PTH

JERUSALEM, March 08, 2024 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered peptides, today reported financial results and key business updates for the fourth quarter and year ended December 31, 2023. “2023 was an inflection point for Entera, with consistent validation of our disruptive N-Tab™ oral peptide technology platform and the unveiling of our goal to advance five potential first-in-class oral peptide programs, Phase 1 through Phase 3, into the clinic by the end of 2025. Each of these programs has been carefully selected to align with our platform and our mission to develop treatments that stand to become the number one choice for patients requiring peptide therapies, in a simple and convenient tablet format. Each of these programs is expected to have important catalysts during 2024. Following our December 2023 financing, we expect to have sufficient cash to fund operations through the first half of 2025,” said Miranda Toledano, CEO of Entera. EB613: First Oral PTH(1-34) Daily Osteoanabolic Tablets for Osteoporosis In March 2023, a Type D meeting between Entera and the U.S. Food and Drug Administration (FDA) re-affirmed that a placebo-controlled phase 3 study design with Bone Mineral Density (BMD) and not fracture as primary endpoint could support a New Drug Application for EB613 In November 2023, Entera echoed the American Society for Bone and Mineral Research (ASBMR) announcement that the Strategy to Advance BMD as a Regulatory Endpoint (SABRE) team had submitted its final qualification plan to the FDA At the Annual ASBMR Meeting in October 2023, Entera presented the differentiated pharmacokinetic profile of EB613, versus Forteo® PTH(1-34) 20 µg which requires a daily subcutaneous injection. EB613 consistently shows an increased Cmax and shorter duration of systemic exposure versus Forteo®. Furthermore, EB613’s brief “pulsatile” action appears to simultaneously stimulate both a dual bone formation and a mild anti-resorptive effect, as compared to Forteo® During the fourth quarter of 2023, Entera submitted its Phase 2 manuscript for potential publication in a major medical journal related to its phase 2, 6-month, 161-patient, placebo-controlled study in post-menopausal women with low bone mass and osteoporosis which met primary and secondary endpoints “We expect an update on the qualification process of SABRE and BMD as the surrogate endpoint for fracture in 2024. We view this as the final de-risking event from a regulatory standpoint to move EB613 to Phase 3. We believe EB613 stands as the first program to potentially avail itself of the landmark SABRE initiative which is also the first biomarker to potentially be approved as part of the 2016 21st Century Cures Act. As the first potential oral tablet osteoanabolic treatment, EB613 holds the potential to address the treatment chasm in this severe, potentially lethal disease which remains significantly undertreated despite efficacious injectable treatments. Fracture rates continue to rise globally, and we have not seen any new drugs approved for osteoporosis since 2019 due to the ethical concerns and the costs of fracture endpoint studies. Our discussions with key clinicians and patient advocacy groups and other key stakeholders in this ecosystem indicate that an oral anabolic treatment is absolutely warranted and a potential ‘game changer’ for the estimated 200 million women with osteoporosis globally. We continue to hold strategic discussions related to EB613 and look forward to initiating our pivotal phase 3 study once the final qualification of the SABRE endpoint is announced by FDA,” said Miranda Toledano, CEO of Entera. EB612: First Oral PTH(1-34) Peptide Replacement Therapy Tablets for HypoparathyroidismEB612, is being developed as the first oral PTH(1-34) peptide replacement treatment for hypoparathyroidism. Entera is currently evaluating its hypoparathyroidism program with an improved formulation of EB612 using the naked PTH(1-34) peptide and new intellectual property, tailored to optimize its PK profile and the potential for reduced daily dosing. Entera is also combining its N-Tab™ platform with an alternative PTH receptor agonist in a third party collaboration. Entera expects to submit data from the Phase 1 of its next generation EB612 program using the naked PTH(1-34) peptide in the first half of 2024. First GLP-2 Peptide Tablets for Short Bowel SyndromeUnder a collaboration agreement with OPKO Health (“OPKO”), Entera is combining its N-Tab™ technology with a proprietary long-acting GLP-2 peptide for the development of the first potential daily oral GLP-2 for