Bluejay Diagnostics Inc

Previous wording

Since inception we have incurred net losses from operations each year and we expect to continue to incur losses for the foreseeable future. We incurred net losses of approximately $2.5 million and $4.8 million for the three and six months ended June 30, 2024. We had negative cash flow from operating activities of approximately $4.1 million and $4.4 million for the six months ended June 30, 2024, and 2023, respectively, and had an accumulated deficit of approximately $31.8 million as of June 30, 2024.

Current wording

Since inception we have incurred net losses from operations each year and we expect to continue to incur losses for the foreseeable future. We incurred net losses of approximately $1.5 million and $6.3 million for the three and nine months ended September 30, 2024. We had an accumulated deficit of approximately $33.2 million as of September 30, 2024.

Previous wording

As further described below under “Liquidity and Going Concern Uncertainty” as of June 30, 2024, the Company possessed cash and cash equivalents of approximately $8.1 million, while having current liabilities of approximately $2.1 million. During the six months ended June 30, 2024, the Company’s net cash used in operating activities was approximately $4.1 million. The Company expects that it will need to raise additional capital in the next twelve (12) months to continue as a going concern, and absent such funding, cash resources will be sufficient to fund its operations through the first quarter of 2025.

Current wording

As further described below under “Liquidity and Going Concern Uncertainty” as of September 30, 2024, the Company possessed cash and cash equivalents of approximately $5.8 million, while having current liabilities of approximately $1.0 million. During the nine months ended September 30, 2024, the Company’s net cash used in operating activities was approximately $6.1 million. The Company expects that it will need to raise additional capital in the next twelve months to continue as a going concern, and absent such funding, cash resources will be sufficient to fund its operations only through the first quarter of 2025.

Previous wording

Comparison of the Three and Six Months Ended June 30, 2024 and 2023

Current wording

Comparison of the Three and Nine Months Ended September 30, 2024 and 2023

Previous wording

The following table sets forth our results of operations for the three and six months ended June 30, 2024 and 2023:

Current wording

The following table sets forth our results of operations for the three and nine months ended September 30, 2024 and 2023:

Previous wording

Research and development expenses for the three months ended June 30, 2024 were approximately $1.0 million as compared to approximately $1.7 million for the same period in 2023. The decrease in research and development expenses was primarily due to a reduction in technology transfer efforts which offset increased clinical trial expenses. We expect future research and development expenses to be focused on costs specifically associated with our clinical trial program supporting our regulatory strategy, technology transfer efforts and any necessary manufacturing improvements.

Current wording

Research and development expenses for the three months ended September 30, 2024 were approximately $0.6 million as compared to approximately $1.4 million for the same period in 2023. The decrease in research and development expenses was primarily due to a reduction in technology transfer efforts which offset increased clinical trial expenses. We expect future research and development expenses to be focused on costs specifically associated with our clinical trial program supporting our regulatory strategy, technology transfer efforts and any necessary manufacturing improvements.

Previous wording

General and administrative expenses for the three months ended June 30, 2024, were approximately $0.9 million as compared to approximately $1.1 million for the comparable period in 2023. The minor decrease in general and administrative expenses is due to continued efforts to preserve capital by limiting our investment in infrastructure and reducing professional services commensurate with our commercialization timeline. We expect to monitor and continue to pare our general and administrative spend, as necessary, to optimize operational alignment.

Current wording

General and administrative expenses for the three months ended September 30, 2024, were approximately $0.8 million as compared to approximately $1.0 million for the comparable period in 2023. The minor decrease in general and administrative expenses is due to continued efforts to preserve capital by limiting our investment in infrastructure and reducing professional services commensurate with our commercialization timeline. We expect to monitor and continue to pare our general and administrative spend, as necessary, to optimize operational alignment.

Previous wording

Sales and marketing expenses for the three months ended June 30, 2024 were approximately $300 as compared to approximately $154,000 for the comparable period in 2023. The decrease in sales and marketing expenses was due to a reduction in spending in all sales and marketing efforts.

Current wording

Sales and marketing expenses for the three months ended September 30, 2024 were $753 as compared to $(19,619) for the comparable period in 2023. The low sales and marketing expenses in 2024 are due to a reduction in spending in all sales and marketing efforts and the negative 2023 amount is related to the cancellation and forfeiture of equity awards by terminated personnel.

Previous wording

Other income, net for the three months ended June 30, 2024, was approximately $560,000 of expense as compared to $90,000 of income for the same periods in 2023. The decrease in net other income was primarily due to higher interest expense ($631,000) associated with our notes payable under the Bridge Note Financing.

