IntelGenx Files Preliminary Short Form Prospectus in Connection With a Proposed Offering of Units
SAINT LAURENT, Quebec, Dec. 19, 2019 (GLOBE NEWSWIRE) -- IntelGenx Technologies Corp. (TSXV: IGX) (OTCQX: IGXT) (the “Company” or “IntelGenx”) is pleased to announce that it has filed a preliminary short form prospectus (the “Prospectus”) with respect to an offering (the “Offering”) of units (“Units”) for a minimum of Cdn$4,000,000 and a maximum of Cdn$10,000,000 aggregate gross proceeds. Each Unit will consist of one share (an “Offered Share”) of the common stock of the Company (“Common Stock”) and one half of one common stock purchase warrant (each whole common stock purchase warrant, a “Warrant”). Each Warrant will entitle the holder to purchase one share of Common Stock (a “Warrant Share”). Concurrently with the filing of the Prospectus, the Corporation has filed a registration statement on Form S-1 (the “Registration Statement”) with the United States Securities and Exchange Commission (the “SEC”) to register the Units and the Warrant Shares.
The Offering is being conducted on a commercially reasonable best efforts basis by Echelon Wealth Partners Inc. (the “Agent”) in the provinces of British Columbia, Alberta, Manitoba and Ontario. Final pricing of the Units (the “Offering Price”), the Warrant exercise price and term, and the determination of the number of Units to be sold pursuant to the Offering will be determined in the context of the market prior to the filing of the final short form prospectus in respect of the Offering.
The Company has granted to the Agent an option to increase the size of the Offering by up to 15%, exercisable in whole or in part at any time for a period of 30 days after and including the closing date of the Offering.
The net proceeds from the Offering will be used for the Company’s Phase 2A Montelukast Study, general working capital requirements, and, depending on the size of the offering, expansion of the Company’s manufacturing facility.
The Company will apply to list the Offered Shares and the Warrant Shares underlying the Units on the TSX Venture Exchange (the “TSXV”). There is no established trading market for the Warrants and IntelGenx does not expect a market to develop. A copy of the Prospectus is available under the Corporation’s profile at www.sedar.com and a copy of the Registration Statement can be obtained from the SEC’s website at www.sec.gov or by request to Echelon Wealth Partners Inc. at This email address is being protected from spambots. You need JavaScript enabled to view it.. The Offering is subject to certain customary conditions including, but not limited to, the receipt of all necessary approvals, including the approval of the TSXV and the SEC declaring the Registration Statement effective.
A registration statement relating to these securities has been filed with the SEC but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. No offer to buy the securities can be accepted and no part of the purchase price can be received until the registration statement has become effective, and any such offer may be withdrawn or revoked, without obligation or commitment of any kind, at any time prior to notice of its acceptance given after the effective date.
About IntelGenx
IntelGenx is a drug delivery company focused on the development and manufacturing of pharmaceutical films.
IntelGenx’s film technologies, including VersaFilm®, VetaFilm™ and transdermal, allow pharmaceutical products that address unmet medical needs. IntelGenx’s product pipeline offer benefits to patients and physicians for many therapeutic conditions.
IntelGenx's team provides pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx's manufacturing facility offers full service by providing lab-scale to pilot- and commercial-scale production.
Forward-Looking Information and Statements
This document may contain forward-looking information or forward-looking statements within the meaning of applicable U.S. and Canadian securities laws. These statements are statements that are not purely historical. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. These statements are statements that are not purely historical and include, but are not limited to, statements about the completion of the Offering, the use of the Offering proceeds, 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. These forward-looking statements include statements regarding the terms of the Offering, the use of proceeds, the listing of the Offered Shares and Warrant Shares on the TSXV, the declaration of the effectiveness of the Registration Statement, and the timing for closing of the Offering. 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 the Registration Statement and 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 and www.sedar.com. The Company does not undertake any obligation to update or revise any Forward-Looking Information, whether as a result of events or circumstances occurring after the date of this press release, unless so required by legislation.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
No securities regulatory authority has either approved or disapproved of the contents of this press release. This press release does not constitute an offer to sell or a solicitation of an offer to buy any securities of the Company in any jurisdiction in which such offer or solicitation of sale would be unlawful.
For more information, please contact:
Stephen Kilmer
Investor Relations
(514) 331-7440 ext 232
This email address is being protected from spambots. You need JavaScript enabled to view it.
OR
Andre Godin, CPA, CA
President and CFO
IntelGenx Technologies Corp.
(514) 331-7440 ext 203
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IntelGenx Enters Animal Health Market by Signing Feasibility Agreement for VetaFilm™ Platform
SAINT LAURENT, Quebec, Jan. 09, 2020 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) (“IntelGenx”) a leader in pharmaceutical films, today announced that it has entered into a Feasibility Study Agreement (the “Agreement”) with an undisclosed partner (the “Partner”) focused on bringing innovative animal health products to the market.
