Thimble Point Acquisition

Mar 31, 2022

Nicole DeFeudis Editor Not so bad for its first earnings report. In a quarterly call on Monday, Pear Therapeutics CEO Corey McCann celebrated the company’s “strong financial results” since jumping onto Nasdaq last year — work he says will lay the foundation for an even more fruitful year ahead. Pear $PEAR raked in $4.2 million last year, coming in just above its forecast of $4 million. Execs tracked a drop in total revenue year-over-year due to a one-time collaboration payment of $9.2 million — but the company thinks a 24-fold boost in sales from two of its prescription digital therapeutics (PDTs) is a good sign of growth to come. Next year, Pear is pegging a massive $22 million in total revenue. “The pandemic seems to have turned a digital health evolution into a digital health revolution. And PDTs are part of that digital health revolution. The space is exploding,” McCann said on the company’s Q4 call. Pear backflipped onto Nasdaq back in December when it completed a SPAC merger with Thimble Point Acquisition Corp, generating $175 million in the process. And as a newly public company, its priorities will be expanding payer coverage for its PDT products, increasing adoption, and growing out the platform. reSET and reSET-O are Pear’s currently authorized PDTs for the treatment of substance abuse and opioid use disorder, respectively. While reSET is currently cleared for addiction to cannabis, cocaine and stimulants (as well as alcohol in combination with any of those substances), the company says it’s exploring a potential expansion into alcohol use disorder alone. There’s also Somryst, its chronic insomnia product authorized back in 2020. The overall goal is to treat disease through software, McCann said on the call, using therapeutic interventions through a smartphone or tablet. For example, Somryst is designed to provide Cognitive Behavioral Therapy for insomnia (CBTi). It’s driven by algorithms made to improve the symptoms of insomnia, and it allows patients to do things like set a sleep window. It’s not your typical wellness app, McCann emphasized — all of Pear’s products pursue “similar regulatory standards as pharmacotherapy in terms of safety, effectiveness, indications for use and quality.” The products generated more than 14,000 prescriptions last year, well over the 12,500 Pear execs had forecasted. They also achieved more than 31 million lives covered, just over the low end of Pear’s predictions for the year. Chris Guiffre “We think Pear’s rapid acquisition of covered lives in 2021 driven by real-world outcomes data is a great reason to believe PDTs are here to stay,” McCann said. Looking ahead to 2022, Pear is anticipating 50,000 to 60,000 new prescriptions, and between 100 million and 120 million covered lives. And they’re hoping for $22 million in earnings. “We believe we’ve shown strong execution so far as a public company, just as we did as a private company,” CFO and COO Chris Guiffre said. “Our track record of execution in 2021 allowed us to meet our revenue guidance for the year while building the capability to excel in 2022 and beyond.” AUTHOR Amber Tong Senior Editor In a disappointing setback for one of the brightest candidates in the next-gen checkpoint race, tiragolumab — Roche’s “breakthrough” TIGIT drug — has failed a Phase III trial. The candidate failed to meet the co-primary endpoint of progression-free survival among a group of patients with extensive-stage small cell lung cancer (ES-SCLC), Roche disclosed Wednesday morning. Overall survival, the other co-primary endpoint in the SKYSCRAPER-02 study, was not met at the interim analysis and is “unlikely to reach statistical significance at the planned final analysis,” the company added. Keep reading Endpoints with a free subscription Unlock this story instantly and join 137,600+ biopharma pros reading Endpoints daily — and it's free. SIGN UP Biohaven’s newest “celebrity” is also its top science leader. CSO Charlie Conway is hosting its new unbranded video series “Ideahaven: Migraine Voices.” The monthly series launched last month will tap physicians, advocates and people living with migraine to cover topics from stigma to therapies. However, the maker of Nurtec ODT and well-known for its celebrity spokespeople, isn’t totally stepping away from famous faces in the unbranded work. The first guest on Conway’s show is country music singer Allie Sealey who talks about her migraine experience and about the song she wrote for the migraine community called “Not All in Your Head.” Keep reading Endpoints with a free subscription Unlock this story instantly and join 137,600+ biopharma pros reading Endpoints daily — and it's free. SIGN UP John Carroll Editor & Founder Humira hit another big record in megablockbuster history in 2021, breaking the $20 billion mark in sales and steering the company to a stellar 22% spike in annual revenue as new drugs in the portfolio gained traction. And the board didn’t neglect CEO Rick Gonzalez’s reward. The chief who steered the company through the division at Abbott in 2013 and laid out a clear promise of increasing sales for their aging cash cow while promising to deliver new products picked up a pay package last year worth $23.9 million. Read More March 30, 2022 04:52 PM EDTUpdated 07:21 PM Max Gelman Editor In a marathon hearing Wednesday, outside FDA advisors recommended to the agency that a single randomized study did not provide conclusive proof over whether an experimental ALS drug is effective. Panelists voted 6-4 in the negative, substantiating the agency’s concerns about the robustness of data in a Phase II study run by Amylyx Pharmaceuticals — by the slimmest possible margin. The drug, known as AMX0035, produced a statistically significant reduction on a functional rating scale, but the effect proved unconvincing to the committee. Keep reading Endpoints with a free subscription Unlock this story instantly and join 137,600+ biopharma pros reading Endpoints daily — and it's free. SIGN UP Paul Schloesser Associate Editor In yet another opioid settlement, Florida is the next state to agree to a deal — but not without making sure it’s getting what it thinks is due. The state of Florida reached a settlement with CVS, Endo, Teva and Allergan for a combined $878 million, Florida AG Ashley Moody said in a press release on Wednesday. More than half — $484 million — comes from CVS, with another $195 million from Teva, $134 million from Allergan and $65 million from Endo. All the deals include the official “settlement amount,” plus legal fees ranging into the millions. Read More