Gregory Aurand, Senior Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
FQ3 2023 reported for the period ending October 31, 2022. As expected, no revenues were reported by the Company yesterday. Overall, expenses were higher than expectations, with lower than expected G&A and R&D expenses reported. Fair value adjustments in embedded derivatives, higher share based compensation and financing costs accounted for the difference in reported loss per share of $0.04 vs. our expected $0.03 loss per share. Our full fiscal year 2023 loss per share moves to $0.11 from prior $0.10.
ORTHO-R Phase I trial for rotator cuff completed. The initial portion was completed in early November. There were no safety issues reported, opening up Phase II enrollment at all 10 clinical sites. Phase II enrollment is now expected to be completed by end of calendar second quarter 2023, although this is a slight slippage from our earlier expectations. Patient assessment and scoring will occur after 12-month follow-up.
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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Helping the Liver Regenerate Itself Could Give Patients with End-Stage Liver Disease a Treatment Option Besides Waiting for a Transplant
The liver is known for its ability to regenerate. It can completely regrow itself even after two-thirds of its mass has been surgically removed. But damage from medications, alcohol abuse or obesity can eventually cause the liver to fail. Currently, the only effective treatment for end-stage liver disease is transplantation.
However, there is a dearth of organs available for transplantation. Patients may have to wait from 30 days to over five years to receive a liver for transplant in the U.S. Of the over 11,600 patients on the waiting list to receive a liver transplant in 2021, only a little over 9,200 received one.
But what if, instead of liver transplantation, there were a drug that could help the liver regenerate itself?
This article was republished with permission from The Conversation, a news site dedicated to sharing ideas from academic experts. It represents the research-based findings and thoughts of Satdarshan (Paul) Singh Monga, MD, FAASLD, Professor of Pathology and Medicine, University of Pittsburgh Health Sciences.
I am the founding director of the Pittsburgh Liver Research Center and run a lab studying liver regeneration and cancer. In our recently published research, my team and I found that activating a particular protein with a new medication can help accelerate regeneration and repair after severe liver injury or partial surgical removal in mice.
Key Players in Liver Regeneration
The liver performs over 500 key functions in your body, including producing proteins that carry fat through the body, converting excess glucose into glycogen for storage and breaking down toxins like ammonia, among others.
Liver cells, or hepatocytes, take on these many tasks by a divide-and-conquer strategy, also called zonation. This separates the liver into three zones with different tasks, and cells are directed to perform specialized functions by turning on specific genes active in each zone. However, exactly what controls the expression of these genes has been poorly understood.
Over the past two decades, my team and other labs have identified one group of 19 proteins called Wnts that play an important role in controlling liver function and regeneration. While researchers know that Wnt proteins help activate the repair process in damaged liver cells, which ones actually control zonation and regeneration, as well as their exact location in the liver, have been a mystery.
To identify these proteins and where they came from, my team and I used a new technology called molecular cartography to identify how strongly and where 100 liver function genes are active. We found that only two of 19 Wnt genes, Wnt2 and Wnt9b, were functionally present in the liver. We also found that Wnt2 and Wnt9b were located in the endothelial cells lining the blood vessels in zone 3 of the liver, an area that plays a role in a number of metabolic functions.
To our surprise, eliminating these two Wnt genes resulted in all liver cells expressing only genes typically limited to zone 1, significantly limiting the liver’s overall function. This finding suggests that liver cells experience an ongoing push and pull in gene activation that can modify their functions, and Wnt is the master regulator of this process.
Eliminating the two Wnt genes from endothelial cells also completely stopped liver cell division, and thus regeneration, after partial surgical removal of the liver.
Liver Regeneration After Tylenol Overdose
We then decided to test whether a new drug could help recover liver zonation and regeneration. This drug, an antibody called FL6.13, shares similar functions with Wnt proteins, including activating liver regeneration.
