<PAGE> 1
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
Report of Foreign Issuer
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For the month of September 30, 1998
Nymox Pharmaceutical Corporation
9900 Cavendish Blvd., St. Laurent, PQ, Canada H4M 2V2
(Address of principal executive offices)
[indicate by check mark whether the registrant files or will file annual
reports under cover Form 20-F or Form 40-F.]
Form 20-F [X] Form 40-F [ ]
[Indicate by check mark whether the registrant by furnishing the
information contained in this Form is also thereby furnishing the information to
the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of
1934.]
Yes [X] No [ ]
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, thereunto duly authorized.
NYMOX PHARMACEUTICAL CORPORATION
--------------------------------
(Registrant)
Date: November 13, 1998 BY: /s/ ROY WOLVIN
-----------------------------
Roy Wolvin
<PAGE> 2
MESSAGE TO SHAREHOLDERS
Nymox is pleased to present its results for the third quarter of 1998.
R&D ACTIVITIES
Nymox announced at the beginning of August that several experimental studies
on its drug candidate for Alzheimer's disease (AD) yielded promising results.
The lead compound NXD2858 was designed by Nymox to inhibit the formation
of Alzheimer plaques from spherons, and therefore slow down or arrest the
progression of the disease. The new studies have demonstrated that the drug
is orally bioavailable, has good blood-brain barrier penetration, and continues
to show no evidence thus far of any toxicity or significant potential
side effects. Nymox is targeting the drug for human testing in less than
one year.
Studies by Nymox and confirmed in other laboratories have shown that spherons
are unique protein balls found in every person's brain, which in AD later
develop into the amyloid plaques found in AD brains (Journal of Alzheimer's
Disease 1, 1-34, 1998, IOS Press). Spherons slowly enlarge throughout life
until they become so large that they burst forming the deadly amyloid plaques.
Spherons have the unique and identical location as plaques, the same nuclei
of the brain, the same histological and cytological location in the
tissue, and the same electron microscopical location. Spherons have the same
species specificity as plaques. The number of spherons per unit volume of brain
tissue corresponds to that of plaques; the size of individual spherons and
individual plaques strongly correlates; and the spherons and plaques have
closely similar geometrical, spatial distribution, and topological
characteristics. The mass of the plaque lesion and the mass of the spheron
precursor closely correlate, and both satisfy focal concentration and
concentration gradient criteria. Intermediary stages of spheron degeneration
into plaques are identifiable. Spherons are extractable in unit quanta,
are unique to the brain, are capable of reproducing the plaques in the test
tube as well as in the brain of the experimental animal, both in 1:1
quantitative balance. Biochemical analysis of spherons shows that they contain
the plaque biochemical markers. Nymox believes that these and other criteria
uniquely validate the relevance of the Nymox drug candidates.
Nymox announced in mid-August 1998 that its Medical Advisory Board for AD7C(TM)
has been expanded significantly. This board consists of experienced experts in
the field who will function as spokespersons to other doctors for Nymox's
testing technology, and who will advise on the latest developments in the field.
New additions to the board include: Donald Marks, MD, Neurologist, Clinical
Instructor in Neurology, Harvard Medical School in Boston, MA; Patrick
Mathiasen, MD, Psychiatrist, Clinical Assistant Professor, Department of
Psychiatry and Behavioral Sciences, University of Washington School of Medicine,
Seattle, WA; Ross Finesmith, MD, Neurologist, Clinical Instructor of Neurology,
New York University Medical School; William Giakas, MD, Geriatric Psychiatrist,
Clinical Assistant Professor, University of Illinois at Chicago, Chicago, IL;
<PAGE> 3
Gregory Golden, Ph.D., Neuroscientist, Associate Professor, Department of
Neurology, Jefferson Medical College, Thomas Jefferson University, Philadelphia,
PA; Richard Pellegrino, MD, Ph.D., Neurologist, Clinical Assistant Professor
of Neurology, University of Arkansas; Howard Crystal, MD, Professor of
Neurology, Albert Einstein College of Medicine, New York; Andrew Cutler, MD,
Internist and Psychiatrist, University Behavioral Center and Florida Hospital,
Orlando, FL; Jay Ellis, MD, Neurologist, Berkshire Medical Center, Pittsfield,
MA; Colin Bier, Ph.D., Pathologist, Montreal; Andrew Scanameo, MD, Internist
and Geriatric Specialist, Senior Geriatric Consultant, Tallahassee
Community Hospital.
