Please wait while we load the requested 10-Q report or click the link below:
https://last10k.com/sec-filings/report/1636282/000156459021054228/agle-10q_20210930.htm
SEC Filings
AGLE Annual Reports
AGLE Quarterly Reports
AGLE Corporate News
Bylaw Change
Event for Officers
Financial Exhibit
Regulated Disclosure November 2023
Bylaw Change
Financial Exhibit
Regulated Disclosure
Vote of Security Holders November 2023
Financial Exhibit
Other Events November 2023
Earnings Release
Financial Exhibit November 2023
Financial Exhibit
Regulated Disclosure October 2023
Event for Officers
Financial Exhibit
Other Events October 2023
New Agreement October 2023
Event for Officers
Financial Exhibit
Listing Status
New Agreement September 2023
Bylaw Change
Financial Exhibit
Other Events
Regulated Disclosure
Security Holders Change September 2023
Event for Officers
Financial Exhibit
Other Events September 2023
Bylaw Change
Event for Officers
Financial Exhibit
Regulated Disclosure
Event for Officers
Financial Exhibit
Regulated Disclosure
November 2023
Bylaw Change
Financial Exhibit
Regulated Disclosure
Vote of Security Holders
Financial Exhibit
Regulated Disclosure
Vote of Security Holders
November 2023
Financial Exhibit
Other Events
Other Events
November 2023
Earnings Release
Financial Exhibit
Financial Exhibit
November 2023
Financial Exhibit
Regulated Disclosure
Regulated Disclosure
October 2023
Event for Officers
Financial Exhibit
Other Events
Financial Exhibit
Other Events
October 2023
New Agreement
October 2023
Event for Officers
Financial Exhibit
Listing Status
New Agreement
Financial Exhibit
Listing Status
New Agreement
September 2023
Bylaw Change
Financial Exhibit
Other Events
Regulated Disclosure
Security Holders Change
Financial Exhibit
Other Events
Regulated Disclosure
Security Holders Change
September 2023
Event for Officers
Financial Exhibit
Other Events
Financial Exhibit
Other Events
September 2023
Last10K.com | 10-Q Quarterly Report Thu Nov 04 2021
Exhibit 99.1
Aeglea BioTherapeutics Reports Second Quarter 2021 Financial Results and Corporate Highlights
Initiated Dosing in Phase 1/2 Clinical Trial of AGLE-177 in Homocystinuria
Strengthened Leadership Team with Key Appointments, Including Jonathan Alspaugh as Chief Financial Officer
Austin, Texas, August 5, 2021 -
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 second quarter ended June 30, 2021, and reviewed recent corporate updates and program highlights.“2021 is proving to be a pivotal year for Aeglea. In the second quarter, we achieved a significant milestone in our second clinical development program. With the initiation of dosing in our Phase 1/2 clinical trial of AGLE-177, Aeglea is making progress for patients who suffer from Homocystinuria, a rare and progressive disease which currently has limited treatment options,” said Anthony Quinn, M.B Ch.B, Ph.D., president and chief executive officer of Aeglea. “Additionally, with the strengthening of our leadership team, deepening relationship with the rare disease community and advancing our scientific communications platform, we continue to prepare for the data readout for our Phase 3 clinical trial of pegzilarginase in Arginase 1 Deficiency in the fourth quarter as well as lay the groundwork for potential approval and commercialization.”