the treatment of short bowel syndrome and other GI disorders such as Crohn’s and Celiac disease for which GLP-2 has relevance. Entera published pre-clinical data in May 2023 demonstrating that its oral peptide delivery platform enables gastric absorption of teduglutide (Gattex®), the only approved GLP-2 treatment, as a convenient potential tablet alternative to daily injections. Pre-IND in vivo PK data for oral GLP-2 using OPKO’s long-acting analogue is expected in the first half of 2024. First GLP-1/Glucagon Agonist (Oxyntomodulin) Peptide Tablets for ObesityUnder a collaboration agreement with OPKO, Entera is combining its N-Tab™ technology with a proprietary long-acting Oxyntomodulin (OXM) peptide for the development of the first potential daily OXM treatment for obesity and other metabolic diseases. Previously, an injectable pegylated version of this OXM peptide demonstrated significant reductions in weight loss and decreased plasma triglyceride levels with cardioprotective benefits in over 420 patients in phase 2/2B studies. Pre-IND in vivo PK data for oral OXM using OPKO’s long acting, modified analogue is expected in mid-2024. EB613: First Oral PTH(1-34) Osteoanabolic Tablets to Treat Intense Sport and Military Stress InjuriesEntera is collaborating with leading researchers in orthopedics and sports medicine to contribute its proprietary oral PTH(1-34) tablets for an investigator sponsored Phase 2 Study seeking to treat young women and men athletes that experience stress fractures as a result of intense sports training. More details on this study are expected in the second half of 2024. Financial Results for the year Ended December 31, 2023 As of December 31, 2023, Entera had cash and cash equivalents of $11.0 million. The Company believes that its existing cash resources will be sufficient to meet its projected operating requirements through the second quarter of 2025, which includes the capital required to fund our ongoing operations, including R&D, the completion of the Phase 1 PK study related to our new generation platform and the GLP-2/OXM collaborative research we are conducting with OPKO. Research and development expenses for the year ended December 31, 2023 were $4.5 million, as compared to $5.8 million for the year ended December 31, 2022. The decrease of $1.3 million was primarily due to a decrease of $1.5 million in pre-clinical activity and materials costs and a decrease of $0.6 million in employee compensation, including a one-time payment made to a former employee pursuant to the terms of his separation agreement. The decrease was partially offset by an increase of $0.8 million in clinical expenses for our Phase 1 PK study related to our new generation platform and new formulations for EB612. General and administrative expenses for the year ended December 31, 2023 were $4.4 million, compared to $7.3 million for the year ended December 31, 2022. The decrease of $2.8 million was mainly attributable to a decrease of $1.1 million in employee compensation, including a one-time payment to our former employee pursuant to the terms of his separation agreement, a decrease of $0.8 million as part of a restructuring of professional fees and other advisor expenses, a decrease in Board fees of $0.2 million due to the Board’s forfeiture of their fees for the third and fourth quarters of 2023 and a decrease of $0.7 million in D&O insurance costs. Operating expenses for year ended December 31, 2023 were $8.9 million, as compared to $13.0 million for the year ended December 31, 2022. Net loss was $8.9 million, or $0.31 per ordinary share (basic and diluted), for the year ended December 31, 2023, as compared to $13.1 million, or $0.45 per ordinary share (basic and diluted), for the year ended December 31, 2022. About Entera Bio Entera is a clinical stage company focused on developing oral peptide or protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform and its pipeline includes five differentiated, first-in-class oral peptide programs, expected to enter into the clinic (Phase 1 to Phase 3) by 2025. The Company’s most advanced product candidate, EB613 (oral PTH(1-34), teriparatide), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for post-menopausal women with low BMD and high-risk osteoporosis, with no prior fracture. