Search This Blog

Saturday, July 10, 2021

AIM-listed cell engineering platform MaxCyte files for a $100 million US IPO

 MaxCyte, which provides cell engineering devices and services, filed on Friday with the SEC to raise up to $100 million in an initial public offering. The company is currently listed on London's AIM (MXCT).


MaxCyte's Flow Electroporation technology facilitates the complex engineering of a variety of cells. It uses electroporation, which is the process of applying an electric field to temporarily increase the permeability of the cell membrane, allowing intracellular delivery of molecules, such as genetic material and proteins. The company's flagship product, the ExPERT platform, can be used across the continuum of the rapidly-expanding cell therapy sector. 

The Gaithersburg, MD-based company was founded in 1998 and booked $27 million in sales for the 12 months ended March 31, 2021. It plans to list on the Nasdaq under the symbol MXCT. MaxCyte filed confidentially on May 14, 2021. Cowen, Stifel, William Blair, BTIG, and Stephens Inc. are the joint bookrunners on the deal. No pricing terms were disclosed.

Pain-free investing: Nalu Medical files for a $100 million IPO

 Nalu Medical, which is commercializing a nerve stimulation implant for chronic neuropathic pain, filed on Friday with the SEC to raise up to $100 million.


Nalu states that its miniaturized implantable pulse generator (IPG) delivers gentle electrical pulses to the nervous system to modulate pain signals to the brain, addressing unmet need for chronic neuropathic pain with clinical and practical benefits of a battery-free, minimally invasive implant. The company is targeting both spinal cord stimulation (SCS) and peripheral nerve stimulation (PNS) indications. Its device received clearance in 2019, but Nalu delayed its commercial launch to the third quarter of 2020 due to the pandemic; in the first quarter it generated revenue of $1.4 million.

The Carlsbad, CA-based company was founded in 2014 and booked $5 million in sales for the 12 months ended March 31, 2021. It plans to list on the Nasdaq under the symbol NALU. Nalu Medical filed confidentially on February 16, 2021. J.P. Morgan, BofA Securities, and William Blair are the joint bookrunners on the deal. No pricing terms were disclosed.

Healthcare tech-focused SPAC AfterNext HealthTech Acquisition files for a $300 million IPO

 AfterNext HealthTech Acquisition, a blank check company backed by TPG targeting healthcare technology, filed on Friday with the SEC to raise up to $300 million in an initial public offering.


The Fort Worth, TX-based company plans to raise $300 million by offering 30 million units at $10 per unit. Each unit contains one share of common stock and one-fourth of a warrant, exercisable at $11.50. At the proposed deal size, the company would command a market value of $375 million.

AfterNext HealthTech Acquisition is led by CEO and Chairman Halsey Wise, former CEO and Chairman of MedAssets and Integraph, President and Director Anthony Colaluca, former CFO and EVP of MedAssets and Integraph, and CFO Martin Davidson, Partner and CAO of TPG Capital. The company aims to leverage management's experience to target businesses that lie at the intersection of healthcare and technology.

The company was founded in 2021 and plans to list on the NYSE under the symbol AFTR.U. AfterNext HealthTech Acquisition filed confidentially on June 7, 2021. Goldman Sachs, Deutsche Bank, and BofA Securities are the joint bookrunners on the deal. 

Heart disease biotech Tenaya Therapeutics files for a $100 million IPO

 Tenaya Therapeutics, a preclinical biotech developing multiple therapies to treat heart disease, filed on Friday with the SEC to raise up to $100 million.


The company's multi-modality drug discovery platform targets both genetic and non-genetic forms of heart disease, and consists of (1) a gene therapy program using AAVs, (2) a cellular regeneration program which also uses viral vectors to deliver gene combinations to regenerate cardiomyocytes in the heart, and (3) a precision medicine program using human induced pluripotent stem cell-derived cardiomyocytes. The company plans to submit INDs for its gene therapy and precision medicine platforms in 2022.

In addition to VC backers The Column Group and Casdin Capital, Tenaya's key shareholders include Walmart heir Thomas Walton.

The South San Francisco, CA-based company was founded in 2016 and plans to list on the Nasdaq under the symbol TNYA. Tenaya Therapeutics filed confidentially on May 7, 2021. Morgan Stanley, Cowen, and Piper Sandler are the joint bookrunners on the deal. No pricing terms were disclosed.

Friday, July 9, 2021

U.K. regulator accepts Humanigen's COVID drug for speedy review; analysts hopeful for FDA nod

 After a successful data hit at the start of spring, a new chief medical officer and a jump in stock price, Humanigen is starting the summer with the U.K.'s drug regulator accepting its COVID hopeful lenzilumab for review.