Pursuant to the Agreement, IntelGenx will conduct a feasibility study on an undisclosed molecule for buccal absorption using IntelGenx’s proprietary VetaFilm™ platform. Based on successful feasibility, IntelGenx will have exclusive rights to further develop, manufacture and supply the developed product to the Partner.
“This agreement marks our foray into the animal health space,” said Dr. Horst G. Zerbe, CEO of IntelGenx. “Previous studies have demonstrated that our proprietary VetaFilm™ drug delivery platform offers a unique way of delivering drugs to companion animals, and we believe that this delivery form will become a standard for pets in the future. We are excited to establish this important partnership with a leading animal health industry player that shares our enthusiasm for the prospects of oral thin film delivery in the animal health market.”
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®, VetaFilm™ and transdermal, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offer 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 Statements:
This document may contain forward-looking information about IntelGenx' 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' 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' 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' 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.
Each of the TSX Venture Exchange and OTCQX has neither approved nor disapproved the contents of this press release. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Source: IntelGenx Technologies Corp.
For IntelGenx:
Stephen Kilmer
Investor Relations
(514) 331-7440 ext 232
This email address is being protected from spambots. You need JavaScript enabled to view it.
Or
Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
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IntelGenx Provides Commercial Update on its Two Lead VersaFilm® Product Candidates, Cannabis-Infused Oral Film and RIZAPORT®
SAINT LAURENT, Quebec, Jan. 13, 2020 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) (“IntelGenx”), a leader in pharmaceutical films, today provided a commercial update on its two lead product candidates, cannabis-infused VersaFilm® and RIZAPORT®. IntelGenx is providing this information ahead of its planned participation in investment community meetings to be held in connection with, among other investor events, the 38th Annual J.P. Morgan Healthcare Conference in San Francisco.
Cannabis-Infused VersaFilm® Remains on Track for Commercial Launch in Q1-2020
IntelGenx announced that a cannabis-infused VersaFilm® product has been finalized with its co-development partner, Tilray®, and all manufacturing scale-up work has been successfully completed.
“Because we believe this is an exciting product that will meet, if not exceed, consumer expectations, we think that we're well positioned to become a significant player in this expanding market as new product formats come online,” commented Dr. Horst G. Zerbe, CEO of IntelGenx. “We continue to work with Health Canada in the pursuit of our requisite micro-processing license – the last step before commercial production can commence.”
Specific details of the cannabis-infused VersaFilm® product will be unveiled closer to its commercial launch.
IntelGenx and Orivas Sign Binding Term Sheet for Commercialization of RIZAPORT® in Select European Countries
IntelGenx also announced the signing of a binding term sheet with Orivas for the commercialization of RIZAPORT®, a unique oral thin film for the treatment of acute migraines, pursuant to which Orivas will obtain exclusive rights to market and sell RIZAPORT® in Lithuania, Latvia, Estonia and Poland, with the right of first refusal for a predefined term to include the Republic of Belarus and/or Republic of Ukraine, as well as any of the Scandinavian countries (Finland, Denmark, Sweden and Norway). Financial terms of the agreement were not disclosed.
Established in 2001, Orivas is a private pharmaceutical company based in Lithuania. The company cooperates with drug manufacturers to market innovative prescription and over-the-counter medicines, and medical and oral care products, in the Baltic States.
“We are excited to enter into a binding agreement with Orivas to market RIZAPORT® in these, and potentially additional European territories,” said Dr. Zerbe. “RIZAPORT®, based on IntelGenx’s proprietary VersaFilm® technology, will provide patients suffering from migraines with an innovative solution, and we view this collaboration as an important milestone toward expanding the distribution of this product to new markets.”
IntelGenx Continues to Make Preparations Ahead of RIZAPORT® PDUFA Goal Date of March 26, 2020
Finally, IntelGenx confirmed that it is continuing to make launch preparations with Gensco® Pharma, its U.S. commercialization partner for RIZAPORT® VersaFilm®, ahead of the U.S. Food and Drug Administration’s (“FDA”)-assigned Prescription Drug User Fee Act (“PDUFA”) goal date of March 26, 2020 for completion of its review of the product’s 505(b)(2) New Drug Application (“NDA”).
“Receipt of the FDA’s PDUFA goal date for completion of the its review of the RIZAPORT® NDA marked an important milestone and we are looking forward to continuing to work with the Agency to make this innovative migraine treatment available to patients,” commented Dr. Zerbe.
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®, VetaFilm™ and transdermal, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offer 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 Statements:
This document may contain forward-looking information about IntelGenx' 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' 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' 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' 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.
Each of the TSX Venture Exchange and OTCQX has neither approved nor disapproved the contents of this press release. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Source: IntelGenx Technologies Corp.
