vTv Therapeutics Announces 2024 Second Quarter Financial Results and Provides Corporate Update

Core Insights - vTv Therapeutics Inc. has initiated a pivotal trial for cadisegliatin, a potential first-in-class oral therapy for type 1 diabetes (T1D), while addressing a clinical hold imposed by the FDA [1][3][4] - The company has expanded its licensing agreement with Newsoara Biopharma for the PDE4 inhibitor HPP737 to a global license, contingent upon a $20 million upfront fee [1][3] - Financial results for Q2 2024 show a net loss of $5.2 million, a slight improvement from a net loss of $5.6 million in the same period last year [4][10] Company Developments - The first patient has been screened in the cadisegliatin pivotal trial for T1D, which is part of a series of trials aimed at regulatory submission [3] - The FDA placed a clinical hold on the cadisegliatin program due to unresolved chromatographic signals in a recent study, requiring an additional in vitro study before resuming [3][4] - Cadisegliatin has previously received Breakthrough Therapy designation from the FDA, indicating its potential to improve glycemic control and reduce hypoglycemia in diabetes patients [3] Financial Performance - As of June 30, 2024, the company's cash position increased to $45.5 million from $9.4 million at the end of 2023, primarily due to private placement financing [4] - Research and Development (R&D) expenses decreased to $3.4 million in Q2 2024 from $4.7 million in Q2 2023, attributed to lower spending on cadisegliatin [4][5] - General and Administrative (G&A) expenses rose to $3.7 million in Q2 2024 from $3.3 million in Q2 2023, driven by increased share-based expenses and legal costs [5][10] Licensing and Partnerships - The amended global licensing agreement for HPP737 includes potential development milestones of up to $41 million and sales-related milestones of up to $35 million, along with mid to upper single-digit royalties [3] - Azeliragon, a partnered program with Cantex Pharmaceuticals, received Orphan Drug Designation for pancreatic cancer and is advancing in multiple clinical trials [2][3]