Magnesium Carbonate

HERZLIYA, Israel and CALGARY, AB, Feb. 13, 2024 /PRNewswire/ -- Innocan Pharma Corporation (CSE: INNO) (FSE: IP4) (OTC: INNPF) (the " Company" or " Innocan"), is pleased to provide the following corporate update: Innocan is uniquely positioned within the pharmaceutical technology industry with its dual focus on pharmaceuticals and consumer wellness, leveraging cutting-edge science to enhance patient and consumer well-being. Technological Edge: Innocan's product development is centered around its proprietary CBD-loaded liposome platform technology ("LPT"), a testament to its commitment to innovation. This technology is designed for both human and animal applications, offering a new paradigm in treatment efficacy and safety. Additionally, Innocan's consumer wellness portfolio, featuring topicals and cosmetics, underscores its dedication to health and wellness, catering to the growing consumer demand for effective wellness products. The Opportunity: The global pain management market presents a vast opportunity for Innocan. With over 20% of adults in the US market reporting chronic pain,[1] the need for novel and effective treatments is more pressing than ever. As Innocan enters the market, Innocan's innovative technology and focus on CBD's therapeutic potential positions it well in this sizeable and growing marketplace. Product Overview Innocan's product portfolio includes advanced CBD-based formulations for both injectable and topical applications. The product portfolio includes patent-pending, injectable liposome-delivery platforms for human and veterinary use, and a range of topical products for direct pain relief and wellness product lines. Each product category is at a strategic development and growth stage backed by clinical & efficacy trials. Market Summary The pain management market for human applications continues to grow, targeting US$109 billion by 2032.[2] Similarly, the market for topical pain relief is forecasted to grow significantly, from US$10.68 billion in 2023 to over US$14 billion by 2028.[3] For animal applications, the global veterinary medicine market is expected to reach nearly US$50 billion by 2024, with the pain management segment experiencing robust growth.[4] Regulatory Pathway "The development of our LPT platform is progressing much faster than is usual in the pharmaceutical sector," said Prof. Chezy Barenholz, Innocan's scientific director. Innocan has been able to obtain extensive data derived from several pre-clinical studies previously conducted on various animal models including mice, dogs, and goats. The data obtained from these studies indicated a similar behavior of the drug among the different animals exhibited by long pharmacokinetics over weeks, high bioavailability, good drug tolerance and long-lasting efficacy. Studies conducted in large mammals supported LPT-CBD efficacy by showing long lasting relieving effect in indications such as chronic pain and drug resistance epileptic seizures. Innocan is currently testing the LPT platform on a new animal species and expects to receive results shortly. Following successful pre-clinical trials, Innocan is actively pursuing United States Food and Drug Administration (" FDA") approval for our human pharmaceutical applications. Innocan expects that pre-investigational new drug applications will be submitted to the FDA before the end of March, 2024. Innocan boasts a robust intellectual property portfolio, comprising 12 families of patent applications. These applications include a diverse range of conditions, including pain management, diabetes and vaginal applications. One patent family has already been granted in the United States related to the Company's combined cannabis and magnesium topical pain-relief technology. Preliminary Q4 and Fiscal Year 2023 Financial Highlights (unaudited) Innocan's preliminary revenues for Q4 2023 are expected to be at least US$4.89M, representing an approximate increase of 20% from Q3 2023 and an increase of at least 331% compared to Q4 2022. For the 2023 fiscal year, Innocan's preliminary revenues are expected to be at least US$13.6 million, representing an approximate increase of 433% over fiscal year 2022. This surge in revenue is primarily attributable to the robust sales performance of Innocan's subsidiary, B.I. Sky Global Ltd. These preliminary revenue figures exceed expenses in the respective periods. The above information should be read in conjunction with Innocan's audited consolidated financial statements as of December 31, 2023 (the " Audited Financial Statements"), and the accompanying management's discussion and analysis for the year ended December 31, 2023, which will be filed on the Innocan's SEDAR+ profile at . Corporate Update Link About Innocan Innocan is a pharmaceutical tech company that operates under two main segments: Pharmaceuticals and Consumer Wellness. In the Pharmaceuticals segment, Innocan focuses on developing innovative drug delivery platform technologies comprises with cannabinoids science, to treat various conditions to improve patients' quality of life. This segment involves two drug delivery technologies: (i) LPT CBD-loaded liposome platform facilitating exact dosing and the prolonged and controlled release of CBD into the blood stream. The LPT delivery platform research is in the preclinical trial phase for two indications: Epilepsy and Pain Management. In the Consumer Wellness segment, Innocan develops and markets a wide portfolio of innovative and high-performance self-care products to promote a healthier lifestyle. Under this segment Innocan has established a Joint Venture by the name of BI Sky Global Ltd. that focuses developing on advanced targeted online sales. For further information, please contact: For Innocan Pharma Corporation: Iris Bincovich, CEO +1 5162104025 +972-54-3012842 +442037699377 [email protected] NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE. Disclaimer Regarding Financial Information The financial information presented in this press release is based on preliminary, unaudited financial statements prepared by management, for the fourth quarter and fiscal year ended December 31, 2023. Accordingly, such financial information may be subject to change. While the Company does not expect there to be any material changes to the financial information presented in this press release, to the extent that it is inconsistent with the information contained in the Audited Financial Statements, the financial information contained in this news release shall be deemed to be modified or superseded by such Audited Financial Statements. The making of a modifying or superseding statement shall not be deemed an admission for any purposes that the modified or superseded statement, when made, constituted a misrepresentation for purposes of applicable securities laws. Caution regarding forward-looking information Certain information set forth in this news release, including, without limitation, the Company's positioning in the global pain management market, expectations regarding the size of the human and veterinary pain management markets, growth potential for the Company's products as they are introduced to the market, plans for strategic expansion in the human pharmaceuticals, veterinary and topical market segments, statements relating to the Company's financial results for Q4 2023 and the 2023 fiscal year, expectations regarding the timing for submission of the Company's pre-investigational new drug applications to the FDA, and expectations regarding the Company's pending patent applications, is forward-looking information within the meaning of applicable securities laws. By its nature, forward-looking information is subject to numerous risks and uncertainties, some of which are beyond Innocan's control. The forward-looking information contained in this news release is based on certain key expectations and assumptions made by Innocan, including expectations and assumptions concerning the anticipated benefits of the products, satisfaction of regulatory requirements in various jurisdictions and satisfactory completion of requisite production and distribution arrangements. Forward-looking information is subject to various risks and uncertainties which could cause actual results and experience to differ materially from the anticipated results or expectations expressed in this news release. The key risks and uncertainties include but are not limited to: general global and local (national) economic, political, market and business conditions; governmental and regulatory requirements and actions by governmental authorities; and potential disruption of relationships with suppliers, manufacturers, customers, business partners and competitors. There are also risks that are inherent in the nature of product distribution, including import / export matters and the failure to obtain any required regulatory and other approvals (or to do so in a timely manner) and availability in each market of product inputs and finished products. The anticipated timeline for entry to markets may change for a number of reasons, including the inability to secure necessary regulatory requirements, or the need for additional time to conclude and/or satisfy the manufacturing and distribution arrangements. As a result of the foregoing, readers should not place undue reliance on the forward-looking information contained in this news release concerning the timing of launch of product distribution. A comprehensive discussion of other risks that impact Innocan can also be found in Innocan's public reports and filings which are available under Innocan's profile at . Readers are cautioned that undue reliance should not be placed on forward-looking information as actual results may vary materially from the forward-looking information. Innocan does not undertake to update, correct or revise any forward-looking information as a result of any new information, future events or otherwise, except as may be required by applicable law. [1] One in Five U.S. Adults Have Chronic Pain — Pain News Network, Study finds high rates of persistent chronic pain among US adults (medicalxpress.com); Pain Management Therapeutics Market Size Report 2022 to 2030 (precedenceresearch.com) [2] Pain Management Drugs Market Share, Trends & Forecast, 2032 (gminsights.com) [3]Study finds high rates of persistent chronic pain among US adults (medicalxpress.com), [4] Veterinary Medicine Market - Trends, Growth & Size (mordorintelligence.com) Logo: SOURCE Innocan Pharma Corporation

