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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Aeglea BioTherapeutics Inc | NASDAQ:AGLE | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 12.01 | 11.20 | 14.00 | 0 | 01:00:00 |
“Despite the operating challenges posed by the global pandemic, we continued to advance our pegzilarginase program in the first half of the year. The presentation of long-term data showing sustained lowering of arginine levels and durable clinical response with pegzilarginase treatment, as well as progress in our patient identification efforts, reinforce our belief in its potential as a life-changing therapy for those with Arginase 1 Deficiency and lay a strong foundation for the commercial launch of pegzilarginase,” said Anthony Quinn, M.B Ch.B, Ph.D., president and chief executive officer of Aeglea. “Additionally, we initiated our Phase 1/2 clinical trial of ACN00177 for Homocystinuria in the second quarter. We are continuing our patient identification activities and look forward to dosing the first patient once the clinical sites are able to begin screening patients.”
Recent Highlights and UpdatesPegzilarginase in Arginase 1 Deficiency
ACN00177 in Homocystinuria
Corporate
“Ravi has been a valued and impactful member of the Aeglea team. While we are disappointed by his planned departure, we wish him the best as he returns to his roots in immunology research and development,” said Dr. Quinn. “I look forward to working more closely with Eric as we continue to strengthen our capabilities and advance pegzilarginase towards potential approval and launch.”
Upcoming EventsAeglea will be attending the following virtual investor conferences in the coming quarter.
Further, Aeglea’s leadership looks forward to participating in dialogue about the Company’s enzyme therapeutics platform during the following industry events, with additional details to be announced.
Second Quarter 2020 Financial Results
As of June 30, 2020, Aeglea had available cash, cash equivalents, marketable securities and restricted cash of $159.2 million. Based on Aeglea’s current operating plans, management believes it has sufficient capital resources to fund anticipated operations through 2022.
Research and development expenses totaled $16.9 million for the second quarter of 2020 and $14.8 million for the second quarter of 2019. The increase was primarily associated with investing in manufacturing and pre-commercial activities for Aeglea’s lead product candidate, pegzilarginase; ramp-up in manufacturing activities for ACN00177 in Homocystinuria; and personnel-related expenses offset by decreasing clinical development expenses as a result of completing a Phase 1/2 clinical trial in patients with Arginase 1 Deficiency and closing out cancer trials.
General and administrative expenses totaled $4.7 million for the second quarter of 2020 and $3.8 million for the second quarter of 2019. This increase was primarily due to additional employee headcount, ramping up commercial capabilities, and additional facilities to support company growth.
Net loss totaled $21.4 million and $18.0 million for the second quarter of 2020 and 2019, respectively, with non-cash stock compensation expense of $1.6 million and $1.2 million for the second quarter of 2020 and 2019, respectively.
About Pegzilarginase in Arginase 1 Deficiency
Pegzilarginase is an enhanced human arginase that enzymatically lowers levels of the amino acid arginine. Aeglea is developing pegzilarginase for the treatment of patients with Arginase 1 Deficiency (ARG1-D), a rare debilitating, progressive disease presenting in childhood with persistent hyperargininemia, spasticity, developmental delay, intellectual disability, seizures and early mortality. Pegzilarginase is intended for use as an enzyme therapy to reduce elevated blood arginine levels in patients with ARG1-D. Aeglea’s Phase 1/2 and Phase 2 open-label extension data for pegzilarginase in patients with ARG1-D demonstrated clinical improvements and sustained lowering of plasma arginine. The Company’s single, global pivotal Phase 3 PEACE trial is designed to assess the effects of treatment with pegzilarginase versus placebo over 24 weeks with a primary endpoint of plasma arginine reduction.
About ACN00177 in Homocystinuria Aeglea is developing ACN00177 for the treatment of patients with cystathionine beta synthase (CBS) deficiency, also known as Classical Homocystinuria. Homocysteine accumulation plays a key role in multiple progressive and serious disease-related complications, including thromboembolic vascular events, skeletal abnormalities including severe osteoporosis, developmental delay, intellectual disability, lens dislocation and severe near-sightedness. ACN00177 has been designed as a novel recombinant human enzyme, which degrades the amino acid homocysteine and its related homocystine dimer. With this mechanism, ACN00177 is intended to lower the abnormally high blood levels of homocysteine in patients with Homocystinuria. Preclinical data demonstrated that ACN00177 improved important disease-related abnormalities and survival in a mouse model of Homocystinuria. The Company initiated a Phase 1/2 trial in the second quarter of 2020 and continues patient identification and administrative activities. The timing of first patient dosing in this Phase 1/2 trial will depend on determinations by individual sites as they adjust to impacts from COVID-19.
