Filed pursuant to Rule 424(b)(3)
Registration No.
333-190065
PROSPECTUS SUPPLEMENT NO. 1
(to Prospectus dated
April 30, 2014)
INTELGENX TECHNOLOGIES CORP.
Up to 7,920,346 shares of Common Stock issuable upon exercise of
7,920,346 Warrants
The prospectus supplement modifies and supplements the
prospectus of Intelgenx Technologies Corp. (the Company) dated April 30, 2014,
which relates to the issuance and sale of 7,920,346 shares of the common stock
of the Company to holders of outstanding warrants upon exercise of such
warrants. The warrants were issued on December 16, 2013 in a registered
offering. The warrants have an exercise price of $0.5646 per share and are
exercisable at any time prior to the close of business on December 15, 2018.
This prospectus supplement should be read in conjunction with,
and may not be delivered or utilized without, the prospectus, including any
amendments or supplements thereto. This prospectus supplement is qualified in
its entirety by reference to the prospectus, except to the extent that the
information in this prospectus supplement supersedes the information contained
in the prospectus.
This prospectus supplement includes the attached quarterly
report on Form 10-Q, as filed with the Securities and Exchange Commission (the
SEC) on September 4, 2014.
NEITHER THE SEC NOR ANY STATE SECURITIES COMMISSION HAS
APPROVED OR DISAPPROVED THESE SECURITIES OR PASSED UPON THE ADEQUACY OR ACCURACY
OF THIS PROSPECTUS SUPPLEMENT. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL
OFFENSE.
The date of this prospectus supplement is September 4, 2014.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.
20549
FORM 10-Q
[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 2014
or
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR
15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from _________to________
Commission File Number 000-31187
INTELGENX TECHNOLOGIES CORP.
(Exact name of small business issuer as specified in its
charter)
Delaware |
87-0638336 |
(State or other jurisdiction of |
(I.R.S. Employer Identification No.) |
incorporation or organization) |
|
6425 Abrams, Ville Saint Laurent, Quebec H4S 1X9, Canada
(Address of principal executive offices)
(514) 331-7440
(Issuer's telephone number)
(Former Name, former Address, if changed since last report)
Indicate by checkmark whether the registrant (1) has filed all
reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the
registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days.
Yes [X] No [ ]
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller
reporting company. See the definitions of large accelerated filer,
accelerated filer, non-accelerated filer and smaller reporting company in
Rule 12b-2 of the Exchange Act.
Large accelerated filer [ ] |
|
Accelerated filer [ ] |
Non-accelerated filer [ ] |
(Do not check if a smaller reporting company)
|
Smaller reporting company [X]
|
APPLICABLE ONLY TO ISSUERS INVOLVED IN BANKRUPTCY
PROCEEDS
DURING THE PRECEDING FIVE YEARS
Indicate by check mark whether the registrant has filed all
documents and reports required to be filed by Sections 12, 13, or 15(d) of the
Securities Exchange Act of 1934 subsequent to the distribution of securities
under a plan confirmed by a court.
Yes [ ] No [ ]
APPLICABLE TO CORPORATE ISSUERS:
63,215,656 shares of the issuers common stock, par value
$.00001 per share, were issued and outstanding as of May 8, 2014.
IntelGenx Technologies Corp.
Form 10-Q
TABLE OF CONTENTS
IntelGenx Technologies Corp. |
|
Consolidated Interim Financial Statements |
March 31, 2014 |
(Expressed in U.S. Funds) |
(Unaudited) |
IntelGenx Technologies Corp. |
|
Consolidated Balance Sheet |
(Expressed in Thousands of U.S. Dollars ($000s) Except
Share and Per Share Data) |
(Unaudited) |
|
|
March 31, |
|
|
December 31, |
|
|
|
2014 |
|
|
2013 |
|
Assets |
|
|
|
|
|
|
Current |
|
|
|
|
|
|
Cash and cash equivalents |
$ |
5,166 |
|
$ |
5,005 |
|
Accounts
receivable |
|
26 |
|
|
144 |
|
Prepaid expenses |
|
92 |
|
|
133 |
|
Investment tax credits
receivable |
|
285 |
|
|
268 |
|
Total Current Assets
|
|
5,569 |
|
|
5,550 |
|
Leasehold Improvements and Equipment,
net |
|
664 |
|
|
588 |
|
Intangible Assets (note 4) |
|
70 |
|
|
79 |
|
Total Assets |
$ |
6,303 |
|
$ |
6,217 |
|
Liabilities |
|
|
|
|
|
|
Current |
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
283 |
|
|
593 |
|
Deferred license revenue
(note 5) |
|
358 |
|
|
308 |
|
Total Current
Liabilities |
|
641 |
|
|
901 |
|
Deferred License Revenue, non-current portion (note 5)
|
|
231 |
|
|
308 |
|
Total Liabilities |
|
872 |
|
|
1,209 |
|
Shareholders' Equity |
|
|
|
|
|
|
Capital Stock (note 6)
|
|
1 |
|
|
1 |
|
Additional Paid-in-Capital (note 7)
|
|
22,030 |
|
|
20,934 |
|
Accumulated Deficit
|
|
(16,544 |
) |
|
(16,102 |
) |
Accumulated Other Comprehensive Income |
|
(56 |
) |
|
175 |
|
Total Shareholders Equity |
|
5,431 |
|
|
5,008 |
|
|
$ |
6,303 |
|
$ |
6,217 |
|
See accompanying notes
Approved on Behalf of the Board:
/s/ J.
Bernard Boudreau |
Director |
|
|
/s/ Horst G.
