Financial Performance - Total current assets increased to $23,514,355 as of June 30, 2022, compared to $3,073,195 at December 31, 2021, representing a growth of 664%[14] - Total liabilities rose to $3,058,736 as of June 30, 2022, up from $1,638,120 at December 31, 2021, an increase of 87%[14] - Net loss for the six months ended June 30, 2022, was $6,335,243, compared to a net loss of $1,118,055 for the same period in 2021, reflecting a 467% increase in losses[16] - Net loss per share attributable to common stockholders for the six months ended June 30, 2022, was $(0.70), compared to $(0.44) for the same period in 2021[16] - The company reported a net loss of $6,335,243 for the six months ended June 30, 2022, compared to a net loss of $1,118,055 for the same period in 2021, indicating a significant increase in losses[23] - Cash used in operating activities was $4,068,508 for the six months ended June 30, 2022, compared to $639,353 for the same period in 2021, reflecting a substantial increase in cash outflows[23] - The net loss for the three months ended June 30, 2022, was $4,264,582, compared to a net loss of $792,274 in the same period in 2021, marking a 438.3% increase[210] Research and Development - Research and development expenses for the six months ended June 30, 2022, were $1,748,559, up from $617,779 in the prior year, indicating a 183% increase[16] - The company has focused on the research and development of transformational vaccines, with its lead candidates in the pre-clinical stage[26] - The company anticipates a significant increase in cash outflows for planned pre-clinical development and clinical trial activities[33] - Research and development expenses for the three months ended June 30, 2022, increased by approximately $0.8 million, reaching $1,293,467, compared to $529,542 in the same period in 2021, representing a 144.3% increase[210] - The company anticipates a substantial increase in research and development expenses over the next few years due to the initiation of additional clinical trials and regulatory approvals[205] - The increase in research and development expenses included an increase of approximately $0.7 million in employee compensation and benefits, primarily due to annual bonuses and stock-based compensation[212] Capital and Funding - The company issued 2,222,222 shares of common stock in an initial public offering, netting approximately $17.1 million after offering costs[19] - The company completed its IPO on February 23, 2022, raising approximately $17.1 million in net proceeds after underwriting discounts and offering costs[27] - The company completed a private placement on April 19, 2022, raising approximately $6.9 million in net cash proceeds, and another on August 11, 2022, raising approximately $8.8 million[32] - The company expects to require significant additional capital to support its long-term business plan and plans to seek additional funding through debt or equity financings[33] Expenses - General and administrative expenses for the six months ended June 30, 2022, totaled $4,616,987, compared to $500,276 in the prior year, an increase of 823%[16] - General and administrative expenses for the three months ended June 30, 2022, increased by approximately $2.7 million, totaling $3,001,418, compared to $262,732 in the same period in 2021, reflecting a 1,042.4% increase[210] - The increase in general and administrative expenses includes approximately $1.4 million related to employee and director compensation and benefits[211] Stock and Equity - Total stockholders' equity reached $20,574,961 as of June 30, 2022, compared to $1,446,577 at December 31, 2021, representing a growth of 1,320%[14] - The total number of options to purchase shares of common stock excluded from diluted shares outstanding is 2,857,952 due to anti-dilutive impact[77] - The Company has reserved 1,600,000 shares of common stock for issuance under the 2022 Equity Incentive Plan, which succeeded the 2019 Plan[125] - The Company’s authorized shares remained unchanged at 250,000,000 common shares and 10,000,000 preferred shares after the IPO[101] Agreements and Obligations - The Company holds an exclusive license under the OUI Agreement to develop a vaccine product candidate for influenza, with various milestone payments tied to development progress[90] - Under the St. Jude Agreement, the Company is obligated to achieve specific milestones for developing a vaccine candidate for streptococcus pneumoniae, with potential termination rights for unmet milestones[94] - The CHMC Agreement allows the Company to develop vaccines using norovirus nanoparticles, with obligations to achieve development milestones and potential termination rights for unmet obligations[96] - The company is obligated to pay a 6% royalty on all net sales of licensed products under the OUI Agreement, with an annual minimum royalty payment of $250,000 starting post-product launch[136] - The company is obligated to pay CHMC milestone payments of up to an aggregate of $59.75 million, with specific milestones including approximately $0.5 million for development and approximately $1.25 million for regulatory milestones[143] Tax and Accounting - The company has not recognized any federal, state, or foreign income tax provisions due to net operating losses and has recorded a full valuation allowance against deferred tax assets[158] - The Company adopted ASU 2020-06 on January 1, 2022, which did not impact its financial position, results of operations, cash flows, or net loss per share[79] - The Company is currently evaluating the impact of ASU 2022-03 on its financial statements, which will be effective for public entities after December 15, 2023[84] - The Company does not expect any other recently issued accounting standards to have a material effect on its financial statements[85] Miscellaneous - The ongoing COVID-19 pandemic may continue to impact the company's business operations and financial condition, with uncertainties regarding its effects[201] - The company has not experienced losses on cash accounts exceeding the Federal Depository Insurance Coverage limit, indicating a stable cash management strategy[39] - The Company has not declared or paid any cash dividends and does not plan to do so in the foreseeable future[58] - The company has no products approved for sale and has not generated any revenue from product sales to date[178] - The company relies on third parties for preclinical studies, clinical trials, and manufacturing, with no internal manufacturing capabilities[182]
Blue Water Biotech(BWV) - 2022 Q2 - Quarterly Report