−Removed: MANAGEMENT’S DISCUSSION AND ANALYSIS
−Removed: OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
−Removed: You should read the following discussion and
−Removed: analysis together with our Consolidated Financial Statements and the notes thereto included elsewhere in this Form 10-K.
−Removed: This discussion
−Removed: contains forward-looking statements that involve risks and uncertainties.
−Removed: For additional discussion, see “CAUTIONARY NOTE REGARDING
−Removed: FORWARD-LOOKING STATEMENTS” above.
−Removed: We are a clinical-stage medical diagnostics company
−Removed: developing rapid, tests using whole blood on our Symphony platform (“Symphony”) to improve patient outcomes in critical care
−Removed: Our Symphony technology platform is an exclusively licensed, patented system that consists of a mobile device and single-use
−Removed: test cartridges that if cleared, authorized, or approved by the U.S.
−Removed: Food and Drug Administration (“FDA”), can provide a solution
−Removed: to a significant market need in the United States.
−Removed: Clinical trials indicate Symphony produces laboratory-quality results in less than
−Removed: 20 minutes in critical care settings, including Intensive Care Units (“ICUs”) and Emergency Rooms (“ERs”), where
−Removed: rapid and reliable results are required.
−Removed: Since inception, we have incurred net losses from
−Removed: operations each year and we expect to continue to incur losses for the foreseeable future.
−Removed: We incurred net losses of approximately $10.0
−Removed: million and $9.3 million for the years ended December 31, 2023 and 2022, respectively.
−Removed: We had negative cash flow from operating
−Removed: activities of approximately $8.3 million and $7.7 million for the years ended December 31, 2023 and 2022, respectively, and had an accumulated
−Removed: deficit of approximately $26.9 million and $17.0 million as of December 31, 2023 and 2022, respectively.
−Removed: Results of Operations
−Removed: Comparison of Years Ended December 31, 2023
−Removed: The following table sets forth our results of operations for the years
−Removed: ended December 31, 2023 and 2022:
+Added: MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
+Added: should read the following discussion and analysis together with our Consolidated Financial Statements and the notes thereto included
+Added: elsewhere in this Form 10-K.
+Added: This discussion contains forward-looking statements that involve risks and uncertainties.
+Added: For additional
+Added: discussion, see “CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS” above.
+Added: are a clinical-stage medical diagnostics company developing rapid tests using whole blood on our Symphony platform (“Symphony”)
+Added: to improve patient outcomes in critical care settings.
+Added: Our Symphony technology platform is an exclusively licensed, patented system that
+Added: consists of a mobile device and single-use test cartridges that if cleared, authorized, or approved by the U.S.
+Added: Food and Drug Administration
+Added: (“FDA”), could provide a solution to a significant market need in the United States.
+Added: Clinical trials indicate Symphony produces
+Added: laboratory-quality results in less than 20 minutes in critical care settings, including Intensive Care Units (“ICUs”) and
+Added: Emergency Rooms (“ERs”), where rapid and reliable results are required.
+Added: inception, we have incurred net losses from operations each year and we expect to continue to incur losses for the foreseeable future.
+Added: We incurred net losses of approximately $7.7 million and $10.0 million for the years ended December 31, 2024 and 2023, respectively.
+Added: We had negative cash flow from operating activities of approximately $7.5 million and $8.3 million for the years ended December 31, 2024
+Added: and 2023, respectively, and had an accumulated deficit of approximately $34.7 million and $26.95 million as of December 31, 2024 and
+Added: 2023, respectively.
+Added: of Operations
+Added: of Years Ended December 31, 2024 and 2023
+Added: following table sets forth our results of operations for the years ended December 31, 2024 and 2023:
For Years Ended
−Removed: Cost of sales
Operating expenses:
6 unchanged sentences
Other income (expense):
−Removed: Impairment of property and equipment
+Added: Interest expense
Interest income
Other income, net
−Removed: Total other income
+Added: Total other income (expense)
$ (7,717,794 )
$ (9,953,888 )
−Removed: Revenue and Gross Profit
−Removed: Revenue and gross profit decreased approximately
−Removed: $0.2 million and $0.1 million respectively, for the year ended December 31, 2023, as compared to 2022.
