Acambis Plc

MONTPELLIER, France--(BUSINESS WIRE)-- Regulatory News: Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders, announces the appointment of David Lawrence as Chief Financial Officer, effective as of March 1st, 2023. Mr Lawrence was previously Chief Financial Officer of Valneva, a specialty vaccine company, where he served as a member of the Management Board; his responsibilities included Investor Relations and Communications in addition to overseeing the financial management of the company. During his tenure at Valneva he was instrumental in several financings including a NASDAQ Initial Public Offering (IPO) and by the point of his retirement from Valneva the market capitalisation of the company had grown to over €2bn. He has also previously served as Chief Financial Officer of Acambis and as VP of Finance, Business Development and Strategy at Chiron Vaccines. In 2011 he supported the establishment and development of Synpromics Ltd, a synthetic promoter company that was acquired by AskBio in 2019. Mr Lawrence has over 30 years’ experience of leadership roles in life sciences, ranging from large biopharma companies such as GSK to start-ups and earlier stage companies, including Synpromics Ltd. He brings with him extensive industry experience including strategy, business development and M&A, and currently sits on the Boards of Enterobiotix Limited and is an advisor to ACM Biolabs Pty. He has also advised several Venture Capital firms between 2006 and 2017. Nawal Ouzren, Chief Executive Officer of Sensorion, commented: “We are delighted to have been able to attract David to join Sensorion as CFO. David has deep experience in capital markets and strategic partnering, alongside years of operational leadership in biopharma companies. This is a critical time for Sensorion as we advance our gene therapy programs towards clinical development and plan our longer-term business strategy while maintaining rigorous capital discipline. I look forward to working closely with him and welcoming him to the team.” David Lawrence said: “I have watched Sensorion from afar and I’m thrilled to be joining the company at such an exciting time in its development. I’ve been involved in gene therapy since helping to set up Synpromics in 2011 alongside its CSO and Founder. Gene therapy for the ear is an exciting new frontier, offering huge potential to transform lives, and the Sensorion ecosystem in Europe provides a platform for a valuable franchise in the US and beyond. I’m looking forward to working with Nawal, the Board and the team to help unlock the enormous potential in this company.” About Sensorion Sensorion is a pioneering clinical-stage biotech company, which specializes in the development of novel therapies to restore, treat and prevent hearing loss disorders, a significant global unmet medical need. Sensorion has built a unique R&D technology platform to expand its understanding of the pathophysiology and etiology of inner ear related diseases, enabling it to select the best targets and mechanisms of action for drug candidates. Its portfolio combines both inner ear gene therapy and small molecule programs. Its clinical-stage portfolio includes one Phase 2 product: SENS-401 (Arazasetron) progressing in a planned Phase 2 Proof of Concept clinical study of SENS-401 in Cisplatin-Induced Ototoxicity (CIO) and, with partner Cochlear Limited, in a study of SENS-401 in patients scheduled for cochlear implantation. A Phase 2 study of SENS-401 was also completed in Sudden Sensorineural Hearing Loss (SSNHL) in January 2022. Sensorion pursues its broad strategic collaboration with Institut Pasteur focused on the genetics of hearing. It has two gene therapy programs aimed at correcting hereditary monogenic forms of deafness including OTOF-GT, targeting deafness caused by mutations of the gene encoding for otoferlin, and hearing loss related to mutations in GJB2 gene to potentially address important hearing loss segments in adults and children (GJB2-GT). The Company is also working on the identification of biomarkers to improve diagnosis of these underserved illnesses. Label: SENSORION ISIN: FR0012596468 Mnemonic: ALSEN Disclaimer This press release contains certain forward-looking statements concerning Sensorion and its business. Such forward looking statements are based on assumptions that Sensorion considers to be reasonable. However, there can be no assurance that such forward-looking statements will be verified, which statements are subject to numerous risks, including the risks set forth in the 2021 full year financial report published on April 28, 2022, and available on our website and to the development of economic conditions, financial markets and the markets in which Sensorion operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Sensorion or not currently considered material by Sensorion. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Sensorion to be materially different from such forward-looking statements. This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Sensorion shares in any country. The communication of this press release in certain countries may constitute a violation of local laws and regulations. Any recipient of this press release must inform oneself of any such local restrictions and comply therewith. View source version on businesswire.com: Contacts Investor Relations David Lawrence, Chief Financial Officer (US/UK) Noémie Djokovic, Investor Relations and Communications (Europe/France) ir.contact@sensorion-pharma.com International Media Relations Consilium Strategic Communications Matthew Cole/Jessica Hodgson/Sue Stuart +44 7593 572720 +44 7561 424788 Sensorion@consilium-comms.com Source: Sensorion View this news release online at:

