Hoth Therapeutics, Inc. (NasdaqCM: HOTH) is an innovative biopharmaceutical company that is taking advantage of both science and technology to target important therapeutic drug markets in the U.S., while at the same time securing exclusive rights to the cutting-edge BioLexa Platform to advance their technology to the global stage. Primarily focused on the atopic dermatitis (eczema) market, for now, HOTH is leveraging its recent publication of potentially best-in-class results from a study at the University of Miami's, Miller School of Medicine, that show they are on the right track to effectively treat many of the estimated 32 million patients in the U.S. market that suffer from eczema, aesthetic dermatology issues, chronic wounds, and surgical site infections.
The combined market potential from the indications listed above already eclipses the $7 billion level and is expected to grow into a $24 billion market by 2027. But beyond eczema and atopic dermatitis related indications, HOTH is also demonstrating that its BioLexa Platform may also be an effective therapeutic tool for treating diabetic skin disorders, a separate market that is expected to grow into a $7.7 billion drug market opportunity by 2023. Combined, the target markets provide enormous opportunity for companies, like HOTH, that combine innovation with technology to deliver a new standard of care for patients.
At HOTH, much of the groundwork to provide a better therapeutic option for patients is already complete after the company secured a global and exclusive license from the University of Cincinnati to take advantage of the cutting-edge benefits of its BioLexa Platform, a tool that is showing signs of becoming a potential best-in-class therapeutic option for treating multiple dermatological indications.
Beyond the licensing deal with the U of C, HOTH has done exceedingly well by executing on several of its corporate growth initiatives that include a recently completed $7 million IPO, a listing on the NasdaqCM, and two newly-announced research agreements that are intended to expand the market opportunities for the BioLexa Platform.
Hoth Therapeutics, Inc. Completes $7M IPO, Targets U.S. Eczema Market
Hoth Therapeutics, Inc. (“HOTH”) who labels itself as a biopharmaceutical company, is working on advancing both science and innovative technology to take advantage of next-generation medical needs. Already leveraging the cutting-edge scientific applications inherent to the University of Cincinnati's designed and developed BioLexa Platform, HOTH is primarily focused on bringing to the market proprietary therapeutic options for patients suffering from indications such as atopic dermatitis (eczema).
According to opinion research, the market is ripe for new treatment options, and many of the 32 million patients in the U.S. market that suffer from eczema and atopic dermatitis complain that currently available topical solutions cause, among other things, stinging, irritation, skin infection, and fragile skin. If HOTH can continue to publish results similar to what they have already noted in preclinical trials, it supports that HOTH is in the right market, with the right technology, at the right time to earn substantial support from patients that need better treatment.The exclusive and global license to the BioLexa Platform may inevitably boost HOTH’s standing in the therapeutic community and attract additional interest from industry insiders. Why? Because study data to date from the BioLexa Platform is yielding exceptional trial results, and when a small company demonstrates potentially disruptive technology, it does not take long for others to want a piece of the action.
Perhaps the strategic advantage for HOTH at this point, however, is that they are now well-funded to advance the science independently, which makes them less susceptible to hostile actors that can dilute their technological leverage. Thus, by having cash in the bank, and a global license to what may prove to be an impressive tool for treating patients in a significant and growing market, HOTH is in a unique position to answer the phone rather than calling out for help. And, it's the BioLexa Platform that is making HOTH a popular newcomer in the sector.
The BioLexa Platform, Showing Superior Results In Treating Skin Disorders
For Hoth Therapeutics, Inc. (“HOTH”) it's the BioLexa Platform that is attracting significant interest. The Platform is based on cutting-edge scientific research developed at the University of Cincinnati, that earned its first set of patent protection in 2008. By continuing to develop the potential applications of the platform, the University was awarded additional patents in 2013 and 2017, respectively, which increased the scope of the BioLexa patent protection to include biochemical and protein science indications.The primary advantage of the BioLexa Platform is that it is targeting a primary cause of severe infection, "biofilms."
