Aankondiging • Sep 09
ChitogenX Inc. announced that it expects to receive CAD 0.3 million in funding ChitogenX Inc. announced that it has entered into a binding letter of intent for a private placement of secured debentures for a gross proceeds of $300,000 on September 8, 2025. The transaction will include participation from new lender, Oligo Medic. Board Change • Jul 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 9 experienced directors. 2 highly experienced directors. Independent Director Tim Cunningham was the last director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. New Risk • Dec 31
New major risk - Revenue and earnings growth Earnings have declined by 18% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-CA$1.8m free cash flow). Share price has been highly volatile over the past 3 months (24% average weekly change). Negative equity (-CA$5.9m). Earnings have declined by 18% per year over the past 5 years. Shareholders have been substantially diluted in the past year (63% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (CA$5.40m market cap, or US$4.08m). Aankondiging • Nov 10
Chitogenx Inc. Demonstrates ORTHO-R Efficacy and Osteoarthritidevelopment in Large Animal Study ChitogenX Inc. announced that ORTHO-R, its proprietary chitosan/PRP based biopolymer matrix, has successfully demonstrated protection from joint degeneration post meniscal repair surgery in a large animal study. In a study of 22 mature sheep, a radial meniscus tear was surgically induced and immediately surgically repaired. The sheep were randomized to three groups: surgery alone,ii) surgery and PRP, and surgery + ORTHO-R and PRP combined. Results were observed 6 months post-surgery. Results showed that the large majority of menisci from the two control groups (surgery alone or surgery + PRP alone) experienced severe structural changes and most control sheep displayed moderate to severe signs of osteoarthritis ("OA"). The medial menisci from the ORTHO-R treated group retained better structure and much milder form of OA and, in some cases, appeared near normal. This study provides the first evidence that treatment with ChitogenX's proprietary chitosan-based biopolymer + PRP prevents structural changes to radially incised and sutured menisci in a large animal model, and most likely contributed to protecting the joints against OA development. This study contributes to a growing and strong body of evidence that the Company's proprietary chitosan -based biopolymer, combined with PRP can potentially bring significant benefit to human tissue repair. New Risk • Sep 29
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -CA$1.8m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-CA$1.8m free cash flow). Share price has been highly volatile over the past 3 months (24% average weekly change). Negative equity (-CA$5.9m). Shareholders have been substantially diluted in the past year (54% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (CA$10.2m market cap, or US$7.54m). Aankondiging • Sep 27
Chitogenx Concludes Enrolment for Its U.S. Phase I/II Rotator Cuff Tear Repair Clinical Trial ChitogenX Inc. announced that it has concluded enrolment at 20 subjects in its U.S. multi-site rotator cuff tear repair phase I/II clinical trial entitled: A Blinded, Randomized Controlled Study Investigating the Safety of Ortho-R® for Rotator Cuff Repair Compared with Standard of Care: ORT-2020-01 (Ortho-R® Study). All study activities will be completed by June 2024 as per the clinical trial protocol following completion of the clinical follow-up and safety analysis for the 20 recruited subjects. Study results are expected during the summer of 2024. ChitogenX is grateful to the sites and subjects for their contribution to this important clinical trial. Thus far, there have been no safety issues reported with every subject having been treated between 3 and 12 months. The original U.S. Phase I/II clinical trial protocol was for a blinded, randomized controlled study investigating the safety of ORTHO-R® for rotator cuff tear repair compared with standard of care in a total of 78 subjects at ten clinical sites throughout the U.S. The return on the investment required to complete the full recruitment of the trial is difficult to justify based on the little incremental benefit expected statistically. Board Change • Jun 27
Less than half of directors are independent Following the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Director Tim Cunningham was the last independent director to join the board, commencing their role in 2021. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. New Risk • Jun 18
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of Canadian stocks, typically moving 17% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (17% average weekly change). Negative equity (-CA$9.8m). Shareholders have been substantially diluted in the past year (54% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (CA$8.65m market cap, or US$6.56m). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (CA$14m net loss in 3 years). Aankondiging • May 27