−Removed: The decrease was due to a minor
−Removed: sale of five Symphony analyzers to our business partner, Toray, during 2022.
−Removed: Future sales to Toray after 2022 are not anticipated.
−Removed: Research and Development
−Removed: Research and development expenses increased approximately
−Removed: $1.6 million, or 38%, for the year ended December 31, 2023, as compared to 2022.
−Removed: The increase in research and development expenses was
−Removed: primarily due to an approximately $0.2 million increase in personnel related costs, approximately $0.6 million of additional product development
−Removed: costs related to bringing the Symphony analyzer and cartridges in compliance with the FDA manufacturing standards, and approximately $0.6
−Removed: million of additional depreciation expense associated with the acceleration of depreciation of certain assets used for research and development
−Removed: We expect increases in our future research and
−Removed: development expenses which will be focused on our clinical trial program and any necessary manufacturing improvements.
−Removed: General and Administrative
−Removed: General and administrative expenses decreased
−Removed: approximately $0.5 million, or 9%, for the year ended December 31, 2023, as compared to 2022.
−Removed: The decrease in general and administrative
−Removed: expenses is primarily due to the cost reduction efforts focused on reducing personnel and insurance costs.
−Removed: We expect to monitor and continue to reduce our
−Removed: general and administrative spend, as necessary, to optimize operational alignment.
−Removed: Sales and Marketing
−Removed: Sales and marketing expenses decreased approximately
−Removed: $0.2 million, or 37%, for year ended December 31, 2023, as compared to 2022.
−Removed: The decrease was primarily attributable to the Company’s
−Removed: cost savings efforts as the Company seeks to limit marketing costs.
−Removed: Total other income increased approximately $0.3
−Removed: million, or 1,616%, for the year ended December 31, 2023 as compared to 2022.
−Removed: The increase primarily related to increases in interest
−Removed: income from the Company’s sweep account due to increased interest rates as compared to the prior period, as well as no material
−Removed: impairment charge being recognized during 2023 as compared to 2022, which had an impairment charge of approximately $0.2 million.
−Removed: Summary Statement of Cash Flows
−Removed: The following table sets forth the primary sources
−Removed: and uses of cash and cash equivalents for each of the periods presented.
+Added: and development
+Added: and development expenses decreased approximately $2.2 million, or 39%, for the year ended December 31, 2024, as compared to 2023.
+Added: decrease in research and development expenses was primarily due to a $0.5 million decrease in personnel related costs, a $0.8 million
+Added: decrease in depreciation expense, and a $1.1 million decrease in product development costs, which was partially offset by a $0.5 million
+Added: increase in clinical development costs.
+Added: decrease in research and development expenses was primarily due to a reduction in technology transfer efforts which offset increased
+Added: clinical trial expenses.
+Added: We expect future research and development expenses to be focused on costs specifically associated with our clinical
+Added: trial program supporting our regulatory strategy, technology transfer efforts and any necessary manufacturing improvements.
+Added: and administrative
+Added: and administrative expenses decreased approximately $0.6 million, or 14%, for the year ended December 31, 2024, as compared to 2023.
+Added: The decrease in general and administrative expenses is primarily due to the cost reduction efforts focused on reducing personnel and
+Added: other administrative costs.
+Added: expect to monitor and continue to reduce our general and administrative spend, as necessary, to optimize operational alignment.
+Added: and marketing
+Added: and marketing expenses decreased approximately $0.3 million, or 97%, for year ended December 31, 2024, as compared to 2023.
+Added: The low sales
+Added: and marketing expenses in 2024 are due to a reduction in spending in all sales and marketing efforts.