At target dose (~30 mg/kg), SRP-5051 dosed monthly resulted in mean dystrophin expression of 5.17% and mean exon skipping of 11.11% at 28 weeks (n=20) The data support a positive benefit-risk pro SRP-5051 Sarepta will host a conference call at 8:30 a.m. Eastern time on Jan. 29, 2024 CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced positive data from Part B of the MOMENTUM study (Study SRP-5051-201), a global, Phase 2, multi-ascending dose clinical trial of SRP-5051 (vesleteplirsen) that enrolled patients aged 8 to 21 years. SRP-5051 is a next-generation peptide phosphorodiamidate morpholino oligomer (PPMO) treatment for patients with Duchenne muscular dystrophy who are amenable to exon 51 skipping. Data from Part B of MOMENTUM found that at the higher, target dose, approximately 30 mg/kg dosed every four weeks, SRP-5051 resulted in mean dystrophin expression of 5.17%, and mean exon skipping of 11.11% at 28 weeks (n=20). Consistent dystrophin expression was seen in ambulatory (4.76%, n=11) and non-ambulatory (5.67%, n=9) participants at 28 weeks. Hypomagnesemia has previously been identified in patients taking SRP-5051 and was managed and monitored through prophylactic magnesium supplementation as part of the study protocol. “SRP-5051 dosed every four weeks is showing substantially higher increases in dystrophin and exon skipping compared to eteplirsen dosed weekly,” said Louise Rodino-Klapac, Ph.D., executive vice president, chief scientific officer and head of research and development, Sarepta Therapeutics. “The data suggest a favorable benefit-risk pro SRP-5051 and we look forward to discussing the results and next steps with FDA. As the leader in Duchenne, Sarepta is committed to advancing meaningful treatments for those with Duchenne and other rare diseases where there is unmet need.” High dose results at 28 weeks (~30 mg/kg, dosed every four weeks, n=20): 5.17% mean dystrophin expression as measured by western blot 4.53% mean change from baseline, P < 0.0001 Mean exon skipping of 11.11%, as measured by digital drop polymerase chain reaction (ddPCR), and a mean change from baseline in exon skipping of 10.07% The changes from baseline represent a 12.2-fold increase in dystrophin expression and a 24.6-fold increase in exon skipping compared to a weekly 30 mg/kg dose of eteplirsen at 24 weeks (mean dystrophin expression of 0.82%, mean exon skipping of 0.59%, n=16). Low dose results at 28 weeks (~20 mg/kg, dosed every four weeks, n=20): 2.81% mean dystrophin expression as measured by western blot 1.60% mean change from baseline, P= 0.0012 Mean exon skipping of 2.47%, as measured by ddPCR, and a mean change from baseline in exon skipping of 2.00% The changes from baseline represent a 4.3-fold increase in dystrophin expression and a 4.9-fold increase in exon skipping compared to a weekly 30 mg/kg dose of eteplirsen at 24 weeks. “The dystrophin production delivered by SRP-5051 in the MOMENTUM study is very encouraging. Importantly, with effective supplementation and monitoring, we have not seen additional complications from the hypomagnesemia,” said Eugenio Mercuri, M.D., Ph.D., head of the Neuromuscular Unit, Catholic University, Rome, Italy, and an investigator in the study. “The results with SRP-5051 to date suggest it could play an important role in the treatment of Duchenne patients with a confirmed exon 51-amenable mutation.” There were seven serious, treatment-emergent adverse events in MOMENTUM Part B, four serious events of hypomagnesemia and three serious cases of hypokalemia. Hypomagnesemia has been seen in earlier clinical studies of SRP-5051 and, throughout MOMENTUM Part B, supplemental magnesium was administered prophylactically. No treatment-related discontinuations occurred in the study. Conference call details At 8:30 a.m. Eastern time on Jan. 29, 2024, Sarepta will host a conference call and webcast to discuss the results. The event will be webcast live under the investor relations section of Sarepta’s website at and following the event a replay will be archived there for one year. Interested parties participating by phone will need to register using this online form. After registering for dial-in details, all phone participants will receive an auto-generated e-mail containing a link to the dial-in number along with a personal PIN number to use to access the event by phone. About SRP-5051 (vesleteplirsen) SRP-5051 is an investigational agent using Sarepta’s PPMO chemistry and exon-skipping technology to skip exon 51 of the dystrophin gene. SRP-5051 is designed to bind to exon 51 of dystrophin pre-mRNA, resulting in exclusion of this exon during mRNA processing in patients with genetic mutations that are amenable to exon 51 skipping. Exon skipping is intended to allow for production of an internally shortened dystrophin protein. PPMO is Sarepta’s next-generation chemistry platform designed around a proprietary cell-penetrating peptide conjugated to the PMO backbone, with the goal of increasing tissue penetration, increasing exon skipping, and significantly increasing dystrophin production. Around 13% of Duchenne patients have mutations that make them amenable to skipping exon 51. If successful, the PPMO offers the potential for improved efficacy and less frequent dosing for patients. About MOMENTUM (Study SRP-5051-201) MOMENTUM is a global, Phase 2, multi-arm, ascending dose study of SRP-5051, infused every four weeks, and will assess dystrophin protein levels in skeletal muscle tissue following SRP-5051 treatment. The study will also assess safety and tolerability. Part B enrolled 40 participants, both ambulant and non-ambulant, between the ages of 8 to 21 at sites in the U.S., Canada, and Europe. More information can be found on . About EXONDYS 51 EXONDYS 51 (eteplirsen) uses Sarepta’s proprietary phosphorodiamidate morpholino oligomer (PMO) chemistry and exon-skipping technology to bind to exon 51 of dystrophin pre-mRNA, resulting in exclusion, or “skipping”, of this exon during mRNA processing in patients with genetic mutations that are amenable to exon 51 skipping. Exon skipping is intended to allow for production of an internally truncated dystrophin protein. EXONDYS 51 is indicated for the treatment of Duchenne muscular dystrophy in patients who have a confirmed mutation of the dystrophin gene that is amenable to exon 51 skipping. This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in some patients treated with EXONDYS 51. Continued approval may be contingent upon verification