SAINT LAURENT, Quebec, Nov. 11, 2021 (GLOBE NEWSWIRE) — IntelGenx Technologies Corp. (TSX:IGX) (OTCQB:IGXT) (the “Company” or “IntelGenx”) today reported financial results for the third quarter ended September 30, 2021. All dollar amounts are expressed in U.S. currency, unless otherwise indicated, and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise.
2021 Third Quarter Financial Summary:
- Revenue was $593,000, compared to $510,000 in the 2020 third quarter.
- Net comprehensive loss was $2.2 million, compared to $1.6 million in Q3-2020.
- Adjusted EBITDA loss was $1.4 million, compared to $1.2 million in the 2020 third quarter.
Third Quarter and Recent Developments:
- Resumed patient screening in the ongoing ‘BUENA’ Montelukast VersaFilm® Phase 2a clinical trial in patients with mild to moderate Alzheimer’s Disease (“AD”) following Health Canada’s issuance of a No Objection Letter in response to the Company’s amended Clinical Trial Application.
- Graduated to the Toronto Stock Exchange.
- Announced that its co-development and commercialization partner for Tadalafil oral films for the treatment of erectile dysfunction (ED) and benign prostatic hyperplasia (BPH), Aquestive Therapeutics, Inc. (NASDAQ:AQST), entered into a definitive license and supply agreement with an undisclosed leading men’s health company.
- Announced that atai Life Sciences AG (“atai”) committed $6.0 million in future financial support to IntelGenx via amendments to the loan facility between the parties.
- Announced that Exeltis Healthcare S.L., the Company’s commercialization partner in the European Union for RIZAPORT®, a unique treatment for acute migraines, launched the product in Spain.
- Completed an initial shipment of CBD Filmstrips in support of Heritage Cannabis Holdings Corp.’s (CSE:CANN) Canadian market launch of its “CB4 Control” branded product.
- Closed a $2.1 million private placement of 8% convertible notes due July 31, 2025, which the Company intends to use to finance its BUENA trial of Montelukast in AD.
- Increased the size of the Board of Directors from six to eight with the appointments of Srinivas (Srini) G. Rao, M.D., Ph.D. and Frank Stegert.
“The past few months have been a very productive and exciting period for IntelGenx, marked by the achievement of five major milestones,” commented Dr. Horst G. Zerbe, CEO of IntelGenx. “Our graduation to the TSX, Canada’s most senior exchange, came on the heels of our successful transition from a development-stage to a commercial-stage leader in pharmaceutical films as well as our transformational partnership with atai. We were also pleased to resume patient screening in our ongoing ‘BUENA’ Montelukast VersaFilm Phase 2a clinical trial in patients with mild to moderate AD. Having executed on many elements of our growth strategy this quarter, we look forward to continuing to advance our portfolio of innovative film products and product candidates.”
Financial Results:
Total revenues for the three-month period ended September 30, 2021 amounted to $593,000, an increase of $83,000, or 16%, compared to $510,000 for the three-month period ended September 30, 2020. The change is mainly attributable to increases in sales milestone revenues of $320,000, product revenues of $70,000, partially offset by a $308,000 decrease in revenues from licensing agreements.
Operating costs and expenses were $2.2 million for the third quarter of 2021, versus $1.9 million for the corresponding three-month period of 2020. The increase for the three-month period ended September 30, 2021 is mainly attributable to increases of $26,000 in R&D expense, $255,000 in manufacturing expenses, $37,000 in selling, general and administrative expenses, $17,000 in depreciation of tangible assets.
For the third quarter of 2021, the Company had an operating loss of $1.6 million, compared to an operating loss of $1.4 million for the comparable period of 2020.
Net comprehensive loss for the three-month period ended September 30, 2021 was $2.2 million, or $0.01 per basic and diluted share, compared to net comprehensive loss of $1.6 million, or $0.01 per basic and diluted share, for the comparable period of 2020.
As at September 30, 2021, the Company’s cash and short-term investments totalled $12.0 million.