For IntelGenx:
Stephen Kilmer
Investor Relations
(514) 331-7440 ext 232
This email address is being protected from spambots. You need JavaScript enabled to view it.
Or
Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
This email address is being protected from spambots. You need JavaScript enabled to view it.
IntelGenx Receives Health Canada Authorization to Proceed with New Amendment for Montelukast VersaFilm® Phase 2a Trial
- Ongoing BUENA Trial to Continue at Increased Daily Dose -
SAINT LAURENT, Quebec, Jan. 15, 2020 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) (“IntelGenx”), a leader in pharmaceutical films, today announced that Health Canada has issued a No Objection Letter in response to IntelGenx’s amended Clinical Trial Application (“CTA”) for the ongoing Montelukast VersaFilm® Phase 2a (“BUENA”) clinical trial in patients with mild to moderate Alzheimer’s Disease (“AD”).
“We are delighted with Health Canada providing the authorization for IntelGenx to proceed with our amended protocol, which enables us to continue the BUENA trial at an increased daily dose,” commented Dr. Horst G. Zerbe, CEO of IntelGenx. “We are looking forward to continuing enrollment at our Canadian sites under this amended protocol, which is based on preclinical data demonstrating Montelukast VersaFilm’s increased efficacy at higher doses. In addition, we continue to evaluate the trial’s expansion to the United States via a potential Investigational New Drug Application filing with the U.S. Food and Drug Administration.”
IntelGenx’s amended CTA was based on additional efficacy testing of Montelukast in an AD mouse model, conducted in collaboration with Prof. Dr. Ludwig Aigner’s group at the Paracelsus Medical University in Salzburg. As reported in the manuscript entitled, Montelukast dose-dependently improves cognitive outcome in the 5xFAD mouse model of Alzheimer’s Disease1, overall results demonstrated that the treatment effect was dose-dependent, with higher doses of Montelukast significantly increasing the mice’s cognition in two behavioural tests. These results are supported by a case report2 confirming that Montelukast, when given at higher doses, significantly improves cognition in patients suffering from memory impairment and dementia.
1 Michael J. Rabl R., Poupardin R. , Tevini J., Felder T., Paiement N., Zerbe H., Hutter-Paier B. , Aigner L.
2 Rozin, S.I., Case Series Using Montelukast in Patients with Memory Loss and Dementia. Open Neurol J, 2017. 11: p. 7-10.
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®, VetaFilm™ and transdermal, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offer 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 Statements:
This document may contain forward-looking information about IntelGenx' 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' 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' 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' 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.
Each of the TSX Venture Exchange and OTCQX has neither approved nor disapproved the contents of this press release. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Source: IntelGenx Technologies Corp.
For IntelGenx:
Stephen Kilmer
Investor Relations
(514) 331-7440 ext 232
This email address is being protected from spambots. You need JavaScript enabled to view it.
Or
Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
This email address is being protected from spambots. You need JavaScript enabled to view it.
IntelGenx Announces Pricing of Equity Offering
SAINT LAURENT, Quebec, Jan. 27, 2020 (GLOBE NEWSWIRE) -- IntelGenx Technologies Corp. (TSXV: IGX) (OTCQX: IGXT) (the “Company” or “IntelGenx”) announced today the pricing of an agency offering (the “Offering”) of up to 20,000,000 units, subject to a minimum offering of 10,000,000 units (the “Units”), for gross proceeds of between $5,000,000 and $10,000,000, assuming no exercise of the over-allotment option granted to the Agent (as defined below), at a price of $0.50 per Unit. Each Unit will consist of one share (each, an “Offered Share”) of common stock of the Company (“Common Stock”) and one warrant (each, a “Warrant”) to purchase one share of Common Stock at an exercise price of $0.75 per share (a “Warrant Share”). The Warrants will be exercisable immediately and will expire on the third anniversary of the date of their issuance.
The Offering is being conducted on a commercially reasonable best efforts basis by Echelon Wealth Partners Inc. (the “Agent”) in the provinces of British Columbia, Alberta, Manitoba and Ontario. Closing of the Offering is expected to occur on or about February 11, 2020.
The Company has granted to the Agent an option to increase the size of the Offering by up to 15%, exercisable in whole or in part at any time for a period of 30 days after and including the closing date of the Offering.
The net proceeds from the Offering will be used for the Company’s Phase 2A Montelukast Study and general working capital requirements.
The Company has applied to list the Offered Shares, the Warrants and the Warrant Shares underlying the Units on the TSX Venture Exchange (the “TSXV”). The approval is subject to fulfillment by the Company of customary closing conditions of the TSXV.
The Company intends to file a final short form prospectus (the “Prospectus”) in the provinces of British Columbia, Alberta, Manitoba, Ontario and Quebec, as well as an amended registration statement on Form S-1 (the “Registration Statement”) with the United States Securities and Exchange Commission (the “SEC”) with respect to the Offering today. The Offering is subject to certain customary conditions including, but not limited to, the receipt of all necessary approvals, including the SEC declaring the Registration Statement effective.
