Form 8-K - Current report
29 February 2024 - 11:15PM
Edgar (US Regulatory)
false 0001744659 0001744659 2024-02-29 2024-02-29
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 29, 2024
Akero Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
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001-38944 |
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81-5266573 |
(State or other jurisdiction of incorporation) |
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(Commission File Number) |
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(I.R.S. Employer Identification No.) |
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601 Gateway Boulevard, Suite 350 South San Francisco, CA |
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94080 |
(Address of principal executive offices) |
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(Zip Code) |
Registrant’s telephone number, including area code (650) 487-6488
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
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Trading symbol(s) |
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Name of each exchange on which registered |
Common Stock, par value $0.0001 per share |
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AKRO |
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The Nasdaq Global Select Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 |
Results of Operations and Financial Condition |
On February 29, 2024, Akero Therapeutics, Inc. (the “Company”) announced its financial results for the quarter and full year ended December 31, 2023. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Current Report on Form 8-K and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 |
Financial Statements and Exhibits. |
(d) Exhibits
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Date: February 29, 2024 |
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AKERO THERAPEUTICS, INC. |
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By: |
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/s/ Andrew Cheng |
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Name: Title: |
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Andrew Cheng, M.D., Ph.D. President and Chief Executive Officer |
Exhibit 99.1
Akero Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business
Update
SOUTH SAN FRANCISCO, Calif., Feb. 29, 2024 Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing
transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today reported fourth quarter and full year financial results for the period ending December 31, 2023.
We concluded 2023 by dosing the first patients in our two Phase 3 SYNCHRONY studies evaluating EFX in the treatment of patients with pre-cirrhotic MASH, said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero. In the first half of 2024, we look forward to reporting results from the second on-treatment biopsy in our 96-week Phase 2b HARMONY study in patients with pre-cirrhotic MASH and initiating our third Phase 3
SYNCHRONY study in patients with cirrhosis due to MASH.
Phase 3 SYNCHRONY Program Update
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In December 2023 the first patients were enrolled in two of three planned clinical trials comprising the Phase 3
SYNCHRONY program. |
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SYNCHRONY Histology is evaluating the safety and efficacy of 28 and 50mg doses of efruxifermin (EFX) in
patients with biopsy confirmed pre-cirrhotic MASH (F2-F3). The primary endpoint, ≥1-stage fibrosis improvement and
resolution of MASH after 52 weeks, is designed to support an application for accelerated approval for pre-cirrhotic MASH. Additional patients will be enrolled and followed for long-term clinical outcomes to
support an application for full marketing approval. |
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SYNCHRONY Real-World is assessing the safety and tolerability of EFX in patients with non-invasively diagnosed MASH or metabolic dysfunction-associated steatotic liver disease (MASLD). Results will support evaluation of safety for inclusion in an application for accelerated approval.
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SYNCHRONY Outcomes, which is expected to be initiated in the first half of 2024, will evaluate the safety
and efficacy of EFX in patients with compensated cirrhosis (F4) due to MASH. Consistent with feedback from the FDA in a recent Type B meeting, the trial is likely to include two primary endpoints: (1) evaluation of histology from a cohort of
patients who will be biopsied after 96 weeks of treatment to assess the extent of regression of hepatic fibrosis and (2) assessment of clinical outcomes to support an application for full marketing approval. |
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In all EFX Phase 3 studies, patients will self-administer EFX using the LyoJect 3S dual chamber syringe, a pre-filled device intended for commercial use in the event EFX is approved for marketing. This optimized formulation delivers blood levels of EFX comparable to those of the liquid formulation used in prior clinical
studies. |
Phase 2b SYMMETRY Week 36 Results and Study Update
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In the fourth quarter of 2023, Akero reported results for the week 36 analysis of the Phase 2b SYMMETRY study in
patients with cirrhosis due to MASH. |
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A trend, which was not statistically significant, was observed for the primary endpoint, with 22% and 24% of the
28mg and 50mg EFX-treated groups, respectively, experiencing at least a one-stage improvement in liver fibrosis and no worsening of MASH, compared with 14% for placebo.
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Statistically significant rates of MASH resolution in 67% and 60% of patients at week 36 were observed for the
28mg and 50mg EFX-treated groups, respectively, compared with 26% for placebo. |
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Statistically significant improvements were also observed for both EFX groups in
non-invasive markers of liver injury and fibrosis, insulin sensitization and lipoproteins. |
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EFX was reported to be generally well-tolerated. Overall, the most frequent adverse events were transient,
gastrointestinal grade 1 or 2 events. |
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Preliminary, topline results for histopathology and noninvasive measurements after 96 weeks of treatment in the
SYMMETRY study are expected to be reported in the first quarter of 2025. |
Full Year and Fourth Quarter 2023 Financial Results
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Akeros cash, cash equivalents, short-term and long-term marketable securities for the year ended
December 31, 2023 were $569.3 million. |
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Akero believes that its cash, cash equivalents, short-term and long-term marketable securities will be sufficient
to fund its current operating plan into 2026. |
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Research and development expenses for the three-month and twelve-month periods ended December 31, 2023 were
$53.4 million and $141.8 million, respectively, compared to $18.3 million and $85.3 million for the comparable periods in 2022. These increases are attributable to higher expenses associated with the ongoing Phase 2b HARMONY and
SYMMETRY studies, initiation of the Phase 3 SYNCHRONY Histology and SYNCHRONY Real-World studies, manufacturing required to support Phase 3 and potential marketing applications, as well as higher expenses for personnel. |
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General and administrative expenses for the three-month and twelve-month periods ended December 31, 2023
were $8.5 million and $31.1 million, respectively, compared to $7.1 million and $29.9 million for the comparable periods in 2022. These increases are attributable to higher expenses for personnel, and professional services and
other costs associated with operating as a public company. |
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Total operating expenses were $61.9 million and $172.9 million for the three-month and twelve-month
periods ended December 31, 2023, respectively, compared to $25.4 million and $115.2 million for the comparable periods in 2022. |
About Efruxifermin
Efruxifermin (EFX), Akeros 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 is designed 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 MASH
MASH is a serious form of MASLD that is projected to affect over 25 million Americans by 2030. 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. Approximately 20% of patients with MASH will progress to cirrhosis, which
has a higher risk of mortality. There are no approved treatments for the condition and MASH is the fastest growing cause of liver transplants and liver cancer in the US and Europe.
