Loss-making Connect Biopharma says Phase 3 clinical trials of its CBP-201 drug for atopic dermatitis will begin in second half of this year
Connect Biopharma shares, which more than halved after its November release of initial Phase 2 clinical trial data, fell further after latest update
By Mia Shanley
China’s Connect Biopharma Holdings Ltd. (NASDAQ: CNTB) is just itching to bring in its first-ever revenue with a drug for moderate-to-severe atopic dermatitis that’s making steady progress in the clinical testing process. But it’s having a hard time winning over investors, even after releasing extra data last week from recent clinical trials. That included details on its plans to start Phase 3 trials – considered the final phase before seeking regulatory approval – later this year.
The new drug, CBP-201, could be a potential alternative to Regeneron’s (NASDAQ: REGN) and Sanofi’s (NASDAQ: SNY) blockbuster drug Dupixent, which brought in 3.5 billion euros ($4 billion) in 2020 and which the drug makers believe has the potential to reach peak annual sales of 10 billion euros. Other pharmaceutical giants like Eli Lilly(NYSE: LLY) and Pfizer (NYSE: PFE) are also in the race with their own treatments for dermatitis.
Connect Biopharma said in its Jan. 5 announcement that additional analysis from its Phase 2b clinical trials showed that CBP-201 could be safely administered at various dosing schedules. It touted one of its schedules in particular – 300 mg once every four weeks (Q4W) – as being a “more convenient” option to current treatments.
“We are very encouraged by the findings from the additional analyses and remain confident on the potential for a highly competitive efficacy and safety profile for CBP-201 coupled with a more convenient and differentiated Q4W dosing schedule,” said Zheng Wei, co-founder and CEO of Connect Biopharma, in the statement.
Despite that upbeat tone, investors were less impressed. The company’s stock fell 7% the day of the announcement last Wednesday, though it later clawed back most of those losses. Still, the shares have lost more than two-thirds of their value over the last 52 weeks as investors remain unimpressed about the new drug’s prospects.
Atopic dermatitis has an estimated lifetime prevalence of up to 20%, is on the rise internationally and is the most commonly diagnosed chronic inflammatory skin disorder. Beyond that market, Connect Biopharma also hopes its product can be used to treat asthma and chronic rhinosinusitis.
But the 10-year old company, which has a pipeline of four drug candidates but no revenues yet, must prove that CBP-201 – its lead product candidate – is at least as good as, or has an edge over, products already on the market. That appears to be the big sticking point for skeptical investors.
Sanofi is moving fast to maintain its dominant position. It has already secured green lights for Dupixent in new markets like China for adolescents suffering from atopic dermatitis and for use as an add-on treatment for patients with asthma by the U.S. Food and Drug Administration.
Connect Biopharma said on a call with analysts after the latest findings that discussions with Chinese authorities were ongoing and so far “positive” and “productive”.
Meanwhile, quarterly sales of Dupixent have nearly tripled in the last two years. Sanofi posted 1.4 billion euros in revenues from the drug in last year’s third quarter, a 55% increase on the same period a year ago, thanks to growth not just in the U.S. where it is dominant, but also in its home European market and also in Japan.
It’s looking increasingly difficult for Connect Biopharma, whose current market capitalization stands at a modest $283 million, to stand out in a sea of pharmaceutical giants. Perhaps reflecting that reality, the company’s shares lost more than half their value after it released initial data about its Phase 2 clinical trial for CBP-201 in November.
The updated findings this month have done little to support the shares, which closed Tuesday at $4.93, not far off an all-time low of $4.06 and just a fraction of the $17 IPO price when the company listed on the Nasdaq last March. Potentially adding to ongoing concerns, Connect Biopharma said it plans to begin phase 3 trials of the drug in the “second half of 2022”, which sounds like a potential slight delay over the expectation for “mid-2022” commencement used in its November statement.
But the bigger concern for investors appears to be the simpler issue of big competition. In December, Pfizer won approval from the European Commission for its abrocitinib drug to treat adults with moderate-to-severe atopic dermatitis. Eli Lilly also said last month its lebrikizumab demonstrated significant skin improvement and itch relief when combined with topical corticosteroids in people with atopic dermatitis in a third Phase 3 study.