Other members of the Board include: Christopher Kircher, MD, Neurologist, Christ
Hospital, Cincinnati, OH; George Perry, Ph.D., Professor of Neuropathology,
Case Western Reserve University; Philipp Kahle, Ph.D., Neuroscientist,
Department of Neurobiology, Stanford University School of Medicine; Douglas
Brandt, MD, Psychiatrist, Clinical Assistant Professor, Department of
Neuropsychiatry & Behavioral Science, University of South Carolina School of
Medicine; Ira Goodman, MD, Neurologist, Associate Professor of Medicine,
University of Florida School of Medicine; Garth Bissette, Ph.D., Professor,
Division of Neurobiology & Behavioral Research, University of Mississippi
Medical Center; Robert Tureen, Ph.D., Adjunct Associate Professor of Psychology,
Miami University of Ohio, and University of Cincinnati; Steven Gulevich, MD,
Neurologist, Director of Colorado Neurological Institute; John J. Feibel, MD,
Neurologist, Associate Clinical Professor of Neurology, Riverhills Healthcare,
Cincinnati, Ohio.
Nymox also announced that large multi-center clinical trials of its new urine
test for use in Alzheimer's disease yielded very positive results. These new
studies indicate that the AD7C(TM) test is now proven to be accurate and useful
as a urinary test. The new data extends the practical uses of the AD7C(TM) test
which have been proven in published clinical studies in the past years,
including recently in the Journal of Clinical Investigation, the Journal of
Clinical and Laboratory Analysis and the Journal of Contemporary Neurology.
The new studies included patients with AD, age matched controls and neurological
disease controls from the following centers: St. Louis University Health
Sciences Center, St. Louis, Missouri; Long Island Jewish Medical Center,
Long Island, New York; Department of Veterans Affairs Medical Center,
Coatesville, Pennsylvania; Affiliated Research Centers, Gurnee, Illinois;
Colorado Neurology and Headache Center, Denver, Colorado; Christ Hospital,
Cincinnati, Ohio.
Nymox subsequently announced that the anti-infective program of the
Company's Pharmaceutical Division made significant progress with its candidate
NXB-4221, an antibacterial designed for the treatment of difficult chronic and
persistent urinary tract infections. NXB-4221 has been shown to be highly
effective against virulent bacteria in large studies of cultures from patients.
NXB-4221 is targeted to treat acute and chronic urinary tract infections where
currently available treatments are often inadequate in the elderly and in
children, particularly in persons with spinal disorders and with chronic
<PAGE> 4
bladder catheterization. NXB-4221 has thus far successfully completed several
toxicity studies. Formulation and manufacturing protocols have been successfully
established. NXB-4221 has demonstrated acceptable stability and a very good
dose-response curve.
At the end of August, Nymox announced that it has significantly advanced the
process in its cell biology laboratories for one of its key screening models for
selecting and developing new AD drug candidates. This AD7C screening model has
unique properties which make it highly relevant to AD. The system is being used
by Nymox's Pharmaceutical Division to further extend the pipeline of candidate
drugs for neurodegenerative diseases such as AD. The model is based on human
neuronal cells which have the AD7C-NTP gene inserted into them and where this
gene has become an integral part of the cell. The cells produce AD7C-NTP,
subsequently start the process of neuronal sprouting, going through a
degenerative process, and then finally die by apoptosis. This sequence of
cellular events very closely mimics what is known to occur in the degenerating
neurons in the brains of Alzheimer patients. The AD7C screening system is
distinct compared with the Company's other drug development programs (such
as spheron targeted therapies). The technology underlying this Nymox screening
system was licensed in 1997 from the Massachusetts General Hospital in
a sponsored research and licensing agreement.