Zerbe |
Director |
2
IntelGenx Technologies Corp. |
|
Consolidated Statement of Shareholders' Equity
|
For the Period Ended March 31, 2014 |
(Expressed in Thousands of U.S. Dollars ($000s) Except
Share and Per Share Data) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
|
|
|
Other |
|
|
Total |
|
|
|
Capital Stock |
|
|
Paid-In |
|
|
Accumulated |
|
|
Comprehensive |
|
|
Shareholders' |
|
|
|
Number |
|
|
Amount |
|
|
Capital |
|
|
Deficit |
|
|
Income |
|
|
Equity |
|
Balance - December 31,
2013 |
|
60,984,267 |
|
$ |
1 |
|
$ |
20,934 |
|
$ |
(16,102 |
)
|
$ |
175 |
|
$ |
5,008 |
|
Foreign currency translation adjustment |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
(231 |
) |
|
(231 |
) |
Warrants exercised (note 7)
|
|
1,666,388 |
|
|
- |
|
|
1,064 |
|
|
- |
|
|
- |
|
|
1,064 |
|
Stock-based compensation (note 7) |
|
- |
|
|
- |
|
|
32 |
|
|
- |
|
|
- |
|
|
32 |
|
Net loss for the period |
|
- |
|
|
- |
|
|
- |
|
|
(442 |
) |
|
- |
|
|
(442 |
) |
Balance March 31, 2014 |
|
62,650,655 |
|
$ |
1 |
|
$ |
22,030 |
|
$ |
(16,544 |
) |
$ |
(56 |
) |
$ |
5,431 |
|
See accompanying notes
3
IntelGenx Technologies Corp. |
|
Consolidated Statement of Comprehensive Loss |
(Expressed in Thousands of U.S. Dollars ($000s) Except
Share and Per Share Data) |
(Unaudited) |
|
|
For the
Three-Month Period |
|
|
|
Ended March 31, |
|
|
|
2014 |
|
|
2013 |
|
Revenues |
|
|
|
|
|
|
Royalties |
$ |
97 |
|
$ |
80 |
|
License and other
revenue |
|
125 |
|
|
77 |
|
Total Revenues |
|
222 |
|
|
157 |
|
Expenses |
|
|
|
|
|
|
Research and development expense |
|
188 |
|
|
167 |
|
Selling, general and administrative expense |
|
460 |
|
|
456 |
|
Depreciation of tangible assets |
|
7 |
|
|
10 |
|
Amortization of
intangible assets |
|
9 |
|
|
10 |
|
Total Costs and Expenses |
|
664 |
|
|
643 |
|
Net Loss |
|
(442 |
) |
|
(486 |
)
|
Other Comprehensive Loss |
|
|
|
|
|
|
Foreign currency
translation adjustment |
|
(231 |
) |
|
(36 |
) |
Comprehensive Loss |
$ |
(673 |
) |
$ |
(522 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted Weighted Average Number of Shares
Outstanding |
|
62,064,139 |
|
|
50,236,255 |
|
Basic and Diluted Loss Per Common Share (note 9) |
$ |
(0.01 |
) |
$ |
(0.01 |
) |
See accompanying notes
4
IntelGenx Technologies Corp. |
|
Consolidated Statement of Cash Flows |
(Expressed in thousands of U.S. Dollars ($000s) Except
Share and Per Share Data) |
(Unaudited) |
|
|
For the
Three-Month Period |
|
|
|
Ended March 31, |
|
|
|
2014 |
|
|
2013 |
|
Funds Provided (Used)
- |
|
|
|
|
|
|
Operating Activities |
|
|
|
|
|
|
Net loss |
$ |
(442 |
) |
$ |
(486 |
)
|
Amortization and depreciation |
|
16 |
|
|
20 |
|
Stock-based compensation
|
|
32 |
|
|
18 |
|
|
|
(394 |
) |
|
(448 |
) |
Changes in assets and liabilities: |
|
|
|
|
|
|
Accounts receivable |
|
118 |
|
|
1,112 |
|
Prepaid expenses |
|
41 |
|
|
13 |
|
Investment tax credits receivable |
|
(17 |
) |
|
(30 |
) |
Accounts payable and accrued liabilities |
|
(309 |
) |
|
(560 |
)
|
Deferred
revenue |
|
(27 |
) |
|
(77 |
) |
Net change in assets
and liabilities |
|
(194 |
) |
|
458 |
|
Net cash (used) / provided
by operating activities |
|
(588 |
) |
|
10 |
|
|
|
|
|
|
|
|
Financing Activities |
|
|
|
|
|
|
Proceeds from exercise
of warrants |
|
1,064 |
|
|
195 |
|
Net cash provided by
financing activities |
|
1,064 |
|
|
195 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investing
Activities |
|
|
|
|
|
|
Additions to property and
equipment |
|
(105 |
) |
|
(69 |
) |
Net cash used in
investing activities |
|
(105 |
) |
|
(69 |
) |
Increase in Cash and Cash Equivalents
|
|
371 |
|
|
136 |
|
Effect of Foreign Exchange
on Cash and Cash Equivalents |
|
(210 |
) |
|
(27 |
)
|
Cash and Cash Equivalents |
|
|
|
|
|
|
Beginning of Period |
|
5,005 |
|
|
2,059 |
|
End of Period |
$ |
5,166 |
|
$ |
2,168 |
|
See accompanying notes
5
IntelGenx Technologies Corp. |
|
Notes to Consolidated Interim Financial Statements
|
March 31, 2014 |
(Expressed in U.S. Funds) |
(Unaudited) |
1. |
Basis of Presentation |
|
|
|
The accompanying unaudited consolidated financial
statements have been prepared in accordance with generally accepted
accounting principles for interim financial information and with the
instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly,
they do not include all of the information and footnotes required by
generally accepted accounting principles for complete consolidated
financial statements. In the opinion of management, all adjustments
considered necessary for a fair presentation have been included. All such
adjustments are of a normal and recurring nature. |
|
|
|
These financial statements should be read in conjunction
with the audited consolidated financial statements at December 31, 2013.
Operating results for the three months ended March 31, 2014 are not
necessarily indicative of the results that may be expected for the year
ending December 31, 2014. The Company prepares its financial statements in
accordance with accounting principles generally accepted in the United
States (U.S. GAAP). This basis of accounting involves the application of
accrual accounting and consequently, revenues and gains are recognized
when earned, and expenses and losses are recognized when incurred.
|
|
|
|
The consolidated financial statements include the
accounts of the Company and its subsidiary companies. On consolidation,
all inter-entity transactions and balances have been eliminated.
|
|
|
|
The financial statements are expressed in U.S. funds.
|
|
|
|
Management has performed an evaluation of the Companys
activities through the date and time these financial statements were
issued and concluded that there are no additional significant events
requiring recognition or disclosure. |
|
|
2. |
Adoption of New Accounting Standards
|
|
|
|
The FASB issued Update No. 2013-04, Liabilities (Topic
405)Obligations Resulting from Joint and Several Liability Arrangements
for Which the Total Amount of the Obligation Is Fixed at the Reporting
Date. The amendments in this Update provide guidance for the recognition,
measurement, and disclosure of obligations resulting from joint and
several liability arrangements for which the total amount of the
obligation within the scope of this Update is fixed at the reporting date,
except for obligations addressed within existing guidance in U.S. GAAP.
The guidance requires an entity to measure those obligations as the sum of
the amount the reporting entity agreed to pay on the basis of its
arrangement among its co-obligors and any additional amount the reporting
entity expects to pay on behalf of its co-obligors. The guidance in this
Update also requires an entity to disclose the nature and amount of the
obligation as well as other information about those obligations. For
public entities, the amendments in this ASU were applicable for fiscal
years, and interim periods within those years, beginning after December
15, 2013. The adoption of this Statement did not have a material effect on
the Companys financial position or results of operations.
