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Digital therapy maker Pear Therapeutics shakes the money tree, with plans to go public in $1.6B SPAC deal

On June 22, 2021 Pear Therapeutics reported that it is taking the SPAC track, going public through a deal expected to provide about $400 million in new funding as the company looks to expand its prescription apps to a wider range of conditions (Press release, Pear Therapeutics, JUN 22, 2021, View Source [SID1234584359]).

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Those proceeds include $125 million gathered from private investments in Pear’s newfound public equity, plus $276 million held by Thimble Point Acquisition Corp., a blank-check company backed by the Pritzker Vlock Family Office, whose investment portfolio spans several medtech and biotech companies.

Following the closure of the deal—which represents a total pro forma equity value of about $1.6 billion—the newly combined Pear Holdings Corp. is expected to begin trading on the Nasdaq, under the ticker PEAR, before the end of this year with its current management in place.

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"In our view, Pear is at a commercial inflection point, with the potential for rapid expansion," President and CEO Corey McCann said in a statement.

The company’s ultimate goal is to provide a platform for clinically validated prescription digital therapeutics, or PDTs, either as stand-alone software treatments or alongside pharmaceuticals for major medical conditions, McCann said.

RELATED: SoftBank’s Vision Fund backs Pear Therapeutics in $80M VC round to forge new market paths for digital treatment apps

The private investment round includes participation from 5AM Ventures, Arboretum Ventures, Blue Water Science Advisors, Novartis’ dRx Capital, The Eleven Fund, FORTH Management, Health Innovation Capital, JAZZ Venture Partners, Neuberger Berman funds, Palantir, Pilot House, QUAD Investment Management, Sarissa Capital, Shanda Group, SoftBank Vision Fund 2, Temasek and Trustbridge Partners.

Earlier this year, Pear announced plans to make its digital therapies a little more tangible, with the addition of wearable sensors and activity trackers through a partnership with the medical smartwatch maker Empatica, plus a digital pill project with etectRx for tracking drug adherence.

Previously, Pear focused on treating addiction and substance use disorders by offering cognitive behavioral therapy through its FDA-cleared reSET and reSET-O software programs, with the latter focused on opioids.

RELATED: Pear Therapeutics launches digital insomnia app through direct-to-patient telehealth model

In November 2020, the former Fierce 15 winner launched its app for insomnia, Somryst, through a direct-to-patient telehealth model, combining telemedicine visits with the digital delivery of the prescription app.

Late last year also saw Pear raise $80 million in a venture capital round backed by SoftBank’s Vision Fund 2, among others, to help support the company’s push to secure reimbursement coverage for Somryst and its reSET offerings.

Around the same time, the Institute for Clinical and Economic Review—the U.S. drug pricing watchdog known as ICER—threw cold water on multiple digital therapeutics for opioid use disorder, including reSET-O, saying it could not find strong evidence that the apps provided benefits over long time periods.

Pear, meanwhile, pointed to real-world data showing that users were able to complete the software’s therapy modules outside of normal clinic hours, with 88% passing drug screenings and 85% remaining in active treatment for months. An additional, retrospective economic analysis showed fewer hospitalizations and emergency room visits.

RELATED: Pear Therapeutics to take digital treatments physical with sensor, activity tracker deals

Since then, the company raised another $100 million through a series D round closed in March. Its pipeline currently has 14 product candidates, including for alcohol use disorder, schizophrenia, post-traumatic stress disorder, bipolar disorder, anxiety and depression, as well as chronic pain, migraines, multiple sclerosis, cancer and a range of chronic conditions.

Biogen to Participate in SVB Leerink’s 3rd Annual CNS Forum

On June 22, 2021 Biogen Inc. (Nasdaq: BIIB) reported that it will participate in SVB Leerink’s 3rd Annual CNS Forum. The webcast will be live on Tuesday, June 29, at 1:50 p.m. ET (Press release, Biogen, JUN 22, 2021, View Source [SID1234584282]). To access the live webcast, please go to the investors section of Biogen’s website at investors.biogen.com. An archived version of the webcast will be available following the presentation.

