Wall Street Transcript Interview with Ophir Shahaf, Chief Executive Officer of Hadasit Bio-Holdings Ltd. (HADSY)

Wall Street Transcript

67 WALL STREET, New York - September 20, 2012 - The Wall Street Transcript has just published its Biotechnology and Pharmaceuticals Report offering a timely review of the sector to serious investors and industry executives. This special feature contains expert industry commentary through in-depth interviews with public company CEOs, Equity Analysts and Money Managers. The full issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.

Topics covered: Biotechnology and Pharmaceutical Valuations - Oncology Drug Development - Orphan Drugs - FDA Approval Process - Reimbursement Trends

Companies include: Hadasit Bio-Holdings Ltd. (HADSY) and many others.

In the following excerpt from the Biotechnology and Pharmaceuticals Report, the CEO of Hadasit Bio-Holdings discusses the outlook for his company for investors:

TWST: Please tell us about Hadasit Bio-Holdings.

Mr. Shahaf: Hadasit Bio-Holdings is a subsidiary of the Hadassah Hospital, which is one of the leading medical and scientific research institutes in Israel. It also operates two large hospitals in the city of Jerusalem and employs around 1,200 physicians and researchers. Some of them are very creative, very entrepreneurial, and we were set up with the mandate to commercialize the I.P. coming out of this extremely bright group of physicians. More than half of the translational research in Israel is conducted at Hadassah.

We went public on the Tel Aviv Stock Exchange in 2006 as HDST, raised public funding in several rounds of financing and have been traded as an over-the-counter ADR since mid-2011 as HADSY. We currently have six portfolio companies on board and own a controlling interest in most of them.

We have a very hands-on approach to the management of these companies, which includes sitting on the board of all of them. Our goal is to move these companies forward into advanced clinical trials to the point where they become attractive to key strategic investors, financial investors or both.

TWST: These portfolio companies - Enlivex Therapeutics, Cell Cure, KAHR Medical, BioMarCare Technologies, ProtAb, Thrombotech - what does the market look like for these companies?

Mr. Shahaf: When we screen new technologies coming out of Hadassah, we look for new products and developments aimed at addressing an unmet need as in diseases with no effective or safe treatment. We will look for companies that target these unmet markets, companies that are close to a clinical trial and that can generate significant data in that clinical trial, so that we have a package which is powerful. Powerful in terms of the clinical data, in terms of regulatory status, in terms of business potential, so that we can approach prospective partners at a relatively early stage. There is no arguing that biotech investing is risky, and early-stage biotech even more so. Our model is one that does not take these drugs all the way to the market or even to an advanced Phase III. We don't have the resources for that, and that's not where our competitive advantage lies. We focus on the early clinical stages, where the most substantial value appreciation can be achieved.

Our mandate is to reduce the risk level and then bring these companies to a point where they are attractive enough to potential pharmaceutical or strategic investors. Once we are able to bring in a major partner, like we have done for nearly all of our portfolio companies so far, we dilute ourselves to ownership of around 40% or 50%, but in exchange we now have some deeper pockets around the table as well as the added value of these key strategic connections, and we see significant value building in the stock.

In terms of sectors, we focus on the fields of oncology, regenerative medicine, stem cells and inflammatory disease. It's very easy to lose this focus when you're in the midst of a very active, very prolific research center, but we have to keep this focused approach because these are the hot markets we've identified, and this is where Hadassah's scientific excellence really lies. In order to take advantage of the best minds in the field, the best infrastructure, equipment and exposure to the source of leading scientific publications, we must remain in these fields. We are really a lean and mean organization riding on top of a big, well-funded, world-renowned scientific organization.

The markets that you asked about are extremely active and are crying out for innovation, and we intend to provide these required solutions. If you look at the big pharmaceuticals, you can see that they are consolidating, and companies are very hungry for a new drug in order to feed their pipeline. A lot of patents are expiring, a lot of revenues are being lost to generic drugs, so that these companies need to compensate for these revenue losses. They do that by investing in or licensing new drugs from early-stage biotech companies, like our portfolio companies.

TWST: Taking a look at Enlivex Therapeutics, for example, working on Crohn's disease, it would seem to represent the best near-term promise amongst these companies. Is that correct?

Mr. Shahaf: Enlivex is really one of the flagships of the portfolio. Their initial focus is graft versus host disease, GVHD, which is a fatal condition with no effective cure. They have just completed a Phase I/II clinical trial in thirteen patients that have undergone a bone marrow transplant, which is a risky condition to begin with. These are patients that have a very compromised immune system undergoing chemo, and a third of them are likely to develop GVHD. Enlivex has developed a unique, prophylactic cell therapy treatment to minimize the risks associated with the transplant and reduce cases of GVHD to a minimum.

The study's results were outstanding, and none of the 13 patients developed this very dangerous condition. The statistical significance of the trial, despite the relatively low number of subjects, is indeed powerful. Enlivex is currently looking for partners for the next round of fundraising to move into an advanced Phase II clinical trial, which we are extremely excited about.

If I can mention one other example, I would mention Cell Cure. Cell Cure is based on some very unique proprietary human embryonic stem cell lines that Hadassah has been growing and cultivating over the past 10 years. These are really omnipotent cells that can differentiate and multiply into almost any type of cell in the human body. The scientists at Cell Cure are working on a disease called AMD, or age-related macular degeneration, which is the leading cause of blindness in the elderly population. By creating and differentiating these cells into the type of cells that start malfunctioning during AMD, they can create replacements and transplant healthy cells to replace the defective, diseased cells. While this procedure is not in human clinical trials yet, we have seen amazing results from animal data and models they've been utilizing.

TWST: What's the agenda for Hadasit Bio-Holdings? What are the priorities for the next 12 months and what would make that time frame a success?

For more from this interview and many others visit the Wall Street Transcript - a unique service for investors and industry researchers - providing fresh commentary and insight through verbatim interviews with CEOs, portfolio managers, and research analysts. This special issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.

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