|
6
IntelGenx Technologies Corp. |
|
Notes to Consolidated Interim Financial Statements
|
March 31, 2014 |
(Expressed in U.S. Funds) |
(Unaudited) |
2. |
Adoption of New Accounting Standards
(Contd) |
|
|
|
The FASB issued Update No. 2013-05, Foreign Currency
Matters (Topic 830)Parents Accounting for the Cumulative Translation
Adjustment upon Derecognition of Certain Subsidiaries or Groups of Assets
within a Foreign Entity or of an Investment in a Foreign Entity. The
amendments in this Update resolve the diversity in practice about whether
Subtopic 810-10, ConsolidationOverall, or Subtopic 830-30, Foreign
Currency Matters Translation of Financial Statements, applies to the
release of the cumulative translation adjustment into net income when a
parent either sells a part or all of its investment in a foreign entity or
no longer holds a controlling financial interest in a subsidiary or group
of assets that is a nonprofit activity or a business (other than a sale of
in substance real estate or conveyance of oil and gas mineral rights)
within a foreign entity. In addition, the amendments in this Update
resolve the diversity in practice for the treatment of business
combinations achieved in stages (sometimes also referred to as step
acquisitions) involving a foreign entity. For public entities, the
amendments in this ASU were effective prospectively for fiscal years, and
interim reporting periods within those years, beginning after December 15,
2013. The adoption of this Statement did not have a material effect on the
Companys financial position or results of operations. |
|
|
|
The FASB issued Update No. 2013-07, Presentation of
Financial Statements Liquidation Basis of Accounting. The objective of
this Update is to clarify when an entity should apply the liquidation
basis of accounting and to provide principles for the measurement of
assets and liabilities under the liquidation basis of accounting, as well
as any required disclosures. These amendments were effective for entities
that determine liquidation is imminent during annual reporting periods
beginning after December 15, 2013, and interim reporting periods therein.
Entitles should apply the requirements prospectively from the day that
liquidation becomes imminent. The adoption of this Statement did not have
a material effect on the Companys financial position or results of
operations. |
|
|
|
The FASB issued Update No. 2013-11, Income Taxes (Topic
740)Presentation of an Unrecognized Tax Benefit When a Net Operating Loss
Carryforward, a Similar Tax Loss, or a Tax Credit Carryforward Exists.
The amendments in this ASU provide guidance on the financial statement
presentation of an unrecognized tax benefit when a net operating loss
carryforward, similar tax loss, or tax credit carryforward exists. The
amendments were effective for fiscal years, and interim periods within
those years, beginning after December 15, 2013 and should be applied
prospectively to all unrecognized tax benefits that exist at the effective
date. The adoption of this Statement did not have a material effect on the
Companys financial position or results of operations. |
|
|
3. |
Significant Accounting Policies |
|
|
|
Recently Issued Accounting
Pronouncements |
|
|
|
None of the new pronouncements issued by the FASB but not
yet effective as of March 31, 2014 are applicable to the
Company. |
7
IntelGenx Technologies Corp. |
|
Notes to Consolidated Interim Financial Statements
|
March 31, 2014 |
(Expressed in U.S. Funds) |
(Unaudited) |
4. |
Intangible Assets |
|
|
|
As of March 31, 2014 NDA acquisition costs of $70
thousand (December 31, 2013 - $79 thousand) were recorded as intangible
assets on the Companys balance sheet and represent the net book value of
the final progress payment related to the acquisition of 100% ownership of
Forfivo XL®. The asset is being amortized over its estimated useful life
of 39 months. The Company commenced amortization upon commercial launch of
the product in October 2012. |
|
|
5. |
Deferred License Revenue |
|
|
|
Deferred license revenue represents upfront payments
received for the granting of licenses to the Companys patents,
intellectual property, and proprietary technology, for commercialization.
Deferred license revenue is recognized in income over the period where
sales of the licensed products will occur. |
|
|
|
Upon entering into the licensing agreement with Edgemont
Pharmaceuticals the Company received an upfront fee of $1 million, which
the Company recognized as deferred license revenue. The deferred license
revenue is being amortized in income over a period of 39 months, which is
the minimum period where sales of Forfivo XL® are expected to be
exclusive. |
|
|
|
In January, 2014 IntelGenx entered into a development and
commercialization agreement with Par Pharmaceutical, Inc. for two
products. The Company received $100 thousand upon execution of the
agreement, of which $50 thousand has been recognized as deferred revenue
until certain development milestones have been achieved. |
|
|
|
As a result of this policy, the Company has a deferred
revenue balance of $589 thousand at March 31, 2014 (December 31, 2013 -
$616 thousand) that has not been recognized as revenue. |
|
|
6. |
Capital Stock |
|
|
|
March 31, |
|
|
December 31, |
|
|
|
|
2014 |
|
|
2013 |
|
|
Authorized - |
|
|
|
|
|
|
|
100,000,000 common shares of $0.00001 par
value |
|
|
|
|
|
|
|
20,000,000 preferred shares of $0.00001
par value |
|
|
|
|
|
|
|
Issued - |
|
|
|
|
|
|
|
62,650,655 (December 31, 2013 - 60,984,267) common shares
|
|
$ 627 |
|
|
$ 610 |
|
8
IntelGenx Technologies Corp. |
|
Notes to Consolidated Interim Financial Statements
|
March 31, 2014 |
(Expressed in U.S. Funds) |
(Unaudited) |
7. |
Additional Paid-In Capital |
|
|
|
Stock options |
|
|
|
No stock options were exercised during the three month
period ended March 31, 2014. During the three month period ended March 31,
2013 a total of 50,000 stock options were exercised for 50,000 common
shares having a par value of $0 thousand in aggregate, for cash
consideration of $23 thousand, resulting in an increase in additional
paid-in capital of $23 thousand. |
|
|
|
Compensation expenses for stock-based compensation of $32
thousand and $18 thousand were recorded during the three-month periods
ended March 31, 2014 and 2013 respectively. The entire amount expensed in
2014 relates to stock options granted to employees and directors. Of the
amount expensed in 2013, $13 thousand relates to stock options granted to
employees and directors and $5 thousand relates to options granted to
independent third party consultants. As at March 31, 2014 the Company has
$194 thousand (2013 - $50 thousand) of unrecognized stock-based
compensation. |
|
|
|
Warrants |
|
|
|
During the three month period ended March 31, 2014 a
total of 1,666,388 (2013 - 362,500) warrants were exercised for 1,666,388
(2013 - 362,500) common shares having a par value of $0 thousand in
aggregate, for cash consideration of $1,064 thousand (2013 - $172
thousand), resulting in an increase in additional paid-in capital of
$1,064 thousand (2013 - $171 thousand). |
|
|
8. |
Related Party Transactions |
|
|
|
Included in management salaries are $15 thousand (2013 -
$3 thousand) for options granted to the Chief Executive Officer and $11
thousand (2013 - $2 thousand) for options granted to the Chief Financial
Officer under the 2006 Stock Option Plan and $3 thousand (2013 - $4
thousand) for options granted to non-employee directors. In addition,
included in management salaries during the first three months of 2013 are
$1 thousand for options granted to a director, who is also an employee of
the Company. |
|
|
|
Also included in management salaries are director fees of
$22 thousand (2013 - $22 thousand) for attendance to board meetings and
audit committee meetings. In addition, during the first three months of
2013 the Company paid $54 thousand in fees to a director under a
management consultancy agreement. |
|
|
|
The above related party transactions have been measured
at the exchange amount which is the amount of the consideration
established and agreed to by the related parties. |
9
IntelGenx Technologies Corp. |
|
Notes to Consolidated Interim Financial Statements
|
March 31, 2014 |
(Expressed in U.S. Funds) |
(Unaudited) |
9. |
Basic and Diluted Loss Per Common Share |
|
|
|
Basic and diluted loss per common share is calculated
based on the weighted average number of shares outstanding during the
period. The warrants, share-based compensation and convertible notes have
been excluded from the calculation of diluted loss per share since they
are anti-dilutive. |
|
|
10. |
Subsequent Events |
|
|
|
Subsequent to the end of the quarter 565,000 warrants
were exercised for 565,000 common shares having a par value of $0 thousand
for cash consideration of approximately $370 thousand, resulting in an
increase in additional paid-in capital of approximately $370
thousand. |
10
Item 2: MANAGEMENTS DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Introduction to managements discussion and analysis
The purpose of this section, Managements Discussion and
Analysis of Financial Condition and Results of Operations, is to provide a
narrative explanation of the financial statements that enables investors to
better understand the business of the Company, to enhance the Companys overall
financial disclosures, to provide the context within which the Companys
financial information may be analyzed, and to provide information about the
quality of, and potential variability of, the Companys financial condition,
results of operations and cash flows. Unless otherwise indicated, all financial
and statistical information included herein relates to continuing operations of
the Company. Unless otherwise indicated or the context otherwise requires, the
words, IntelGenx, Company, we, us, and our refer to IntelGenx
Technologies Corp. and its subsidiaries, including IntelGenx Corp. This
information should be read in conjunction with the accompanying unaudited
Consolidated Financial Statements and Notes thereto.
