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Entry into a Material Definitive Agreement

On June 22, 2021, BioXcel Therapeutics, Inc. (the "Company") reported that entered into an underwriting agreement (the "Underwriting Agreement") with BofA Securities, Inc., as representative of the several underwriters named therein (collectively, the "Underwriters") and the selling stockholder named therein (the "Selling Stockholder"), in connection with the issuance and sale by the Company in a public offering of 3,155,000 shares of the Company’s common stock at a public offering price of $31.70 per share, less underwriting discounts and commissions, pursuant to an effective shelf registration statement on Form S-3ASR (Registration No. 333-240118) and a related prospectus supplement filed with the Securities and Exchange Commission (the "SEC") (Filing, 8-K, BioXcel Therapeutics, JUN 22, 2021, View Source [SID1234584368]). Under the terms of the Underwriting Agreement, the Selling Stockholder has also granted the Underwriters an option exercisable for 30 days to purchase up to an additional 473,250 shares of common stock at the public offering price, less underwriting discounts and commissions. The Company will not receive any of the proceeds from any sale of shares in the offering by the Selling Stockholder.

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The Company received net proceeds from the offering of approximately $96.8 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. The Company intends to use the net proceeds of the offering to fund ongoing clinical trials, commercialization preparation and for general corporate purposes.

The Underwriting Agreement contains customary representations, warranties and agreements by the Company and the Selling Stockholder, customary conditions to closing, indemnification obligations of the Company, the Selling Stockholder and the Underwriters, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties and termination provisions.

The foregoing description of the Underwriting Agreement is not complete and is qualified in its entirety by reference to the full text of the Underwriting Agreement, a copy of which is filed as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated by reference herein. An opinion of Latham & Watkins LLP regarding the validity of the shares to be issued and sold in the offering by the Company is filed as Exhibits 5.1 and an opinion of the Company’s Chief Legal Officer regarding the validity of the shares to be sold in the offering by the Selling Stockholder is filed as Exhibit 5.2.

Based on the planned use of proceeds from the offering, the Company believes that the net proceeds from the offering and its existing cash and cash equivalents will be sufficient to enable it to fund operating expenses and capital expenditure requirements into the first half of 2023. The Company has based this estimate on assumptions that may prove to be incorrect, and could utilize available capital resources sooner than currently expected. The amounts and timing of the Company’s actual expenditures will depend on numerous factors, including the progress of the Company’s clinical trials and other development efforts and other factors, as well as the amount of cash used in the Company’s operations.

AI-driven biotech firm Insilico Medicine raises $255 mln in new financing

On June 22, 2021 Hong Kong-based company Insilico Medicine, which uses artificial intelligence (AI) for drug discovery and development, reported that it has raised $255 million in a new funding round by U.S. private equity firm Warburg Pincus , it said on Tuesday (Press release, Insilico Medicine, JUN 22, 2021, View Source [SID1234584360]).

The fundraising attracted nearly 20 investors according to the company’s announcement, including CPE, Sequoia Capital China and Mirae Asset Capital.

Existing investors including Qiming Venture Partners, Sinovation Ventures and Baidu Ventures also joined in the funding round.

Insilico did not disclose its valuation in the release.

Founded in 2014 by Scientist Alex Zhavoronkov, Insilico develops AI systems that utilize deep generative models, reinforcement learning (RL), transformers, and other modern machine learning techniques for the generation of new molecular structures with specific properties.

It also develops software for the generation of synthetic biological data, target identification, and the prediction of clinical trials outcomes.

The new funds raised will be used to progress Insilico’s current therapeutic programs into human clinical trials, initiate multiple new programs for novel and difficult targets, and further develop its AI and drug discovery capabilities, the company said.

The company is known for its 2019 research about its development of an AI system that was able to design a drug in 21 days and was named a 2020 breakthrough technology by MIT Technology Review.

It now operates in six locations worldwide with over 160 scientists, according to its website.

The company has raised over $310 million from expert pharmaceutical, and technology investors since its inception, it said. (Reporting by Kane Wu)

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]).

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.