• Pear Therapeutics announces the acquisition and license of two digital therapeutic assets designed to treat patients with a range of depression symptoms

• Pear is developing a prescription digital therapeutic (PDT) candidate that may be developed for use alone or in combination with pharmacotherapy to treat patients across a continuum of depression subtypes and severities

• Pear intends to incorporate both newly acquired and licensed assets into Pear’s depression candidate, which will require clinical evaluation, and if promising, would then be evaluated in a potential pivotal clinical trial to support FDA submission

• Depression represents one of the largest areas of unmet medical need in mental and behavioral health with more than 19 million U.S. patients suffering from depression before the COVID-19 pandemic¹ with an estimated health economic cost of approximately $326 billion per year²

Pear Therapeutics, Inc. (Nasdaq: PEAR), the leader in developing and commercializing software-based medicines called prescription digital therapeutics (PDTs), announced today the continued development of its PDT product candidate pipeline. Pear acquired and/or licensed two new digital therapeutic assets, from Waypoint Health Innovations, LLC and a researcher named Fredrik Holländare of Örebro University, that are designed for the treatment of a spectrum of depression conditions. Pear intends to leverage these two new assets to expand its depression product candidate to treat mild, moderate, severe, and treatment-refractory depression.

Pear’s depression product candidate is being developed to be used alone or in combination with other treatments to help patients with a wide range of depression symptoms. Pear intends to incorporate both newly acquired and licensed assets into Pear’s depression candidate, which will require clinical evaluation, and if promising, would then be evaluated in a potential pivotal clinical trial to support FDA submission.

The asset acquired from Waypoint Health Innovations, is a digital therapeutic designed for treatment of depression based on structured and proven cognitive behavioral therapy (CBT) techniques. CBT is recommended as treatment for depression by the American Psychiatric Association.³ The Waypoint asset delivers CBT through the use of standardized symptom assessments, video, interactive tools, and algorithms that dynamically personalize each individual’s experience. The Waypoint asset has been the subject of published, preliminary clinical studies but has not been submitted to FDA for review. Pear believes the Waypoint asset has the potential to deliver treatment for depression of varying severity.

For example, in a randomized controlled trial of the Waypoint asset, 343 adults with depression symptoms received either usual care or usual care plus the Waypoint asset and were evaluated for changes in depression and anxiety symptom severity, work and social functioning, and psychological resilience.⁴ Over the 8-week comparison period, the group using the Waypoint asset experienced significantly greater improvement on all four measures compared to those who received usual care alone (each P<.001) with the outcome measures of PHQ-9, GAD-7, WSAS (Work and Social Adjustment Scale) and CD-RISC10 (ten-item Connor-Davidson Resilience Scale). The effect on depression symptoms was one of the largest reported for a CBT digital therapeutic delivered without clinician interaction. Participants who received access to the Waypoint asset maintained their improvement on all four measures throughout the 12-month evaluation period.⁵ Three other published studies evaluated earlier versions of the Waypoint asset.^6-8

The Holländare asset involves internet-based CBT (iCBT) for the treatment of residual symptoms of depression and is aimed at preventing relapse. The treatment centers around nine modules, including an introduction to CBT and depression module, two modules on behavioral activation, cognitive restructuring, sleep and relaxation, mindfulness, physical activity, reducing anxiety, and defining long-term goals. The Holländare asset has been the subject of a published, preliminary clinical study but has not been submitted to FDA for review. Pear believes this asset has the potential to deliver treatment for relapsing depression.

For example, in a randomized controlled trial, 84 patients with residual symptoms of depression were assigned to either 10 weeks iCBT or to a control condition. The primary outcome was relapse in depression according to the DSM-IV criteria. This was established by structured clinical interviews by a psychologist. Results showed that iCBT significantly reduced the proportion of relapse compared with the control condition (P = 0.006). In the group that received iCBT, 10.5% compared with 37.8% in the control condition experienced relapse during the first 6 months.⁹ The follow up of the two groups continued, and after 24 months 13.7% of patients had relapsed in the iCBT group compared with 60.9% in the control group, showing a strong durable effect from the intervention of iCBT.¹⁰

“The addition of these depression assets to our portfolio fits squarely in our near-term focus to expand our leadership in psychiatry. With these deals, we have the potential to optimize our depression PDT candidate to help address one of the largest patient populations in mental and behavioral health,” said Corey McCann, President and CEO of Pear Therapeutics.

The COVID-19 pandemic has significantly worsened depression in the U.S. over the last two years. In 2019, an estimated 7.8% of all U.S. adults had at least one major depressive episode and approximately 35% did not receive any type of treatment.¹ A recent study by Brown University and Boston University found that in 2021, 32.8% of U.S. adults experienced depressive symptoms compared to 27.8% of adults in the beginning of the pandemic and 8.5% before the pandemic.¹¹ This rapid increase in depressive symptoms due to the pandemic highlights the ever-increasing need for new modes of treatment for depression.

Pear’s end-to-end platform discovers, develops, and delivers PDTs to patients. Pear’s platform is designed to be scalable with the ability to host multiple PDTs developed by Pear and potentially by third parties. Pear’s development platform, PearCreate™, is aimed toward the development of PDT candidates, and Pear’s commercial platform, PearConnect™, is aimed toward the commercialization of PDT products.