ChitogenX Inc., Annual General Meeting, Jul 19, 2023 ChitogenX Inc., Annual General Meeting, Jul 19, 2023. Aankondiging • May 06
ChitogenX Inc. announced that it has received CAD 3.856348 million in funding On May 5, 2023, ChitogenX Inc. closed the transaction. The company has issued 25,708,988 units at a price of CAD 0.15 per unit for total gross proceeds of CAD 3,856,348.20. The transaction included participation from Insiders for CAD 1,800,000. Aankondiging • Feb 15
ChitogenX Inc. Demonstrates Ortho-R Residency Properties in Meniscus Study ChitogenX Inc. announced that it has successfully confirmed soft-tissue residency properties of its chitosan/PRP based biopolymer matrix, ORTHO-R, in a grant-supported large animal meniscus tear repair study. The meniscus tear repair study confirmed the presence of tissue adherence and the aggregation of PRP regenerative cells imbedded in the tear. It represents the second orthopedic ORTHO-R soft tissue proof of concept application to be successfully confirmed following similar results generated in a previously reported similar study for rotator cuff tear repair. Aankondiging • Feb 10
ChitogenX Inc. announced that it expects to receive CAD 6.1 million in funding ChitogenX Inc. announced a best-efforts private placement of 19,333,333 units at an issue price of CAD 0.225 per unit for gross proceeds of up to CAD 4,349,999.925, and non-brokered private placement issue up to 7,777,777 units at an issue price of CAD 0.225 per unit for gross proceeds of up to CAD 1,749,999.825 on February 9, 2023. Each unit will consist of one class A share of the company and one share purchase warrant of the company. Each warrant will entitle the holder to purchase one share of the company at a price of CAD 0.35 per warrant share at any time on or before the date which is 60 months after the closing date of the offering, subject to adjustment in certain events. If, at any time following the date that is 6 months following the closing date, the daily volume weighted average trading price of the shares on the Canadian Securities Exchange is greater than CAD 0.50 per share for the preceding 10 consecutive trading days, the company shall have the right to accelerate the expiry date of the warrants to a date that is at least 30 days following the date of such notice to holders of warrants. The company has granted the agents an option to arrange for the sale of up to an additional 15% of the units at the issue price. The agent’s option may be exercised in whole or in part at any time up to 48 hours prior to the closing date, subject to limitations prescribed by the LIFE exemption. The best-efforts private placement and non-brokered private placement is scheduled to close on or around February 28, 2023, and is subject to certain conditions including, but not limited to, receipt of all necessary approvals including satisfaction of listing conditions of the Canadian Securities Exchange. The closing of the best-efforts private placement is conditional upon the closing of the non-brokered private placement. Aankondiging • Nov 10
Chitogenx Successfully Completes Initial Portion of Its U.S. Phase I/Ii Rotator Cuff Repair Clinical Trial ChitogenX Inc. announced that it has successfully completed the initial portion of its U.S. Phase I/II ORTHO-R rotator cuff tear repair clinical trial requiring staggered enrolment of 5 patients and Data Safety Monitoring Committee review and sequential clearance for each trial participant. The staggered recruitment phase of the trial required a waiting period of up to a week after each case to allow the Data Safety Monitoring Committee to evaluate whether there was any need to change the protocol or retard trial progress due to any unforeseen safety issues. Company reported that no such issues arose and recruitment at all approved U.S. clinical sites can now proceed simultaneously. The U.S. Phase I/II clinical trial is a blinded, randomized controlled study investigating the safety of ORTHO-R® for rotator cuff tear repair compared with standard of care in a total of 78 patients at ten clinical sites throughout the U.S. Initial safety phase. Aankondiging • Oct 14
ChitogenX Inc. Launches Second Orthopedic Development Program in Meniscus Repair ChitogenX Inc. announced the launch of its second orthopedic development program in meniscus repair following the development completion of its preclinical arthroscopic surgery program. Board Change • Jul 31
High number of new directors CEO, President & Director Phil Deschamps was the last director to join the board, commencing their role in 2022. Aankondiging • Jul 28
