Ankündigung • Jul 04
Akili, Inc.(NasdaqCM:AKLI) dropped from NASDAQ Composite Index Akili, Inc removed from NASDAQ Composite Index. Ankündigung • Jun 19
Akili Announces FDA Authorization of EndeavorOTC, the First FDA Clearance of a Digital Treatment for Adults with AdHD Through a Video Game Akili, Inc. announced U.S. Food and Drug Administration (FDA) clearance of EndeavorOTC (AKL-T01) as an over-the-counter treatment for adults with attention-deficit/hyperactivity disorder (ADHD). Delivered through an engaging video game experience, EndeavorOTC is indicated to improve attention function as measured by computer-based testing in men and women with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue. EndeavorOTC is Akili's second digital ADHD therapeutic product to receive FDA authorization, and is the only FDA-authorized digital therapeutic for ADHD available without a prescription. EndeavorOTC was reviewed and cleared through FDA's 510(k) pathway. The clinical study supporting EndeavorOTC's FDA clearance involved 221 adults with a verified diagnosis of inattentive or combined the brain who all received AKL-T01 (the investigational name for EndeavorOTC and EndeavorRx) for 6 weeks. Overall, 83% of study participants reported improvement in focus as measured by the TOVA attentional control score. It is not intended to be used as a stand-alone therapeutic and is not a substitution for a child's medication. The most common side effect observed in children in EndeavorRx's clinical trials was a feeling of frustration, as the game can be quite challenging at times. No serious adverse events were associated with its use. EndeavorRx is recommended to be used for approximately 25 minutes a day, 5 days a week, over initially at least 4 consecutive weeks, or as recommended by your child’s health care provider. Ankündigung • May 31
Virtual Therapeutics Corp. entered into an agreement to acquire Akili, Inc. (NasdaqCM:AKLI) for $35 million. Virtual Therapeutics Corp. entered into an agreement to acquire Akili, Inc. (NasdaqCM:AKLI) for $35 million on May 29, 2024. As part of consideration, Virtual Therapeutics will pay $0.4340 per share in cash and Akili surviving the merger as a wholly-owned subsidiary of Virtual Therapeutics. If the merger agreement is terminated under certain circumstances specified in the merger agreement, including in connection with the Akili’s entry into an agreement with respect to a superior proposal, the Akili will be required to pay Virtual Therapeutics a termination fee of $1,050,000. The Akili is also obligated to pay to Virtual Therapeutics a payment up to a maximum of $175,000 if Virtual Therapeutics terminates the merger agreement following the expiration of the Offer as of the-then applicable expiration time of the Offer. Under the Merger Agreement, Virtual Therapeutics is required to commence the Offer as promptly as practicable, and in any event no later than June 3, 2024.
The transaction has been unanimously approved by both of Virtual Therapeutics' and Akili's board of directors. The transaction is subject to the tender of a majority of Akili shares into a tender offer to be launched by Virtual Therapeutics, Consummation of the Offer and Akili having not less than a specified amount of cash-on-hand, depending on the closing time. The transaction is expected to close in third quarter of 2024.
TD Securities (USA) acted as financial advisor and fairness opinion provider and Joshua Zachariah, Tevia Pollard and Sarah Ashfaq of Goodwin Procter LLP acted as legal counsel to Akili. Derek Liu and Piotr Korzynski of Baker & McKenzie LLP acted as legal counsel to Virtual Therapeutics. Ankündigung • Apr 30
Akili, Inc. Plans to Continue to Pursue Marketing Authorization from the U.S. Food and Drug Administration for Its EndeavorOTC Product Akili, Inc. plans to continue to pursue marketing authorization from the U.S. Food and Drug Administration (the “FDA”) of the Company’s EndeavorOTC product, which remains under review, in parallel with exploration of broader strategic options. In conjunction with this restructuring, the Company has substantially reduced promotional activity for its EndeavorRx and EndeavorOTC products, but plans to continue to support current users of its products and make its products available for purchase. EndeavorOTC is a digital therapeutic indicated to improve attention function, ADHD symptoms and quality of life in adults 18 years of age and older with primarily inattentive or combined-type ADHD. EndeavorOTC utilizes the same proprietary technology underlying EndeavorRx, a prescription digital therapeutic indicated to improve attention function in children ages 8 - 17. EndeavorOTC is available under the FDA’s current Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. EndeavorOTC has not been cleared or authorized by the FDA for any indications. It is recommended that patients speak to their health care provider before starting EndeavorOTC treatment. No serious adverse events have been reported in any of our clinical studies. EndeavorRx is a digital therapeutic indicated to improve attention function as measured by computer-based testing in children ages 8-17 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue. Patients who engage with EndeavorRx demonstrate improvements in a digitally assessed measure Test of Variables of Attention (TOVA®) of sustained and selective attention and may not display benefits in typical behavioral symptoms, such as hyperactivity. EndeavorRx should be considered for use as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder. EndeavorRx is available by prescription only. It is not intended to be used as a stand-alone therapeutic and is not a substitution for a child’s medication. The most common side effect observed in children in EndeavorRx’s clinical trials was a feeling of frustration, as the game can be quite challenging at times. No serious adverse events were associated with its use. EndeavorRx is recommended to be used for approximately 25 minutes a day, 5 days a week, over initially at least 4 consecutive weeks, or as recommended by your child’s health care provider. Ankündigung • Apr 24
