−Removed: MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
−Removed: should read the following discussion and analysis together with our Consolidated Financial Statements and the notes thereto included
−Removed: elsewhere in this Form 10-K.
−Removed: This discussion contains forward-looking statements that involve risks and uncertainties.
−Removed: For additional
−Removed: discussion, see “CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS” above.
−Removed: are a clinical-stage medical diagnostics company developing rapid tests using whole blood on our Symphony platform (“Symphony”)
−Removed: to improve patient outcomes in critical care settings.
−Removed: Our Symphony technology platform is an exclusively licensed, patented system that
−Removed: consists of a mobile device and single-use test cartridges that if cleared, authorized, or approved by the U.S.
+Added: MANAGEMENT’S DISCUSSION AND ANALYSIS
+Added: OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
+Added: You should read the following discussion and
+Added: analysis together with our Consolidated Financial Statements and the notes thereto included elsewhere in this Form 10-K.
+Added: This discussion
+Added: contains forward-looking statements that involve risks and uncertainties.
+Added: For additional discussion, see “CAUTIONARY NOTE REGARDING
+Added: FORWARD-LOOKING STATEMENTS” above.
+Added: We are a clinical-stage medical diagnostics company
+Added: developing rapid tests using whole blood on our Symphony platform (“Symphony”) to improve patient outcomes in critical care
+Added: settings, with a focus on sepsis.
+Added: Our Symphony technology platform is an exclusively licensed, patented system that consists of an analyzer
+Added: and single-use protein detection cartridges that we believe, if cleared, authorized, or approved by the U.S.
Food and Drug Administration
(“FDA”), could provide a solution to a significant market need in the United States.
−Removed: Clinical trials indicate Symphony produces
−Removed: laboratory-quality results in less than 20 minutes in critical care settings, including Intensive Care Units (“ICUs”) and
−Removed: Emergency Rooms (“ERs”), where rapid and reliable results are required.
−Removed: inception, we have incurred net losses from operations each year and we expect to continue to incur losses for the foreseeable future.
−Removed: We incurred net losses of approximately $7.7 million and $10.0 million for the years ended December 31, 2024 and 2023, respectively.
−Removed: We had negative cash flow from operating activities of approximately $7.5 million and $8.3 million for the years ended December 31, 2024
−Removed: and 2023, respectively, and had an accumulated deficit of approximately $34.7 million and $26.95 million as of December 31, 2024 and
−Removed: 2023, respectively.
−Removed: of Operations
−Removed: of Years Ended December 31, 2024 and 2023
−Removed: following table sets forth our results of operations for the years ended December 31, 2024 and 2023:
+Added: The Symphony device candidate is designed
+Added: to produce laboratory-quality results in approximately 20 minutes in critical care settings, including Intensive Care Units (“ICUs”)
+Added: and Emergency Rooms (“ERs”), where rapid and reliable results are required.
+Added: Since inception, we have incurred net losses
+Added: from operations each year and we expect to continue to incur losses for the foreseeable future.
+Added: We incurred net losses of approximately
+Added: $6.8 million and $7.7 million for the years ended December 31, 2025 and 2024, respectively.
+Added: We had negative cash flow from operating
+Added: activities of approximately $6.1 million and $7.8 million for the years ended December 31, 2025 and 2024, respectively, and had an accumulated
+Added: deficit of approximately $41.5 million and $34.7 million as of December 31, 2025 and 2024, respectively.
+Added: Results of Operations
+Added: Comparison of Years Ended December 31, 2025
+Added: The following table sets forth our results of operations for the years
+Added: ended December 31, 2025 and 2024:
For Years Ended
5 unchanged sentences
Operating loss
−Removed: (10,311,217 )
Other income (expense):
3 unchanged sentences
Total other income (expense)
+Added: Deemed dividend on warrant modification
+Added: Net loss applicable to common shareholders
$ (6,848,483 )
$ (20,940,847 )
−Removed: and development
−Removed: and development expenses decreased approximately $2.2 million, or 39%, for the year ended December 31, 2024, as compared to 2023.
−Removed: decrease in research and development expenses was primarily due to a $0.5 million decrease in personnel related costs, a $0.8 million
−Removed: decrease in depreciation expense, and a $1.1 million decrease in product development costs, which was partially offset by a $0.5 million
−Removed: increase in clinical development costs.
−Removed: decrease in research and development expenses was primarily due to a reduction in technology transfer efforts which offset increased
−Removed: clinical trial expenses.
−Removed: We expect future research and development expenses to be focused on costs specifically associated with our clinical
−Removed: trial program supporting our regulatory strategy, technology transfer efforts and any necessary manufacturing improvements.