+Added: income (expense)
+Added: other income (expense) decreased approximately $0.9 million for the year ended December 31, 2024 as compared to 2023.
+Added: The decreases primarily
+Added: related to the $0.8 million increase in interest expense associated with the Bridge Note Financing.
+Added: Statement of Cash Flows
+Added: following table sets forth the primary sources and uses of cash and cash equivalents for each of the periods presented.
Cash proceeds provided by (used in):
Operating activities
+Added: $ (7,819,769 )
+Added: $ (8,313,870 )
Investing activities
Financing activities
−Removed: Net (decrease) increase in cash and cash equivalents
−Removed: Net cash used in operating activities
−Removed: During 2023, we used approximately $8.3 million
−Removed: in cash for operating activities, an increase of approximately $0.6 million from 2022.
−Removed: The increase in net cash used in operating activities
−Removed: was primarily due to increases in personnel and product development costs, which ultimately led to the reduction of personnel in the second
−Removed: and third quarters of 2023.
−Removed: Net cash used in investing activities
+Added: Net increase (decrease) in cash and cash equivalents
+Added: $ (7,906,474 )
+Added: cash used in operating activities
During 2024, we used approximately $7.8 million
−Removed: in cash for investing activities, an approximately $0.5 million decrease from 2022.
−Removed: The Company acquired laboratory equipment and manufacturing
−Removed: equipment for the development of the Symphony devices in both 2022 and 2023.
−Removed: Net cash provided by financing activities
−Removed: During 2023, we generated approximately $1.1 million
−Removed: in cash from financing activities, as compared to less than $0.1 million in 2022.
+Added: in cash for operating activities, a decrease of approximately $0.5 million from 2023.
+Added: The decrease in net cash used in operating activities
+Added: was primarily due to a decrease in the net loss and partially offset by the timing of payments to vendors and other decreases in working
+Added: capital during 2024.
+Added: cash used in investing activities
+Added: 2024, we used approximately $0.3 million in cash for investing activities, an approximately $0.4 million decrease from 2023.
+Added: acquired laboratory equipment and manufacturing equipment for the development of the Symphony devices in both 2024 and 2023.
+Added: cash provided by financing activities
+Added: During 2024, we generated approximately $10.2
+Added: million in cash from financing activities, as compared to $1.1 million in 2023.
The increase in net cash provided by financing activities
−Removed: was primarily due to the proceeds from the August 2023 Financing.
−Removed: Contractual Obligations
−Removed: See Note 8 to consolidated financial statements
−Removed: for our lease obligations and Note 9 to the consolidated financial statements for our other non-cancellable contractual obligations.
−Removed: Liquidity and Going Concern
+Added: was primarily due to the proceeds from our public offerings in January 2024 and June 2024 as compared to our private placement of common
+Added: stock in August 2023.
+Added: Note 9 to consolidated financial statements for our lease obligations and Note 10 to the consolidated financial statements for our other
+Added: non-cancellable contractual obligations.
+Added: and Going Concern
The Company had cash and cash equivalents of $4,301,945
−Removed: $2,208,516, as of December 31, 2023.
−Removed: The Company has incurred net losses since its inception, and has negative cash flows from
−Removed: operations and had the accumulated deficit of $26,950,990 as of December 31, 2023.
−Removed: The Company continues to develop the Symphony
−Removed: device and its first test for the measurement of IL-6.
−Removed: The Company remains committed to obtaining FDA clearance and will conduct
−Removed: clinical trials to obtain sufficient data to support its FDA submission, while also continuing to build its manufacturing operations
−Removed: with its contract manufacturing organizations.
+Added: and current liabilities of $810,368 on its balance sheet as of December 31, 2024.
+Added: The Company has incurred net losses since its inception,
+Added: and has negative cash flows from operations and had an accumulated deficit of $34,668,784 as of December 31, 2024.
+Added: The Company continues
+Added: to develop its Symphony device and its first test for the measurement of IL-6.
