Aeglea BioTherapeutics Reports Second Quarter 2023 Financial Results
- None.
- None.
Acquisition of Spyre's assets and concurrent oversubscribed
Sale of legacy pipeline candidate, pegzilarginase, further streamlines operations and increases focus on IBD strategy
"With the acquisition of Spyre Therapeutics and concurrent financing, we are in a privileged position to create meaningful new medicines for patients with IBD and build an industry-leading development organization," said Cameron Turtle, DPhil, Chief Operating Officer of Aeglea. "Our pipeline of differentiated and potentially best-in-class IBD programs, including a4b7 and TL1A, combined with a strategy to investigate therapeutic combinations and precision medicine approaches, offers the possibility to transform the treatment of this chronic and debilitating disease."
"In parallel, we have made significant progress streamlining the organization with the sale of pegzilarginase and pivoting our operations and strategy around the new IBD assets," said Jonathan Alspaugh, President and Chief Financial Officer of Aeglea. "We are working to rapidly advance our co-lead product candidates with an expectation of initiating clinical studies for both SPY001 and SPY002 in 2024."
Recent Program and Corporate Updates
Corporate
- Completed the asset acquisition (the "Acquisition") of Spyre Therapeutics, Inc. ("Spyre"), a privately held biotechnology company with a pipeline of antibody therapeutics possessing the potential to transform the treatment of IBD alongside its research partner, Paragon Therapeutics, Inc. ("Paragon")
- Raised
in gross proceeds (before deducting approximately$210.0 million in placement fees and other offering expenses) through a sale of Series A non-voting convertible preferred stock (the "Series A Preferred Stock") in a private placement to a group of investors.$12.7 million
IBD Portfolio
With the Acquisition, Aeglea shifted its focus to the development of a potentially best-in-class IBD portfolio including:
- SPY001 – a highly potent and selective anti-α4β7 monoclonal antibody engineered with half-life extension technology and formulated for high concentration, convenient dosing.
- SPY001 is currently progressing through IND-enabling studies and is expected to enter first-in-human ("FIH") studies in the first half of 2024. Data from a healthy volunteer study are expected by the end of 2024.
- SPY002 – a highly potent and selective anti-TL1A monoclonal antibody engineered with half-life extension technology. TL1A has emerged as one of the most promising targets in IBD and broader immunology indications.
- We expect to begin FIH studies of the SPY002 program in the second half of 2024 with healthy volunteer data expected in the first half of 2025.
Pegzilarginase
- Sold global rights to pegzilarginase in development for Arginase 1 Deficiency to Immedica Pharma AB ("Immedica") for
upfront cash proceeds and up to$15.0 million of contingent milestone payments. The sale of pegzilarginase to Immedica supersedes the previous license agreement between the companies.$100.0 million - Marketing Authorisation Application for pegzilarginase is under review by the European Medicines Agency.
- The milestone payments are contingent on formal reimbursement decisions by national authorities in key European markets and pegzilarginase approval by the FDA, among other events.
- Net proceeds of the sale are to be distributed to holders of contingent value rights ("CVR") pursuant to the terms of the CVR Agreement dated July 7, 2023 by and between the Company and a rights agent.
Second Quarter 2023 Financial Results
As of June 30, 2023, Aeglea had available cash and cash equivalents and restricted cash of
Aeglea recognized development fee and royalty revenues of
Research and development expenses totaled
General and administrative expenses totaled
Acquired in-process research and development expenses totaled
Change in the fair value of forward contract liability expense was
Net loss totaled
About Aeglea BioTherapeutics
In June 2023, Aeglea completed the asset acquisition of Spyre and shifted its disease focus to IBD. Aeglea is advancing a pipeline of antibody therapeutics with the potential to transform the treatment of IBD. The approaches combine novel antibody engineering, rational therapeutic combinations, and precision immunology approaches to maximize efficacy, safety, and convenience of treatments for IBD.
For more information, please visit http://aeglea.com.
Follow Aeglea BioTherapeutics on social media: @aegleabio and LinkedIn.
About the Paragon Agreement
In May 2023, Spyre entered into an antibody discovery option and license agreement with Paragon (the "Paragon Agreement"). As part of the Paragon Agreement, Paragon identifies, evaluates and develops antibodies directed against certain mutually agreed therapeutic targets of interest to the Company. The arrangement currently includes four selected targets: α4β7, TL1A, IL-23, and an undisclosed fourth target. Subsequent to the Acquisition, the Company has exercised its option for the α4β7 program and will be granted an exclusive license to develop, manufacture and commercialize the antibody and products directed to the target, and plans to exercise its option for the other programs upon development candidate selection. From time to time, the Company can choose to add additional targets to the arrangement by mutual agreement with Paragon.