Before investing, you should read the Prospectus and the Registration Statement, as well as other documents the Company has filed or will file late today with the SEC and the Canadian securities regulators for more complete information about the Company and this Offering. A copy of the Prospectus is available under the Corporation’s profile at www.sedar.com and a copy of the Registration Statement can be obtained from the SEC’s website at www.sec.gov or by request to Echelon Wealth Partners Inc. at This email address is being protected from spambots. You need JavaScript enabled to view it..
A registration statement relating to these securities has been filed with the SEC but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. No offer to buy the securities can be accepted and no part of the purchase price can be received until the registration statement has become effective, and any such offer may be withdrawn or revoked, without obligation or commitment of any kind, at any time prior to notice of its acceptance given after the effective date.
About IntelGenx
IntelGenx is a drug delivery company focused on the development and manufacturing of pharmaceutical films.
IntelGenx’s film technologies, including VersaFilm®, VetaFilm™ and transdermal, allow pharmaceutical products that address unmet medical needs. IntelGenx’s product pipeline offer benefits to patients and physicians for many therapeutic conditions.
IntelGenx's team provides pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx's manufacturing facility offers full service by providing lab-scale to pilot- and commercial-scale production.
Forward-Looking Information and Statements
This document may contain forward-looking information or forward-looking statements within the meaning of applicable U.S. and Canadian securities laws. These statements are statements that are not purely historical. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. These statements are statements that are not purely historical and include, but are not limited to, statements about the completion of the Offering, the use of the Offering proceeds, 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. These forward-looking statements include statements regarding the completion of the Offering, the use of proceeds, the listing of the Offered Shares, the Warrants and Warrant Shares on the TSXV, the declaration of the effectiveness of the Registration Statement, and the timing for closing of the Offering. 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 the Registration Statement and 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 and www.sedar.com. The Company does not undertake any obligation to update or revise any Forward-Looking Information, whether as a result of events or circumstances occurring after the date of this press release, unless so required by legislation.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
No securities regulatory authority has either approved or disapproved of the contents of this press release. This press release does not constitute an offer to sell or a solicitation of an offer to buy any securities of the Company in any jurisdiction in which such offer or solicitation of sale would be unlawful.
For more information, please contact:
Stephen Kilmer
Investor Relations
(514) 331-7440 ext 232
This email address is being protected from spambots. You need JavaScript enabled to view it.
OR
Andre Godin, CPA, CA
President and CFO
IntelGenx Technologies Corp.
(514) 331-7440 ext 203
This email address is being protected from spambots. You need JavaScript enabled to view it.
IntelGenx Completes C$8.2 Million Equity Offering
SAINT LAURENT, Quebec, Feb. 11, 2020 (GLOBE NEWSWIRE) -- IntelGenx Technologies Corp. (TSXV: IGX) (OTCQX: IGXT) (the “Company” or “IntelGenx”) is pleased to announce that it has closed its offering (the “Offering”) of 16,317,000 units (the “Units”) at a price of C$0.50 per Unit (the “Offering Price”) for gross proceeds of C$8,158,500.
Each Unit consists of one share of common stock (the “Offered Shares”) and one warrant (a “Warrant”) entitling the holder to purchase one share of common stock of the Company at an exercise price of C$0.75 per share (a “Warrant Share”). The Warrants are exercisable immediately and will expire on the third anniversary of the date of their issuance.
The Units were distributed under a short form prospectus dated January 27, 2020 filed by the Company in connection with the Offering and available on SEDAR at www.sedar.com and have been registered with the United States Securities and Exchange Commission pursuant to a Form S-1 Registration Statement that was declared effective on January 31, 2020 (the “Registration Statement”). The Offering was conducted, on a best efforts basis, by Echelon Wealth Partners Inc. (the “Agent”). In consideration for the services rendered by the Agent, the Company has paid the Agent an agency fee equal to 7% of the gross proceeds of the Offering and has issued the Agent a number of warrants (the “Agent Warrants”) equal to 7% of the number of Units issued under the Offering, each Agent Warrant entitling the holder to purchase one share of common stock of the Company at an exercise price of C$0.75 per share until the third anniversary of the date of their issuance. After the payment of the Agent’s commissions and the reimbursement of certain of the Agent’s Offering expenses and the payment of other Offering expenses, the Company expects the net proceeds from the Offering to be approximately C$7.4 million.
The Company has granted the Agent an over-allotment option exercisable, in whole or in part, at the sole discretion of the Agent, at any time prior to 5:00 p.m. (Montreal time) on the date that is the 30th day after the date hereof, to offer and sell up to an additional number of Units representing 15% of the number of Units sold pursuant to the Offering, at the Offering Price to cover over-allocations, if any, and for market stabilization purposes.
