IntelGenx Technologies Corp. - Quarter Report: 2018 June (Form 10-Q)

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 June 30, 2018

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)

6420 Abrams, Ville Saint Laurent, Quebec H4S 1Y2, 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.

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       [ ]

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [ ]

APPLICABLE TO CORPORATE ISSUERS:

70,989,337 shares of the issuer’s common stock, par value $.00001 per share, were issued and outstanding as of August 5, 2018.

1

IntelGenx Technologies Corp.
Form 10-Q

TABLE OF CONTENTS

2

IntelGenx Technologies Corp.

Consolidated Interim Financial Statements
June 30, 2018
(Expressed in U.S. Funds)
(Unaudited)

3

IntelGenx Technologies Corp.

Consolidated Balance Sheet
(Expressed in Thousands of U.S. Dollars ($000’s) Except Share and Per Share Data)
(Unaudited)

See accompanying notes

4

IntelGenx Technologies Corp.

Consolidated Statement of Shareholders' Equity
For the Period Ended June 30, 2018
(Expressed in Thousands of U.S. Dollars ($000’s) Except Share and Per Share Data)
(Unaudited)

See accompanying notes

5

IntelGenx Technologies Corp.

Consolidated Statement of Comprehensive Loss
(Expressed in Thousands of U.S. Dollars ($000’s) Except Share and Per Share Data)
(Unaudited)

See accompanying notes

6

IntelGenx Technologies Corp.

Consolidated Statement of Cash Flows
(Expressed in thousands of U.S. Dollars ($000’s) Except Share and Per Share Data)
(Unaudited)

See accompanying notes

7

IntelGenx Technologies Corp.

Notes to Consolidated Interim Financial Statements
June 30, 2018
(Expressed in U.S. Funds)
(Unaudited)

8

IntelGenx Technologies Corp.

Notes to Consolidated Interim Financial Statements
June 30, 2018
(Expressed in U.S. Funds)
(Unaudited)

9

IntelGenx Technologies Corp.

Notes to Consolidated Interim Financial Statements
June 30, 2018
(Expressed in U.S. Funds)
(Unaudited)

10

IntelGenx Technologies Corp.

Notes to Consolidated Interim Financial Statements
June 30, 2018
(Expressed in U.S. Funds)
(Unaudited)

11

IntelGenx Technologies Corp.

Notes to Consolidated Interim Financial Statements
June 30, 2018
(Expressed in U.S. Funds)
(Unaudited)

12

IntelGenx Technologies Corp.

Notes to Consolidated Interim Financial Statements
June 30, 2018
(Expressed in U.S. Funds)
(Unaudited)

Upon retirement or disposal, the cost of the asset disposed of and the related accumulated depreciation are removed from the accounts and any gain or loss is reflected in income. Expenditures for repair and maintenance are expensed as incurred.

Recent Accounting Pronouncements

ASU 2018-07 – Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting

The FASB issued ASU 2018-07 to expand the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. These amendments are effective for a public business entity for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. The Company is currently evaluating the impact of this Statement on its consolidated financial statements.

ASU 2018-02 – Income Statement – Reporting Comprehensive Income (Topic 220): Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income

The FASB issued ASU 2018-02 which provides financial statement preparers with an option to reclassify stranded tax effects within AOCI to retained earnings in each period in which the effect of the change in the U.S. federal corporate income tax rate in the Tax Cuts and Jobs Act (or portion thereof) is recorded. These amendments are effective for fiscal years beginning after December 15, 2018. The Company is currently evaluating the impact of the Statement on its consolidated financial statements.

ASU 2017-04 – Intangibles – Goodwill and Other (Topic 350) Simplifying the Test for Goodwill Impairment

The FASB issued ASU 2017-04 which eliminates Step 2 from the goodwill impairment test and eliminates the requirements for any reporting unit with a zero or negative carrying amount to perform a qualitative assessment. These amendments are effective for a public business entity for fiscal years beginning after December 15, 2019. Early adoption is permitted in any interim or annual period and should be applied on a retrospective basis. The Company is currently evaluating the impact of this Statement on its consolidated financial statements.

13

IntelGenx Technologies Corp.

Notes to Consolidated Interim Financial Statements
June 30, 2018
(Expressed in U.S. Funds)
(Unaudited)

14

IntelGenx Technologies Corp.

Notes to Consolidated Interim Financial Statements
June 30, 2018
(Expressed in U.S. Funds)
(Unaudited)

The Company’s term loan facility consists of a total of CAD$4 million ($3.04 million) bearing interest at the Bank’s prime lending rate plus 2.50%, with monthly principal repayments of CAD$62 thousand ($47 thousand). The term loan is subject to the same security and financial covenants as the bank indebtedness (see note 6).

