SOUTH SAN FRANCISCO, Calif., Aug. 13, 2021 (GLOBE NEWSWIRE) — Akero Therapeutics, Inc. (Nasdaq: AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today reported second quarter financial results for the period ending June 30, 2021.
“Our clinical and manufacturing momentum is a testament to our confidence in efruxifermin (EFX), which has the potential to be among the first investigational NASH therapies approved for treatment of both pre-cirrhotic (F2/F3) and cirrhotic (F4) NASH,” said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero. “We are excited to initiate our second Phase 2b clinical trial in patients with late-stage cirrhotic NASH (F4), who are at increased risk of liver failure and thus have the highest unmet medical need.”
Second Quarter Business Highlights & Company Updates
Second Quarter 2021 Financial Results
About Akero Therapeutics
Akero Therapeutics is a clinical-stage cardio-metabolic company developing transformational treatments for non-alcoholic steatohepatitis (NASH), a disease without any approved therapies. Akero’s investigational drug product candidate, efruxifermin (EFX) 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 is designed to offer convenient once-weekly subcutaneous dosing. The consistency and magnitude of effects observed in clinical studies position EFX to be a potentially best-in-class medicine, if approved, for treatment of NASH. EFX is currently being evaluated in two Phase 2b clinical trials: the HARMONY study in pre-cirrhotic patients with F2/F3 fibrosis and the SYMMETRY study in cirrhotic (F4) patients. Akero is headquartered in South San Francisco. Visit www.akerotx.com for more information.
Forward-Looking Statements
Statements 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, upcoming milestones, and therapeutic effects of EFX, as well as the dosing, safety and tolerability of EFX; Akero’s Phase 2a BALANCED clinical trial, including additional analysis of its data and potential therapeutic benefits; Akero’s Phase 2b HARMONY and SYMMETRY clinical trials; expectations regarding Akero’s use of capital, expenses and other future financial results; and the potential impact of COVID-19 on strategy, future operations, enrollment and clinical trials. 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: risks related to the impact of COVID-19 on Akero’s ongoing and future operations, including potential negative impacts on Akero’s employees, third-parties, manufacturers, supply chain and production as well as on global economies and financial markets; 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, as filed with the Securities and Exchange Commission (SEC) and quarterly reports on Form 10-Q filed with the 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 Tartaglia
212.362.1200
IR@akerotx.com
Media Contact:
650.487.6488
media@akerotx.com
Akero Therapeutics, Inc. | |||||||||||||||
Condensed Consolidated Balance Sheets | |||||||||||||||
(Unaudited) | |||||||||||||||
(In thousands) | |||||||||||||||
June 30, 2021 | December 31, 2020 | ||||||||||||||
Assets | |||||||||||||||
Cash, cash equivalents and short-term marketable securities | $ | 230,028 | $ | 268,387 | |||||||||||
Other current assets | 6,194 | 2,958 | |||||||||||||
Non-current assets | 1,787 | 1,994 | |||||||||||||
Total assets | $ | 238,009 | $ | 273,339 | |||||||||||
Liabilities and Stockholders’ Equity | |||||||||||||||
Current liabilities | $ | 16,459 | $ | 13,111 | |||||||||||
Non-current liabilities | 1,417 | 1,516 | |||||||||||||
Stockholders’ equity | 220,133 | 258,712 | |||||||||||||
Total liabilities and stockholders’ equity | $ | 238,009 | $ | 273,339 | |||||||||||
Akero Therapeutics, Inc. | |||||||||||||||
Condensed Consolidated Statements of Operations and Comprehensive Loss | |||||||||||||||
(Unaudited) | |||||||||||||||
(In thousands, except share and per share amounts) | |||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 23,976 | $ | 13,037 | $ | 34,578 | $ | 21,828 | |||||||
General and administrative | 4,990 | $ | 3,417 | 9,516 | 7,005 | ||||||||||
Total operating expenses | 28,966 | 16,454 | 44,094 | 28,833 | |||||||||||
Loss from operations | (28,966 | ) | (16,454 | ) | (44,094 | ) | (28,833 | ) | |||||||
Other income,net | 33 | 247 | 71 | 740 | |||||||||||
Net loss | $ | (28,933 | ) | $ | (16,207 | ) | $ | (44,023 | ) | $ | (28,093 | ) | |||
Comprehensive loss | $ | (28,940 | ) | $ | (16,162 | ) | $ | (44,029 | ) | $ | (27,997 | ) | |||
Net loss per common share, basic and diluted | $ | (0.83 | ) | $ | (0.57 | ) | $ | (1.27 | ) | $ | (0.98 | ) | |||
Weighted-average number of shares used in computing net loss per common share, basic and diluted | 34,814,631 | 28,602,976 | 34,779,647 | 28,551,227 | |||||||||||
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