Conducting clinical trials during the Covid-19 pandemic has also posed its own challenges, and Connect Biopharma noted that it had a higher patient discontinuation rate during trials. Indeed, the company said on the analyst call that as many as one in five patients had dropped out of parts of its global study as restrictions on movement were implemented.
The company said it expects its retention rate to improve as it pushes into Phase 3 trials and as the pandemic eases.
With investors still on the fence about the prospects for Connect Biopharma’s lead product, the company’s shares are likely to remain under pressure. It has three other drugs in the pipeline – one also in phase 2 trials that targets ulcerative colitis and Crohn’s Disease, and two others that are in earlier stages.
Meanwhile, the bleeding of money will continue. Connect Biopharma, with headquarters in China and operations in the U.S. and Australia, posted an operating loss of 268.4 million yuan ($42.1 million) in the first half of 2021, up sharply from a 62.5 million yuan loss in the same period the previous year, on rising R&D costs related to clinical trials, personnel and lab expenses.
But after raising $204.5 million in its 2021 IPO the company had 2 billion yuan in cash and cash equivalents at the end of the first half of 2021, meaning it has plenty of cash remaining before it would need to raise more.
That may buy the company just enough time until it can start generating its first revenues, which are unlikely to arrive for at least a year or more. Until then, investors will want to see that Phase 3 clinical trials are firmly on track, hopefully showing its dermatitis drug is as good as or more of a standout than what is already on the market.
The company currently trades at a lowly price-to-book (P/B) ratio of just 0.76. That’s less than the P/B of 1.25 for the similarly revenue-less cancer treatment specialist JW Therapeutics (2126.HK), and far less than a P/B of 4.85 for another cancer specialist I-Mab (NASDAQ: IMAB), which has begun to receive revenue through partnerships but has yet to get any from actual drug sales.
Source Here: benzinga.com
Sen. Elizabeth Warren Questions Fidelity on Crypto 401(k) Product: What You Need to Know
Sen. Elizabeth Warren (D-Massachusetts) is calling on Fidelity Investments to explain its decision to allow its investors to add Bitcoin BTC/USD to their 401(k) retirement accounts.
What Happened: Warren and Sen. Tina Smith (D-Minnesota) sent a letter to Fidelity CEO Abigail Johnson expressing concern about the company’s new Digital Assets Account, which allows investors to have a portion of their retirement savings allocated to Bitcoin through their 401(k) plan. The senators claim Fidelity ignored a U.S. Department of Labor warning to 401(k) plan fiduciaries to exercise “extreme care” when deciding to include cryptocurrency as an investment vehicle.
“Investing in cryptocurrencies is a risky and speculative gamble, and we are concerned that Fidelity would take these risks with millions of Americans’ retirement savings,” the senators wrote, adding that “Bitcoin’s volatility is compounded by its susceptibility to the whims of just a handful of influencers. Elon Musk’s tweets alone have led to Bitcoin value fluctuations as high as 8%. The high concentration of Bitcoin ownership and mining exacerbates these volatility risks. One study estimates that just 10% of Bitcoin miners are responsible for processing 90% of Bitcoin transactions and that 1,000 individuals control 3 million Bitcoins – about 15% of the current Bitcoin supply.”
What Else Happened: The senators also questioned if the company had a conflict of interest because it was involved in crypto mining.
“Despite a lack of demand for this option – only 2% of employers expressed interest in adding cryptocurrency to their 401(k) menu – Fidelity has decided to move full speed ahead with supporting Bitcoin investments,” they said.
The senators gave Fidelity until May 18 to answer questions regarding risks related to cryptocurrency and whether this offering posed a conflict of interest.
The Wall Street Journal reported Fidelity responded to the senators’ concerns via an emailed statement.
“As a Massachusetts-based company with a proven 75-plus-year history of doing what’s in the best interest of our customers, we look forward to continuing our respectful dialogue with policy makers to responsibly provide access with all appropriate consumer protections and educational guidance for plan sponsors as they consider offering this innovative product,” the company said. “Consistent with our ongoing dialogue with regulators and policy makers, we will respond directly.”
