SEC Company Response from NYMOX PHARMACEUTICAL CORP (NYMXF) (CIK 0001018735) (NYMXF) — Oct 3, 2005
NYMOX PHARMACEUTICAL CORP (NYMXF) (CIK 0001018735)
Date: Oct. 3, 2005 · CIK: 0001018735 · Accession: 0000897069-05-002389
AI Filing Summary & Sentiment
File numbers found in text: 001-12033
Referenced dates: July 22, 2005
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CORRESP
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filename1.htm
9900 Cavendish Blvd., Suite 306
St-Laurent, Qc Canada H4M 2V2
Tel: 800-93NYMOX (800-936-9669)
Fax: 514-332-2227
Email: info@nymox.com
October 3, 2005
Jim B. Rosenberg
Senior Assistant Chief Accountant
United States Securities and Exchange Commission
Division of Corporation Finance
450 Fifth Street, N.W.
Washington, D.C. 20549
Re:
Nymox
Pharmaceutical Corporation
Form 20-F for the Fiscal Year Ended December 31, 2004
Filed June 30, 2005
File No. 001-12033
Dear Mr. Rosenberg:
This is our revised response to the
comments in your letter dated July 22, 2005 with respect to the above-referenced Form
20-F, based on comments we received from Oscar Young of your Staff on September 27, 2005.
Our response is keyed the comments in your letter and set out in disclosure-type format.
We have filed this letter on EDGAR under the form type label CORRESP as directed.
Inconnection with this response to
the Staff’s comments to Nymox’s Form 20-F, filed June 30, 2005, Nymox
acknowledges that:
1.
Nymox
is responsible for the adequacy and accuracy of the disclosure in the filings;
2.
Staff
comments or changes to disclosure in response to staff comments in the filings reviewed
by the staff do not foreclose the Commission from taking any action with respect to the
filing; and
3.
Nymox
may not assert staff comments as a defense in any proceeding initiated by
the Commission or any person under the federal securities laws of the
United States.
SEC Comment:
“Item 5 Operating
and Financial Review and Prospects, page 26
1.
Please refer to the Division of Corporation Finance “Current Issues and
Rulemaking Projects Quarterly Update” under section VIII – Industry
Specific Issues – Accounting and Disclosure by Companies Engaged in
Research and Development Activities. You can find it at the following website
address: http://www.sec.gov/divisions/corpfin/cfcrq032001.htm.
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Please
provide us the following information in disclosure-type format to help us evaluate the
adequacy of your disclosure for each of your major research and development projects:
a.
The
current status of the project;
b.
The
costs incurred during each period presented and to date on each project;
c.
The
nature, timing and estimated costs of the efforts necessary to complete each
project;
d.
The
anticipated completion dates of each project;
e.
The
risks and uncertainties associated with completing development on schedule, and
the consequences to operations, financial position and liquidity if each
project is not completed timely; and finally
f.
The
period in which material net cash inflows from significant projects are
expected to commence for each project.
Regarding
b., if you do not maintain any research and development costs by project, please state
that fact and explain why management does not maintain and evaluate research and
development costs by project. In this regard, please provide other quantitative or
qualitative disclosure that indicates the amount of the company’s resources being
used on the project.
Regarding
c. and d., please state the amount or range of estimated costs and timing to complete the
phase in process and each future phase. To the extent that information is not estimable,
please state those facts and circumstances that preclude you from making a reasonable
estimate.”
Nymox’s Response:
Nymox’s response to this
comment, set out in disclosure-type format per your request, is as follows:
Research
and Development, Patents and Licensees
Nymox’s
research and development policies are targeted at the development of novel therapeutic and
diagnostic proprietary products that are subject to patent rights either directly owned by
the company or licensed to the company through exclusive licensing agreements of patent
rights. Over the last three financial years, the company’s major research and
development activities were in the following program areas:
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•
Diagnostic products for Alzheimer’s disease. The major project in this area, the
development and validation of a kit version of our AlzheimAlert™ product for sale to
laboratories and hospitals in the U.S. and in the E.U., was completed in 2004. We are
currently marketing the kit in Europe under the CE mark. We also provide
AlzheimAlert™ as a laboratory testing service through our CLIA-certified clinical
reference laboratory in New Jersey. We are seeking FDA approval to sell the kit version of
the AlzheimAlert™ test to other laboratories and hospitals in the U.S. We received a
not approvable letter for the kit from the FDA in July 2004 and amended our application in
response to the issues raised by the FDA. In July 2005 an FDA advisory panel voted 5-2 to
recommend non-approval of our application. We anticipate that we will continue to pursue
our application with the FDA for marketing approval for the kit version of the
AlzheimAlert™ test. At this time, we cannot provide an estimate of the costs and
timing to pursue our application with the FDA as it is uncertain at this stage the nature
and extent of FDA requirements for approval based on discussions with us.