Back in late March, a phase 3 test of Humanigen’s lenzilumab in hospitalized COVID-19 patients met its primary endpoint, a result it now hopes will help it gain approval in the U.K., which is being hit hard by a third wave from the delta variant, despite high vaccine uptake.

Today, the Californian biotech said the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) has allowed an expedited COVID-related rolling review, an extra speedy method that could see the drug on the U.K. market more quickly than the average drug. The company did not say, however, what that timeline might be.

“We are grateful this submission will receive expedited consideration by MHRA,” said Cameron Durrant, M.D., CEO of Humanigen. “The global spread of variants of concern, such as the Delta variant, highlights the continued need for proven therapies that are variant-agnostic for millions who remain at risk of COVID-19.”


Lenzilumab targets GM-CSF, a cytokine associated with negative outcomes in COVID-19 patients. By neutralizing the cytokine, drug developers including Humanigen and GlaxoSmithKline have predicted they may be able to counter life-threatening complications that arise when the immune system reacts particularly strongly to the virus.

To test the hypothesis, investigators recently randomized 520 hospitalized COVID-19 patients to receive an infusion of lenzilumab or placebo on top of standard-of-care treatments such as dexamethasone and Gilead Sciences' Veklury.

In the data posted in March, after 28 days, the rate of ventilator-free survival was higher in the lenzilumab arm, causing the trial to hit its primary endpoint with a p-value of 0.0365. Humanigen changed the primary endpoint twice in the months after initiating the phase 3 trial in April 2020. 

In the treatment group, the Kaplan-Meier estimate for invasive mechanical ventilation and/or death was 15.6%, compared to 22.1% in the placebo group. Humanigen also reported a “favorable trend” in the mortality rate, which was 9.6% in the lenzilumab arm and 13.9% in the placebo group.

It also took these data to the FDA for an emergency use authorization. Before the MHRA announcement, analysts at Jefferies said in a note to clients Thursday evening that lenzilumab “is well positioned for winning an EUA approval in hospitalized Covid patients,” adding that Humanigen’s stock could move up by 60% to 80% if approved, though the downside is limited to minus 20% to 30% if a larger safety data set or additional trial are requested by the FDA.

As it was, Humanigen shares were up 15% premarket Friday morning, but quickly dropped after the market opened to be up just 1% by midday.

If approved, lenzilumab could serve a set of hospitalized patients who have proven difficult to treat with other COVID-19 drugs. Anti-SARS-CoV-2 antibodies have struggled in the population, potentially because in hospitalized COVID-19 patients the immune response is as much of a factor as the virus itself. Researchers have tested other drugs designed to tamp down immune responses, including Roche’s Actemra and Sanofi’s Kevzara, with mixed results.  

Analysts at Cantor have already predicted blockbuster sales, with Jefferies noting that with the delta variant hitting countries like the U.K., Israel and now the U.S., all three of which have high vaccine uptake, this means COVID may well become like flu and still require a high level of treatment outside of inoculation.

https://www.fiercebiotech.com/biotech/u-k-regulator-accepts-humanigen-s-covid-drug-for-speedy-review-as-analysts-spell-out

Sight Sciences pitches $150M IPO for its glaucoma, dry eye devices

 Ophthalmic device developer Sight Sciences hopes to see its way to nearly a $1 billion valuation through a $150 million Nasdaq IPO.

The company’s portfolio includes the Omni Surgical System, a hand-held, single-use device used to help drain fluids from the eye and reduce intraocular pressure in patients with glaucoma. The system can also help deliver a viscoelastic material through a microcatheter to enlarge the eye’s canals and relieve pressure through an alternative surgical method.

Meanwhile, its nonsurgical device, the TearCare system, is worn over the eyelid to apply localized heat as a treatment for dry eye as well as gland dysfunction. Between glaucoma and dry eye disease, Sight estimates the two markets total about $16 billion, with the former making up 94% of the company’s revenues over 2020.

And despite the COVID-19 pandemic, last year saw positive sales growth compared to the 2019 calendar year, with revenues of $27.6 million over $23.3 million, respectively.

By going public, the Menlo Park, California-based company hopes to fund ongoing and future clinical trials for both of its marketed systems as well as other R&D and commercial efforts, according to a prospectus filed with the Securities and Exchange Commission. The IPO includes 7 million shares under the ticker symbol "SGHT" at a price ranging from $20 to $23, according to Renaissance Capital. Sight had previously filed for a $100 million IPO in late June.