−Removed: and administrative
−Removed: and administrative expenses decreased approximately $0.6 million, or 14%, for the year ended December 31, 2024, as compared to 2023.
−Removed: The decrease in general and administrative expenses is primarily due to the cost reduction efforts focused on reducing personnel and
−Removed: other administrative costs.
−Removed: expect to monitor and continue to reduce our general and administrative spend, as necessary, to optimize operational alignment.
−Removed: and marketing
−Removed: and marketing expenses decreased approximately $0.3 million, or 97%, for year ended December 31, 2024, as compared to 2023.
−Removed: The low sales
−Removed: and marketing expenses in 2024 are due to a reduction in spending in all sales and marketing efforts.
−Removed: income (expense)
−Removed: other income (expense) decreased approximately $0.9 million for the year ended December 31, 2024 as compared to 2023.
−Removed: The decreases primarily
−Removed: related to the $0.8 million increase in interest expense associated with the Bridge Note Financing.
−Removed: Statement of Cash Flows
−Removed: following table sets forth the primary sources and uses of cash and cash equivalents for each of the periods presented.
+Added: Research and development
+Added: Research and development expenses decreased approximately
+Added: $0.4 million, or 12%, for the year ended December 31, 2025, as compared to 2024.
+Added: The decrease in research and development expenses was
+Added: primarily due to a $0.2 million decrease in personnel related costs, a $0.1 million decrease in other costs, and a $0.2 million decrease
+Added: in product development costs, which was partially offset by a $0.1 million increase in clinical development costs.
+Added: The decrease in research and development expenses
+Added: was primarily due to a reduction in technology transfer efforts which offset increased clinical trial expenses.
+Added: We expect future research
+Added: and development expenses to be focused on costs specifically associated with our clinical trial program supporting our regulatory strategy,
+Added: technology transfer efforts and any necessary manufacturing improvements.
+Added: General and administrative
+Added: General and administrative expenses increased
+Added: approximately $0.2 million, or 6%, for the year ended December 31, 2025, as compared to 2024.
+Added: The increase in general and administrative
+Added: expenses is primarily due to a $0.3 million increase in Delaware franchise tax cost and a $0.1 million increase in personnel related costs,
+Added: with was partially offset by a $0.2 million decrease in consulting expenses.
+Added: We expect to monitor and continue to reduce our
+Added: general and administrative spend, as necessary, to optimize operational alignment.
+Added: Sales and marketing
+Added: Sales and marketing expenses decreased 100%, for
+Added: year ended December 31, 2025, as compared to 2024.
+Added: The low sales and marketing expenses in 2025 are due to a reduction in spending in
+Added: all sales and marketing efforts.
+Added: Other income (expense)
+Added: Total other income (expense) decreased approximately
+Added: $0.7 million for the year ended December 31, 2025 as compared to 2024.
+Added: The decreases primarily related to the $0.8 million in interest
+Added: expense associated with the 2024 Bridge Note Financing.
+Added: Deemed dividend on warrant modification
+Added: Upon stockholder approval of the issuance of Class
+Added: C Warrants and Class D Warrants on August 21, 2024, the Class C Warrants, which had an initial exercise price of $392.00 per share of
+Added: common stock, were adjusted to be exercisable at an exercise price of $65.20 per share and the number of shares of common stock issuable
+Added: upon exercise was proportionately increased to 343,146 shares.
+Added: Concurrently, the number of shares of common stock issuable upon exercise
+Added: of the Class D Warrants increased to four shares per warrant for the remaining unexercised warrants.
+Added: In connection with the reset in the
+Added: exercise price and number of shares issuable pursuant to exercise of the Class C Warrants and Class D Warrants, we recorded a deemed dividend
+Added: of $13,223,053 based on the excess of the fair value of the modified Class C Warrants and Class D Warrants over the fair value of the
+Added: Class C Warrants and Class D Warrants before the modification, the effect of which was an increase in the net loss attributable to common
+Added: shareholders in the statement of operations for the year ended December 31, 2024.
+Added: Summary Statement of Cash Flows
+Added: The following table sets forth the primary sources
+Added: and uses of cash and cash equivalents for each of the periods presented.
Cash proceeds provided by (used in):
4 unchanged sentences
Financing activities
−Removed: Net increase (decrease) in cash and cash equivalents
−Removed: $ (7,906,474 )
−Removed: cash used in operating activities
+Added: Net increase in cash and cash equivalents
+Added: Net cash used in operating activities
During 2025, we used approximately $6.1 million
3 unchanged sentences
capital during 2025.