Safe Harbor / Forward Looking Statements
This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the
Aeglea BioTherapeutics, Inc. Condensed Consolidated Balance Sheets | ||||
(Unaudited, in thousands, except share and per share amounts) | ||||
June 30, | December 31, | |||
2023 | 2022 | |||
ASSETS | ||||
CURRENT ASSETS | ||||
Cash and cash equivalents | $ 235,358 | $ 34,863 | ||
Marketable securities | — | 20,848 | ||
Development receivables | 1,646 | 375 | ||
Prepaid expenses and other current assets | 2,882 | 6,172 | ||
Total current assets | 239,886 | 62,258 | ||
Restricted cash | 1,317 | 1,553 | ||
Property and equipment, net | — | 3,220 | ||
Operating lease right-of-use assets | 2,316 | 3,430 | ||
Other non-current assets | 10 | 683 | ||
TOTAL ASSETS | $ 243,529 | $ 71,144 | ||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||
CURRENT LIABILITIES | ||||
Accounts payable | $ 2,854 | $ 677 | ||
Forward contract liability | 164,382 | — | ||
CVR liability | 10,500 | — | ||
Operating lease liabilities | 4,331 | 625 | ||
Deferred revenue | 930 | 517 | ||
Accrued and other current liabilities | 28,427 | 12,837 | ||
Related party accounts payable | 20,810 | — | ||
Total current liabilities | 232,234 | 14,656 | ||
Non-current CVR liability | 19,000 | — | ||
Non-current operating lease liabilities | — | 4,004 | ||
Deferred revenue, net of current portion | 2,341 | 2,179 | ||
TOTAL LIABILITIES | 253,575 | 20,839 | ||
Commitments and Contingencies (Note 11) | ||||
Series A non-voting convertible preferred stock, | 197,323 | — | ||
STOCKHOLDERS' (DEFICIT) EQUITY | ||||
Preferred stock, | — | — | ||
Common stock, | 6 | 6 | ||
Additional paid-in capital | 453,741 | 475,971 | ||
Accumulated other comprehensive income (loss) | 11 | (48) | ||
Accumulated deficit | (661,127) | (425,624) | ||
TOTAL STOCKHOLDERS' (DEFICIT) EQUITY | (207,369) | 50,305 | ||
TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' (DEFICIT) EQUITY | $ 243,529 | $ 71,144 |
Aeglea BioTherapeutics, Inc. Condensed Consolidated Statements of Operations | ||||||||
(Unaudited, in thousands, except share and per share amounts) | ||||||||
Three Months Ended | Six Months Ended | |||||||
June 30, | June 30, | |||||||
2023 | 2022 | 2023 | 2022 | |||||
Revenue: | ||||||||
Development fee and royalty | $ 688 | $ 625 | $ 886 | $ 1,987 | ||||
Total revenue | 688 | 625 | 886 | 1,987 | ||||
Operating expenses: | ||||||||
Research and development | 17,386 | 15,373 | 31,162 | 32,351 | ||||
General and administrative | 12,062 | 7,675 | 17,290 | 16,500 | ||||
Acquired in-process research and development | 130,486 | — | 130,486 | — | ||||
Total operating expenses | 159,934 | 23,048 | 178,938 | 48,851 | ||||
Loss from operations | (159,246) | (22,423) | (178,052) | (46,864) | ||||
Other income (expense): | ||||||||
Interest income | 350 | 104 | 770 | 139 | ||||
Change in fair value of forward contract liability | (58,170) | — | (58,170) | — | ||||
Other income (expense), net | (8) | 5 | (80) | 1 | ||||
Total other (expense) income | (57,828) | 109 | (57,480) | 140 | ||||
Loss before income tax expense | (217,074) | (22,314) | (235,532) | (46,724) | ||||
Income tax (expense) benefit | (7) | (9) | 29 | (35) | ||||
Net loss | $ (217,081) | $ (22,323) | $ (235,503) | $ (46,759) | ||||
Net loss per share, basic and diluted | $ (2.27) | $ (0.27) | $ (2.48) | $ (0.63) | ||||
Weighted-average common shares outstanding, basic and diluted | 95,565,118 | 82,209,032 | 94,917,487 | 73,650,146 |
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SOURCE Aeglea BioTherapeutics, Inc.
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