Financial Performance - The company reported a net income of $1,534 thousand for the three months ended March 31, 2024, a significant improvement from a net loss of $3,611 thousand in the same period of 2023[28]. - Basic income per share improved to $0.04 for Q1 2024, compared to a loss of $0.08 per share in Q1 2023[28]. - Revenues for the three-month period ended March 31, 2024 were $0, a decrease from $666,000 in the same period in 2023 due to the timing of revenue recognition[135]. - Net financial income increased by 219% to $5,088,000 for the three-month period ended March 31, 2024, compared to $1,597,000 in 2023, driven by revaluation of transactions and interest from deposits[153]. Assets and Liabilities - Total current assets increased to $177,095 thousand as of March 31, 2024, compared to $162,584 thousand as of December 31, 2023, reflecting a growth of approximately 8.5%[23]. - Total liabilities decreased to $37,931 thousand as of March 31, 2024, down from $57,658 thousand as of December 31, 2023, indicating a reduction of approximately 34%[23]. - The company’s total stockholders' equity increased to $166,639 thousand as of March 31, 2024, compared to $163,821 thousand as of December 31, 2023, reflecting a growth of about 1.1%[24]. - As of March 31, 2024, total current liabilities were $33,556,000, resulting in a working capital surplus of $143,539,000[167]. Cash Flow - Cash and cash equivalents at the end of the period increased to $18,576 thousand from $9,055 thousand at the beginning of the period, marking an increase of 105%[34]. - The company generated net cash used in operating activities of $1,476 thousand for the three months ended March 31, 2024, a decrease from $5,549 thousand in the same period of 2023[34]. - Total net cash provided by investing activities was $29,998 thousand for Q1 2024, compared to a cash outflow of $13,203 thousand in Q1 2023[34]. - Financing activities used cash of $19,000,000 in the three months ended March 31, 2024, compared to cash provided of $2,430,000 in the same period in 2023[171]. Research and Development - Research and development expenses decreased to $1,179 thousand in Q1 2024 from $4,427 thousand in Q1 2023, representing a reduction of approximately 73%[28]. - The company is currently incurring lower research and development expenses following the termination of the Phase 3 trials and is conducting a strategic review process[45]. - The ORA-D-013-1 Phase 3 trial for oral insulin did not meet its primary or secondary endpoints, leading to the termination of the ORA-D-013-2 trial as well[120]. - A new Phase 3 clinical trial protocol is being developed based on positive responses from specific patient subpopulations, showing over 1% placebo-adjusted reduction in HbA1c[120]. Joint Ventures and Agreements - On January 22, 2024, the Company entered into a joint venture agreement with Hefei Tianhui Biotech Co., Ltd., focusing on oral drug delivery technology[40]. - The joint venture will initially have equal shares, with the Company contributing $20,000, including $10,000 in cash and $10,000 in common stock[42]. - The Company will receive a 3% royalty on gross revenues generated from assets related to the joint venture[42]. - A joint venture agreement was established with HTIT Biotech, with Oramed contributing $20 million and intellectual property, while HTIT will contribute $70 million in cash[121][123]. Stock and Equity - The weighted average number of shares used in computing diluted income per share increased to 41,564,007 in Q1 2024 from 40,041,258 in Q1 2023[28]. - The Company granted a total of 150,000 RSUs to board members, with a fair value of $359, based on a share price of $2.39[1]. - An additional 37,610 RSUs were granted to certain board members, valued at $90, also based on a share price of $2.39[2]. - The Company issued 950,500 RSUs to executive officers and one employee, with a total fair value of $2,272[3]. - The Company granted 294,000 PSUs to executive officers, with a fair value of $691, contingent on achieving specific stock price targets[4]. Strategic Outlook - The company is evaluating strategic opportunities to enhance shareholder value following the termination of the Phase 3 trials[144]. - The company expects to maintain current planned activities for at least the next 12 months based on available cash resources, although additional financing may be needed[161].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number 001-35813 ORAMED PHARMACEUTICALS INC. | Delaware | 98-0376008 | | --- | --- | | (State or Other Jurisdiction of | (I.R.S. Employer | | Incorporation or Organization) | Identification ...

