On March 25, 2021 IntelGenx Technologies Corp. (TSX V:IGX)(OTCQX:IGXT) (the "Company" or "IntelGenx") reported financial results for the fourth quarter and twelve-month periods ended December 31, 2020 (Press release, IntelGenx, MAR 25, 2021, View Source,%242.1%20million%20in%20Q4%2D2019. [SID1234577214]). 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.

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2020 Fourth Quarter Financial Highlights:

Revenue was $790,000, compared to $68,000 in the 2019 fourth quarter.
Net comprehensive loss was $1.3 million, compared to $2.7 million in the 2019 fourth quarter.
Adjusted EBITDA loss was $754,000, compared to $2.1 million in Q4-2019.
2020 Full-Year Financial Highlights:

Revenue was $1.5 million, compared to $742,000 in 2019.
Net comprehensive loss was $7.1 million, compared to $10.3 million in 2019.
Adjusted EBITDA loss was $5.3 million, compared to $8.5 million in 2019.
Recent Developments:

Announced a strategic partnership with atai Life Sciences ("atai"), including a proposed equity investment by atai, positioning IntelGenx as a leader within the novel therapeutics field of psychedelics and providing the requisite financial resources to continue to advance its robust portfolio of other innovative pharmaceutical film product candidates towards commercialization.
The Company’s wholly owned subsidiary, IntelGex Corp., also received a $2.0 million secured loan from atai, of which $628,000 was used to fully repay the Company’s outstanding credit facilities with the Bank of Montreal.
Received a Notice of Allowance for US Patent Application 16/110.737, entitled "Film Dosage Form with Extended Release Mucoadhesive Particle," covering novel disintegrating oral film formulations designed for the transmucosal absorption of drug, especially tetrahydrocannabinol (THC), which protects its DisinteQTM products.
Filed a new provisional patent application at the United States Patent and Trademark Office entitled "High Loading Oral Film Formulation," which covers the incorporation of high concentrations of active ingredients in products based on its VetaFilm proprietary veterinary oral film technology.
Announced the appointment of Mr. Tommy Kenny as Vice President, Intellectual Property and Legal Affairs, General Counsel of IntelGenx Corp., the Company’s operating subsidiary.
Received its first purchase order from Heritage Cannabis Holdings, recently upsized from 50,000 to 75,000 CBD Filmstrips, pursuant to a definitive supply agreement.
"While we were pleased to see the positive impact of our performance improvement program continuing to be reflected in our financial results, it was the transformative partnership that we entered into with atai subsequent to year-end that truly served to validate our long-term growth strategy," commented Dr. Horst G. Zerbe, CEO of IntelGenx. "We are confident that this transaction is the best way forward to maximize value for our shareholders, and encourage them to vote "FOR" all related proposals at our Annual Meeting on May 11, 2021."

Financial Results:

Total revenues for the three-month period ended December 31, 202 amounted to $790,000, an increase of $722,000, or 1,062%, compared to $68,000 for the three-month period ended December 31, 2019. The change is mainly attributable to an increase in revenues from licensing agreements of $671,000 and an increase in R&D revenues of $51,000. Operating costs and expenses were $1.8 million for the fourth quarter of 2020, versus $2.4 million for the corresponding three-month period of 2019. For Q4-2020, the Company had an operating loss of $1.0 million, compared to operating loss of $2.4 million for the comparable period of 2019. Net comprehensive loss was $1.3 million, or $0.01 per basic and diluted share, for the fourth quarter of 2020, compared to net comprehensive loss of $2.7 million, or $0.03 per basic and diluted share, for the comparable period of 2019.

Total revenues for the twelve-month period ended December 31, 2020 amounted to $1.5 million, representing an increase of $802,000, or 108% compared, to $742,000 for the year ended December 31, 2019. Operating costs and expenses were $7.8 million for the full year 2020, versus $10.3 million for the corresponding 12-month period of 2019. For the twelve-month period of 2020, the Company had an operating loss of $973,000, compared to an operating loss of $2.4 million for the comparable period of 2019. Net comprehensive loss was $7.1 million, or $0.07 per basic and diluted share, for the twelve-month period of 2020, compared to net comprehensive loss of $10.3 million, or $0.11 per basic and diluted share, for the comparable period of 2019.

As at December 31, 2020, the Company’s cash and short-term investments totalled $2.2 million, which did not include the $2.0 million secured loan granted to IntelGenx Corp. by atai in March 2021.

Annual Filings:

The Company’s annual report on Form 10-K and financial statements for the year ended December 31, 2012, as well as the 2021 Proxy Statement, will be filed with the United States Securities and Exchange Commission and the Canadian Securities regulatory authorities today, March 25, 2021.