Akili, Inc. Receives A Letter from the Listing Qualifications Staff of the Nasdaq Stock Market LLC On April 23, 2024, Akili, Inc. (the ‘Company’) received a letter from the Listing Qualifications Staff (the ‘Nasdaq Staff’) of The Nasdaq Stock Market LLC (‘Nasdaq’) notifying the Company that it has been granted an additional 180-day compliance period, or until October 21, 2024 (the ‘Extension Notice’), to regain compliance with Nasdaq's minimum closing bid price rule required by the continued listing requirements of Nasdaq Listing Rule 5550(a)(2) (the ‘Bid Price Requirement’). Nasdaq's determination follows the Company's recent request for such additional compliance period and is based, in part, on the Company's written notice to the Nasdaq Staff of its intention to cure the deficiency during the additional compliance period and if necessary, by effecting a reverse stock split. Previously, on October 24, 2023, the Company received a written notification from Nasdaq notifying the Company that the bid price of the Company's common stock, par value $0.0001 per shares (‘common stock’) had closed below $1.00 per share for 30 consecutive business days and that the Company therefore was not in compliance with the Bid Price Requirement. The Extension Notice has no immediate effect on the listing of the Company's common stock on the Nasdaq Capital Market, which will continue to be listed and traded on the Nasdaq Capital Market subject to the listing rules. To regain compliance, the closing bid price of the Company's common stock must be at least $1.00 per share for a minimum of 10 consecutive business days before October 21, 2024. If the Company does not regain compliance during the additional compliance period, then Nasdaq will notify the Company of its determination to delist the Company's common stock, at which point the Company would have an opportunity to appeal the delisting determination to a hearings panel. There can be no assurance that the Company will be successful in regaining compliance with the Nasdaq listing rules or in maintaining its listing of common stock on the Nasdaq Capital Market. The Company intends to actively monitor the closing bid price of its common stock and will evaluate available options to resolve the deficiency and regain compliance with the Bid Price Requirement. Reported Earnings • Mar 03
Full year 2023 earnings: EPS exceeds analyst expectations while revenues lag behind Full year 2023 results: US$0.76 loss per share (further deteriorated from US$0.64 loss in FY 2022). Net loss: US$59.5m (loss widened 213% from FY 2022). Revenue missed analyst estimates by 9.4%. Earnings per share (EPS) exceeded analyst estimates by 14%. Revenue is forecast to grow 27% p.a. on average during the next 3 years, compared to a 11% growth forecast for the Healthcare Services industry in the US. Ankündigung • Feb 27
Akili Announces Positive Results from Shionogi's Phase 3 Clinical Trial of Localized Version of Akili's Endeavorrx®? for Pediatric Adhd Patients in Japan Akili, Inc. announced that its Japanese partner Shionogi & Co. Ltd. has submitted Akili's digital therapeutic SDT-001 for marketing approval with the Ministry of Health, Labor, and Welfare. SDT-001 is the Japanese, localized version of Akili's AKL-T01 (marketed as EndeavorRx®? in the United States), which has previously been authorized by the U.S. Food and Drug Administration (FDA) as the world's first prescription digital therapeutic for improving attentional functioning in pediatric ADHD patients aged 8 to 17. The submission for marketing approval in Japan is based on the favorable results of the Phase 3 clinical trial conducted by SHIONOGI in the country. The trial aimed to evaluate the efficacy and safety of SDT-001 in 164 pediatric ADHD patients aged 6 to 17 who received conventional treatments such as environmental adjustments and psychosocial therapies. The SDT-001 group, undergoing approximately 25 minutes of treatment once daily for 6 weeks (1 cycle), demonstrated statistically significant improvements in the change from baseline in the attention-Deficit/Hyperactivity Disorder Rating Scale IV (ADHD-RS-IV) Inattention score compared to the control group (continuing conventional treatments) at the 6-week mark (p < 0.05), achieving the primary endpoint of the trial. No safety concerns or serious adverse events related to SDT-001 were observed. Furthermore, symptom improvements were sustained even after two cycles of SDT-001 use, with no safety concerns noted. New Risk • Feb 27
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 32% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risk Share price has been highly volatile over the past 3 months (32% average weekly change). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$47m net loss in 3 years). Revenue is less than US$5m (US$1.0m revenue). Market cap is less than US$100m (US$35.5m market cap). Ankündigung • Dec 22