Company background
We are a drug delivery company established in 2003 and
headquartered in Montreal, Quebec, Canada. Our focus is on the development of
novel oral immediate-release and controlled-release products for the
pharmaceutical market. Our business strategy is to develop pharmaceutical
products based on our proprietary drug delivery technologies and, once the
viability of a product has been demonstrated, to license the commercial rights
to partners in the pharmaceutical industry. In certain cases, we rely upon
partners in the pharmaceutical industry to fund development of the licensed
products, complete the regulatory approval process with the U.S. Food and Drug
Administration (FDA) or other regulatory agencies relating to the licensed
products, and assume responsibility for marketing and distributing such
products.
In addition, we may choose to pursue the development of certain
products until the project reaches the marketing and distribution stage. We will
assess the potential for successful development of a product and associated
costs, and then determine at which stage it is most prudent to seek a partner,
balancing such costs against the potential for additional returns earned by
partnering later in the development process.
We have also undertaken a strategy under which we will work
with pharmaceutical companies in order to develop new dosage forms for
pharmaceutical products for which patent protection is nearing expiration. Under
§(505)(b)(2) of the Food, Drug, and Cosmetics Act, the FDA may grant market
exclusivity for a term of up to three years of exclusivity following approval of
a listed drug that contains previously approved active ingredients but is
approved in a new dosage, dosage form, route of administration or combination,
or for a new use, the approval of which was required to be supported by new
clinical trials, other than bioavailability studies, conducted by or for the
sponsor.
We are currently continuing to develop the existing products in
our pipeline and may also perform research and development on other potential
products as opportunities arise.
We currently purchase and/or lease, on an as-needed basis, the
equipment necessary for performing research and development activities related
to our products.
We plan to hire new personnel, primarily in the areas of
research and development, manufacturing, and administration on an as-needed
basis as we enter into partnership agreements, establish our pilot plant
VersaFilm manufacturing capability, and increase our research and development
activities.
11
Key developments
Par Pharmaceutical, Inc.
On January 13, 2014 we announced the
execution of a second development and commercialization agreement with Par
Pharmaceutical, Inc. ("Par") for two new products utilizing our proprietary oral
drug delivery platforms.
Under the terms of the agreement, Par
has obtained certain exclusive rights to market and sell our products in the
USA. In exchange we will receive upfront and milestone payments, together with a
share of the profits upon commercialization. In accordance with confidentiality
clauses contained in the agreement, the specifics of the products and financial
terms remain confidential.
Anti-migraine VersaFilm product
On February 4, 2014 we, together with
our co-development partner RedHill Biopharma Ltd. ("RedHill"), announced receipt
of a Complete Response Letter ("CRL") from the U.S. Food and Drug Administration
("FDA") regarding the New Drug Application ("NDA") for our VersaFilm product
for the treatment of acute migraines. The anti-migraine VersaFilm product is a
proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor
agonist and the active drug in Merck & Co.'s Maxalt®.
A CRL is issued by the FDA's Center for
Drug Evaluation and Research to inform companies that certain questions and
deficiencies remain that preclude the approval of the application in its present
form. The questions raised by the FDA in the CRL regarding the NDA for the
anti-migraine VersaFilm product primarily relate to Chemistry, Manufacturing
and Controls ("CMC") and to the packaging and labeling of the product. No
questions or deficiencies were raised relating to the product's safety and the
FDA's CRL does not require additional clinical studies.
On March 3, 2014 we, together with
RedHill, announced the submission of a response to the FDAs CRL and, subsequent
to the end of the quarter, on April 24, 2014 IntelGenx and RedHill (the
Companies), reported that the FDA had acknowledged receipt of our response and
has requested additional CMC data, which the Companies believe they can supply
within several weeks based on available information.
The Companies further reported that a
supplier of raw material for the anti-migraine VersaFilm product is currently
holding compliance discussions with the FDA, which are independent of RedHill
and IntelGenx and are not specific to our anti-migraine VersaFilm product. The
Companies are diligently working on a variety of options to ensure continued
supply of the raw material regardless of the result of these compliance
discussions.
The Companies believe that FDA approval
of the anti-migraine VersaFilm product NDA is subject to the satisfactory
resolution of the remaining CMC questions, as well as securing a compliant
source of the raw material. Therefore, IntelGenx and RedHill will continue to
work with the FDA in order to submit all the data requested, and will provide an
update as and when applicable.
Subsequent to the end of the quarter,
on April 28, 2014 the Companies announced the commencement of a comparative
bioavailability clinical study comparing the anti-migraine VersaFilm product to
the European reference drug. The study is intended to support the planned
submission of a European Marketing Authorization Application ("MAA") and follows
a positive scientific advice meeting with the German Federal Institute for Drugs
and Medical Devices ("BfArM") announced by RedHill in November 2013. This
single-dose, crossover, comparative bioavailability study includes 26 healthy
volunteers and is intended to evaluate and compare the relative bioavailability
and to assess the bioequivalence of the anti-migraine VersaFilm product and the
reference drug, Maxalt® lingua, marketed in Germany by MSD SHARP & DOHME
GMBH.
12
Results of the bioavailability study
are anticipated by June 2014. Subject to the results of the study and to the
required regulatory process, and in light of the data from prior successful
studies conducted with the anti-migraine VersaFilm product, the Companies plan
to submit a European MAA in the third quarter of 2014, with Germany as the
reference member state, under the European Mutual Recognition Procedure ("MRP").
