Akili, Inc. - AKLI STOCK NEWS

Akili (Nasdaq: AKLI) has received FDA clearance for EndeavorOTC®, a digital therapeutic game designed for adults with ADHD. This approval marks the first over-the-counter digital treatment for ADHD, improving attention function as verified through clinical trials. EndeavorOTC, available on iOS and Android, effectively enhances attention measures in adults with inattentive or combined-type ADHD. In a study of 221 adults, 83% reported better focus, and nearly 73% noted improved quality of life. The treatment is part of Akili's broader range of digital therapeutics, including EndeavorRx® for children and adolescents. Common side effects included minor nausea and headache, but no serious adverse events were recorded.

PureTech Health (Nasdaq: PRTC) announced that its founded entity, Akili Interactive (Nasdaq: AKLI), signed a definitive merger agreement with Virtual Therapeutics. The merger aims to create a leading digital health company focused on mental health solutions using immersive games. Akili shareholders will receive $0.4340 per share, representing a 4% premium to Akili's closing stock price on May 28, 2024, and an 85% premium to the closing price on April 29, 2024. The combined entity will operate as Virtual Therapeutics, with Akili as a wholly owned subsidiary. The merger is expected to close in Q3 2024, subject to certain conditions.

Virtual Therapeutics and Akili announced a definitive merger agreement to form a leading digital health company. Akili shareholders will receive $0.4340 per share, a 4% premium on May 28, 2024 closing price and 85% premium on April 29, 2024, pre-announcement price. Post-merger, the new entity will operate as Virtual Therapeutics with Akili as a wholly owned subsidiary. The merger aims to leverage Virtual Therapeutics' VR-based solutions and Akili's validated digital therapeutics for mental health. The deal, subject to approval and conditions, is expected to close in Q3 2024. Akili's stock will be delisted post-transaction.

Akili (Nasdaq: AKLI) reported Q1 2024 financial results. The company prepaid its debt and terminated its loan agreement with Silicon Valley Bank on May 8, 2024. Following recent restructuring and workforce reductions, Akili's focus is on supporting Shionogi’s regulatory activities and evaluating strategic alternatives. Cash and equivalents were $63.2M as of March 31, 2024, down from $75.2M at the end of 2023. Q1 revenue was $383K, a drop from $749K in Q4 2023. Total operating expenses decreased to $11.1M (GAAP) and $9.8M (non-GAAP) due to reduced advertising spend. Net loss narrowed to $9.8M (GAAP) and $9.3M (non-GAAP). The company will not provide financial guidance amid ongoing strategic evaluations.

Akili, Inc. (Nasdaq: AKLI), a digital medicine company, announced an amended agreement with Shionogi, including cash payments and debt forgiveness, strategic business exploration with workforce reduction, and the release date for first quarter 2024 financial results. Shionogi canceled a $5.0 million debt and will make payments for SDT-001. Akili will receive $10.5 million upfront, up to $4.5 million for development and support services, and up to $3.0 million in potential regulatory milestone payments. The board is exploring strategic alternatives to maximize shareholder value, leading to a revised operating plan and budget for 2024, a 46% reduction in workforce, and a focus on Shionogi’s activities. The Company plans to release financial results on May 14, 2024, and continue marketing authorization efforts for EndeavorOTC.

Akili, Inc. (Nasdaq: AKLI) reports significant revenue growth in FY 2023, with total revenues of $1.7M, a 420% increase over FY 2022. The company's partner, Shionogi, releases positive Phase 3 trial results for SDT-001, submitting it for marketing approval in Japan. Akili lowers FY 2024 non-GAAP total operating expense guidance and reaffirms gross margins guidance. The company ends FY 2023 with $75.2 million in cash and cash equivalents, ensuring cash runway into 2H 2025.

PureTech Health's Japanese partner, Shionogi & Co. Ltd, submits Akili's digital therapeutic SDT-001 for marketing approval in Japan, a localized version of AKL-T01. The Phase 3 clinical trial results show significant improvements in pediatric ADHD patients. Positive outcomes pave the way for potential nationwide marketing approval.

Akili, Inc. (Nasdaq: AKLI) and its Japanese partner, Shionogi & Co. Ltd, have submitted SDT-001 for marketing approval in Japan. SDT-001 is the Japanese version of Akili's AKL-T01, known as EndeavorRx® in the US, the world's first prescription digital therapeutic for pediatric ADHD. The Phase 3 trial in Japan showed significant improvements in ADHD symptoms with no safety concerns.

Akili, Inc. (Nasdaq: AKLI) announced plans to disclose Q4/FY 2023 financial results on February 29, 2024. CEO Matthew Franklin will participate in a fireside chat at TD Cowen’s 44th Annual Healthcare Conference on March 4, 2024. The company appointed John Spinale to the Board of Directors and Audit Committee. Akili also provided updates on the April 17, 2024 Annual Meeting and efforts to regain compliance with Nasdaq rules.