Eyepoint Pharmaceuticals (NASDAQ:EYPT), GeoVax Labs (NASDAQ:GOVX), Telesis Bio (NASDAQ:TBIO), Organovo Holdings (NASDAQ:ONVO), TRACON Pharmaceuticals (NASDAQ:TCON), and Abivax: exclusive interviews with the CEOs of these six biotech companies uncovers six different business strategies for investors to contemplate.
In this exclusive 2,965 word interview, this biotech CEO from Eyepoint Pharmaceuticals Inc. (NASDAQ:EYPT) emphasizes that the target market is worth billions.
Nancy Lurker has been the Chief Executive Officer of Eyepoint Pharmaceuticals Inc. since September 2016.
From 2008 to 2015, Ms. Lurker served as President and Chief Executive Officer and a director of PDI, Inc., a Nasdaq-listed health care commercialization company now named Interpace Diagnostics Group.
“EyePoint is an ophthalmology company focused on back-of-the-eye diseases; we call it retinal eye diseases. And most importantly, we have two Phase II studies ongoing right now in very high unmet need, very, very large areas.
Wet AMD is the first one and we’re on track right now to announce those results in December.
…Once you start treatment — and probably the average age at diagnosis oftentimes is in your 60s, you have to keep going into the doctor’s office every one, two or three months.
And it’s a real problem because patients just can’t do that forever. As a result, there’s an enormous treatment burden, plus these visits cost a lot in addition to the amount of time it takes.
Even so, Eylea is a $10 billion drug and Lucentis is a $5 billion drug.
There are also some biosimilars on the market recently launched that are also now available but they cost about 20% less then Eylea and Lucentis.
But the big problem is that none of them can get patients out longer than three, maximum four months, and that’s even for just a small segment of patients.
So our drug with our proven drug delivery technology, called DURASERT, can potentially get a majority of patients out to once-every-six-month dosing.
It’s a very, very tiny little bioerodible insert which combines our DURASERT drug delivery technology with an active ingredient ANTI-VEGF called vorolanib.
The tiny bioerodible insert is an injection into the back of the eye, otherwise known as an intravitreal injection which while no fun to have done, is certainly better than getting your eye injected every month or every other month.
And with this tiny bioerodible insert, our goal is to be able to get a majority of patients out to every six months before they need another injection of our tiny bioerodible insert.”
In this 2,779 word exclusive interview, the CEO of GeoVox declares that the latest recapitalization of his publicly traded biotech company will be the best with a cure for advanced head and neck cancer.
David A. Dodd is Chairman, President & CEO of GeoVax Labs (NASDAQ:GOVX). He was named to the GeoVax board of directors in March 2010, was elected Chairman in January 2011, and in September 2018, Mr. Dodd was also appointed CEO of GeoVax.
“In 2020, the company successfully recapitalized and uplisted on Nasdaq at the end of September 2020.
This was followed by further capital development, in support of targeted strategic transactions which occurred in 2021, catapulting the company from preclinical status into having two programs in Phase II clinical development.
This includes a gene therapy, known as Gedeptin, initially being developed as therapy for patients with advanced head and neck cancers.
The initial portion of the Gedeptin Phase II trial is being funded by the FDA’s orphan drugs clinical trials program with the product, previously having received orphan drug status.
The other transaction brought to GeoVax a next-generation SARS-CoV-2/Covid-19 vaccine, GEO-CM04S1, currently in two Phase II clinical trials.
This vaccine is being developed to address patient populations for whom the current authorized COVID-19 vaccines appear to be inadequate, especially those patients with compromised immune systems as a result of either existing medical conditions such as various blood cancers or other conditions that deplete their immune systems from appropriately responding to the current authorized Covid-19 vaccines.
Whereas the current authorized vaccines primarily induce a strong antibody immune response, our vaccine is structured to induce both strong antibody and strong cellular immune responses. ”
An exclusive 4,517 word interview with CEO Keith Murphy explains the cutting edge clinical trial design for his biotech company.
Keith Murphy is Founder and Executive Chairman of Organovo Holdings (NASDAQ:ONVO), as well as the CEO and Chairman of Viscient Bio, Inc. He is also a serial entrepreneur and investor in biotech.
He co-invented the NovoGen MMX bioprinter platform and grew Organovo through early investments and pharma corporate partnerships.
“One good example would be because we’re using cells from individual patients, we can actually look at, let’s say, 100 different patients’ donated cells and understand what percentage of those patients a drug will work in, and if it doesn’t work in a set, identify that set.
Then, moving forward, you can say, well, I can design a better clinical trial because I know how to predict which patients this drug should work in.
When you think about the success rates of clinical trials, often you’re going to get a 30% response rate in a clinical trial. That means a 70% failure rate.
As long as placebo is 14% or 15%, you’re going to see a difference.
But what if you could see a 70% response rate?