Erectile Dysfunction VersaFilm product
On February 24, 2014 we announced the
completion of a pilot biostudy with our proprietary VersaFilm tadalafil product
for erectile dysfunction that indicated bioequivalence with the leading brand
reference listed drug (RLD) tadalafil product.
This was a randomized, two-period,
two-way crossover study in healthy male subjects. The study was designed to
determine whether VersaFilm tadalafil was bioequivalent as measured by industry
standard pharmacokinetic measures of peak plasma concentration (Cmax) and area
under the curve (AUC). The study results demonstrated that VersaFilm tadalafil
was within an acceptable range of bioequivalency with the RLD on both of these
measures.
Government Funding for CNS VersaFilm product
Subsequent to the end of the quarter,
on April 30, 2014 we announced financial support from the National Research
Council of Canada Industrial Research Assistance Program (NRC-IRAP). In addition
to advisory services and technological expertise, the funding provided by
NRC-IRAP will support further development of a product for the treatment of
central nervous system (CNS) diseases and disorders. The product will be based
upon our proprietary, oral thin film, VersaFilm, technology.
In order to maintain our competitive
advantage, no specific details related to this project are being disclosed at
this time.
U.S. patent allowances
On February 26, 2014 we announced
receipt of a Notice of Allowance ("NOA") from the United States Patent and
Trademark Office ("USPTO") for U.S. Patent Application Serial No. 11/647,033
entitled "Multilayer tablet" which covers the technology used in our
hypertension product currently under development. A second NOA has been received
for U.S. Patent Application Serial No. 11/782,838 entitled "Controlled-release
pharmaceutical tablets" which is related to the drug delivery technology used in
Forfivo XL®, our first FDA-approved product currently commercialized in the U.S.
These two NOA's conclude the examination of each U.S. patent application and
will result in the issuance of two U.S. patents after administrative processes
are completed.
Subsequent to the end of the quarter,
on April 16, 2014 we announced receipt of a further NOA from the USPTO for U.S.
Patent Application Serial No. 12/836,810 entitled "Oral mucoadhesive dosage
form" which covers IntelGenx' proprietary AdVersa mucoadhesive drug delivery
technology. This NOA concludes the examination of the U.S. patent application
and will result in the issuance of a U.S. patent after the administrative
process is completed.
Currency rate fluctuations
Our operating currency is Canadian
dollars, while its reporting currency is U.S. dollars. Accordingly, our results
of operations and balance sheet position have been affected by currency rate
fluctuations. The following management discussion and analysis takes this into
consideration whenever material.
13
Results of operations for the three month period ended March
31, 2014 compared with the three month period ended March 31, 2013.
|
|
|
|
|
|
|
|
Increase/ |
|
|
Percentage |
|
In U.S.$
thousands |
|
2014 |
|
|
2013 |
|
|
|
|
|
Increase/ |
|
|
|
|
|
|
|
|
|
(Decrease) |
|
|
(Decrease) |
|
Revenue |
$ |
222 |
|
$ |
157 |
|
$ |
65 |
|
|
41% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
Development Expenses |
|
188 |
|
|
167 |
|
|
21 |
|
|
13% |
|
Selling, General and
Administrative Expenses |
|
460 |
|
|
456 |
|
|
4 |
|
|
1% |
|
Depreciation of
tangible assets |
|
7 |
|
|
10 |
|
|
(3 |
) |
|
(30% |
) |
Amortization of intangible
assets |
|
9 |
|
|
10 |
|
|
(1 |
) |
|
(10% |
)
|
Net Loss
|
|
(442 |
) |
|
(486 |
) |
|
(44 |
) |
|
(9% |
) |
Revenue
Total revenue in the first three months of 2014 increased to
$222 thousand from $157 thousand in the same period of 2013.
Of the total revenue recorded during the first quarter of 2014,
$173 thousand (2013: $157 thousand) relates to Forfivo XL®, our first FDA
approved product, which was launched in October 2012 under a licensing
partnership with Edgemont Pharmaceuticals LLP (Edgemont). Upon entering into
the licensing agreement, Edgemont paid us an upfront fee of $1 million, which we
recognized as deferred license revenue. The deferred license revenue is
amortized in income over the period where sales of Forfivo XL® are expected to
be exclusive. As a result of this policy, we recognized $77 thousand in income
during the first quarter of 2014 (2013: $77 thousand). In addition, we
recognized approximately $96 thousand of royalty income earned from the sale of
Forfivo XL® in the first quarter of 2014. This compares with approximately $80
thousand in the same period of 2013, the majority of which related to initial
supplies for the launch of the product in Q4, 2012. Pursuant to the contractual
terms, royalty income relates to sales of Forfivo XL® recorded by Edgemont
during the quarter preceding receipt of the royalty income by us. Forfivo XL® is
indicated for the treatment of Major Depressive Disorder (MDD) and is the only
extended-release bupropion HCl product to provide a once-daily, 450mg dose in a
single tablet.
The level of sales achieved for Forfivo XL® to date has been
considerably lower than anticipated, resulting in a proportionately lower level
of royalty income. Management continues to work diligently with the
commercialization partner to explore options to accelerate sales growth of
Forfivo XL®, which have grown by an average of approximately 97% per quarter for
the last three quarters ending December 31, 2013.
Revenue for the three months ended March 31, 2014 also includes
a $50 thousand milestone payment in respect of one of the two new projects being
developed in accordance with our new development and commercialization agreement
with Par, utilizing our proprietary oral drug delivery platforms. As previously
stated, in accordance with confidentiality clauses contained in the agreement,
the specifics of the product and financial terms remain confidential.
Research and development (R&D) expenses
R&D expenses, net of R&D investment tax credits,
totaled $188 thousand in the three months ended March 31, 2014, representing an
increase of $21 thousand, or 13%, to the amount of $167 thousand expensed in the
same period of last year.
14
The increase in R&D expenses primarily relates to the costs
of a pilot clinical study for our VersaFilm product for erectile dysfunction
that indicated bioequivalence with the leading brand reference listed drug
tadalafil product, partly offset by a reduction in R&D staff salaries, as
described below.
Included within R&D expenses for the first three months of
2014 are R&D Salaries of $115 thousand, of which approximately $2 thousand
represents non-cash compensation. This compares to R&D salaries of $153
thousand in the first three months of 2013, of which approximately $3 thousand
represented non-cash compensation. The reduction in R&D salaries is
primarily attributable to the retirement, effective December 31, 2013, of Dr.
Horst Zerbe, our founder, and former President and CEO. 50% of Dr. Zerbes
expenses were previously apportioned to the R&D department. Dr. Zerbe
remains available to us to consult on R&D activities.
In the three months ended March 31, 2014 we recorded estimated
Research and Development Tax Credits and refunds of $27 thousand, compared with
$35 thousand that was recorded in the same period of the previous year.
Selling, general and administrative (SG&A) expenses
SG&A expenses increased by $4 thousand, to $460 thousand,
in the first three months of 2014 compared with $456 thousand in the first three
months of 2013.