The secured loan has a principal balance authorized of CAD$1 million ($759 thousand) bearing interest at prime plus 7.3%, reimbursable in monthly principal payments of CAD$17 thousand ($13 thousand) from January 2017 to March 2021. The loan is secured by a second ranking on all present and future property of the Company. The terms of the banking agreement require the Company to comply with certain debt service coverage and debt to net worth financial covenants on an annual basis at the end of the Company’s fiscal year.

Principal repayments due in each of the next four years are as follows:

15

IntelGenx Technologies Corp.

Notes to Consolidated Interim Financial Statements
June 30, 2018
(Expressed in U.S. Funds)
(Unaudited)

The accrued interest on the convertible debentures for the six-month period ended June 30, 2018 amounts to CAD$304 thousand ($238 thousand) and is recorded in financing and interest expense and accrued liabilities. On July 3, 2018, the accrued interest was paid by issuance of 307,069 common shares.

16

IntelGenx Technologies Corp.

Notes to Consolidated Interim Financial Statements
June 30, 2018
(Expressed in U.S. Funds)
(Unaudited)

The convertible notes have been recorded as a liability. Total transactions costs in the amount of U.S.$111 thousand were recorded against the liability. The accretion expense for the six-month period ended June 30, 2018 amounts to U.S. $22,000.

The components of the convertible notes are as follows:

The interest on the convertible notes for the six-month period ended June 30, 2018 amounts to $14 thousand and is recorded in financing and interest expense.

17

IntelGenx Technologies Corp.

Notes to Consolidated Interim Financial Statements
June 30, 2018
(Expressed in U.S. Funds)
(Unaudited)

18

IntelGenx Technologies Corp.

Notes to Consolidated Interim Financial Statements
June 30, 2018
(Expressed in U.S. Funds)
(Unaudited)

19

IntelGenx Technologies Corp.

Notes to Consolidated Interim Financial Statements
June 30, 2018
(Expressed in U.S. Funds)
(Unaudited)

The following table presents our revenues disaggregated by timing of recognition:

The following table presents our revenues disaggregated by geography, based on the billing addresses of our customers:

Remaining performance obligations

As at June 30, 2018, the aggregate amount of the transaction price allocated to the remaining performance obligation is $329 representing research and development agreements, the majority of which is expected to be recognized in the next twelve months. The Company is also eligible to receive up to $4,051 in research and development milestone payments; up to $28,751 in commercial sales milestone payments. In addition, the Company is entitled to receive royalties on potential sales.

20

IntelGenx Technologies Corp.

Notes to Consolidated Interim Financial Statements
June 30, 2018
(Expressed in U.S. Funds)
(Unaudited)

21

Item 2: Management’s Discussion and Analysis of Financial Condition and Results of Operations Introduction to Management’s Discussion and Analysis

This Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) comments on our business operations, performance, financial position and other matters for the three-month and six-month periods ended June 30, 2018 and 2017.

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 MD&A should be read in conjunction with the accompanying unaudited Consolidated Financial Statements and Notes thereto. We also encourage you to refer to the Company’s MD&A for the year ended December 31, 2017. In preparing this MD&A, we have taken into account information available to us up to August 9, 2018, the date of this MD&A, unless otherwise indicated.

Additional information relating to the Company, including our Annual Report on Form 10-K for the fiscal year ended December 31, 2017 (the “2017 Form 10-K”), is available on SEDAR at www.sedar.com and on the U.S. Securities and Exchange Commission (the “SEC”) website at www.sec.gov.

All dollar amounts are expressed in U.S. dollars, unless otherwise noted.

Cautionary Statement Concerning Forward-Looking Statements

Certain statements included or incorporated by reference in this MD&A constitute forward-looking statements within the meaning of applicable securities laws. All statements contained in this MD&A that are not clearly historical in nature are forward-looking, and the words “anticipate”, “believe”, “continue”, “expect”, “estimate”, “intend”, “may”, “plan”, “will”, “shall” and other similar expressions are generally intended to identify forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. All forward-looking statements are based on our beliefs and assumptions based on information available at the time the assumption was made. These forward-looking statements are not based on historical facts but on management’s expectations regarding future growth, results of operations, performance, future capital and other expenditures (including the amount, nature and sources of funding thereof), competitive advantages, business prospects and opportunities. Forward-looking statements involve significant known and unknown risks, uncertainties, assumptions and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from those implied by forward-looking statements. These factors should be considered carefully and you should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in this MD&A or incorporated by reference herein are based upon what management believes to be reasonable assumptions, there is no assurance that actual results will be consistent with these forward-looking statements. These forward-looking statements are made as of the date of this MD&A or as of the date specified in the documents incorporated by reference herein, as the case may be. We undertake no obligation to update any forward looking statements to reflect events or circumstances after the date on which such statements were made or to reflect the occurrence of unanticipated events, except as may be required by applicable securities laws. The factors set forth in Item 1A., "Risk Factors" of the 2016 Form 10-K, as well as any cautionary language in this MD&A, provide examples of risks, uncertainties and events that may cause our actual results to differ materially from the expectations we describe in our forward-looking statements. Before you invest in the common stock, you should be aware that the occurrence of the events described as risk factors and elsewhere in this report could have a material adverse effect on our business, operating results and financial condition.