+Added: The Company remains committed to obtaining FDA clearance
+Added: and hopes to conduct clinical trials to obtain sufficient data to support its FDA submission, while also continuing to build its manufacturing
+Added: operations with its contract manufacturing organizations.
Current cash resources and expected operating expenses are considered in determining
−Removed: its liquidity requirement;
−Removed: as well as $1,771,375 of current liabilities on its balance sheet as of December 31, 2023.
−Removed: Company estimates cash resources will be sufficient to fund its operations through the second quarter of 2024.
−Removed: will need additional capital to fund its planned operations for the next 12 months.
−Removed: These conditions raise substantial doubt about
−Removed: the Company’s ability to continue as a going concern.
+Added: its liquidity requirements.
+Added: The Company estimates cash resources will be sufficient to fund its operations up to the third quarter of
+Added: The Company will need additional capital to fund its planned operations for the next 12 months.
+Added: These conditions raise substantial
+Added: doubt about the Company’s ability to continue as a going concern within one year from the date these financial statements are issued.
The consolidated financial statements for the
−Removed: years ended December 31, 2023 and 2022 were prepared under the assumption that the Company will continue as a going concern, which contemplates
−Removed: that the Company will be able to realize assets and discharge liabilities in the normal course of business.
−Removed: The Company expects that it will seek to raise
−Removed: such additional capital through public or private equity offerings, grant financing and support from governmental agencies, convertible
−Removed: debt, collaborations, strategic alliances and distribution arrangements.
−Removed: Additional funds may not be available when it needs them on terms
−Removed: that are acceptable to them, or at all.
−Removed: If adequate funds are not available, it may be required to delay its FDA regulatory strategy,
−Removed: and to delay or reduce the scope of its research or development programs, its commercialization efforts or its manufacturing commitments
−Removed: and capacity.
−Removed: In addition, if it raises additional funds through collaborations, strategic alliances or distribution arrangements with
−Removed: third parties, it may have to relinquish valuable rights to its technologies or future revenue streams.
−Removed: Recent Offerings
−Removed: August 2023 Offering
−Removed: On August 24, 2023, the Company entered into a
−Removed: securities purchase agreement with certain institutional and accredited investors (the “Purchase Agreement”) relating to the
−Removed: registered direct offering and sale of 216,000 shares of the Company’s common stock at a purchase price of $7.365 per share (the
−Removed: In a concurrent private placement, the Company
−Removed: also issued to such institutional and accredited investors unregistered warrants to purchase up to 216,000 shares of Common Stock (the
−Removed: Pursuant to the terms of the Purchase Agreement, for each share of Common Stock issued in this offering an accompanying
−Removed: Warrant was issued to the purchaser thereof.
−Removed: Each Warrant is exercisable for one share of Common Stock (the “Warrant Shares”)
−Removed: at an exercise price of $7.24 per share, will be immediately exercisable upon issuance and will expire five years from the date of issuance.
−Removed: The Warrants were offered and sold at a purchase price of $0.125 per underlying warrant share, which purchase price is included in the
−Removed: offering price per share of Common Stock issued in the Offering (the “Private Placement”).
−Removed: Pursuant to an engagement letter, dated as of
−Removed: August 7, 2023 (the “Engagement Letter”), between the Company and H.C.
+Added: years ended December 31, 2024 and 2023 were prepared under the assumption that the Company will continue as a going concern, and do not
+Added: include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification
+Added: of liabilities that might result from the outcome of this uncertainty.
+Added: Company expects that it will seek to raise such additional capital through public or private equity offerings, grant financing and support
+Added: from governmental agencies, convertible debt, collaborations, strategic alliances and distribution arrangements.
+Added: Additional funds may
+Added: not be available when it needs them on terms that are acceptable to them, or at all.
+Added: If adequate funds are not available, it may be required
+Added: to delay its FDA regulatory strategy, and to delay or reduce the scope of its research or development programs, its commercialization
+Added: efforts or its manufacturing commitments and capacity.
