Sorrento Mesa-based Crinetics Pharmaceuticals’ (CRNX: NASDAQ) stock went soaring following the release of its initial findings from a late-stage study over its novel therapeutic aimed at treating acromegaly, a rare but serious growth hormone disease. If approved by the FDA, the drug – paltusotine – would be the company’s first product to hit the commercial market.
Founder & CEO
Crinetics
Shares sat at $15.97 before the Sept. 10 announcement, which catapulted the value more than 80% to close last week $29.49, putting shares at their highest point since January of 2019. The enterprise value has risen to nearly $1.4 billion.
Following the release of the study results, Crinetics announced an upsized underwritten public offering of 11,441,648 shares of its common stock at a price to the public of $30.59 per share, with gross proceeds expected to raise approximately $350 million.
“This positive Phase 3 data shows we are really onto something here – it’s a very exciting time for all of us who have worked so hard to bring this molecule forward,” Crinetics Founder and CEO Dr. Scott Struthers, PhD said. “The impact we can have on people, helping them live their lives without constantly worrying about controlling their disease keeps us motivated.”
Patients Report Positive Results
The randomized, double-blind, placebo-controlled 36-week study findings revealed that 83% of patients taking the compound achieved positive results by being able to maintain levels of IGF-1, a type of growth hormone.
When the body produces too much growth hormone, it can cause tissues and bones to grow more quickly, called acromegaly. “Acromegaly happens when growth hormone (GH) producing cells in the pituitary form a benign tumor that makes too much GH which then causes the liver to make too much [IGF-1]. In people with acromegaly, IGF-1 levels in the blood can be many times the upper limit of normal. It’s rare, but if this tumor forms in children, they can grow to be exceedingly tall, and this is called gigantism. However, most of the time acromegaly occurs in adults who can’t grow any taller, but then a whole bunch of other problems are caused by having too much GH and IGF-1,” added Dr. Struthers. If untreated, acromegaly can lead to serious health problems and possibly death.
Symptoms usually develop in middle-aged adults who may experience headaches, joint aches, fatigue, sleep apnea, severe sweating, oily skin, bone and cartilage overgrowth, abnormal growth of hands and feet, enlargement of the heart and liver, among other organs, and altered facial features.
A 2017 study published in the National Institutes of Health’s National Library of Medicine found that prevalence ranges between 2.8 and 13.7 cases per 100,000 people.
Putting on the Brakes
Crinetics’ investigational drug, paltusotine, mimics the action of somatostatin, the hormone that puts the brakes on GH production. If approved, the once daily oral drug would provide easier treatment options for patients who currently resort to monthly injections. “These injections usually control IGF-1 levels but [use] large gauge needles that are commonly associated with pain, injection site reactions and an increased burden on the lives of patients (for example, they have to be given by a healthcare professional at a hospital that can be far away from a patient’s home),” he added. “Also, the drug inside these injections often wears off at the end of the month, so patients’ symptoms often come back before the next injection.”
Paltusotine was originally called CRN-00808. “[That’s because it was the 808th molecule we made in our lab,” shared Dr. Struthers. “The first 807 just weren’t good enough. We have optimized every single atom in this molecule.”
Crinetics has a second Phase 3 study of paltusotine underway, with results expected to be reported in the first quarter of 2024. In the second half of 2024, the company plans to submit results to the FDA, which will take about a year to complete its review. That means a potential commercial launch could be on the horizon for 2025.
“Our mission is to solve all the endocrine diseases, so we’ve got a lot of work ahead of us,” Dr. Struthers added.
Crinetics Pharmaceuticals, Inc.
FOUNDED: 2008
FOUNDER & CEO: Dr. Scott Struthers, PhD
HEADQUARTERS: Sorrento Mesa
STOCK: CRNX (NASDAQ)
REVENUE: $4.7 million (FY2022)
EMPLOYEES: 260
BUSINESS: biopharma
WEBSITE: crinetics.com
CONTACT: 858-450-6464
NOTABLE: Crinetics is a dog-friendly workplace so at any given time dogs walk around its office and they know exactly which people keep treats for them at their desks.