About Aeglea BioTherapeuticsAeglea BioTherapeutics is a clinical-stage biotechnology company redefining the potential of human enzyme therapeutics to benefit people with rare and other high burden diseases. Aeglea's lead product candidate, pegzilarginase, is in a pivotal Phase 3 trial for the treatment of Arginase 1 Deficiency and has received both Rare Pediatric Disease and Breakthrough Therapy Designation. The Company initiated a Phase 1/2 clinical trial of ACN00177 for the treatment of Homocystinuria in the second quarter of 2020. Aeglea has an active discovery platform, with the most advanced program for Cystinuria. For more information, please visit http://aegleabio.com. Safe Harbor / Forward Looking Statements This press release 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 we expect. Examples of forward-looking statements include, among others, statements we make regarding our cash forecasts, the timing and success of our 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 our clinical trials and related data, our ability to enroll patients into our clinical trials, the expected impact of the COVID-19 pandemic on our operations and clinical trials, success in our collaborations, the potential addressable markets of the our product candidates and the potential therapeutic benefits and economic value of our lead product candidate or other product candidates. Further information on potential risk factors that could affect our business and its financial results are detailed in our most recent Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 filed with the Securities and Exchange Commission (SEC), and other reports as filed with the SEC. We undertake 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.
Media Contact:Kelly Boothe, Ph.D. Director, Corporate Communications Aeglea BioTherapeutics 512.399.5458 media@aegleabio.com
Investor Contact:Joey PerroneSenior Director, Finance & Investor RelationsAeglea BioTherapeuticsinvestors@aegleabio.com
Financials
Aeglea BioTherapeutics, Inc.Condensed Consolidated Balance Sheets(Unaudited)
(In thousands, except share and per share amounts)
June 30, | December 31, | |||||||
2020 | 2019 | |||||||
ASSETS | ||||||||
CURRENT ASSETS | ||||||||
Cash and cash equivalents | $ | 65,713 | $ | 19,253 | ||||
Marketable securities | 92,017 | 52,696 | ||||||
Prepaid expenses and other current assets | 4,136 | 2,556 | ||||||
Total current assets | 161,866 | 74,505 | ||||||
Restricted cash | 1,500 | 1,500 | ||||||
Property and equipment, net | 4,896 | 2,385 | ||||||
Operating lease right-of-use assets | 4,557 | 4,726 | ||||||
Other non-current assets | 92 | 67 | ||||||
TOTAL ASSETS | $ | 172,911 | $ | 83,183 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
CURRENT LIABILITIES | ||||||||
Accounts payable | $ | 4,151 | $ | 3,154 | ||||
Operating lease liabilities | 228 | 351 | ||||||
Accrued and other current liabilities | 11,511 | 14,854 | ||||||
Total current liabilities | 15,890 | 18,359 | ||||||
Non-current operating lease liabilities | 4,695 | 4,712 | ||||||
Other non-current liabilities | 68 | 31 | ||||||
TOTAL LIABILITIES | 20,653 | 23,102 | ||||||
STOCKHOLDERS’ EQUITY | ||||||||
Preferred stock, $0.0001 par value; 10,000,000 shares authorizedas of June 30, 2020 and December 31, 2019; no shares issued andoutstanding as of June 30, 2020 and December 31, 2019 | — | — | ||||||
Common stock, $0.0001 par value; 500,000,000 shares authorized as of June 30, 2020 and December 31, 2019; 44,599,847 shares and 29,084,437 shares issued and outstanding as of June 30, 2020 and December 31, 2019, respectively | 5 | 3 | ||||||
Additional paid-in capital | 387,475 | 255,142 | ||||||
Accumulated other comprehensive income | 39 | 51 | ||||||
Accumulated deficit | (235,261 | ) | (195,115 | ) | ||||
TOTAL STOCKHOLDERS’ EQUITY | 152,258 | 60,081 | ||||||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 172,911 | $ | 83,183 |
Aeglea BioTherapeutics, Inc.Condensed Consolidated Statements of Operations(Unaudited)
(In thousands, except share and per share amounts)
Three Months EndedJune 30, | Six Months EndedJune 30, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | 16,869 | 14,806 | 31,431 | 29,195 | ||||||||||||
General and administrative | 4,691 | 3,816 | 9,151 | 7,084 | ||||||||||||
Total operating expenses | 21,560 | 18,622 | 40,582 | 36,279 | ||||||||||||
Loss from operations | (21,560 | ) | (18,622 | ) | (40,582 | ) | (36,279 | ) | ||||||||
Other income (expense): | ||||||||||||||||
Interest income | 161 | 619 | 461 | 1,126 | ||||||||||||
Other expense, net | (19 | ) | (16 | ) | (25 | ) | (33 | ) | ||||||||
Total other income | 142 | 603 | 436 | 1,093 | ||||||||||||
Net loss | $ | (21,418 | ) | $ | (18,019 | ) | $ | (40,146 | ) | $ | (35,186 | ) | ||||
Net loss per share, basic and diluted | $ | (0.40 | ) | $ | (0.55 | ) | $ | (0.93 | ) | $ | (1.14 | ) | ||||
Weighted-average common shares outstanding, basic and diluted | 52,941,603 | 32,840,357 | 43,019,670 | 30,936,623 |
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1 Month Aeglea BioTherapeutics Chart |
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