Second Quarter and Recent Highlights and Updates
AGLE-177 in Homocystinuria
|
|
• |
Initiated dosing with AGLE-177 in a Phase 1/2 clinical trial in people with Homocystinuria. The trial is anticipated to enroll 16–20 patients at sites located in the United Kingdom and Australia. Aeglea expects to provide a clinical update prior to the end of 2021. |
Pegzilarginase in Arginase 1 Deficiency
|
|
• |
Published 20-week data from a Phase 1/2 and open-label extension studies of pegzilarginase in the Journal of Inherited Metabolic Disease. The article, titled “Clinical Effect and Safety Profile of Pegzilarginase In Patients with Arginase 1 Deficiency,” is available in the July issue. |
Corporate
|
|
• |
Strengthened the leadership team with appointment of Jonathan Alspaugh as chief financial officer and Jim Kastenmayer as general counsel. |
|
|
o |
Mr. Alspaugh joined Aeglea from Evercore, where he most recently served as a managing director in the firm's corporate advisory business. |
|
|
o |
Mr. Kastenmayer joined Aeglea from Viela Bio, where he provided strategic guidance and legal advice, including advising Viela in connection with the FDA approval and launch of its first commercial product. |
|
|
• |
Expanded the board of directors with the appointment of Marcio Souza. Mr. Souza serves as the president & chief executive officer of Praxis Precision Medicines. |
|
|
• |
Participated in Rare Disease Awareness Week on Capitol Hill 2021, meeting with patient advocates and law makers to raise awareness and discuss the specific needs facing the rare disease community. |
|
|
• |
Supported the launch of the Rare Disease Company Coalition, a unified voice of life science companies committed to discovering, developing and delivering rare disease treatments, of which Aeglea is a founding member. |
Upcoming Investor Events
|
|
• |
Wells Fargo 2021 Virtual Healthcare Conference, September 9–10 |
|
|
• |
HC Wainwright 23rd Annual Global Investment Conference, September 13–15 |
|
|
• |
2021 Cantor Virtual Healthcare Conference, September 27–30 |
Second Quarter 2021 Financial Results
As of June 30, 2021, Aeglea had available cash, cash equivalents, marketable securities and restricted cash of $130.4 million inclusive of the $21.5 million upfront cash payment received from Immedica Pharma AB pursuant to the March 2021 license and supply agreement. The Company expects its cash, cash equivalents and investments will enable it to fund its operating expenses and capital
The following information was filed by Aeglea Biotherapeutics, Inc. (AGLE) on Thursday, August 5, 2021 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.
View differences made from one quarter to another to evaluate Aeglea Biotherapeutics, Inc.'s financial trajectory
Compare this 10-Q Quarterly Report to its predecessor by reading our highlights to see what text and tables were removed , added and changed by Aeglea Biotherapeutics, Inc..
Assess how Aeglea Biotherapeutics, Inc.'s management team is paid from their Annual Proxy
Aeglea Biotherapeutics, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2021 10-K Annual Report includes:
- Voting Procedures
- Board Members
- Executive Team
- Salaries, Bonuses, Perks
- Peers / Competitors
SEC Filing Tools
Rating
Learn More
Filter Sentiment:
Filter Category:
Filter Subcategory:
-
Revenue - Product Highlight
In July 2020, we filed a shelf registration statement on Form S-3 that was declared effective by the SEC 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.
-
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 trial and BLA filing.
-
Financial - Expense Highlight
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.
-
Financial - Expense Highlight
We anticipate that our expenses will increase as we continue our clinical development activities for our product candidates and prepare for the potential commercialization of our lead product candidate, pegzilarginase; concurrently develop our pipeline product candidates; expand and protect our intellectual property portfolio; hire additional personnel; and continue to operate as a public company.
-
Financial - Expense Highlight
Research and development expenses decreased by $3.6 million, or 8%, to $40.3 million for the nine months ended September 30, 2021 from $43.9 million for the nine months ended September 30, 2020.