At the beginning of September, Nymox announced that its Pharmaceutical Division
had developed a potent new antibacterial, NXC4720, which has been shown to be
highly active against all known substrains of E. Coli 0157, the bacteria
implicated in "Hamburger Disease". The new Nymox antibacterial destroys all
0157 strains, including H7, efficiently, rapidly and at a very low dose. NXC4720
is targeted for industrial testing in the next 6-12 months. Work to date has
indicated that NXC4720 is non-toxic in animals, has a good stability profile and
a very useful host range. E. Coli 0157:H7 is a highly virulent bacteria, which
causes severe diarrhea that can have serious secondary effects. The infection
affects approximately 100,000 persons per year. The serious secondary effects,
which occasionally occur with the infection, include hemorrhage in the
gastrointestinal tract, anemia and kidney failure. 0157:H7 infection is
increasingly becoming one of the world's most important food-borne infections.
The infection can be transmitted from vegetables, water, dairy products and
other sources. Grinding beef distributes the deadly bacteria into all levels
of the hamburger patty. The contamination does not usually occur on steak
because the bacteria are found on the surface only and are generally killed
by cooking. The cattle industry was allowed last year to begin irradiating beef
to kill bacteria, although the concept of radiation of a food source has
drawbacks. Antibiotic treatment of infected humans poses dangers because of
toxin release from the killed bacteria, and therefore this has focused work
on preventative measures.
In mid-September, Nymox announced that a peer-reviewed publication on the new
AD7C(TM) urinary assay for AD appeared in the Journal of Clinical and Laboratory
Analysis (September 1998; vol.12:285-288). The report documents in detail the
AD7C(TM) urine test method and results from coded, double blind trials on 200
individuals. The results have shown that urinary AD7C(TM) is a useful peripheral
AD marker which can
<PAGE> 5
significantly aid the physician in the diagnosis of AD. Alzheimer patients had a
urinary AD7C(TM) level of over three times higher than that of age-matched,
non-AD controls. The sensitivity (over 80%) and specificity (over 90%) values
were comparable to those of the AD7C(TM) test in spinal fluid. The urinary test
is newly available and will be marketed initially from the Nymox Reference
Laboratory in Rockville.
The Company also announced that two new abstracts were published in the Society
for Neuroscience Journal (vol.24,1998,503.11 and 478.10). The data was for
presentation at the November meeting of the Society for Neurosciences in Los
Angeles, including data on the accuracy of the urine test and an independent
study verifying AD7C(TM) accuracy done at Stanford University.
FINANCIAL RESULTS
Revenues for the 3 months ended September 30, 1998 were Can$115,600. versus
Can$25,386 for the comparable prior year period. The Company also reported a net
loss of Can$2,064,307 or Can$0.10 per share, as compared to a net loss of
Can$1,474,483. or Can$0.08 per share for the same period last year. The net loss
is due primarily to rising expenditures in S,G & A, while R & D expenditures
remained constant. This was due to new marketing expenses associated with
the new urinary test product introduction.
Since the end of December 1997, the Corporation has completed private placements
totaling 217,000 common shares, and all of its 696,491 Series A warrants were
exercised for total proceeds to the Company of Can$7,787,273. The proceeds
are being used for working capital and general corporate purposes. At
September 30, 1998, cash and cash equivalents totaled Can$3,779,825.
The marketing progress of Nymox's AD7CJ product is on time. Although it is too
soon to be certain, since the urine test has only recently become available,
indications give management reason to believe that the company could be
cash flow positive in the first half of 1999. Sales to date in the fourth
quarter have been higher than anticipated and are now accelerating, reflecting
the new availability of the urine test. It is our conviction that this
test technology is the most reliable and non-invasive product for this need
on the market, and has a great potential over the next few years. The Company
is fully prepared to handle increases in product demand.
Nymox has recently signed a letter of intent with a highly respected U.S.
company for a co-marketing agreement for AD7C(TM), fuller details of which will
be announced once a final agreement is completed. The Company also anticipates
that other agreements being negotiated in Europe and Asia will be finalized
in 1999.
The management of Nymox wishes to express its appreciation to our shareholders
for their continued support.
