PolyPid(US:PYPD)2025-08-13 21:06Financial Performance - Net loss for the six months ended June 30, 2025, was $18,245,000, compared to a net loss of $12,742,000 for the same period in 2024, reflecting a 43.5% increase in losses[7] - The company reported a net loss of $18,245,000 for the six months ended June 30, 2025, compared to a net loss of $12,742,000 for the same period in 2024, representing a 43.9% increase in losses year-over-year[23] - Cash flows from operating activities resulted in a net cash outflow of $12,711,000 for the six months ended June 30, 2025, compared to a net cash outflow of $8,494,000 for the same period in 2024, indicating a 49.0% increase in cash used[23] - The company incurred a loss of $18,245,000 during the six-month period ended June 30, 2025, with negative cash flows from operating activities of $12,711,000[23] - The accumulated deficit as of June 30, 2025, was $285,576,000, reflecting the ongoing financial challenges faced by the company[23] Assets and Liabilities - Total assets increased to $37,687,000 as of June 30, 2025, compared to $25,220,000 as of December 31, 2024, representing a 49.5% growth[3] - Current assets rose to $29,988,000, up from $16,573,000, marking an increase of 80.6%[3] - Total current liabilities increased to $13,155,000 as of June 30, 2025, from $12,681,000 at the end of 2024, an increase of 3.7%[5] - Long-term liabilities decreased to $4,056,000 as of June 30, 2025, from $4,855,000 at the end of 2024, a reduction of 16.4%[5] - Cash and cash equivalents increased to $17,448,000 as of June 30, 2025, compared to $15,641,000 as of December 31, 2024, a rise of 11.5%[3] Shareholder Equity and Shares - Total shareholders' equity increased to $20,476,000 as of June 30, 2025, from $7,684,000 at the end of 2024, a growth of 166.5%[5] - The number of ordinary shares outstanding increased to 15,654,129 as of June 30, 2025, from 10,190,904 at the end of 2024, representing a 54.1% increase[5] - Basic and diluted loss per share for the six months ended June 30, 2025, was $1.48, compared to $2.62 for the same period in 2024, a decrease of 43.5%[7] Research and Development - Research and development expenses for the six months ended June 30, 2025, were $12,332,000, up from $9,810,000 in 2024, indicating a 25.4% increase[7] - The company plans to continue incurring substantial losses during its clinical development phase, which may span many years and require significant expenditures[23] - The company successfully completed the SHIELD II Phase 3 trial for its lead product candidate D-PLEX100, achieving a 58% reduction in surgical site infections compared to the standard of care[23] Financing and Funding - The company plans to seek additional equity financing through private and public offerings or strategic partnerships to support its operations[24] - The Company sold 419,680 Ordinary shares under an at-the-market offering for a total amount of $1,472 during the six months ended June 30, 2025[46] - On January 4, 2024, the Company raised $14,999 from a private placement financing by selling 3,143,693 Ordinary shares at $4.81 per share[46] - The Company received $26,690 from the exercise of Existing Warrants under an inducement offer letter agreement on June 16, 2025[51] Warrants and Options - As of June 30, 2025, the company has a total of 11,124,135 outstanding warrants, with an average exercise price of $4.50 per share[63] - The company has 1,181,191 warrants exercisable at an exercise price of $5.50, expiring in January 2026[63] - The company has 7,626,514 warrants exercisable at an exercise price of $4.50, expiring in June 2027[63] - The company has 593,351 warrants with an exercise price of $0.0001 and no maturity date[63] - The company has 1,676,588 warrants exercisable at an exercise price of $3.61, expiring in August 2026[63] - As of June 30, 2025, there were 2,886,193 options outstanding under the Company's Share Option Plan, with a weighted average exercise price of $8.88[62] - The Company increased its options pool by 1,200,000 options on May 12, 2025, bringing the total to 3,512,403[56] - The average exercise price for milestone-based options granted in May 2025 was $2.67, linked to top-line results from the SHIELD II Phase 3 trial[59] Regulatory and Legislative Impact - The One Big Beautiful Bill Act (OBBBA) was signed into law on July 4, 2025, which includes changes to U.S. federal tax law[67] - The company is currently assessing the impact of new legislation on its consolidated financial statements[66] Other Financial Information - The Company recognized interest expenses of $626,000 for the six-month period ended June 30, 2025, compared to $756,000 for the same period in 2024, showing a decrease of 17.2%[40] - The Company has unrecognized compensation costs of $6,908 expected to be recognized over approximately 2.69 years[62] - The total share-based compensation expense recognized for the six months ended June 30, 2025, was $2,875, compared to $1,440 for the same period in 2024[62] - The company excluded 11,112,391 potential ordinary shares from the computation of diluted loss per share for the six months ended June 30, 2025, due to anti-dilutive effects[65] - The company reported 10,530,784 warrants excluded from diluted loss per share computation for the six months ended June 30, 2025[65] - In July 2025, the company sold 243,072 ordinary shares under the ATM for a total amount of $861, net of issuance costs[67] - The Company received participation payments totaling $4,888 from the Israel Innovation Authority, with a commitment to pay royalties at a rate of 3% of sales of developed products[41] - As of June 30, 2025, the Company has not paid or accrued any royalties[43]