Financial Performance - Revenues for the nine months ended September 30, 2023, were $1.340 million, a decrease of 33.7% from $2.022 million in the same period of 2022[27]. - The net loss attributable to stockholders for the nine months ended September 30, 2023, was $7.811 million, compared to a loss of $28.018 million for the same period in 2022, reflecting a decrease of 72.1%[27]. - Basic and diluted loss per share for the nine months ended September 30, 2023, was $0.19, down from $0.72 in the same period of 2022[27]. - The net loss for the nine months ended September 30, 2023, was $8,208, compared to a net loss of $29,028 for the same period in 2022[37]. - Basic and diluted loss per share for the three-month period ended September 30, 2023, decreased by 56% to $0.08, compared to $0.18 for the same period in 2022[165]. - The company has incurred aggregate losses of $170,892,000 from inception through September 30, 2023[169]. Assets and Liabilities - Total assets increased to $230.893 million as of September 30, 2023, compared to $161.642 million as of December 31, 2022, representing a growth of 42.7%[24]. - Total stockholders' equity decreased to $149.132 million as of September 30, 2023, from $151.812 million as of December 31, 2022, a decline of 1.8%[24]. - Cash and cash equivalents decreased significantly to $5.468 million as of September 30, 2023, from $40.464 million as of December 31, 2022[24]. - Total current liabilities rose to $78.175 million as of September 30, 2023, from $5.746 million as of December 31, 2022, an increase of 1,261.5%[24]. - As of September 30, 2023, total current assets were $175.705 million and total current liabilities were $78.175 million, resulting in a working capital surplus of $97.530 million[177]. Cash Flow - The company incurred total net cash used in operating activities of $8,877 for the nine months ended September 30, 2023, compared to $19,856 for the same period in 2022[37]. - Cash and cash equivalents at the end of the period were $5,468, down from $40,464 at the beginning of the period[37]. - Operating activities used cash of $8,877,000 in the nine-month period ended September 30, 2023, compared to $19,856,000 in the same period of 2022[179]. - Investing activities used cash of $103,035,000 in the nine-month period ended September 30, 2023, compared to cash provided by investing activities of $18,951,000 in the same period of 2022[180]. - Financing activities provided cash of $76,978,000 in the nine-month period ended September 30, 2023, compared to $6,604,000 in the same period of 2022[181]. Research and Development - Research and development expenses for the nine months ended September 30, 2023, were $7.205 million, down from $20.362 million in the prior year, indicating a reduction of 64.7%[27]. - The company has not generated significant revenues from operations and is currently incurring lower research and development expenses[42]. - Research and development expenses for the three-month period ended September 30, 2023, decreased by 82% to $957,000, compared to $5,347,000 for the same period in 2022[152]. Strategic Initiatives - The company is currently evaluating its existing pipeline and considering strategic opportunities to enhance shareholder value following the termination of two Phase 3 trials[41]. - The company entered into a Stock Purchase Agreement to acquire equity securities of Scilex for a purchase price of $105,000[44]. - A Senior Secured, Super-Priority Debtor-in-Possession Loan Agreement was entered into for $100,000, intended to be used as credit for the purchased securities[45]. - The company entered into a joint venture with Hefei Tianhui Incubator of Technologies Co. Ltd., focusing on the development and commercialization of oral insulin products, with HTIT investing $60 million and Oramed investing $10 million[134][136]. - The joint venture will initiate a Phase 3 oral insulin trial in the United States[135]. Stockholder Information - The company issued common stock, netting $2.428 million during the nine-month period ended September 30, 2023[31]. - The Company issued 1,971,447 shares under the Cantor Equity Distribution Agreement, generating aggregate net proceeds of $26,253 as of September 30, 2023[106]. - Stock-based compensation for the nine months ended September 30, 2023, was $2,845, down from $8,961 in the same period in 2022[37]. Financial Agreements and Securities - The company received a Senior Secured Promissory Note from Scilex for $101,875,000, maturing on March 21, 2025, with interest at Term SOFR plus 8.5%[120][122]. - A Senior Secured Promissory Note was issued to Oramed Pharmaceuticals Inc. by Scilex Holding Company on September 21, 2023[201]. - A Registration Rights Agreement was established between Oramed Pharmaceuticals Inc. and Scilex Holding Company on September 21, 2023[201]. - A Security Agreement was signed among Oramed Pharmaceuticals, Acquiom Agency Services LLC, and Scilex Holding Company on September 21, 2023[201]. Management and Administrative Expenses - General and administrative expenses for the nine-month period ended September 30, 2023, decreased by 43% to $6,314,000, compared to $11,085,000 for the same period in 2022[159]. - General and administrative expenses for the three-month period ended September 30, 2023, decreased by 15% to $2,599,000, compared to $3,061,000 for the same period in 2022[160]. - The President and CEO's monthly consulting fee is NIS 88,023 ($23), and he receives a gross monthly salary of NIS 46,901 ($12) from the subsidiary[111][112]. - There were no relocation expenses for the President and CEO during the nine months ended September 30, 2023, compared to $201 for the same period in 2022[109].

