Oramed(ORMP) - 2022 Q2 - Quarterly Report

Financial Performance - Revenues for the six months ended June 30, 2022, were $1.34 million, consistent with the same period in 2021[27] - The net loss for the six months ended June 30, 2022, was $21.8 million, compared to a net loss of $10.0 million for the same period in 2021, indicating a 118% increase in losses[27] - Basic and diluted loss per share increased to $0.54 for the six months ended June 30, 2022, compared to $0.32 for the same period in 2021[27] - Operating loss for the six months ended June 30, 2022, was $22.7 million, up from $11.1 million in the prior year, representing a 104% increase[27] - Net loss for the six months ended June 30, 2022 was $21,775,000, compared to a net loss of $9,972,000 for the same period in 2021[1] Assets and Equity - Total assets decreased to $162.3 million as of June 30, 2022, down from $177.8 million at the end of 2021, representing a decline of approximately 8.7%[24] - Total stockholders' equity decreased to $153.7 million as of June 30, 2022, down from $166.5 million at the end of 2021, a decline of about 7.7%[24] - Cash and cash equivalents increased to $29.9 million as of June 30, 2022, from $27.5 million at the end of 2021, showing a growth of approximately 8.3%[24] - Cash and cash equivalents at the end of the period on June 30, 2022, were $29,892,000, down from $79,622,000 at the end of June 30, 2021[36] Expenses - Research and development expenses increased to $15.0 million for the six months ended June 30, 2022, compared to $9.4 million in the prior year, reflecting a rise of approximately 60%[27] - General and administrative expenses for the six months ended June 30, 2022 increased by 165% to $8,024,000, compared to $3,028,000 for the same period in 2021[132] - Sales and marketing expenses for the six months ended June 30, 2022 were $970,000, compared to no expenses for the same period in 2021[129] - The company reported stock-based compensation of $5,911,000 for the six months ended June 30, 2022, compared to $1,616,000 for the same period in 2021, indicating a significant increase in compensation expenses[36] Cash Flow - Total net cash used in operating activities for the six months ended June 30, 2022, was $17,615,000, which is a 111% increase compared to $8,350,000 for the same period in 2021[36] - Financing activities provided cash of $2,291,000 in the six months ended June 30, 2022, compared to $57,552,000 provided in the same period in 2021[148] Investments and Agreements - The company issued 277,000 shares of common stock during the six-month period ended June 30, 2022, raising approximately $2.97 million[31] - The company issued common stock, net of issuance costs, resulting in proceeds of $2,968,000 for the six months ended June 30, 2022, down from $47,140,000 in the same period of 2021[36] - The Company acquired 63% of Oravax's capital stock for $1,500, consolidating Oravax in its financial statements[92] - The Company signed a pre-purchase agreement for 10 million doses of oral COVID-19 vaccines with Tan Thanh Holdings for commercialization in Southeast Asia[113] Clinical Trials and Development - The Company is conducting two Phase 3 trials for its oral insulin capsule, ORMD-0801, involving approximately 1,125 patients over a treatment period of 6 to 12 months[103] - Topline efficacy data for the ORA-D-013-1 trial is expected in January 2023, with a BLA filing anticipated in 2024, granting at least 12 years of marketing exclusivity[105] - The Company initiated a double-blind, placebo-controlled trial for NASH treatment with ORMD-0801, completing patient enrollment in March 2022[109] - The company experienced approximately six months of delays in clinical trials due to recruitment slowdowns related to COVID-19[114] Revenue Recognition and Milestones - The company has not generated significant revenues from its operations and expects to incur substantial expenditures in connection with the regulatory approval process for its product candidates[43] - As of June 30, 2022, the company recognized revenue of $17,679 associated with the HTIT License Agreement, with $674 recognized in the quarter ended June 30, 2022, and deferred revenue of $4,703[53] - The company has received milestone payments totaling $20,500, with the initial payment of $3,000 received in January 2016 and subsequent payments received upon achieving specific milestones[60] - The HTIT License Agreement includes a royalty rate of 10% on net sales of the related commercialized products, which may be reduced to a minimum of 8% if certain conditions are not met[58] Regulatory and Compliance - The company's financial statements are prepared in accordance with U.S. GAAP and reflect all necessary adjustments for fair presentation[54] - The company's disclosure controls and procedures were evaluated as effective by the Chief Executive Officer and Chief Financial Officer as of June 30, 2022[154] - No changes in internal control over financial reporting occurred during the quarter ended June 30, 2022, that materially affected the reporting[155]