Item 7.01 Regulation FD Disclosure.
On January 13, 2020, Aeglea BioTherapeutics, Inc. (the "Company") issued a press
release announcing it has filed a Clinical Trial Application ("CTA") with the
United Kingdom's Medicines and Healthcare Products Regulatory Agency ("MHRA")
for ACN00177, a novel engineered human enzyme therapy designed to treat
homocystinuria, a serious metabolic disorder that results in elevated levels of
plasma homocysteine.
Additionally, the Company will present at the 38th Annual J.P. Morgan Healthcare
Conference ("J.P. Morgan Conference") in San Francisco, California on January
15, 2019 at 2:30 p.m. Pacific Time. The Company will present an overview of its
strategic focus in developing innovative human enzyme therapeutics with defined
potential to address patients with Arginase 1 Deficiency, Homocystinuria and
Cystinuria. A copy of the press release and corporate presentation are attached
as Exhibits 99.1 and 99.2, respectively, to this Current Report on Form 8-K. The
corporate presentation will also be available on the Company's website in the
Events & Presentations section at www.aegleabio.com.
The information furnished with this report, including Exhibit 99.1, shall not be
deemed "filed" for purposes of Section 18 of the Securities Exchange Act of
1934, as amended ("Exchange Act"), or otherwise subject to the liabilities of
that section, nor shall it be deemed incorporated by reference into any other
filing under the Securities Act of 1933, as amended, or the Exchange Act, except
as expressly set forth by specific reference in such a filing.
Item 8.01 Other Events.
On January 13, 2020, the Company announced it has filed a CTA with the MHRA for
ACN00177, a novel engineered human enzyme therapy designed to treat
homocystinuria, a serious metabolic disorder that results in elevated levels of
plasma homocysteine. The Company expects to initiate a Phase 1/2 trial in the
second quarter of 2020 and provide initial clinical data in the first quarter of
2021.
Additionally, on January 15, 2020, the Company will provide updates on its
strategic focus and new market estimates for Arginase 1 Deficiency based genetic
prevalence methodology, including key geographic distribution, at the J.P.
Morgan Conference. A recent genetic prevalence analysis commissioned by the
Company suggests that the Arginase 1 Deficiency population may exceed 2,500
patients in the global addressable markets, as compared to greater than 1,000
patients as estimated based on scientific literature.
This current report contains "forward-looking" statements within the meaning of
the safe harbor provisions of the U.S. Private Securities Litigation Reform Act
of 1995. Forward-looking statements can be identified by words such as:
"anticipate," "intend," "plan," "goal," "seek," "believe," "project,"
"estimate," "expect," "strategy," "future," "likely," "may," "should," "will"
and similar references to future periods. These statements are subject to
numerous risks and uncertainties that could cause actual results to differ
materially from what the Company expects. Examples of forward-looking statements
include, among others, statements the Company makes regarding its cash
forecasts, the timing and success of its clinical trials and related data, the
timing and expectations for regulatory submissions and approvals, timing and
results of meetings with regulators, the timing of announcements and updates
relating to the Company's clinical trials and related data, its ability to
enroll patients into its clinical trials, success in collaborations, potential
addressable markets of the Company's product candidates and the potential
therapeutic benefits and economic value of the Company's product candidates.
Further information on potential risk factors that could affect our business and
its financial results are detailed in the Company's most recent Quarterly Report
on Form 10-Q for the quarter ended September 30, 2019 filed with the Securities
and Exchange Commission (SEC), and other reports as filed with the SEC. The
Company undertakes no obligation to publicly update any forward-looking
statement, whether written or oral, that may be made from time to time, whether
as a result of new information, future developments or otherwise.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit Number Description
99.1* Press Release
99.2* Corporate Presentation
* Previously filed
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