+Added: In addition, if it raises additional funds through collaborations, strategic alliances
+Added: or distribution arrangements with third parties, it may have to relinquish valuable rights to its technologies or future revenue streams.
+Added: 2023 Offering
+Added: August 24, 2023, the Company entered into a securities purchase agreement with certain institutional and accredited investors (the “Purchase
+Added: Agreement”) relating to the registered direct offering and sale of 540 shares of the Company’s common stock at a purchase
+Added: price of $2,946.00 per share (the “Offering”).
+Added: a concurrent private placement, the Company also issued to such institutional and accredited investors unregistered warrants to purchase
+Added: up to 540 shares of Common Stock (the “Warrants”).
+Added: Pursuant to the terms of the Purchase Agreement, for each share of Common
+Added: Stock issued in this offering an accompanying Warrant was issued to the purchaser thereof.
+Added: Each Warrant is exercisable for one share
+Added: of Common Stock (the “Warrant Shares”) at an exercise price of $2,896.00 per share, will be immediately exercisable upon
+Added: issuance and will expire five years from the date of issuance.
+Added: The Warrants were offered and sold at a purchase price of $50.00 per underlying
+Added: warrant share, which purchase price is included in the offering price per share of Common Stock issued in the Offering (the “Private
+Added: to an engagement letter, dated as of August 7, 2023, between the Company and H.C.
Wainwright & Co., LLC, or the placement agent,
−Removed: the Company agreed to pay the placement agent a total cash fee equal to 7.0% of the gross proceeds received in the Offering and the Private
−Removed: The Company also agreed to pay the placement agent in connection with the Offering and the Private Placement a management fee
−Removed: equal to 1.0% of the gross proceeds raised in the Offering and Private Placement, $45,000 for non-accountable expenses, and $15,950 for
−Removed: clearing fees.
−Removed: In addition, the Company agreed to issue to the placement agent, or its designees, warrants to purchase up to 15,120 shares
−Removed: of Common Stock (the “Placement Agent Warrants”), which represents 7.0% of the aggregate number of shares of Common Stock
−Removed: sold in the Offering.
−Removed: The Placement Agent Warrants have substantially the same terms as the Warrants, except that the Placement Agent
−Removed: Warrants have an exercise price equal to $ 9.2063, or 125% of the offering price per share of Common Stock sold in the Offering, and a
−Removed: term of five years from the commencement of the sales pursuant to the Offering.
−Removed: The gross proceeds to the Company from the Offering
−Removed: and the Private Placement are $1,590,840.
+Added: the Company paid the placement agent a total cash fee of $111,359 equal to 7.0% of the gross proceeds received in the Offering and the
+Added: Private Placement.
+Added: The Company also agreed to pay the placement agent in connection with the Offering and the Private Placement a management
+Added: fee equal to $15,908 or 1.0% of the gross proceeds raised in the Offering and Private Placement, $45,000 for non-accountable expenses,
+Added: and $15,950 for clearing fees.
+Added: In addition, the Company agreed to issue to the placement agent, or its designees, warrants to purchase
+Added: up to 36 shares of Common Stock (the “Placement Agent Warrants”), which represents 7.0% of the aggregate number of shares
+Added: of Common Stock sold in the Offering.
+Added: The Placement Agent Warrants have substantially the same terms as the Warrants, except that the
+Added: Placement Agent Warrants have an exercise price equal to $3,684.00, or 125% of the offering price per share of Common Stock sold in the
+Added: Offering, and a term of five years from the commencement of the sales pursuant to the Offering.
+Added: gross proceeds to the Company from the Offering and the Private Placement are $1,590,840.
The Company incurred offering costs of $413,544.
−Removed: January 2024 Offering
−Removed: On January 2, 2024, the Company sold in a public
−Removed: offering (such transaction, the “January 2024 Offering”) (i) 537,768 shares of the Company’s common stock, par value
−Removed: $0.0001 per share and (ii) prefunded warrants to purchase up to an aggregate 2,154,540 shares of Common Stock (the “Prefunded Warrants”).