Conference Call Details:
IntelGenx will host a conference call to discuss these third quarter 2021 financial results today at 4:30 p.m. ET. The dial-in number for the conference call is (888) 506-0058 (Canada and the United States) and (973) 528-0135 (International), access code 995615. The call will also be webcast live and archived on the Company’s website at www.intelgenx.com under “Webcasts” in the Investors section.
About IntelGenx
IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films.
IntelGenx’s superior film technologies, including VersaFilm®, DisinteQ™, VetaFilm™ and transdermal VevaDerm™, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offers significant benefits to patients and physicians for many therapeutic conditions.
IntelGenx’s highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx’s state-of-the-art manufacturing facility offers full service by providing lab-scale to pilot- and commercial-scale production. For more information, visit www.intelgenx.com.
Forward-Looking Information and Statements
This document may contain forward-looking information about IntelGenx’s operating results and business prospects that involve substantial risks and uncertainties. Statements that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, but are not limited to, statements about IntelGenx’s plans, objectives, expectations, strategies, intentions or other characterizations of future events or circumstances and are generally identified by the words “may,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “could,” “would,” and similar expressions. All forward looking statements are expressly qualified in their entirety by this cautionary statement. Because these forward-looking statements are subject to a number of risks and uncertainties, IntelGenx’s actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed under the heading “Risk Factors” in IntelGenx’s annual report on Form 10-K, filed with the United States Securities and Exchange Commission and available at www.sec.gov, and also filed with Canadian securities regulatory authorities at www.sedar.com. IntelGenx assumes no obligation to update any such forward-looking statements.
Source: IntelGenx Technologies Corp.
For IntelGenx:
Stephen Kilmer
Investor Relations
(647) 872-4849
stephen@kilmerlucas.com
Or
Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
andre@intelgenx.com
IntelGenx Technologies Corp.
Consolidated Balance Sheet
(Expressed in Thousands of U.S. Dollars ($000’s) Except Share and Per Share Data)
(Unaudited)
|
September 30, 2021 |
December 31, 2020 |
| Assets |
|
|
|
|
|
|
| Current |
|
|
|
|
|
|
| Cash |
$ |
6,019 |
|
$ |
1,205 |
|
| Short-term investments |
|
6,013 |
|
|
1,038 |
|
| Accounts receivable |
|
1,162 |
|
|
260 |
|
| Prepaid expenses |
|
116 |
|
|
162 |
|
| Investment tax credits receivable |
|
407 |
|
|
635 |
|
| Contract asset |
|
– |
|
|
354 |
|
| Security deposits |
|
204 |
|
|
407 |
|
| Inventories |
|
68 |
|
|
244 |
|
| Total current assets |
|
13,989 |
|
|
4,305 |
|
| Leasehold improvements and equipment, net |
|
5,348 |
|
|
5,851 |
|
| Security deposits |
|
252 |
|
|
252 |
|
| Operating lease right-of-use-asset |
|
1,050 |
|
|
710 |
|
| Total assets |
$ |
20,639 |
|
$ |
11,118 |
|
| Liabilities |
|
|
|
|
|
|
| Current |
|
|
|
|
|
|
| Accounts payable and accrued liabilities |
|
2,304 |
|
|
1,989 |
|
| Current portion of long-term debt |
|
– |
|
|
561 |
|
| Current portion of operating lease liability |
|
248 |
|
|
141 |
|
| Current portion of finance lease liability |
|
35 |
|
|
25 |
|
| Deferred revenue |
|
192 |
|
|
166 |
|
| Convertible notes |
|
– |
|
|
1,486 |
|
| Convertible debentures |
|
5,317 |
|
|
– |
|
| Total current liabilities |
|
8,096 |
|
|
4,368 |
|
|
|
|
| Long-term debt |
|
2,500 |
|
|
171 |
|
| Convertible notes |
|
3,965 |
|
|
1,505 |
|
| Convertible debentures |
|
– |
|
|
5,461 |
|
| Operating lease liability |
|
691 |
|
|
482 |
|
| Finance lease liability |
|
92 |
|
|
84 |
|
| Deferred income tax liability |
|
82 |
|
|
– |
|
| Total liabilities |
|
15,426 |
|
|
12,071 |
|
| Contingencies |
|
|
|
|
|
|
| Subsequent event |
|
|
|
|
|
|
| Shareholders’ equity |
|
|
|
|
|
|
| Capital stock, common shares, $0.00001 par value; 450,000,000 shares authorized; 150,627,761 shares issued and outstanding (2020: 111,429,532 common shares) |
|
1 |
|
|
1 |
|
| Additional paid-in capital |
|
61,589 |
|
|
48,453 |
|
| Accumulated deficit |
|
(55,005) |
|
|
(48,551) |
|
| Accumulated other comprehensive loss |
|
(1,372) |
|
|
(856) |
|
| Total shareholders’ equity (deficit) |
|
5,213 |
|
|
(953) |
|
|
$ |
20,639 |
|
$ |
11,118 |
|
|
|
|
|
|
|
|
IntelGenx Technologies Corp.