22

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.

More recently, we have made the strategic decision to enter the oral film market and have implemented commercial oral film manufacturing capability. This enables us to offer our partners a comprehensive portfolio of pharmaceutical services, including pharmaceutical R&D, clinical monitoring, regulatory support, tech transfer and manufacturing scale-up, and commercial manufacturing.

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, license the commercial rights to partners in the pharmaceutical industry. In certain cases, we rely upon partners in the pharmaceutical industry to fund the development of the licensed products, complete the regulatory approval process with the 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.

Our primary growth strategies are based on three pillars: (1) out licensing commercial rights of our existing pipeline products, (2) partnering on contract development and manufacturing projects leveraging our VersaFilm™ technology, (3) expanding our current pipeline through:

Contract Development and Manufacturing based on VersaFilm™ technology

We have established a state-of-the-art manufacturing facility for the future manufacture of our VersaFilm™ products. We believe that this (1) represents a profitable business opportunity, (2) will reduce our dependency upon third-party contract manufacturers, thereby protecting our manufacturing process know-how and intellectual property, and (3) allows us to offer our development partners a full service from product conception through to supply of the finished product.

Lifecycle Management Opportunities

We are seeking to position our delivery technologies as an opportunity for lifecycle management of products for which patent protection of the active ingredient is nearing expiration. While the patent for the underlying substance cannot be extended, patent protection can be obtained for a new and improved formulation by filing an application with the FDA under Section 505(b)(2) of the U.S. Federal Food, Drug and Cosmetic Act. Such applications, known as a “505(b)(2) NDA”, are permitted for new drug products that incorporate previously approved active ingredients, even if the proposed new drug incorporates an approved active ingredient in a novel formulation or for a new indication. A 505(b)(2) NDA may include information regarding safety and efficacy of a proposed drug that comes from studies not conducted by or for the applicant. The first formulation for a respective active ingredient filed with the FDA under a 505(b)(2) application may qualify for up to three years of market exclusivity upon approval. Based upon a review of past partnerships between third party drug delivery companies and pharmaceutical companies, management believes that drug delivery companies which possess innovative technologies to develop these special dosage formulations present an attractive opportunity to pharmaceutical companies. Accordingly, we believe “505(b)(2) products” represent a viable business opportunity for us.

23

Product Opportunities that provide Tangible Patient Benefits

Our focus will be on developing oral film products leveraging our VersaFilm™ technology that provide tangible patient benefits versus existing drug delivery forms. Patients with difficulties swallowing medication, pediatrics or geriatrics may benefit from oral films due to the ease of use. Similarly, we are working on oral films to improve bio-availability and/or response time versus existing drugs and thereby reducing side effects.

Development of New Drug Delivery Technologies

The rapidly disintegrating film technology contained in our VersaFilm™, and our AdVersa® mucosal adhesive tablet, are two examples of our efforts to develop alternate technology platforms. As we work with various partners on different products, we seek opportunities to develop new proprietary technologies.

Repurposing Existing Drugs

We are working on the repurposing of already approved drugs for new indications using our VersaFilm™ film technology. This program represents a viable growth strategy for us as it will allow for reduced development costs, improved success rates and shorter approval times. We believe that through our repurposing program we will be able minimize the risk of developmental failure and create value for us and potential partners.

Generic Drugs with High Barriers to Entry

We plan to pursue the development of generic drugs that have certain barriers to entry, e.g., where product development and manufacturing is complex and can limit the number of potential entrants into the generic market. We plan to pursue such projects only if the number of potential competitors is deemed relatively insignificant.

Corporate

Manufacturing facility

We currently manufacture products only for clinical and testing purposes in our own facility and we do not yet manufacture products for commercial use. In order to establish ourselves as a full-service partner for our thin film products, we invested approximately $6.5 million to establish a state-of-the-art manufacturing facility for the commercial manufacture of products developed using our VersaFilm™ drug delivery technology. Since we recently received our cGMP-compliant rating from Health Canada for manufacturing and packaging activities, we anticipate the manufacturing of our products to commence on the first half of 2019.

Expansion to the existing Manufacturing Facility

On March 6, 2017 IntelGenx executed an agreement to lease approximately an additional 11,000 square feet in a property located at 6410 Abrams, St-Laurent, Quebec. The Lease has an 8 year and 5-month term commencing on October 1, 2017 and IntelGenx has retained two options to extend the Lease, with each option being for an additional five years. Under the terms of the Lease IntelGenx will be required to pay base rent of approximately CA$74 thousand (approximately $59 thousand) per year, which will increase at a rate of CA$0.25 ($0.20) per square foot every two years. IntelGenx plans to use the newly leased space to expand its manufacture of oral film VersaFilm TM.

