Financial Performance - The company incurred a net cash used in operating activities of $22 million for the year ended December 31, 2024, compared to $17.2 million for the previous year, primarily due to ongoing clinical trials [529]. - The company has not generated any revenue from product sales and does not expect to do so for at least the next few years, necessitating substantial additional funding [533]. - The company has a shareholders' equity of $7.7 million as of December 31, 2024, and anticipates continued losses and negative cash flows until products reach commercial profitability [534]. - As of September 30, 2024, the company's stockholders' equity was approximately $2.2 million, below the Nasdaq minimum requirement of $2.5 million [538]. - The company does not expect to generate any revenue from product sales for at least the next few years [541]. - The company has not generated any revenue from product sales to date and does not anticipate doing so in the near future [541]. Funding and Capital Raising - The company raised $32.4 million from financing activities in 2024, a significant increase from $10 million in 2023, mainly attributed to private placements [532]. - The company sold 3,143,693 Ordinary Shares at $4.81 per share in January 2024, resulting in gross proceeds of $16.2 million, intended for clinical trials and working capital [522]. - The company sold 3,386,962 Ordinary Shares at $3.22 per share in December 2024, generating gross proceeds of $14.5 million for ongoing clinical trials [524]. - The company plans to continue raising capital through the sale of equity securities, debt, or strategic partnerships to mitigate going concern risks [534]. - The company entered into a Loan Agreement for up to $15 million, with the first tranche of $10 million drawn in April 2022 and a restructuring amendment in March 2023 [516][519]. Research and Development - The company incurred $174.4 million in research and development expenses from inception through December 31, 2024, to advance clinical-stage product candidates [541]. - The company has a research and development team of 50 scientists, doctors, and clinicians based in Petach Tikva, Israel [539]. - Non-cash share-based compensation expenses were $4.3 million, $3.4 million, and $2.8 million for the years ended December 31, 2022, 2023, and 2024, respectively [548]. Commercialization and Regulatory Compliance - The company expects to incur significant commercialization expenses if marketing approval is obtained for any product candidates [533]. - The company expects to incur significant commercialization expenses if it obtains marketing approval for any product candidates [541]. - The company must comply with restrictions associated with IIA grants, which may affect its ability to outsource manufacturing or engage in change of control transactions [553]. Intellectual Property - The patent estate includes 156 issued patents and 20 pending patent applications as of February 26, 2025, covering the PLEX technology platform and product candidates [540]. - The company has received royalty-bearing grants totaling $4.9 million, with a royalty obligation of 3.0% on revenues from products developed with these grants [552].
PolyPid(PYPD) - 2024 Q4 - Annual Report