−Removed: cash used in investing activities
−Removed: 2024, we used approximately $0.3 million in cash for investing activities, an approximately $0.4 million decrease from 2023.
−Removed: acquired laboratory equipment and manufacturing equipment for the development of the Symphony devices in both 2024 and 2023.
−Removed: cash provided by financing activities
−Removed: During 2024, we generated approximately $10.2
−Removed: million in cash from financing activities, as compared to $1.1 million in 2023.
−Removed: The increase in net cash provided by financing activities
−Removed: was primarily due to the proceeds from our public offerings in January 2024 and June 2024 as compared to our private placement of common
−Removed: stock in August 2023.
−Removed: Note 9 to consolidated financial statements for our lease obligations and Note 10 to the consolidated financial statements for our other
−Removed: non-cancellable contractual obligations.
−Removed: and Going Concern
+Added: Net cash used in investing activities
+Added: During 2025, we used approximately $0.2 million
+Added: in cash from investing activities, an approximately $0.1 million decrease from 2024.
+Added: The Company acquired less manufacturing equipment
+Added: for the development of the Symphony devices in 2025 and 2024.
+Added: Net cash provided by financing activities
+Added: During 2025, we generated approximately $7.1 million
+Added: in cash from financing activities, as compared to $10.2 million in 2024.
+Added: The decrease in net cash provided by financing activities was
+Added: primarily due to the proceeds from our private placements in April 2025 and October 2025 compared to our public offerings in January 2024
+Added: and June 2024.
+Added: Contractual Obligations
+Added: See Note 9 to consolidated financial statements
+Added: for our lease obligations and Note 10 to the consolidated financial statements for our other non-cancellable contractual obligations.
+Added: Liquidity and Going Concern
The Company had cash and cash equivalents of $5,164,875
17 unchanged sentences
of liabilities that might result from the outcome of this uncertainty.
−Removed: Company expects that it will seek to raise such additional capital through public or private equity offerings, grant financing and support
−Removed: from governmental agencies, convertible debt, collaborations, strategic alliances and distribution arrangements.
−Removed: Additional funds may
−Removed: not be available when it needs them on terms that are acceptable to them, or at all.
−Removed: If adequate funds are not available, it may be required
−Removed: to delay its FDA regulatory strategy, and to delay or reduce the scope of its research or development programs, its commercialization
−Removed: efforts or its manufacturing commitments and capacity.
−Removed: In addition, if it raises additional funds through collaborations, strategic alliances
−Removed: or distribution arrangements with third parties, it may have to relinquish valuable rights to its technologies or future revenue streams.
−Removed: 2023 Offering
−Removed: August 24, 2023, the Company entered into a securities purchase agreement with certain institutional and accredited investors (the “Purchase
−Removed: Agreement”) relating to the registered direct offering and sale of 540 shares of the Company’s common stock at a purchase
−Removed: price of $2,946.00 per share (the “Offering”).
−Removed: a concurrent private placement, the Company also issued to such institutional and accredited investors unregistered warrants to purchase
−Removed: up to 540 shares of Common Stock (the “Warrants”).
−Removed: Pursuant to the terms of the Purchase Agreement, for each share of Common
−Removed: Stock issued in this offering an accompanying Warrant was issued to the purchaser thereof.
−Removed: Each Warrant is exercisable for one share
−Removed: of Common Stock (the “Warrant Shares”) at an exercise price of $2,896.00 per share, will be immediately exercisable upon
−Removed: issuance and will expire five years from the date of issuance.
−Removed: The Warrants were offered and sold at a purchase price of $50.00 per underlying
−Removed: warrant share, which purchase price is included in the offering price per share of Common Stock issued in the Offering (the “Private
−Removed: to an engagement letter, dated as of August 7, 2023, between the Company and H.C.
−Removed: Wainwright & Co., LLC, or the placement agent,
−Removed: 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
−Removed: Private Placement.
−Removed: The Company also agreed to pay the placement agent in connection with the Offering and the Private Placement a management
−Removed: 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,
−Removed: and $15,950 for clearing fees.
−Removed: In addition, the Company agreed to issue to the placement agent, or its designees, warrants to purchase
−Removed: up to 36 shares of Common Stock (the “Placement Agent Warrants”), which represents 7.0% of the aggregate number of shares
−Removed: of Common Stock sold in the Offering.
−Removed: The Placement Agent Warrants have substantially the same terms as the Warrants, except that the
−Removed: 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
−Removed: Offering, and a term of five years from the commencement of the sales pursuant to the Offering.
−Removed: gross proceeds to the Company from the Offering and the Private Placement are $1,590,840.
