Financial Performance - The total operating expenses for the three months ended June 30, 2023, were $5.9 million, compared to $0.2 million in 2022, resulting in a loss from operations of $5.9 million [105]. - The net loss for the three months ended June 30, 2023, was $6.7 million, compared to a net loss of $0.3 million in the same period of 2022 [105]. - The total operating expenses for the six months ended June 30, 2023, were $6.9 million, compared to $0.4 million in 2022, leading to a loss from operations of $6.9 million [110]. - The net loss for the six months ended June 30, 2023, was $8.9 million, compared to a net loss of $0.6 million in the same period of 2022 [110]. - Net losses for the six months ended June 30, 2023, were $8.9 million, compared to $0.6 million for the same period in 2022, resulting in an accumulated deficit of $27.4 million [115]. Research and Development - Research and development expenses increased to $0.9 million for the three months ended June 30, 2023, compared to $0.1 million in the same period of 2022, reflecting a $0.8 million increase primarily due to GRI-0621 development costs [106]. - Research and development expenses for the six months ended June 30, 2023, were $1.0 million, up from $0.1 million in 2022, with a $0.9 million increase primarily due to GRI-0621 development [111]. - GRI-0621 is being developed for severe fibrotic lung diseases, with a Phase 2a trial expected to initiate in the second half of 2023 and topline results anticipated in the second half of 2024 [93]. - GRI-0803 is being developed for autoimmune disorders, with an IND filing expected in the first half of 2024 for initial trials targeting systemic lupus erythematosus [94]. Expenses and Costs - General and administrative expenses rose to $5.1 million for the three months ended June 30, 2023, from $0.1 million in 2022, with a $3.8 million increase attributed to professional fees related to the merger [107]. - General and administrative expenses for the six months ended June 30, 2023, were $5.9 million, compared to $0.3 million in 2022, with a $4.5 million increase related to merger-associated professional fees [112]. - The increase in interest expense, net, was $2.1 million for the six months ended June 30, 2023, compared to $0.2 million in 2022, attributed to the Bridge Notes [114]. - Cash flows from operating activities showed a net outflow of $2.1 million for the six months ended June 30, 2023, compared to an outflow of $0.1 million in 2022 [117]. Cash and Financing - Cash and cash equivalents as of June 30, 2023, totaled $4.8 million, with a net cash increase of $4.79 million during the six months [116]. - Net cash provided by financing activities was $6.9 million, primarily due to $12.3 million from the Equity SPA, offset by merger-related costs and liabilities [119]. - The company has financed working capital through common stock, warrants, convertible notes, and promissory notes since inception [116]. - The company expects to incur significant additional costs related to planned clinical trials and product development, indicating a need for substantial future funding [122]. - The company anticipates that existing cash and cash equivalents will be sufficient to fund operations for twelve months post-merger, excluding Series T Warrant Exercises [123]. Going Concern - There is substantial doubt about the company's ability to continue as a going concern if adequate additional funding is not secured [124]. - The company is classified as an "emerging growth company" and intends to rely on exemptions from certain disclosure requirements [128].
VALLON PHARMACEU(VLON) - 2023 Q2 - Quarterly Report