Over the course of two days, we gave this drug to mice that were genetically engineered to lack Wnt2 and Wnt9b in their liver endothelial cells. We found that the drug was able to nearly completely recover liver cell division and repair functions.
Lastly, we wanted to test how well this drug worked to repair the liver after Tylenol overdose. Tylenol, or acetaminophen, is an over-the-counter medication commonly used to treat fever and pain. However, an overdose of Tylenol can cause severe liver damage. Without immediate medical attention, it can lead to liver failure and death. Tylenol poisoning is one of the most common causes of severe liver injury requiring liver transplantation in the U.S. Despite this, there is currently only one medication available to treat it, and it is only able to prevent liver damage if taken shortly after overdose.
We tested our new drug on mice with liver damage from toxic doses of Tylenol. We found that one dose was able to decrease liver injury biomarkers – proteins the liver releases when injured – in the blood and reduce liver tissue death. These findings indicate that liver cell repair and tissue regeneration are occurring.
Reducing the Need for Transplantation
One way to address liver transplantation shortages is to improve treatments for liver diseases. While current medications can effectively cure hepatitis C, a viral infection that causes liver inflammation, other liver diseases haven’t seen the same progress. Because very few effective treatments are available for illnesses like nonalcoholic fatty liver disease and alcoholic liver disease, many patients worsen and end up needing a liver transplant.
My team and I believe that improving the liver’s ability to repair itself could help circumvent the need for transplantation. Further study of drugs that promote liver regeneration may help curb the burden of liver disease worldwide.
Gregory Aurand, Senior Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Pre-clinical in meniscus repair officially begins. ChitogenX announced the second orthopedic indication for ORTHO-R is moving from feasibility studies to formal pre-clinical status, beginning November 2022. Meniscus repair is needed due to acute trauma tears and degenerative tears, but surgical failure rates are currently in the 20%-40% range, offering substantial opportunity for ChitogenX’s platform technology to improve healing outcomes.
Meniscus repair program will test 22 sheep. The sheep will be tested with sutures alone (current standard of care) vs. platelet rich plasma (PRP) alone vs. PRP delivered by ORTHO-R biopolymer. Repair surgeries are scheduled beginning mid-November and should be completed by first of December. Results are expected approximately in 12 months in fall of 2023.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Gregory Aurand, Senior Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
FQ2 2023 reported for period ending July 31, 2022. As a clinical stage company, ChitogenX reported no revenues in the quarter. Expenses, both G&A and R&D, were lower than our quarter expectations, offset by higher share-based compensation expense. R&D expenses were reduced by a $500,000 (all figures in C$) grant received in May 2022 to advance the meniscus repair indication. The result was a net loss of $1.363 million vs. expected $1.59 million. Loss per share was $0.03 vs. expected loss of $0.03.
ChitogenX is pushing well beyond orthopedics. The rebranding recently instituted was more than a simple name change. The Company is leveraging its chitosan biopolymer technology expertise to attack a much larger global regenerative medicine market, including areas like oncology, neurology, and cardiology. Regenerative medicines have an inherent inability to stick to repair sites and ChitogenX seeks to resolve the problem with their ChitogenX Biopolymer. We expect the Company to establish partnerships, license the technology, or seek grants in these additional markets.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Gregory Aurand, Senior Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
What’s in a name? The rebranding identifies the Company’s CHITOSAN based regenerative medicine technology while expanding the scope of the technology beyone orthopedics. While the near term pipeline is focused on the repair of orthopedic soft tissue (rotator cuff and meniscus) as initial markets with great need, the Company’s proprietary platform has much broader potential regenerative applications, including in cardiovascular, dermatology, wound healing, oncology and neurology.
Tickers will change. The corporate rebranding was approved at the last Annual General and Special Meeting of Shareholders held July 21, 2022, following the passing of a special resolution authorizing a name change. Effective on or around September 12th, shares will begin trading on the CSE as CHGX. Subject to change, it is expected that the OTCQB ticker will also be updated to CHGX.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
