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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) December 29, 1999
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BOSTON LIFE SCIENCES, INC.
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(Exact name of registrant as specified in its charter)
Delaware 0-6533 87-0277826
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(State or other jurisdiction of (Commission (I.R.S. Employer
incorporation or organization) File No.) Identification No.)
137 Newbury Street
8th Floor
Boston, Massachusetts 02116
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(Address of principal executive offices) Zip Code
Registrant's telephone number, including area code (617) 425-0200
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Item 5. Other Events.
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On December 29, 1999 Boston Life Sciences, Inc. announced that it would be
meeting with the FDA during the first quarter of 2000 to informally discuss its
application for the approval of Therafectin(R), its drug for the treatment of
rheumatoid arthritis. The agency granted the meeting following its submission
of a letter to the Company wherein BLSI was informed that the FDA felt that the
Company's trial for Therafectin submitted in 1998 had not provided sufficient
evidence of a statistically significant treatment effect and that it
consequently would not approve the drug at this time. The letter did not
specifically detail what the Agency considers the shortfalls or deficiencies in
demonstrating efficacy for the drug. Following receipt of the letter, the
Company was informed that it would be given a full opportunity to learn the
specific basis of the FDA's position on efficacy as well as what could be done
to possibly gain approval for Therafectin.
The Company noted that it was not in a position to comment at this time on the
future of Therafectin since it must first determine, with the guidance and input
of the FDA, what, if any, potential the drug may have. The Company noted that
the expenditures allocated to Therafectin since 1995 represent scarcely ten
percent of the Company's aggregate funding to date and totaled less than $1.5
million over the last two years. The Company also stated that it did not expect
to incur any further material expenditures in connection with Therafectin
The Company's believes its cash resources, approximately $16 million at December
31, 1999, will be adequate to support its primary programs well into 2001.
Item 7. Exhibits.
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The following Exhibits are filed as part of this report on Form 8-K:
99.1 Press Release, dated December 29, 1999.
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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: January 4, 2000 By: /s/Joseph Hernon
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Joseph Hernon
Chief Financial Officer
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BOSTON LIFE SCIENCES, INC.
CURRENT REPORT ON FORM 8-K
EXHIBIT INDEX
Exhibit No. Page
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99.1 Press Release, dated December 29, 1999 4
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Exhibit 99.1
BOSTON LIFE SCIENCES TO MEET WITH FDA ON THERAFECTIN(R) EFFICACY ISSUES
December 29, 1999--Boston Life Sciences, Inc. (NASDAQ:BLSI) announced that it
will be meeting with the FDA during the first quarter of 2000 to informally
discuss its application for the approval of Therafectin(R), its drug for the
treatment of rheumatoid arthritis. The agency granted the meeting following its
submission of a letter to the Company wherein BLSI was informed that the FDA
felt that the Company's trial for Therafectin submitted in 1998 had not provided
sufficient evidence of a statistically significant treatment effect and that it
consequently would not approve the drug at this time. The letter, which
contains the only substantive information received by BLSI from the FDA since
its submission last year of the results of its latest Phase III trial, did not
specifically detail what the Agency considers the shortfalls or deficiencies in
demonstrating efficacy for the drug. Following receipt of the letter, the
Company was informed that it would be given a full opportunity to learn the
specific basis of the FDA's position on efficacy as well as what could be done
to possibly gain approval for Therafectin.
The Company noted that it was not in a position to comment at this time on the
future of Therafectin since it must first determine, with the guidance and input
of the FDA, what, if any, potential the drug may have. David Hillson, the
Company's Chairman and CEO commented, "Therafectin, our only potential product
that is not part of Boston Life Sciences' primary portfolio of Harvard Medical
School technologies, represents a very late stage, relatively low cost
opportunity that we, and our clinical rheumatologist advisors, felt should not
be allowed to languish. The expenditures allocated by Boston Life Sciences to
Therafectin since its ownership of the drug in 1995, represent scarcely ten
percent of the Company's aggregate funding to date and totaled less than $1.5
million over the last two years. We do not expect to incur any further material
expenditures in connection with Therafectin."
"With our well-advanced clinical programs in Parkinson's/ADHD diagnostics, our
well-recognized anti-angiogenesis agent, Troponin, and groundbreaking work in
axonal regeneration in the spinal tract as well as our research collaboration in
allergy and asthma with Pfizer, Boston Life Sciences is looking forward to a
very productive year in 2000. Our cash resources, approximately $16 million at
December 31, 1999, appear quite adequate to support our primary programs well
into 2001."
BLSI is developing novel treatments for cancer, autoimmune diseases, and central
nervous system disorders. In addition to Therafectin, BLSI's products in
clinical trials or in preclinical development include: Altropane(TM), a
radioimaging agent for the diagnosis of Parkinson's Disease and Attention
Deficit Hyperactivity Disorder; Troponin I, a naturally-occurring anti-
angiogenesis factor for the treatment of solid tumors; AF-1 and Inosine, nerve
growth factors for the treatment of acute and chronic CNS disorders; and
transcription factors that may control the expression of molecules associated
with autoimmune disease and allergies.
Statements made in this press release other than statements of historical fact
represent forward-looking statements. Such statements include, without
limitation, statements regarding expectations or beliefs as to future results or
events, such as the adequacy of the Company's capital resources, discussions
with regulatory agencies, expected timing and results of clinical trials,
schedules of IND, NDA and all other regulatory submissions, the possible
approval of products, the timing of product introductions, the market size for
the Company's products and possible advantages of the Company's products. All
such forward-looking statements involve substantial risks and uncertainties and
actual results may vary materially from these statements. Factors that may
affect future results include: regulatory decisions, 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, the availability and adequacy of financial resources,
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, including the Company's Annual Report on
Form 10-K/A.
For further information, please contact:
Media Contact Investor Contact Corporate Contact
Jim Weinrebe, ext. 6650 Maria Zapf Boston Life Sciences, Inc.
Schwartz Communications Boston Life Sciences, Inc. Marc Lanser, MD
781.684.0770 617.425.0200 Chief Scientific Officer
617.425.0200
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