In March 2020, the company raised $30 million through a series E round led by D1 Capital Partners to help expand its commercial efforts. A year later, Sight counted more than 100 on its direct sales, marketing and support staff, according to the prospectus.

https://www.fiercebiotech.com/medtech/sight-sciences-pitches-150m-ipo-for-its-glaucoma-dry-eye-devices

Moving the vaccination needle: Behavioral tactics that work—and don’t

 One of the big questions today is how to get more people vaccinated. Should you offer free stuff? That works sometimes. Remind them that they’re good parents? That actually doesn’t work.

It turns out that not getting vaccinated is pretty irrational, thanks to human beings’ cognitive biases.

Marketers often try to overcome cognitive bias by using behavioral interventions to temper the personal subjective realities that behavioral scientists label with fancy handles like "confirmation bias" or "loss aversion."

But when it comes to vaccinations, which interventions work and which don't?

ZS researchers wanted to find out. So they put 19 different behavioral interventions for cognitive biases to the test. They surveyed three different groups of vaccine-hesitant people—those who were wary about COVID-19 vaccines, adult vaccines or pediatric vaccines, Jacob Braude who leads the applied behavioral science team at ZS said.


The result? Only 10 of the 19 tactics worked. Seven worked for COVID vaccine-hesitant people, four for those worried about adult vaccinations and five with pediatric concerns. While some tactics worked across one or two of the vaccine-hesitant groups, only one behavioral intervention worked across all three groups.

Confirmation bias, which has been getting a lot of media attention recently in the context of politics, was the only successfully mitigated behavior in ZS’ study of more than 6,300 vaccine-hesitant people across seven countries.

What is confirmation bias? In general, it’s the tendency by people to favor or overvalue information that supports what they already think and to ignore contradictory information. So if a person believes vaccines aren’t safe, they can and will find media, data and reports that support that belief.

Knowing that confirmation bias is likely rampant in the vaccine-hesitant group, ZS didn’t test for it, but they did try a mitigation tactic.

Researchers told people that they understood the person doesn’t want a vaccine but asked them to think about reasons why other people might want to get vaccinated. After the test subjects went through the mental exercise using their own thoughts and words, ZS researchers asked if they were interested in getting vaccinated. And some said yes.


Overall, 20% more people said they would get vaccinated when compared to the baseline group. Among men under age 50, the jump was even higher with 22% changing their minds.

“Often we see people trying to persuade by saying ‘OK, here are the facts. Here’s why you should get vaccinated,’ ” Braude said. “But this research says actually what you should say is ‘OK, why would someone want to get vaccinated?’ and have them go through the process in their own words. That works much better than the persuasion techniques we see people trying to use.”

Another behavioral tactic springing up around COVID vaccination drives is prospect theory. States giving out prize money, or as they are in West Virginia, chances to win trucks and shotguns, are using a winning tactic.

Other behavioral intervention tactics that worked for COVID vaccine hesitators were effort justification (I put a lot of effort into something so it’s valuable, even if it’s not) and social facilitation (if people know others are watching them, they will behave more pro-socially).

What about other tactics being used? Celebrity endorsements, for instance, probably work—right? Nope, not according to ZS’ study.

Researchers asked people to name any celebrity or public figure who they believe to be a credible authority. The answers ranged widely—some people in the U.S. chose controversial Fox opinion show host Sean Hannity—but the result was always the same.


ZS tested the participants by repeating back the same credible authority they named along with a second choice of someone the participant said was not credible and said these people recommend getting vaccinated. The test subjects’ response? No thanks—even when the recommendation came from the exact credible authority they chose.

Interestingly, that doesn’t mean all recommendations don’t work. Among vaccine-hesitant parents in the pediatric study group, something called in-group bias did work. The bias is the tendency to go along with people you like and agree with and consider to be in your group more often than you would agree with people outside your perceived group. When told that people in their group are getting their kids vaccinated, they were more likely to also do it, Braude said.

The tricky part of individual bias is just that, they’re individual.

“The way biases work is that every person has a different set of mental shortcuts,” Braude said. “The goal is to layer these bias triggers in a way to try to drive vaccinations. If we look at all of the individual responses, we got anywhere from 20 to 44% of people who started the survey saying they wouldn’t get vaccinated to change their mind.”

Braude acknowledged it is a study but added while the results may be less in the real world “even half, I would take that. If we could get 20% of people to get vaccinated who previously wouldn’t, I would take that in a heartbeat.”

https://www.fiercepharma.com/marketing/moving-vaccination-needle-study-examines-behavioral-tactics-work-and-don-t