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AllianThera Biopharma comes out of stealth and collaborates on AI with Insilico Medicine

On March 25, 2021 AllianThera Biopharma (ATB), a Suzhou, China-based startup focusing on inventing and developing innovative medicines for a broad range of diseases, and Insilico Medicine, a global leader in deep learning for drug discovery and development, reported a collaboration to discover and develop molecules for novel targets in cancer and autoimmune diseases (Press release, AllianThera Biopharma, MAR 25, 2021, View Source [SID1234577227]).

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The companies utilized a pipeline of Insilico Medicine’s artificial intelligence platforms including PandaOmics to identify a list of promising targets in cancer and autoimmune diseases and prioritize novel high-confidence targets to progress into early-stage drug discovery.

ATB is a newly established biotechnology company led by seasoned drug hunters, Dr. Yuan-Hua Ding (CEO) and Dr. Javier Cote-Sierra (CSO), with seed money from Bohe Angel Fund, Anlong Venture and Katai Capital. Dr. Ding and Dr. Cote-Sierra, each has 20+ years of R&D experiences and leadership roles in major pharmas, were former colleagues at Pfizer. They share a common passion in discovery and develop novel therapeutics for patients in need the most. In the recent past, Dr. Ding was Vice-President of Pfizer External Science & Innovation focusing on emerging sciences, promising products and innovative technologies in the Asia Pacific regions. In this role, Dr. Ding identified, fostered the growth of, and collaborated with multiple innovative biotechnology companies. Dr. Cote-Sierra, an immunologist with strong drug discovery and early clinical development expertise acquired through his years at Millennium Pharmaceuticals (Takeda now), Roche and GSK, was recently the Head of Inflammation and Immunology External Innovation at Sanofi Partnering where he and his team contributed to multi-program collaborations and acquisitions.

Dr. Ding and Dr. Cote-Sierra together with Prof. Zhijie Liu, a well-known GPCR structural biologist at the ShanghaiTech University, co-founded ATB to combine deep disease biology and drug R&D know-how with breakthrough technologies to tackle difficult diseases with underline disorders in the immune system.

"Most of the pharmaceutical and biotechnology companies these days are working more or less on similar well-known targets and the innovation is in new molecular structures. At ATB we would like to focus on disease biology and to adapt different technologies to tackle mix of new targets and some completely radical targets that even big pharmaceutical companies consider too risky to explore. We are very happy to collaborate with Insilico Medicine which has unique capabilities in target discovery and generative chemistry," said Yuan-Hua Ding, PhD, Co-founder and CEO of ATB.

"Dr. Ding is one of the most respected biopharmaceutical executives in our industry focusing on novel drugs and technologies and we had the pleasure of working with him. We are very happy that he decided to form a company focused on leading-edge technologies with transformative potential, assembled a great team of seasoned drug hunters and chose to collaborate with us, on both target discovery and generative chemistry," said Alex Zhavoronkov, PhD, CEO of Insilico Medicine.

IntelGenx Reports Fourth Quarter and Full-Year 2020 Financial Results

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.

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.

Alkermes to Take Part in Stifel’s 3rd Annual CNS Day

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.

Upstate researcher lands five-year NIH grant for $2.2 million to study chaperone proteins linked to cancer

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]).

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.

HTG Molecular Diagnostics Reports Full Year 2020 Results

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]).

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: