Shane Schaffer, Cingulate CEO
A few months after filing its S-1, Cingulate finally joined the biotech IPO crowd yesterday — but it wasn’t greeted with quite the same fanfare that other life science companies saw earlier this year.
The Kansas-based biotech, focused on creating longer-acting ADHD meds, priced 4.2 million shares at $6 apiece, raising a meager $25 million. That price was the low end of an already revised range of $6 to $8.
Cingulate had originally planned to offer 4.5 million shares at a $10 to $12 range, then lowered the offering to 4.4 million shares at $8 to $10 in October. In November, the company lowered the proposed deal even further to 3.6 million shares at $6 to $8.
A vast majority of the funds — about $13 million — will go toward Cingulate’s lead candidate CTx-1301, according to an S-1/A. While most ADHD meds currently approved are stimulants taken in the morning with quick-acting effects, CTx-1301 is designed to slowly release its active ingredients in three phases throughout the day. Those quick-acting stimulants make up about 90% of the ADHD market, Cingulate estimates in its S-1, and leave patients needing additional pills in the afternoon after they experience a ‘crash.’
Extended-release or long-acting stimulants constitute about 60% of stimulant prescriptions, according to Cingulate, but most of these patients still receive a second ‘booster’ dose later in the day.
CTx-1301 is designed to release the first portion of its active ingredients — accounting for about 35% of the total medicine contained in the pill — immediately, delivered over 30 minutes. The second part, coming about three to four hours later, comprises 45% of the total medicine and is delivered over a 90-minute period.
These first two release schedules are comparable to some meds on the market such as Focalin, Cingulate says, but CTx-1301 has a third timed release built-in as a ‘booster’ making up the remaining 20%, which is released about seven hours after taking the pill.
The program has already passed a Phase I/II test comparing it to Focalin, and a Phase III program is planned to start in early 2022, according to the filing. If all goes well, Cingulate will look to submit an NDA via the FDA’s accelerated approval pathway in late 2023.
Next up will be CTx-1302, a follow-up candidate aimed solely at children. That candidate’s entering a Phase I/II bioavailability study in early 2023. It was created on the same precision timed release platform, but researchers have designed the medicine to release in 45%-35%-20% portions, rather than the 35%-45%-20% schedule for the lead program. A total of $0.3 million is going toward that program.
CEO Shane Schaffer, who spent more than 25 years in senior roles at Pfizer, Novartis and Sanofi, holds 7.57% of shares, according to the S-1/A, while CMO Matthew Brams has a 6.07% stake and CSO Raul Silva has a 4.36% stake.
The company will list under the symbol $CING.
The US House of Representatives voted almost unanimously on Wednesday evening (423-3) to pass a bill that will provide $500 million over five years to certain small drugmakers to cover the costs of R&D and to expand access to patients not eligible for clinical trials for potential amyotrophic lateral sclerosis drugs.
Rare neurodegenerative diseases, like ALS, have been historically very difficult to treat and to develop treatments for. But this bipartisan bill, introduced by Rep. Mike Quigley (D-IL) and dozens of cosponsors, will provide $100 million for each of fiscal years 2022 through 2026 to help HHS award grants to facilitate the development and access to ALS drugs intended to prevent, diagnose, mitigate, treat, or cure the disease.
Mathai Mammen, J&J EVP of pharmaceuticals, R&D (Rob Tannenbaum)
The new J&J has a fresh corporate face to show the public — several in fact.
As the healthcare conglomerate follows a now familiar pharma path in separating itself into an innovation-focused R&D-based group from its less appealing consumer side, it’s promoting some key individuals to the executive committee that steers the company.
Those fresh faces include Mathai Mammen, the global head of R&D who joins the inner circle as executive vice president of pharmaceuticals, R&D. External innovation chief Bill Hait becomes executive vice president, chief external innovation, medical safety and global public health officer. Jim Swanson, until today simply the chief information officer, adds the EVP part to his title in moving onto the committee. And Vanessa Broadhurst, company group chairman, global commercial strategy organization, has been appointed EVP, global corporate affairs.