Termination of a Material Definitive Agreement

On June 22, 2021, United Therapeutics Corporation (the "Company") and Medtronic, Inc. ("Medtronic") reported that agreed to discontinue further efforts to develop and commercialize the Implantable System for Remodulin ("ISR") (Filing, 8-K, United Therapeutics, JUN 23, 2021, View Source [SID1234584280]). By way of background, the ISR has been developed over the past 12 years in collaboration with Medtronic to deliver Remodulin (treprostinil) Injection for patients with pulmonary arterial hypertension ("PAH") via an implantable system developed by Medtronic. On February 25, 2019, Medtronic and the Company entered into a Commercialization Agreement governing the parties’ collaboration to commercialize the ISR in the United States (the "Commercialization Agreement"). Despite approval by the U.S. Food and Drug Administration ("FDA") of Medtronic’s premarket approval application ("PMA") for the ISR in December 2017, commercial launch of the product required Medtronic, as the applicant, to satisfy certain conditions to its PMA approval. Based on the evolution of treatment options and paradigms in PAH over the past few years, and the anticipated efforts required to satisfy the FDA’s conditions of approval, the Company and Medtronic have decided to discontinue further efforts to develop and commercialize the ISR. The Company and Medtronic plan to work together on a mutually-agreed approach to wind-down the development program, and to support patients already enrolled in clinical studies of the ISR, at the Company’s sole expense. Effective June 22, 2021, the parties mutually agreed to terminate the Commercialization Agreement. There were no penalties associated with the termination of the Commercialization Agreement.

Grant of Restricted Stock Units and Warrants to Employees in Genmab

On June 22, 2021 Genmab A/S (Nasdaq: GMAB) reported that at a board meeting the board decided to grant 15,241 restricted stock units and 16,335 warrants to employees of the company and three of the company’s subsidiaries (Press release, Genmab, JUN 22, 2021, View Source [SID1234584260]).

Each restricted stock unit is awarded cost-free and provides the owner with a right to receive one share in Genmab A/S of nominally DKK 1. The fair value of each restricted stock unit is equal to the closing market price on the date of grant of one Genmab A/S share, DKK 2,698.

The restricted stock units will vest on the first banking day of the month following a period of three years from the date of grant. Furthermore, the restricted stock units are subject to vesting conditions set out in the restricted stock unit program adopted by the board of directors in accordance with the Remuneration Policy adopted by the shareholders at the annual general meeting. Information concerning Genmab’s restricted stock unit program can be found on www.genmab.com under Investors > Governance > Compensation > Restricted stock units.

The exercise price for each warrant is DKK 2,698. Each warrant is awarded cost-free and entitles the owner to subscribe one share of nominally DKK 1 subject to payment of the exercise price. By application of the Black-Scholes formula, the fair value of each warrant can be calculated as DKK 839.14.

The warrants vest three years after the grant date, and all warrants expire at the seventh anniversary of the grant date. The new warrants have been granted on the terms and conditions set out in the warrant program adopted by the board of directors on February 23, 2021. Information concerning Genmab’s warrant schemes can be found on www.genmab.com under Investors > Governance > Compensation > Warrants.

Photocure: Asieris Announces First Patient Administration in Europe within the Phase III Clinical Trial for APL-1702 (Cevira)

On June 22, 2021 Photocure ASA (OSE:PHO) reported that its partner Asieris Pharmaceuticals (Asieris) has administered the first European patient in its phase III clinical trial for APL-1702 (Cevira) (Press release, PhotoCure, JUN 22, 2021, View Source [SID1234584253]).

Asieris announced dosing of the first patient in Europe in its multinational, multicenter, Phase III clinical trial called APRICITY that started last November. The photodynamic drug-device combination product APL-1702, Cevira, licensed to Asieris by Photocure, is being developed for a novel non-surgical treatment of cervical high-grade squamous intraepithelial lesions (HSIL).

"The multinational phase III clinical trial for Cevira is an important milestone towards a non-surgical treatment of high-grade cervical dysplasia. This step shows once more that our partner Asieris is making great progress and is on track with their clinical program and development of this innovative photodynamic drug-device combination," says Daniel Schneider, Chief Executive Officer of Photocure.

In China, the clinical trial application for APL-1702, Cevira multinational Phase III trial was approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in July 2020. Photocure reported Asieris’ dosing of the first patient in China on November 11, 2020 (View Source).

HSIL is a pre-cancerous condition caused by a persistent HPV infection. Each year there are approximately 10 million cases of high-grade disease and over 500,000 new cases of cervical cancer worldwide. In China, approximately 2% of women develop HSIL each year.