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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) August 17, 1999
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BOSTON LIFE SCIENCES, INC.
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(Exact name of registrant as specified in its charter)
<TABLE>
<CAPTION>
<S> <C> <C>
Delaware 0-6533 87-0277826
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(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
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(Address of principal executive offices) Zip Code
</TABLE>
Registrant's telephone number, including area code (617) 425-0200
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Item 5. Other Events.
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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.
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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 August 17, 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: August 18, 1999 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. Pages
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99.1 Press Release, dated August 3, 1999 5 - 7
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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
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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
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BOSTON LIFE SCIENCES, INC.
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(amounts in thousands except per share data)
(Unaudited)
<TABLE>
<CAPTION>
Three Months Ended Six Months Ended
JUNE 30, JUNE 30,
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1999 1998 1999 1998
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<S> <C> <C> <C> <C>
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
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Loss from operations (1,872) (1,929) (4,080) (3,828)
Net interest income 236 194 365 445
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Net loss (1,636) (1,735) (3,715) (3,383)
Preferred stock preferences - - (4,240) -
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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) -
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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
======= ======= ======= =======
</TABLE>
SELECTED BALANCE SHEET INFORMATION
(amounts in thousands)
(Unaudited)
<TABLE>
<CAPTION>
June 30, December 31,
1999 1998
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<S> <C> <C>
Cash and investments $ 12,651 $ 7,910
Total assets $ 16,903 $ 12,269
Stockholders' equity $ 9,135 $ 10,535
</TABLE>
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