Conference Call Details:

IntelGenx will host a conference call to discuss these 2020 fourth quarter and full year financial results today at 4:30 p.m. ET. The dial-in number for the conference call is (877) 876-9174 (Canada and the United States) and (785) 424-1669 (International). The call will be also be webcast live and archived on the Company’s website at www.intelgenx.com under "Webcasts" in the Investors section.

On March 25, 2021 Alkermes plc (Nasdaq: ALKS) reported that management will participate in a virtual fireside chat at Stifel’s 3rd Annual CNS Day on Thursday, Apr. 1, 2021 at 8:30 a.m. ET (1:30 p.m. BST) (Press release, Alkermes, MAR 25, 2021, View Source [SID1234577213]). The presentation may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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On March 25, 2021 An Upstate Medical University researcher and professor reported that it has received a five-year $2.2 million grant from the National Institutes of Health to study the chaperone code, which plays an important role in cancer and neurodegenerative diseases (Press release, SUNY Upstate, MAR 25, 2021, View Source [SID1234577209]).

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Mehdi Mollapour, PhD, vice chair for translational research for the department of urology, received a highly prestigious Maximizing Investigators’ Research Award (MIRA or R35) award from the National Institute of General Medical Sciences (NIGMS), which is part of NIH. The $2.2 million, five-year MIRA/R35 grant focuses on decrypting the chaperone code. Mollapour, a professor of urology, biochemistry and molecular biology, has studied the chaperone code for nearly 20 years.

The MIRA program supports investigators’ overall research programs through a single, unified grant rather than individual project grants. The goal is to provide investigators with greater stability and flexibility, thereby enhancing scientific productivity and the chances for important breakthroughs.

Mollapour’s work for the past two decades has been aimed at understanding and deciphering the chaperone code. Molecular chaperones are a group of proteins that are involved in looking after other proteins that play an essential role in health and maladies, such as cancer and neurodegenerative diseases. One such chaperone, Hsp90, is a guardian of cancer that can be targeted by small molecule inhibitors. These drugs are currently being evaluated in Phase III clinical trials in cancer patients.

"While the genetic code specifies how DNA makes proteins, the chaperone code controls how proteins are folded to produce a functional proteome," Mollapour said. "Deciphering or cracking the code is important in understanding how chaperones work in normal cells as well as cancer cells. It will also allow us to improve the efficacy of chaperone drugs (Hsp90 drugs) in treating cancer patients."

Mollapour credits the work of everyone in his lab as well as department leadership for help obtaining this grant. "This kind of work is only possible in a department like ours because Gennady Bratslavsky, MD, the chair of Urology, has created a research environment that allows us to conduct high-level research." The Journal of Biological Chemistry recently published an invited review by Mollapour on this subject.

In 2020, Mollapour and his colleague, Dimitra Bourboulia, PhD, an assistant professor of urology, biochemistry and molecular biology at Upstate, and Andrew Truman, assistant professor at the University of North Carolina at Charlotte, organized a first-ever International Symposium on The Chaperone Code. The event was held virtually and more information can be found here: www.chaperonecode.com/past-meetings.

"Because of the COVID-19 pandemic we were forced to hold this meeting virtually, but the good news was that we had more than 300 attendees," he said. "We also have a speaker every month presenting their research via webinar. This is exciting as the chaperone code has attracted so many researchers."

Mollapour is currently planning a 2021 Chaperone Code meeting.

On March 25, 2021 HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a life science company whose mission is to advance precision medicine, reported its financial results for the year ended December 31, 2020 (Press release, HTG Molecular Diagnostics, MAR 25, 2021, View Source [SID1234577207]).

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Recent Business Highlights

In February 2021, released a second technical white paper characterizing HTG’s planned transcriptome panel using the HTG EdgeSeq technology (the "Panel") that is in late-stage development. The white paper addresses the feasibility and performance of a prototype of the Panel for multiple cancer indications, as compared to RNA sequencing ("RNA-Seq") including:

Ability to differentiate samples based on gene expression profiles;
Repeatability amongst replicates from multiple cancer indications with archived samples;
Accuracy of differential expression analysis using a direct comparison to RNA-Seq; and
Potential as a robust alternative to RNA-Seq for gene expression profiling while maintaining the advantages of the HTG EdgeSeq technology.
Launched an Early Access Program for the Panel in December 2020. Since this program was announced, 15 organizations have agreed to participate in this program. The Early Access Program is intended to allow select customers access to the panel in their laboratories or through services to be performed in HTG’s development laboratory prior to commercial launch of the Panel.

