Ortho Regenerative Technologies Reports its Second Quarter 2021 Results
- Closed non-brokered and oversubscribed Private Placements for total gross proceeds of $2.6 million, including $353,000 from management and Board members
- Preclinical results confirmed safety of Ortho-R and statistical significance over standard of care for rotator cuff repair
- Ortho-R designated as a Drug/Biologics combination product by the FDA Office for Combination Products
- Entered into strategic agreement with Ingenew Pharmaceuticals to expand its proprietary biopolymer platform to include the delivery of therapeutics.
MONTREAL, Sept. 25, 2020 /PRNewswire/ - Ortho Regenerative Technologies Inc. (CSE: ORTH) ("Ortho RTI" or the "Company"), an emerging orthobiologics company, today reported its financial results and highlights for the second quarter of 2021 ended July 31, 2020.
"We are pleased with the significant progress accomplished with our Ortho-R lead program during the quarter. We delivered new and final positive preclinical results confirming overall superior repair in Rotator Cuff Tear ("RCT") and statistically significant superiority to standard of care surgery", said Claude LeDuc, President and CEO of Ortho RTI. "Having now secured a Drug / Biologics combination product designation from the FDA, we can confidently proceed with the filing of our Investigational New Drug regulatory application and finalize preparation activities to start our U.S. Ortho-R RCT clinical trial".
Commenting on the results of the second quarter of 2021, Luc Mainville, Ortho RTI's Senior Vice-President and Chief Financial Officer, said: "We were successful once again in securing the required funds to advance our Ortho-R lead program. With total gross proceeds exceeding $2.6 million from the recent oversubscribed and follow-on private placements, we are now well funded to continue moving ahead with our first Ortho-R human clinical trial preparatory work".
Second Quarter 2021 Ortho-R Program Highlights
- In July 2020, the Company announced new positive results following completion of its pivotal preclinical study report in Rotator Cuff Tear (RCT) repair. The new evidence confirmed improved tendon, tendon insertion site and overall repair in Rotator Cuff Tear ("RCT"). The Ortho-R treated groups showed statistically significant superiority to standard of care surgery control.
Second Quarter 2021 Financial and Other Corporate Highlights
- In June 2020, the Company announced the appointment of Mr. Michael Atkin as its new independent Chairman of the Board. Ortho RTI founder Mr. Steve Saviuk served as Chairman during the 2015-2017 and 2019-2020 periods and continues to serve the Company as a Board Director; and
- In May 2020, the Company entered into a strategic and licensing agreement with Ingenew Pharmaceuticals Inc. to explore the expansion of the scope of Ortho RTI's proprietary technological platform applications to include the delivery of therapeutics.
Second Quarter 2021 Subsequent Events
- In September 2020, the Company completed a $137,600 additional non-brokered private placement of units (the "Additional Private Placement"). The Additional Private Placement was conducted at the same terms and followed the closing of a non-brokered and oversubscribed $2.5 million private placement of units completed on August 21, 2020 bringing the overall gross proceeds raised through the two private placements to $2.6 million;
- In August 2020, the Company announced the closing of a non-brokered $2.5 million private placement of units (the "Private Placement"). The Company issued 7,733,812 units (the 'Units") at a purchase price of $0.32 per Unit for total gross proceeds of $2,474,820. Each Unit consists of one (1) class A share of the Company (a "Share") and one (1) Share purchase warrant of the Company (a "Warrant"). Each Warrant is exercisable into one (1) Share in the capital of the Company (a "Warrant Share") at the price of $0.50 per Warrant Share for a period of 36 months from closing. In the event that the daily VWAP over any twenty (20) consecutive trading days is greater or equal to $1.00, the Company may give notice to the Warrant holder, at any time after February 5 , 2021, that all remaining Warrants must be exercised within a period of 30- days from the date of receipt of the notice, failing which the Warrants will automatically expire. The "VWAP" is the average of the volume weighted average market price of the Company's Common Shares on a single day. The Common Shares and the Warrants issued under the Private Placement are subject to a statutory 4-months hold period under the applicable securities laws and in such case the certificates evidencing the Shares and the Warrants will bear a legend to that effect, as applicable. The Company paid $51,366 in finder's fees in connection with the Private Placement. No broker or agent was involved in the transaction. Senior executives, including the Chief Executive Officer, two Directors, family members and 1 senior staff member participated in the Private Placement for an aggregate amount of $353,160; and
- In August 2020, the Company announced that Ortho-R was designated as a Drug/Biologics combination product, by the FDA Office for Combination Products and that the jurisdictional assignment for Ortho-R would be the Center for Biologics Evaluation and Research (CBER).
Financial Statements and MD&A
Ortho RTI's financial statements and Management's Discussion and Analysis for the three and six months ended July 31, 2020 are available on SEDAR at www.sedar.com.
About Ortho Regenerative Technologies Inc.
Ortho RTI is an emerging orthobiologics company dedicated to the development of novel therapeutic soft tissue repair technologies to dramatically improve the success rate of orthopedic and sports medicine surgeries. Our proprietary RESTORE technology platform is a proprietary muco-adhesive Chitosan-based biopolymer matrix, specifically designed to deliver biologics such as Platelet-Rich Plasma (PRP) or Bone Marrow Aspirate Concentrate (BMAC), to augment and guide the regeneration of new tissue in various musculoskeletal conditions. Ortho-R, our lead Chitosan-PRP hybrid biologic implant product, is formulated and designed to increase the healing rates of occupational and sports related injuries to tendons, meniscus and ligaments. Other formulations are being developed for cartilage repair, bone void filling and osteoarthritis treatment. The Chitosan-PRP combination ORTHO-R implant can be directly applied into the site of injury by a surgeon during a routine operative procedure without significantly extending the time of the surgery and without further intervention. A multi-site US Ortho-R Rotator Cuff Tear Repair Pilot Phase I/II clinical trial is being planned and organized. In parallel, an FDA IND submission is planned for the fall of 2020. Considering the significant potential of our technology platform, Ortho RTI continues to assess new therapeutic target uses outside of the soft tissue repair field. Further information about Ortho RTI is available on the Company's website at www.orthorti.com and on SEDAR at www.sedar.com. Also follow us on LinkedIn and Twitter.
This news release may contain certain forward-looking statements regarding the Company's expectations for future events. Such expectations are based on certain assumptions that are founded on currently available information. If these assumptions prove incorrect, actual results may differ materially from those contemplated by the forward-looking statements contained in this press release. Factors that could cause actual results to differ include, amongst others, uncertainty as to the final result and other risks. The Company disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, other than as required by security laws.
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SOURCE Ortho Regenerative Technologies Inc.
Company Codes: CNSX:ORTH