Financial Performance - The company reported revenues of $1.34 million for the six months ended June 30, 2023, consistent with the same period in 2022 [26]. - The net loss attributable to stockholders for the six months ended June 30, 2023, was $4.589 million, compared to a net loss of $20.958 million for the same period in 2022, indicating an improvement of approximately 78.1% [26]. - Basic and diluted loss per share improved to $0.11 for the six months ended June 30, 2023, compared to $0.54 for the same period in 2022 [26]. - The net loss for the six months ended June 30, 2023, was $4,924, compared to a net loss of $21,775 for the same period in 2022 [37]. - The Company reported a net loss of $4.92 million for the six months ended June 30, 2023, significantly lower than the $21.78 million loss for the same period in 2022 [112]. Assets and Liabilities - As of June 30, 2023, total assets decreased to $156.314 million from $161.642 million as of December 31, 2022, representing a decline of approximately 3.5% [23]. - Total current liabilities decreased to $1.067 million as of June 30, 2023, from $5.746 million as of December 31, 2022, a reduction of approximately 81.5% [23]. - The company’s total stockholders' equity as of June 30, 2023, was $151.546 million, slightly down from $151.812 million as of December 31, 2022 [23]. - As of June 30, 2023, the total stockholders' equity was $150,655, an increase from $150,148 as of March 31, 2023 [34]. - Cash and cash equivalents at the end of the period were $6,767, down from $40,464 at the beginning of the period [37]. - The total long-term liabilities remained relatively stable at $4.592 million as of June 30, 2023, compared to $4.740 million as of December 31, 2022 [23]. Expenses - Research and development expenses significantly decreased to $6.248 million for the six months ended June 30, 2023, down from $15.015 million in the same period of 2022, a reduction of approximately 58.4% [26]. - General and administrative expenses for the six months ended June 30, 2023 decreased by 54% to $3,715,000, down from $8,024,000 in the same period in 2022 [132]. - Sales and marketing expenses decreased by 61% to $376,000 for the six months ended June 30, 2023, compared to $970,000 for the same period in 2022 [129]. - Sales and marketing expenses decreased by 49% to $192,000 for the three months ended June 30, 2023, compared to $380,000 for the same period in 2022 [130]. - The company incurred stock-based compensation of $1,993 for the six months ended June 30, 2023, compared to $5,911 for the same period in 2022 [37]. Financial Income - Financial income increased to $4.075 million for the six months ended June 30, 2023, compared to $0.894 million in the same period of 2022, an increase of approximately 355.4% [26]. - Net financial income increased by 356% to $4,075,000 for the six months ended June 30, 2023, compared to $894,000 for the same period in 2022 [134]. Strategic Developments - The company is evaluating potential strategic opportunities to enhance shareholder value following the trial results [41]. - The company is currently evaluating a path forward with Medicox following the results of the ORA-D-013-1 Phase 3 trial [62]. - The joint venture with HTIT will focus on the development and commercialization of oral insulin and POD™ technology, with HTIT investing $60 million and Oramed investing $10 million [108]. - The company is considering a path forward for its oral insulin candidate based on positive responses from specific patient subpopulations [125]. Agreements and Transactions - The company entered into a DIP Loan Agreement for $100,000 on August 9, 2023, which will significantly reduce its cash position [43]. - The Company entered into a controlled equity offering agreement allowing for the issuance of shares with an aggregate offering price of up to $100,000, resulting in net proceeds of $26,253 from 1,971,447 shares issued as of August 10, 2023 [79]. - The Company entered into a Stock Purchase Agreement to acquire securities of Scilex Holding Company for a total purchase price of $105,000, subject to bankruptcy court approval [87]. - The Company will provide a DIP Facility of $100,000 to the Debtors, with proceeds used to refinance approximately $82,000 of existing obligations and for working capital [91]. - The Stock Purchase Agreement includes several closing conditions, including governmental approvals and no occurrence of a trigger event in Scilex's governance documents [162]. Marketable Securities - As of June 30, 2023, the company's marketable securities totaled $943, down from $3,743 as of December 31, 2022 [69]. - The fair value of held to maturity securities as of June 30, 2023, was estimated at $500, compared to $3,224 as of December 31, 2022 [74]. - The company recorded an $824 increase in the value of its non-marketable equity securities due to a Series C investment round in Diasome closing in June 2023 [77]. - The company holds approximately 1.4% of DNA's outstanding ordinary shares, with a fair value of $334 as of June 30, 2023 [70]. Trial Results - The ORA-D-013-1 Phase 3 trial did not meet its primary and secondary endpoints, leading to its termination [41]. - The ORA-D-013-1 Phase 3 trial did not meet its endpoints, leading to its termination, but analysis indicates potential for specific patient subpopulations to respond well to oral insulin [99].