-
Other - Other
Under the terms of the...Read more
-
Other - Other
Under the terms of the...Read more
-
Revenue - Product
Since our inception and through...Read more
-
Financial - Expense
The process of conducting the...Read more
-
Other - Other
We have based this estimate...Read more
-
Financial - Expense
The change in research and...Read more
-
Financial - Expense
The increase in general and...Read more
-
Financial - Expense
Our research and development expenses...Read more
-
Other - Other
Since we are a clinical-stage...Read more
-
Other - Other
Cash used in investing activities...Read more
-
Financial - Expense
The increase in general and...Read more
-
Financial - Expense
General and administrative expenses increased...Read more
-
Financial - Expense
General and administrative expenses increased...Read more
-
Revenue - Product
We have recognized license and...Read more
-
Financial - Expense
Research and development expenses increased...Read more
-
Financial - Expense
The capitalized amounts are expensed...Read more
-
Other - Other
For Arginase 1 Deficiency, which...Read more
-
Other - Other
We believe these enhancements will...Read more
-
Other - Other
At Week 48, spasticity was...Read more
-
Financial - Expense
The net change in operating...Read more
-
Financial - Expense
Additionally, we have incurred and...Read more
-
Revenue - Product
In the future, we may...Read more
-
Other - Other
Based on the terms and...Read more
-
Other - Other
We may continue to experience...Read more
-
Financial - Expense
Additional offsets included a $1.6...Read more
Financial Statements, Disclosures and Schedules
Inside this 10-Q Quarterly Report
Document And Entity Information
Condensed Consolidated Balance Sheets (Unaudited)
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical)
Condensed Consolidated Statements Of Cash Flows (Unaudited)
Condensed Consolidated Statements Of Changes In Stockholders' Equity (Unaudited)
Condensed Consolidated Statements Of Comprehensive Loss (Unaudited)
Condensed Consolidated Statements Of Operations (Unaudited)
Accrued And Other Current Liabilities
Accrued And Other Current Liabilities (Details)
Accrued And Other Current Liabilities (Tables)
Cash Equivalents And Marketable Securities
Cash Equivalents And Marketable Securities (Tables)
Cash Equivalents And Marketable Securities - Additional Information (Details)
Cash Equivalents And Marketable Securities - Schedule Of Estimated Fair Value Of Cash Equivalents And Marketable Securities (Details)
Cash Equivalents And Marketable Securities - Schedule Of Gross Unrealized Losses And Fair Value By Investment Category And Age (Details)
Cash Equivalents And Marketable Securities - Summary Of Contractual Maturities Of Marketable Securities At Estimated Fair Value (Details)
Fair Value Measurement (Tables)
Fair Value Measurements
Fair Value Measurements - Additional Information (Details)
Fair Value Measurements - Financial Assets And Liabilities Measured At Fair Value On Recurring Basis (Details)
License And Development Agreement
License And Development Agreement (Tables)
License And Development Agreement - Additional Information (Details)
License And Development Agreement - Summary Of Changes In Contract Liabilities (Details)
Net Loss Per Share
Net Loss Per Share (Tables)
Net Loss Per Share - Weighted-Average Equity Instruments Excluded From Calculation Of Diluted Net Loss Per Share (Details)
Stockholders' Equity
Stockholders' Equity (Tables)
Stockholders' Equity - Additional Information (Details)
Stockholders' Equity - Schedule Of Company's Stock Awards Granted (Details)
Stockholders' Equity - Schedule Of Estimate Fair Value Of Stock Options Granted (Details)
Stockholders' Equity - Summary Of Pre-Funded Warrants For Common Stock Issued And Outstanding (Details)
Stockholders' Equity - Summary Of Stock-Based Compensation Expense (Details)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Policies)
Summary Of Significant Accounting Policies (Tables)
Summary Of Significant Accounting Policies - Additional Information (Details)
Summary Of Significant Accounting Policies - Summary Of Useful Lives Of Property And Equipment (Details)
The Company And Basis Of Presentation
The Company And Basis Of Presentation - Additional Information (Details)
Material Contracts, Statements, Certifications & more
Aeglea Biotherapeutics, Inc. provided additional information to their SEC Filing as exhibits
Ticker: AGLE
CIK: 1636282
Form Type: 10-Q Quarterly Report
Accession Number: 0001564590-21-054228
Submitted to the SEC: Thu Nov 04 2021 7:04:07 AM EST
Accepted by the SEC: Thu Nov 04 2021
Period: Thursday, September 30, 2021
Industry: Pharmaceutical Preparations
External Resources:
Stock Quote
Social Media
SEC.gov
Bookmark the Permalink: https://last10k.com/sec-filings/agle/0001564590-21-054228.htm
SEC Filing Exhibit
PDF Download
Loading SEC Filing Exhibit...
Excel DownloadLoading SEC Filing Financial Summary...