The TSX Venture Exchange (the “TSXV”) has conditionally approved the listing of the Warrants and the common stock that will be issued by the Company in the Offering, including the shares of common stock issuable upon the exercise of the Warrants and the Agent Warrants. Listing on the TSXV will be subject to the Company fulfilling all of the listing requirements of the TSXV within 15 days of the closing of the Offering.
The Warrants will be listed on the TSXV under the symbol “IGX.WT” and will commence trading effective at the opening of the market on Thursday, February 13, 2020.
The Company intends to use the net proceeds from the Offering for its Phase 2A Montelukast Study and general working capital requirements.
About IntelGenx
IntelGenx is a drug delivery company focused on the development and manufacturing of pharmaceutical films.
IntelGenx’s film technologies, including VersaFilm®, VetaFilm™ and transdermal, allow pharmaceutical products that address unmet medical needs. IntelGenx’s product pipeline offer benefits to patients and physicians for many therapeutic conditions.
IntelGenx's team provides pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx's manufacturing facility offers full service by providing lab-scale to pilot- and commercial-scale production.
Forward-Looking Information and Statements
This document may contain forward-looking information or forward-looking statements within the meaning of applicable U.S. and Canadian securities laws. These statements are statements that are not purely historical. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. These statements are statements that are not purely historical and include, but are not limited to, statements about the completion of the Offering, the use of the Offering proceeds, 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. These forward-looking statements include statements regarding the use of proceeds, the listing of the Offered Shares, the Warrants and Warrant Shares on the TSXV, the declaration of the effectiveness of the Registration Statement, and the timing for closing of the Offering. 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 the Registration Statement and 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 and www.sedar.com. The Company does not undertake any obligation to update or revise any Forward-Looking Information, whether as a result of events or circumstances occurring after the date of this press release, unless so required by legislation.
For more information, please contact:
Stephen Kilmer
Investor Relations
(514) 331-7440 ext 232
This email address is being protected from spambots. You need JavaScript enabled to view it.
OR
Andre Godin, CPA, CA
President and CFO
IntelGenx Technologies Corp.
(514) 331-7440 ext 203
This email address is being protected from spambots. You need JavaScript enabled to view it.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
No securities regulatory authority has either approved or disapproved of the contents of this press release. This press release does not constitute an offer to sell or a solicitation of an offer to buy any securities of the Company in any jurisdiction in which such offer or solicitation of sale would be unlawful.
INTELGENX TO REPORT FOURTH QUARTER AND FULL-YEAR 2019 FINANCIAL RESULTS ON MARCH 26; CONFERENCE CALL TO FOLLOW ON MARCH 27
SAINT LAURENT, Quebec, March 23, 2020 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) (“IntelGenx”), a leader in pharmaceutical films, today announced that it will release its fourth quarter and full-year 2019 financial results before market open on Thursday, March 26, 2020.
As previously announced, the U.S. Food and Drug Administration has assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 26, 2020 for completion of its review of IntelGenx’s 505(b)(2) New Drug Application (“NDA”) for RIZAPORT® VersaFilm® for the treatment of acute migraines.
In order to facilitate a discussion on both the financial results and the FDA’s anticipated decision on the RIZAPORT® NDA, a conference call has been scheduled for Friday, March 27. The call will be hosted by Dr. Horst G. Zerbe, Chief Executive Officer, and Mr. Andre Godin, President and Chief Financial Officer. Details of the conference call and webcast are below:
Date: Friday, March 27, 2020
Time: 8:30 a.m. ET
Conference dial-in: (833) 231-8269
International dial-in: (647) 689-4114
Conference ID: 5685777
Live Webcast Registration: Click here
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®, VetaFilm™ and transdermal, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offer 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 Statements:
This document may contain forward-looking information about IntelGenx' 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' 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' 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' 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.
Each of the TSX Venture Exchange and OTCQX has neither approved nor disapproved the contents of this press release. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Source: IntelGenx Technologies Corp.
For IntelGenx:
Stephen Kilmer
Investor Relations
(514) 331-7440 ext 232
This email address is being protected from spambots. You need JavaScript enabled to view it.
Or
Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
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IntelGenx Reports Fourth Quarter and Full-Year 2019 Financial Results
SAINT LAURENT, Quebec, March 26, 2020 (GLOBE NEWSWIRE) -- IntelGenx Technologies Corp. (TSX V:IGX)(OTCQX:IGXT) (the "Company" or "IntelGenx") today reported financial results for the fourth quarter and twelve-month periods ended December 31, 2019. 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.
2019 Fourth Quarter Financial Highlights:
- Revenue was $68,000, compared to $651,000 in the 2018 fourth quarter
- Adjusted EBITDA was ($2.1 million), compared to ($2.0 million) in Q4-2018
2019 Full-Year Financial Highlights:
- Revenue was $742,000, compared to $1.8 million in 2018
- Net comprehensive loss was $10.3 million, compared to net comprehensive loss of $10.6 million in 2018
- Adjusted EBITDA was ($8.5 million), compared to ($7.9 million) in 2018
Recent Highlights:
- Closed an offering of 16,317,000 units (the “Units”) at a price of C$0.50 per Unit for gross proceeds of C$8.2 million.