Akili Receives Non-Compliance Notice from Nasdaq On December 19, 2023, Kenneth Ehlert resigned from his position as a member of the board of directors (the ‘Board’) of Akili, Inc. (the ‘Company’) and as a member of the Audit Committee and Nominating and Corporate Governance Committee of the Board, effective immediately. On December 19, 2023, the Company provided notice to Nasdaq disclosing the Company’s noncompliance with the Nasdaq governance requirements described below. And on December 20, 2023, the Company received a letter from the Nasdaq Listing Qualifications Staff confirming such noncompliance and confirming that Nasdaq will provide the Company with the cure period set forth below in order to regain compliance with these governance requirements. With Mr. Ehlert’s resignation, the Board no longer has a majority of ‘independent directors’ (as defined in Nasdaq Stock Market (‘Nasdaq’) Rule 5605(a)(2)) as required by Nasdaq Rule 5605(b)(1); the Board now has three independent directors and three non-independent directors. In addition, the Audit Committee no longer has three members as required by Nasdaq Rule 5605(c)(2)(A); the Audit Committee now has two members. The foregoing has no immediate effect on the Company’s Nasdaq listing and its common stock will continue to be listed and traded on the Nasdaq Capital Market under the symbol ‘AKLI’ subject to the listing rules. The Company is in the process of reviewing and evaluating potential options to regain compliance with these continued listing requirements noted above in a manner consistent with the cure periods set out in Nasdaq Rule 5605(b)(1)(A) and Nasdaq Rule 5605(c)(4)(B) of the Nasdaq rules. These cure periods provide that the Company will have until the earlier of its next annual meeting of stockholders or December 19, 2024; provided, however, that if the Company’s next annual meeting of stockholders is held before June 17, 2024, then the Company must evidence compliance no later than June 17, 2024. There can be no assurance that the Company will successfully regain compliance with these continued listing requirements within the applicable cure periods. Ankündigung • Dec 21
Akili, Inc. Announces Kenneth Ehlert Resigns as A Member of the Board of Director, Member of the Audit Committee and Nominating and Corporate Governance Committee of the Board On December 19, 2023, Kenneth Ehlert resigned from his position as a member of the board of directors of Akili, Inc. and as a member of the Audit Committee and Nominating and Corporate Governance Committee of the Board, effective immediately. With Mr. Ehlert’s resignation, the Board no longer has a majority of “independent directors” . The Board now has three independent directors and three non-independent directors. Price Target Changed • Dec 19
Price target increased by 25% to US$5.00 Up from US$4.00, the current price target is provided by 1 analyst. New target price is 1,003% above last closing price of US$0.45. Stock is down 56% over the past year. The company is forecast to post a net loss per share of US$0.88 next year compared to a net loss per share of US$0.64 last year. Ankündigung • Dec 18
Akili, Inc. Receives Authorization from the U.S. Food and Drug Administration Akili, Inc. announced that it has received authorization from the U.S. Food and Drug Administration (FDA) to expand the label for EndeavorRx(R) from 8 to 12 year-old patients with primarily inattentive or combined-type ADHD who have a demonstrated attention issue to include older children aged 13 - 17. This increased age range is expected to more than double the number of pediatric patients with ADHD who are now eligible for EndeavorRx -- the only FDA-authorized, game-based digital therapeutic -- with a prescription from a healthcare provider. (Akili also offers a non-prescription product for adults with ADHD, using the same technology, EndeavorOTC(TM). The clinical study on which the FDA's label expansion authorization for EndeavorRx is based involved 162 adolescents with a verified diagnosis of inattentive and combined-type ADHD who all received EndeavorRx for 4 weeks and subsequently demonstrated significant improvements in TOVA-measured attentional control. EndeavorOTC is available under the U.S. Food & Drug Administration's current Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. EndeavorOTC has not been cleared or authorized by the U.S. Food. Food and Drug Administration for any indications. The most common side effect observed in children in EndeavorRx's clinical trials was a feeling of frustration, as the game can be quite challenging at times. Akili's approach of leveraging technologies designed to directly target the brain establishes a new category of medicine -- medicine that is validated through clinical trials like a drug or medical device, but experienced like entertainment. These forward-looking statements include, without limitation, statements in this press release related to: expectations regarding the number of pediatric patients withAD who can now access EndeavorRx and ability to expand the use of EndeavorRx in those patients in connection with the label expansion for EndeavorRx to include adolescents ages 13 to 17 with ADHD; that the adoption and efficacy of Endeavor Rx in patients aged 13 to 17 with ADHD will be similar to younger patients; and that the results of clinical studies are predictive of future clinical trials or results. 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: ability to continue to commercialize EndeavorRx in patients aged 13 to17; ability to obtain regulatory clearance from FDA to convert products to over-the-counter-labeling; ability to successfully create, and navigate, a new category of medicine and to achieve broad adoption of digital therapeutics among customers and healthcare providers; ability to continue to advance clinical development pipeline; ability to defend intellectual property and satisfy various FDA and other regulatory requirements in and outside of the United States; the risk of adverse macroeconomic or political changes and a changing regulatory landscape in the highly competitive industry in which company operate; the timing and results expected from and partners' clinical trials and its reliance on third parties for certain aspects of business; and other risks identified in current filings and any subsequent filings made with the Securities and Exchange Commission. Reported Earnings • Nov 11
