Boston Life Sciences, Inc. 2002 Annual Report to Shareholders
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Boston Life Sciences, Inc. 2002 Annual Report to Shareholders ......................... ........................................................................................................................................................... ............................................................................................................................... Boston Life Sciences, Inc. 2002 Annual Report to Shareholders To Our Shareholders: During 2002, we made substantial Other Scientific Programs have the opportunity to accomplish progress in positioning Boston Life While the two lead programs described some significant milestones. Sciences, Inc. for continued achievement. above have and will continue to be our We completed a comprehensive top priorities, we also furthered We have also had encouraging assessment of our technology portfolio development on two other scientific discussions with potential partners for and established clear goals through the programs during the year. Our second both Altropane for Parkinsonian end of 2004. We also made important Phase II trial of the use of Altropane and Syndrome, and Inosine for stroke. We strides on our two key near-term SPECT brain imaging as a diagnostic for believe that the filing of the NDA for objectives: the filing of a New Drug Attention Deficit Hyperactivity Disorder Altropane and the initiation of clinical Application (NDA) for Altropane as a (ADHD) is ongoing. There have been trials for Inosine will provide a platform diagnostic for Parkinsonian Syndrome, statistically significant differences in the for more extensive discussions with such including Parkinson’s disease, and the Altropane brain images of “normal” parties. initiation of human clinical trials of volunteers versus those clinically I would like to thank our employees, Inosine in patients who have suffered an diagnosed with ADHD at the center that scientific collaborators, and directors for acute ischemic stroke. has the most subjects enrolled to date. their continued diligence and dedication. However, because there may be some NDA filing for Altropane A special acknowledgement is extended variability between centers in the criteria Over the past year, we have focused on to Dr. Ira Lieberman for his more than used to diagnose ADHD, we are completing the NDA for Altropane as a ten years of service on the Board. I initiating three more centers into the diagnostic for Parkinsonian Syndrome. believe we have assembled a strong team trial to better understand this issue. This filing represents the culmination of of professionals that have the necessary more than a decade of effort – including Fine-tuning the manufacturing process of skills and experience to support our extensive pre-clinical research, the Troponin – the anti-angiogenic protein scientific programs during this critical completion of three separate clinical that we are developing for the treatment stage of development. In addition, I trials, the establishment of a commercial of cancer – has been challenging. Due to would like to thank David Hillson for his manufacturing process, and the recent FDA guidelines pertaining to the many years of service as President and preparation of the NDA filing. Each of manufacture and use of recombinant CEO. David will continue his role as these activities represents an important proteins such as Troponin, we cannot Chairman of the Board. milestone in Altropane’s development. substantially change any detail of the I would also like to thank you, our Collectively, they position us to seek U.S. manufacturing process from the shareholders, for your support. The past Food and Drug Administration (FDA) beginning of pre-clinical studies through three years have been an extremely marketing clearance for Altropane. all phases of clinical trials without challenging period for investors, and the incurring substantial costs and time Initiation of Clinical Trials for Inosine biotechnology sector has not been delays. While we have made progress, Stroke is the third leading cause of death immune from the stock market’s we continue our efforts to scale up in the United States. Only two-thirds of difficulties. However, we believe that the production so that we can commence stroke victims survive, and patient care long-term prospects for the biotech pre-clinical studies. costs for stroke are among the highest industry in general, and Boston Life of any medical condition. We believe Financial Resources & Partnerships Sciences in particular, are very strong. there is a long-term market potential for We have made important progress in Inosine because current therapies for ensuring that we have the resources to As always, I encourage you to contact stroke offer little or no hope of achieve our ambitious goals. In March me if you have any questions or functional recovery. We are making 2003, we generated gross proceeds of concerns that you would like to discuss. steady progress with our pre-clinical $10 million in a private placement. We program and additional animal studies completed this transaction at an above- Sincerely, are currently underway. We will include market price, without incurring any the data from these studies in the placement agent fees or having to issue Investigational New Drug (IND) any warrants to the investors. Following application that we plan to file with the the closing, we had cash and investments FDA. Upon receipt of FDA approval, we of approximately $15 million. We believe expect to commence our initial clinical that this will be sufficient to sustain our Dr. Robert J. Rosenthal trials with patients who have suffered operations at least through the end of President and Chief Executive Officer acute ischemic stroke. 2004 – a period during which we will May 1, 2003 SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K È ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2002 OR ‘ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period Commission file number 0-6533 BOSTON LIFE SCIENCES, INC. (Exact name of registrant as specified in its charter) DELAWARE 87-0277826 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) 20 NEWBURY STREET, 5th FLOOR 02116 BOSTON, MASSACHUSETTS (Zip Code) (Address of principal executive offices) Registrant’s telephone number, including area code: (617) 425-0200 Securities registered pursuant to Section 12(b) of the Act: NONE Securities registered pursuant to Section 12(g) of the Act: Common Stock, Par Value $.01 Per Share Warrants to Purchase Common Stock Rights to Purchase Preferred Stock (Title of Class) Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes È No ‘ Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K ((§) 229.405 of this chapter) is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. È Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Act). Yes ‘ No È Based on the last sales price of the Registrant’s Common Stock as reported on the Nasdaq National Market on June 30, 2002 (the last day of our most recently completed second fiscal quarter), the aggregate market value of the 22,123,580 outstanding shares of voting stock held by nonaffiliates of the Registrant was $27,875,711. As of March 24, 2003, there were 32,469,588 shares of the Registrant’s Common Stock issued and outstanding. Documents incorporated by reference: Portions of the Registrant’s definitive proxy statement to be filed with the Securities and Exchange Commission relative to the Registrant’s 2003 Annual Meeting of Stockholders are incorporated by reference into Items 10, 11, 12 and 13 of Part III of this annual report on Form 10-K. PART I Item 1. Business. Overview We are a development stage biotechnology company engaged in the research and development of biopharmaceutical products for the diagnosis and treatment of central nervous system, or CNS, diseases and for the treatment of some cancers and autoimmune diseases. We were originally a privately held company founded in 1992 and merged with a publicly held company effective June 15, 1995. Our principal executive offices are located at 20 Newbury Street, 5th Floor, Boston, Massachusetts 02116, and our telephone number is (617) 425-0200. We are strategically located in one of the world’s most prominent centers of biotechnology research – Boston, Massachusetts. Many of the world’s leading universities and hospitals are located in the Boston area and these institutions have established highly regarded medical schools and research facilities. Since its founding in 1992, the Company has effectively utilized its close relationships with these institutions to secure the rights to a broad array of diagnostic and therapeutic discoveries. We currently have 13 technologies in our product portfolio, all of which were invented or discovered by researchers working at Harvard University and its affiliated