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n=161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint which is expected to occur in 2024. The EB612 program is being developed as the first oral PTH(1-34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity; and first oral GLP-2 peptide tablet as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com or follow us on LinkedIn, Twitter, Facebook, Instagram. Cautionary Statement Regarding Forward-Looking Statements Various statements in this press release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward-looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. Important factors that could cause actual results to differ materially from those reflected in Entera’s forward-looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s expectations regarding licensing, business transactions and strategic collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statements Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10-K filed with the SEC, as well as the company’s subsequently filed Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward-looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward-looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law. ENTERA BIO LTD.CONSOLIDATED BALANCE SHEETS(U.S. dollars in thousands) December 31 December 31 2023 2022 (Unaudited) (Audited) Cash and cash equivalents11,019 12,309Accounts receivable and other current assets238 540Property and equipment, net100 139Other assets, net408 139Total assets11,765 13,127 Accounts payable and other current liabilities1,091 1,341Total non-current liabilities288 32Total liabilities1,379 1,373Total shareholders' equity10,386 11,754Total liabilities and shareholders' equity11,765 13,127 ENTERA BIO LTD.CONSOLIDATED STATEMENTS OF OPERATIONS(U.S. dollars in thousands, except share and per share data) (Unaudited) Year Ended December 31, 2023 2022 REVENUES- 134COST OF REVENUES- 101GROSS PROFIT - 33OPERATING EXPENSES: Research and development4,510 5,848General and administrative4,430 7,253Other income(49) (51)TOTAL OPERATING EXPENSES8,891 13,050OPERATING LOSS8,891 13,017FINANCIAL INCOME, NET (31) (83)LOSS BEFORE INCOME TAX 8,860 12,934INCOME TAX EXPENSES29 137NET LOSS8,889 13,071 BASIC AND DILUTED LOSS PER SHARE0.31 0.45WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF29,007,794 28,808,090BASIC AND DILUTED LOSS PER SHARE

- Final European Commission decision expected within 67 days after positive opinion; if approved, first European Union launch planned in Germany in early 2024 Ascendis Pharma A/S (Nasdaq: ASND) today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion and recommended the approval of TransCon PTH (palopegteriparatide) as a parathyroid hormone (PTH) replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism. The European Commission’s final decision on the Company’s Marketing Authorisation Application is expected within 67 days after the positive opinion. TransCon PTH is a prodrug of parathyroid hormone (PTH [1-34]) administered once daily. “We are pleased to have received this positive CHMP opinion for TransCon PTH and look forward to the final European Commission decision,” said Birgitte Volck, M.D., Ph.D., Executive Vice President, Head of Clinical Development & Medical Affairs, Endocrinology Rare Diseases at Ascendis Pharma. “Hypoparathyroidism is the last endocrine deficiency for which replacement of the missing hormone is not widely available. Based on our clinical and patient-reported data and a robust supply chain, we are confident in our ability to address the hypoparathyroidism community’s urgent need for new treatment options to safely and effectively address the burden of their disease.” CHMP adopted its positive opinion following its review of the totality of the Company’s clinical package for TransCon PTH (palopegteriparatide), which included data from the global Phase 3 PaTHway and Phase 2 PaTH Forward trials in adult patients with hypoparathyroidism, both of which used the same drug/device combination product that Ascendis plans to make available as its commercial product, if approved. Ascendis plans its first European Union launch of TransCon PTH (palopegteriparatide), if approved, in Germany in early 2024. About Ascendis Pharma A/S Ascendis Pharma is applying its innovative TransCon technology platform to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients’ lives. Guided by its core values of patients, science and passion, the company uses its TransCon technologies to create new and potentially best-in-class therapies. Ascendis is headquartered in Copenhagen, Denmark and has additional facilities in Germany (Heidelberg, Berlin and Munich) and the United States (Palo Alto and Redwood City, California, and Princeton, New Jersey). Please visit ascendispharma.com to learn more. The content above comes from the network. if any infringement, please contact us to modify.

