The following was provided while participating in the 2023 Destination Startup® Showcase.
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What We Do
Reglagene is a preclinical-stage therapeutics company developing a breakthrough therapy for the safe and effective treatment of brain cancers.
Affiliated Institution: University of Arizona
Have we formed a company? Yes
Funding: Grant Funding, Direct/Indirect University Support, Angel Funding (including Self or Friends/Family), Venture Capital
Our Company and the Problem We Are Trying To Solve
Reglagene is a preclinical stage therapeutics company developing a breakthrough therapy for the safe and effective treatment of brain cancers. Reglagene is based in Tucson, Arizona and was built by pharmaceutical R&D professionals. Great strides have been made in treating cancer. But innovations that are effective for the treatment of brain tumors have been lagging. The standard of care therapy for glioblastoma was approved by the FDA in 1999 and affords patients an average of 2.5 months of additional survival with the trade-off of severe side effects. The number one reason cancer therapies fail is because of the blood brain barrier. The BBB is a filter that we all have that keeps toxins from entering the brain. The problem is that it also keeps what would otherwise be effective therapies out of the brain. Reglagene has built an efficient drug development engine that interweaves internal R&D capabilities with renowned global service providers and academic partners. This engine enabled the design, manufacture, and testing of over 800 prototypes to identify an orally administered, safe, potent, cancer medicine that works through inhibition of tubulin, the number one clinically validated target in the history of cancer therapy. This is protected by a Reglagene exclusive composition of matter patent with 19 years remaining. We aim to reach patients as quickly as possible and utilize the FDA accelerated drug development and approval programs to reduce timelines and cost. Patients will no longer choose between palliative care and toxic medicines that barely extend their lives.
Our Go-to-Market Strategy
We do not intend to take this all the way to the market. The quickest and most efficient way for Reglagene to exit is by being acquired, or out-licensing an asset to a pharmaceutical company. Big pharmaceutical companies have the resources, talent, and clout to push a new medicine through clinical development. This is the route Reglagene intends to pursue. M&A’s and out-licensing deals frequently occur in the oncology therapeutic market, and most frequently happens before the initiation of a phase II clinical trial. Since Reglagene is pursuing brain cancer, which afflicts less than 200,000 US patients per year, we can utilize the FDA accelerated drug development and approval programs to reduce timelines and cost. We can apply for these programs early in development, making acquisition or out licensing deals more attractive for prospective pharmaceutical partners. There are several marketed cancer therapies that target tubulin, but they all are given by IV and none cross into the brain. These previous therapies have shown efficacy in animal models when glioblastoma is implanted on the side of mice. Yet, when the tumor is behind the blood-brain barrier, they have not shown efficacy as they do not penetrate the brain. The pharmaceutical industry has spent decades reformulating existing microtubule therapies to allow for brain penetration without success. With a completely new structural class of medicines, Reglagene’s produced prototypes that offer outstanding efficacy and brain penetration, the combination needed to decimate brain cancer. This completely differentiates Reglagene’s product from any marketed therapy.
How We Will Generate Revenue
Reglagene will generate revenue through licensing its products to pharmaceutical partners. Most pharmaceutical companies have limited early-stage product development capability and rely on in-licensing or acquisition to fill development pipelines. The oncology space is by far the most active disease area for licensing deals. These deals typically are made between preclinical development and Phase II human clinical trials, provide an up-front payment, and are backloaded with development milestone payments and royalties on product sales. Reglagene’s first product is within months of entering the licensing window. Reglagene’s business objective is to exit by M&A or IPO. Cancer therapeutics companies exit frequently (one per week over the last five years) with 50% of the exits by IPO. Completion of a Phase I trial demonstrating safety and efficacy is the standard for transition to the public markets. IPO valuations >$1B are common at this stage. Considering an M&A exit, frequently it is the filing of IPO documentation that precipitates offers from acquirers. Reglagene’s business imperative is to behave like an IPO company, even if the eventual exit comes by M&A.
How We Will Benefit From Destination Startup®
Reglagene’s objective for Destination Startup is to build relationships with prospective investors in the Denver area. If there is interest in engaging with Reglagene, we would schedule follow-on meetings to take deeper dives into Reglagene’s product development activities and business plan. Reglagene has a signed $3M Series A term sheet. Reglagene’s lead investor is the Desert Angels out of Tucson, Arizona. The first $1.65M has been closed, and we are in active talks about the remainder of the round. At this point, Reglagene has spoken with nearly every firm and organization in Arizona and is beginning to branch out to neighboring states as our financing needs continue to increase as we near the clinic. Reglagene’s round size allows us to pursue both angels and venture capital firms. Talent acquisition is a major part of the use of proceeds. Reglagene’s transition from product discovery to product development demands new skill sets. We have identified candidates who we will contract for critical roles such as, a Pharmacology and Toxicology Director, Chemistry, Manufacturing, and Controls (CMC) Director, and a Chief Medical Officer.
Our Team
Reglagene’s CEO, Richard Austin PhD, MBA, is a pharmaceutical R&D veteran with over 25 years of experience ranging from the laboratory bench to operations management at well-known pharmaceutical companies (GlaxoSmithKline and Sanofi). His expertise in early drug discovery and development and operations management makes him the ideal CEO for a startup biotech therapeutics company. Reglagene’s CSO, Laurence Hurley, PhD is a serial entrepreneur who has brought multiple medicines into human clinical trials. Reglagene’s product development leaders Vijay Gokhale PhD, and Teri Suzuki, PhD have decades of experience in academics and the pharmaceutical industry, respectively. Dr. Gokhale has brought forth the intellectual property for many startup companies and Dr. Suzuki has led teams through preclinical development. Reglagene’s Director of Operations, Michel Abrahamson, PharmD, is a pharmacist by training with successful startup experience and clinical toxicology consulting.