24

The Company has initiated a project to expand the existing manufacturing facility, the timing of which will be dictated in part by the completion of agreements with our commercial partners as well as obtaining the necessary funding. This expansion became necessary following requests by commercial partners to increase manufacturing capacity and provide solvent film manufacturing capabilities. The new facility should create a fivefold increase of our production capacity in addition to offering a one-stop shopping opportunity to our partners and provide better protection of our Intellectual Property. The Company has signed agreements in the amount of Euro1,911 thousand with three suppliers with respect to equipment for solvent film manufacturing. As at June 30, 2018 an amount of Euro988 thousand has been paid.

Most recent key developments

On May 8, 2018, IntelGenx announced the closing of an offering by way of private placement. In connection with the Offering, the Company issued 320 units at a subscription price of $10,000 per Unit for gross proceeds of $3,200,000. The Corporation intends to use the proceeds for its Montelukast phase 2a clinical trial and for general working capital purposes. Each Unit is comprised of (i) 7,940 common shares of the Corporation, (ii) a $5,000 convertible 6% note, and (iii) 7,690 warrants to purchase common shares of the Corporation. Each Note bears interest at a rate of 6% (payable quarterly, in arrears, with the first payment being due on September 1, 2018), matures on June 1, 2021 and is convertible into Common Shares at a conversion price of $0.80 per Common Share. Each Warrant entitles its holder to purchase one Common Share at a price of $0.80 per Common Share until June 1, 2021.

Cantone Research, Inc. acted as placement agent in respect of certain sales under the U.S. portion of the Offering and Leede Jones Gable Inc. acted as placement agent in respect of the Canadian portion of the Offering. In connection with the Offering, the Company paid to the Agents a cash commission of approximately $157,800 in the aggregate and issued non-transferable agents’ warrants to the Agents, entitling the Agents to purchase 243,275 common shares at a price of $0.80 per share until June 1, 2021. The Common Shares, Notes and Warrants issued to Canadian residents and the agents’ warrants issued to Leede Jones Gable Inc. are subject to a four-month statutory hold period until September 9, 2018.

A related party of the Company participated in the Offering and subscribed for an aggregate of two Units.

On May 14, 2018, IntelGenx announced that all patent litigation between the Company, Par Pharmaceutical, Inc., Indivior, Inc., Indivior UK Limited, and Aquestive Therapeutics, Inc. (formerly MonoSol Rx, LLC) related to Suboxone® film had been settled. The settlement agreement permits Par to begin selling a generic version of Suboxone® film on January 1, 2023, or earlier under certain circumstances. Par is IntelGenx’s commercial and development partner for a generic version of Suboxone® sublingual film product, which is indicated for the treatment of opioid dependence.

On June 11, 2018, IntelGenx announced that the Company’s board of directors granted options to acquire a total of 800,000 common shares under the 2016 Stock Option Plan. Of the total stock options granted, 200,000 were granted to each of Horst G. Zerbe, Chief Executive Officer and President and Andre Godin, Executive Vice President and Chief Financial Officer. Furthermore, 100,000 stock options were granted to each of two officers of IntelGenx Corp., Nadine Paiement, Vice President Research and Development and Dana Matzen, Vice President of Business and Corporate Development. Also included in the total number of options granted are 200,000 granted to two employees of IntelGenx Corp. The options have an exercise price of $0.76 (CAD$0.99), vest over a period of two years at the rate of 25% every six months and expire on June 10, 2028.

25

On June 19, 2018, IntelGenx announced that the European Patent Office had issued a “Notice of Intention to Grant” for the Company’s European Patent Application Number 14832172.2 entitled, “Instantly Wettable Oral Film Dosage Form Without Surfactant or Polyalcohol." This is the first key patent allowed in Europe for the Company’s VersaFilm™ technology. Once the administrative process is complete, the patent that issues from this application will provide intellectual property protection for the formulation of the Company’s VersaFilm™ technology used in its Rizaport^® product, an oral thin film formulation of rizatriptan benzoate for the treatment of acute migraines, in Europe through 2034. IntelGenx received a similar formulation patent covering its Rizaport^® VersaFilm™ technology from the United States Patent and Trademark Office in 2016 and has additional applications pending in other countries.

On July 3, 2018, IntelGenx issued 307,069 common shares of the Corporation at a deemed price of CAD$0.99 per Common Share in payment of an aggregate of $304,000 in interest owing on the Corporation’s 8.00% convertible unsecured subordinated debentures due June 30, 2020. Under the terms of the trust indenture governing the Debentures, the Corporation has the option to pay the semi-annual interest on the Debentures in either cash or Common Shares, subject to customary conditions set forth in the Indenture.