About Akero Therapeutics
Akero
Therapeutics is a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, including MASH, a disease without any approved therapies. Akeros lead product
candidate, EFX, is currently being evaluated in 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 or MASLD. A third clinical trial, the SYNCHRONY
Outcomes study in patients with cirrhosis due to MASH, is expected to be initiated in the first half 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 and the SYMMETRY study in patients with cirrhosis due to MASH. Akero is headquartered in South San Francisco. Visit us at akerotx.com and follow us on LinkedIn and
Twitter 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 Akeros upcoming milestones, including the expected timing to report the week 96 results of Akeros Phase 2b HARMONY and SYMMETRY studies; Akeros business plans and objectives; the potential
therapeutic effects of EFX, as well as the dosing, safety and tolerability of EFX; the SYNCHRONY Phase 3 program, including the design and enrollment of the SYNCHRONY Histology, SYNCHRONY Real-World, and SYNCHRONY Outcomes
studies; and plans related to use of a new formulation designed for self-administration in Phase 3 clinical trials. Any forward-looking statements in this press release are based on managements 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 Akeros product candidate development activities and planned clinical trials; Akeros ability to execute on its strategy; positive results from any of its clinical
studies may not necessarily be predictive of the results of future or ongoing clinical studies; regulatory developments in the United States and foreign countries; Akeros ability to fund operations; Akeros ability to fully enroll
patients in its SYNCHRONY Phase 3 studies including the SYNCHRONY Histology, SYNCHRONY Real-World, and SYNCHRONY Outcomes studies; as well as those risks and uncertainties set forth more fully under the caption Risk
Factors in Akeros 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 Akeros 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:
Sarah OConnell
732.456.0092
sarah.oconnell@vergescientific.com
Akero Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands)
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December 31, 2023 |
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December 31, 2022 |
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Assets |
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Cash, cash equivalents and short-term marketable securities |
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$ |
550,010 |
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$ |
351,449 |
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Other current assets |
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9,952 |
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3,724 |
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Non-current assets |
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20,309 |
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1,397 |
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Total assets |
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$ |
580,271 |
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$ |
356,570 |
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Liabilities and Stockholders Equity |
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Current liabilities |
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$ |
19,128 |
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$ |
19,083 |
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Non-current liabilities |
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25,837 |
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10,925 |
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Stockholders equity |
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535,306 |
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326,562 |
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Total liabilities and stockholders equity |
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$ |
580,271 |
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$ |
356,570 |
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Akero Therapeutics, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(In thousands, except
share and per share amounts)
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Three Months Ended December 31, |
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Year Ended December 31, |
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2023 |
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2022 |
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2023 |
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2022 |
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Operating expenses: |
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Research and development |
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$ |
53,392 |
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$ |
18,320 |
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$ |
141,798 |
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$ |
85,284 |
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General and administrative |
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8,481 |
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7,100 |
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31,072 |
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29,872 |
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Total operating expenses |
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61,873 |
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25,420 |
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172,870 |
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115,156 |
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Loss from operations |
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(61,873 |
) |
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(25,420 |
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(172,870 |
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(115,156 |
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Interest expense |
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(897 |
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(362 |
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(3,099 |
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(739 |
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Interest and other income, net |
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7,584 |
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2,723 |
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24,210 |
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3,862 |
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Net loss |
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$ |
(55,186 |
) |
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$ |
(23,059 |
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$ |
(151,759 |
) |
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$ |
(112,033 |
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Comprehensive loss |
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$ |
(54,410 |
) |
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$ |
(23,022 |
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$ |
(151,526 |
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$ |
(111,969 |
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Net loss per common share, basic and diluted |
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$ |
(0.99 |
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$ |
(0.49 |
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$ |
(2.89 |
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$ |
(2.87 |
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Weighted-average number of shares used in computing net loss per common share, basic and
diluted |
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55,717,726 |
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46,760,783 |
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52,568,159 |
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38,984,772 |
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Akero Therapeutics (NASDAQ:AKRO)
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From Jun 2024 to Jul 2024
Akero Therapeutics (NASDAQ:AKRO)
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From Jul 2023 to Jul 2024