"Though it remains clear that COVID-19 placed significant pressure on our core oncology business, including planned studies and laboratory operations of our customers throughout 2020, we remained agile and continued to make strategic shifts in our business into areas less impacted by the pandemic throughout the year, and expect to continue to do so as we begin the next fiscal year," said John Lubniewski, President and CEO of HTG. "We believe strategic adjustments made throughout 2020 to lessen the impact of COVID-19 on our business have been working. Our efforts to focus on customer diversification to include a larger number of smaller and mid-sized biopharma customers and academic medical centers, who have appeared to return to work more quickly than our larger customers, resulted in programs with a number of new customers, including 9 new biopharma customers in 2020. In addition, we worked diligently to adjust spending and commercial efforts to mitigate the impacts of COVID-19 on our organization throughout 2020, and believe our full year operating loss, ending cash and short-term available-for-sale investments balances reflect those efforts. The ultimate impact of COVID-19 remains uncertain, but we continue to see positive trends in non-oncology opportunities and believe direct revenue from our core oncology business will continue to move toward pre-COVID levels as vaccines are rolled out and global economies continue returning to work in 2021."

Mr. Lubniewski continued, "Our product development team was able to perform on our key milestones throughout 2020 despite the challenges placed on our organization by COVID-19. We were very excited to share the details of our recent progress with the Panel in the white paper published in February and look forward to continued progress in the coming months as our development and marketing teams work toward design lock in the second quarter of 2021 and formal design verification and commercialization, currently scheduled for the third quarter of 2021. We look forward to the additional opportunities that this technology will present for HTG in the later part of 2021 and beyond."

Full Year 2020 Financial Highlights:

Total revenue for the year ended December 31, 2020 was $8.5 million, compared with $19.2 million for the year ended December 31, 2019. HTG believes the decrease in revenue is a result of the impact of the COVID-19 pandemic requiring the closure of customer facilities, causing a significant reduction in oncology-related clinical trial activity or limiting the ability of our customers to operate at pre-pandemic levels.

Product and product-related services revenue was $7.9 million for the year ended December 31, 2020, compared with $14.6 million for the year ended December 31, 2019. Throughout the pandemic, HTG’s ability to ship instruments and consumables to customer facilities and the ability of its customers to prepare and ship samples to HTG’s VERI/O laboratory for processing has been limited. In addition to the impacts of the COVID-19 pandemic, this decrease reflects a decline in lower margin subcontracted laboratory services revenue when compared with the year ended December 31, 2019.

Collaborative development services revenue for the year ended December 31, 2020 was $0.7 million compared with $4.6 million for the year ended December 31, 2019, reflecting the completion of remaining tasks under existing arrangements. The Company has ongoing sales efforts to identify and contract new programs in this area.

Net loss from operations for the year ended December 31, 2020 was $19.6 million, compared with $19.0 million for the year ended December 31, 2019. Net loss per share was $(4.51) for the year ended December 31, 2020 compared with $(7.60) for the year ended December 31, 2019.

Cash, cash equivalents and short-term available-for-sale securities totaled $28.7 million as of December 31, 2020, with current liabilities of approximately $7.2 million and non-current liabilities of $13.5 million.

Conference Call and Webcast:

HTG will host a conference call for the investment community today beginning at 4:30 p.m. Eastern Time. Conference call and webcast details are as follows:

On March 25, 2021 Athersys, Inc. (NASDAQ: ATHX) reported its fourth quarter 2020 and annual 2020 financial results and recent highlights (Press release, Athersys, MAR 25, 2021, View Source [SID1234577196]).

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"Despite a difficult operating environment, Athersys has made meaningful progress over the past year," commented Mr. William (B.J.) Lehmann, Interim Chief Executive Officer of Athersys. "We made considerable progress in developing our large-scale manufacturing processes. On the clinical front, we took advantage of the opportunity, with the onset of the COVID-19 pandemic, to accelerate the development of our MultiStem therapy for ARDS with the launch of the MACOVIA study. The MASTERS-2 study moved forward but at a slower pace than expected. Importantly, we entered into a cooperation agreement with our partner, Healios, to put us on a better path to jointly prepare for potential commercialization of the MultiStem therapy in Japan.

"In 2021, we expect to see the top-line results from both the TREASURE and ONE-BRIDGE studies, the TREASURE study giving us the first look at late-stage clinical trial data for MultiStem treatment of ischemic stroke. We are also working to achieve proof-of-principle for our large-scale manufacturing processes, an important milestone on the way to establishing the capability to serve large potential markets such as ischemic stroke," added Mr. Lehmann.

