As part of this collaboration, devices designed by SHL Medical, such as the Molly^® Connected Cap – a smart retrofittable add-on for SHL Medical’s Molly^® modular platform autoinjector – will benefit from Aptar Digital Health’s SaMD platform to enhance the patient experience by offering additional support during self-administration via a digital solution.

Aptar Digital Health’s SaMD platform offers digital health solutions adapted to the patient’s profile, disease state and treatment plan to empower them during their treatment journey. Through this partnership, SHL Medical will recommend Aptar Digital Health as a trusted digital partner that is recognized for its large portfolio of regulated digital health solutions and connected devices spanning multiple therapeutic areas and modes of administration. The partnership will leverage the capabilities of both companies to develop end-to-end solutions for the pharmaceutical industry that will support the enhancement of the patient experience during self-injection of innovative drugs such as GLP-1 for instance.

“Embarking on a self-injection therapy and adhering to a consistent injection schedule can pose a challenge to patients in being actively involved in their treatment journey,” stated Sai Shankar, President of Aptar Digital Health. “By joining forces with SHL Medical, a world-class leader in innovative drug delivery systems, we aim to positively and durably change the experience of patients who must self-inject regularly.”

“The increasing need for home-based treatments and the evolving healthcare landscape have created a need for collaborative innovation within the drug delivery industry,” added Ralph Howald, Chief Technical Officer at SHL Medical. “With our combined expertise, the partnership with Aptar Digital Health will serve as the first step in realizing a thoroughly-needed digital ecosystem for injectable drugs, starting with a digital transformation that will impact the end-to-end value chain in the future.”

With this partnership, Aptar Digital Health aims at reinforcing their portfolio of digital products and services to enhance the patient experience across the treatment journey. This offer spans from pre-prescription – direct-to-patient services, patient identification and activation – to support during and after prescription – companion apps, disease management platforms and targeted SaMDs to augment innovative drugs and contribute to improved patient adherence.

About SHL Medical AG

As a world-leading solutions provider of advanced drug delivery systems, SHL Medical is the partner of choice for many leading pharma and biotech companies. Driven by their company purpose – Enabling Patients’ Independence – SHL Medical offers patient-centric solutions for the design, development, and manufacturing of autoinjectors, pen injectors, as well as innovative specialty delivery systems for large-volume and high-viscosity formulations. SHL Medical also offers final assembly, labeling, and packaging solutions for their drug delivery systems.

In response to the rising trend in home therapy, SHL has increased developmental work in the digital healthcare sector to help improve the drug delivery ecosystem.

Located across Switzerland, Taiwan, Sweden and the US, their global team of experts collaborate seamlessly as one team in utilizing their comprehensive in-house manufacturing capabilities. Their solutions offer customization and optimization for each project while proactively weaving sustainability-driven measures into their designs and processes to contribute to a cleaner earth. For additional information, visit www.shl-medical.com.

About Aptar Digital Health

Aptar Pharma’s Digital Health division is part of AptarGroup, Inc., a global leader in drug and consumer product dosing, dispensing and protection technologies. Aptar Digital Health creates end-to-end solutions to enhance patient experiences every day, leveraging a holistic ecosystem of digital interventions. Amplified by an industry-leading portfolio of products and solutions, Aptar Digital Health’s offering combines mobile and web apps, connected drug delivery systems, onboarding, training and advanced data analytics services to actively empower patients and create a positive treatment journey. Aptar is headquartered in Crystal Lake, Illinois and has more than 13,000 dedicated employees in 20 countries. For more information, please visit www.aptardigitalhealth.com and www.aptar.com.

Contacts

Ciara Jackson
Aptar Pharma
+49 151 1951 6502
ciara.jackson@aptar.com

Low-intensity CBT has demonstrated efficacy in 30 systematic reviews and 50 controlled trials. The Iona Mind platform contains low-intensity CBT programs for managing common mental health conditions and general wellbeing. Leveraging the latest innovations in software, data science and user experience design, the Iona Mind platform can create bespoke digital products to support patients at any point of their journey.

These products can be used to help chronic disease patients who typically have high rates of common mental health issues such as anxiety, low mood, and persistent recurring negative thoughts. Compared to the general population, it is estimated that mental health conditions are two to three times more likely to occur in people with chronic diseases. Consequently, mental health comorbidities increase overall treatment complexity and costs. For instance, people diagnosed with major depression use healthcare services more, and this can lead to a twofold increase in healthcare spending¹.

Iona Mind uses its proprietary development program IMDP (Iona Mind Development Program) to work with patient advocate groups and ensure each product is adapted for the population at hand. This ensures inclusivity and accessibility when serving diverse patient populations, such as underrepresented groups or patients with chronic illnesses.

Under this partnership, Aptar Digital Health, with its extensive experience in SaMDs, companion apps and disease management solutions, will bring a comprehensive understanding of patient and healthcare professional needs. Aptar Digital Health’s platform and expertise in developing and implementing end-to-end digital health solutions at a global scale will complement Iona Mind’s ability to deliver mental health support at various stages of the patient journey. The partnership aims to bring evidence-based and scalable mental health support to any patient, using solutions based on the Aptar Digital Health platform. This powerful combination has the potential to make mental health support more accessible to millions of chronic disease patients.

Sai Shankar, President of Aptar Digital Health, commented, “We are excited to join forces with Iona Mind and bring our combined expertise to address the mental health challenges faced by patients with chronic diseases. Our collaboration represents a major step forward in our shared mission to improve the lives of millions of people worldwide.”

Added Geneviève D’Orsay, Chief Medical Officer at Aptar Digital Health, “Supporting the mental health of patients with cancer is crucial for enhancing their overall journey. A growing number of evidence shows the importance of considering the emotional distress associated with the patient experience, especially in the field of cancer. We are pleased to collaborate with Iona Mind, and to offer accessible mental health support to more patients.”

Jonathan Baker, CEO and Founder of Iona Mind, stated, “At Iona Mind, we are delighted to be collaborating with Aptar Digital Health. By combining Aptar’s proven experience with digital patient support with Iona Mind’s industry-leading expertise in low-intensity cognitive behavioral therapy and mental health, we know that together, we will be able to significantly impact many lives.”