Included in SG&A expenses are approximately $27 thousand
(2013: $5 thousand) in non-cash compensation from options granted to management
employees in 2012 and 2013, $3 thousand (2013: $4 thousand) in non-cash
compensation from options granted to non-employee directors in 2013, and $Nil
(2013: $6 thousand) in non-cash compensation from options granted to consultants
in 2012.
Depreciation of tangible assets
In the three months ended March 31, 2014 we recorded an expense
of $7 thousand for the depreciation of tangible assets, compared with an expense
of $10 thousand for the same period of the previous year.
Amortization of intangible assets
The amortization of intangible assets expense for the first
three months of 2014 totaled $9 thousand, compared with $10 thousand in the same
period of last year. The expense relates to the amortization of NDA acquisition
costs in respect of the final progress payment to acquire 100% ownership of
Forfivo XL®. Commercialization of Forfivo XL® in October 2012 triggered
amortization of the asset over its estimated useful life of 39 months.
Share-based compensation expense, warrants and stock based
payments
Share-based compensation expense, warrants and share-based
payments totaled $32 thousand for the three months ended March 31, 2014,
compared with $18 thousand for the three months ended March 31, 2013.
We expensed approximately $29 thousand in the first three
months of 2014 for options granted to our employees in 2011 and 2012 under the
2006 Stock Option Plan, and approximately $3 thousand for options granted to
non-employee directors in 2013, compared with $8 thousand and $4 respectively
that was expensed in the same period of the previous year.
We also expensed $6 thousand in the first three months of 2013
for options granted to consultants.
There remains approximately $194 thousand in stock based
compensation to be expensed in fiscal 2014 and 2015, all of which relates to the
issuance of options to our employees and directors during 2012 and 2013. We
anticipate the issuance of additional options and warrants in the future,
which will continue to result in stock-based compensation expense.
15
Key items from the balance sheet.
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
In U.S.$
thousands |
|
March 31, |
|
|
December |
|
|
Increase/ |
|
|
Increase/ |
|
|
|
2014 |
|
|
31, 2013 |
|
|
(Decrease) |
|
|
(Decrease) |
|
Current Assets
|
$ |
5,569 |
|
$ |
5,550 |
|
$ |
19 |
|
|
0% |
|
Leasehold improvements and
Equipment |
|
664 |
|
|
588 |
|
|
76 |
|
|
13% |
|
Intangible
Assets |
|
70 |
|
|
79 |
|
|
(9 |
) |
|
(11% |
) |
Current Liabilities |
|
642 |
|
|
901 |
|
|
(259 |
) |
|
(29% |
)
|
Deferred
License Revenue |
|
231 |
|
|
308 |
|
|
(77 |
) |
|
(25% |
) |
Capital Stock |
|
1 |
|
|
1 |
|
|
0 |
|
|
0% |
|
Additional
Paid-in-Capital |
|
22,030 |
|
|
20,934 |
|
|
1,094 |
|
|
5% |
|
Current assets
Current assets totaled $5,569 thousand at March 31, 2014
compared with $5,550 thousand at December 31, 2013. The increase of $19 thousand
is attributable to an increase in cash and cash equivalents of approximately
$161 thousand and an increase in investment tax credits receivable of
approximately $17 thousand, partly offset by a decrease in accounts receivable
of approximately $118 thousand and a decrease in prepaid expenses of
approximately $41 thousand.
Cash and cash equivalents
Cash and cash equivalents totaled $5,166 thousand as at March
31, 2014 representing an increase of $161 thousand compared with the balance of
$5,005 thousand as at December 31, 2013. The increase in cash on hand relates to
net cash provided by financing activities of $1,064 thousand, partly offset with
net cash used by operating activities of $588 thousand, net cash used in
investing activities of $105 thousand and an unrealized foreign exchange loss of
$210 thousand.
The cash provided by financing activities derives from the
exercise of 1,666,388 warrants that were exercised for 1,666,388 common shares
for cash consideration of $1,064 thousand.
Accounts receivable
Accounts receivable totaled $26 thousand as at March 31, 2014
representing a decrease of $118 thousand compared with the balance of $144
thousand as at December 31, 2013. The decreased balance relates to the payment
of client invoices in Q1, 2014 that were issued and outstanding at December 31,
2013.
Prepaid expenses
As of March 31, 2014 prepaid expenses totaled $92 thousand
compared with $133 thousand as of December 31, 2013. The decrease in prepaid
expenses relates to a deposit paid in December 2013 for a biostudy undertaken in
the first quarter of 2014, and a deposit paid in 2013 for R&D machinery to
be supplied and installed in 2014.
16
Investment tax credits receivable
R&D investment tax credits receivable totaled approximately
$285 thousand as at March 31, 2014 compared with $268 thousand as at December
31, 2013. The increase relates to the accrual recorded for the first quarter of
2014, partly offset by the unrealized foreign exchange loss of converting our
operating currency of CAD$ into our reporting currency of US$.
Leasehold improvements and equipment
As at March 31, 2014, the net book value of leasehold
improvements and equipment amounted to $664 thousand, compared to $588 thousand
at December 31, 2013. In the three months ended March 31, 2014 additions to
assets totaled $105 thousand and comprised $49 thousand for pilot plant
manufacturing equipment for our VersaFilm products, $38 thousand for R&D
equipment, $16 thousand for leasehold improvements and $2 thousand for computer
equipment. In the three months ended March 31, 2014 we recorded depreciation on
leasehold improvements and equipment of $7 thousand and incurred an unrealized
foreign exchange loss of $22 thousand.
Intangible assets
As at March 31, 2014 NDA acquisition costs of $70 thousand
(December 31, 2013 - $79 thousand) were recorded as intangible assets on our
balance sheet and are related to the acquisition of 100% ownership of Forfivo
XL®. The asset is being amortized over its expected useful life of 39 months and
amortization commenced upon commercial launch of Forfivo XL® in the fourth
quarter of 2012.
Current liabilities
Current liabilities totaled $642 thousand as at March 31, 2014
(December 31, 2013 - $901 thousand) and consisted of accounts payable and
accrued liabilities of $284 thousand (December 31, 2013 - $593 thousand) and the
current portion of deferred license revenue of $358 thousand (December 31, 2013
- $308 thousand).
Included in the accounts payable and accrued liabilities
balance of $284 thousand as at March 31, 2014 is approximately $22 thousand
relating to research and development activities, approximately $69 thousand
relating to professional fees, and approximately $144 thousand relates to
accrued payroll liabilities. This compares with approximately $100 thousand
relating to research and development activities, approximately $180 thousand
relating to professional fees, of which approximately $87 thousand relates to
the public offering completed in December, 2013, and approximately $301 thousand
relates to accrued payroll liabilities, that was included in the accounts
payable and accrued liabilities balance as at December 31, 2013.