Fourth Quarter, 2020 and Recent Highlights:

Assisted HEALIOS K.K. (Healios), our partner in Japan, in its regulatory preparations as it advanced enrollment to near completion in its TREASURE ischemic stroke and ONE-BRIDGE acute respiratory distress syndrome (ARDS) studies;
Reached a cooperation agreement with Healios to resolve the legal matter between its CEO and Athersys Board member, Dr. Kagimoto, and the Company, and to set the stage for addressing open matters important to continued development, regulatory progress and successful commercialization in Japan following approval;
Received INN designation for "invimestrocel" as the non-proprietary name for the MultiStem cell therapy and made progress in registering our proprietary brand name for the product candidate;
Received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for MultiStem therapy for the treatment of ARDS;
Initiated and conducting the MACOVIA study for the treatment of ARDS in COVID-19 patients, and amended the protocol with the FDA to include other pathogen-induced ARDS patients;
Launched the MATRICS-1 study evaluating MultiStem treatment in severe trauma patients, with the first patient enrolled in the fourth quarter;
Made important leadership hires in key areas, including Mr. Ivor Macleod as Chief Financial Officer and Ms. Maia Hansen as Senior Vice President, Operations and Supply Chain;
Appointed four new directors to our board, adding experience and diversity, to help the Company achieve its growth objectives and success;
Raised gross proceeds of approximately $57.6 million, before deducting the underwriting discount and offering expenses, through an underwritten public offering of 25.6 million shares of common stock, providing additional working capital for key initiatives;
Recognized revenues of $1.3 million and net loss of $22.2 million, or $0.11 net loss per share, for the quarter ended December 31, 2020; and
Had $51.5 million in cash and cash equivalents as of December 31, 2020, $61.5 million in cash and cash equivalents as of March 19, 2021.
"We believe deeply in the quality and distinctiveness of our science and technology and the potential to help patients in important critical care areas. Though there are risks ahead of us, we believe we are well-situated to advance our programs and Company over the course of this year," concluded Mr. Lehmann.

Fourth Quarter 2020 Financial Results

Revenues increased to $1.3 million for the three months ended December 31, 2020 compared to $0.3 million for the three months ended December 31, 2019. Our collaboration revenues are primarily derived from our Healios arrangement. We expect our collaboration revenues to vary over time as we contract with Healios to perform manufacturing services and as we potentially enter into new collaborations.

Research and development expenses increased to $18.7 million for the three months ended December 31, 2020 from $7.6 million for the comparable period in 2019. The $11.1 million increase is primarily associated with clinical trial and manufacturing process development costs, timing of reagent purchases used for our internal process development activities, and personnel costs, including stock compensation expense.

General and administrative expenses increased to $4.3 million for the three months ended December 31, 2020 from $2.4 million in the comparable period in 2019. The $1.9 million increase in the fourth quarter of 2020 over the same period of 2019 was due primarily to increased personnel costs, including stock compensation costs, as well as legal and professional services.

Net loss for the fourth quarter was $22.2 million in 2020 compared to a net loss of $9.9 million in the fourth quarter of 2019. The difference of $12.3 million reflects the above variances, as well as a decrease of $0.3 million in other income items.

Full Year 2020 Financial Results

Revenues decreased to $1.4 million for the year ended December 31, 2020 from $5.6 million in 2019. Our contract revenues from our collaboration with Healios decreased $4.1 million year over year. Our collaboration revenues fluctuate from period-to-period based on new licenses conferred and the delivery of goods and services under our arrangement with Healios.

Research and development expenses increased to $63.0 million for the year ended December 31, 2020 from $39.0 million for the year ended December 31, 2019. The $24.0 million increase in research and development expenses year-over-year was due primarily to increased clinical trial and manufacturing process development costs of $15.0 million, internal research supply costs of $4.2 million, personnel costs of $3.0 million, including stock-based compensation, outside service costs of $0.9 million, and other costs of $0.9 million.

General and administrative expenses increased to $15.9 million in 2020 from $11.4 million in 2019. The $4.5 million increase was due primarily to increases in personnel costs including stock-based compensation, legal and professional services, and other outside services.

Net loss was $78.8 million in 2020 compared to a net loss of $44.6 million in 2019. The difference of $34.2 million reflects the above variances, as well as an increase in other net expenses.

In the twelve months ended December 31, 2020, net cash used in operating activities was $61.8 million compared to $35.3 million in the twelve months ended December 31, 2019. The difference is primarily associated with overall increases in cash usage to fund our clinical development activity in 2020.

At December 31, 2020, we had $51.5 million in cash and cash equivalents, compared to $35.0 million at December 31, 2019.

We encourage shareholders to listen using the webcast link above. If you would like to dial in using the phone to ask a question, please register for the conference call ahead of time using the call registration link above. Once registered, you will receive an email containing the toll-free number, a direct entry passcode and a registrant ID.

A replay of the event will be available on the webcast link at www.athersys.com under the investors’ section approximately two hours after the call has ended. Shareholders may also call in for on-demand listening approximately three hours after the completion of the call until 11:59 PM Eastern Time on April 5, 2021, by dialing (800) 585-8367 or (416) 621-4642 and entering the conference code 8674678.