Ortho Regenerative Technologies Inc. Announces Enrollment of First Patient in Its U.S. Phase I/II Rotator Cuff Tear Repair Clinical Trial Ortho Regenerative Technologies Inc. announced the initiation of patients' enrollment following completion of the first patient surgery in its U.S. Phase I/II rotator cuff tear repair clinical trial. The first patient surgery was successfully completed at the Tucson Orthopaedic Institute in Tucson, Arizona. The ORTHO-R Phase I/II clinical study is a prospective, randomized, controlled, and blinded clinical trial, to evaluate the safety and efficacy of ORTHO-R as an adjunct to standard of care surgery vs. standard of care surgery alone for rotator cuff tear repair. The clinical trial will enroll a total of 78 patients at ten clinical sites throughout the U.S. Aankondiging • Jun 14
Ortho Regenerative Technologies Inc. Initiates Patients Recruitment for its U.S. Phase I/II Rotator Cuff Tear Repair Clinical Trial Ortho Regenerative Technologies Inc. provided report on the progress of its U.S. Phase I/II rotator cuff tear repair clinical trial. The following clinical sites are currently recruiting and screening patients for randomization in the Phase I/II study: Rothman Institute, PA; OrthoIndy Research Foundation, IN; University Orthopedics, PA; Tucson Orthopedics, AZ; Holy Cross Orthopedic Institute, FL; OrthoVirginia Institute, VA, (site activation imminent). Remaining four sites to be activated over the coming months. The Company intended to report regularly on key clinical milestones going forward, such as first patient recruitment, the end of the Phase 1 safety portion of the program after 5 patients treated, and general patient recruitment status at the end of each quarter. The Company also continues to look at additional potential applications to be derived for its proprietary Drug/Biologic PRP combination product to maximize value creation for all its shareholders. Aankondiging • May 05
Ortho Regenerative Technologies Receives Key U.S. Composition and Method Patent for Ortho-R Soft Tissue Repair Platform Ortho Regenerative Technologies Inc. announced that the United States Patent and Trademark Office (the "USPTO") has issued a patent related to the Company's ORTHO-R soft tissue repair platform. Board Change • Apr 27
High number of new directors There are 5 new directors who have joined the board in the last 3 years. CEO, President & Director Phil Deschamps was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Aankondiging • Apr 07
Ortho Regenerative Technologies Inc. announced that it has received CAD 3.2 million in funding On April 6, 2022 Ortho Regenerative Technologies Inc. closed the transaction. The company has issued 16,000,000 units in an over subscribed transaction for gross proceeds of CAD 32,000,000. Aankondiging • Feb 12
Ortho Regenerative Technologies Inc. announced that it expects to receive CAD 3 million in funding Ortho Regenerative Technologies Inc. announced a non-brokered private placement of up to 10,000,000 units at a price of CAD 0.30 per unit for gross proceeds of up to CAD 3,000,000 on February 11, 2022. Each unit consists of one common share and one share purchase warrant exercisable at CAD 0.50 per warrant for a period of 48 months from closing, subject accelerated expiry clause. If the daily volume weighted average price over any 10 consecutive trading days is greater or equal to CAD 1.25 per share, the company may give notice, at any time after the statutory 4-month hold period, to the warrant holder that it must exercise its remaining warrants within a period of 30-days from the date of receipt of the notice. The securities to be issued are subject to a statutory 4-months hold period. Closing of the transaction is expected to occur on or about February 28, 2022 and is subject to certain conditions, including but not limited to, the receipt of all necessary regulatory and stock exchange approvals, including the approval of the Canadian Stock Exchange. The units will be offered and sold by private placement in Canada to "accredited investors" within the meaning of regulation 45-106 respecting prospectus exemptions and other exempt purchasers in each province of Canada, in the United States on a private placement basis only under regulation d, rule 144a or other available United States registration exemptions. The company will pay finders' fee of 7% of the gross proceeds raised from accredited investors introduced to the company by finder, payable in cash; and finder's warrants equal to 7% of the number of units issued to accredited investors introduced to the company by finder, each finder's warrant entitling the holder to purchase one common share at a purchase price of CAD 0.50 for a period of 18 months from the date of issuance of the finder's warrants. Aankondiging • Aug 21
Ortho Regenerative Technologies Announces Extension of FDA Clinical Hold of ORTHO-R Investigational New Drug Application Ortho Regenerative Technologies Inc. announced that the U.S. Food and Drug Administration ("FDA") has extended the clinical hold on the Company's Investigational New Drug ("IND") application to proceed with the initiation of a U.S. Phase I/II clinical trial of ORTHO-R in rotator cuff tear repair.