About Iona Mind

Iona Mind is a global leader in scalable mental health solutions, specializing in low-intensity cognitive behavioral therapy. With a focus on innovative technologies and patients, Iona Mind is dedicated to improving outcomes and reducing the burden of these complex conditions. The company’s Iona Mind platform coupled with the Iona Mind Development Program enable providers to quickly create bespoke solutions that meet the psychological needs of their populations. For more information, visit https://www.ionamind.com.

About Aptar Digital Health

Aptar Pharma’s Digital Health division is part of AptarGroup, Inc., a global leader in drug and consumer product dosing, dispensing and protection technologies. Aptar Digital Health creates end-to-end solutions to enhance patient experiences every day, leveraging a holistic ecosystem of digital interventions. Amplified by an industry-leading portfolio of products and solutions, Aptar Digital Health’s offering combines mobile and web apps, connected drug delivery systems, onboarding, training and advanced data analytics services to actively empower patients and create a positive treatment journey. Aptar is headquartered in Crystal Lake, Illinois and has more than 13,000 dedicated employees in 20 countries. For more information, please visit www.aptardigitalhealth.com and www.aptar.com.

^{______________________________
1} Major Depression: The Impact on Overall Health (2018)
https://www.bcbs.com/the-health-of-america/reports/major-depression-the-impact-overall-health

Contacts

Ciara Jackson
Aptar Pharma
+49 151 1951 6502
ciara.jackson@aptar.com

BOSTON–(BUSINESS WIRE)–PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the “Company”), a clinical-stage biotherapeutics company, noted today that its Founded Entity, Akili, Inc. (Nasdaq: AKLI), a leading digital therapeutics company, and Virtual Therapeutics, a company focused on improving mental health at scale using engaging, immersive games, announced the signing of a definitive merger agreement to form a diversified, leading digital health company.

As of May 7, 2024, PureTech owned 12,527,477 of the outstanding shares of Akili common stock.

The full text of the announcement from Akili and Virtual Therapeutics is as follows:

Virtual Therapeutics, Akili Interactive Enter Into Definitive Merger Agreement to Establish Leading Digital Health Company

Akili to operate as wholly owned subsidiary of Virtual Therapeutics

Kirkland, Wash., and Boston, Mass.– Virtual Therapeutics, a company focused on improving mental health at scale using engaging, immersive games, and Akili, Inc. (Nasdaq: AKLI), a leading digital therapeutics company, today announced the signing of a definitive merger agreement to form a diversified, leading digital health company.

Under the terms of the agreement, Akili shareholders will receive $0.4340 per share of common stock in cash. The per share purchase price represents an approximately 4% premium to Akili’s closing stock price on May 28, 2024 and an approximately 85% premium to Akili’s closing price on April 29, 2024, the last trading day prior to Akili’s public announcement that it was evaluating potential strategic alternatives. Following completion of the transaction, the combined organization will operate as Virtual Therapeutics, a privately held company, with Akili operating as a wholly owned subsidiary.

“In today’s global mental health crisis, patients deserve access to clinically validated solutions that address their specific needs. We have been able to advance multiple solutions on our platform since founding Virtual Therapeutics, and we look forward to taking a significant step forward through this merger,” said Dan Elenbaas, co-founder and CEO of Virtual Therapeutics. “The team at Akili has been successful in applying clinical and scientific rigor to bring new products forward, and we believe their expertise will complement our efforts. Together, we can build a company that brings these behavioral services to as many patients as possible – regardless of where they are or barriers that exist for them today.”

“Akili ran a thorough strategic process and we believe that this transaction represents Akili’s commitment to delivering value to the Akili stockholder,” added Matt Franklin, Chief Executive Officer of Akili. “Virtual Therapeutics has been built by a team with decades of success in the gaming industry and elected to focus their expertise to help solve the growing mental health crisis. Combining our proven track record developing and deploying rigorously validated mobile digital therapeutics with Virtual Therapeutics’ robust portfolio of VR-based mental health solutions and gaming expertise, we aim to create a compelling platform to address mental health needs across several high-impact indications.”

Transaction Details

The transaction, approved by both of Virtual Therapeutics’ and Akili’s board of directors, is expected to close in the third quarter of 2024, subject to certain closing conditions, including the tender of a majority of Akili shares into a tender offer to be launched by Virtual Therapeutics and Akili having not less than a specified amount of cash-on-hand, depending on the closing time. The transaction is not subject to a financing condition.

Upon completion of the transaction, Akili’s common stock will no longer be listed on any public stock exchange.

Advisors

TD Cowen is acting as exclusive financial advisor and Goodwin Procter LLP is acting as legal counsel to Akili. Baker & McKenzie LLP is acting as legal counsel to Virtual Therapeutics.

About Akili

Akili is pioneering the development of cognitive treatments through game-changing technologies. 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. Akili’s platform is powered by proprietary therapeutic engines designed to target cognitive impairment at its source in the brain, informed by decades of research and validated through rigorous clinical programs. Driven by Akili’s belief that effective medicine can also be fun and engaging, Akili’s products are delivered through captivating action video game experiences. For more information, please visit www.akiliinteractive.com.

About Virtual Therapeutics

Virtual Therapeutics is a digital health company delivering scalable, accessible, affordable, and personalized solutions for mental health and mental fitness. Leveraging extensive expertise as game developers, the company crafts and curates rich, appealing experiences that combine proven therapeutic techniques with modern gameplay mechanisms to delight and engage users. Virtual Therapeutics uses powerful cloud-based platform to gather and analyze various data streams to continuously measure, validate, and report effectiveness, seamlessly deploy and maintain its solutions, and provide users and partners with a truly turnkey experience. For more information, visit https://www.vthera.com/.

Contact

For Akili
Matt Franklin, President and Chief Executive Officer
InvestorRelations@akiliinteractive.com or PR@akiliinteractive.com

For Virtual Therapeutics
Ian Stone, Inizio Evoke Communications
ian.stone@inizioevoke.com
619-518-3518

Forward-looking Statements

This communication relates to the proposed transaction pursuant to the terms of the Agreement and Plan of Merger, dated May 29, 2024, by and among Virtual Therapeutics Corporation (“Parent”), Alpha Merger Sub, Inc. (“Purchaser”), and Akili, Inc. (“Akili”). This communication includes express or implied forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), about the proposed acquisition of Akili by Parent and the operations of the combined company that involve risks and uncertainties relating to future events and the future performance of Akili. Actual events or results may differ materially from these forward-looking statements. Words such as “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “future,” “opportunity” “will likely result,” “target,” variations of such words, and similar expressions or negatives of these words are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words.