All amounts are expressed in thousands of U.S. dollars unless otherwise stated.

Currency rate fluctuations

Our operating currency is Canadian dollars, while our reporting currency is U.S. dollars. Accordingly, our results of operations and balance sheet position have been affected by currency rate fluctuations. In summary, our financial statements for the six-month period ended June 30, 2018 report an accumulated other comprehensive loss due to foreign currency translation adjustments of $745 primarily due to the fluctuations in the rates used to prepare our financial statements, $107 of which negatively impacted our comprehensive loss for the six-month period ended June 30, 2018. The following Management Discussion and Analysis takes this into consideration whenever material.

Reconciliation of Comprehensive Loss to Adjusted Earnings before Interest, Taxes, Depreciation and Amortization (Adjusted EBITDA)

Adjusted EBITDA is a non-US GAAP financial measure. A reconciliation of the Adjusted EBITDA is presented in the table below. The Company uses adjusted financial measures to assess its operating performance. Securities regulations require that companies caution readers that earnings and other measures adjusted to a basis other than US-GAAP do not have standardized meanings and are unlikely to be comparable to similar measures used by other companies. Accordingly, they should not be considered in isolation. The Company uses Adjusted EBITDA to measure its performance from one period to the next without the variation caused by certain adjustments that could potentially distort the analysis of trends in our operating performance, and because the Company believes it provides meaningful information on the Company’s financial condition and operating results.

IntelGenx obtains its Adjusted EBITDA measurement by adding to comprehensive loss, finance income and costs, depreciation and amortization, income taxes and foreign currency translation adjustment incurred during the period. IntelGenx also excludes the effects of certain non-monetary transactions recorded, such as share-based compensation, for its Adjusted EBITDA calculation. The Company believes it is useful to exclude these items as they are either non-cash expenses, items that cannot be influenced by management in the short term, or items that do not impact core operating performance. Excluding these items does not imply they are necessarily nonrecurring. Share-based compensation costs are a component of employee and consultant’s remuneration and can vary significantly with changes in the market price of the Company’s shares. Foreign currency translation adjustments are a component of other comprehensive income and can vary significantly with currency fluctuations from one period to another. In addition, other items that do not impact core operating performance of the Company may vary significantly from one period to another. As such, Adjusted EBITDA provides improved continuity with respect to the comparison of the Company’s operating results over a period of time. Our method for calculating Adjusted EBITDA may differ from that used by other corporations.

26

Reconciliation of Non-US-GAAP Financial Information

Adjusted Earnings before Interest, Taxes, Depreciation and Amortization (Adjusted EBITDA)

Adjusted EBITDA decreased by $1,482 for the three-month period ended June 30, 2018 to ($1,872) compared to ($390) for the three-month period ended June 30, 2017. The decrease in Adjusted EBITDA of $1,482 for the three-month period ended June 30, 2018 is mainly attributable to a decrease in revenues of $892, an increase in SG&A expenses of $480 before consideration of stock-based compensation and an increase in R&D expenses of $199 before consideration of stock-based compensation. Adjusted EBITDA decreased by $3,153 for the six-month period ended June 30, 2018 to ($3,660) compared to ($507) for the six-month period ended June 30, 2018. The decrease in Adjusted EBITDA of $3,153 for the six-month period ended June 30, 2018 is mainly attributable to a decrease in revenues of $2,006, an increase in SG&A expenses of $977 before consideration of stock-based compensation and an increase in R&D expenses of $351 before consideration of stock-based compensation.

27

Results of operations for the three-month and six-month periods ended June 30, 2018 compared with the three-month and six-month periods ended June 30, 2017.

Revenue

Total revenues for the three-month period ended June 30, 2018 amounted to $234, representing a decrease of $892 or 79% compared to $1,126 for the three-month period ended June 30, 2017. Total revenues for the six-month period ended June 30, 2018 amounted to $473, representing a decrease of $2,006 or 81% compared to $2,479 for the six-month period ended June 30, 2017. The decrease for the three-month period ended June 30, 2018 compared to the last year’s corresponding period is mainly attributable to a decrease in deferred revenues on monetization of $915. The decrease for the six-month period ended June 30, 2018 compared to the last year’s corresponding period is mainly attributable to a decrease in upfronts of $405, deferred revenues on monetization of $1,829 offset by an increase in R&D revenues of $228.