The FDA has accepted the three most complex requested additional information submitted in response to the initial clinical hold letter received in early June 2021. The FDA has however requested supplemental clarifications on two advanced methods of characterization of impurities. planned Phase I/II clinical trial is a prospective, randomized, controlled and blinded study to evaluate the safety and efficacy of ORTHO-R + standard of care surgery vs standard of care surgery alone in rotator cuff tear repair. The clinical trial will enroll a total of 78 patients at ten clinical sites throughout the U.S., starting during Fall 2021. Aankondiging • Jun 05
Ortho Regenerative Technologies Inc. Receives Clinical Hold Letter from the U.S. Food and Drug Administration Ortho Regenerative Technologies Inc. has received a clinical hold letter from the U.S. Food and Drug Administration ("FDA") related to its Investigational New Drug (IND) application to begin a phase I/II clinical trial for ORTHO-R, its drug/biologic combination product candidate used as an adjunct to standard of care surgery in rotator cuff tear repair. The FDA has requested additional Chemistry, Manufacturing, and Control ("CMC") related information. The Company is confident in its ability to address and provide the FDA with the required information and testing data over the coming four to six weeks. Breakeven Date Change • Jun 02
Forecast to breakeven in 2026 The analyst covering Ortho Regenerative Technologies expects the company to break even for the first time. New forecast suggests the company will make a profit of CA$40.9m in 2026. Average annual earnings growth of 52% is required to achieve expected profit on schedule. Is New 90 Day High Low • Mar 05
New 90-day low: CA$0.54 The company is down 32% from its price of CA$0.79 on 04 December 2020. The Canadian market is up 6.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 10.0% over the same period. Recent Insider Transactions Derivative • Feb 26
President exercised options to buy CA$106k worth of stock. On the 23rd of February, Claude LeDuc exercised options to buy 173k shares at a strike price of around CA$0.30, costing a total of CA$52k. This transaction amounted to 173% of their direct individual holding at the time of the trade. Since September 2020, Claude has owned 100.00k shares directly. Company insiders have collectively bought CA$50k more than they sold, via options and on-market transactions, in the last 12 months. Aankondiging • Feb 25
Ortho Regenerative Technologies Inc. Announces Board Changes Ortho Regenerative Technologies Inc. announced the appointment of Patrick O'Donnell to its Board of Directors, effective immediately. The company also announced the retirement of Prof Michael Buschmann and Prof. Caroline Hoemann from its Board of Directors, effective February 22, 2021. Prof Buschmann and Prof Hoemann have both provided the company with more than five years of scientific leadership as company founders, inventors, Board members and as members of the Scientific Advisory Board ("SAB"). Patrick O'Donnell is the President and Chief Executive Officer of HD LifeSciences, a prominent life sciences executive with over 25 years of experience guiding companies in both the pre-commercial and commercial stages. Mr. O'Donnell brings a comprehensive understanding of the medical device, orthobiologics and biomaterial industries in the orthopedic, spine, neurosurgery, and sports medicine markets. Aankondiging • Jan 06
Ortho Regenerative Technologies Inc. Enters into Global Licensing Agreement with Hanuman Pelican Inc Ortho Regenerative Technologies Inc. announced that it has entered into a global licensing agreement with Hanuman Pelican Inc. (Hanuman) for the use of the Buoy Suspension Fractional System in combination with Ortho-R, Ortho RTI's lead Chitosan-PRP hybrid drug/biologic implant combination product. The Agreement grants Ortho RTI an exclusive global license (excluding Japan) to use, manufacture, sublicense and sell the Buoy Suspension Fractional System in combination with Ortho-R in the following fields: 1) Tendons, 2) Ligaments, 3) Meniscus, 4) Cartilage, and 5) Wound Healing (non-exclusive). Hanuman will also supply its Buoy Suspension Fractional System as the exclusive Platelet Concentration System to be used in Ortho RTI's clinical trial at each clinical site participating in the upcoming US ORTHO-R phase I /II clinical trial for rotator cuff tears repair. Ortho-RTI will pay royalties on net sales of the Buoy Suspension Fractional System portion of the combined Ortho-R package. Aankondiging • Dec 04
Ortho Regenerative Technologies Inc. announced that it has received CAD 3 million in funding from Leede Jones Gable Inc. Ortho Regenerative Technologies Inc. announced announced a non-brokered private placement of 3,000 secured non-convertible debenture units at a price of CAD 1,000 per unit for gross proceeds of CAD 3,000,000 on December 3, 2020. The transaction included participation from insiders and employees for CAD 350,000, existing shareholder Leede Jones Gable Inc, and other investors. Each unit consists of one 3-year, 10% secured non-convertible debenture of the company in the principal amount of CAD 1,000 and 500 class A share purchase warrants. Each warrant will entitle the holder thereof to purchase one class A share at an exercise price of CAD 0.75 at any time up to 36 months following the closing date. The units will be subject to a statutory hold period. The company has paid CAD 127,500 in commissions and issued 170,850 broker warrants in connection with the transaction, in compliance with applicable securities laws. Is New 90 Day High Low • Oct 30