These statements are based on current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. A number of important factors, including those described in this communication, could cause actual results to differ materially from those contemplated in any forward-looking statements. Factors that may affect future results and may cause these forward-looking statements to be inaccurate include, without limitation: uncertainties as to the timing of the tender offer and merger; uncertainties as to how many of Akili’s stockholders will tender their stock in the offer; the possibility that competing offers will be made by third parties; the occurrence of events that may give rise to a right of one or both of Parent and Akili to terminate the merger agreement; the possibility that various closing conditions for the proposed transaction may not be satisfied or waived on a timely basis or at all, including the possibility that a governmental entity may prohibit, delay, or refuse to grant approval, if required, for the consummation of the proposed transaction (or only grant approval subject to adverse conditions or limitations); the difficulty of predicting the timing or outcome of consents or regulatory approvals or actions, if any; the possibility that the proposed transaction may not be completed in the time frame expected by Parent and Akili, or at all; the risk that Akili may not realize the anticipated benefits of the proposed transaction in the time frame expected, or at all; the effects of the proposed transaction on relationships with Akili’s employees, business or collaboration partners or governmental entities; the ability to retain and hire key personnel; potential adverse reactions or changes to business relationships resulting from the announcement or completion of the proposed transaction; significant or unexpected costs, charges or expenses resulting from the proposed transaction; potential negative effects related to this announcement or the consummation of the proposed acquisition on the market price of Akili’s common stock; unknown liabilities related to Parent or Akili; the nature, cost and outcome of any litigation and other legal proceedings involving Akili or its officers and directors, including any legal proceedings related to the proposed acquisition; and risks related to global as well as local political and economic conditions, including interest rate and currency exchange rate fluctuations. While the foregoing list of factors presented here is considered representative, no list should be considered to be a complete statement of all potential risks and uncertainties. There can be no assurance that the proposed transaction or any other transaction described above will in fact be consummated in the manner described or at all. A more complete description of these and other material risks can be found in Akili’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the year ended December 31, 2023, subsequent Quarterly Reports on Form 10-Q and other documents that may be filed by Akili from time to time with the SEC, as well as the Schedule TO and related tender offer documents to be filed by Parent and its indirect wholly owned subsidiary, Purchaser, and the Schedule 14D-9 to be filed by Akili. Parent and Akili also plan to file other relevant documents with the SEC regarding the proposed transaction.

Any forward-looking statements speak only as of the date of this communication and are made based on management’s current beliefs and assumptions and on information currently available to Parent and Akili, and the reader is cautioned not to rely on any forward-looking statements. Parent and Akili do not undertake, and specifically decline, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law.

Additional Information and Where to Find It

The tender offer for all of the outstanding shares of common stock of Akili referenced in this document has not yet commenced. This document is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell securities of Akili, nor is it a substitute for the tender offer materials that Parent, Purchaser or Akili will file with the SEC. The solicitation and offer to buy the common stock of Akili will only be made pursuant to an Offer to Purchase and related tender offer materials that Parent and Purchaser intend to file with the SEC. At the time the tender offer is commenced, Parent and Purchaser will file with the SEC a Tender Offer Statement on Schedule TO, and thereafter Akili will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the tender offer. AKILI’S STOCKHOLDERS AND OTHER INVESTORS ARE URGED TO READ CAREFULLY THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 BECAUSE THEY WILL EACH CONTAIN IMPORTANT INFORMATION THAT HOLDERS OF AKILI SECURITIES AND OTHER INVESTORS SHOULD CONSIDER BEFORE MAKING ANY DECISION WITH RESPECT TO THE TENDER OFFER. The Offer to Purchase, the related Letter of Transmittal, certain other tender offer documents, as well as the Solicitation/Recommendation Statement will be made available to all stockholders of Akili at no expense to them and will also be made available for free at the SEC’s website at www.sec.gov. Additional copies may be obtained for free by contacting either Parent or Akili. Copies of the documents filed with the SEC by Akili will be available free of charge on Akili’s website at www.Akiliinteractive.com or by contacting Akili’s Investor Relations Department at InvestorRelations@Akiliinteractive.com or PR@Akiliinteractive.com.

In addition to the Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, Akili files annual, quarterly and current reports and other information with the SEC. Akili’s filings with the SEC are also available to the public from commercial document-retrieval services and at the website maintained by the SEC at http://www.sec.gov.

About PureTech Health

PureTech is a clinical-stage biotherapeutics company dedicated to giving life to new classes of medicine to change the lives of patients with devastating diseases. The Company has created a broad and deep pipeline through its experienced research and development team and its extensive network of scientists, clinicians and industry leaders that is being advanced both internally and through its Founded Entities. PureTech’s R&D engine has resulted in the development of 29 therapeutics and therapeutic candidates, including two that have received both U.S. FDA clearance and European marketing authorization and a third (KarXT) that has been filed for FDA approval. A number of these programs are being advanced by PureTech or its Founded Entities in various indications and stages of clinical development, including registration enabling studies. All of the underlying programs and platforms that resulted in this pipeline of therapeutic candidates were initially identified or discovered and then advanced by the PureTech team through key validation points.

For more information, visit www.puretechhealth.com or connect with us on X (formerly Twitter) @puretechh.

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that are or may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation those related to the proposed acquisition of Akili by Virtual Therapeutics and the resulting proceeds to be received by the Company as a shareholder of Akili, as well as our future prospects, developments and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks, uncertainties and other important factors that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risks, uncertainties and other important factors described under the caption “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2023 filed with the SEC and in our other regulatory filings. These forward-looking statements are based on assumptions regarding the present and future business strategies of the Company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, we disclaim any obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts

PureTech
Public Relations
publicrelations@puretechhealth.com

Investor Relations
IR@puretechhealth.com

UK/EU Media
Ben Atwell, Rob Winder
+44 (0) 20 3727 1000
puretech@fticonsulting.com

US Media
Nichole Bobbyn
+1 774 278 8273
nichole@tenbridgecommunications.com

KIRKLAND, Wash. & BOSTON–(BUSINESS WIRE)–Virtual Therapeutics, a company focused on improving mental health at scale using engaging, immersive games, and Akili, Inc. (Nasdaq: AKLI), a leading digital therapeutics company, today announced the signing of a definitive merger agreement to form a diversified, leading digital health company.