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-35813 ORAMED PHARMACEUTICALS INC. (Exact Name of Registrant as Specified in Its Charter) | Delaware | 98-0376008 | | --- | --- | | (State or Other Jurisdiction of | (I.R.S. Em ...

Clinical Trials and Research - The ORA-D-013-1 Phase 3 trial for the oral insulin candidate did not meet its primary and secondary endpoints, leading to the termination of both ORA-D-013-1 and ORA-D-013-2 trials[21] - The company is conducting a comprehensive analysis of the trial data to explore potential paths forward for the oral insulin candidate[21] - The company plans to continue clinical trials to demonstrate the effectiveness of its oral dosage form for insulin delivery[20] - The oral vaccine developed by Oravax has shown significant antibody response (2-6 fold over baseline) in preliminary Phase 1 data, with no safety issues reported[25] - The company experienced approximately six months of delays in clinical trials due to COVID-19, but does not expect material impact on its development timeline[30] - Oramed Ltd. is currently evaluating collaboration paths with both HTIT and Medicox following the results of the ORA-D-013-1 Phase 3 trial[42][45] Market Opportunities and Demand - The estimated global diabetes population is projected to increase from 537 million in 2021 to 783 million by 2045, highlighting significant market demand for diabetes-related products[29] - The oral insulin capsule is anticipated to be competitive due to its efficacy and safety profile, despite existing treatment options for diabetes[64] Financial Performance and Assets - As of December 31, 2022, the company had $40.5 million in cash and cash equivalents, $111.5 million in short-term and long-term bank deposits, and $3.7 million in marketable securities[233] - The company owns 1,701,357 common shares of DNA and 117,000 ordinary shares of Entera, which are classified as marketable securities[236] - The company aims to preserve financial assets, maintain adequate liquidity, and maximize returns while minimizing exposure to market risks[234] Patents and Licensing Agreements - The company holds 112 patents, with 20 issued during the fiscal year ended December 31, 2022, covering technologies for oral delivery of proteins and diabetes treatment[34] - The HTIT License Agreement grants HTIT an exclusive commercialization license for ORMD-0801 in China, with royalties of 10% on net sales and milestone payments totaling $37.5 million, of which $20.5 million has been received[41] - The Medicox distribution license agreement allows Medicox to distribute ORMD-0801 in South Korea for ten years, with up to $15 million in developmental milestones and 15% royalties on gross sales[44] - The Oravax License Agreement includes 7.5% royalties on net sales and potential milestone payments ranging from $25 million to $100 million based on sales achievements[43] - Oramed Ltd. has entered into a Patent Transfer Agreement with Entera, receiving 3% royalties on Entera's net revenues from a patent application related to oral administration of proteins[40] - As of December 31, 2022, Entera had not paid any royalties to Oramed Ltd., and Oramed held approximately 0.4% of Entera's outstanding ordinary shares[40] Strategic Evaluation and Shareholder Value - The company is evaluating potential strategic opportunities to enhance shareholder value[16] - Research and development expenses are expected to continue being the company's major expenditure, impacting short- and long-term capital requirements[18] Competition and Industry Landscape - Competition in the biomedical and pharmaceutical sectors is intense, with many companies having greater financial and technical resources[60] - The drug approval process is time-consuming and resource-intensive, influenced by factors such as illness severity and alternative treatments available[58] - The FDA's review of a Biological License Application can take an average of 18 months, providing 12 years of exclusivity in the U.S. market upon approval[55] Human Resources and Talent Management - The company has contracted with seventeen individuals for employment or consulting