Deferred license revenue
Pursuant to the execution of a licensing agreement for Forfivo
XL®, we received an upfront fee from Edgemont Pharmaceuticals in the first
quarter of 2012, which we recognized as deferred license revenue. The deferred
license revenue is amortized in income over the period where sales of Forfivo
XL® are expected to be exclusive. As a result of this policy, we have a
deferred revenue balance related to this upfront fee of $539 thousand at March
31, 2014 (December 31, 2013: $616 thousand) that has not been recognized as
revenue, with $231 thousand recognized as the non-current portion and $308
thousand recognized in current assets as the current portion, versus $308
thousand and $308 thousand respectively as at December 31, 2013.
In January, 2014 IntelGenx entered into a development and
commercialization agreement with Par Pharmaceutical, Inc. for two products. The
Company received $100 thousand upon execution of the agreement, of which $50
thousand has been recognized in current liabilities as deferred revenue until
certain development milestones that are expected to be achieved in 2014 have been realised.
17
Shareholders equity
As at March 31, 2014 we had accumulated a deficit of $16,544
thousand compared with an accumulated deficit of $16,102 thousand as at December
31, 2013. Total assets amounted to $6,303 thousand and shareholders equity
totaled $5,431 thousand as at March 31, 2014, compared with total assets and
shareholders equity of $6,217 thousand and $5,008 thousand respectively, as at
December 31, 2013.
Capital stock
As at March 31, 2014 capital stock amounted to $627 compared to
$610 at December 31, 2013. The increase reflects the issuance of 1,666,388
shares related to the exercise of warrants, with all shares issued at par value
of $0.00001. Capital stock is disclosed at its par value with the excess of
proceeds shown in Additional paid-in-capital.
Additional paid-in-capital
Additional paid-in capital totaled $22,030 thousand at March
31, 2014, compared with $20,934 thousand at December 31, 2013. Additional
paid-in capital increased by $1,064 thousand for warrants exercised during the
first quarter, and by $32 thousand for stock based compensation attributable to
the amortization of stock options granted to employees and directors.
Key items from the statement of cash flows
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
In U.S.$ thousands |
|
March
31, |
|
|
March
31, |
|
|
Increase/ |
|
|
Increase/ |
|
|
|
2014 |
|
|
2013 |
|
|
(Decrease) |
|
|
(Decrease) |
|
Operating Activities |
$ |
(588 |
)
|
$ |
10 |
|
$ |
(598 |
)
|
|
(5,980% |
)
|
Financing Activities |
|
1,064 |
|
$ |
195 |
|
$ |
869 |
|
|
446% |
|
Investing Activities |
|
(105 |
)
|
|
(69 |
)
|
|
36 |
|
|
52% |
|
Cash and cash equivalents - end of period |
|
5,166 |
|
|
2,168 |
|
|
2,998 |
|
|
138% |
|
Statement of cash flows
Net cash used by operating activities was $588 thousand in the
three months ended March 31, 2014, compared with net cash generated of $10
thousand for the three months ended March 31, 2013. In the first quarter of
2014, net cash used by operating activities consisted of an operating loss of
$394 thousand (2013: $448 thousand) net of non-cash related expenses of
approximately $48 thousand (2013: $38 thousand), and a decrease in non-cash
operating elements of working capital of $194 thousand, compared with an
increase in non-cash operating elements of working capital of $458 thousand in
the same period of the previous year.
Operating activities will continue to consume our available
funds until we are able to generate increased revenues.
The net cash provided by financing activities was $1,064
thousand in the first three months of 2014, compared with $195 thousand provided
in the same period of the previous year. The net cash provided in the first
quarter of 2014 resulted from the exercise of 1,666,388 warrants, whereas the
cash provided in the first quarter of 2013 resulted from the exercise of 362,500 warrants and 50,000 options.
18
Net cash used in investing activities amounted to $105 thousand
in the three months ended March 31, 2014 compared with $69 thousand in the three
months ended March 31, 2013. Included within the use of funds in the first
quarter of 2014 is an investment of approximately $49 thousand (2013: $68
thousand) for pilot plant manufacturing equipment for our VersaFilm products,
$38 thousand (2013: $Nil) for R&D equipment, $16 thousand (2013: $Nil) for
leasehold improvements and $2 thousand (2013: $1 thousand) for computer
equipment.
The balance of cash and cash equivalents as at March 31, 2014
amounted to $5,166 thousand, compared with $2,168 thousand at March 31,
2013.
Off-balance sheet arrangements
We have no off-balance sheet arrangements.
Item 3. Controls and Procedures.
As of the end of the period covered by
this report, we carried out an evaluation, under the supervision and with the
participation of management, including our chief executive officer and principal
financial officer, of the effectiveness of the design and operation of our
disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e)
of the Securities Exchange Act of 1934. Based upon that evaluation, our chief
executive officer and principal financial officer concluded that our disclosure
controls and procedures are effective to cause the material information required
to be disclosed by us in the reports that we file or submit under the Exchange
Act to be recorded, processed, summarized and reported within the time periods
specified in the SEC's rules and forms. There have been no significant changes
in our internal controls or in other factors which could significantly affect
internal controls subsequent to the date we carried out our evaluation.
PART II
Item 1. |
Legal Proceedings |
|
This Item is not applicable |
|
|
Item 2. |
Unregistered Sales of Equity Securities and
Use of Proceeds |
|
This Item is not applicable. |
|
|
Item 3. |
Defaults Upon Senior Securities |
|
This Item is not applicable. |
|
|
Item 4. |
(Reserved) |
|
|
Item 5. |
Other Information |
|
This Item is not applicable. |
|
|
Item 6. |
Exhibits |
19
Exhibit
31.1 Certification
of C.E.O. Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
Exhibit
31.2 Certification
of Principal Accounting Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002. |
|
Exhibit
32.1 Certification
of C.E.O. pursuant to 18 U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley
Act of 2002. |
|
Exhibit
32.2
Certification
of Principal Accounting Officer pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of
the Sarbanes-Oxley Act of 2002. |
SIGNATURES
In accordance with the
requirements of the Securities Exchange Act of 1934, the Registrant caused this
report to be signed on its behalf by the undersigned, thereunto duly authorized.