In fact, the Centers for Disease Control indicate that biofilms are implicated in more than two-thirds of all skin infections. These biofilms provide the primary barrier between quick treatment and a growing infection, by becoming functional bacterial colonies that are highly resistant to both antibiotics and natural immune responses. In simpler terms, consider these colonies as a protective layer of support for the infection that inhibits productive treatment, thus allowing the infection to not only thrive - but grow.What HOTH has found, however, is that staph infection requires zinc to not only form the biofilms, but it also needs it for the bacteria to grow and resist treatment.
Now, by understanding the role of zinc in the bacterial growth process, HOTH is utilizing the BioLexa Platform to deliver a synergistic combination of a zinc chelator (binding agent) and an antibiotic that prevents biofilms from forming, leaving the bacterial susceptible to elimination by both the antibiotic and the patients natural immune system. In other words, HOTH has found a way to utilize zinc, which the infection needs to grow, in a way that inevitably fools the infected area to get treated with an antibiotic payload. Although it may sound like a simple solution, the science behind delivering that antibiotic payload has taken years of research, which is why it enjoys strong patent protection.
University Studies Prove The Effectiveness Of The BioLexa Platform
Two studies have proved the effectiveness of the BioLexa Platform. The first set of positive data resulted from years of scientific research at the University of Cincinnati, and the other collection of data came from a preclinical trial conducted at the University of Miami's, Miller School of Medicine.By focusing on the root cause of the dermatological indications, both were able to demonstrate the effectiveness of the BioLexa Platform.
Then, by understanding that biofilms are specialized colonies of bacteria that adhere to a surface as well as to one another, the scientists at the University of Cincinnati were looking for a way to interrupt the growth process of the infection. Also knowing that the staph bacteria are highly resistant to antibiotic and natural immune response, they were able to isolate the importance of zinc as a means of getting into these hard to treat, recurring infections. Once the determination was validated at University of Cincinnati's Herr Lab, that zinc is not only an essential element for the formation of staph biofilms, but that zinc also triggers the adhesive properties that allow these bacteria to stick to one another, a plan of action was formalized.
Thus, the resulting BioLexa Platform was designed to trap all of the zinc ions by adding a binding agent (chelator) called DTPA, which prevents the staph biofilm from adhering to one another which then inhibited bacterial growth and colonization. The next step was to put the theory into practice, and the BioLexa Platform demonstrated impactful results. The preclinical study, which was conducted at the University of Miami's, Miller School of Medicine, was set up to test the ability of the BioLexa DTPA chelator to bind with an antibiotic payload in an animal study.
As part of the controlled preclinical test, the researchers introduced high levels of staph bacteria to wounds on the skin of pigs, used for the similarity of skin properties to humans, to determine the effectiveness of treatment. In the study, forty-four deep, partial-thickness wounds were created on the paravertebral area on two pigs. Also, four wounds each were randomly assigned to eleven treatment groups and inoculated with S. aureus ATCC 6538 (Staphylococcus).
Additionally, wounds were treated with approximately 200 mg of appropriate treatment to maintain study disciplines. On day 2 of the preliminary evaluation, wounds were assessed using a flush and scrub technique to recover planktonic and biofilm-associated bacterial count, respectively. The results showed that all treatment groups, despite the variance in concentrations of DTPA alone showed a reduction in bacterial counts (planktonic and biofilm) as compared to untreated control wounds.
The highest concentration of DTPA (30000 µM) alone showed the most significant reduction of both planktonic and biofilm bacterial counts as compared to other DTPA concentrations. DTPA at 5000, 10000 and 30000 µM concentrations, when combined with Gentamicin, showed a 99.99% reduction of Staphylococcus aureus planktonic bacterial count as compared to untreated wounds. Comparably, the results were statistically impactful, and not only did the BioLexa Platform perform strongly to significantly decrease bacterial infection to allow the antibiotics to do their job, but in some cases, the bacterial count was so low that it was below detectable levels.
