Financial Performance - Total operating expenses for the three months ended March 31, 2023, were $2,848,259, compared to $2,070,661 for the same period in 2022, representing an increase of approximately 37.5%[69] - The net loss for the three months ended March 31, 2023, was $2,846,644, compared to a net loss of $2,070,661 for the same period in 2022, indicating an increase in losses of about 37.4%[69] - The net loss per share attributable to common stockholders for the three months ended March 31, 2023, was $(0.18), an improvement from $(0.34) in the same period of 2022[69] - Net cash used in operating activities was $4,446,083 for the three months ended March 31, 2023, significantly higher than the $886,091 used in the same period in 2022, indicating a substantial increase in cash outflows[72] - The company reported a net loss of $2,846,644 for the three months ended March 31, 2023, compared to a net loss of $2,070,661 for the same period in 2022, representing an increase in losses of approximately 37.4%[72] - The Company expects to continue incurring significant operating losses for the foreseeable future[122] Research and Development - Research and development expenses increased significantly to $1,082,237 for the three months ended March 31, 2023, from $455,092 in the same period of 2022, reflecting a growth of approximately 137.5%[69] - The Company is developing multiple vaccine candidates, including BWV-201 for pneumococcal diseases and BWV-101 and BWV-102 as universal influenza vaccines, all currently in pre-clinical development[95] - The Company incurred approximately $335,000 in research and development expenses during the three months ended March 31, 2023, compared to approximately $217,000 for the same period in 2022, reflecting an increase of about 54.3%[133] - The Company incurred approximately $8,000 in research and development costs related to a co-development agreement as of March 31, 2023, but determined that achieving specified milestones is not yet probable[109] - The Company has entered into a co-development agreement with AbVacc, Inc. for vaccine candidates, with milestone payments ranging from $2.1 million to $4.75 million, plus royalties of 2% to 4%[135] - The Company has a license agreement with St. Jude Children's Research Hospital, which includes milestone payments and royalties for developing a vaccine candidate for streptococcus pneumoniae[129] - The Company is utilizing a virus-like particle platform to develop vaccine candidates against various infectious diseases, including norovirus and malaria[95] Capital and Liquidity - The company has expressed the need to raise substantial additional capital to fund its operations, highlighting potential liquidity challenges[55] - The Company is required to secure additional capital to fund ongoing operations and product commercialization, with no current commitments for further financing[98] - Cash and restricted cash at the end of the period totaled $21,255,803, down from $25,752,659 at the beginning of the period, reflecting a decrease of approximately 17.5%[82] - The company completed its IPO on February 23, 2022, raising approximately $17.1 million in net proceeds after offering costs, which contributed to its financing activities[76] - The Company received net proceeds of approximately $17.1 million from its IPO after deducting underwriting discounts and offering costs[139] - The company has entered into an At The Market Offering Agreement to sell up to $3,900,000 of shares of common stock, with a commission of 3.0% on gross proceeds from each sale[173] Assets and Liabilities - Total liabilities decreased from $3,922,445 as of December 31, 2022, to $2,808,619 as of March 31, 2023, showing a reduction of approximately 28.4%[65] - Total stockholders' equity decreased from $22,388,002 as of December 31, 2022, to $19,693,482 as of March 31, 2023, reflecting a decline of about 12.1%[67] - The company had total current assets of $22,472,391 as of March 31, 2023, compared to $26,257,741 as of December 31, 2022, indicating a decrease of about 14.5%[89] - As of March 31, 2023, total accrued expenses decreased to $1,292,951 from $2,409,128 as of December 31, 2022, representing a reduction of approximately 46.4%[127] - Accrued research and development expenses were $549,762 as of March 31, 2023, down from $847,747 as of December 31, 2022, indicating a decrease of about 35.2%[127] Stock and Shareholder Information - The company had 15,905,732 shares of common stock outstanding as of May 12, 2023[52] - The company’s weighted average number of common shares outstanding increased from 6,339,435 as of March 31, 2022, to 15,910,415 as of March 31, 2023, reflecting the impact of the IPO and other equity transactions[91] - The Company repurchased 32,638 shares of common stock at an average price of $1.03 per share during the three months ended March 31, 2023, totaling approximately $33,500[140] - The Company has approximately 4.5 million shares remaining that can be repurchased under the Repurchase Program as of March 31, 2023[140] - The company has a stock repurchase program allowing the repurchase of up to 5.0 million shares of common stock at a maximum price of $2.00 per share, with no expiration date[165] Regulatory and Market Considerations - The company continues to evaluate the impact of the COVID-19 pandemic on its financial position and operations, indicating ongoing uncertainty in the market[46] - The company is focused on obtaining necessary regulatory approvals to market and commercialize its products, which is critical for future growth[60] - The Company has substantial doubt about its ability to continue as a going concern for one year from the issuance of the condensed financial statements due to historical and expected operating losses[80] Strategic Developments - The Company completed the acquisition of ENTADFI® in April 2023, requiring an initial payment of $20.0 million, with $6.0 million paid at closing and $9.0 million due within one year[122] - The company has hired key personnel, including a Senior Vice President of Marketing and Business Development and a Chief Medical Officer, to support the launch of ENTADFI[160] - The company announced a joint development agreement with AbVacc for vaccine candidates targeting monkeypox and Marburg virus disease, utilizing its norovirus shell and protrusion virus-like particle platform[161] - The company has developed a remediation plan for material weaknesses in its internal control over financial reporting[180]
Blue Water Biotech(BWV) - 2023 Q1 - Quarterly Report