Under the terms of the agreement, Akili shareholders will receive $0.4340 per share of common stock in cash. The per share purchase price represents an approximately 4% premium to Akili’s closing stock price on May 28, 2024 and an approximately 85% premium to Akili’s closing price on April 29, 2024, the last trading day prior to Akili’s public announcement that it was evaluating potential strategic alternatives. Following completion of the transaction, the combined organization will operate as Virtual Therapeutics, a privately held company, with Akili operating as a wholly owned subsidiary.

“In today’s global mental health crisis, patients deserve access to clinically validated solutions that address their specific needs. We have been able to advance multiple solutions on our platform since founding Virtual Therapeutics, and we look forward to taking a significant step forward through this merger,” said Dan Elenbaas, co-founder and CEO of Virtual Therapeutics. “The team at Akili has been successful in applying clinical and scientific rigor to bring new products forward, and we believe their expertise will complement our efforts. Together, we can build a company that brings these behavioral services to as many patients as possible – regardless of where they are or barriers that exist for them today.”

“Akili ran a thorough strategic process and we believe that this transaction represents Akili’s commitment to delivering value to the Akili stockholder,” added Matt Franklin, Chief Executive Officer of Akili. “Virtual Therapeutics has been built by a team with decades of success in the gaming industry and elected to focus their expertise to help solve the growing mental health crisis. Combining our proven track record developing and deploying rigorously validated mobile digital therapeutics with Virtual Therapeutics’ robust portfolio of VR-based mental health solutions and gaming expertise, we aim to create a compelling platform to address mental health needs across several high-impact indications.”

Transaction Details

The transaction, approved by both of Virtual Therapeutics’ and Akili’s board of directors, is expected to close in the third quarter of 2024, subject to certain closing conditions, including the tender of a majority of Akili shares into a tender offer to be launched by Virtual Therapeutics and Akili having not less than a specified amount of cash-on-hand, depending on the closing time. The transaction is not subject to a financing condition.

Upon completion of the transaction, Akili’s common stock will no longer be listed on any public stock exchange.

Advisors

TD Cowen is acting as exclusive financial advisor and Goodwin Procter LLP is acting as legal counsel to Akili. Baker & McKenzie LLP is acting as legal counsel to Virtual Therapeutics.

About Akili

Akili is pioneering the development of cognitive treatments through game-changing technologies. 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. Akili’s platform is powered by proprietary therapeutic engines designed to target cognitive impairment at its source in the brain, informed by decades of research and validated through rigorous clinical programs. Driven by Akili’s belief that effective medicine can also be fun and engaging, Akili’s products are delivered through captivating action video game experiences. For more information, please visit www.akiliinteractive.com.

About Virtual Therapeutics

Virtual Therapeutics is a digital health company delivering scalable, accessible, affordable, and personalized solutions for mental health and mental fitness. Leveraging extensive expertise as game developers, the company crafts and curates rich, appealing experiences that combine proven therapeutic techniques with modern gameplay mechanisms to delight and engage users. Virtual Therapeutics uses powerful cloud-based platform to gather and analyze various data streams to continuously measure, validate, and report effectiveness, seamlessly deploy and maintain its solutions, and provide users and partners with a truly turnkey experience. For more information, visit https://www.vthera.com/.

Forward-looking Statements

This communication relates to the proposed transaction pursuant to the terms of the Agreement and Plan of Merger, dated May 29, 2024, by and among Virtual Therapeutics Corporation (“Parent”), Alpha Merger Sub, Inc. (“Purchaser”), and Akili, Inc. (“Akili”). This communication includes express or implied forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), about the proposed acquisition of Akili by Parent and the operations of the combined company that involve risks and uncertainties relating to future events and the future performance of Akili. Actual events or results may differ materially from these forward-looking statements. Words such as “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “future,” “opportunity” “will likely result,” “target,” variations of such words, and similar expressions or negatives of these words are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words.

These statements are based on current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. A number of important factors, including those described in this communication, could cause actual results to differ materially from those contemplated in any forward-looking statements. Factors that may affect future results and may cause these forward-looking statements to be inaccurate include, without limitation: uncertainties as to the timing of the tender offer and merger; uncertainties as to how many of Akili’s stockholders will tender their stock in the offer; the possibility that competing offers will be made by third parties; the occurrence of events that may give rise to a right of one or both of Parent and Akili to terminate the merger agreement; the possibility that various closing conditions for the proposed transaction may not be satisfied or waived on a timely basis or at all, including the possibility that a governmental entity may prohibit, delay, or refuse to grant approval, if required, for the consummation of the proposed transaction (or only grant approval subject to adverse conditions or limitations); the difficulty of predicting the timing or outcome of consents or regulatory approvals or actions, if any; the possibility that the proposed transaction may not be completed in the time frame expected by Parent and Akili, or at all; the risk that Akili may not realize the anticipated benefits of the proposed transaction in the time frame expected, or at all; the effects of the proposed transaction on relationships with Akili’s employees, business or collaboration partners or governmental entities; the ability to retain and hire key personnel; potential adverse reactions or changes to business relationships resulting from the announcement or completion of the proposed transaction; significant or unexpected costs, charges or expenses resulting from the proposed transaction; potential negative effects related to this announcement or the consummation of the proposed acquisition on the market price of Akili’s common stock; unknown liabilities related to Parent or Akili; the nature, cost and outcome of any litigation and other legal proceedings involving Akili or its officers and directors, including any legal proceedings related to the proposed acquisition; and risks related to global as well as local political and economic conditions, including interest rate and currency exchange rate fluctuations. While the foregoing list of factors presented here is considered representative, no list should be considered to be a complete statement of all potential risks and uncertainties. There can be no assurance that the proposed transaction or any other transaction described above will in fact be consummated in the manner described or at all. A more complete description of these and other material risks can be found in Akili’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the year ended December 31, 2023, subsequent Quarterly Reports on Form 10-Q and other documents that may be filed by Akili from time to time with the SEC, as well as the Schedule TO and related tender offer documents to be filed by Parent and its indirect wholly owned subsidiary, Purchaser, and the Schedule 14D-9 to be filed by Akili. Parent and Akili also plan to file other relevant documents with the SEC regarding the proposed transaction.

Any forward-looking statements speak only as of the date of this communication and are made based on management’s current beliefs and assumptions and on information currently available to Parent and Akili, and the reader is cautioned not to rely on any forward-looking statements. Parent and Akili do not undertake, and specifically decline, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law.