Third quarter 2023 earnings: EPS and revenues exceed analyst expectations Third quarter 2023 results: US$0.20 loss per share (down from US$1.38 profit in 3Q 2022). Net loss: US$15.9m (down 131% from profit in 3Q 2022). Revenue exceeded analyst estimates by 117%. Earnings per share (EPS) also surpassed analyst estimates by 20%. Revenue is forecast to grow 39% p.a. on average during the next 3 years, compared to a 11% growth forecast for the Healthcare Services industry in the US. Ankündigung • Oct 28
Akili Receives Non-Compliance Notice from Nasdaq On October 24, 2023, Akili, Inc. (the “Company”), received a letter from the Listing Qualifications Staff (the “Nasdaq Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that for the 30 consecutive business days from September 11, 2023, through October 23, 2023, the bid price of the Company’s common stock, par value $0.0001 per share (“common stock”) had closed below $1.00 per share, the minimum closing bid price required by the continued listing requirements of Nasdaq Listing Rule 5550(a)(2). The notification received has no immediate effect on the listing of the Company’s common stock on the Nasdaq Capital Market, which will continue to be listed and traded on the Nasdaq Capital Market subject to the listing rules. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has 180 calendar days, or until April 22, 2024 (the “Compliance Date”), to regain compliance with the minimum bid price requirement. To regain compliance, the closing bid price of the Company’s common stock must be at least $1.00 per share for a minimum of 10 consecutive business days before the Compliance Date unless Nasdaq requires a longer period under certain circumstances. If the Company’s common stock does not achieve compliance by the Compliance Date, the Company may be eligible for an additional 180-day period to regain compliance if it meets the continued listing requirement for market value of publicly held shares and all other initial listing standards for the Nasdaq Capital Market, with the exception of the bid price requirement, and provides written notice to Nasdaq of its intention to cure the deficiency during the second 180-day compliance period, by effecting a reverse stock split, if necessary. However, if it appears to the Nasdaq Staff that the Company will not be able to cure the deficiency, or if the Company does not regain compliance within the allotted compliance period, including any extensions that may be granted, Nasdaq will provide written notification to the Company that its common stock is subject to delisting. At that time, the Company may appeal the delisting determination to a hearings panel pursuant to the procedures set forth in the applicable Nasdaq listing rules. There can be no assurance that the Company will be eligible for the additional 180 calendar day compliance period, if applicable, or that the Nasdaq Staff would grant the Company’s request for continued listing subsequent to any delisting notification. In addition, there can be no assurance that, if the Company does appeal a delisting determination by Nasdaq to the panel, such appeal would be successful. The Company intends to actively monitor the closing bid price of its common stock and will evaluate available options to resolve the deficiency and regain compliance with the minimum bid price rule. Ankündigung • Oct 13
Akili, Inc. Releases Results from A New Study Examining the Way in Which Adhd Impacting the U.S. Workforce Akili, Inc. released results from a new study examining the ways in which ADHD impacts the U.S. workforce. Akili engaged Wakefield Research to survey 500 employees with ADHD to better understand the experience of working with ADHD, as well as 500 managers to explore how prepared workplaces are to support employees with ADHD. Employees want their managers to know they have ADHD: Most employees (85%) have disclosed their ADHD diagnosis to a supervisor, and the majority of them (79%) are happy with their choice. Employees are looking for support and resources from their managers: In sharing their diagnosis, employees are looking for acceptance of how their work style may be different from that of their colleagues (55); better awareness of how their supervisor can support them (54); and discussions about where and why they struggle with some tasks (44%). They also want to better understand the medical benefits specific to their condition (30%) and the workplace resources (24%) that are available to them. Understanding is the most important benefit: more than 9 out of 10 employees (93%) said that having a supervisor who knows how to support and work with them is more valuable than any other office benefit or perk. EndeavorOTC impacts an estimated 11 million adults in the