After three leadership change in less than six months, vTv Therapeutics (Nasdaq: VTVT) finally has a permanent CEO – one who says he is committed to getting the company back on the right track.
Paul Sekhri was named CEO of the High Point biotechnology firm this summer, bringing almost 30 years of health care experience with stints as president and CEO at companies such as eGenesis, Lycera Corp. and Cerimon Pharmaceuticals. He has also held senior business development and strategy roles at Sanofi, Teva Pharmaceutical Industries Ltd., TPG Biotech, Cerimon, Ariad Pharmaceuticals and Novartis Pharma AG.
Sekhri takes the helm at vTv at a critical time, as it reported a net loss of $17.6 million last year and laid off 65% of its 25-person workforce, all while gearing up for Phase 3 trials of its lead product.
A clinical-stage pharmaceutical company, vTv is developing an orally delivered treatment for Type 1 Diabetes called TTP399.
The liver-glucokinase activator has shown about 40% reduction in hypoglycemic episodes in its Phase 2 study and was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration last year.
Earlier this year, the company formed strategic partnerships with CinRx Pharma of Ohio and G42 Healthcare of United Arab Emirates, whereby those companies will receive stock in exchange for collaboration and licensing. It received a $25 million investment from G42 Healthcare and a $10 million investment from CinRx.
Sekhri, who said he will be soon relocating to the Triad from New York, spoke recently with Triad Business Journal about his background, plans for getting TTP399 through Phase 3 trials and goals as CEO.
This interview has been edited for brevity and clarity.
When I heard about the company and what it was doing, it was an easy decision. Not a lot of companies have Phase-3-ready drugs that have received Breakthrough Designation from the FDA in a market of huge unmet need – Type 1 Diabetes, in this case, where there is literally one drug for all intents and purposes. That got me very excited.
I count myself as lucky and unique in the standpoint that I’ve worked across Big Pharma, Small Pharma, biotech, venture capital, private equity. I think the most important part is this is my third or fourth CEO job, and I’ve learned how to lead a company, lead a team and work with a board of directors.
I think my goal now as CEO … is looking at what the company needs in everything from capital raising to additional human resources to moving this drug into Phase 3 to looking at the rest of our pipeline and figuring out where things stand with those assets. The top priority is to get TTP399 into Phase 3 and through that and into the FDA finally.
It’s not so much different than from a private company. Of course, at a public company, there’s much more disclosure required. We look for interesting news flow to tell our shareholders and investors in the company.
A Phase 3 trial, which is really the pivotal trial prior to getting approval, is to demonstrate to the FDA that a drug is safe and efficacious. I think we’re well poised to do that.
We’re still optimistic that we’ll be in our first patient by the end of this year – that’s the goal. And then it’s probably about 12 to 18 months for the trial. It depends on recruitment, but it’s not a super long trial.
Honestly, I think it’s too early to say too much about that because I’m just learning the pipeline myself. We do have several other assets – some are partnered, some are partially partnered, some are unencumbered completely. My job is going to be to look at those and figure out what makes sense to do with those. TTP399 is a top priority.
They definitely will, and they get us strongly into Phase 3. Given everything we want to do with this drug and other parts of the pipeline, potentially we’ll look to raise more money. It’s too early to tell exactly when and how, but it would make sense to me and so that just needs to be discussed internally and with our board to figure out the direction we want to take there.
I would take nothing off the table – whether it’s government grant money or investigator-sponsored trials or typical venture investments or other ways of raising money. I can’t tell what [amount] we would look to raise because I need to understand what our needs are.
It’s looking to see what the spend for the Phase 3 trials will be, potentially adding additional headcount and then understanding what other assets the company has, which we might want to take forward ourselves or with a partner. It’s a little early for me to comment on what that would really look like, but that’s an idea of the focus that I have.
That’s something I’m looking at now. It’s too premature to say. Will we need some people? I would say probably yes. But I can’t tell you the number. I can’t tell you who because I don’t have enough information yet. But again, it’s all to support getting this drug through clinical trials and to approval. Whatever we need in that regard – internally at the company and externally working with consultants – we’re going to do.
My focus is to turn the company around and get it back on track. I can’t and won’t comment on what my predecessors did with the company because I don’t know them. I don’t have any context, to be honest. I don’t know if [the restructuring] was the right thing to do, the wrong thing to do or somewhere in between. All I know is the company I now have to lead. My goal is most importantly to get TTP399 into the hands of the patients that need it. Everything that’s affiliated with that – raising money, getting the right people into the company, getting the drug through clinical trials and filing with the FDA – I’m going to do to ensure that happens. The unmet need of this drug is tremendous, and this can help the disease and the patients’ quality of life so dramatically. That’s what is the most exciting for me.
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