Additional Information and Where to Find It

The tender offer for all of the outstanding shares of common stock of Akili referenced in this document has not yet commenced. This document is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell securities of Akili, nor is it a substitute for the tender offer materials that Parent, Purchaser or Akili will file with the SEC. The solicitation and offer to buy the common stock of Akili will only be made pursuant to an Offer to Purchase and related tender offer materials that Parent and Purchaser intend to file with the SEC. At the time the tender offer is commenced, Parent and Purchaser will file with the SEC a Tender Offer Statement on Schedule TO, and thereafter Akili will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the tender offer. AKILI’S STOCKHOLDERS AND OTHER INVESTORS ARE URGED TO READ CAREFULLY THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 BECAUSE THEY WILL EACH CONTAIN IMPORTANT INFORMATION THAT HOLDERS OF AKILI SECURITIES AND OTHER INVESTORS SHOULD CONSIDER BEFORE MAKING ANY DECISION WITH RESPECT TO THE TENDER OFFER. The Offer to Purchase, the related Letter of Transmittal, certain other tender offer documents, as well as the Solicitation/Recommendation Statement will be made available to all stockholders of Akili at no expense to them and will also be made available for free at the SEC’s website at www.sec.gov. Additional copies may be obtained for free by contacting either Parent or Akili. Copies of the documents filed with the SEC by Akili will be available free of charge on Akili’s website at www.Akiliinteractive.com or by contacting Akili’s Investor Relations Department at InvestorRelations@Akiliinteractive.com or PR@Akiliinteractive.com.

In addition to the Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, Akili files annual, quarterly and current reports and other information with the SEC. Akili’s filings with the SEC are also available to the public from commercial document-retrieval services and at the website maintained by the SEC at http://www.sec.gov.

Contacts

For Akili
Matt Franklin, President and Chief Executive Officer
InvestorRelations@akiliinteractive.com or PR@akiliinteractive.com

For Virtual Therapeutics
Ian Stone, Inizio Evoke Communications
ian.stone@inizioevoke.com
619-518-3518

MILAN–(BUSINESS WIRE)–XGEN Venture – a newly formed Venture Capital firm – announces its first fund, XGEN Venture Life Science Fund, with €160 million in subscriptions. With this fund, XGEN Venture will be working alongside talented scientists and entrepreneurs to create and invest in up to 15 companies, delivering impactful solutions to patients through new therapeutics, medical devices, diagnostics and digital health solutions. While taking a global view to scientific innovation, a good portion of XGEN-backed companies will be formed from technologies originated in Italian research institutes.

Launched in December 2022, the fund will continue its fundraising efforts towards a final target of €200 million. It is supported by a strong base of institutional investors including EIF, CDP VC, UniCredit, Quaestio Capital, Banco BPM, Inarcassa, ENPAM, Fondazione di Sardegna and Banca Sella Holding, as well as many prominent family offices, with Micheli Associati, the majority shareholder of Genextra, participating to the launch of the fund as anchor investor together with EIF and CDP VC. XGEN has, so far, invested in five companies including Page Therapeutics and Nouscom, focused on breakthrough therapies to treat cancer, Protembis, improving cardiovascular interventional procedures, TES Pharma, a drug-discovery boutique targeting orphan receptors, and a – soon to be announced – gene-therapy company for rare diseases. The fund promotes best ESG practices within the meaning of SFDR art.8.

XGEN founders and managing partners, Paolo Fundarò, Federica Draghi and Daniele Scarinci have been previously working together building and investing in innovative life science startups for nearly two decades while at Genextra. The three partners were the first in Italy to specialize in life science venture capital investments, successfully investing over €200 million in early stage startups. XGEN’s team also includes eight high profile venture partners that bring extensive operational backgrounds in various areas of the life sciences industry, and three investment professionals. The founding partners, the venture partners and the team members have all invested in the fund, with a total GP commitment of 2.5% of the total fund.

“We are pleased to have reached this ambitious target for our first fund” said Paolo Fundarò, “with a diversified investor base of over 75% institutional and with the participation as anchor investor of the Micheli family – with whom we have worked for the past twenty years at Genextra – we are deeply appreciative of the continued support and trust from our LPs. This new fund will allow us to continue our established strategy of building and growing companies that conduct complex clinical programs for serious health conditions.”

XGEN has been assisted by the law firm ALMA – LED for all legal and regulatory matters.

About XGEN Venture

XGEN Venture is a Milan-based, newly created life science venture capital firm. We work with a group of exceptional scientists and entrepreneurs to translate high level science into solutions for patients. Our company creation strategy identifies and supports the most convincing opportunities to build effective businesses and create value.

Investing in technologies that truly improve severe health conditions is at the core of what XGEN does and is committed to doing so in a responsible and impactful way, promoting best ESG practices within the meaning of SFDR art 8. For more information, please visit www.xgenventure.com .

Contacts

Media and Investor Relations:
Mariagiulia Davide
Analyst
XGEN Venture SGR SpA
+39 02 36515110
mariagiulia.davide@xgenventure.com

LOS ANGELES–(BUSINESS WIRE)–#VR—AppliedVR, a pioneer in immersive therapeutics advancing a novel approach to medicine, has launched its flagship RelieVRx® prescription therapeutic into workers’ compensation. The RelieVRx device is the first comprehensive, immersive adjunctive virtual reality treatment for chronic lower back pain to ever be FDA-authorized.

The RelieVRx device provides a fully immersive VR experience that helps workers’ compensation patients learn skills that help them reduce and manage CLBP. It is a cost-effective, non-pharmacologic adjunctive pain therapy that has been clinically demonstrated to reduce pain intensity and interference.

“The RelieVRx program is a safe and effective alternative to common treatment modalities without any of the risks that opioids and surgeries carry,” said AppliedVR’s Co-Founder and President Josh Sackman. “We believe this program will receive broad acceptance in the workers’ comp community.”

The RelieVRx program incorporates scientifically developed and validated principles of cognitive behavioral therapy, biofeedback, and emotional regulation to teach people how to manage and relieve their pain. A team of clinicians, pain specialists and psychologists led by Stanford University School of Medicine Professor Beth Darnall, PhD, developed the therapeutic program used by RelieVRx.

