-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, RzQU1FQuuxqFXhux+f86Gg1uFbCMnBe519pM0uRqX5OTWyVNtTgFA+okIvEOjrJd dG4Bao8iCybTyB1KFd/8pw== 0001036050-99-001781.txt : 19990823 0001036050-99-001781.hdr.sgml : 19990823 ACCESSION NUMBER: 0001036050-99-001781 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 19990817 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 19990820 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BOSTON LIFE SCIENCES INC /DE CENTRAL INDEX KEY: 0000094784 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 870277826 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: SEC FILE NUMBER: 000-06533 FILM NUMBER: 99696501 BUSINESS ADDRESS: STREET 1: 137 NEWBURY STREET STREET 2: 8TH FLOOR CITY: BOSTON STATE: MA ZIP: 02116 BUSINESS PHONE: 6174250200 MAIL ADDRESS: STREET 1: 137 NEWBURY STREET STREET 2: 8TH FLOOR CITY: BOSTON STATE: MA ZIP: 02116 FORMER COMPANY: FORMER CONFORMED NAME: GREENWICH PHARMACEUTICALS INC DATE OF NAME CHANGE: 19920703 FORMER COMPANY: FORMER CONFORMED NAME: STRATEGIC MEDICAL RESEARCH CORP /DE DATE OF NAME CHANGE: 19790521 8-K 1 FORM 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of Earliest Event Reported) August 17, 1999 --------------- BOSTON LIFE SCIENCES, INC. -------------------------------------------------------- (Exact name of registrant as specified in its charter)
Delaware 0-6533 87-0277826 - ----------------------- ------ ---------------------------- (State or other jurisdiction of (Commission (I.R.S. Employer Identification No.) incorporation or organization) File No.) 137 Newbury Street 8th Floor Boston, Massachusetts 02116 - ------------------------------------------ ------------- (Address of principal executive offices) Zip Code
Registrant's telephone number, including area code (617) 425-0200 ----------------- Item 5. Other Events. ------------- On August 17, 1999, the Company reported financial results for the three and six month periods ended June 30, 1999. For the second quarter ended June 30, 1999, the Company reported a net loss of $1,636,042 or $0.11 per common share compared to a loss of $1,735,448 or $0.13 per common share for the quarter ended June 30, 1998. For the six month period ended June 30, 1999, the Company reported a net loss, including non-cash preferred stock preferences of $4,240,000, of $7,954,827 or $0.56 per common share compared to a loss of $3,383,353 or $0.26 per common share for the same period in 1998. Reported cash, cash equivalents and investments were $12,904,119 at June 30, 1999. The Company also reviewed progress in the development of its technologies during the first half of 1999 including: 1. Use in Attention Deficit Hyperactivity Disorder multiplies Altropane(TM) market potential. The Company plans to enter Altropane(TM) into development for use in the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD). An analysis of its ADHD pilot study performed under a Physician's Sponsored Investigational New Drug application generated highly successful results. In that study, patients with previously confirmed ADHD showed significant abnormal elevation in the number of dopamine transporters versus normal patients when scanned with Altropane(TM). The Company believes that the potential market for an ADHD imaging agent is five to ten times that of Parkinson's Disease, and that with both markets, Altropane(TM) could prove to be one of the biggest radio-imaging agent ever introduced to the market. 2. Latest results establish premier anti-angiogenic position for Troponin I. The Company reported that in the most recent experiment this year, Troponin I scored a dramatic 95% reduction in total volume of metastases in animals injected with human sarcoma (a very aggressive type of cancer) versus the untreated group. The Company believes that this degree of suppression of metastatic tumor burden has not previously been achieved with experimental anti-angiogenic therapy. The Company also announced that an analog (fragment) of Troponin I appears to have approximately 10 times the in vitro activity of Troponin, and appears therefore to have great advantages in dosage, solubility and purification. 3. CNS regeneration and cytokine regulation programs generate unprecedented advances. The Company reported that experiments completed in its central nervous system regeneration program had demonstrated regeneration of severed axons within the optic nerve, which has potential relevance in the treatment of glaucoma, a major eye disease. In another animal model, substantial re- growth of axons in the pyramidal tract of injured spinal cords was achieved. The Company also stated that partnering discussions were in progress in its transcription factor and gene vector programs. The Company hopes to co- develop two gene therapy products, and at least four small molecule inhibitors for the treatment of autoimmune disease, allergies, cancer and AIDS within these programs. Statements made above regarding the expected timing and results of clinical trials, schedules of IND, NDA, and other regulatory submissions, discussions with potential partners, submissions to scientific publications, the timing of product introductions, the market size for the Company's products and possible advantages with respect to ease of manufacturing, potency and dosage are forward looking statements and, as such, involve risks and uncertainties by which actual results may vary materially from these expectations. Meaningful factors that may affect these results include: results of scientific data from clinical trials; delays in the regulatory or development processes; the ability to obtain intellectual property protection, the outcome of discussions with potential partners, market acceptance of the Company's products and other possible risks and uncertainties that have been noted in reports filed by the Company with the Securities and Exchange Commission. 