−Removed: The Shares and Prefunded Warrants were sold together with warrants to purchase up to an aggregate of 2,692,308 shares of Common Stock
−Removed: at an exercise price of $1.30 per share (the “January 2024 Warrants”).
−Removed: The combined public offering price was $1.30 per share
−Removed: of Common Stock and related January 2024 Warrant and $1.2999 per Prefunded Warrant and related January 2024 Warrant.
−Removed: The Company intends
−Removed: to use the net proceeds from the January Offering to fund matters related to obtaining FDA approval (including clinical studies related
−Removed: thereto), as well as for other research and development activities, and for general working capital needs.
−Removed: The Prefunded Warrants are immediately exercisable
−Removed: and may be exercised at any time until all of the Prefunded Warrants are exercised in full.
−Removed: The January 2024 Warrants are exercisable
−Removed: immediately upon issuance for a period of five years following the date of issuance.
−Removed: Pursuant to an engagement letter, dated as of
−Removed: August 7, 2023, as amended October 11, 2023 (the “Amended Engagement Letter”), by and between the Company and the Placement
−Removed: Agent, the Company paid the Placement Agent a total cash fee of $245,000 equal to 7.0% of the gross proceeds received in the January 2024
−Removed: The Company also paid the Placement Agent in connection with the January Offering a management fee of $35,000 equal to 1.0%
−Removed: of the gross proceeds raised in the January 2024 Offering and certain expenses incurred in connection with the January Offering.
−Removed: the Company issued to the Placement Agent, warrants to purchase up to an aggregate 188,462 shares of Common Stock (the “January
−Removed: 2024 Placement Agent Warrants”), which represents 7.0% of the aggregate number of shares of Common Stock and Prefunded Warrants
−Removed: sold in the January 2024 Offering.
−Removed: The January 2024 Placement Agent Warrants have substantially the same terms as the January 2024 Warrants,
−Removed: except that the January 2024 Placement Agent Warrants have an exercise price equal to $1.6250, or 125% of the offering price per share
−Removed: of Common Stock and related January 2024 Warrant sold in the January Offering and expire on the fifth anniversary from the date of the
−Removed: commencement of sales in the January 2024 Offering.
−Removed: Concurrently with the closing of the January 2024
−Removed: Offering, certain purchasers have elected to exercise Prefunded Warrants to purchase 174,770 shares of Common Stock.
−Removed: Critical Accounting Policies and Estimates
−Removed: Some of our critical accounting policies require
−Removed: us to make difficult, subjective or complex judgments or estimates.
−Removed: An accounting estimate is considered to be critical if it meets both
−Removed: of the following criteria:
−Removed: (i) the estimate requires assumptions about matters that are highly uncertain at the time the accounting
−Removed: estimate is made, and (ii) different estimates reasonably could have been used, or changes in the estimate that are reasonably likely
−Removed: to occur from period to period may have a material impact on the presentation of our financial condition, changes in financial condition
−Removed: or results of operations.
−Removed: As an emerging growth company, we have elected
−Removed: to opt-in to the extended transition period for new or revised accounting standards.
−Removed: As a result, our consolidated financial statements
−Removed: may not be comparable to those of companies that comply with public company effective dates.
−Removed: Stock-Based Compensation
−Removed: Our stock-based compensation expense for stock
−Removed: awards is estimated at the grant date based on the award’s fair value as determined by the consideration received or as calculated
−Removed: by the Black-Scholes option pricing model, whichever is more readily measurable.
−Removed: The Black-Scholes pricing model requires various highly
−Removed: judgmental assumptions including expected volatility and expected term.
−Removed: The expected volatility is based on the historical stock volatilities
−Removed: of several similar public companies over a period equal to the expected terms of the awards as we do not have a sufficient trading history
−Removed: to use the volatility of our own common stock.