Moreover, with the data showing tremendous promise in the BioLexa Platform for the treatment of infection in chronic wound and skin disorders, HOTH intends to extend the utility of the BioLexa Platform to make it more than a one-dimensional asset. In fact, recent announcements indicate that they plan to do significantly more with the Platform.
Recent Collaborative Agreement Ties Hoth Therapeutics With Additional Major Universities
Now, fresh off a successful IPO, an exclusive license for the BioLexa Platform, and compelling preclinical research conducted at the Miller School of Medicine, HOTH has attracted additional interest from the research community.In March of 2019, Hoth Therapeutics announced two new collaborations. The first is a pilot study with the Massachusetts General Hospital Vaccine and Immunology Center to study the BioLexa Platform on diabetic skin disorders, a market that surpassed $4 billion in 2018. The study will focus on chronic diabetic ulcers, both with and without substantial bacterial burdens.
That study is expected to commence quickly, and HOTH has noted in a previous press release that they have provided MGH with the BioLexa compound.
The second is a commercial licensing agreement with the University of Maryland at Baltimore, and Isoprene Pharmaceuticals, Inc. That agreement grants HOTH complete evaluation and option rights in the Dermatology Evaluation Field to develop and commercialize therapeutic compounds for the treatment of dermatological conditions in humans, another multi-billion dollar market opportunity. Expressly, HOTH has been granted an exclusive license for VNLG-152 which has demonstrated encouraging preclinical results for the treatment of psoriasis and acne.
Additionally, VNLG -152 has shown robust preclinical data in treating dermatologic cancers and other dermatologic indications as well.And, success attracts interest. The licensing agreement with UMB came about from the research results reported by UMB relating to the effect that Retinoic acid metabolism blocking agents offer in treating cancer and dermatology-related issues. This research, too, may lead to additional multi-billion dollar market opportunities.
The partnerships with both Universities demonstrate the importance of innovation that results from academic research and cutting-edge technology. And, for Hoth Therapeutics, these two agreements may open the door to additional possibilities to commercialize their BioLexa Platform through licensing agreements, partnership agreements, and collaborative trials.
Is The Table Set For Hoth Therapeutics?
Is the table set for Hoth Therapeutics? Perhaps.But like any emerging biopharmaceutical company, patience is a virtue when watching the company develop. However, it's fair to say that HOTH is off to a good start and can point to its successful IPO, its impactful results from its animal study at the U of M, and its two recently added licensing agreements with major Universities. And, with the current scientific momentum being strong for Hoth Therapeutics, it's important to note that Hoth is currently limiting its focus to only the U.S. markets, primarily targeting the roughly 32 million patients with atopic dermatitis. When factoring in the global opportunity using the BioLexa Platform, the number of patients and potential revenues rise exponentially, especially if the new university studies can show proof of concept for additional indications for BioLexa compounds.
Another plus for HOTH, though, is that big pharma appears to be hungry for new dermatological drugs. In 2016, Pfizer acquired Anacor for $4.9 billion, which represented a 60% premium over their then current stock price. Pfizer's primary interest was to get Eucrisa, a topical treatment for mild to moderate eczema that is expected to generate market sales of $1.3 billion by 2022. Sanofi and Regeneron also received FDA approval for their drug Dupixent, a nonsteroidal, injectable treatment for moderate to severe atopic dermatitis. The expected sales for that drug are targeted to hit $8 billion by 2024.
Although those two deals are just a small sampling of the active market, it does provide an indication that big pharma is looking for innovative drugs for the atopic dermatitis (eczema) market that is growing cumulatively by more than 7% per year. Actively trading on the NasdaqCM, Hoth Therapeutics is a low-float (9.6 million shares O/S as of 4/29/19), well-capitalized company whose cutting-edge BioLexa Platform may provide a fresh and practical approach to treating atopic dermatitis, diabetic skin disorders, and chronic wound and skin indications.
And, with a combined market opportunity of more than $9 billion from just their initial target markets, this emerging biopharmaceutical company may be poised for considerable growth in the coming quarters, and represent a compelling value opportunity today.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.