Current wording

Other income (expense), net for the three months ended September 30, 2024, was $(120,352) of expense as compared to $43,235 of income for the same periods in 2023. The decrease in other income (expense), was primarily due to higher interest expense incurred associated with our notes payable under the Bridge Note Financing.

Previous wording

Our operations to date have been funded primarily through equity financings. As of June 30, 2024, the Company had cash and cash equivalents of approximately $8.1 million, and current liabilities of approximately $2.2 million. During the six-month period ended June 30, 2024, the Company’s net cash used in operating activities was approximately $4.1 million. The future viability of the Company is largely dependent on its ability to raise additional capital to finance its operations. The Company expects that it will need to raise additional capital within the next twelve months to continue its operations as the current, cash resources will be sufficient to fund its operations through the first quarter of 2025. Although the Company has been successful in raising capital in the past, there is no assurance that it will be successful in obtaining such additional financing on terms acceptable to the Company, if at all. If the Company is unable to obtain funding, the Company could be forced to delay, reduce or eliminate its research and development program, product development or commercialization efforts, which could adversely affect its business prospects.

Current wording

Our operations to date have been funded primarily through equity financings. As of September 30, 2024, the Company had cash and cash equivalents of approximately $5.8 million and current liabilities of approximately $1.0 million. During the nine-month period ended September 30, 2024, the Company’s net cash used in operating activities was approximately $6.1 million. The future viability of the Company is largely dependent on its ability to raise additional capital to finance its operations. The Company expects that it will need to raise additional capital within the next twelve months to continue its operations as the current, cash resources will be sufficient to fund its operations through the first quarter of 2025. Although the Company has been able to raise capital in the past, there is no assurance that it will be successful in obtaining additional financing on terms acceptable to the Company, if at all. In addition, recent fundraising by the Company has resulted in very high ownership dilution to shareholders, and given the Company’s current market capitalization and financing needs, it is likely that future fundraising may also be highly dilutive. If the Company is unable to obtain funding, the Company could be forced to delay, reduce or eliminate its research and development program, product development or commercialization efforts, which could adversely affect its business prospects.

Previous wording

We continue to develop the Symphony device and its first test for the measurement of IL-6, including conducting clinical trials to obtain additional data to support a submission to obtain FDA clearance of the Symphony device. However, our ability to continue these activities and continue operations (over the next 12 months) is dependent on the Company obtaining additional capital within twelve (12) months. If we fail to obtain additional financing within twelve (12) months, , and we could be forced to abandon such activities entirely and cease operations, with the possible loss of such properties or assets.

Current wording

We continue to develop the Symphony device and its first test for the measurement of IL-6, including conducting clinical trials to obtain additional data to support a submission to obtain FDA clearance of the Symphony device. However, our ability to continue these activities and continue operations (over the next twelve months) is dependent on the Company obtaining additional capital. If we fail to obtain additional financing within twelve months, we could be forced to abandon such activities entirely, with the possible loss of such properties or assets.

Previous wording

During the six months ended June 30, 2024, we used approximately $4.1 million in cash for operating activities, a decrease of approximately $300,000 as compared to the same period in 2023. The decrease is primarily driven by the timing of payments made by the Company to their vendors when comparing the two periods.

Current wording

During the nine months ended September 30, 2024, we used approximately $6.1 million in cash for operating activities, an increase of approximately $545,000 as compared to the same period in 2023. The increase is primarily driven by the timing of payments made by the Company to their vendors when comparing the two periods.

Previous wording

During the six months ended June 30, 2024, we used approximately $305,000 in cash for investing activities, a decrease of approximately $236,000 as compared to the same period in 2023. The decrease in net cash used in investing activities was due to limited purchasing of manufacturing equipment.

Current wording

During the nine months ended September 30, 2024, we used approximately $306,000 in cash for investing activities, a decrease of approximately $311,000 as compared to the same period in 2023. The decrease in net cash used in investing activities was due to limited purchasing of manufacturing equipment.

Previous wording

During the six months ended June 30, 2024, we raised approximately $10.3 million in cash through financing activities, an increase of approximately $10.4 million as compared to the same period in 2023. The increase in net cash generated by financing activities was due our public offering on January 2, 2024, a Bridge Note Financing in June 2024 and our public offering on June 28, 2024.

Current wording

During the nine months ended September 30, 2024, we raised approximately $9.9 million in cash through financing activities, an increase of approximately $8.8 million as compared to the same period in 2023. The increase in net cash generated by financing activities was due our public offering on January 2, 2024, the Bridge Note Financing in June 2024 and our public offering on June 28, 2024 as compared to our private placement of common stock in August 2023.