Financial Performance - Total current assets decreased from $128,653,000 as of June 30, 2024, to $98,694,000 as of December 31, 2024, a decline of approximately 23.3%[14] - Total assets decreased from $132,737,000 as of June 30, 2024, to $112,007,000 as of December 31, 2024, representing a decrease of about 15.6%[14] - Net loss for the six months ended December 31, 2024, was $31,108,000, compared to a net loss of $28,433,000 for the same period in 2023, reflecting an increase in loss of about 9.4%[16] - The company reported a comprehensive loss of $30,965,000 for the six months ended December 31, 2024, compared to a comprehensive loss of $28,130,000 for the same period in 2023, indicating a worsening of approximately 10.2%[16] - As of December 31, 2024, the company reported an accumulated deficit of $360.6 million and incurred a net loss of $31.1 million for the six months ended December 31, 2024[37] - The company incurred cumulative net losses of $360.6 million since inception and has not generated meaningful revenue to date[175] - The net loss for the six months ended December 31, 2024, was $31.1 million, compared to a net loss of $28.4 million in the same period of 2023, reflecting an increase of $2.7 million[193] Cash and Investments - Cash and cash equivalents decreased from $70,396,000 at the beginning of the period to $8,932,000 at the end of the period, a decline of approximately 87.3%[21] - The company had cash and cash equivalents of $8.9 million, short-term investments in marketable debt securities of $87.6 million, and long-term investments of $8.8 million as of December 31, 2024[37] - Cash and cash equivalents as of December 31, 2024, were $8.9 million, with short-term marketable debt securities of $87.6 million, resulting in total working capital of approximately $88.1 million[175] - Net cash used in investing activities for the six months ended December 31, 2024, amounted to $37.9 million, with total purchases of marketable debt securities reaching $98.7 million[195] - For the six months ended December 31, 2023, net cash provided by investing activities was $20.4 million, primarily from the maturity of marketable debt securities totaling $60.5 million[196] Operating Expenses - Total operating expenses for the six months ended December 31, 2024, were $34,021,000, compared to $31,108,000 for the same period in 2023, an increase of approximately 9.2%[16] - G&A expenses for the three months ended December 31, 2024, increased by $1.3 million (41%) to $4.5 million compared to $3.2 million in 2023, primarily due to increased consulting expenses and compensation[163] - Total G&A expenses for the six months ended December 31, 2024, increased by $1.8 million (26%) to $8.6 million compared to $6.9 million in 2023, mainly due to higher consulting and compensation expenses[170] - R&D expenses for the six months ended December 31, 2024, rose by $1.1 million (5%) to $25.4 million from $24.3 million in 2023, driven by increased costs related to ersodetug and other preclinical activities[168] Capital Raising Activities - The company raised $6,000,000 from the issuance of common stock in a private placement during the six months ended December 31, 2024[19] - The company completed a private placement in July 2024, selling 1.5 million shares of common stock for gross cash proceeds of $6.0 million[38] - The 2024 Underwritten Offering raised gross proceeds of $67.1 million from the issuance of 11,250,000 shares at $4.00 per share and pre-funded warrants for 3,750,000 shares[67][71] - The company executed a securities exchange agreement on March 8, 2024, purchasing 3,000,000 shares of common stock for $5.7 million, which were immediately cancelled[72] - The company has a maximum of $50.0 million remaining for sale under an open market sales agreement with Jefferies LLC as of December 31, 2024[76] Research and Development - The company is focused on developing treatments for hyperinsulinism and diabetic macular edema, with key clinical assets including ersodetug and RZ402[24] - Research and development expenses for the three months ended December 31, 2024, were $12,627,000, compared to $12,039,000 for the same period in 2023, an increase of about 4.9%[16] - The increase in R&D expenses was primarily due to a $2.8 million net increase in ersodetug R&D costs, driven by manufacturing and clinical costs related to the tHI phase 3 study expected to start in Q2 2025[161] - The company has received over 25 unsolicited physician inquiries regarding ersodetug for tumor hypoglycemia, leading to the treatment of nine patients[137] - Currently, four patients with chronic hypoglycemia are receiving ersodetug as part of the Expanded Access Program, with treatment durations ranging from 6 months to over 2 years[136] Clinical Trials and Market Potential - The company is focused on executing two Phase 3 clinical trials for ersodetug, aiming for complete enrollment of ex-U.S. participants in the sunRIZE study[116] - The sunRIZE Phase 3 study is evaluating the safety and efficacy of ersodetug in participants with congenital hyperinsulinism, with topline results expected in Q4 2025[120] - An interim analysis of the primary endpoint for the sunRIZE study is planned for the current quarter, with results to be announced early in the second quarter[122] - The U.S. market for congenital hyperinsulinism is estimated to have over 1,500 individuals who could be immediately addressed by the Company's treatments[124] - The Phase 3 registrational study for tumor hyperinsulinism is set to commence patient enrollment in Q2 2025, with topline results anticipated in the second half of 2026[126] Financial Obligations and Risks - The company has long-term contractual obligations for milestone payments up to $30.0 million to XOMA and $25.0 million to ActiveSite, with $5.0 million expected to be payable to XOMA in the next 12 months[180] - Future commercialization of ersodetug and RZ402 may require additional milestone payments and royalties totaling up to $202.5 million[183] - The company faces risks related to unstable market conditions, which may adversely affect its financial performance and stock price[208] Shareholder Equity and Stock Options - As of December 31, 2024, total shareholders' equity was $99.589 million, a decrease from $113.441 million as of September 30, 2024, reflecting a net loss of $15.730 million during the quarter[58] - The company authorized an increase in common shares from 100 million to 165 million shares as of December 31, 2024[59] - The company has a weighted average remaining lease term of 2.8 years and total future cash payments under operating leases amounting to $2.1 million[47][48] - The intrinsic value of outstanding options as of December 31, 2024, was approximately $19.2 million, while the aggregate intrinsic value of vested stock options was approximately $8.6 million[88] Miscellaneous - The company has not generated any revenue since its inception in March 2010 and does not expect to generate revenue from product candidates for several years[159] - The company did not recognize any income tax benefit due to a full valuation allowance on its deferred income tax assets for the three and six months ended December 31, 2024[100] - The company had no off-balance sheet transactions for the periods covered by this report[201] - There were no changes in internal control over financial reporting that materially affected the company's financial reporting during the period[204]
Rezolute(RZLT) - 2025 Q2 - Quarterly Report