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Akili, Inc. (Nasdaq: AKLI) is a pioneering digital medicine company focused on developing innovative cognitive treatments through advanced technology. Akili leverages video game experiences to create clinically-validated digital therapeutics aimed at improving attention and cognitive function. Their flagship products, EndeavorRx and EndeavorOTC, target ADHD in children and adults respectively. These treatments are grounded in rigorous scientific research and have shown significant efficacy in clinical trials.
In recent developments, Akili reported a significant revenue increase in the third quarter of 2023, with total revenues reaching $702 thousand, a 5x growth from the previous quarter. Notably, Akili has shifted its business strategy to focus on non-prescription models, simplifying access to its treatments. The company recently submitted EndeavorOTC to the FDA for authorization as an over-the-counter treatment for adult ADHD. Additionally, Akili has partnered with Shionogi for the Japanese market, where the Phase 3 study for pediatric ADHD is underway.
Financially, Akili ended the third quarter with a robust cash position of $86.3 million. Despite operating expenses, the company maintains a positive gross margin of approximately 60%. CEO Matt Franklin expressed optimism about achieving profitability through these strategic shifts and ongoing regulatory advancements.
Akili's commitment to innovation extends beyond ADHD. The company is exploring broader applications of its technologies, aiming to transform digital therapeutics into a mainstream treatment modality. With a dedication to rigorous clinical validation and user engagement, Akili stands at the forefront of the digital medicine revolution.
Virtual Therapeutics announced the successful completion of its tender offer to acquire all outstanding shares of Akili Interactive for $0.4340 per share. The offer, initiated on June 3, 2024, expired on July 1, 2024, with 88.2% of Akili's shares validly tendered. This acquisition leads to Akili becoming a wholly owned subsidiary of Virtual Therapeutics, with the merger to be finalized on July 2, 2024. Consequently, Akili's shares will cease trading on Nasdaq and will be delisted. This acquisition aims to expand Virtual Therapeutics' capabilities in digital mental health services.
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.
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