−Removed: To estimate the expected term, we have opted to use the simplified method, which uses of
−Removed: the midpoint of the vesting term and the contractual term.
−Removed: We recognize the compensation cost of share-based awards on a straight-line
−Removed: basis over the requisite service period, however, for stock awards for which vesting is subject to performance – based milestones,
−Removed: the expense is recorded over the implied service period after the point when the achievement of the milestone is probable, or the performance
−Removed: condition has been achieved.
−Removed: If any of the assumptions used in the Black-Scholes pricing model changes significantly, stock-based compensation
−Removed: expense may differ materially in the future from that recorded in the current period.
−Removed: Recently Adopted Accounting Standards
−Removed: See Note 2 to consolidated financial statements
−Removed: (under the caption “Recently Issued Accounting Standards”).
−Removed: Recently Issued Accounting Standards
−Removed: See Note 2 to consolidated financial statements
−Removed: (under the caption “Recently Issued Accounting Standards”).
−Removed: QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET
−Removed: Information requested by this Item is not applicable
−Removed: as we are electing scaled disclosure requirements available to Smaller Reporting Companies with respect to this Item.
+Added: 2024 Offering
+Added: January 2, 2024, the Company sold in a public offering (such transaction, the “January 2024 Offering”) (i) 1,344 shares of
+Added: the Company’s common stock, par value $0.0001 per share and (ii) prefunded warrants to purchase up to an aggregate 5,386 shares
+Added: of Common Stock (the “January Prefunded Warrants”).
+Added: The Shares and January Prefunded Warrants were sold together with warrants
+Added: to purchase up to an aggregate of 6,730 shares of Common Stock at an exercise price of $520.00 per share (the “January 2024 Warrants”).
+Added: The combined public offering price was $520.00 per share of Common Stock and related January 2024 Warrant and $519.96 per January Prefunded
+Added: Warrant and related January 2024 Warrant.
+Added: of December 31, 2024, all January Prefunded Warrants have been exercised in full.
+Added: The January 2024 Warrants are exercisable for a period
+Added: of five years following the date of issuance.
+Added: to an engagement letter, dated as of August 7, 2023, as amended October 11, 2023, by and between the Company and the Placement Agent,
+Added: the Company paid the Placement Agent a total cash fee of $245,000 equal to 7.0% of the gross proceeds received in the January 2024 Offering.
+Added: The Company also paid the Placement Agent in connection with the January Offering a management fee of $35,000 equal to 1.0% of the gross
+Added: proceeds raised in the January 2024 Offering and certain expenses incurred in connection with the January Offering.
+Added: In addition, the
+Added: Company issued to the Placement Agent, warrants to purchase up to an aggregate 471 shares of Common Stock (the “January 2024 Placement
+Added: Agent Warrants”), which represents 7.0% of the aggregate number of shares of Common Stock and Prefunded Warrants sold in the January
+Added: 2024 Offering.
+Added: The January 2024 Placement Agent Warrants have substantially the same terms as the January 2024 Warrants, except that
+Added: the January 2024 Placement Agent Warrants have an exercise price equal to $650.00, or 125% of the offering price per share of Common
+Added: Stock and related January 2024 Warrant sold in the January Offering and expire on the fifth anniversary from the date of the commencement
+Added: of sales in the January 2024 Offering.
+Added: gross proceeds to the Company from the January 2024 Offering were $3,500,000.
+Added: The Company incurred offering costs of $711,031.
+Added: 2024 Bridge Note Financing
+Added: May 31, 2024, the Company entered into a Note Purchase Agreement with an accredited investor (the “NPA”), and a Securities
+Added: Purchase Agreement with three accredited investors (the “SPA”).
+Added: Under the terms of the NPA, the investor provided the Company
+Added: with a $1,000,000 cash subscription in exchange for the issuance of a senior secured note.
+Added: As of December 31, 2024, a total of $1,176,470
+Added: was repaid to the NPA investors.