From the comfort of their homes, injured workers follow a series of 56 chapters averaging approximately six minutes each. Each session builds upon the last to induce neuroplasticity, which helps to regulate the neural regions of the brain that are associated with pain.

AppliedVR has conducted extensive clinical research evaluating the RelieVRx program’s efficacy, including a large study with more than 1,000 participants that recently published in the Mayo Clinical Proceedings: Digital Health. Studies show that the device produces clinically meaningful reductions in both pain intensity and its interference with activities, sleep, mood, and stress both at end of treatment and 24 months post treatment.

In 2021, the RelieVRx program became the first and only FDA-authorized VR therapeutic for CLBP, and two years later AppliedVR became the first virtual reality provider to receive a unique Healthcare Common Procedure Coding System (HCPCS) Level II code from the Centers for Medicare and Medicaid Services for RelieVRx. Additionally, the RelieVRx program has been added to the Federal Supply Schedule and has been used by the Veterans Health Administration nationwide since early 2023.

To learn more about the workers’ compensation program, please see Workers Comp | RelieVRx.

About AppliedVR

Based in Van Nuys, California, AppliedVR is a pioneer in immersive therapeutics (ITx), a new category of medicine that treats intractable health conditions. Its flagship RelieVRx program is the first and only VR-based prescription therapeutic to receive Breakthrough Device and De Novo authorization by the FDA for CLBP. AppliedVR’s wellness programs have been trusted by more than 200 leading health systems and thousands of healthcare professionals globally, used by more than 60,000 patients. For more information, visit https://www.appliedvr.io/.

Contacts

Helen King Patterson, King Knight Communications, 813-690-4787, helen@kingknight.com

The study, “Comprehensive Cardiovascular Risk Factor Control with a Mobile Health Cardiovascular Risk Self-Management Program,” highlights the potential use of digital health technology in the comprehensive control of risk factors for cardiovascular disease (CVD), the leading cause of death and disability in the United States. The study is the largest and most robust of its kind to date, examining 102,475 Hello Heart users with high BP (hypertension) between January 2018 and December 2022. Users were equipped with Hello Heart’s connected heart health monitor and mobile app with digital coaching.

The Hello Heart monitor and app recorded BP, heart rate, and the appearance of irregular heartbeat. The app also recorded other significant heart health risk factors, such as cholesterol, weight, and physical activity via integration with external sources including electronic medical records and fitness trackers. In addition, users inputted and tracked medications related to their heart health (e.g. statins).

Based on these data points, the app used artificial intelligence (AI) and behavioral science to provide personalized and actionable heart health insights to participants, aligned with clinical guidelines – for instance, the correlation over time between a participant’s medication usage, physical activity, and trends in their key heart health metrics.

Results from the study showed that:

• At two years, participants with baseline systolic BP (SBP) above 140 mm Hg reduced SBP by 19 mm Hg.
• At 13 months, participants with baseline TC above 240 mg/dL reduced TC by 66 mg/dL.
• At 13 months, participants with baseline LDL-C above 160 mg/dL reduced LDL-C by 67 mg/dL.
• At 7.2 months, participants with baseline body mass index (BMI) above 30 kg/m2 lost 12 pounds, or 5.1% of their body weight.
• Interaction with Hello Heart’s lifestyle-based digital coaching was associated with greater reductions in BP, TC, LDL-C, and weight.

“Hypertension, high cholesterol, and obesity are among the most common risk factors of cardiovascular disease and mortality — but getting these risk factors under control can be very challenging,” said Edo Paz, MD, the study’s lead author and SVP, Medical Affairs, Hello Heart. “This study suggests that digital heart health management tools can make a significant, sustainable impact across these risk factors, and ultimately help people take control of their heart attack and stroke risk.”

“An estimated one in five Americans will die from cardiovascular disease, so the need for effective, scalable interventions is crucial,” said Erin Michos, MD, study co-author and Director, Women’s Cardiovascular Research and Associate Director, Preventive Cardiology, Johns Hopkins Medicine. “A growing body of evidence shows that accessible digital devices and apps are among the most scalable of these interventions, impacting everything from medication adherence to lifestyle behavior change.”

About the Study

Participants with hypertension, with or without dyslipidemia, enrolled in Hello Heart, a workplace-deployed mHealth app-based CV risk self-management program, between January 2018 through December 2022. Retrospective evaluation explored the influence of app engagement on changes in BP, TC, LDL-C and weight. Multiple regression analyses examined the influence of guideline-based, non-pharmacological lifestyle-based digital coaching on outcomes adjusting for confounders. Of 102,475 participants, 49.1% were female. Median age was 53 years, median BP was 134 mm Hg, median TC was 183 mg/dL, LDL-C was 106 mg/dL, and median BMI was 30 kg/m2.

About Hello Heart

Hello Heart is the digital leader in preventive heart health. We provide users with a connected blood pressure monitor and AI-driven digital coaching app. Through human-centric design, users receive tailored and actionable insights around healthy eating, activity, and medications. Users can also track key heart metrics like blood pressure and cholesterol unique to each person and consistent with clinical guidelines. By building a habit of monitoring heart health, users create sustained lifestyle changes. Validated in peer-reviewed studies, Hello Heart users achieve significant reductions in blood pressure and other cardiovascular risk factors over a sustained period. Founded in 2013, Hello Heart is a member of the American Heart Association’s Innovators’ Network and trusted by leading Fortune 1000 employers, national health plans and pharmacy benefit managers. Visit www.helloheart.com for more information.

Contacts

Andrew Padgett
media@helloheart.com

SAN FRANCISCO–(BUSINESS WIRE)–#capitalraise—Woebot Health today announced that it has won the “Mental Health Innovation Award” in the 8^th annual MedTech Breakthrough Awards program conducted by MedTech Breakthrough, an independent market intelligence organization that recognizes the top companies, technologies and products in the global digital health and medical technology market.

The honor recognizes the Woebot Health Platform, which is built on a foundation of clinically proven techniques and infused with artificial intelligence (AI). The platform offers instantly accessible, chat-based, adjunctive mental health support and the tools and insights needed to enhance the care experience, automate the collection of population insights and increase provider efficiency. The award also recognizes Woebot, the digital companion at the heart of the platform that delivers personalized, in-the-moment support through chat-based conversations and techniques. Woebot’s conversations are written by conversational writers using elements from evidence-based approaches like Cognitive Behavioral Therapy (CBT), Interpersonal Psychotherapy (IPT) and Dialectical Behavioral Therapy (DBT), along with collaboration from clinical experts.