U.S., meaning that it's inevitably prevalent across the workforce. "97% of the study's employee respondents felt that they could accomplish more at work if they could better manage their symptoms. This overwhelming majority makes it clear that the company need to rethink treatment, resources, and understanding across the board." Earlier this year, Akili released EndeavorOTC, a game-based ADHD treatment for adults, built with technology from the world's first FDA-authorized video game treatment for pediatric patients with ADHD, EndeavorRx. EndeavorOTC has been clinically proven to improve attention and focus in adults with ADHD. The treatment is available on Android's Google Play™? and Apple's iOS App Store®?, providing an accessible treatment option for American adults living with ADHD. All participants provided written informed consent. Participants were compensated at fair market value. All data collected were de-identified, and only aggregate data were analyzed and presented. Akili's suite of cognitive treatment products for ADHD includes EndeavorOTC and EndeavorRx. endeavorOTC is a digital therapeutic indicated to improve attention function, ADHD symptoms and quality of life in adults 18 years of age and older with primarily inattentive or combined-type ADHD. EndeavorOTC utilizes the same proprietary technology underlying EndeavorRx, a prescription digital therapeutic indicated to improve attention functions in children ages 8-12. EndeavorOTC is available under the U.S. Food and Drug Administration's current Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. EndeavorOTC have not been cleared or authorized by the U.S. Food & Drug Administration for any indications. It is recommended that patients speak to their health care provider before starting EndeavorRx treatment. No serious adverse events have been reported in any of clinical studies. EndeavorRx is available by prescription only. It is not intended to be used as a stand-alone therapeutic and is not a substitution for a child's medication. The most common side effect observed in children in EndeavorRx's clinical trials was a feeling of frustration, as the game can be quite challenging at times. No serious adverse events were associated with its use. EndeavorRx are recommended to be used for approximately 25 minutes a day, 5 days a week, over initially at least 4 consecutive weeks, or as recommended by child's health care provider. Ankündigung • Sep 22
Akili Releases EndeavorOTC on Android Devices, Expanding Treatment Access for Millions of Adults with Adhd Akili, Inc. announced that EndeavorOTC, the mobile video game treatment clinically proven to improve attention and focus in adults with ADHD, is now available on Google Play for popular Android devices, including most Samsung Galaxy and Google Pixel models. Out of the estimated 11 million adults living with ADHD in the United States, approximately 40% are Android users so the company believes this release represents a crucial step in offering an accessible non-drug treatment option to adults with ADHD, particularly amid the continued stimulant medication shortage and ongoing mental health crisis. EndeavorOTC is built on the same technology as Akili’s EndeavorRx®, the world’s first and only FDA-authorized video game treatment, for children 8-12 years old with ADHD. In a recent clinical trial, EndeavorOTC significantly improved focus, attention, and overall quality of life in adults struggling with ADHD symptoms. On average, participants’ ability to focus improved by 85%; over one-third of participants no longer exhibited an attention deficit following treatment, and 73% of participants reported quality of life improvements. The release of EndeavorOTC comes at a time when the ADHD community faces continued challenges accessing care. Fueled by manufacturing issues and record-high prescription rates, the stimulant shortage continues and now affects multiple ADHD drugs. Last month, the U.S. Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) issued a joint statement on the ongoing nationwide shortage of stimulants for the treatment of conditions such as ADHD, noting the FDA’s support of non-drug treatment options including Akili’s EndeavorRx product. The Android release follows EndeavorOTC’s release on the Apple iOS App Store® in June 2023. EndeavorOTC now features Akili’s recently released Focus Score, a new metric for users. Focus Score provides a measurement of how quickly and accurately patients can complete a task despite distractions during gameplay, assisting with setting benchmarks and quantifying progress. A patient’s personalized baseline Focus Score is calculated during treatment onboarding, along with a target Focus Score that serves as a treatment goal. In Akili’s recent adult ADHD clinical trial, Focus Score improvements were directly related to improvement in ADHD-related symptoms and overall quality of life—things like being able to complete tasks or keep track of important items like wallet and keys. Price Target Changed • Sep 20
Price target decreased by 25% to US$3.00 Down from US$4.00, the current price target is provided by 1 analyst. New target price is 361% above last closing price of US$0.65. Stock is down 76% over the past year. The company is forecast to post a net loss per share of US$0.88 next year compared to a net loss per share of US$0.64 last year. New Risk • Sep 15
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 12% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 12% per year for the foreseeable future. Revenue is less than US$1m (US$420k revenue). Minor Risks Large one-off items impacting financial results. Market cap is less than US$100m (US$72.3m market cap). Major Estimate Revision • Aug 31