+Added: The difference between such note and the subscription amount, initially recorded as a discount on the
+Added: notes, was the result of the discount factor included in the NPA of approximately 17.6%.
+Added: the terms of the SPA, the three investors agreed to collectively provide the Company with a separate $1,000,000 cash subscription in
+Added: exchange for the issuance of senior secured notes ($333,333 each), and the collective issuance of 1,451 shares of the Company’s
+Added: common stock.
+Added: The fair value of the common stock issued in connection with the SPA was $307,563.
+Added: As of December 31, 2024, a total of
+Added: $1,111,110 was repaid to the SPA investors.
+Added: The difference between such notes and the subscription amounts, initially recorded as a discount
+Added: on the notes, was the result of the discount factor included in the SPA of 11.11%.
+Added: expense recorded on the NPA and SPAs was $807,797 for the year ended December 31, 2024, including debt issuance costs related to the
+Added: NPA and SPA totaling $212,654.
+Added: 2024 Offering
+Added: June 28, 2024, the Company sold in a public offering ( the “June 2024 Offering”), (i) 11,541 common units (the “Common
+Added: Units”), each consisting of one share of common stock, two Class C Warrants and one Class D Warrant and (ii) 95,815 prefunded warrants
+Added: (the “Prefunded Units”), each consisting of one prefunded warrant to purchase one share of common stock (each, a “Prefunded
+Added: Warrant”), two Class C Warrants and one Class D Warrant to purchase Common Shares.
+Added: Aegis Capital Corp.
+Added: the “Underwriter”) partially exercised its over-allotment option in respect to 13,573 Class C Warrants and 6,787 Class D
+Added: Warrants (the “Over-Allotment Warrants”).
+Added: The Common Units were sold at a price of $81.50 per unit and the Prefunded Warrants
+Added: were sold at a price of $81.495 per unit.
+Added: As of December 31, 2024, all Prefunded Warrants have been exercised in full.
+Added: to an engagement letter dated June 6, 2024, by and between the Company and Aegis, the Company paid Aegis a total cash fee of $743,750
+Added: equal to 8.5% of the gross proceeds received in the June 2024 Offering.
+Added: gross proceeds to the Company from the June 2024 Offering were $8,569,075.
+Added: The Company incurred offering costs of $1,133,419.
+Added: Accounting Policies and Estimates
+Added: of our critical accounting policies require us to make difficult, subjective or complex judgments or estimates.
+Added: An accounting estimate
+Added: is considered to be critical if it meets both of the following criteria:
+Added: (i) the estimate requires assumptions about matters that
+Added: are highly uncertain at the time the accounting estimate is made, and (ii) different estimates reasonably could have been used,
+Added: or changes in the estimate that are reasonably likely to occur from period to period may have a material impact on the presentation of
+Added: our financial condition, changes in financial condition or results of operations.
+Added: an emerging growth company, we have elected to opt-in to the extended transition period for new or revised accounting standards.
+Added: As a result, our consolidated financial statements may not be comparable to those of companies that comply with public company effective
+Added: See Note 2 to consolidated financial statements for a summary of significant
+Added: accounting policies.
+Added: Adopted Accounting Standards
+Added: Note 2 to consolidated financial statements (under the caption “Recently Issued Accounting Standards”).
+Added: Issued Accounting Standards
+Added: Note 2 to consolidated financial statements (under the caption “Recently Issued Accounting Standards”).
+Added: QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
+Added: requested by this Item is not applicable as we are electing scaled disclosure requirements available to Smaller Reporting Companies with
+Added: respect to this Item.
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
−Removed: Our Consolidated Financial Statements and The
−Removed: Report of Independent Registered Public Accounting Firm are included in this Form 10-K on pages F-1
−Removed: through F-20.
−Removed: CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING
−Removed: AND FINANCIAL DISCLOSURE
+Added: Consolidated Financial Statements and The Report of Independent Registered Public Accounting Firm are included in this Form 10-K
+Added: on pages F-1 through F-19.
+Added: CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.