Paul Averback MD - President
November 15, 1998
<PAGE> 6
Consolidated Financial Statements of
(Unaudited)
NYMOX PHARMACEUTICAL CORPORATION
Periods ended September 30, 1998, 1997 and 1996
<PAGE> 7
NYMOX PHARMACEUTICAL CORPORATION
Consolidated Financial Statements
(Unaudited)
Periods ended September 30, 1998, 1997 and 1996
<TABLE>
<CAPTION>
<S> <C>
FINANCIAL STATEMENTS
Consolidated Balance Sheets............................... 1
Consolidated Statements of Earnings....................... 2
Consolidated Statements of Deficit........................ 3
Consolidated Statements of Changes in Financial Position.. 4
Notes to Consolidated Financial Statements................ 5
</TABLE>
<PAGE> 8
NYMOX PHARMACEUTICAL CORPORATION
Consolidated Balance Sheets
(Unaudited)
September 30, 1998 and 1997, with comparative figures as at December 31, 1997
(in Canadian dollars)
<TABLE>
<CAPTION>
September 30, September 30, December 31,
1998 1997 1997
----------- ----------- -----------
(Unaudited) (Unaudited) (Audited)
<S> <C> <C> <C>
Assets
Current assets:
Cash $ 837,253 $1,875,482 $ 507,259
Short-term investments 2,942,572 653,462 1,780,086
Accrued interest 119,262 - 4,200
Accounts receivable 56,042 39,942 28,790
Relocation loan to director/officer 222,024 - -
Subscriptions receivable 26,000 - -
Research tax credits receivable 5,347 384,500 150,000
---------- ---------- ----------
4,208,500 2,953,386 2,470,335
Advance to director 56,000 56,000 56,000
Capital assets 1,606,675 1,454,348 1,419,462
---------- ---------- ----------
$5,871,175 $4,463,734 $3,945,797
========== ========== ==========
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable and accrued liabilities $ 89,166 $ 189,042 $ 292,330
Shareholders' equity:
Capital stock 21,831,103 13,852,154 13,852,632
Capital stock subscription - - 504,000
Deficit (16,049,094) (9,577,462) (10,703,165)
----------- ----------- -----------
5,782,009 4,274,692 3,653,467
----------- ----------- -----------
$ 5,871,175 $ 4,463,734 $ 3,945,797
=========== =========== ===========
</TABLE>
See accompanying notes to unaudited consolidated financial statements.
-1-
<PAGE> 9
NYMOX PHARMACEUTICAL CORPORATION
Consolidated Statements of Earnings
(Unaudited)
Periods ended September 30, 1998, 1997 and 1996
(in Canadian dollars)
<TABLE>
<CAPTION>
Three months ended September 30, Nine months ended September 30,
--------------------------------------------- -------------------------------------------
1998 1997 1996 1998 1997 1996
----------- ----------- ----------- ----------- ----------- ----------
<S> <C> <C> <C> <C> <C> <C>
Revenues:
Interest $ 88,838 $ 25,386 $ 42,463 $ 187,464 $ 46,855 $ 114,556
Service fees 26,762 - - 60,135 18,927 -
----------- ----------- ----------- ----------- ----------- -----------
115,600 25,386 42,463 247,599 65,782 114,556
Expenses:
Research and development 924,641 1,026,682 764,478 2,198,823 2,039,761 1,433,552
Less investment tax credits (13,315) (46,500) (19,000) (18,662) (144,500) (115,500)
----------- ----------- ----------- ----------- ----------- -----------
911,326 980,182 745,478 2,180,161 1,895,261 1,318,052
General and administrative 133,988 77,645 756,175 608,894 470,783 1,071,752
Marketing 902,597 370,512 - 2,570,594 1,442,639 -
Depreciation and amortization 41,659 40,834 39,835 128,230 119,781 51,636
Interest and bank charges 18,073 5,310 1,729 22,649 11,070 347
----------- ----------- ----------- ----------- ----------- -----------
2,007,643 1,474,483 1,543,217 5,510,528 3,939,534 2,441,787
----------- ----------- ----------- ----------- ----------- -----------
Net loss $(1,892,043) $(1,449,097) $(1,500,754) $(5,262,929) $(3,873,752) $(2,327,231)
=========== =========== =========== =========== =========== ===========
Loss per share $ (0.10) $ (0.08) $ (0.08) $ (0.27) $ (0.21) $ (0.13)
=========== =========== =========== =========== =========== ===========
Weighted average number of
ommon shares outstanding 19,592,274 18,631,783 17,926,882 19,239,411 18,234,967 17,565,306
=========== =========== =========== =========== =========== ===========
</TABLE>
See accompanying notes to unaudited consolidated financial statements.