- Received a No Objection Letter from Health Canada in response to IntelGenx’s amended Clinical Trial Application for the ongoing Montelukast VersaFilm® Phase 2a (“BUENA”) clinical trial in patients with mild to moderate Alzheimer’s Disease.
- Announced that a cannabis-infused VersaFilm® product has been finalized with its co-development partner, Tilray, Inc. (NASDAQ:TLRY) (“Tilray®”) and all manufacturing scale-up work has been successfully completed.
- Signed a binding term sheet with Orivas for the commercialization of RIZAPORT® pursuant to which Orivas will obtain exclusive rights to market and sell RIZAPORT® in Lithuania, Latvia, Estonia and Poland, with the right of first refusal for a predefined term to include the Republic of Belarus and/or the Republic of Ukraine, as well as any of the Scandinavian countries (Finland, Denmark, Sweden and Norway).
"There are several very near-term milestones that represent potential value inflection points for our Company,” said Dr. Horst G. Zerbe, CEO of IntelGenx. “We are anticipating receipt of the U.S. Food and Drug Administration’s decision on our 505(b)(2) New Drug Application for RIZAPORT® VersaFilm® for the treatment of acute migraines later today. On the heels of that, we also expect to receive Health Canada’s requisite micro-processing license in the coming weeks, which will enable us to begin commercial production of cannabis-infused oral films for our partner, Tilray®, with product sales expected to begin as soon as practicable thereafter. In addition, we are planning to resume enrollment for our Phase 2a BUENA trial at our Canadian sites under a Health Canada-approved dose increase and are looking forward to providing initial trial data as they become available.”
Financial Results:
Total revenues for the three-month period ended December 31, 2019 amounted to $68,000, a decrease of $583,000 compared to $651,000 for the three-month period ended December 31, 2018. The change is mainly attributable to a decrease in R&D revenues of $583,000. Operating costs and expenses were $2.4 million for the fourth quarter 2019, versus $2.9 million for the corresponding three-month period of 2018. For Q4-2019, the Company had an operating loss of $2.4 million, compared to operating loss of $2.2 million for the comparable period of 2018.
Total revenues for the twelve-month period ended December 31, 2019 amounted to $742,000, compared to $1.8 million for the twelve-month period ended December 31, 2018. Operating costs and expenses were $10.3 million for the full year 2019, versus $10.8 million for the corresponding 12-month period of 2018. For the twelve-month period of 2019, the Company had an operating loss of $9.6 million, compared to an operating loss of $9.0 million for the comparable period of 2018. Net comprehensive loss was $10.3 million, or $0.11 per basic and diluted share, for the twelve-month period of 2019, compared to net comprehensive loss of $10.6 million, or $0.14 per basic and diluted share, for the comparable period of 2018.
As at December 31, 2019, the Company's cash and short-term investments totalled $1.9 million, which did not include gross proceeds of C$8.2 million raised by the Company in its February 2020 equity offering.
Annual Filings:
The Company's annual report on Form 10-K and financial statements for the year ended December 31, 2019, as well as its 2020 Proxy Statement, will be filed with the United States Securities and Exchange Commission and the Canadian Securities regulatory authorities today, Thursday, March 26, 2020 at 9:00 a.m. ET.
Conference Call Details:
IntelGenx will host a conference call to discuss these 2019 fourth quarter and full year financial results on Friday, March 27, 2020 at 8:30 a.m. ET. The dial-in number for the conference call is (833) 231-8269 (Canada and United States) or (647) 689-4114 (International), conference ID 5685777. The call will be also be webcast live and archived for twelve months at www.intelgenx.com.
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®, VetaFilm™ and transdermal, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offer 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 Statements:
This document may contain forward-looking information about IntelGenx' 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' 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' 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' 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. In addition, there is uncertainty about the spread of the COVID-19 virus and the impact it will have on IntelGenx`s operations, the demand for its products, global supply chains and economic activity in general. IntelGenx assumes no obligation to update any such forward-looking statements.
Each of the TSX Venture Exchange and OTCQX has neither approved nor disapproved the contents of this press release. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Source: IntelGenx Technologies Corp.
For IntelGenx:
Stephen Kilmer
Investor Relations
(514) 331-7440 ext 232
This email address is being protected from spambots. You need JavaScript enabled to view it.
Or
Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
This email address is being protected from spambots. You need JavaScript enabled to view it.