Highlights progress, recent developments and upcoming key milestonesCompany continues to build growing body of data across pipeline, advancing towards first in human studiesStrong financial position with cash projected to fund operations and advancement of priority pipeline programs into 2025 TORONTO, ONTARIO, July 13, 2023 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (“Aeterna” or the “Company”), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products, today provided an update on its therapeutic and diagnostic development pipeline programs and outlined upcoming key milestones. “We are encouraged by our significant progress across all of our active development programs, and based on the prioritization of our pipeline, have strengthened our focus on our diagnostic and therapeutic programs as we execute on key decision points,” commented Dr. Klaus Paulini, Chief Executive Officer of Aeterna. “Additionally, in our ongoing DETECT clinical trial, we are making significant progress regarding patient recruitment and believe we are well-positioned to continue building momentum towards completion of the study by year’s end. Further, based upon our active outreach and discussions, we expect to secure an alternate development and commercialization partner for Macrilen® for the U.S. and Canada.” Therapeutics Development Pipeline Update Autoimmunity Modifying ("AIM") Biologicals: Targeted, highly specific autoimmunity modifying fusion proteins for the potential treatment of neuromyelitis optica spectrum disorder ("NMOSD") and Parkinson's disease (“PD”) AIM Biologicals represent a unique platform technology with the potential to address the cause and not only the symptoms of auto-immune and inflammatory, neurodegenerative disorders at early stages. This approach is based on induction of selective and highly target-specific immune de-sensibilization based on the natural concept of feto-maternal tolerance. Dr. Paulini added, “We have received encouraging feedback from our collaborator and scientific advisor on the NMOSD indication, Dr. Michael Levy, Research Director of the Division of Neuroimmunology & Neuroinfectious Disease at Massachusetts General Hospital. Dr. Levy shares our vision that presenting antigens on soluble HLA-G fusion proteins is a promising, novel approach to induce antigen specific immune tolerance among NMOSD and PD patients. Together, we look forward to furthering the development of this program.” Recent Highlights Demonstrated positive pre-clinical proof-of-concept in various in-vitro and in-vivo models.In-depth profiling of a limited set of candidates for potential use in clinical development.Confirmed AIM Biologicals’ mechanism of action and efficacy in ex-vivo studies in human blood samples from both NMOSD and PD patients. Next Steps Evaluation of manufacturing strategy and initiation of production of selected development candidates.Ongoing compilation of a comprehensive pre-clinical data package for scientific advice meetings with regulatory authorities, expected to take place in the near future. Delayed Clearance Parathyroid Hormone ("DC-PTH", AEZS-150) Fusion Proteins: Potential treatment for chronic hypoparathyroidism AEZS-150 is a fusion protein of PTH [1-34] coupled to a modified human growth-hormone binding protein (GHBP). Preclinical results so far indicate the potential for maintaining regular calcium and phosphate levels in blood longer and more consistently than with current treatments. This project aims to address this debilitating orphan disease, which is currently without satisfactory treatment options, with weekly instead of daily injections. “There is a major unmet need for physiological parathyroid hormone replacement in patients with hypoparathyroidism, either congenital or acquired from neck surgery, who have an impaired quality of life and increased morbidity and mortality on current therapy. DC-PTH will address this unmet need,” commented Prof. Richard Ross, MD, FRCP, Department of Oncology and Metabolism at Sheffield University (UK). “Aeterna has made great progress in the manufacturing process development of AEZS-150 and repeating validation studies in models of hypoparathyroidism required before undertaking trials in patients.” Recent Highlights Detailed profiling of AEZS-150 through in-vitro studies and in-vivo models of hypoparathyroidism.Established a master cell bank for a cell line expressing AEZS-150 in good yield.Continued progress in the development of a production process suitable for larger scale GMP manufacturing. Next Steps Meet with regulatory authorities to determine the development path forward; Company expects such a meeting in Q4/2023, and as outcome, an abbreviated safety and toxicology program as the active principle ([1-34]-PTH fragment) is already approved and in use.Initiate IND-enabling preclinical studies in 2024. Macimorelin Therapeutic (AEZS-130): Ghrelin agonist in development for the treatment of ALS (Lou Gehrig's disease) Amyotrophic Lateral Sclerosis (ALS) is a debilitating and deadly orphan disease, and those who suffer from this terminal condition have few treatment options. Macimorelin’s (AEZS-130) multiple modes of action should have the potential to improve the quality of life for these patients. Recent Highlights Successful development of an alternative formulation suitable for use in ALS.Accumulating data for positive effects of AEZS-130 treatment on survival of motor-neurons.Continued assessment of AEZS-130 in transgenic mouse ALS models and in human patient-derived neuron cultures.Completion of initial toxicology and safety studies to support clinical development as a therapeutic, in addition to the already existing body of safety and toxicology data from our macimorelin diagnostic development. Next Steps Following achievement of proof-of-concept, the Company will seek to have a scientific advice meeting with regulatory authorities to discuss program development