2014

Hadasit Bio-Holdings CEO Letter to Shareholders

JERUSALEM, April 9, 2013 /PRNewswire/ -- Hadasit Bio-Holdings Ltd. (TASE: HDST, OTC: HADSY), a publicly traded portfolio of biotech companies, all based on intellectual property developed and owned by Hadassah University Hospital, Israel's foremost medical research center, today announced that it has released the following letter to its shareholders:

Dear Shareholders and Investors,

2012 proved to be a year of maturation and growth for Hadasit Bio-Holdings (HBL). Over the past twelve months our portfolio companies have advanced significantly both scientifically and operationally.  We've taken this momentum into the current year and already we are starting to reap the benefits of our diligence, patience and execution.  As a recent example, one of our flagship portfolio companies, Enlivex Therapeutics, just received orphan drug status for its ApoCell treatment.  The orphan drug status grants Enlivex seven years of exclusivity for treatment based on immune tolerance for GVHD.  This is just one example of the successful milestones our portfolio companies have been able to achieve and will continue to achieve over the coming months and years.

Not only will all of our portfolio companies continue to push forward and advance their science following the successes we had in the past year, but we will also advance ourselves from the holding company level.  For instance, in the midst of a very tough market our shareholders continued to display confidence in our growth potential after we saw over 99% participation in a rights offering we held earlier in 2012 that raised capital of over 5M NIS to be reinvested into the portfolio. 

The past year was highlighted by our portfolio companies attracting new strategic partners, earning successful results in various clinical trials, receiving sizable grants from various sources—including the Israeli government—and completing a merger with a public company. Despite a difficult year in regards to the Company's value, we believe that HBL has reached a trough and are now positioned to thrive both clinically and financially in 2013; thus bringing strong returns to the portfolio and its investors.

In the following I've outlined the Company's recent developments and our future plans, which we hope you will partake in as a potential shareholder.

Recent Developments:

Successful Clinical Trials

  • Following a Phase I clinical trial with THR-18, which was designed to show safety of Thrombotech's lead product for the treatment of stroke victims, the company was merged into a publicly traded company, D-Pharm, and is now conducting a Phase II clinical trial. The Phase I trial showed positive initial results of efficacy in treating additional conditions as well.
  • Enlivex completed a Phase I/II study on patients undergoing bone marrow transplants and was successful in showing a very significant reduction in Graft vs Host Disease (GVHD) severity.
  • BioMarCare has collected hundreds of samples from cancer patients for its development of cancer diagnostic kits, as part of a clinical trial.

New Strategic Partners and Additional Investments 

  • Micromedic Technologies Ltd. invested in our BioMarCare Technologies Ltd.
  • Sanofi and Recipharm invested 10M NIS in our portfolio company KAHR Medical Ltd.
  • Clal Biotechnology Industries and Pontifax provided ProtAb with additional funds to support its current activities and prepare for a broad clinical trial.
  • BioTime Inc. signed an agreement to provide Cell Cure with $3.5M of BioTime stock.

Grants and Financial Achievements

  • BioMarCare received a grant from the Israel-U.S. Binational Industrial Research and Development (BIRD) Foundation to support BioMarCare's partnership with Ariadne Inc. (based in Florida).
  • The Israeli Office of the Chief Scientist (OCS) in the Ministry of Industry, Trade and Labor provided our companies with substantial grants totaling over $3M.
  • Over 5M NIS were raised from the public through a rights-offering with an outstanding participation of over 99% of eligible rights holders. Several leading Israeli institutional investors participated.
  • Hadasit Bio-Holdings Ltd. was one of the first Israeli biotech companies to establish an American Depositary Receipts (ADR) program exposing the TASE stock in a liquid and transparent manner to the American market. We are now 'Blue Sky' approved in over 30 states and the ADR holders have purchased over 2.5% of the outstanding TASE shares.
  • Thrombotech Ltd. was acquired by D-Pharm and we now hold ~14% of the publicly traded company.

Future Plans:

Over the year we saw a substantial increase in the global interest in the growth potential of the Israeli biotechnology industry, and more specifically, an increase concerning HBL. We believe this growing interest in our Company was generated due to our unique model of a holding company that maintains a strong affinity for and involvement with a leading and innovative private hospital. In the coming year, we intend to take advantage of this interest by forging ties and building strategic partnerships with leading pharmaceutical entities, manufacturers and investors.

With the ongoing maturation of the current portfolio companies, investment options in new and attractive companies are always being examined. In order to manage risk in the best possible way and thoroughly utilize the relative advantage HBL has as a holding company with a hospital in its 'back yard', we have developed an innovative business model for these potential investments. The model is conditionally based on initially investing a relatively small amount of capital in order to finance a feasibility trial with one of Hadassah's specialists, while having the option of investing significantly after the initial trial if successful. We are also looking into the possibility of diversifying our portfolio by adding companies that develop  products which require less regulation and present a shorter time to market, such as medical devices and medical IT – fields in which Hadassah is already an established world leader.

In summary, we feel that our maturing portfolio, unique list of valuable assets, proven expertise in numerous fields of science, and experienced and hands-on management, coupled with an attractive share price and substantial growth potential for the Israeli biotechnology industry – all make HBL a highly attractive investment opportunity. Furthermore, the fact that an investment in the Company would directly help progress the research and development of innovative medical treatments with the potential to save thousands or even millions of lives from all over the world make it not only rewarding financially, but important in many other ways.

We remain confident in our assertion that 2013 promises to be a noteworthy year for HBL and its investors. We are immensely proud to have your confidence as shareholders, potential investors and partners for success. Your continued support and involvement only validates and affirms our corporate mission; to not only be a success financially, but to succeed in providing innovative medical treatments for the betterment of mankind.

About Hadasit Bio-Holdings

Hadasit Bio-Holdings, Ltd., established in 2006, is the publicly traded subsidiary of Hadasit Ltd. - the technology transfer company of the Hadassah University Hospital, Israel's foremost medical research center. The Company was established for the purpose of promoting and commercializing the intellectual property and R&D capabilities generated by Hadassah.

HADSY is the domestically traded ADR of Hadasit Bio-Holdings, a public investment vehicle of six portfolio biotech companies all based on inventions developed by Hadassah.  Hadasit Bio-Holdings focuses on advancing companies that have already shown proof of concept and successful preclinical trials to completion of Phase I/II.

The portfolio companies develop drugs with blockbuster potential (targeting markets that are worth over a billion dollars) operating in the fields of cancer, inflammatory diseases and tissue regeneration using stem cells - areas in which the Hadassah Hospital has extensive knowledge and recognition as a global leader. The company is managed by Ophir Shahaf.

For more information please visit: www.hbl.co.il

Forward-Looking Statements

Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for Hadasit Bio-Holdings ("HBL") and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will", "believes", "plans", "anticipates", "expects", "estimates") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of HBL and its subsidiaries. HBL disclaims any intent or obligation to update these forward-looking statements.

Contact:

KCSA Strategic Communications
Phil Carlson / Josh Dver
212-896-1233 / 1239
pcarlson@kcsa.com / jdver@kcsa.com

SOURCE Hadasit Bio-Holdings Ltd.



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http://www.hbl.co.il

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