-2-
<PAGE> 10
NYMOX PHARMACEUTICAL CORPORATION
Consolidated Statements of Deficit
(Unaudited)
Periods ended September 30, 1998, 1997 and 1996
(in Canadian dollars)
<TABLE>
<CAPTION>
Three months ended September 30, Nine months ended September 30,
------------------------------------------ -------------------------------------------
1998 1997 1996 1998 1997 1996
------------ ----------- ----------- ------------ ----------- -----------
<S> <C> <C> <C> <C> <C> <C>
Deficit, beginning of period $(14,157,051) $(8,007,365) $(2,532,076) $(10,703,165) $(5,472,710) $(1,539,686)
Net loss (1,892,043) (1,449,097) (1,500,754) (5,262,929) (3,873,752) (2,327,231)
Share issue costs - (121,000) (68,047) (83,000) (231,000) (233,960)
------------ ----------- ----------- ------------ ----------- -----------
Deficit, end of period $(16,049,094) $(9,577,462) $(4,100,877) $(16,049,094) $(9,577,462) $(4,100,877)
============ =========== =========== ============ =========== ===========
</TABLE>
See accompanying notes to unaudited consolidated financial statements.
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<PAGE> 11
NYMOX PHARMACEUTICAL CORPORATION
Consolidated Statements of Changes in Financial Position
(Unaudited)
Periods ended September 30, 1998, 1997 and 1996
(in Canadian dollars)
<TABLE>
<CAPTION>
Three months ended September 30, Nine months ended September 30,
---------------------------------------------- --------------------------------------------
1998 1997 1996 1998 1997 1996
----------- ----------- ----------- ----------- ----------- -----------
<S> <C> <C> <C> <C> <C> <C>
Cash provided by (used in):
Operations:
Net loss $(1,892,043) $(1,449,097) $(1,500,754) $(5,262,929) $(3,873,752) $(2,327,231)
Item not involving cash:
Depreciation and
amortization 41,659 40,834 39,835 128,230 119,781 51,636
Net change in non-cash
operating working
capital items (156,387) (119,645) 5,477 (447,270) (286,320) (198,669)
----------- ----------- ----------- ----------- ----------- -----------
(2,006,771) (1,527,908) (1,455,442) (5,581,969) (4,040,291) (2,474,264)
Financing:
Issuance of capital stock - - 16,250 7,978,471 - 16,250
Subscription to capital
stock - - - (504,000) 4,549,463 5,263,800
Share issue costs - (121,000) (68,047) (83,000) (231,000) (233,960)
----------- ----------- ---------- ----------- ----------- -----------
- (121,000) (51,797) 7,391,471 4,318,463 5,046,090
Investment:
Additions to capital assets (90,359) (41,119) (520,187) (317,022) (256,155) (724,820)
----------- ----------- ---------- ----------- ----------- -----------
Increase (decrease) in cash
and short-term investments (2,097,130) (1,690,027) (2,027,426) 1,492,480 22,017 1,847,006
Cash and short-term
investments, beginning
of period 5,876,955 4,218,971 6,042,006 2,287,345 2,506,927 2,167,574
----------- ----------- ---------- ----------- ----------- -----------
Cash and short-term
investments, end of period $ 3,779,825 $ 2,528,944 $ 4,014,580 $ 3,779,825 $ 2,528,944 $ 4,014,580
=========== =========== =========== =========== =========== ===========
</TABLE>
See accompanying notes to unaudited consolidated financial statements.