Consolidated Statement of Comprehensive Loss
(Expressed in Thousands of U.S. Dollars ($000’s) Except Share and Per Share Data)
(Unaudited)
|
For the Three-Month Period
|
For the Nine-Month Period |
|
Ended September 30,
|
Ended September 30, |
|
2021 |
2020 |
2021 |
2020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
| Revenues |
$ |
593 |
|
$ |
510 |
|
$ |
1,041 |
|
$ |
754 |
|
| Total revenues |
|
593 |
|
|
510 |
|
|
1,041 |
|
|
754 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
| Research and development expense |
|
874 |
|
|
848 |
|
|
1,910 |
|
|
2,300 |
|
| Manufacturing expenses |
|
499 |
|
|
244 |
|
|
1,598 |
|
|
1,042 |
|
| Selling, general and administrative expense |
|
662 |
|
|
625 |
|
|
2,419 |
|
|
2,167 |
|
| Depreciation of tangible assets |
|
199 |
|
|
182 |
|
|
589 |
|
|
536 |
|
| Total expenses |
|
2,234 |
|
|
1,899 |
|
|
6,516 |
|
|
6,045 |
|
| Operating loss |
|
(1,641) |
|
|
(1,389) |
|
|
(5,475) |
|
|
(5,291) |
|
| Finance and interest income |
|
1 |
|
|
3 |
|
|
152 |
|
|
405 |
|
| Financing and interest expense |
|
(365) |
|
|
(274) |
|
|
(1,134) |
|
|
(881) |
|
| Net financing and interest income (expense) |
|
(364) |
|
|
(271) |
|
|
(982) |
|
|
(476) |
|
| Loss before income taxes |
|
(2,005) |
|
|
(1,660) |
|
|
(6,457) |
|
|
(5,767) |
|
| Deferred income tax |
|
3 |
|
|
– |
|
|
3 |
|
|
– |
|
| Net loss |
|
(2,002) |
|
|
(1,660) |
|
|
(6,454) |
|
|
(5,767) |
|
| Other comprehensive (loss) income |
|
|
|
|
|
|
|
|
|
|
|
|
| Foreign currency translation adjustment |
|
(175) |
|
|
40 |
|
|
(518) |
|
|
(108) |
|
| Change in fair value |
|
4 |
|
|
51 |
|
|
2 |
|
|
79 |
|
|
|
(171) |
|
|
91 |
|
|
(516) |
|
|
(29) |
|
| Comprehensive loss |
$ |
(2,173) |
|
$ |
(1,569) |
|
$ |
(6,970) |
|
$ |
(5,796) |
|
| Basic and diluted weighted average number of shares outstanding |
|
150,590,729 |
|
|
110,259,652 |
|
|
131,576,774 |
|
|
107,818,057 |
|
| Basic and diluted loss per common share |
$ |
(0.01) |
|
$ |
(0.01) |
|
$ |
(0.05) |
|
$ |
(0.05) |
|
