Nuvectis Pharma(US:NVCT)2024-11-05 13:31Financial Performance - The company reported a net loss of $4,153,000 for the three months ended September 30, 2024, compared to a net loss of $5,881,000 for the same period in 2023, indicating an improvement of about 29.3%[19]. - The basic and diluted net loss per common share outstanding for the three months ended September 30, 2024, was $0.24, an improvement from $0.37 for the same period in 2023[19]. - The net loss for the nine months ended September 30, 2024, was $12.8 million, compared to a net loss of $15.6 million for the same period in 2023[24]. - The operating loss for the nine months ended September 30, 2024, was $13,398 thousand, an improvement from an operating loss of $16,031 thousand for the same period in 2023[19]. - The basic net loss attributable to common stockholders for the three months ended September 30, 2024, was $4.2 million, resulting in a basic net loss per share of $0.24[60]. Assets and Liabilities - As of September 30, 2024, total assets amounted to $17,307,000, a decrease from $19,185,000 as of December 31, 2023, representing a decline of approximately 9.8%[18]. - The total liabilities as of September 30, 2024, were $6,316,000, a slight decrease from $6,984,000 as of December 31, 2023, showing a reduction of about 9.6%[18]. - The total stockholders' equity as of September 30, 2024, was $10,991,000, down from $12,201,000 as of December 31, 2023, representing a decrease of approximately 9.9%[18]. - Cash and cash equivalents as of September 30, 2024, totaled $17.2 million[92]. - The accumulated deficit of the company reached $67.0 million as of September 30, 2024, reflecting ongoing net operating losses since inception[27]. Research and Development - Research and development expenses for the three months ended September 30, 2024, were $2,819,000, down from $4,486,000 in the same period of 2023, reflecting a decrease of approximately 37.1%[19]. - The company anticipates a substantial increase in research and development expenses due to ongoing and planned clinical development activities[79]. - Total research and development expenses for the nine months ended September 30, 2024, were $8.4 million, down $2.7 million from $11.1 million in the same period in 2023[87]. - The company has licensed exclusive worldwide development and commercial rights to NXP800 and NXP900, focusing on innovative treatments for oncology[68][73]. - NXP800 has received Fast Track Designation from the FDA for the treatment of platinum-resistant ARID1a-mutated ovarian carcinoma, and Orphan Drug Designation for cholangiocarcinoma[71][72]. Capital and Financing - For the nine months ended September 30, 2024, the company sold 965,911 common shares under its At-the-Market Program, generating approximately $8.1 million in gross proceeds[29]. - The company has approximately $26.6 million of securities remaining available for sale under the At-the-Market Program as of September 30, 2024[49]. - The company expects to require additional capital for regulatory approval and commercialization of product candidates[99]. - The company will need to raise additional capital to complete clinical trials for its product candidates, with no assurance of securing sufficient financing[31]. - The company has sold 1,337,654 shares under the at-the-market offering program, receiving $12.9 million in net proceeds as of September 30, 2024[96]. Employment and Workforce - The company currently has 13 full-time employees and plans to grow its workforce to support future operations[15]. - Employee compensation and benefits increased by $0.6 million to $4.4 million for the nine months ended September 30, 2024, compared to $3.8 million in the same period in 2023[87]. General and Administrative Expenses - General and administrative expenses for the three months ended September 30, 2024, were $1.540 million, compared to $1.672 million for the same period in 2023, a decrease of about 7.9%[82]. - General and administrative expenses for the nine months ended September 30, 2024, increased by $0.1 million to $5.0 million compared to $4.9 million in the same period in 2023[90]. Clinical Trials and Product Development - The Phase 1 clinical trial for NXP900 commenced in September 2023, with ongoing assessments of safety and pharmacokinetics[76]. - The FDA cleared the IND for NXP900 in May 2023, with the Phase 1 clinical trial initiated in September 2023[76]. - The company announced a collaboration with Mayo Clinic to conduct an investigator-sponsored clinical trial for NXP800 in patients with cholangiocarcinoma[72]. - NXP900 demonstrated significant inhibition of tumor growth in various cancer models, with on-target pharmacodynamic effects observed[75].