IntelGenx Receives Complete Response Letter from FDA for RIZAPORT® NDA
SAINT LAURENT, Quebec, March 27, 2020 (GLOBE NEWSWIRE) -- IntelGenx Technologies Corp. (TSX V:IGX)(OTCQX:IGXT) (the "Company" or "IntelGenx"), a leader in pharmaceutical films, today announced that it has received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding its resubmitted 505(b)(2) New Drug Application (“NDA”) for RIZAPORT® VersaFilm® for the treatment of acute migraines.
The CRL states that the FDA cannot approve the application in its present form. The Agency requested additional information, but no new bioequivalence study.
“Obviously, we are surprised and disappointed,” said Dr. Horst G. Zerbe, CEO of IntelGenx. “We are committed to addressing the concerns raised by the FDA in the CRL. To that end, we will request a meeting with the Agency as soon as reasonably possible to discuss the scope of the CRL comments to obtain clarification and determine next steps.”
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®, VetaFilm™ and transdermal, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offer 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 Statements:
This document may contain forward-looking information about IntelGenx' 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' 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' 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' 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.
Each of the TSX Venture Exchange and OTCQX has neither approved nor disapproved the contents of this press release. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Source: IntelGenx Technologies Corp.
For IntelGenx:
Stephen Kilmer
Investor Relations
(514) 331-7440 ext 232
This email address is being protected from spambots. You need JavaScript enabled to view it.
Or
Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
This email address is being protected from spambots. You need JavaScript enabled to view it.
IntelGenx Announces Adjusted VersaFilm® Business Strategy, Next Steps for RIZAPORT® VersaFilm® Program
SAINT LAURENT, Quebec, April 06, 2020 (GLOBE NEWSWIRE) -- IntelGenx Technologies Corp. (TSX V:IGX)(OTCQX:IGXT) (the "Company" or "IntelGenx"), a leader in pharmaceutical films, today announced various initiatives aimed at helping the Company address, and satisfactorily respond to, the Complete Response Letter (“CRL”) that it recently received from the U.S. Food and Drug Administration (“FDA”) regarding its resubmitted 505(b)(2) New Drug Application for RIZAPORT® VersaFilm®, as well as maintain IntelGenx’s financial stability in light of the current market environment and the challenges posed by the global COVID-19 pandemic.
“The decision by the FDA to issue a CRL for our RIZAPORT® NDA significantly reduces our internal revenue expectations for 2020. Additionally, the current COVID-19 crisis and its potential effect on the capital markets may make it more difficult to secure additional capital and the long-term financial stability of the Company,” commented Dr. Horst G. Zerbe, CEO of IntelGenx. “In order to address these issues, the Board and Management of the Company have decided to launch an aggressive performance improvement program that focusses on: (1) generating near-term revenue; (2) reducing staff headcount and implementing other measures to preserve the Company’s resources and extend its cash runway; (3) implementing organizational changes to strengthen various parts of IntelGenx’s business, including regulatory affairs and manufacturing operations; (4) comprehensively and satisfactorily responding to the CRL; (5) undertaking steps to accelerate the launch of RIZAPORT® in Spain and, subsequently, in other European countries; and (6), to the extent possible, working to mitigate the impact of the COVID-19 pandemic on the Company’s employees, customers and other stakeholders.”
Key components of the performance improvement program include:
Adjusted VersaFilm® Business Development Strategy
While IntelGenx’s business development strategy will continue to focus on partnering its current product pipeline, which includes 10 pharmaceutical oral film product candidates, and pursuing potential oral thin film manufacturing opportunities, in light of recent unforeseeable developments, the Company will also accelerate its focus to pursue short-term revenue generating opportunities by expanding its pipeline to include additional products for which there is not an FDA or Health Canada (“HC”) approval requirement. These include nutraceutical films, for which IntelGenx is already in active discussions with potential partners. Finally, the Company will continue to work with HC to finalize the review of its micro-processing license application. Once the micro-processing license is received, which IntelGenx currently expects to occur in April 2020, the Company will be able to commence commercial production of cannabis-infused VersaFilm® for its partner, Tilray®, with product sales anticipated to begin as soon as practicable thereafter.
“Rapidly disintegrating pharmaceutical oral film products provide tangible benefits for patients, such as improved efficacy due to better bioavailability, quicker onset of action and reduced side effects,” commented Dana Matzen, IntelGenx’s VP of Business and Corporate Development. “As many as 40% of American adults have experienced difficulty swallowing traditional tablets and capsules, making our VersaFilm® products an ideal solution, especially for pediatric and geriatric patients. Many of these attributes can be just as important in the nutraceutical space, which will now be an increased focus for the next few quarters, as we continue to build our product pipeline.”
Maintaining Financial Stability
As at December 31, 2019, IntelGenx had cash and short-term investments totalling $1.9 million, which the Company believes, together with the gross proceeds of C$8.2 million received from its February 2020 equity offering, are sufficient to fund planned operations into the fourth quarter of 2020. The Company has also taken immediate measures to reduce its burn rate by initially cutting 10% of its employee headcount, as well as decreasing non-essential expenses in all areas of its business. Additional cost reduction measures are being analysed in order to further extend the cash runway and may be implemented in the near future.