NEW YORK, Nov. 10, 2022 /PRNewswire/ -- Oramed Pharmaceuticals Inc. ("Oramed" or the "Company") (Nasdaq: ORMP) (TASE: ORMP) (), a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, today reported its financial results for the quarter ended September 30, 2022. "We are pleased to share our quarterly report for the third quarter of 2022. We had a strong quarter filled with important milestones, including positive Phase 2 NASH data and initial positive results from our Phase 1 oral Covid-19 vaccine trial. Over the next few months, we look forward to sharing multiple milestones, most notably topline data from our first Phase 3 oral insulin trial expected in January," said Oramed Chief Executive Officer, Nadav Kidron. "Oramed remains in a strong financial position with approximately $160 million in cash and investments as of September 30, 2022, allowing us to continue advancing all aspects of our pipeline and giving us sufficient runway to complete our pivotal oral insulin (ORMD-0801) Phase 3 trials and advance us towards potential FDA approval." Financial Results for the Three Month Period Ended September 30, 2022 As of September 30, 2022, we had approximately $160 million in cash and investments, comprised of $33,196,000 of available cash, $121,119,000 of short-term bank deposits and $5,234,000 of marketable securities. Research and development expenses for the three month period ended September 30, 2022 decreased by 12% to $5,347,000, compared to $6,086,000 for the three month period ended September 30, 2021. The decrease was mainly due to lower research and development expenses in our subsidiary Oravax Inc. ("Oravax") in the third quarter of 2022. Stock-based compensation expenses for the three month period ended September 30, 2022 were $771,000, compared to $495,000 during the three month period ended September 30, 2021. This increase was mainly due to equity awards granted to employees in 2022, and equity awards granted by Oravax to employees and board members of Oravax and to other service providers in September 2022. Sales and marketing expenses for the three month period ended September 30, 2022 increased by 169% to $463,000, compared to $172,000 for the three month period ended September 30, 2021. The increase was primarily due to stock-based compensation expenses and consulting expenses. Stock-based compensation costs for the three month period ended September 30, 2022 were $303,000, compared to $142,000 for the three month period ended September 30, 2021. This increase was mainly due to equity awards granted to an employee during fiscal years 2021 and 2022. General and administrative expenses for the three month period ended September 30, 2022 increased by 60% to $3,061,000 compared to $1,909,000 for the three month period ended September 30, 2021. The increase was mainly due to higher stock-based compensation expenses and salary expenses. Stock-based compensation costs for the three month period ended September 30, 2022 were $1,977,000, compared to $644,000 for the three month period ended September 30, 2021. This increase was mainly due to equity awards granted to directors, officers and other employees in 2022, and equity awards granted by Oravax to employees and board members of Oravax and to other service providers in September 2022. Basic and diluted loss per share of common stock for the three month period ended September 30, 2022 decreased by 14% to $0.18, compared to $0.21 for the three month period ended September 30, 2021. The decrease in loss was mainly due to a higher number of weighted average shares of common stock in the three month period ended September 30, 2022 compared to the three month period ended September 30, 2021. Full financial tables are included below. About Oramed Pharmaceuticals Oramed Pharmaceuticals (Nasdaq/TASE: ORMP) is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, with offices in the United States and Israel, Oramed has developed a novel Protein Oral Delivery (POD™) technology. Oramed is seeking to transform the treatment of diabetes through its proprietary lead candidate, ORMD-0801, which is being evaluated in two pivotal Phase 3 studies and has the potential to be the first commercial oral insulin capsule for the treatment of diabetes. In addition, Oramed is developing an oral GLP-1 (Glucagon-like peptide-1) analog capsule (ORMD-0901). For more information, please visit . Forward-looking statements: This press release contains forward-looking statements. For example, we are using forward-looking statements when we discuss the potential development and timing of an oral COVID-19 vaccine, what our financial position is expected to allow us to achieve, our expectations to share multiple milestones, including topline data from our first Phase 3 oral insulin trial, the expected timing of results of our clinical trials, the expected timing and achievement of milestones and other anticipated future results. In addition, historic results of scientific research and clinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. These forward-looking statements are based on the current expectations of the management of Oramed only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for our product candidates; competition from other pharmaceutical or biotechnology companies; and our ability to obtain additional funding required to conduct our research, development and commercialization activities. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from competition; laboratory results that do not translate to equally good results in real settings; our patents may not be sufficient; and finally that products may harm recipients, all of which could cause the actual results or performance of Oramed to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Oramed undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Oramed, reference is made to Oramed' s reports filed from time to time with the Securities and Exchange Commission. Company Contact: Zach Herschfus +1-844-9-ORAMED [email protected] FINANCIAL TABLES Logo - SOURCE Oramed Pharmaceuticals Inc.