You can take that group that normally doesn’t respond, reduce the numbers of that group, and reduce the whole trial size as a result.
Take yourself from designing a trial with either 3,000 patients so you could get 80% power, to 1,000 patients with 80% power, or from 1,000 patients with 80% power up to 1,000 patients, which you still need for safety, but with 95% power.
So there’s just a real opportunity to improve clinical trial design here.”
An exclusive 2,385 word interview with this biotech CEO reveals a major partnership as a strategic linchpin.
Todd R. Nelson, Ph.D., has served as the President and Chief Executive Officer and a member of the board of directors of Telesis Bio (NASDAQ:TBIO) since July 2018.
Prior to joining the company, Dr. Nelson served as the Chief Executive Officer of several life science companies through expansive phases of financial and commercial growth.
“We signed an agreement with Pfizer in the fourth quarter of 2021 and announced our first successful milestone being complete during the fourth quarter of 2022.
The agreement with Pfizer is around a new and novel way that our company has developed to make DNA.
It’s called enzymatic DNA synthesis or EDS for short, and our particular brand for that is called SOLA.
It’s an innovative, new way to make DNA that allows customers to make it at benchtop without having to order from suppliers or wait to perform experiments.
The reason Pfizer wanted to partner with us is that this technology is the best available for building long genes very rapidly with very high fidelity.
If a gene is a sentence, one would want to make your sentences with as few typos as possible, which is one of the core strengths of the technology.
They’ll be using it for flu vaccines or COVID vaccines where the ability to rapidly iterate on the DNA template can lead to a more robust vaccine down the way.
Just anecdotally, flu vaccines, as an example, are 40%, 50%, 60% efficacious. But with mRNA vaccines, such as the one that Pfizer’s working on, that efficacy can go up significantly.”
This exclusive 2,940 word interview reveals a strategy based on a rare drug being developed for a severe disease.
Charles P. Theuer, M.D., has served as the President, Chief Executive Officer and a member of board of directors of TRACON Pharmaceuticals (NASDAQ:TCON) since July 2006.
From 2004 to 2006, Dr. Theuer was the Chief Medical Officer and Vice President of Clinical Development at TargeGen, Inc., a biotechnology company, where he led the development of small molecule kinase inhibitors in oncology, ophthalmology and cardiovascular disease.
“I’m the CEO and president at TRACON Pharmaceuticals.
TRACON is a late-stage developmental therapeutics company focused on oncology. And our lead program is a subcutaneous checkpoint inhibitor.
So this is a drug that works by a similar mechanism of action as drugs you’ve heard about that are marketed by, for instance, Merck, namely KEYTRUDA, and Bristol-Myers, namely OPDIVO.
We’re using a checkpoint inhibitor in a rare tumor called sarcoma that has a very high unmet medical need.
And we’re dosing it in a pivotal study, meaning a study that’s designed to provide the efficacy and safety data for a potential accelerated approval of the drug within the next two years.
We at TRACON have a unique business model as well.
We have a focus on developmental excellence in the sense that we run our own trials with our own team.
And by so doing and insourcing that activity, we run trials at much lower cost according to much faster timelines and also at higher quality than companies that typically will outsource their trials to a third party, namely what’s called a contract research organization.
That’s our unique business model that says develop therapeutics at lower cost and then faster than most other companies.
Our pipeline is also broad.
We have three other clinical-stage assets as well.”
This 1,906 word interview focuses in on how an EU based biotech makes it into the lucrative US market.
Prof. Hartmut J. Ehrlich, M.D., is Chief Executive Officer of Abivax. Prof. Ehrlich is a physician with 30 years of experience in academia and in the biopharmaceutical industry, 20 of which were in product development at Baxter and Sandoz (now Novartis).
Didier Blondel is EVP, Chief Financial Officer and Board Secretary of Abivax. Mr. Blondel was Chief Financial Officer at Sanofi Pasteur MSD, a Lyon-based joint venture between Sanofi and Merck, and European leader in human vaccines, since 2012.
“Abivax was founded in late 2013 by Truffle Capital, a Parisian-based investment fund.
The management, together with the founders, set the objective right from the beginning to do an IPO at Euronext Paris within 18 months of the founding, which we actually accomplished in June 2015.
Today, Abivax is a late-stage biotech company with around 50 collaborators based at its headquarters in Paris and its research facilities in Montpellier, in France.
Our lead drug candidate, obefazimod, has generated promising results in Phase IIa and Phase IIb clinical trials for the treatment of ulcerative colitis, a chronic inflammatory bowel disease, and in a Phase IIa clinical trial in rheumatoid arthritis, another chronic inflammatory condition.
At present, the company is focusing on conducting its ongoing global Phase III clinical program with obefazimod for the treatment of ulcerative colitis.
This program consists of two induction trials followed by a single subsequent maintenance trial to confirm the long-term safety and efficacy of obefazimod in this indication.”
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