Cost of royalty and license revenue

We recorded $Nil for the cost of royalty and license revenue in the three-month period ended June 30, 2018 compared with $89 in the same period of 2017. We recorded $Nil for the cost of royalty and license revenue in the six-month period ended June 30, 2018 compared with $181 in the same period of 2017. This expense relates to a Project Transfer Agreement that was executed in May 2010 with one of our former development partners whereby we acquired full rights to, and ownership of, Forfivo XL^®, our novel, high strength formulation of Bupropion hydrochloride, the active ingredient in Wellbutrin XL^®. Pursuant to the Project Transfer Agreement and following commercial launch of Forfivo XL^® in October 2012, we are required, after recovering an aggregate $200 for management fees previously paid, to pay our former development partner 10% of net product sales received from the sale of Forfivo XL^®. We recovered the final portion of the management fees in December 2014, thereby invoking payments to our former development partner. Following the monetization of Forfivo XL^®’s royalties, we are required to record 10% of the deferred revenues from the monetization as cost of royalty and license revenue until December 31, 2017 which represented $Nil for the first half of 2018.

Research and development (“R&D”) expenses

R&D expenses for the three-month period ended June 30, 2018 amounted to $857, representing an increase of $203 or 31%, compared to $654 for the three-month period ended June 30, 2017. R&D expenses for the six-month period ended June 30, 2018 amounted to $1,654, representing an increase of $356 or 27%, compared to $1,298 for the six-month period ended June 30, 2017.

28

The increase in R&D expenses for the three-month period ended June 30, 2018 is mainly attributable to an increase in study costs of $207, an increase in R&D salaries due to hiring of additional employees of $117 as well as an increase in analytical costs of $97, offset by a decrease in lab supplies of $165. The increase in R&D expenses for the six-month period ended June 30, 2018 is mainly attributable to an increase in study costs of $364, an increase in R&D salaries due to hiring of additional employees of $228 as well as an increase in analytical costs of $135, offset by a decrease in lab supplies of $214.

In the three-month period ended June 30, 2018 we recorded estimated Research and Development Tax Credits and refunds of $78, compared with $30 that was recorded in the same period of the previous year. In the six-month period ended June 30, 2018 we recorded estimated Research and Development Tax Credits and refunds of $157, compared with $60 that was recorded in the same period of the previous year.

Selling, general and administrative (“SG&A”) expenses

SG&A expenses for the three-month period ended June 30, 2018 amounted to $1,322, representing an increase of $496 or 60%, compared to $826 for the three-month period ended June 30, 2017. SG&A expenses for the six-month period ended June 30, 2018 amounted to $2,602 representing an increase of $872 or 50%, compared to $1,730 for the six-month period ended June 30, 2017.

The increase in SG&A expenses for the three-month period ended June 30, 2018 is mainly attributable to an increase in salaries and compensation expenses of $338, rent and utilities expenses of $56, manufacturing expense of $73 and general office expenses of $28. The increase in SG&A expenses for the six-month period ended June 30, 2018 is mainly attributable to an increase in salaries and compensation expenses of $325, professional fees of $312, manufacturing expense of $114, rent and utilities expenses of $92 and office and general expenses of $87. The increase in professional fees were mainly related to costs attributable to the aborted capital raise as well as the Laboval acquisition which is currently on hold. These expenses are deemed to be non-recurring in nature.

Depreciation of tangible assets

In the three-month period ended June 30, 2018 we recorded an expense of $179 for the depreciation of tangible assets, compared with an expense of $170 for the same period of the previous year. In the six-month period ended June 30, 2018 we recorded an expense of $362 for the depreciation of tangible assets, compared with an expense of $340 for the same period of the previous year.

Share-based compensation expense, warrants and stock-based payments

Share-based compensation warrants and share-based payments expense for the three-month period ended June 30, 2018 amounted to $73 compared to $53 for the three-month period ended June 30, 2017. Share-based compensation warrants and share-based payments expense for the six-month period ended June 30, 2018 amounted to $123 compared to $223 for the six-month period ended June 30, 2017.

We expensed approximately $68 in the three-month period ended June 30, 2018 for options granted to our employees in 2016, 2017 and 2018 under the 2016 Stock Option Plan, approximately $3 for options granted to non-employee directors in 2016 and 2017, and approximately $2 for options granted to a consultant in 2016, compared with $47, $5, and $1, respectively that was expensed in the same period of the previous year.

29

We expensed approximately $113 in the six-month period ended June 30, 2018 for options granted to our employees in 2016, 2017 and 2018 under the 2016 Stock Option Plan, approximately $6 for options granted to non-employee directors in 2016 and 2017, and approximately $4 for options granted to a consultant in 2016, compared with $96, $124, and $3, respectively that was expensed in the same period of the previous year.

There remains approximately $550 in stock-based compensation to be expensed in fiscal 2018 and 2019, of which $549 relates to the issuance of options to our employees and directors during 2016 to 2018 and $1 relates to the issuance of options to a consultant in 2016. We anticipate the issuance of additional options and warrants in the future, which will continue to result in stock-based compensation expense.