INTELGENX TECHNOLOGIES CORPORATION
Date: May 13, 2014 |
By: |
/s/ |
Rajiv Khosla |
|
|
|
Rajiv Khosla |
|
|
|
President, C.E.O. and
|
|
|
|
Director |
|
|
|
|
|
|
|
|
|
|
|
|
Date: May 13, 2014 |
By: |
/s/ |
Paul Simmons |
|
|
|
Paul A. Simmons
|
|
|
|
Principal Accounting
Officer |
20
Exhibit 31.1
CERTIFICATION PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY
ACT OF 2002
I, Rajiv Khosla, Chief Executive Officer of IntelGenx
Technologies Corp. (the "registrant"), certify that:
1. I have reviewed this quarterly report on Form 10-Q of
IntelGenx Technologies Corp.;
2. Based on my knowledge, this
report does not contain any untrue statement of a material fact or omit to state
a material fact necessary to make the statements made, in light of the
circumstances under which such statements were made, not misleading with respect
to the period covered by this report;
3. Based on my knowledge, the
financial statements, and other financial information included in this report,
fairly present in all material respects the financial condition, results of
operations and cash flows of the registrant as of, and for, the periods
presented in this report;
4. The registrant's other
certifying officer and I are responsible for establishing and maintaining
disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e)
and 15d-15(e)) and internal control over financial reporting (as defined in
Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and we have:
a) Designed such disclosure
controls and procedures, or caused such disclosure controls and procedures to be
designed under our supervision, to ensure that material information relating to
the registrant, including its consolidated subsidiaries, is made known to us by
others within those entities, particularly during the period in which this
report is being prepared;
b) Designed such internal control
over financial reporting, or caused such internal control over financial
reporting to be designed under our supervision, to provide reasonable assurance
regarding the reliability of financial reporting and the preparation of
financial statements for external purposes in accordance with generally accepted
accounting principles;
c) Evaluated the effectiveness of
the registrant's disclosure controls and procedures and presented in this report
our conclusions about the effectiveness of the disclosure controls and
procedures, as of the end of the period covered by this report based on such
evaluation; and
d) Disclosed in this report any
change in the registrant's internal control over financial reporting that
occurred during the registrant's most recent fiscal quarter (the registrant's
fourth fiscal quarter in the case of an annual report) that has materially
affected, or is reasonably likely to materially affect, the registrant's
internal control over financial reporting; and
5. The registrant's other
certifying officer and I have disclosed, based on our most recent evaluation of
internal control over financial reporting, to the registrant's auditors and the
audit committee of registrant's board of directors (or persons performing the
equivalent functions):
a) All significant deficiencies
and material weaknesses in the design or operation of internal control over
financial reporting which are reasonably likely to adversely affect the
registrant's ability to record, process, summarize and report financial
information; and
b) Any fraud, whether or not
material, that involves management or other employees who have a significant
role in the registrant's internal control over financial reporting.
Date: May 13, 2014
/s/ Rajiv Khosla
|
Rajiv Khosla
|
Chief Executive Officer
|
Exhibit 31.2
CERTIFICATION PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY
ACT OF 2002
I, Paul A. Simmons, Principal
Accounting Officer of IntelGenx Technologies Corp. (the "registrant"), certify
that:
1. I have reviewed this quarterly report on Form 10-Q of
IntelGenx Technologies Corp. ;
2. Based on my knowledge, this
report does not contain any untrue statement of a material fact or omit to state
a material fact necessary to make the statements made, in light of the
circumstances under which such statements were made, not misleading with respect
to the period covered by this report;
3. Based on my knowledge, the
financial statements, and other financial information included in this report,
fairly present in all material respects the financial condition, results of
operations and cash flows of the registrant as of, and for, the periods
presented in this report;
4. The registrant's other
certifying officer and I are responsible for establishing and maintaining
disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e)
and 15d-15(e)) and internal control over financial reporting (as defined in
Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and we have:
a) Designed such disclosure
controls and procedures, or caused such disclosure controls and procedures to be
designed under our supervision, to ensure that material information relating to
the registrant, including its consolidated subsidiaries, is made known to us by
others within those entities, particularly during the period in which this
report is being prepared;
b) Designed such internal control
over financial reporting, or caused such internal control over financial
reporting to be designed under our supervision, to provide reasonable assurance
regarding the reliability of financial reporting and the preparation of
financial statements for external purposes in accordance with generally accepted
accounting principles;
c) Evaluated the effectiveness of
the registrant's disclosure controls and procedures and presented in this report
our conclusions about the effectiveness of the disclosure controls and
procedures, as of the end of the period covered by this report based on such
evaluation; and
d) Disclosed in this report any
change in the registrant's internal control over financial reporting that
occurred during the registrant's most recent fiscal quarter (the registrant's
fourth fiscal quarter in the case of an annual report) that has materially
affected, or is reasonably likely to materially affect, the registrant's
internal control over financial reporting; and
5. The registrant's other
certifying officer and I have disclosed, based on our most recent evaluation of
internal control over financial reporting, to the registrant's auditors and the
audit committee of registrant's board of directors (or persons performing the
equivalent functions):
a) All significant deficiencies
and material weaknesses in the design or operation of internal control over
financial reporting which are reasonably likely to adversely affect the
registrant's ability to record, process, summarize and report financial
information; and
b) Any fraud, whether or not
material, that involves management or other employees who have a significant
role in the registrant's internal control over financial reporting.
Date: May 13, 2014
/s/ Paul
A. Simmons |
Paul A. Simmons |
Principal Accounting Officer |
Exhibit 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly
Report of IntelGenx Technologies Corporation (the "Company") on Form 10-Q for
the period ending March 31, 2014, as filed with the Securities and Exchange
Commission on the date hereof (the "Report"), I, Rajiv Khosla, Chief Executive
Officer of the Company, certify, pursuant to 18 U.S.C. Sec. 1350, as adopted
pursuant to Sec. 906 of the Sarbanes-Oxley Act of 2002, that, to the best of my
knowledge and belief:
(1) The Report fully complies
with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act
of 1934; and
(2) The information contained in
the Report fairly presents, in all material respects, the financial condition
and result of operations of the Company.
/s/ Rajiv Khosla
|
Rajiv Khosla |
Chief Executive Officer |
May 13, 2014 |
A signed original of this written
statement required by Section 906, or other document authenticating,
acknowledging, or otherwise adopting the signature that appears in typed form
within the electronic version of this written statement has been provided to the
Company and will be retained by the Company and furnished to the Securities and
Exchange Commission or its staff upon request. The foregoing certifications are
accompanying the Company's Form 10-Q solely pursuant to section 906 of the
Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, chapter 63
of title 18, United States Code) and is not being filed as part of the Form 10-Q
or as a separate disclosure document.
Exhibit 32.2
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly
Report of IntelGenx Technologies Corporation(the "Company") on Form 10-Q for the
period ending March 31, 2014, as filed with the Securities and Exchange
Commission on the date hereof (the "Report"), I, Paul A. Simmons, Principal
Accounting Officer of the Company, certify, pursuant to 18 U.S.C. Sec. 1350, as
adopted pursuant to Sec. 906 of the Sarbanes-Oxley Act of 2002, that, to the
best of my knowledge and belief:
(1) The Report fully complies
with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act
of 1934; and
(2) The information contained in
the Report fairly presents, in all material respects, the financial condition
and result of operations of the Company.
/s/ Paul A.
Simmons |
Paul A. Simmons |
Principal Accounting Officer |
May 13, 2014 |
A signed original of this written
statement required by Section 906, or other document authenticating,
acknowledging, or otherwise adopting the signature that appears in typed form
within the electronic version of this written statement has been provided to the
Company and will be retained by the Company and furnished to the Securities and
Exchange Commission or its staff upon request. The foregoing certifications are
accompanying the Company's Form 10-Q solely pursuant to section 906 of the
Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, chapter 63
of title 18, United States Code) and is not being filed as part of the Form 10-Q
or as a separate disclosure document.
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