next steps.Completion of toxicology and safety studies to support treatment over prolonged periods. Diagnostics Development and Commercialization Update Macimorelin Diagnostic: Approved and commercialized as test for adult growth hormone deficiency and in clinical Phase 3 development for childhood-onset growth hormone deficiency ("CGHD") testing. Aeterna is currently conducting its pivotal Phase 3 safety and efficacy study AEZS-130-P02 (the “DETECT-trial”) evaluating macimorelin for the diagnosis of Childhood Onset Growth Hormone Deficiency (“CGHD”). Most clinical sites in the U.S. as well as European countries are open for patient recruitment. Recent Highlights Phase 3 Study: Significant progress made with DETECT patient recruitment also by engagement of an additional Clinical Research Organization (CRO). Currently three new countries (Armenia, Slovakia, and Turkey), have ongoing DETECT clinical trial application activities and almost half the foreseen subjects have meanwhile concluded the trial.Macimorelin Commercialization: Having regained full rights to Macrilen® for the U.S. and Canada from Novo Nordisk in May 2023, the Company is actively focused on identifying an alternate development and commercialization partner for Macrilen® for U.S. and Canada. “We continue to manage our cash responsibly with a balanced de-risked development approach, which we believe enables us to optimize the Company's capital and human resources,” added Giuliano La Fratta, Chief Financial Officer of Aeterna. “We remain focused on advancing our programs to their next phase of development, guided by the data and financial risk/reward as we do so. Based on our current projections, we believe the Company has the ability to meet its currently anticipated cash needs into 2025.” About Aeterna Zentaris Inc. Aeterna Zentaris is a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products focused on areas of significant unmet medical need. The Company's lead product, macimorelin (Macrilen®; Ghryvelin™), is the first and only U.S. FDA and European Commission approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). The Company is leveraging the clinical success and compelling safety profile of macimorelin to develop it for the diagnosis of childhood-onset growth hormone deficiency (CGHD), an area of significant unmet need. Aeterna Zentaris is dedicated to the development of its therapeutic asset and has established a pre-clinical development pipeline to potentially address unmet medical needs across a number of indications, including neuromyelitis optica spectrum disorder (NMOSD), Parkinson's disease (PD), hypoparathyroidism and amyotrophic lateral sclerosis (ALS; Lou Gehrig's disease). For more information, please visit www.zentaris.com and connect with the Company on Twitter, LinkedIn and Facebook. Forward-Looking Statements This press release contains statements that may constitute forward-looking statements within the meaning of U.S. and Canadian securities legislation and regulations, and such statements are made pursuant to the safe-harbor provision of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements are frequently, but not always, identified by words such as "expects," "aiming", "anticipates," "believes," "intends," "potential," "possible," and similar expressions. Such statements, based as they are on current expectations of management, inherently involve numerous risks, uncertainty and assumptions, known and unknown, many of which are beyond our control. Forward-looking statements in this press release include, but are not limited to, those relating to Aeterna's expectations regarding: its preclinical and clinical studies, its ability to secure regulatory approvals for Macrilen™, its efforts to obtain a development and commercialization partner for Macrilen™ in the U.S. and Canada and the ability to meet its currently anticipated cash needs into 2025. Forward-looking statements involve known and unknown risks and uncertainties, and other factors which may cause the actual results, performance or achievements stated herein to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information. Such risks and uncertainties include, among others, our reliance on the success of the DETECT clinical trial in the European Union and U.S. for Macrilen™ (macimorelin) in CGHD; results from our ongoing or planned pre-clinical studies and our DETECT clinical trial under development may not be successful or may not support advancing the product further in pre-clinical studies, to human clinical trials or regulatory approval; our ability to raise capital and obtain financing to continue our currently planned operations; our now heavy dependence on the success of Macrilen™ (macimorelin) and related out-licensing arrangements and the continued availability of funds and resources to successfully commercialize the product; the global instability due to the global pandemic of COVID-19 and the war in the Ukraine, and their unknown potential effect on our planned operations; our ability to enter into out-licensing, development, manufacturing, marketing and distribution agreements with other pharmaceutical companies and keep such agreements in effect; and our ability to continue to list our common shares on the NASDAQ. Investors should consult our quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties, including those risks discussed in our Annual Report on Form 20-F and annual information form, under the caption "Risk Factors". Given the uncertainties and risk factors, readers are cautioned not to place undue reliance on these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or applicable law. No securities regulatory authority has either approved or disapproved of the contents of this news release. The Toronto Stock Exchange accepts no responsibility for the adequacy or accuracy of this release. Investor Contact: Jenene ThomasJTC TeamT (US): +1 (833) 475-8247E: aezs@jtcir.com