Key items from the balance sheet

Going Concern

The Company has financed its operations to date primarily through public offerings of its common stock, convertible debentures, convertible notes, bank loans, royalty, up-front and milestone payments, license fees, proceeds from exercise of warrants and options, research and development revenues and the sale of U.S. royalty on future sales of Forfivo XL®. The Company has devoted substantially all of its resources to its drug development efforts, conducting clinical trials to further advance the product pipeline, the expansion of its facilities, protecting its intellectual property and general and administrative functions relating to these operations. The future success of the Company is dependent on its ability to develop its product pipeline and ultimately upon its ability to attain profitable operations. As of June 30, 2018, the Company had cash and short-term investments totaling approximately $3,683. The Company does not have sufficient existing cash and short-term investments to support operations for the next year following the issuance of these financial statements. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans to alleviate these conditions include pursuing one or more of the following steps to raise additional funding, none of which can be guaranteed or are entirely within the Company’s control:

30

As of June 30, 2018, there are also 3,120,902 warrants outstanding at an exercise price of $0.5646 which expire on December 15, 2018.

If the Company is unable to raise capital when needed or on attractive terms, or if it is unable to procure partnership arrangements to advance its programs, the Company would be forced to delay, reduce or eliminate its research and development programs.

The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The accompanying financial statements do not include any adjustments or classifications that may result from the possible inability of the Company to continue as a going concern. Should the Company be unable to continue as a going concern, it may be unable to realize the carrying value of its assets and to meet its liabilities as they become due.

Current assets

Current assets totaled $5,209 as at June 30, 2018 compared with $6,044 at December 31, 2017. The decrease of $835 is mainly attributable to decreases in short-term investments of $1,951 and accounts receivable of $138, offset by increases in cash of $730, prepaids of $387 and investment tax credits receivable of $137.

Cash

Cash totaled $2,321 as at June 30, 2018 representing an increase of $730 compared with the balance of $1,591 as at December 31, 2017. The increase in cash on hand relates to net cash used by operating activities of $3,715, offset by net cash provided by financing activities of $3,099 and net cash provided by investing activities of $1,454.

Accounts receivable

Accounts receivable totaled $485 as at June 30, 2018 representing a decrease of $138 compared with the balance of $623 as at December 31, 2017. The main reason for the decrease is related to the collection in 2018 of revenues accounted for as at December 31, 2017.

Prepaid expenses

As at June 30, 2018 prepaid expenses totaled $590 compared with $203 as of December 31, 2017. The increase in prepaid expenses is attributable to a payment of CAD$275 with respect to the Laboval acquisition (from which CAD$200 is refundable if the acquisition does not take place), and an advance payment for R&D materials in the amount of $250.

Investment tax credits receivable

R&D investment tax credits receivable totaled approximately $451 as at June 30, 2018 compared with $314 as at December 31, 2017. The increase is attributable to the accrual estimated and recorded for the first half of 2018.

31

Leasehold improvements and equipment

As at June 30, 2018, the net book value of leasehold improvements and equipment amounted to $6,149, compared to $6,346 at December 31, 2017. In the six-month period ended June 30, 2018 additions to assets totaled $454 and mainly comprised of $444 for manufacturing equipment, $5 for office equipment and $5 for computer equipment.

Security deposit

A security deposit in the amount of CAD$300 in respect of an agreement to lease approximately 17,000 square feet in a property located at 6420 Abrams, St-Laurent, Quebec, Canada was recorded as at June 30, 2018. Security deposits in the amount of CAD$650 for the term loans and CAD$15 for utilities were also recorded as at June 30, 2018.

Accounts payable and accrued liabilities

Accounts payable and accrued liabilities totaled $2,000 as at June 30, 2018 compared with $1,305 as at December 31, 2017. The increase is mainly attributable to the convertible debenture interest accrual in the amount of $231, the accrual for DSUs to independent board of Director members in the amount of $224 and payables related to R&D expenses incurred in the six-month period ended June 30, 2018.

Long-term debt

Long-term debt totaled $2,275 as at June 30, 2018 (December 31, 2017 - $2,764). An amount of $1,845 is attributable to term loan from the lender secured by a first ranking movable hypothec on all present and future movable property of the Company and a 50% guarantee by Export Development Canada, a Canadian Crown corporation export credit agency. The reimbursement of the term loan started in September 2015 and should be fully reimbursed by October 2021.

An amount of $430 is attributable to a second loan secured by a second ranking on all present and future property of the Company reimbursable in monthly principal payments starting January 2017 to December 2021.

Convertible debentures

Convertible debentures totaled $5,094 as at June 30, 2018 as compared to $5,199 as at December 31, 2017. The Corporation issued a total aggregate principal amount of CAD$7,600,000 of debentures at a price of CAD$1,000 per debenture in July 2017 and August 2017. The convertible debentures have been recorded as a liability. Total transactions costs in the amount of CAD$1,237,000 were recorded against the liability. The accretion expense for the six-month period ended June 30, 2018 amounts to CAD$185,000 ($Nil in 2017). The interest on the convertible debentures as at June 30, 2018 amounts to CAD$304,000 ($Nil in 2017) and is recorded in Financing and interest expense and accrued liabilities. In July 2018, the accrued interest was paid in shares.