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Adam Margolin, NextVivo CEO
When conducting preclinical tests in drug development, researchers have for years used different kinds of animal models, from mice to nonhuman primates. But what if the need for such models became obsolete?
It’s one of many questions hoping to be answered by the biotech NextVivo, which emerged from stealth Thursday morning with a small $7.9 million seed round. With prominent Silicon Valley VC Khosla Ventures as the lead, it’s clear NextVivo has, at the very least, tickled the minds of big-name investors.
KEY POINTS
Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients. The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers. A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.
Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.
Please signup to continue — it’s fast and free. This article is sponsored by Catalent and produced by Endpoints Studio. Each year, we aim to highlight 20 extraordinary women who are leaving their mark on drug R&D — and this year’s group was no exception.
Our list, while by no means exhaustive, includes scientists, CEOs, researchers and professors who are supercharging the discovery and development of new therapies worldwide. Our team of writers spent time with each honoree (with a few exceptions), learning their stories and sketching profiles, which you’ll find in our special report.
For the second time, we brought the celebration to a live virtual audience, featuring an award presentation followed by a panel on what it takes to break the glass ceiling in biopharma with Kojin Therapeutics CEO Luba Greenwood, AskBio CEO Sheila Mikhail, and Silverback Therapeutics CEO Laura Shawver. Our panelists had a lively discussion on how the industry’s culture has changed, how to handle sexual harassment, the progress we’ve made and the challenges that still hold women back today.
We applaud each of our honorees for scaling the heights of biopharma R&D. You got to meet most of them via brief recordings we played during our live event. Below, you’ll find bonus videos offering a longer glimpse into those interviews. And if you didn’t get a chance to tune in to our main event live, you can replay the entire show.
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Members of the public disembark a train at King Cross Station in London, on the day that extra measures are put in place to fight the spread of the Omicron variant of Covid-19. Since Nov. 30, it’s been mandatory for people in England to wear face coverings in shops and on public transport. (Ben Cawthra/Sipa USA/Sipa via AP Images)
Like hundreds of other virologists and epidemiologists, Benjamin tenOever’s Thanksgiving weekend was interrupted with emails about an emergency Omicron meeting.
But when he logged onto a WHO conference call 9 a.m. Monday morning, officials had a surprisingly upbeat spin on the little-understood variant that had already prompted leaders around the world, fearful the strain could evade vaccines, to close their borders to broad swaths of Southern Africa.
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Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.
Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.
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Terry Connolly, K36 Therapeutics CEO
After being in stealth for nearly 11 months, a new biotech has made itself known, complete with an influx of cash from some big-name investors.
K36 Therapeutics, an oncology biotech out of Cambridge, MA, emerged from stealth this morning — announcing a long-finished $30M Series A co-led by F-Prime Capital, Atlas Venture and global investment firm Eight Roads Ventures.
K36 CEO Terry Connolly told Endpoints News that the series was actually closed back in February — and is now just being announced. Connolly said that he expects the funding to get K36 through proof-of-concept studies and hopefully push the candidate to the IND phase, which the biotech plans to file by the end of June next year.
Stephen Hahn (AP Photo/Alex Brandon, File)
Since leaving the FDA’s top post last January, Steve Hahn has been busy, jumping between multiple industry positions thanks to Flagship Pioneering, and most recently taking the helm at a startup focused on the detection of early cancer with a simple blood test.
Hahn’s new company, known as Harbinger Health, will receive $50 million from Flagship to use a proprietary platform combining AI and machine learning to potentially create an entirely new paradigm for cancer diagnosis, enabling early therapeutic interventions or prevention. Hahn’s prior work as chief medical executive of the University of Texas MD Anderson Cancer Center will likely inform his new role, where he’s serving as a Flagship CEO-partner as well as CEO of Harbinger.
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https://endpts.com/cingulate-prices-a-downsized-public-offering-as-ipo-party-appears-to-die-down/
