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Last10K.com | 10-Q Quarterly Report Thu Aug 05 2021
Exhibit 99.1
Aeglea BioTherapeutics Reports First Quarter 2021 Financial Results and Corporate Highlights
Completed Patient Randomization for Phase 3 PEACE Clinical Trial; Topline Data Expected in Q4
Entered into Ex-U.S. Commercialization Agreement for Pegzilarginase with
Upfront and Milestone Payments Up to $151.5 Million Plus Royalty Percentage in the Mid-Twenties
Launched THINK ARGININETM, a Disease Education and Diagnostic Testing Initiative for Arginase 1 Deficiency
Austin, Texas, May 10, 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 reported its first quarter 2021 financial results, and provided recent corporate and program highlights.“We’ve had a strong start to 2021 and I am excited to see the significant momentum we have built for our pegzilarginase program from a clinical perspective as well as strengthening our commercial foundation in preparation for a potential FDA approval and launch. In just the last two months, we completed patient randomization for PEACE, secured a commercialization partner for pegzilarginase in Europe and the Middle East and launched THINK ARGININE, an Arginase 1 Deficiency disease education and diagnostic testing initiative in the United States,” said Anthony Quinn, M.B Ch.B, Ph.D., president and chief executive officer of Aeglea. “This substantial progress sets us up well for the rest of 2021. We expect to provide topline data from the PEACE study in the fourth quarter, continue progressing our commercial strategy for pegzilarginase and advance our AGLE-177 clinical program in Homocystinuria. These accomplishments are critical milestones as we move closer to our mission of bringing impactful therapies to patients with rare metabolic disorders who currently have limited treatment options.”
Recent Highlights and Updates
Corporate
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In March, Aeglea announced it has entered into a license and supply agreement with Immedica Pharma AB granting Immedica exclusive commercialization rights in Europe and several Middle Eastern countries. Aeglea will receive an upfront payment of $21.5 million and is eligible for commercial and regulatory milestones of up to approximately $130 million and mid-twenties percentage royalties on net sales. |
Pegzilarginase in Arginase 1 Deficiency
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In April, the Company completed patient screening and randomization for PEACE, its pivotal Phase 3 clinical trial. Trial enrollment of 32 patients exceeded the target of 30 patients, underscoring the high levels of interest seen from patients, caregivers and investigators. Topline data are expected in the fourth quarter of 2021. |
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In May, we announced the launch of THINK ARGININE, a disease education initiative to improve the awareness and diagnosis of Arginase 1 Deficiency (ARG1-D). The initiative consists of a comprehensive healthcare provider education campaign and a no-charge diagnostic testing program for adults and children with suspected ARG1-D in the United States. |
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The no-charge diagnostic testing program includes amino acid testing working with Mayo Clinic Laboratories and genetic testing partnered with Invitae. |
Upcoming Events
Aeglea will participate in the upcoming virtual conferences and events:
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ISPOR 2021, May 17-20 |
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Virtual Rare Disease Week on Capitol Hill 2021, July 14-22 |
First Quarter 2021 Financial Results
As of March 31, 2021, Aeglea had available cash, cash equivalents, marketable securities and restricted cash of $128.5 million, which excludes the upfront license receivable from Immedica for $21.5 million. Based on Aeglea’s current operating plan, management believes it has sufficient capital resources to fund anticipated operations into 2023.
Research and development expenses totaled $11.9 million for the first quarter of 2021 and $14.6 million for the first quarter of 2020. The decrease was primarily associated with completing certain pre-commercial manufacturing activities for Aeglea’s lead product
The following information was filed by Aeglea Biotherapeutics, Inc. (AGLE) on Monday, May 10, 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
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Aeglea Biotherapeutics, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2021 10-K Annual Report includes:
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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.
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Revenue - Product Highlight
The net change in operating assets and liabilities of $2.9 million was primarily related to a $7.8 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.
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Financial - Expense Highlight
The increase in general and administrative expenses was primarily due to a $2.2 million increase in compensation and other personnel expenses, including $0.7 million in non-cash stock compensation, driven by additional headcount to establish and execute our commercial planning activities, and $1.7 million of expenses related to professional service and legal costs primarily to support the ramp up of our commercial capabilities.
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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.
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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.
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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)
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Fair Value Measurements - Additional Information (Details)
Fair Value Measurements - Financial Assets And Liabilities Measured At Fair Value On Recurring Basis (Details)
License And Collaboration Agreement
License And Collaboration Agreement (Tables)
License And Collaboration Agreement - Additional Information (Details)
License And Collaboration Agreement - Summary Of Changes In Contract Liabilities (Details)
Net Loss Per Share
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Net Loss Per Share - Weighted-Average Equity Instruments Excluded From Calculation Of Diluted Net Loss Per Share (Details)
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Stockholders' Equity (Tables)
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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: 0001564590-21-041216
Submitted to the SEC: Thu Aug 05 2021 8:33:47 AM EST
Accepted by the SEC: Thu Aug 05 2021
Period: Wednesday, June 30, 2021
Industry: Pharmaceutical Preparations
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