Consensus revenue estimates decrease by 14% The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast fell from US$1.44m to US$1.24m. EPS estimate unchanged from -US$0.84 per share at last update. Healthcare Services industry in the US expected to see average net income growth of 4.3% next year. Consensus price target of US$4.00 unchanged from last update. Share price rose 3.2% to US$0.98 over the past week. Major Estimate Revision • Aug 17
Consensus revenue estimates decrease by 44% The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast fell from US$2.68m to US$1.49m. EPS estimate unchanged from -US$0.84 per share at last update. Healthcare Services industry in the US expected to see average net income growth of 4.3% next year. Consensus price target of US$3.44 unchanged from last update. Share price fell 9.0% to US$1.01 over the past week. Reported Earnings • Aug 11
Second quarter 2023 earnings: EPS exceeds analyst expectations while revenues lag behind Second quarter 2023 results: US$0.15 loss per share (improved from US$18.25 loss in 2Q 2022). Net loss: US$11.8m (loss narrowed 56% from 2Q 2022). Revenue missed analyst estimates by 52%. Earnings per share (EPS) exceeded analyst estimates by 25%. Revenue is forecast to grow 57% p.a. on average during the next 3 years, compared to a 12% growth forecast for the Healthcare Services industry in the US. Ankündigung • Jun 08
Akili Releases EndeavorOTC Video Game Treatment to Improve Attention in Adults with Adad Akili, Inc. released EndeavorOTC, a new immersive mobile video game treatment that is clinically proven to improve attention and focus, specifically in adults with ADHD. EndeavorOTC is built on the same technology as Akili's EndeavorRx R, the world's first and only FDA-authorized video game treatment now being prescribed for children 8-12 years old with ADHD. This announcement comes on the heels of recently announced clinical trial data showing that EndeavorOTC (AKL-T01) significantly improved focus, attention, and overall quality of life in adults struggling with ADHD symptoms: 83% of participants reported clinical improvements in their focus; On average, participants' ability to focus improved by 85%. Over one-third of participants no longer exhibited an attention deficit following treatment; 73% of participants reported quality of life improvements, including completing tasks on time, managing multiple tasks at once, and keeping track of important items like wallets or keys; Amid a persistent mental health crisis, an increasing number of adults are seeking help for ADHD symptoms including inattention and lack of focus while facing an ongoing nationwide shortage of ADHD medication. As the gap between demand for care and availability of effective treatments widens, Akili released EndeavorOTC under FDA's enforcement policy established shortly after the onset of the COVID-19 pandemic to facilitate rapid access to certain low-risk, mental health-related digital health devices. The release of EndeavorOTC provides immediate access to this clinically-proven non-drug option for those seeking new safe and effective solutions to their treatment needs. The first generation of EndeavorOTC is available now in the Apple App Store for adults 18 and older with ADHD. Akili will actively involve adults using EndeavorOTC in the ongoing development of the product, gathering feedback that will help shape future generations of the game. By working closely with the community and embracing their perspective, Akili will continue to enhance EndeavorOTC to make the experience even more engaging, enjoyable and impactful. Ankündigung • Jun 01
Akili, Inc. to Present Clinical Data from Pivotal Trial of Video Game Treatment in Adolescents with Adolescents At 2023 Akili, Inc. is presenting pivotal trial data on EndeavorRx(R) (AKL-T01) in adolescents with attention-deficit/hyperactivity disorder (ADHD) at the 2023 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting in Miami Beach on May 31, 2023, and at the Elevate Psych Congress in Las Vegas on June 2-3, 2023. The poster presentations highlight results of Akili's STARS-ADHD-Adolescents label expansion trial evaluating the efficacy and safety of EndeavorRx in adolescents ages 13-17 with ADHD. In the STARS-ADHD- Adolescents trial, EndeavorRx demonstrated a statistically significant improvement in adolescents' attention function as measured by a change in the attention Comparison Score (ACS) of the FDA-cleared Test of Variables of attention (TOVA(R), the trial's predefined primary efficacy endpoint. Nearly two-thirds (66%) of adolescents met the prespecified definition of clinical response on the TOVA-ACS. The magnitude of improvement in attention function in adolescents was nearly three times larger than what was observed in the STARS-ADHD pivotal trial in 8-12 year olds that served as the basis for EndeavorRx's FDA authorization. The mean change from baseline on the TOVA-AC S in adolescents was 2.6 (SD=3.8; P < 0.0001) as compared to 0.93 (p<0.001) in 8-12 year olds. EndeavorRx is currently authorized for use in 8-12 year olds with ADHD. Based on these new data, Akili has filed with FDA to expand its current EndeavorRx label to include 13-17 year olds. In May, Akili announced topline data from a successful pivotal study of EndeavorRx In May, Akili announced the successful pivotal study of Ende flavorRx in adults with ADHD 18 years of age and older, demonstrating that improvements in both objective measures of attention and clinical outcomes surpassed those seen in both pediatric and adolescent patient populations. EndeavorRx Indication and Overview EndeavorRx is the first-and-only FDA-authorized treatment delivered through a video game experience. Major Estimate Revision • May 19