arrangements, including six in senior management and four in research and development[75] - The company provides competitive compensation, health, and retirement programs, along with bonuses and stock-based compensation for eligible employees[76] - The company focuses on attracting and retaining top talent to create an inclusive and diverse workplace[74] - The company has a Scientific Advisory Board consisting of recognized experts in the field, enhancing its research and development capabilities[65] Financial Risk Management - The company does not use any currency hedging transactions to mitigate financial exposure from fluctuations in the exchange rate of the U.S. dollar against the NIS[239] - The average exchange rate of the U.S. dollar to the NIS for the year ended December 31, 2022, was 3.358, with a period-end rate of 3.519[239] - The company is exposed to a potential exchange rate gain of approximately $206,000 with a 10% appreciation of the NIS against the U.S. dollar, and a loss of approximately $169,000 with a 10% devaluation[238]

Financial Performance - Revenues for the nine months ended September 30, 2022, were $2.0 million, consistent with the same period in 2021[26] - Net loss for the nine months ended September 30, 2022, was $29.0 million, compared to a net loss of $17.5 million for the same period in 2021, indicating an increase of approximately 65.8%[26] - Basic and diluted loss per share for the nine months ended September 30, 2022, was $0.72, compared to $0.54 for the same period in 2021, an increase of approximately 33.3%[26] - Operating loss for the nine months ended September 30, 2022, was $30.9 million, compared to $18.5 million for the same period in 2021, reflecting an increase of approximately 66.7%[26] - Net loss for the nine-month period ended September 30, 2022, was $29,028,000, compared to a net loss of $17,508,000 for the same period in 2021[116] - Net financial income for the nine-month period ended September 30, 2022, was $1,930,000, compared to $1,031,000 for the same period in 2021[136] Assets and Liabilities - Total assets as of September 30, 2022, decreased to $164.4 million from $177.8 million as of December 31, 2021, representing a decline of approximately 7.9%[23] - Total stockholders' equity decreased to $153.8 million as of September 30, 2022, from $166.5 million as of December 31, 2021, a decline of about 7.6%[23] - Total current liabilities decreased to $6.5 million as of September 30, 2022, from $7.4 million as of December 31, 2021, a reduction of about 11.5%[23] - Long-term liabilities increased to $4.8 million as of September 30, 2022, from $3.8 million as of December 31, 2021, an increase of approximately 24.1%[23] - Cash and cash equivalents increased to $33.2 million as of September 30, 2022, from $27.5 million as of December 31, 2021, a growth of approximately 20.0%[23] - Cash and cash equivalents at the end of the period on September 30, 2022, were $33,196,000, down from $84,413,000 at the end of the same period in 2021[36] - The company incurred aggregate losses of $154,538,000 from inception through September 30, 2022, while raising a total of $248,769,000 through various stock offerings[142] Research and Development - Research and development expenses increased to $20.4 million for the nine months ended September 30, 2022, up from $15.5 million in the prior year, reflecting a rise of approximately 31.5%[26] - The company reported stock-based compensation of $8,961,000 for the nine months ended September 30, 2022, compared to $2,896,000 for the same period in 2021, indicating a significant increase in compensation expenses[36] - The company incurred $15,280 in research and development expenses under a CRO Services Agreement for its phase 3 clinical trial for oral insulin, with a total amended payment of $22,684[72] - The company recognized $7,357 in research and development expenses from another CRO Services Agreement for the same phase 3 clinical trial, with a total amended payment of $15,796[72] - Research and development expenses increased by 32% to $20,362,000 for the nine-month period ended September 30, 2022, compared to $15,452,000 for the same period in 2021[127] - 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 same period in 2021[128] Financing Activities - The company had total net cash provided by financing activities of $6,604,000 for the nine months ended September 30, 2022, compared to $97,739,000 in the same period of 2021, reflecting a decrease in financing activities[36] - The company plans to seek additional financing through public or private equity markets to support future research and development activities[143] - The company issued 1,334,695 shares under the Cantor Equity Distribution Agreement, generating aggregate net