1 Item 7. Exhibits. --------- The following Exhibits are filed as part of this report on Form 8-K: 99.1 Press Release, dated August 17, 1999. 2 SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto authorized. BOSTON LIFE SCIENCES, INC. Dated: August 18, 1999 By: /s/ Joseph Hernon --------------------------- Joseph Hernon Chief Financial Officer 3 BOSTON LIFE SCIENCES, INC. CURRENT REPORT ON FORM 8-K EXHIBIT INDEX Exhibit No. Pages - ------------- ----- 99.1 Press Release, dated August 3, 1999 5 - 7 4 EX-99.1 2 PRESS RELEASE Exhibit 99.1 BOSTON LIFE SCIENCES, INC. REPORTS SECOND QUARTER 1999 FINANCIAL RESULTS AND REVIEWS IMPORTANT FIRST HALF PROGRESS August 17, 1999, Boston, Mass.--Boston Life Sciences, Inc. (NASDAQ: BLSI) today reported financial results for the three and six month periods ended June 30, 1999. For the second quarter ended June 30, 1999, the Company reported a net loss of $1,636,042 or $0.11 per common share compared to a loss of $1,735,448 or $0.13 per common share for the quarter ended June 30, 1998. For the six month period ended June 30, 1999, the Company reported a net loss, including non-cash preferred stock preferences of $4,240,000, of $7,954,827 or $0.56 per common share compared to a loss of $3,383,353 or $0.26 per common share for the same period in 1998. The Company reported cash, cash equivalents and investments of $12,904,119 at June 30, 1999. "The first half of 1999 has probably been the most important and eventful six months in our history. We believe progress in virtually all areas of our technology portfolio has been remarkable," stated David Hillson, President and Chief Executive Officer. Use in Attention Deficit Hyperactivity Disorder Hugely Multiplies Altropane(TM) Market Potential "In addition to the Parkinson's Disease (PD) market, we are entering Altropane(TM) into development for use in the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD). There is currently no objective test to diagnose ADHD, a disorder that affects millions of children. It poses a particularly difficult challenge in the educational environment, where millions of students are prescribed powerful drugs like Ritalin(R). We are making the commitment to embark on a full human clinical trial program (leading toward an application for a NDA) because an analysis of our ADHD pilot study performed under a Physician's Sponsored Investigational New Drug application generated highly successful results. In that study, patients with previously confirmed ADHD showed significant abnormal elevation in the number of dopamine transporters versus normal patients when scanned with Altropane(TM). We believe that these results demonstrate for the first time that ADHD is associated with a detectable biochemical abnormality in the brain. We believe that the potential market for an ADHD imaging agent is five to ten times that of PD. With both markets going for us, Altropane(TM) could prove to be one of the biggest radio-imaging agent ever introduced to the market. We see the potential for 500,000 scans annually in the U.S. for PD and ADHD combined," added Mr. Hillson. Altropane(TM) was first studied clinically in Parkinson's Disease by Dr. Alan Fischman of Massachusetts General Hospital and was highly successful in a Phase II human clinical trial recently completed by Boston Life Sciences. This multi- center study demonstrated that a single, ten minute image taken after Altropane(TM) injection could accurately differentiate normal subjects from those with early PD. Altropane(TM) is now in a Phase III trial, which to our knowledge is the first Phase III trial for a PD radio-imaging diagnostic agent in the U.S. Latest Results Establish Premier Anti-Angiogenic Position for Troponin I "In the growing spectrum of anti-angiogenic agents, judging strictly from what has been actually published and demonstrated in vivo, Boston Life Sciences' Troponin I appears to be at the head of the class as an unusually potent, naturally occurring inhibitor of blood-vessel growth," commented Dr. Marc Lanser, the Company's Chief Scientific Officer. "As was published in the Proceedings of the National Academy of Sciences (PNAS) on March 16, 1999, relatively small doses of Troponin I given only twice-weekly (with no pre- treatment) suppressed the majority of melanoma lung metastases in a very difficult 5 model. In the most recent experiment this year, the agent also scored a dramatic 95% reduction in total volume of metastases in animals injected with human sarcoma (a very aggressive type of cancer) versus the untreated group. To our knowledge, this degree of suppression of metastatic tumor burden has not previously been achieved with experimental anti-angiogenic therapy. "Our anti-angiogenic development program, one of the very first undertaken by any biotech company, has achieved what appears to be yet another breakthrough in a crowded `me-too!' sector: An analog (fragment) of Troponin I identified by BLSI, appears to have approximately 10 times the in vitro activity of Troponin itself, and appears therefore to have great advantages in dosage, solubility and purification. Given