of a clinical benefit in confirmatory trials. EXONDYS 51 has met the full statutory standards for safety and effectiveness and as such is not considered investigational or experimental. Important Safety Information About EXONDYS 51 Hypersensitivity reactions, bronchospasm, chest pain, cough, tachycardia, and urticaria have occurred in patients who were treated with EXONDYS 51. If a hypersensitivity reaction occurs, institute appropriate medical treatment and consider slowing the infusion or interrupting the EXONDYS 51 therapy. Adverse reactions in Duchenne patients (N=8) treated with EXONDYS 51 30 mg or 50 mg/kg/week by intravenous (IV) infusion with an incidence of at least 25% more than placebo (N=4) (Study 1, 24 weeks) were (EXONDYS 51, placebo): balance disorder (38%, 0%), vomiting (38%, 0%) and contact dermatitis (25%, 0%). The most common adverse reactions were balance disorder and vomiting. Because of the small numbers of patients, these represent crude frequencies that may not reflect the frequencies observed in practice. The 50 mg/kg once weekly dosing regimen of EXONDYS 51 is not recommended. The following adverse reactions have been identified during observational studies that were conducted as part of the clinical development program and continued post approval. In open-label observational studies, 163 patients received at least one intravenous dose of EXONDYS 51, with doses ranging between 0.5 mg/kg (0.017 times the recommended dosage) and 50 mg/kg (1.7 times the recommended dosage). All patients were male and had genetically confirmed Duchenne muscular dystrophy. Age at study entry was 6 months to 19 years. Most (85%) patients were Caucasian. The most common adverse reactions from observational clinical studies (N=163) seen in greater than 10% of the study population were headache, cough, rash, and vomiting. For further information, please see the full Prescribing Information. About Sarepta Therapeutics Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development. Our vast pipeline is driven by our multi-platform Precision Genetic Medicine Engine in gene therapy, RNA and gene editing. For more information, please visit or follow us on Twitter, LinkedIn, Instagram and Facebook. Internet Posting of Information We routinely post information that may be important to investors in the 'For Investors' section of our website at . We encourage investors and potential investors to consult our website regularly for important information about us. Forward-Looking Statements In order to provide Sarepta’s investors with an understanding of its current results and future prospects, this press release contains statements that are forward-looking. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “will,” “may,” “intends,” “prepares,” “looks,” “potential,” “possible” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements relating to our future operations, financial performance and projections, business plans, market opportunities, priorities and research and development programs and technologies; the potential benefits of our technologies and scientific approaches; the potential benefits of SRP-5051, including its potential for higher dystrophin and exon-skipping than eteplirsen and a favorable benefit-risk profile, including that hypomagnesemia is manageable; and plans and milestones, including discussing results and next steps with FDA. These forward-looking statements involve risks and uncertainties, many of which are beyond Sarepta’s control. Actual results could materially differ from those stated or implied by these forward-looking statements as a result of such risks and uncertainties. Known risk factors include the following: success in preclinical and clinical trials, especially if based on a small patient sample, does not ensure that later clinical trials will be successful, and the results of future research may not be consistent with past positive results or may fail to meet regulatory approval requirements for the safety and efficacy of product candidates; certain programs may never advance in the clinic or may be discontinued for a number of reasons, including regulators imposing a clinical hold and us suspending or terminating clinical research or trials; if the actual number of patients suffering from the diseases we aim to treat is smaller than estimated, our revenue and ability to achieve profitability may be adversely affected; because we are developing product candidates for the treatment of certain diseases in which there is little clinical experience and we are using new endpoints or methodologies, there is increased risk that the FDA, the EMA or other regulatory authorities may not consider the endpoints of our clinical trials to provide clinically meaningful results and that these results may be difficult to analyze; we may not be able to execute on our business plans, including meeting our expected or planned regulatory milestones and timelines, research and clinical development plans, and bringing our product candidates to market, for various reasons, some of which may be outside of our control, including possible limitations of company financial and other resources, manufacturing limitations that may not be anticipated or resolved for in a timely manner, and regulatory, court or agency decisions, such as decisions by the United States Patent and Trademark Office with respect to patents that cover our product candidates; and those risks identified under the heading “Risk Factors” in our most recent Annual Report on Form 10-K for the year ended December 31, 2022 and our most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company which you are encouraged to review.