“While we deploy the funds received from our recent financing and anticipated near-term commercial activities, we will also work to further improve our overall cost structure, as well as pursue less dilutive funding opportunities to extend our cash runway,” commented Andre Godin, IntelGenx’s President and Chief Financial Officer. “We believe that these immediate measures will not affect our overall ability to execute on our business development strategy.”
Organizational Changes to Support Future Growth
Pursuant to IntelGenx’s revised business strategy, effective immediately, all product development and manufacturing functions, including R&D, regulatory affairs and operations, will be led by Dr. Zerbe, while Mr. Godin will have overall responsibility for all business functions, including finance and business development. In addition, the Company’s Board and management will immediately conduct a comprehensive review of all functions and reporting relationships in order to determine what, if any, management structural and personnel changes or additions are necessary to help ensure the Company’s future success in these new circumstances.
“It is vital that our Company is optimally staffed and structured to support both our current business and the successful execution of key new initiatives,” concluded Dr. Zerbe. “Indeed, we are determined to build a stronger and more nimble organization.”
Planned RIZAPORT® CRL Response
As previously announced, the March 2020 CRL states that the FDA could not approve the application in its present form. The Agency requested additional information, but no new bioequivalence study. IntelGenx plans to request a meeting with the FDA to discuss the CRL comments, with the goal of obtaining needed clarification and determining next steps.
“We believe that we adequately addressed the questions and concerns outlined in the FDA’s April 2019 CRL in our NDA resubmission. This most recent CRL contains questions and concerns that are sufficiently different from those raised in the April 2019 CRL, such that we could not have reasonably anticipated the FDA’s most recent decision,” said Dr. Zerbe. “That said, we remain committed to working closely with the FDA to get the application approved as soon as possible. We will continue to inform our shareholders in a timely manner of any new developments in this important program.”
Planned Launch of RIZAPORT® in Spain
As previously announced, the Company has established a partnership with Exeltis Healthcare for the commercialization of RIZAPORT® in Spain and potentially other European countries. While IntelGenx was initially pursuing a manufacturing site change with the intent to supply the product from its Canadian manufacturing facility, it is now, together with Exeltis Healthcare, in advanced discussions with the originally listed contract manufacturing organization, which the Spanish marketing authorization lists as the approved manufacturer of the product, to leave the commercial production at its site.
“This should result in a much earlier product launch in Spain and, potentially, other countries in Europe,” commented Dr. Zerbe. “Manufacturing for the U.S. and certain other markets, however, will continue to be performed at the Company’s GMP compliant production facility in Montreal.”
Impact of COVID-19
IntelGenx has informed its employees, business partners and key stakeholders about immediate steps it has taken to manage potential health and business risks. These include proactive, precautionary measures, such as working from home when possible, freezing all non-essential travel, and switching to virtual sales and business meetings only, with the goal of keeping everyone safe. To help protect the well-being of its shareholders, Board and Management, the Company is also exploring the possibility of hosting its Annual General Meeting, which is scheduled to take place on Tuesday, May 12, 2020, via a virtual meeting instead of in-person.
With respect to the impact of the COVID-19 pandemic on IntelGenx’s product development programs, the most immediate change will be to subject enrolment in the ongoing Montelukast VersaFilm® Phase 2a (“BUENA”) clinical trial in patients with mild to moderate Alzheimer’s Disease (“AD”). Because the target study population in the BUENA study is considered to be a higher risk group for severe illness from COVID-19, and out of concern for the health and safety of clinical trial staff, IntelGenx has informed HC that the study is on a temporary recruitment hold.
“We are closely monitoring the situation and will resume enrolment under our amended protocol, which enables us to continue the BUENA trial at an increased daily dose, as soon as practicable,” said Dr. Zerbe. “We also continue to evaluate the trial’s expansion to the United States via a potential IND filing with the FDA at the appropriate time.”
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®, VetaFilm™ and transdermal, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offer 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 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, including, without limitation, anticipated commencement of commercial production of cannabis-infused VersaFilm® and how long operations can be funded based on current assets. 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. In addition, there is uncertainty about the spread of the COVID-19 virus and the impact it will have on IntelGenx’s operations, the demand for its products, global supply chains and economic activity in general. IntelGenx assumes no obligation to update any such forward-looking statements.
Each of the TSX Venture Exchange and OTCQX has neither approved nor disapproved the contents of this press release. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Source: IntelGenx Technologies Corp.
For IntelGenx:
Stephen Kilmer
Investor Relations
(514) 331-7440 ext 232
This email address is being protected from spambots. You need JavaScript enabled to view it.
Or
Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
This email address is being protected from spambots. You need JavaScript enabled to view it.