what we believe is a comfortable patent position, this analog could eventually evolve as our lead commercial formulation. Finally, we are highly gratified to be in the protocol design phase of a multi-center human trial with Troponin at leading cancer centers later this year," continued Dr. Lanser. CNS Regeneration and Cytokine Regulation Programs Generate Unprecedented Advances "Our Central Nervous System (CNS) regeneration program recorded substantial achievements late in the fourth quarter of 1998. Experimental regeneration of severed axons within the optic nerve was demonstrated. This has potential relevance in the treatment of glaucoma, a major eye disease. In another animal model, substantial re-growth of axons in the pyramidal tract of injured spinal cords was achieved. Further larger-scale in vivo results now appear to confirm that our endogenous compound is, to our knowledge, unique in its ability to regenerate both injured optic nerves and spinal cord axons to such a substantial extent. "In addition to chronic diseases of the CNS, such as PD and Alzheimer's Disease, the potential markets for our agents are stroke and spinal cord injury. These latest results have been submitted for publication in a leading peer reviewed scientific journal," added Dr. Lanser. "Within the extremely important transcription factor and gene vector technologies discovered by Professor Laurie Glimcher of Harvard University dealing with the key role that Th1 and Th2 cells play in the development of autoimmune diseases and allergies, we have identified a portfolio of partnering opportunities. Intensive discussions are in progress. We believe that several collaborative relationships can radiate from the core of Dr. Glimcher's work, which is centered on controlling the production of critical cytokines (immune system regulators) at the genetic level. We hope to co-develop two gene therapy products, and at least four small molecule inhibitors for the treatment of autoimmune disease, allergies, cancer and AIDS based on this work," stated Dr. Lanser. "The scope of Dr. Glimcher's elucidation of the fundamental control mechanism in immunology is truly impressive. We expect to see a number of important publications detailing the ground breaking character of this work later this year," added Mr. Hillson. About Boston Life Sciences, Inc. BLSI is developing novel treatments for cancer, autoimmune disease, and central nervous system disorders. In addition to Troponin I, products awaiting FDA review, in clinical trials or in preclinical development by BLSI include Therafectin(R) for the treatment of Rheumatoid Arthritis; AF-1 for the potential treatment of stroke and spinal cord injury; Altropane(TM), a radioimaging agent for the diagnosis of Parkinson's Disease and Attention Deficit Hyperactivity Disorder (ADHD); and transcription factors that may control the expression of molecules associated with autoimmune disease and allergies. Financial Chart Follows 6 BOSTON LIFE SCIENCES, INC. (A Development Stage Company) CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (amounts in thousands except per share data) (Unaudited)
Three Months Ended Six Months Ended JUNE 30, JUNE 30, -------------------------------------- 1999 1998 1999 1998 -------- --------- -------- ------- Revenues $ - $ - $ - $ - Operating Expenses: Research and development 745 1,128 1,679 2,245 Licensing fees - - - 55 Therafectin related 504 134 1,082 261 General and administrative 623 667 1,319 1,267 ------- ------- ------- ------- Loss from operations (1,872) (1,929) (4,080) (3,828) Net interest income 236 194 365 445 ------- ------- ------- ------- Net loss (1,636) (1,735) (3,715) (3,383) Preferred stock preferences - - (4,240) - ------- ------- ------- ------- Net loss available to common shareholders $(1,636) $(1,735) $(7,955) $(3,383) ======= ======= ======= ======= Net loss per common share $ (0.11) $ (0.13) $ (0.26) $ (0.26) Preferred stock preferences - - (0.30) - ------- ------- ------- ------- Net loss per share available to common stockholders ======= ======= ======= ======= $ (0.11) $ (0.13) $ (0.56) $ (0.26) ======= ======= ======= ======= Weighted average shares outstanding 14,493 13,051 14,120 13,032 ======= ======= ======= =======
SELECTED BALANCE SHEET INFORMATION (amounts in thousands) (Unaudited)
June 30, December 31, 1999 1998 -------------- -------------- Cash and investments $ 12,651 $ 7,910 Total assets $ 16,903 $ 12,269 Stockholders' equity $ 9,135 $ 10,535
Statements made in this press release regarding the expected timing and results of clinical trials, schedules of IND, NDA, and other regulatory submissions, discussions with potential partners, submissions to scientific publications, the timing of product introductions, the market size for the Company's products and possible advantages with respect to ease of manufacturing, potency and dosage are forward looking statements and, as such, involve risks and uncertainties by which actual results may vary materially from these expectations. Meaningful factors that may affect these results include: results of scientific data from clinical trials; delays in the regulatory or development processes; the ability to obtain intellectual property protection, the outcome of discussions with potential partners, market acceptance of the Company's products and other possible risks and uncertainties that have been noted in reports filed by the Company with the Securities and Exchange Commission. 7 -----END PRIVACY-ENHANCED MESSAGE-----