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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Akero Therapeutics Inc | NASDAQ:AKRO | 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% | 18.82 | 18.35 | 20.99 | 0 | 01:00:00 |
"We continued to make significant advancements in the clinical development of EFX during the first quarter of this year," said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero. "The increased improvements in fibrosis stage observed from weeks 24 to 96 in the Phase 2b HARMONY study in patients with pre-cirrhotic MASH (F2-F3) showed EFX's potential to result in higher rates of fibrosis improvement after longer treatment. With over $900 million in cash, cash equivalents, and short term marketable securities following a March 2024 equity offering, we are well-positioned to progress our Phase 3 SYNCHRONY program through primary endpoint readout for our two studies in patients with pre-cirrhotic MASH and fund Akero’s current operating plan into the second half of 2027."
Phase 2b HARMONY Study Week 96 Analysis
Phase 2b SYMMETRY Study
Phase 3 SYNCHRONY Program
Public Offering of Common Stock
First Quarter 2024 Financial Results
About EfruxiferminEfruxifermin (EFX), Akero’s lead product candidate for MASH, is a differentiated Fc-FGF21 fusion protein that has been engineered to mimic the balanced biological activity profile of native FGF21, an endogenous hormone that alleviates cellular stress and regulates metabolism throughout the body. EFX appears to reduce liver fat and inflammation, reverse fibrosis, increase insulin sensitivity and improve lipids. This holistic approach offers the potential to address the complex, multi-system disease state of MASH, including improvements in lipoprotein risk factors linked to cardiovascular disease – the leading cause of death in MASH patients. EFX is designed to offer convenient once-weekly dosing and has been generally well tolerated in clinical trials to date.
About MASHMASH is a serious form of MASLD that is estimated to affect more than 17 million Americans. MASH is characterized by an excessive accumulation of fat in the liver that causes stress and injury to liver cells, leading to inflammation and fibrosis, which can progress to cirrhosis, liver failure, cancer and eventually death. MASH is the fastest growing cause of liver transplants and liver cancer in the US and Europe.
About Akero TherapeuticsAkero Therapeutics is a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, including MASH. Akero's lead product candidate, EFX, is currently being evaluated in the ongoing SYMMETRY study, a 96-week Phase 2b clinical trial in patients with compensated cirrhosis due to MASH (F4 fibrosis), as well as two ongoing Phase 3 clinical trials: the SYNCHRONY Histology study in patients with pre-cirrhotic MASH (F2-F3 fibrosis) and the SYNCHRONY Real-World study in patients with MASH (F1-F3 fibrosis) or MASLD. A third clinical trial, the SYNCHRONY Outcomes study in patients with compensated cirrhosis due to MASH (F4 fibrosis), is expected to be initiated in the second quarter of 2024. The Phase 3 SYNCHRONY program builds on the results of two Phase 2b clinical trials, the HARMONY study in patients with pre-cirrhotic MASH (F2-F3) and the SYMMETRY study in patients with compensated cirrhosis due to MASH (F4). Akero is headquartered in South San Francisco. Visit us at akerotx.com and follow us on LinkedIn and X for more information.
Forward Looking StatementsStatements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements, including, but not limited to, statements regarding Akero’s business plans and objectives, including future plans or expectations for EFX and clinical trial design; the therapeutic effects of EFX; the timing and initiation of Akero’s Phase 3 SYNCHRONY program; upcoming milestones, including week 96 results of the Phase 2b SYMMETRY study; the anticipated benefits and optimization of the LyoJect 3S dual chamber syringe; and Akero’s growth as a company and expectations regarding its uses of capital, expenses, and financial results, including the expected cash runway. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of Akero’s product candidate development activities and planned clinical trials; Akero’s ability to execute on its strategy; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; regulatory developments in the United States and foreign countries; Akero’s ability to fund operations; as well as those risks and uncertainties set forth more fully under the caption "Risk Factors" in Akero’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, as filed with the Securities and Exchange Commission (SEC) as well as discussions of potential risks, uncertainties and other important factors in Akero’s other filings and reports with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Akero undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Investor Contact:Christina Tartaglia212.362.1200IR@akerotx.com
Media Contact:Sarah O’Connell732.456.0092soconnell@vergescientific.com
Akero Therapeutics, Inc. | ||||||||
Condensed Consolidated Balance Sheets | ||||||||
(Unaudited) | ||||||||
(In thousands) | ||||||||
March 31, 2024 | December 31, 2023 | |||||||
Assets | ||||||||
Cash, cash equivalents and short-term marketable securities | $ | 903,665 | $ | 550,010 | ||||
Other current assets | 7,615 | 9,952 | ||||||
Non-current assets | 963 | 20,309 | ||||||
Total assets | $ | 912,243 | $ | 580,271 | ||||
Liabilities and Stockholders’ Equity | ||||||||
Current liabilities | $ | 30,259 | $ | 19,128 | ||||
Non-current liabilities | 35,731 | 25,837 | ||||||
Stockholders’ equity | 846,253 | 535,306 | ||||||
Total liabilities and stockholders’ equity | $ | 912,243 | $ | 580,271 | ||||
Akero Therapeutics, Inc. | ||||||||
Condensed Consolidated Statements of Operations and Comprehensive Loss | ||||||||
(Unaudited) | ||||||||
(In thousands, except share and per share amounts) | ||||||||
Three Months Ended March31, | ||||||||
2024 | 2023 | |||||||
Operating expenses: | ||||||||
Research and development | $ | 50,650 | $ | 21,787 | ||||
General and administrative | 9,304 | 6,966 | ||||||
Total operating expenses | 59,954 | 28,753 | ||||||
Loss from operations | (59,954 | ) | (28,753 | ) | ||||
Interest expense | (991 | ) | (457 | ) | ||||
Interest and other income, net | 7,601 | 3,379 | ||||||
Net loss | $ | (53,344 | ) | $ | (25,831 | ) | ||
Comprehensive loss | $ | (53,693 | ) | $ | (25,847 | ) | ||
Net loss per common share, basic and diluted | $ | (0.90 | ) | $ | (0.55 | ) | ||
Weighted-average number of shares used in computing net loss per common share, basic and diluted | 59,307,759 | 46,944,059 | ||||||
1 Year Akero Therapeutics Chart |
1 Month Akero Therapeutics Chart |
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