Editor’s note: This is 13th in a series of stories profiling presenters at this week’s Venture 2003 conference.Startup Regado Biosciences is bringing new meaning to the phrase “stop the bleeding.”

Rather than referring to financial losses and burn rate, Regado is focused on means for doctors and health care providers to improve emergency treatment at the point of care. One project is designed to help stop hemorrhaging.

“Our technology generates matched drug-antidote pairs, and thus our products will enable physicians to provide safer and more effective treatment to patients in the acute care setting,” says Dr. Chris Rusconi, vice president of research and a founder of the company, which is based on technology transferred from Duke University.

“Our lead product is an antidote-controlled anticoagulant. This drug and antidote exhibit robust activity in multiple clinically relevant animal models, and the pair is approximately 18 months from initial clinical testing.”

Regado has developed what it calls a regulatable drug development platform.

Because the company’s founders have spent much time working with and talking to Duke physicians, Rusconi says the company also is targeting “large, unmet clinical needs.”

The firm’s two other founders, Eli Gilboa and Bruce Sullenger, are also scientific founders of Merix Biosciences.

Based on its technology, target markets, drug potential and management team, Regado already has drawn seed funding from The Aurora Funds. Aurora also has committed to lead Regado’s first round.

As it did a year ago, Local Tech Wire is featuring in-depth profiles of presenting firms for Venture 2003 built around a Q&A with a company executive as well as a Fact Box of important information. One profile will appear each day.

LTW put together a Q&A designed to not only produce facts about the presenters but also to give each a chance to state the case for venture capitalists to invest.

Answers were provided by Rusconi.

Venture 2003 took place earlier this week in Chapel Hill. (Previous profiles – Engineous, Hemocelluar, Elsinore, Gentris, A4, SmartPath, Dynogen, ViASIC, Norak, Kucera, Micell and MindValve can be found in LTW archives under Executive Q&A category.)

Times are tough. If you had only one chance and one paragraph to convince an investor, how would you answer this question: “Why should an investor choose your company?”

Regado is unique opportunity. We are a focused, product-driven company backed by a proprietary, platform drug discovery technology. Our technology generates matched drug-antidote pairs, and thus our products will enable physicians to provide safer and more effective treatment to patients in the acute care setting.

Two of our founders, Eli Gilboa and Bruce Sullenger, are also scientific founders of Merix Biosciences, and thus have experience translating laboratory discoveries into successful start-up biopharma companies.

(The third founder isRusconi, who joined the company recently, and helped successfully transfer the science out of Duke and into Regado.)

Maybe most importantly, the development of our Regulatable Drug Discovery platform was driven by many thoughtful discussions between Regado’s Founders and leading clinicians at Duke University Medical Center. Thus our products target large, unmet clinical needs.

Our lead product is an antidote-controlled anticoagulant. This drug and antidote exhibit robust activity in multiple clinically relevant animal models, and the pair is approximately 18 months from initial clinical testing. We believe this product will garner Orphan Product Status (which can mean accelerated FDA approval) for specific patient populations undergoing open-heart surgery as well as angioplasty procedures, which should speed its clinical development.

Finally, while the current funding environment is challenging, our combination of disruptive technology, clinical need and experienced Founders has helped Regado acquire seed funding from The Aurora Funds, and Aurora has committed to leading our Series A round of financing. So, new investors will be joining an experienced and involved investor group.

What is the pain point you address for your customers?

Physicians, especially interventional cardiologists and surgeons, have for years needed safer anti-thrombotic agents (eg. anticoagulant, antiplatelet and thrombolytic agents), as these drugs often cause patients to bleed severely. Not only does this put the patient at acute risk, the presence of these types of drug in a patient’s body can limit or delay the types of treatments physicians can provide to their patients. In acute care settings in which our drugs will be used, patient care is dynamic, so the risk to initiating treatment caused by current antithrombotic agents has a significant impact on patient safety and outcomes.

By providing physicians both a drug and a matched antidote to control the activity of the drug, Regado’s antithrombotic agents will solve both of these problems. If one of our drugs happened to induce bleeding in a patient, the physician could administer the antidote, neutralize the drug and stop the bleeding. Or if a physician needed to initiate treatment that could not be performed in the presence of our drug, the physician could administer the antidote, neutralize the drug, and initiate the required treatment.

Our antidotes work within minutes, so in either scenario, the patients treatment can be quickly and appropriately adjusted by this unique feature of our product.

What makes your company unique? Do you have a proprietary and/or a patented technology? Please explain why it is unique and what the status is of any patent filings.

Regado’s Regulatable Drug Discovery Platform enables the generation of matched drug-antidote pairs. No other company has a generalizable technology that allows for the generation of antidotes to their drugs. Regado is able to make matched drug-antidote pairs because our drugs are composed of nucleic acid (eg. RNA or DNA), and such drugs are unique compared to other classes of therapeutic agents such as monoclonal antibodies or small molecules in that they encode the information for their own antidotes.

The technology driving our platform, as well as specific compositions of matter for our lead compounds were invented by our Founders at Duke University, and two patents from Duke, currently under prosecution, protect this technology and these compositions. The world wide rights to these patents have been exclusively licensed to Regado.

What makes your products unique vs. your competition?

Our competition is large pharmaceutical companies and biopharmaceutical companies developing drugs in the antithrombotic space. These companies have attempted to solve the safety problems associated with antithrombotic therapy by identifying new drug targets with improved safety profiles. However, this has proved to be an incredibly difficult task, and the drugs that have resulted from such efforts do not provide clinicians the control over drug activity they desire. Our solution- the co-development of drugs and their matched antidotes- provides safer therapeutics whose activity can be directly controlled by the physician through the use of the drug’s matched antidote. Ultimately, we believe our regulatable drug approach will be much more effective and have broader applicability than other approaches.

What is your target market? What is the size of that market in terms of dollars? What share of that market do you believe you can win?

Our initial products are focused on the injectables antithrombotics market, which did greater than $4.5 billion in sales in 2001. We are developing our lead Regulatable Anticoagulant for use in open-heart surgeries. In 2000, greater than 600,000 open-heart surgeries were performed in the U.S., and we believe our product will immediately garner approximately 30% of this case load.

What will you do with invested funds? What is the timeline for product delivery?

Series A proceeds will be used to hire a CEO and bring on board personnel with drug development expertise. We will also make significant progress in our drug development programs. We will take our lead Regulatable Anticoagulant through Phase Ia clinical testing within 24 to 30 months, and identify and take into preclinical studies a Regulatable Antiplatelet agent within the same time frame.

What do you want from an investor other then money?

A long-term commitment to back the company and build value in it, and as an early stage company, strategic support in building our series A syndicate and our management team.

What is the exit strategy for the investor from your company? Are there potential strategic relationships with larger companies? Do you wish to take the company public? Or do you wish to grow the company and either sell it or acquire other companies?

Given the current state of the public markets, the most likely exit for an investor in Regado will be through an acquisition by or merger with or a large pharmaceutical or biopharmaceutical company. Our products address large, unmet clinical needs in a unique way, so we anticipate we will enjoy multiple partnership opportunities for the marketing of these therapeutics. Our lead Regulatable Anticoagulant will be entering phase III clinical testing during 2008, and our lead antiplatelet product will be in Phase II testing. Given the size of our target markets and enthusiasm generated among clinicians by these products, we anticipate the company will be at a valuation at that point that would support either a public offering or make the acquisition of Regado an attractive liquidity event for our investors.

Just the facts on Regado: www.localtechwire.com/article.cfm?u=3936