About Pear Therapeutics

Pear Therapeutics, Inc., which is traded on Nasdaq as PEAR, is the parent company of Pear Therapeutics (US), Inc. Pear is the leader in developing and commercializing software-based medicines, called prescription digital therapeutics (PDTs). Pear aims to redefine care through the widespread use of clinically validated software-based therapeutics to provide better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers. Pear has the first end-to-end platform to discover, develop, and deliver PDTs to patients and a pipeline of products and product candidates across therapeutic areas, including the first three PDTs with disease treatment claims from the FDA. Pear’s product, reSET^®, for the treatment of substance use disorder, was the first PDT to receive marketing authorization from the FDA to treat disease. Pear’s second product, reSET-O^®, for the treatment of opioid use disorder, was the first PDT to receive Breakthrough Designation. Pear’s third product, Somryst^® for the treatment of chronic insomnia, was the first PDT submitted through FDA’s traditional 510(k) pathway while simultaneously reviewed through FDA’s Software Precertification Pilot Program. For more information, visit Pear at www.peartherapeutics.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the federal securities laws that are subject to risks and uncertainties and other factors which could cause actual results to differ materially from those expressed or implied by such forward looking statements. Forward looking statements generally relate to future events or involving, or future performance of, Pear. For example, statements regarding Pear’s intent to leverage the two Waypoint Health Innovations assets to expand its depression product candidate to treat mild, moderate, severe, and treatment-refractory depression and the potential for these products to deliver treatment for depression are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “pro forma”, “may”, “should”, “could”, “might”, “plan”, “possible”, “project”, “strive”, “budget”, “forecast”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology.

These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Pear and its management are inherently uncertain. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (i) Pear’s ability to develop a PDT for depression with or without the Waypoint asset or the Holländare asset; (ii) Pear’s ability to obtain FDA authorization or approval for such PDT; (iii) Pear’s ability to successfully commercialize such PDT; (iv) changes in applicable laws or regulations; (v) the possibility that Pear may be adversely affected by other economic, business, regulatory, and/or competitive factors; (vi) Pear’s estimates of expenses and profitability; (vii) the evolution of the markets in which Pear competes; (viii) the ability of Pear to implement its strategic initiatives and continue to innovate its existing products; (ix) the ability of Pear to defend its intellectual property and satisfy regulatory requirements; (x) the ability of Pear to issue equity or equity-linked securities in the future; (xi) the impact of the COVID-19 pandemic on Pear’s business; and (xii) other risks and uncertainties set forth in Pear’s filings with the SEC (including those described in the Risk Factors section). These filings will identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements.

Readers are cautioned not to put undue reliance on forward-looking statements, and Pear assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Pear gives no assurance that Pear will achieve its expectations. The inclusion of any statement in this communication does not constitute an admission by Pear or any other person that the events or circumstances described in such statement are material.

References:

1. https://www.nimh.nih.gov/health/statistics/major-depression.
2. https://www.analysisgroup.com/Insights/cases/quantifying-the-economic-burden-of-depression.
3. Gelenberg AJ, Freeman MP, Markowitz JC, et al. American Psychiatric Association Practice Guideline for the Treatment of Patients With Major Depressive Disorder, Third Edition. Am J Psychiatry. 2010.
4. Schure MB, Lindow JC, Greist JH, Nakonezny PA, Bailey SJ, Bryan WL, Byerly MJ. Use of a Fully Automated Internet-Based Cognitive Behavior Therapy Intervention in a Community Population of Adults With Depression Symptoms: Randomized Controlled Trial. J Med Internet Res 2019;21(11):e14754 DOI: 10.2196/14754.
5. Schure M, McCrory B, Franklin K, Greist J, Weissman R. Twelve-month follow-up to a fully automated internet-based cognitive behavior therapy intervention for community-dwelling adults with depression symptoms. J Med Internet Res. 02/09/2020:21336 (forthcoming/in press) DOI: 10.2196/21336.
6. Whiteside U, Richards J, Steinfeld B, Simon G, Caka S, Tachibana C, Stuckey S, Ludman E. Online cognitive behavioral therapy for depressed primary care patients: a pilot feasibility project. Perm J. 2014 Spring;18(2):21-7.
7. Marks IM, Mataix-Cols D, Kenwright M, Cameron R, Hirsch S, Gega L. Pragmatic evaluation of computer-aided self-help for anxiety and depression. Br J Psychiatry. 2003 Jul;183:57-65.
8. Osgood-Hynes DJ, Greist JH, Marks IM, Baer L, Heneman SW, Wenzel KW, Manzo PA, Parkin JR, Spierings CJ, Dottl SL, Vitse HM. Self-administered psychotherapy for depression using a telephone-accessed computer system plus booklets: an open U.S.-U.K. study. J Clin Psychiatry. 1998 Jul;59(7):358-65.
9. Holländare, F., Johnsson, S., Randestad, M., Tillfors, M., Carlbring, P., Andersson, G., Engström, I. (2011) Randomized trial of Internet-based relapse prevention for partially remitted depression. Acta Psychiatrica Scandinavica: 124, 285-294.
10. Holländare, F., A Anthony, S., Randestad, M., Tillfors, M., Carlbring, P., Andersson, G., Engström, I. (2013) Two-year outcome of internet-based relapse prevention for partially remitted depression. Behaviour Research and Therapy, 51, 719-722.
11. https://www.brown.edu/news/2021-10-05/pandemic-depression.

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