| Item 2.02 | Results of Operation and Financial Condition. |
On June 5, 2023, Akero Therapeutics, Inc. (the “Company”) provided an update regarding the amount of cash, cash equivalents and short-term marketable securities it had on hand as of June 2, 2023. Although the Company has not finalized its financial results for such period, the Company currently anticipates that its cash, cash equivalents and short-term marketable securities were approximately $660 million as of June 2, 2023. This information is unaudited and does not present all information necessary for an understanding of the Company’s financial condition as of June 2, 2023.
| Item 7.01. | Regulation FD Disclosure. |
On June 5, 2023, the Company issued a press release titled “Akero Therapeutics’ Phase 2b SYMMETRY Cohort D Study Met Safety & Tolerability Endpoints and Showed Adding EFX to GLP-1 Therapy Significantly Improved Non-Invasive Markers of NASH-Related Disease.” A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The Company from time to time presents and/or distributes to the investment community slide presentations to provide updates and summaries of its business. A copy of its corporate slide presentation is being furnished herewith as Exhibit 99.2 to this Current Report on Form 8-K. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.2.
The information under this Item 7.01, including Exhibit 99.1 and Exhibit 99.2 hereto, is being furnished herewith and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
On June 5, 2023, the Company released topline data from an expansion cohort (N=31) of the Phase 2b SYMMETRY study known as Cohort D. The primary aim of the 12-week study was to assess safety and tolerability of its lead product candidate, efruxifermin (“EFX”), compared to placebo when added to an existing GLP-1 receptor agonist (“GLP-1”) in patients with Type 2 diabetes (“T2D”) and F1-F3 liver fibrosis due to non-alcoholic steatohepatitis (“NASH”).
EFX was reported to be generally well tolerated in Cohort D with comparable results for the EFX (N=21) and placebo (N=10) groups. The overall tolerability profile was similar to that observed in the Company’s BALANCED and HARMONY studies. The most frequent adverse events for EFX-treated patients were grade 1 or 2 gastrointestinal events (diarrhea, nausea, and increased appetite). One patient treated with EFX discontinued due to nausea and one EFX-treated patient discontinued after withdrawing consent. There were no drug-related serious adverse events. Cohort D also met all key secondary endpoints, including relative reduction of liver fat and proportion of patients whose absolute liver fat level normalized to 5 percent or less.
On June 5, 2023, the Company also announced that it has cash, cash equivalents and short-term marketable securities sufficient to fund its current operating plan into 2026.
Forward-Looking Statements
This Current Report on Form 8-K and certain materials furnished or filed herewith contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding: the Company’s business plans and objectives, including future plans or expectations for EFX, the therapeutic effects and clinical benefits of EFX, as well as the dosing, safety and tolerability of EFX; and expectations regarding its uses of capital, expenses and financial results, including the expected cash runway.
