BELGRADE, Mont.--(BUSINESS WIRE)--Lattice Biologics Ltd. (TSX-V: LBL) (OTCBB: LBLTF) (“Lattice Biologics” or the “Company”) is pleased to announce the addition of Chad Green, RRT, to the clinical development team. Mr. Green is a registered respiratory therapist, and President- elect of the Montana chapter of respiratory therapists. Mr. Green is assisting in patient evaluation, telemedicine, treatment, and monitoring of patients as they undergo treatment for the COVID-19 Phase 1 trial.
“As a registered respiratory therapist, I have been treating lung disease and acute respiratory distress syndrome (ARDS) for many years. Stem cells seem to be very well tolerated in treating COVID-19,2,3” said Mr. Green.
On March 17, 2020, the Company announced it had begun enrollment for patients in its Phase 1 clinical trial to address safety and efficacy of its novel stem cell technology, AmnioBoost, for the treatment of severe acute respiratory syndrome (SARS) related to COVID-19 infection.
“A small study4 in China, which ran January 23-31, 2020, using Mesenchymal Stem Cells (MSC) to treat patients with severe COVID-19 pneumonia, showed clinical improvement as well as reduction in inflammatory markers. Inflammatory modulators present in the amniotic fluid stem cell preparation AmnioBoost should augment the noted effect of MSC. It is only logical that AmnioBoost will show promise in treatment of COVID-19 associated lung disease,” said Kenneth R. Conger, MD, Medical Director for Lattice Biologics Ltd.
The Company was not successful in recruiting patients in the Seattle area, and has decided to conduct the trial in Butte, Montana, and larger metropolitan areas as patients become available. The trial will not be conducted in hospitals, but rather in respiratory therapist offices.
Respiratory distress appears in both symptomatic and asymptomatic patients and a recent study1 showed abnormal CT findings in COVID-19 survivors consistent with viral pneumonia in 41 (54%) of 76 asymptomatic and twenty-two (79%) of 28 symptomatic cases.
To date, the Company continues to enroll patients in Montana and is in negotiations with contract research organizations (CROs) to facilitate patient recruitment. Additional studies are expected to take place outside the U.S.; however, there are multiple companies and competitive trials underway for COVID-19, and patient recruitment is expected to be a significant hurdle to timeliness of studies.
IMPORTANT RISK FACTORS ASSOCIATED WITH LATTICE BIOLOGICS
Our business is at an early stage of development and we may not develop therapeutic products that can be commercialized.
We do not have any products in late stage clinical trials. We are still in the early stages of identifying and conducting research on potential therapeutic products. Our potential therapeutic products will require significant research and development and pre-clinical and clinical testing prior to regulatory approval in the United States and other countries.
The Company does not anticipate supply restrictions or scalabity issues to complete Phase 1 trials. Large scale production of AmnioBoost would be limited by donor supply for amniotic fluid.
The Company’s current revenues are primarily derived from the osteobiologics dental market in the U.S. The American Dental Association’s (ADA) guidance to determine dental surgeries as nonessential has significantly adversely impacted Q3 projected revenues The Company has launched additional products in Q2 2020 for the dental market and has significantly increased capacity, with an additional facility expected to be operational by August 2020. The additional facility provides approximately three times current throughput that will be used to satisfy increased demand from long-term contracts in Q4 2020 and beyond.
About Lattice Biologics Ltd.:
IMPORTANT RISK FACTORS ASSOCIATED WITH LATTICE BIOLOGICS
We may not be able to obtain regulatory approvals, enter new and later stage clinical trials for any of our product candidates, or commercialize any products.
Our product candidates may prove to have undesirable and unintended side effects or other characteristics adversely affecting their safety, efficacy, or cost effectiveness that could prevent or limit their use. Any product using any of our technology may fail to provide the intended therapeutic benefits, or achieve therapeutic benefits equal to or better than the standard of treatment at the time of testing or production. We have expended substantial funds to develop our technologies, products, and product candidates. Based on our financial condition, recurring losses and projected spending, which raise substantial doubts about our ability to continue as a going concern, our independent registered public accounting firm included an explanatory paragraph in its report on our consolidated financial statements as of and for the year ended September 30, 2019, regarding this uncertainty. The inclusion of the going concern statement by our auditors may adversely affect our stock price and our ability to raise needed capital or enter into advantageous contractual relationships with third parties.
Lattice Biologics is traded on the TSX-V under the symbol: LBL. The Company is an emerging personalized/precision medicine leader in the field of cellular therapies and tissue engineering, with a focus on bone, skin, and cartilage regeneration.
Lattice Biologics develops and manufactures biologic products to domestic and international markets. The Company’s products are used in a variety of surgical applications.
Lattice Biologics maintains its headquarters, laboratory, and manufacturing facilities in Belgrade, Montana, as well as offices in Phoenix, Arizona. The facility includes ISO Class 1000 and ISO Class 100 clean rooms, and specialized equipment capable of crafting traditional allografts and precision specialty allografts for various clinical applications. The Lattice Biologics team includes highly trained tissue bank specialists, surgical technicians, certified sterile processing and distribution technicians, and CNC operators who maintain the highest standards of aseptic technique throughout each step of the manufacturing process. From donor acceptance to the final packaging and distribution of finished allografts, Lattice is committed to maintaining the highest standards of allograft quality, innovation, and customer satisfaction.
Lattice Biologics maintains all necessary licensures to process and sell its tissue engineered products within the U.S. and internationally. This includes Certificates to Foreign Governments from the U.S. Food and Drug Administration (FDA) and registrations for 29 countries, which allow the export of bone, tendon, meniscus, ligament, soft tissue, and cartilage products outside of the U.S.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Cautionary Statement on Forward-Looking Information:
Certain information contained in this news release constitutes “forward-looking statements” within the meaning of the ‘safe harbour’ provisions of Canadian securities laws. All statements herein, other than statements of historical fact, are to be considered forward looking. Generally, forward-looking information can be identified by the use of forward-looking terminology such as “planned”, “potential”, “future”, “expected”, “could”, “possible”, “goal”, “intends”, “will” or similar expressions. Forward-looking statements in this news release include, without limitation: information pertaining to the Company’s strategy, plans, or future financial performance, such as statements with respect to the Transaction, and other statements that express management’s expectations or estimates of future performance. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of Lattice to be materially different from those expressed or implied by such forward-looking statements.
Forward-looking statements are necessarily based upon a number of factors and assumptions that, while considered reasonable by management as of the date such statements are made, are inherently subject to significant business, economic and competitive uncertainties and contingencies. The factors and assumptions that could prove to be incorrect, include, but are not limited to: that market prices will be consistent with expectations, the continued availability of capital and financing, and that general economic, market and business conditions will be consistent with expectations. The forward-looking statements are not guarantees of future performance. We disclaim any obligation to update or revise any forward-looking statements, except as required by law. Readers are cautioned not to put undue reliance on these forward-looking statements.
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