proceeds of $19,664[86] - The company raised approximately $46,375 from a registered direct offering of 2,000,000 shares at $25.00 per share on November 5, 2021[86] Clinical Trials and Agreements - The company is conducting two Phase 3 trials for its oral insulin product, involving approximately 1,125 patients[99] - The first Phase 3 trial (ORA-D-013-1) completed enrollment in May 2022, with 710 patients recruited from over 90 clinical sites[103] - The second Phase 3 trial (ORA-D-013-2) aims to recruit 450 patients, with 50% enrolled as of July 2022[104] - Topline efficacy data for the ORA-D-013-1 trial is expected in January 2023, with a BLA filing anticipated in 2024 or 2025[105] - The company has experienced approximately six months of delays in clinical trials due to slow recruitment, with potential for further delays if the pandemic worsens[45] - The Phase 1 trial of Oravax's oral COVID-19 vaccine reported positive preliminary data, meeting primary and secondary endpoints of safety and immunogenicity[112] Revenue Recognition and Agreements - As of September 30, 2022, the company recognized revenue of $18,361 related to the HTIT License Agreement, with $682 recognized in the quarter ended September 30, 2022, and deferred revenue of $4,022[54] - The HTIT License Agreement includes a royalty rate of 10% on net sales of the related products, which may be reduced to a minimum of 8% if certain conditions are not met[59] - The company entered into a non-binding memorandum of agreement with Medicox Co., Ltd. for the exclusive distribution of ORMD-0801 in South Korea, with a non-refundable payment of $2,000 received[55] - The company has not recognized any royalty-related revenue to date, as it applies the sales-based royalty exception under ASC 606[53] Stock and Equity - The company’s balance of common stock increased from $38,564,000 as of June 30, 2022, to $39,113,000 as of September 30, 2022, reflecting ongoing capital activities[34] - The company’s total stockholders' equity as of September 30, 2022, was $153,147,000, a slight decrease from $153,697,000 as of June 30, 2022[34] - The company purchased Series B preferred stock of Diasome Pharmaceuticals for approximately $2,700,000, acquiring less than 5% of Diasome's outstanding stock[153] - The company’s investment in DNA represents approximately 1.4% of its outstanding ordinary shares as of September 30, 2022[82] Lease and Operating Expenses - The company has various operating leases, with operating right-of-use assets valued at $1,005 as of September 30, 2022[91] - Total undiscounted lease payments amount to $951, with a present value of lease liabilities at $900 as of September 30, 2022[91] - The annual lease payment for additional space in Israel is approximately $123, with a lease term of 60 months starting February 1, 2022[72] Market and Future Outlook - The company expects to submit a product for approval by June 2023 under the HTIT License Agreement[117] - The company expects to continue investing heavily in research and development, which will remain its major operating expense in the upcoming years[156] - The company is continuing to assess the impact of COVID-19 on its operations and development timeline[45]

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]

Financial Performance - Revenues remained stable at $666 thousand for the three months ended March 31, 2022, unchanged from the same period in 2021[27] - The net loss for the period was $10,708 thousand, compared to a net loss of $6,063 thousand for the same period in 2021, indicating an increase in losses of 76.5%[27] - Basic and diluted loss per share increased to $0.27 for the three months ended March 31, 2022, compared to $0.20 in the prior year[27] - For the three months ended March 31, 2022, the company reported a net loss of $10.708 million, compared to a net loss of $6.063 million for the same period in 2021, representing a 76.5% increase in losses year-over-year[34] - Revenues for the three-month periods ended March 31, 2022, and March 31, 2021, were both $666,000, with no cost of revenues reported[112][114] Expenses - Research and development expenses were $5,836 thousand, a decrease of 5.4% from $6,168 thousand in the prior year[27] - General and administrative expenses increased significantly to $5,492 thousand, compared to $1,102 thousand in the same period last year, reflecting a rise of 398%[27] - The company incurred stock-based compensation expenses of $4.029 million in the three months ended March 31, 2022, compared to $647 thousand in the same period in 2021, reflecting a substantial increase[34] - Research and development expenses decreased by 5% to $5,836,000 for the three-month period ended March 31, 2022, compared to $6,168,000 for the same period in 