Primary and secondary endpoints of safety and immunogenicity met Oral vaccine elicited a potentially protective IgG response with significant seroconversion from baseline Trial shows proof of concept for oral delivery of vaccines using Oravax technology NEW YORK, Oct. 7, 2022 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) ( ), a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, today announced that its subsidiary, Oravax Medical Inc., reported positive preliminary data from its Phase 1 trial of an oral Covid-19 vaccine candidate. Preliminary Phase 1 trial results from the first cohort include: Significant antibody response (2-6 fold over baseline) as measured by multiple markers of immune response to VLP vaccine antigens observed in majority of the patients dosed No safety issues observed, including mild symptoms Oravax Medical is a clinical-stage vaccine company developing oral vaccines that combine Oramed Pharmaceuticals' POD™ technology with Premas Biotech's D-Crypt™ Platform. Oravax's oral Covid-19 vaccine candidate is designed using D-Crypt™ technology as a triple antigen VLP vaccine that targets three major surface proteins of the SARS-CoV-2 virus - Spike, Membrane and Envelope. This should allow the oral vaccine candidate to trigger a protective response not only against the prevalent strains of the SARS-CoV-2 virus, but also the emerging mutations. "We're very encouraged by this initial data, which indicates that our platform can be safely and successfully used to orally deliver protein-based vaccines," said Nadav Kidron, Chairman of Oravax and CEO of Oramed Pharmaceuticals. "These results, together with the recent evolution of the Covid strains, further raise our confidence in the success of an oral Covid-19 vaccine and the broad potential of our platform along with Oramed's POD™ platform to explore oral vaccines for other infectious diseases," said Dr. Prabuddha Kundu, Co-founder and Managing Director, Premas Biotech. About the Trial An open label, Phase 1, first-in-human, proof-of-concept, dose escalation, dose-finding trial in up to 24 healthy volunteers. The trial will evaluate the safety, tolerability, and immunogenicity of two concentrations of Anti-SARS-CoV-2 vaccine administered orally as a two-dose schedule, administered 21 days apart. The first cohort of 12 eligible subjects received one capsule containing the low dose on day 1 and a second oral dose on day 21. The ongoing trial is to include an additional 12 subjects (subjects 13-24) who are to receive a high dose on day 1 and a second dose on day 21. Subjects will be monitored for safety, tolerability and antibody titers for a period of 24 weeks after the first dose administration. An end of trial visit will take place 24 weeks after the first dose. About Oravax Oravax Medical Inc. was established in 2021 by Oramed Pharmaceuticals Inc., the largest shareholder in Oravax, along with Premas Biotech, MyMD Pharmaceuticals, and certain other shareholders, with a mission to bring an oral Covid-19 vaccine to the market. Oravax combines cutting-edge vaccine technology acquired from Premas Biotech and the proprietary POD™ oral delivery technology of Oramed Pharmaceuticals. For more information, please visit About Oramed Pharmaceuticals Oramed Pharmaceuticals (Nasdaq: ORMP) (TASE: ORMP) is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, with offices in the United States and Israel, Oramed has developed a novel Protein Oral Delivery (POD™) technology. Oramed is seeking to transform the treatment of diabetes through its proprietary lead candidate, ORMD-0801, which is being evaluated in two pivotal Phase 3 studies and has the potential to be the first commercial oral insulin capsule for the treatment of diabetes. In addition, Oramed is developing an oral GLP-1 (Glucagon-like peptide-1) analog capsule (ORMD-0901). For more information, please visit . Forward-looking statements: This press release contains forward-looking statements. For example, we are using forward-looking statements when we discuss the potential development of an oral Covid-19 vaccine, the pace of studies and trials for such oral vaccine and the potential effectiveness, safety, immunogenicity and other advantages of the vaccine against current and future coronavirus strains or for the broader vaccines market and the potential of ORMD-0801 to be the first commercial oral insulin capsule for the treatment of diabetes. In addition, historic results of scientific research and clinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. These forward-looking statements are based on the current expectations of the management of Oramed only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for our product candidates; competition from other pharmaceutical or biotechnology companies; and our ability to obtain additional funding required to conduct our research, development and commercialization activities. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from competition; laboratory results that do not translate to equally good results in real settings; our patents may not be sufficient; and finally that products may harm recipients, all of which could cause the actual results or performance of Oramed to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Oramed undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Oramed, reference is made to Oramed' s reports filed from time to time with the Securities and Exchange Commission. Company Contact: Zach Herschfus +1-844-9-ORAMED zach@oramed.com Logo: Company Codes: NASDAQ-SMALL:ORMP, TelAviv:ORMP