Consensus revenue estimates increase by 32%, EPS downgraded The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast increased from US$2.43m to US$3.22m. EPS estimate fell from -US$0.76 to -US$0.775 per share. Healthcare Services industry in the US expected to see average net income growth of 9.7% next year. Consensus price target down from US$3.75 to US$3.44. Share price rose 2.8% to US$1.45 over the past week. Price Target Changed • May 18
Price target decreased by 8.3% to US$3.44 Down from US$3.75, the current price target is an average from 4 analysts. New target price is 146% above last closing price of US$1.40. Stock is down 86% over the past year. The company is forecast to post a net loss per share of US$0.78 next year compared to a net loss per share of US$0.64 last year. Reported Earnings • May 13
First quarter 2023 earnings: EPS and revenues miss analyst expectations First quarter 2023 results: US$0.27 loss per share (improved from US$17.96 loss in 1Q 2022). Net loss: US$20.7m (loss narrowed 21% from 1Q 2022). Revenue missed analyst estimates by 43%. Earnings per share (EPS) also missed analyst estimates by 35%. Revenue is forecast to grow 95% p.a. on average during the next 3 years, compared to a 12% growth forecast for the Healthcare Services industry in the US. Major Estimate Revision • Mar 16
Consensus revenue estimates decrease by 26%, EPS upgraded The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast fell from US$3.27m to US$2.42m. EPS estimate increased from -US$1.20 to -US$0.76 per share. Healthcare Services industry in the US expected to see average net income growth of 1.0% next year. Consensus price target down from US$4.00 to US$3.75. Share price fell 18% to US$1.35 over the past week. Reported Earnings • Mar 08
Full year 2022 earnings released: US$0.10 loss per share (vs US$106 loss in FY 2021) Full year 2022 results: US$0.10 loss per share (improved from US$106 loss in FY 2021). Net loss: US$7.96m (loss narrowed 94% from FY 2021). Revenue is forecast to grow 49% p.a. on average during the next 3 years, compared to a 12% growth forecast for the Healthcare Services industry in the US. Ankündigung • Jan 06
Akili, Inc. announces Pivotal Trial of Endeavorrx in Adolescents with Adhd Shows Robust Improvements in Attention and Broader Clinical Outcomes Akili, Inc. announced topline results of the STARS-ADHD-Adolescents label expansion study evaluating the efficacy and safety of EndeavorRx? (AKL-T01) in adolescents ages 13-17 with attention-deficit/hyperactivity disorder (ADHD). The pivotal study achieved its predefined primary efficacy outcome, showing statistically significant improvement in attentional functioning after four weeks of treatment. Consistent improvements were also seen in a range of secondary measures of ADHD-related inattention symptoms and functioning. EndeavorRx treatment was generally well-tolerated, with no serious device-related adverse events reported. The multi-center open-label study enrolled 162 adolescents ages 13-17 with inattentive or combined-type ADHD. In the study, EndeavorRx demonstrated a statistically significant improvement in the Test of Variables of Attention (TOVA®)-Attention Comparison Score (ACS) of sustained and selective attention from baseline after one month of treatment (p<0.0001), the study’s predefined primary efficacy outcome. The change from baseline on the TOVA ACS was nearly three times as large as the changes seen in STARS-ADHD, a large randomized controlled trialof children with ADHD ages 8-12 that served as the basis for EndeavorRx’s U.S. Food and Drug Administration (FDA) authorization in that age group. In the STARS-ADHD-Adolescents study, nearly two-thirds (66%) of adolescents met the prespecified definition of clinical response on the TOVA-ACS and nearly a quarter (24.7%) moved into the non-clinical, or normative, range. TOVA is a computerized test cleared by FDA to assess attention deficits and evaluate the effects of interventions in ADHD. Adolescents using EndeavorRx also saw significant improvement in ADHD symptoms, as measured by the Attention Deficit Hyperactive Disorder Rating Scale-5 (ADHD-RS) inattention subscale and total scale scores. ADHD-RS is a clinician-administered questionnaire based on information collected from the child's caregiver. Following treatment, participants in the study showed significant improvement on both the inattention subscale and total score of the ADHD-RS (p<0.0001 for both). A prespecified responder analysis also showed that 27.1% of all participants in the study demonstrated at least a 30% reduction in total scores on the ADHD-RS, a finding similar to the STARS-ADHD trial in children with ADHD (24%). Statistically significant improvements were also observed for parent and child ratings of attention improvement, as well as parent ratings of function across a number of domains, including peer relationships, academic functioning, behavioral functioning, homework functioning, and self-esteem. Overall, 4 (2.5%) participants experienced a treatment-emergent adverse device event (3 decreased frustration tolerance, 1 headache; all mild or moderate). There were no serious adverse device events. Ankündigung • Dec 02