New 90-day high: CA$0.74 The company is up 92% from its price of CA$0.39 on 31 July 2020. The Canadian market is down 26% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 11% over the same period. Aankondiging • Oct 20
Ortho Regenerative Technologies Inc. Announces Appointment of Mukesh Ahuja as Vice-President Clinical and Medical Affairs, Effective November 1, 2020 Ortho Regenerative Technologies Inc. announced the appointment of Mukesh Ahuja, MBBS, MSc as its new Vice-President Clinical and Medical Affairs, effective November 1, 2020. Currently, Dr. Ahuja works at Orthofix Medical Inc. where he was appointed to develop the clinical strategy for the motion preservation program of spine business franchise. He is also responsible to initiate and lead an IDE trial for a two-level cervical disc replacement device. Prior to Orthofix, Dr. Ahuja was the Director of Medical and Clinical Affairs for Medacta USA Inc. At Medacta, he defined and executed a clinical affairs strategy that aligned with the market and commercial needs of company's orthopedic medical devices. He established the clinical department and developed and managed dozens of clinical trials, supporting the needs of the joint reconstruction, spine, and shoulder business units. Aankondiging • Sep 04
Ortho Regenerative Technologies Inc. announced that it has received CAD 0.1376 million in funding On September 2, 2020, Ortho Regenerative Technologies Inc. (CNSX:ORTH) closed the transaction. The company issued 430,000 units for gross proceeds of CAD 137,600. Each unit consists of one class A common share and one share purchase warrant. The transaction does not consist of broker or
agent. Aankondiging • Sep 01
Ortho Regenerative Technologies Inc. announced that it expects to receive CAD 0.2 million in funding Ortho Regenerative Technologies Inc. (CNSX:ORTH) announced a non-brokered private placement of up to 625,000 units at a price of CAD 0.32 per unit for gross proceeds of up to CAD 200,000 on August 31, 2020. Each unit consists of one common share and one share purchase warrant exercisable at CAD 0.50 per warrant for a period of 36 months from closing, subject accelerated expiry clause. If the daily volume weighted average price over any 20 consecutive trading days is greater or equal to CAD 1 per share, the company may give notice, at any time after February 5, 2021, to the warrant holder that it must exercise its remaining warrants within a period of 30-days from the date of receipt of the notice. The securities to be issued are subject to a statutory 4-months hold period. Closing of the transaction is expected to occur on or about September 1, 2020 and is subject to certain conditions, including but not limited to, the receipt of all necessary regulatory and stock exchange approvals, including the approval of the Canadian Stock Exchange. The company will also issue securities in United States pursuant to exemption provided under Regulation D.
The company will pay finders' fee of 7 % of the gross proceeds raised from accredited investors introduced to the company by finder, payable in cash; and finder's warrants equal to 7 % of the gross proceeds raised from accredited investors introduced to the company by finder, each finder's warrant entitling the holder to purchase one common share at a purchase price of CAD 0.50 for a period of 18 months from the date of issuance. Aankondiging • Aug 30
Ortho Regenerative Technologies Inc. announced that it has received CAD 2.47482 million in funding On August 24, 2020, Ortho Regenerative Technologies Inc. (CNSX:ORTH) closed the transaction. The company has issued 7,733,812 units for gross proceeds of CAD 2,474,819.84 in the transaction. The company issued 6,952,562 units for proceeds of CAD 2,224,819.84 in its second and final tranche. The transaction included participation from senior executives, including the Chief Executive Officer, two Directors, family members and 1 senior staff member for CAD 353,160. The company paid CAD 51,366 as finder's fees. Aankondiging • Jul 25
Ortho Regenerative Technologies Inc. announced that it expects to receive CAD 0.64 million in funding Ortho Regenerative Technologies Inc. (CNSX:ORTH) announced a non-brokered private placement of up to 2,000,000 units at a price of CAD 0.32 for gross proceeds of up to 640,000 CAD July 24, 2020.Each unit consisting of one common share and one share purchase warrant. Each warrant is exercisable into one share in the capital of the company at the price of CAD 0.50 per warrant share for a period of 36 months from closing. In the event that the daily volume weighted average price over any 20 consecutive trading days is greater or equal to CAD 1, the company may give notice, at any time after February 5, 2021 to the warrant holder, that it must exercise its remaining warrants within a period of 30-days from the date of receipt of the notice, failing which the warrants will automatically expire. The common shares and the warrants will be subject to a statutory 4-months hold period. The closing is conditional on securing minimum gross proceeds of CAD 1,000,000. Although the transaction is non-brokered, the company will pay finders' fee of 7 % of the gross proceeds raised from accredited investors introduced to the company by finder, payable in cash; and finder's warrants equal to 7 % of the gross proceeds raised from accredited investors Introduced to the company by finder, each finder's warrant entitling the holder to purchase one common share at a purchase price of CAD 0.50 for a period of 18 months from the date of issuance of the finder's warrants. The transaction is expected to occur on or about August 5, 2020 and is subject to certain conditions, including but not limited to, the receipt of all necessary regulatory and Stock Exchange approvals, including the approval of the Canadian Stock Exchange. 