•
Therapeutic products for enlarged prostate (benign prostatic hyperplasia or BPH). In 2003,
we successfully completed the first two Phase 1 and Phase 1-2 U.S. clinical trials for one
treatment candidate, NX-1207, and in 2005 commenced a pivotal Phase 2 clinical trial. We
cannot predict with any certainty the outcome of this trial, what further steps may be
required in order to apply for final FDA approval for this drug or whether the FDA will
ultimately grant us such approval. If there is a favorable outcome of the Phase 2 trial,
we anticipate starting a Phase 3 trial in 2006 and filing a New Drug Application (NDA)
with the FDA in 2007 or later. Given the inherent uncertainties with any Phase 2 clinical
trial, we cannot provide an estimate of the costs and timing of the completion of this
project. The uncertainties include the chances of success of any phase of the clinical
trials, the nature and extent of FDA requirements to proceed with a Phase 3 and for filing
an NDA, and our ability to scale up manufacture in accordance with current good
manufacturing requirements (cGMP) and in sufficient quantities for commercial use.
•
Anti-infectives. Our anti-bacterial agent, NXC-4720, which is being developed as a
treatment of meat at the processing stage, has shown to be capable of substantially
reducing the level of potentially fatal E. coli O157:H7 contamination on fresh beef
according to laboratory studies. Other projects in this area, such as treating E. coli
O157:H7 infection in livestock and treating bacterial infections in humans, are in
preliminary stages of development with more uncertain prospects and timing and course of
development. Because of the early stage of development of this project, it is impossible
to outline the nature, timing or estimated costs of the efforts necessary to complete this
project nor the anticipated completion dates for this project. The facts and circumstances
indicating the uncertainties that preclude us from making a reasonable estimate of the
costs and timing necessary to complete this project include the risks inherent in any
field trials of NXC-4720, the uncertainty as to the nature and extent of regulatory
requirements both for safety and efficacy, and the ability to manufacture NXC-4720 in
accordance with current good manufacturing requirements (cGMP) and in sufficient
quantities both for large scale trials and for commercial use.
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•
Tobacco exposure and other diagnostic tests. We developed and validated NicAlert™,
which is an FDA-cleared test for tobacco product use, and TobacAlert™, which is an
over-the-counter test for second-hand smoke exposure. These are completed projects with
any further research and development costs being related to product improvement and
obtaining regulatory approvals where required in order to expand the market for these
products. The development of other new diagnostic tests using our patented diagnostic
technologies are in early stage development. Because of the early stage of development of
these projects, it is not possible to outline the nature, timing or estimated costs of the
efforts necessary to complete any of them nor their anticipated completion dates. The
facts and circumstances indicating the uncertainties that preclude us from making a
reasonable estimate include the uncertainty whether we will be able to successfully adapt
our patented diagnostic technologies to these new diagnostic indicators, whether any new
diagnostic tests we develop will pass proof-of-principle testing both in the laboratory
and in clinical trials, and whether we will be able to manufacture such tests at a
commercially competitive price.
•
Therapeutic products for Alzheimer’s disease. We are conducting early stage research
and development work into preclinical development of novel drug candidates and original
research into the role spherons play in the Alzheimer’s disease process in order to
pursue spheron-based therapeutics. Because of the early stage of development of this
project, it is impossible to outline the nature, timing or estimated costs of the efforts
necessary to complete this project nor the anticipated completion dates for this project.
The facts and circumstances indicating the uncertainties that preclude us from making a
reasonable estimate include the inherent uncertainties in the pre-clinical and clinical
development of therapeutic candidates. Most pre-clinical drug candidates do not meet
necessary milestones to enter clinical trials; of those which do, only a small percentage
ultimately achieve regulatory approval and enter the marketplace. We also have global
patent rights to the use of statin drugs in the prevention or treatment of
Alzheimer’s disease. Various published epidemiological and other research studies
have shown evidence that statins may help in the prevention or treatment of
Alzheimer’s disease; other studies have shown otherwise. Other companies and
organizations are currently carrying out clinical trials into the use of statin drugs for
Alzheimer’s disease. We do not anticipate that the results of such trials will be
available before 2006. The effect of the results of such trials on this program is
uncertain.