2021[121] - General and administrative expenses increased by 398% to $5,492,000 for the three-month period ended March 31, 2022, compared to $1,102,000 in the prior year[127] Assets and Liabilities - Total assets decreased to $172,224 thousand as of March 31, 2022, down from $177,820 thousand as of December 31, 2021, representing a decline of approximately 3.3%[24] - Total stockholders' equity decreased to $162,349 thousand as of March 31, 2022, down from $166,453 thousand as of December 31, 2021, a decline of approximately 2.5%[24] - Total current liabilities decreased to $6,324 thousand as of March 31, 2022, down from $7,368 thousand as of December 31, 2021, a reduction of 14.2%[24] - As of March 31, 2022, total current assets were $143,562,000, and total current liabilities were $6,324,000, resulting in a working capital surplus of $137,238,000[132] - The accumulated loss as of March 31, 2022, was $136,945,000, an increase from $126,520,000 as of December 31, 2021[132] Cash Flow - Cash and cash equivalents increased slightly to $27,967 thousand from $27,456 thousand, reflecting a growth of 1.9%[24] - Total net cash used in operating activities was $9.125 million for the three months ended March 31, 2022, compared to $3.682 million for the same period in 2021, indicating a significant increase in cash outflow[34] - Cash and cash equivalents at the end of the period were $27.967 million, a decrease from $57.741 million at the end of the same period in 2021[34] - The company reported total net cash provided by investing activities of $7.359 million for the three months ended March 31, 2022, down from $10.753 million in the same period in 2021[34] - Operating activities used cash of $9,125,000 in the three-month period ended March 31, 2022, compared to $3,682,000 used in the same period in 2021[134] Financing Activities - The company issued 405,224 shares of common stock during the three months ended March 31, 2022, resulting in an increase in common stock value to $463 thousand[31] - The Company raised approximately $46,375,000 from a registered direct offering of 2,000,000 shares at an offering price of $25.00 per share on November 5, 2021[82] - The Company issued 841,638 shares under the Cantor Equity Distribution Agreement for aggregate net proceeds of $15,275,000 as of May 12, 2022[82] - The company entered into a controlled equity offering agreement allowing for the issuance of up to $100,000,000 in common stock, with 841,638 shares issued for net proceeds of $15,275,000 as of May 12, 2022[137] - A securities purchase agreement was executed to sell 2,000,000 shares at $25.00 per share, resulting in net proceeds of approximately $46,375,000[138] Clinical Trials and Product Development - The proprietary oral insulin capsule, ORMD-0801, is designed to deliver insulin effectively and is currently undergoing clinical trials[95] - The FDA has indicated that the regulatory pathway for ORMD-0801 will be a BLA, potentially granting 12 years of marketing exclusivity upon approval[98] - The Phase 2b trial for ORMD-0801 showed positive topline data, demonstrating an excellent safety profile with no serious drug-related adverse events[99] - The company is conducting two concurrent Phase 3 trials for ORMD-0801 involving approximately 1,125 patients with type 2 diabetes (T2D) to assess safety and efficacy over 6 to 12 months[100] - The company expects topline results from the trials in January 2023 and plans to file a Biologics License Application (BLA) with the FDA in 2024, which would provide at least 12 years of marketing exclusivity[102] Revenue Recognition and Agreements - The company recognized revenue of $666 thousand in the quarter ended March 31, 2022, from the HTIT License Agreement, with a total of $17.005 million recognized to date under this agreement[51] - The company has deferred $5.377 million in revenue related to the HTIT License Agreement, which is presented as deferred revenues on the balance sheet[51] - The HTIT License Agreement includes a royalty rate of 10% on net sales of commercialized products, which may be reduced to 8% if certain conditions are not met, and potentially to 5% after patent expiration in 2033[56] - The Company has a deferred revenue of $2,000 related to disputed payments from HTIT, with a total disputed amount of $6,000[59] - The Company allocated $38,883 to the HTIT License Agreement as part of a total consideration of $49,500 from the SPA and License Agreement[61]

Addressing the Multibillion-Dollar Injectable Drug Markets with Oral Formulations January 2022 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, including with respect to clinical trials, milestones and the potential benefits of Oramed's products, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from thos ...