Akili, Inc. Announces the Appointment of Scott Kollins, Ph.D., as Chief Medical Officer, Effective December 1, 2022 Akili, Inc. announced the appointment of Scott Kollins, Ph.D., as chief medical officer, effective December 1, 2022. Dr. Kollins will report to Akili’s chief operating officer and join the company’s executive team. Dr. Kollins spent more than 20 years on the faculty in the Department of Psychiatry and Behavioral Sciences at the Duke University School of Medicine, where he maintains an adjunct faculty appointment. He was also the co-lead for the Digital Health Solutions Initiative at the Duke Clinical Research Institute (DCRI). In this role, Dr. Kollins worked with more than a dozen digital health and digital therapeutic companies to develop clinical studies and provide scientific and regulatory guidance. Dr. Kollins was most recently the chief medical officer for Holmusk, the world’s leading real-world evidence company focused on behavioral health. Dr. Kollins’ research has spanned a number of areas, including human psychopharmacology, ADHD across the lifespan, nicotine and other substance use disorders, and clinical trials. He has published nearly 200 scientific papers in peer-reviewed journals. Over the past 20 years, his research was supported by seven different federal agencies, including the NICHD, NIDA, NIMH, NIEHS, NINDS, FDA, and EPA. Dr. Kollins has been ranked among the Top 100 Psychiatry faculty members in the U.S. with respect to NIH funding and also served as principal investigator on more than 50 industry-funded clinical trials, including Akili’s STARS-ADHD trial published in The Lancet Digital Health. Dr. Kollins is an elected member of the College on Problems of Drug Dependence and a fellow of both the American College of Neuropsychopharmacology and the American Psychological Association Division 28 (Psychopharmacology and Substance Abuse). He has served as a reviewer for a wide range of US-based and international granting agencies. Dr. Kollins is a former associate editor for the Journal of Attention Disorders, is the ADHD section editor for the Journal of Child Psychiatry & Psychologyand has reviewed for more than 50 different peer-reviewed journals. He is also a licensed clinical psychologist in the state of North Carolina. Dr. Kollins received his undergraduate degree in psychology from Duke University in 1992 and earned his Master’s and Doctorate degrees in Clinical Psychology from Auburn University in 1995 and 1997, respectively. He completed his clinical internship at the University of Mississippi Medical Center, where he served as chief intern. Following internship, Kollins joined the faculty of the Department of Psychology at Western Michigan University for three years, before joining the Duke faculty in 2000. Major Estimate Revision • Nov 21
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 revenue forecast fell from US$340.0k to US$290.0k. EPS estimate unchanged at -US$1.61 per share. Healthcare Services industry in the US expected to see average net income growth of 7.2% next year. Consensus price target down from US$7.00 to US$4.50. Share price fell 7.4% to US$1.50 over the past week. Board Change • Nov 16
High number of new and inexperienced directors There are 6 new directors who have joined the board in the last 3 years. The company's board is composed of: 6 new directors. 1 experienced director. No highly experienced directors. Independent Non-Executive Director Ken Ehlert is the most experienced director on the board, commencing their role in 2022. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Reported Earnings • Nov 12
Third quarter 2022 earnings released: EPS: US$35.91 (vs US$15.61 loss in 3Q 2021) Third quarter 2022 results: EPS: US$35.91 (up from US$15.61 loss in 3Q 2021). Net income: US$53.2m (up US$71.4m from 3Q 2021). Revenue is forecast to grow 75% p.a. on average during the next 3 years, compared to a 13% growth forecast for the Healthcare Services industry in the US. Ankündigung • Oct 28
Akili, Inc. Announces Board Changes On October 25, 2022, Bharatt Chowrira resigned from his position as a member of the Board of Directors of Akili, Inc. and any committees thereof, effective immediately. Dr. Chowrira's resignation was not due to any disagreement with the Company on any matter relating to the Company's operations, policies, or practices. On October 25, 2022, the Board appointed Mary Hentges to the Board as a Class I director, to serve until the company's annual meeting of stockholders held in 2023 or until her successor is duly elected and qualified, effective immediately. Ms. Hentges was also appointed to serve as the Chair of the Audit Committee of the Board (the Audit Committee") and a member of the Compensation Committee of the Board (the Compensation Committee"). Following Ms. Hentges's appointment to the Board, the Audit Committee consists of Mary Hentges, Kenneth Ehlert and William BJ" Jones, Jr. and the Compensation Committee consists of Christine Lemke and Mary Hentges. The composition of the Nominating and Corporate Governance Committee of the Board remains unchanged and consists of William BJ" Jones, Jr. and Kenneth Ehlert. Reported Earnings • Aug 25
Second quarter 2022 earnings released Second quarter 2022 results: US$18.25 loss per share. Net loss: US$26.9m (flat on 2Q 2021). Board Change • Aug 22
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 8 non-independent directors. Director Kenneth Ehlert was the last director to join the board, commencing their role in 2021. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. 