Photo by Gage Skidmore / Flickr Creative Commons
Original Source: benzinga.com
OgenaShield Pure Oxygen(R) HD Shampoo Now Available on Amazon
SARASOTA, Fla., April 28, 2022 (GLOBE NEWSWIRE) — Ogena Solutions is pleased to announce that our OgenaShield Pure Oxygen(R) HD Shampoo is now listed for sale on Amazon.com (US only). View our listing.
About OgenaShield Pure Oxygen(R) HD Shampoo
Ogena Solutions Pure Oxygen(R) HD Shampoo is a 100% non-toxic, environmentally safe, and veterinarian-recommended way to clean and deodorize dogs, cats, horses and cattle. This rinse-free, fragrance-free animal shampoo converts to oxygen and water vapor, leaves absolutely no active residue and works gently to relieve the animal’s itchy and irritated skin. Besides being excellent for general shampooing Pure Oxygen(R) has been specifically formulated for use in Ogena’s ANIVAC animal bathing systems and when diluted 50/50 with water can also be used in products such as the Bissell Bark Bath for dogs and the eZall and other foaming bathing system for horses.
I’m impressed with this product. Works better than any oral meds or topical or other shampoos I’ve tried in 6 years for animals with skin problems! – Lynn C.
Cleared up my dog’s infection when antibiotics wouldn’t work. Highly recommend it. – Anonymous
Fostered cats for 15 years and recently came across a ringworm fungal strain that was resistant to miconazole topical, terbinafine oral and topical, itraconazole oral and everything else on the planet. This was THE only thing that got rid of it. Miracle product. – S.T.
About Ogena Solutions
Ogena Solutions is a One Health organization focused on safeguarding animals, people and the environment from pathogens and infectious diseases. We offer a Next Generation version of PCO air purifiers, foamers, topicals, application equipment, vacuum systems, and more. All of our products meet a high standard for safety, efficacy, and efficiency, as well as expert protocols for optimum results. Our team has extensive experience working on infection prevention and biosecurity in the veterinary, farm/agriculture, animal shelter and boarding kennel sectors, and we work closely with government agencies, public leaders, corporations and small business owners to implement best practices for the health and safety of their employees, customers and the general public.
For more information, please contact:
BD & Technical Support Mgr – U.S.
1-855-900-8822 ext. 227
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/70f25f1b-09e5-4cdc-a11c-397a94bff576
TierPoint Developing Next Generation Cloud Solutions
ST. LOUIS, April 28, 2022 (GLOBE NEWSWIRE) — TierPoint, a leading provider of secure, connected data center and cloud solutions at the edge of the internet, today announced it is working with Dell Technologies to develop next generation cloud solutions on Dell APEX.
With cross-cloud/hybrid functionality, APEX solutions provide the agility and speed customers want, combined with the control, performance, security, and consistency they need – all packaged in the simplest way possible.
TierPoint Senior Vice President of Product Development Greg Ahlheim said: “To help fuel the growth and success of their organizations, more and more CIOs are embracing hybrid cloud solutions, allowing them to run each application in the type of cloud – private, multitenant, or public – where it performs best. In addition, today’s CIOs are increasingly seeking the flexibility of pay-as-you-go models for their cloud infrastructure. Dell addresses both of these needs through its APEX offerings, and we’re excited to work with them on developing solutions that combine their technology with the exceptional, cloud-agnostic guidance, service and support for which TierPoint is known.”
The first joint solution of the two companies will be a TierPoint Private Cloud powered by Dell APEX, with continuing collaboration on other APEX-powered solutions.
Meeting clients where they are on their journey to IT transformation, TierPoint (tierpoint.com) is a leading provider of secure, connected data center and cloud solutions at the edge of the internet. The company has one of the largest customer bases in the industry, with thousands of clients ranging from the public to private sectors, from small businesses to Fortune 500 enterprises. TierPoint also has one of the largest and most geographically diversified footprints in the nation, with over 40 world-class data centers in 20 markets and 8 multitenant cloud pods, connected by a coast-to-coast network. Led by a proven management team, TierPoint’s highly experienced IT professionals offer a comprehensive solution portfolio of private, multitenant, managed hyperscale, and hybrid cloud, plus colocation, disaster recovery, security, and other managed IT services.
Contact: Pete Abel, 314-720-3129, Pete.Abel@tierpoint.com
Original Post: benzinga.com
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