“We’re thrilled and honored to once again receive an award from MedTech Breakthrough,” said Woebot Health CEO Michael Evers. “We’re seeing more real world evidence that shows how innovative digital solutions can help payors and providers better understand and serve member and patient populations, and become the foundation for even greater advancements in the future.”

The mission of the MedTech Breakthrough Awards is to honor excellence and recognize the innovation, hard work and success in a range of health and medical technology categories, including Telehealth, Clinical Administration, Patient Engagement, Electronic Health Records (EHR), Virtual Care, Medical Devices, Medical Data & Privacy, and many more. This year’s program attracted thousands of nominations from over 18 different countries throughout the world.

“Traditional mental health care is not always there when it’s needed, and mental health issues are front and center in a global conversation, especially with younger populations,” said Steve Johansson, managing director, MedTech Breakthrough. “’Woebot Health is addressing this challenge head on, standing as a mental health ally that is engaging people in their breakthrough mental health solutions at scale. We extend our sincere congratulations to the Woebot Health team for taking home our Mental Health Innovation Award in 2024.”

About Woebot Health

Woebot Health is the mental health ally for people and businesses that is answering the skyrocketing need for mental health support by breaking down the systemic constraints that block equal access to it. Our relational agent, Woebot, is at the heart of a powerful platform that can tailor products for specific intended uses and patient populations. It’s also the foundation of our solutions, which offer CBT-based support tools for adults, adolescents and new mothers. We work directly with virtual primary care companies, payers and IDNs to put scalable and validated mental health solutions directly in the hands of those who need them. For more information, visit woebothealth.com.

About MedTech Breakthrough

Part of Tech Breakthrough, a leading market intelligence and recognition platform for global technology innovation and leadership, the MedTech Breakthrough Awards program is devoted to honoring excellence and innovation in medical & health technology companies, products, services and people. The MedTech Breakthrough Awards provide a platform for public recognition around the achievements of breakthrough healthcare and medical companies and products in categories that include Patient Experience & Engagement, Health & Fitness, Medical Devices, Clinical Administration, Connected Healthcare, Medical Data, Healthcare Cybersecurity and more. For more information visit MedTechBreakthrough.com.

Tech Breakthrough LLC does not endorse any vendor, product or service depicted in our recognition programs, and does not advise technology users to select only those vendors with award designations. Tech Breakthrough LLC recognition consists of the opinions of the Tech Breakthrough LLC organization and should not be construed as statements of fact. Tech Breakthrough LLC disclaims all warranties, expressed or implied, with respect to this recognition program, including any warranties of merchantability or fitness for a particular purpose.

Disclaimers

The Woebot Health Platform is the foundational development platform where components are used for multiple types of products in different stages of development and enforced under different regulatory guidances.

Contacts

Margot Carlson Delogne
Woebot Health Communications
+1 781-492-1039
margot@woebothealth.com

Salerno, Italy | Newel Health, a pioneer in digital therapeutics, is pleased to announce the appointment of Ervin Ukaj as its new Chief Executive Officer. A proven leader with an extensive digital health background, Ervin is well-positioned to drive Newel Health’s impact in the healthcare industry. Ervin’s impressive career includes founding startups acquired through successful mergers and acquisitions with entrepreneurial stint at Oppimi and strategic roles at Novartis Pharmaceuticals.

Ervin will spearhead the commercialization of the company’s pioneering digital therapeutics portfolio. He also aims to expand Newel’s cardiovascular and neuroscience product pipelines through strategic partnerships leveraging the company’s H.Core framework for the rapid development and testing of novel digital therapeutic candidates.

As I step into the role of CEO at Newel Health, I’m driven by a deep sense of purpose, said Ervin Ukaj. ” Our journey in the digital therapeutic realm is about more than just navigating complexities; it’s about fostering understanding, collaboration, and innovation. Together, we’re on a mission to ensure that patients and providers alike recognize the incredible promise of digital therapeutics, backed by rigorous research and validation. We want to forge a future where healthcare isn’t just effective, but compassionate and tailored to each person’s unique needs.

“Ervin’s entrepreneurial experience combined with his field knowledge, make him ideally suited to usher Newel into this new chapter,” said Mauro Pretolani Senior Partner of the FITEC fund-Fondo Italiano d’Investimento SGR, an indirect investor in Newel Health. “Under his guidance, we expect that Newel will accelerate product adoption in this nascent industry.”

Ervin holds an executive MBA from Bologna Business School and an GMP from Harvard Business School.

For media inquiries or to connect with Ervin Ukaj, contact: media@newel.health

About Newel Health:
Newel Health is a pioneering company dedicated to enhancing the lives of individuals with health conditions and supporting the work of their healthcare providers by developing clinically validated digital medicines (DM) and digital therapeutics (DTx) solutions. The company partners with pharmaceutical, medical device, and wellness organizations to broaden its customer base and fulfill its vision for future healthcare. With a history of successful industry collaborations and a patient-centered approach, Newel Health consistently achieves positive outcomes.
The company actively develops new digital product ideas in neuroscience and cardiovascular health and aims to forge new partnerships to expand its DTx offerings. Additionally, Newel Health owns H.Core, a proprietary software framework that speeds up the design, validation, production, and launch of its DM and DTx solutions. Read more at: newel.health

The clearance is based on results of the Supporting Maternal Mental Health and Emotional Regulation (SuMMER) study, a national, sham-controlled, pivotal randomized controlled trial (RCT). The SuMMER study successfully met primary and key secondary endpoints for efficacy, as measured by EPDS scores.

PRINCETON, N.J. & NEW YORK–(BUSINESS WIRE)–Curio Digital Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has granted clearance to MamaLift Plus^TM. MamaLift Plus is the first prescription digital therapeutic for the treatment of postpartum depression (PPD), a complex mental health disorder affecting as many as one in seven women with a recent live birth experience.¹

MamaLift Plus is a prescription‐only digital therapeutic intended to provide neurobehavioral interventions to patients 22 years of and older, as an adjunct to clinician‐managed outpatient care. MamaLift Plus treats mild to moderate postpartum depression by improving a patient’s symptoms of depression.