-4-
<PAGE> 12
NYMOX PHARMACEUTICAL CORPORATION
Notes to Consolidated Financial Statements
(Unaudited)
Periods ended September 30, 1998, 1997 and 1996
(in Canadian dollars)
Nymox Pharmaceutical Corporation (the "Corporation"), incorporated under the
Canada Business Corporations Act, is a development stage biopharmaceutical
corporation which specializes in the research and development of neurological
therapeutics and diagnostics for the aging population, with an emphasis on
Alzheimer's disease.
The Corporation is listed on the Montreal Exchange and on the NASDAQ Stock
Market.
1. BASIS OF PRESENTATION:
(a) Consolidation:
The consolidated financial statements of the Corporation have been prepared
under Canadian generally accepted accounting principles ("GAAP") and include
the accounts of its wholly-owned US subsidiary. Significant intercompany
balances and transactions have been eliminated on consolidation.
(b) Interim financial statements:
The unaudited consolidated balance sheets as at September 30, 1998 and 1997
and the unaudited consolidated statements of earnings and deficit and changes
in financial position for the three- and nine-month periods ended September
30, 1998, 1997 and 1996, respectively, reflect all adjustments which are, in
the opinion of management, necessary for a fair statement of the results of
the interim periods presented. There are no adjustments in these interim
financial statements other than normal recurring adjustments.
- 5 -
<PAGE> 13
NYMOX PHARMACEUTICAL CORPORATION
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Periods ended September 30, 1998, 1997 and 1996
(in Canadian dollars)
2. CANADIAN/U.S. REPORTING DIFFERENCES:
(a) Consolidated statements of earnings:
The reconciliation of earnings reported in accordance with Canadian GAAP
with U.S. GAAP is as follows:
<TABLE>
<CAPTION>
Three months ended September 30, Nine months ended September 30,
--------------------------------------------- -----------------------------------------------
1998 1997 1996 1998 1997 1996
----------- ----------- ----------- ----------- ----------- -----------
<S> <C> <C> <C> <C> <C> <C>
Net loss, Canadian
GAAP $(1,892,043) $(1,449,097) $(1,500,754) $(5,262,929) $(3,873,752) $(2,327,231)
Adjustments:
Amortization of
patents (16,429) (12,322) (9,292) (46,418) (36,967) (27,875)
Stock-based
compensation -
options granted
to non-employees - - (172,000) - - (395,000)
----------- ----------- ----------- ----------- ----------- -----------
Net loss, U.S. GAAP $(1,908,472) $(1,461,419) $(1,682,046) $(5,309,347) $(3,910,719) $(2,750,106)
=========== =========== =========== =========== =========== ===========
Loss per share,
U.S. GAAP $ (0.10) $ (0.08) $ (0.09) $ (0.28) $ (0.21) $ (0.16)
=========== =========== =========== =========== =========== ===========
</TABLE>
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<PAGE> 14
NYMOX PHARMACEUTICAL CORPORATION
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Periods ended September 30, 1998, 1997 and 1996
(in Canadian dollars)
2. CANADIAN/U.S. REPORTING DIFFERENCES (CONTINUED):
(b) Consolidated shareholders' equity:
The reconciliation of shareholders' equity reported in accordance with
Canadian GAAP with U.S. GAAP is as follows:
<TABLE>
<CAPTION>
September 30, December 31,
------------------------- ------------
1998 1997 1997
---------- ---------- ----------
<S> <C> <C> <C>
Shareholders' equity, Canadian GAAP $5,782,009 $4,274,692 $3,653,467
Adjustments:
(i) Amortization of patents:
Cumulative effect to beginning
of the period (180,139) (130,606) (130,606)
Current period (46,418) (36,967) (49,533)
---------- ---------- ----------
(226,557) (167,573) (180,139)
(ii) Stock-based compensation:
Cumulative effect to beginning
of period (742,000) (592,000) (592,000)
Current period - - (150,000)
---------- ---------- ----------
(742,000) (592,000) (742,000)
---------- ---------- ----------
Increase in deficit (968,557) (759,573) (922,139)
---------- ---------- ----------
Shareholders' equity, U.S. GAAP $4,813,452 $3,515,119 $2,731,328
========== ========== ==========
</TABLE>
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