Item 2.05 Costs Associated with Exit or Disposal Activities.
On
In addition, the operating plan includes a pipeline reprioritization of the Company's preclinical and clinical development programs and further prioritization of the Company's resources on its commercial organization and efforts.
Item 7.01 Regulation FD Disclosure.
2023 Non-GAAP Total Operating Expense Guidance
The Company expects 2023 non-GAAP total operating expenses of between
The information contained in this Item 7.01 is being furnished and shall not be deemed "filed" for 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 it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
About Non-GAAP Financial Measures
This Current Report on Form 8-K includes the following non-GAAP financial
measure: non-GAAP total operating expenses on a projected basis. The Company
derives this non-GAAP financial measure by excluding certain expenses and other
items from the GAAP financial measure that is most directly comparable to
the non-GAAP financial measure. Specifically, the projected non-GAAP total
operating expenses financial measure excludes stock-based compensation expense.
The Company's management believes that this non-GAAP financial measure is useful
to both management and investors in analyzing its ongoing business and operating
performance. Management does not intend the presentation of
this non-GAAP financial measure to be considered in isolation or as a substitute
for results prepared in accordance with GAAP, but as a complement to provide
greater transparency. In addition, this non-GAAP financial measure may differ
from similarly named measures used by other companies. A quantitative
reconciliation of projected non-GAAP total operating expenses to projected GAAP
operating expenses is not available, nor is the probable significance of such
reconciling information, due to
Item 8.01 Other Information.
On
In addition, the Company is providing the below business updates to its previously-disclosed pipeline programs and cash runway.
Pipeline and Business Updates
As shown in the updated pipeline chart included below, there are several updates to the Company's pipeline as part of the Company's recently approved 2023 operating plan, and these updates are briefly summarized below.
[[Image Removed: LOGO]] • Pivotal Trial of EndeavorRx (AKL-T01) in Adolescents Ages 13-17 with ADHD (listed above in the pipeline chart as "Pediatric ADHD 13-17 y/o (U.S. )"): As disclosed onJanuary 5, 2023 , the Company announced topline results of this STARS-ADHD-Adolescents label expansion trial evaluating the efficacy and safety of EndeavorRx (AKL-T01) in adolescents ages 13-17 with attention-deficit/hyperactivity disorder (ADHD),
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with the trial meeting its primary endpoint and showing statistically-significant improvement in a number of other symptom outcomes. In addition, the Company announced that it plans to use this study data in its regulatory submission to the FDA in 2023 to seek an expanded label for EndeavorRx and plans to present full data from this study at a future medical meeting. • Pivotal Trial of EndeavorRx (AKL-T01) in Adults Ages 18+ with ADHD (listed above in the pipeline chart as "Adult ADHD 18+ y/o (U.S. )"): As previously disclosed during the Company's earnings call onNovember 10, 2022 , the Company had announced that enrollment of patients in the pivotal trial of EndeavorRx (AKL-T01) in adults with ADHD had been progressing more slowly than anticipated and that it was evaluating potential adjustments. As disclosed onJanuary 5, 2023 , based on the clinical data from the pivotal trial in adolescents and the Company's desire to maximize capital efficiency, the Company has stopped recruitment of this adult study with 224 patients enrolled in order to analyze the trial data ahead of schedule. • Indications beyond ADHD. The Company has development programs using the Selective Stimulus Management Engine (SSME™) technology to address attention/cognitive functioning beyond ADHD, as shown in the above pipeline chart. The Company previously stated that it would not be allocating funds to progress these programs beyond the stated milestones at the current time. For the indications with published clinical study data (Autism Spectrum Disorder (ASD), Multiple Sclerosis (MS), and Major Depressive Disorder (MDD)), the Company held the ASD FDA Q-Sub meeting inOctober 2022 , but no longer intends to hold similar individual Q-Sub meetings for MS and MDD, in order to conserve capital and focus. Similarly, the cognitive monitoring program, which had previously been slated for initiation of a trial in 2023 or beyond, will not be directly funded in the current operating plan. However, the Company will continue investigator-initiated research in these above and related indications and programs outside of ADHD and is assessing various potential ways to efficiently progress indications and programs outside of the core operating plan, including via partnering. Finally, the two COVID Fog trials of the Company's technology being conducted by outside academic research institutions are still slated to be analyzed in, and the Company expects to be able to share topline data in, the first half of 2023.
Cash Runway Update
The Company now expects to be able to fund its operating expenses and capital expenditure requirements into the first quarter of 2025.
The Company's estimates in this Item 8.01 of its ability to fund operations and capital expenditures and above in Item 7.01 of its projected non-GAAP total operating expenses are preliminary and unaudited, represent management estimates as of the date of this Current Report on Form 8-K and are subject to completion of and confirmation through the Company's future financial closing procedures. As a result, the Company's actual financial results may differ materially from the preliminary estimated financial information set forth above.
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Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
No. Description of Exhibit 99.1Akili, Inc. Chief Executive Officer Email to Employees,January 12, 2023 104 Cover Page Interactive Data File (embedded within the Inline XBRL document).
Forward-Looking Statements
This Current Report on Form 8-K and the accompanying exhibit contain
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995, as amended. These forward-looking statements
generally are identified by the words "believe," "project," "expect,"
"anticipate," "estimate," "intend," "strategy," "future," "opportunity," "plan,"
"may," "should," "will," "would," "will be," "will continue," "will likely
result," and similar expressions. Forward-looking statements are predictions,
projections and other statements about future events that are based on current
expectations and assumptions and, as a result, are subject to risks and
uncertainties. These forward-looking statements include, without limitation,
statements in this Current Report on Form 8-K and the accompanying exhibit
related to: the Company's 2023 budget and operating plan and related workforce
reduction; the Company's vision for EndeavorRx and plans to further prioritize
resources on its commercial organization and commercialization efforts; updates
to the Company's plans for its pipeline of digital therapeutics products and
product candidates in ADHD and other indications and patient populations; the
Company's expectation that its existing cash, cash equivalents, and short-term
investments will be sufficient to fund the Company's operating expenses and
capital expenditure requirements into the first quarter of 2025; and the
Company's projections for 2023 non-GAAP total operating expenses. Any
forward-looking statements in this press release are based on management's
current expectations and beliefs and are subject to a number of risks,
uncertainties and important factors that may cause actual events or results to
differ materially from those expressed or implied by any forward-looking
statements contained in this press release, including, without limitation, risks
and uncertainties related to: the Company's ability to successfully further
commercialize EndeavorRx; the Company's ability to successfully create, and
navigate, a new category of medicine and to achieve broad adoption of digital
therapeutics among healthcare providers, caregivers, and patients; the Company's
ability to obtain and maintain adequate coverage and reimbursement for its
digital therapeutics; the Company's ability to continue to advance its clinical
development pipeline; the Company's ability to defend its intellectual property
and satisfy various FDA and other regulatory requirements in and outside of
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