Product Development - The company is developing an oral insulin capsule, ORMD-0801, which allows insulin to be delivered from the gastrointestinal tract to the bloodstream, potentially revolutionizing insulin delivery methods [19]. - The company plans to conduct two concurrent Phase III studies involving approximately 1,125 patients to further assess the safety and efficacy of ORMD-0801 over a treatment period of 6 to 12 months [24]. - The company has initiated trials for its oral GLP-1 capsule, ORMD-0901, with a follow-on trial in T2D patients started in June 2021 [31]. - The company reported a 6.9% reduction in liver fat content in a small NASH trial, indicating potential for ORMD-0801 in treating nonalcoholic steatohepatitis [27]. - The company has completed a Phase IIb clinical trial in patients with Type 2 Diabetes (T2D) and Phase IIa clinical trials of ORMD-0801 in patients with Type 1 Diabetes (T1D) under an IND with the FDA [109]. Regulatory and Approval Process - The FDA has indicated that the regulatory pathway for ORMD-0801 will be a Biologics License Application (BLA), which, if approved, would grant 12 years of marketing exclusivity [20][26]. - The Biological License Application (BLA) process can take an average of 18 months for FDA review, providing 12 years of market exclusivity upon approval [73]. - The European Marketing Approval Application process takes up to 210 days from submission, including an audit of manufacturing facilities [75]. - The company is committed to pursuing regulatory approvals through the FDA and other international bodies, which involves significant clinical testing and adherence to strict protocols [65][66]. - The company may face significant challenges in obtaining regulatory approvals, which are necessary for marketing its products in the U.S. and internationally [93]. Financial Performance - The company has incurred net losses of $114.85 million, $22.24 million, and $11.51 million for the fiscal years 2021, 2020, and 2019 respectively, indicating a history of financial losses [98]. - The company generated revenues of $2.70 million for the fiscal years 2021, 2020, and 2019, showing no significant growth in product revenues [98]. - As of August 31, 2021, the company reported working capital of $88.66 million and stockholders' equity of $116.52 million [98]. - The company expects to require substantial additional financing to continue its research and development programs, with no assurance that such funding will be available on acceptable terms [95]. - The company incurred a net loss for fiscal 2021 of $22,989,000, compared to a net loss of $11,511,000 for fiscal 2020 [170]. Intellectual Property - The company has a strong intellectual property portfolio, actively protecting its technology developments worldwide [43]. - The company holds 36 pending patent applications, with expiration dates ranging from 2026 to 2039, and 87 issued patents covering various technologies related to oral delivery of proteins and diabetes treatment [51][52]. - The company relies on patents to protect its technology, holding several pending patent applications and 87 issued patents across various countries [102]. - The company has a proactive intellectual property strategy, focusing on patent protection and confidentiality agreements to safeguard its technological developments [54][53]. Strategic Partnerships - The company plans to seek strategic commercial partners for the development and commercialization of insulin applications and other orally digestible drugs, anticipating that partners will support late-stage clinical trials and marketing efforts [46]. - The company has entered into a Technology License Agreement with HTIT, granting an exclusive commercialization license for the oral insulin capsule ORMD-0801, with expected royalties of 10% on net sales and milestone payments totaling $37.5 million [61]. - Under the Oravax License Agreement, the company will receive royalties of 7.5% on net sales and potential milestone payments ranging from $25 million to $100 million based on sales achievements [64]. - The company is exploring ways to benefit shareholders through its joint venture, Oravax, potentially issuing shares as a dividend [35]. Market Opportunity - The total cost of diagnosed diabetes in the U.S. was estimated at $327 billion in 2017, highlighting the significant market opportunity for diabetes treatments [42]. - The company anticipates its oral insulin capsule to be a competitive diabetes drug due to its expected efficacy and safety profile [82]. - The biotechnology and biopharmaceutical industries are highly competitive, with the company facing competition from larger firms with greater resources [115]. Operational Challenges - The company is dependent on third-party suppliers for its entire supply of oral insulin and GLP-1 capsules, with no long-term agreements currently in place [111]. - The company anticipates significant strain on its managerial and operational resources due to business expansion, necessitating the recruitment and retention of skilled personnel [116]. - The company relies heavily on its senior management and key personnel, and their loss could adversely affect its competitive position [118]. - Changes in healthcare policy and potential price limitations could negatively impact future revenues from product sales and technology licenses [121]. Financial Risks - The company is exposed to currency exchange rate fluctuations, which could adversely affect its financial results due to expenses incurred in multiple currencies [125]. - The COVID-19 pandemic may disrupt clinical trial operations and impact financial results, with potential delays in obtaining regulatory approvals for product candidates [126][127][128]. - Future sales of common stock or issuance of equity-related securities could adversely affect the trading price of the company's common stock and its ability to raise capital [145]. Research and Development Expenses - Research and development expenses increased by 105% to $20,989,000 from $10,235,000 for fiscal 2020, primarily due to increased expenses related to Phase III clinical trials [181]. - Research and development expenses are expected to remain the major operating expense, with approximately $31 million in clinical research obligations over the next three years [200].

Addressing the Multibillion-Dollar Injectable Drug Markets with Oral Formulations February 2020 Safe Harbor Certain statements contained in this material are forward-looking statements. 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 pr ...