Convertible notes

Convertible notes totaled $997 as at June 30, 2018 as compared to $Nil as at December 31, 2017. The convertible notes have been recorded as a liability. Total transactions costs in the amount of $111 thousand were recorded against the liability. The accretion expense for the period ended June 30, 2018 amounts to $22. The interest in the convertible notes as at June 30, 2018 amounts to $14 ($Nil in 2017) and is recorded in Financing and interest expense.

32

Shareholders’ equity

As at June 30, 2018 we had accumulated a deficit of $25,453 compared with an accumulated deficit of $20,788 as at December 31, 2017. Total assets amounted to $12,091 and shareholders’ equity totaled $1,675 as at June 30, 2018, compared with total assets and shareholders’ equity of $13,147 and $3,829 respectively, as at December 31, 2017.

Capital stock

As at June 30, 2018 capital stock amounted to $0.705 (December 31, 2017: $0.670) . 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 $27,872 as at June 30, 2018, as compared to $25,253 as at December 31, 2017. Additional paid in capital increased by $2,619 from which $1,460 was the value of the common stock issued in the May 2018 private placement offering, $549 came from proceeds from exercise of warrants and stock options, $437 was the value of the warrants issued in the May 2018 private placement, $123 from stock based compensation attributable to the amortization of stock options granted to employees and directors, and $50 was the value attributed to the Agents’ warrants in the May 2018 private placement transaction.

As of June 30, 2018, there are also 3,120,902 warrants outstanding at an exercise price of $0.5646 which expire on December 15, 2018.

Taxation

As at December 31, 2017, the date of our latest annual tax return, we had Canadian and provincial net operating losses of approximately $9,560 (December 31, 2016: $7,585) and $10,052 (December 31, 2016: $7,763) respectively, which may be applied against earnings of future years. Utilization of the net operating losses is subject to significant limitations imposed by the change in control provisions. Canadian and provincial losses will be expiring between 2027 and 2037. A portion of the net operating losses may expire before they can be utilized.

As at December 31, 2017, we had non-refundable tax credits of $1,553 thousand (2016: $1,190 thousand) of which $8 thousand is expiring in 2026, $10 thousand is expiring in 2027, $180 thousand is expiring in 2028, $158 thousand is expiring in 2029, $134 thousand is expiring in 2030, $143 thousand is expiring in 2031, $179 thousand is expiring in 2032 and $119 thousand is expiring in 2033, $90 thousand expiring in 2034, $106 thousand is expiring in 2035, $146 thousand expiring in 2036 and $280 thousand expiring in 2037. We also had undeducted research and development expenses of $7,532 thousand (2016: $5,438 thousand) with no expiration date.

The deferred tax benefit of these items was not recognized in the accounts as it has been fully provided for.

33

Key items from the statement of cash flows

Statement of cash flows

Net cash used in operating activities was $3,701 for the six-month period ended June 30, 2018, compared to $1,963 for the six-month period ended June 30, 2017. For the six-month period ended June 30, 2018, net cash used by operating activities consisted of a net loss of $4,665 (2017: $1,178) before depreciation, accretion expense, stock-based compensation, DSU expense and interest payable by issuance of common shares in the amount of $1,122 (2017: $563) and a decrease in non-cash operating elements of working capital of $158 (2017: $1,348).

The net cash provided by financing activities was $3,099 for the six-month period ended June 30, 2018, compared to $662 provided in the same period of the previous year. An amount of $3,004 derives from the proceeds of a private placement (2017: $nil) and an amount of $549 derives from proceeds from exercise of warrants and stock options (2017: $1,016) offset by repayment of term loans for an amount of $372 (2017: $354) and the transaction costs related to the private placement of $82 (2017: $nil).

Net cash provided by investing activities amounted to $1,454 for the six-month period ended June 30, 2018 compared to $1,870 in the same period of 2017. The net cash provided by investing activities for the six-month period ended June 30, 2018 relates to the redemption of short term investments of $1,908 (2017: $2,325), offset by the purchase of fixed assets of $454 (2017: $455).

The balance of cash as at June 30, 2018 amounted to $2,321, compared to $1,175 as at June 30, 2017.

Subsequent Event

On July 3, 2018, the Company granted 100,000 options to purchase common stock to a consultant. The stock options are exercisable at $0.78 per share and vest over 2 years at 25% every six months.

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.

34

PART II

This Item is not applicable

This Item is not applicable.

This Item is not applicable.

This Item is not applicable.

35

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.

36