MamaLift Plus delivers digital Cognitive Behavioral Therapy (CBT), Behavioral Activation Therapy (BAT), Interpersonal Therapy (IPT), and Dialectical Behavior Therapy (DBT) for postpartum depression. CBT, BAT, IPT, and DBT are neurobehavioral treatments which focus on addressing the maladaptive behaviors, routines, and dysfunctional thoughts that perpetuate during postpartum depression. MamaLift Plus can be used on a mobile device, such as a smartphone or tablet.

“MamaLift Plus opens a new chapter of prescribed digital therapeutics that provide women with a non-pharmaceutical alternative. I am happy to support this groundbreaking innovation,” said Jean-Pierre Lehner, MD, ex-Global CMO Sanofi, and Board of Director Curio.

The clearance of MamaLift Plus is based on results from the Supporting Maternal Mental Health and Emotional Regulation (SuMMER). SuMMER is a national, sham-controlled RCT. 141 participants who had recently had a live birth and were diagnosed with PPD were enrolled in the study.

“Our goal has always been to provide innovative solutions for women’s health, specifically around the challenges they face with behavioral health. MamaLift Plus is the first and only digital solution that can help address the serious unmet need uniquely faced by women who have recently delivered,” said Shailja Dixit, MD, MPH, MS, CEO & Founder of Curio Digital Therapeutics.

The study met its primary endpoint, improvement of four or more points on the Edinburgh Postnatal Depression Scale (EPDS). The EPDS is a clinically validated screener that is recommended by the American College of Obstetricians and Gynecologists (ACOG). In the intent-to-treat (ITT) population, 86.3% (82/95) of participants in the MamaLift Plus arm achieved a clinically meaningful improvement, versus in the sham control arm, where only 23.9% (11/46) of participants achieved a four-point improvement with a p-value <0.0001.

“This is an incredible development for women suffering from postpartum depression who are looking for non-pharmaceutical alternatives given the shortage of trained mental health professionals,” said Alice D. Domar, PhD, top women’s health expert, Curio Scientific Advisor.

Further details of the study are available in the Instructions For Use, available here.

To learn more about MamaLift Plus and sign up for updates, click here. Healthcare providers can access additional information at https://curiodigitaltx.com/.

INDICATION FOR USE

MamaLift Plus is a prescription‐only digital therapeutic intended to provide neurobehavioral interventions to patients 22 years of and older, as an adjunct to clinician‐managed outpatient care. MamaLift Plus treats mild to moderate postpartum depression by improving a patient’s symptoms of depression.

SAFETY INFORMATION

MamaLift Plus is not intended to be used as a stand-alone treatment. MamaLift Plus may not be appropriate for everyone. Patients with severe depression or anxiety, Serious Mental Illness (SMI), psychosis, suicidal thoughts, or who are under the age of 22 should not use MamaLift Plus. Patients should dial 911 or go to the nearest emergency room in the event of a medical emergency. MamaLift Plus is intended to be used under the supervision of a qualified health care provider.

ABOUT SUMMER

SuMMER is a national, sham-controlled, pivotal randomized controlled trial (RCT). The study enrolled 141 participants who had recently given birth and were diagnosed with PPD. Participants were randomized to the MamaLift Plus arm or the sham control arm. Participants were blinded to knowledge of their treatment arm. Participants used MamaLift Plus or sham control every day for eight weeks. Efficacy was measured using the EPDS scale.

ABOUT POSTPARTUM DEPRESSION

Postpartum depression is estimated to affect approximately one in seven women who have given birth in the U.S. or approximately 500,000 women annually.^1,2 Postpartum depression (PPD) is one of the most common medical complications during and after pregnancy.³ Clinical guidelines for treatment of postpartum depression recommend medication and cognitive behavioral therapy. However, many women may not be able to access these medications and treatments due to national shortages in mental health providers, insurance coverage, childcare challenges, transportation issues, or breastfeeding status. Hence, there is an unmet need for novel treatment modalities.

ABOUT PRESCRIPTION DIGITAL THERAPEUTICS

Digital therapeutics are health software intended to treat or alleviate a disease, disorder, condition, or injury by generating and delivering a medical intervention that has a demonstrable positive therapeutic impact on a patient’s health.⁴ A prescription digital therapeutic (PDT) is a digital therapeutic only available to patients by a prescription from a healthcare provider. PDTs can be used independently or in conjunction with medications, devices, or other therapies to optimize patient care under the guidance of their healthcare provider.⁵ As a new modality of treatment, PDTs deliver medical interventions directly to patients from their smartphones using software programs that are subject to clinical evidence requirements and regulatory oversight and are recognized as medical devices by the FDA.

ABOUT CURIO DIGITAL THERAPEUTICS, INC.

Curio Digital is a pioneer in developing digital therapeutics solutions and interventions across the behavioral health continuum for women throughout the cycle of life. Curio aims to create a world where every woman can access a behavioral health solution at her fingertips. Curio is reshaping maternal mental health care by leveraging proprietary algorithms, clinically validated screening tools, and personalized digital behavioral interventions to facilitate timely identification and care. Curio aspires to make women’s health products and solutions across their life cycle. MamaLift Plus is a prescription-only digital therapeutic intended to provide neurobehavioral interventions to patients 22 years of age and older, as an adjunct to clinician-managed outpatient care. Curio’s AI-driven predictive algorithm, Curio-I, identifies and risk stratifies women who would go on to develop common behavioral health conditions. For more information, visit Curio at www.curiodigitaltx.com.

CITATIONS

1. March of Dimes. https://www.marchofdimes.org/find-support/topics/postpartum/postpartum-depression#:~:text=PPD%20is%20the%20most%20common,women%20(about%2015%20percent).
2. Bauman BL, et al. Morbidity and Mortality Weekly Report, 2020;69(19):575-581.X
3. “ACOG Committee Opinion No. 757: Screening for Perinatal Depression.” Obstetrics and gynecology vol. 132, 5 (2018): e208-e212. Doi:10.1907/AOG.0000000000002927.
4. Digital Therapeutics Alliance. www.dtxalliance.org FACT SHEET DTA’s Adoption & Interpretation of ISO’s DTx Definition. Accessed February 13, 2024. https://dtxalliance.org/wp-content/uploads/2023/06/DTA_FS_New-DTx-Definition.pdf
5. Digital Therapeutics for Management and Treatment in Behavioral Health. Accessed February 5, 2024. https://store.samhsa.gov/sites/default/files/pep23-06-00-001.pdf

Contacts

Director of Product & Marketing
Robert Keough
RobertK@curiodigitaltx.com