•
Oncology products. We are in the early stages of developing therapeutic products for
oncological indications. Because of the early stage of development of this project, it is
impossible to outline the nature, timing or estimated costs of the efforts necessary to
complete this project nor its anticipated completion dates. The development of cancer
therapeutics in particular is associated with high risks and many uncertainties and a drug
candidate that shows efficacy can take a long period (7 years or more) to achieve
regulatory approval.
Research and development expenses
allocated to our major research and development programs are as follows:
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Year ending
Dec 31, 2004
Year ending
Dec 31, 2003
Year ending
Dec 31, 2002
Year ending
Dec 31, 2001
Year ending
Dec 31, 2000
Year ending
Dec 31, 1999
Total for
Periods
Presented
Alzheimer’s Disease:
$ 691,183
$ 779,305
$ 332,254
$ 491,051
$ 657,924
$ 253,015
$ 3,204,732
Diagnostics
Alzheimer’s Disease:
$ 282,205
$ 496,658
$ 463,182
$ 528,230
$ 404,850
$ 501,685
$ 2,676,810
Therapeutics
Anti-Infectives
$ 22,224
$ 24,793
$ 1,563
$ 134,098
$ 313,884
$ 195,427
$ 691,989
BPH (Enlarged
$ 615,454
$ 548,064
$ 523,926
*
*
$ 1,687,444
Prostate) Therapeutics*
Tobacco Exposure Tests:
NicAlert™ and
$ 118,636
$ 292,692
$ 308,161
$ 122,159
$ 116,872
$ 958,520
TobacAlert™
Oncology
$ 131,537
$ 368,539
$ 77,000
$ 577,076
General Research (BPH
$ 224,116
$ 590,702
$ 186,995
$ 1,001,813
Therapeutics Included*)
Total
$ 1,861,239
$ 2,510,051
$ 1,706,086
$ 1,499,654
$ 2,084,232
$ 1,137,122
$ 10,798,384
* General Research expenses for the
years ending Dec. 31, 2001 and 2000 include preliminary research relating to the
development of BPH therapeutics.
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For
the earlier periods from 1995 to 1998, the Company did not maintain a cost accounting
system that tracked research and development costs on a project-by-project basis. During
the initial discovery stages, research and development is more general in nature and
cannot be specifically categorized. During the periods 1995 to 1998, the general research
expenses included primarily work on the Alzheimer’s diagnostic and therapeutic
candidates. The breakdown of research and development costs for these periods is as
follows: 1998: $ 2,091,745; 1997: $ 1,775,340; 1996: $ 1,632,370; and 1995: $ 395,770. The
total research and development expenditure for the 1995 to 1998 period was $ 5,895,225.
Total research and development expenditures to date are $ 16,693,609.
The
Company expenses all research and development costs as incurred but does not currently
maintain a cost accounting system to track, record and allocate staffing time on a
specific project-by-project basis. We manage our ongoing research and development projects
and programs in a dynamic, flexible manner. Our researchers, staff and management are
typically involved in more than one of our research and development projects and the
percentage of time an employee may be involved in a project varies according to the
changing needs and progress of that project. As well, a significant portion of the
Company’s research and development expenses, such as laboratory supplies, travel,
information systems and services and facilities costs, benefit multiple projects and are
not necessarily individually tracked or allocated to a specific project when incurred.
Research and development costs are allocated in reasonable and realistic proportion to the
projects that benefited from those costs.
According
to industry statistics, on average it takes 10 to 15 years to research, develop and bring
to market a new prescription medicine in the United States. In light of the steps and
complexities involved, the successful development of our product candidates is highly
uncertain. Actual product timelines and costs are subject to enormous variability and are
very difficult to predict. Accordingly, we cannot provide reliable estimates of the
nature, timing and estimated costs of the efforts necessary to complete our programs. This
is particularly the case for our programs in early stage development. The risk of failure
to complete any such program is high because of uncertain feasibility and commercial
viability, long lead times to program completion and potentially high costs in relation to
anticipated returns. We update and change our product development programs to reflect the
most recent preclinical and clinical data and other relevant information. Many of our
products under development require regulatory approval before being sold. The process of
obtaining such approvals is often lengthy and uncertain and requires the expenditure of
substantial resources. Any failure by us to obtain, or any delay in obtaining, regulatory
approvals could materially adversely affect our business. We cannot assure you that any
such approvals required will be obtained on a timely basis, if at all.
If you have any questions or comments
regarding the foregoing, please do not hesitate to contact the und