6.2 million for the third quarter of 2017 and 2016, respectively.
About Aeglea BioTherapeutics
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Aeglea Biotherapeutics, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2017 10-K Annual Report includes:
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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: 0001564590-17-022228
Submitted to the SEC: Tue Nov 07 2017 4:07:56 PM EST
Accepted by the SEC: Tue Nov 07 2017
Period: Saturday, September 30, 2017
Industry: Pharmaceutical Preparations