−Removed: The Company incurred offering costs of $413,544.
−Removed: 2024 Offering
−Removed: January 2, 2024, the Company sold in a public offering (such transaction, the “January 2024 Offering”) (i) 1,344 shares of
−Removed: the Company’s common stock, par value $0.0001 per share and (ii) prefunded warrants to purchase up to an aggregate 5,386 shares
−Removed: of Common Stock (the “January Prefunded Warrants”).
−Removed: The Shares and January Prefunded Warrants were sold together with warrants
−Removed: 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”).
−Removed: The combined public offering price was $520.00 per share of Common Stock and related January 2024 Warrant and $519.96 per January Prefunded
−Removed: Warrant and related January 2024 Warrant.
−Removed: of December 31, 2024, all January Prefunded Warrants have been exercised in full.
−Removed: The January 2024 Warrants are exercisable for a period
−Removed: of five years following the date of issuance.
−Removed: to an engagement letter, dated as of August 7, 2023, as amended October 11, 2023, by and between the Company and the Placement Agent,
−Removed: 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.
−Removed: 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
−Removed: proceeds raised in the January 2024 Offering and certain expenses incurred in connection with the January Offering.
−Removed: In addition, the
−Removed: Company issued to the Placement Agent, warrants to purchase up to an aggregate 471 shares of Common Stock (the “January 2024 Placement
−Removed: Agent Warrants”), which represents 7.0% of the aggregate number of shares of Common Stock and Prefunded Warrants sold in the January
−Removed: 2024 Offering.
−Removed: The January 2024 Placement Agent Warrants have substantially the same terms as the January 2024 Warrants, except that
−Removed: the January 2024 Placement Agent Warrants have an exercise price equal to $650.00, or 125% of the offering price per share of Common
−Removed: Stock and related January 2024 Warrant sold in the January Offering and expire on the fifth anniversary from the date of the commencement
−Removed: of sales in the January 2024 Offering.
−Removed: gross proceeds to the Company from the January 2024 Offering were $3,500,000.
+Added: The Company expects that it will seek to raise
+Added: such additional capital through public or private equity offerings.
+Added: Additional funds may not be available when it needs them on terms
+Added: that are acceptable to them, or at all.
+Added: If adequate funds are not available, it may be required to delay its FDA regulatory strategy,
+Added: and to delay or reduce the scope of its research or development programs, its commercialization efforts or its manufacturing commitments
+Added: and capacity.
+Added: In addition, if it raises additional funds through collaborations, strategic alliances or distribution arrangements with
+Added: third parties, it may have to relinquish valuable rights to its technologies or future revenue streams.
+Added: Recent Offerings
+Added: January 2024 Public Offering
+Added: On January 2, 2024, the Company sold in a public
+Added: offering (such transaction, the “January 2024 Offering”) (i) 336 shares of the Company’s common stock and (ii) prefunded
+Added: warrants to purchase up to an aggregate 1,346 shares of common stock (the “January Prefunded Warrants”).
+Added: The Shares and January
+Added: Prefunded Warrants were sold together with warrants to purchase up to an aggregate of 1,682 shares of common stock at an exercise price
+Added: of $2,080.00 per share (the “January 2024 Warrants”).
+Added: The combined public offering price was $2,080.00 per share of common
+Added: stock and related January 2024 Warrant and $2,079.84 per January Prefunded Warrant and related January 2024 Warrant.
+Added: As of December 31, 2024, all January Prefunded
+Added: Warrants have been exercised in full.
+Added: The January 2024 Warrants are exercisable for a period of five years following the date of issuance.
+Added: Pursuant to an engagement letter, dated as of
+Added: August 7, 2023, as amended October 11, 2023, by and between the Company and the Placement Agent, the Company paid the Placement Agent
+Added: 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
+Added: Agent in connection with the January Offering a management fee of $35,000 equal to 1.0% of the gross proceeds raised in the January 2024
+Added: Offering and certain expenses incurred in connection with the January Offering.
+Added: In addition, the Company issued to the Placement Agent,
+Added: warrants to purchase up to an aggregate 117 shares of common stock (the “January 2024 Placement Agent Warrants”), which represents
+Added: 7.0% of the aggregate number of shares of common stock and Prefunded Warrants sold in the January 2024 Offering.
+Added: The January 2024 Placement
+Added: Agent Warrants have substantially the same terms as the January 2024 Warrants, except that the January 2024 Placement Agent Warrants have
+Added: an exercise price equal to $2,600.00, or 125% of the offering price per share of common stock and related January 2024 Warrant sold in
+Added: the January Offering and expire on the fifth anniversary from the date of the commencement of sales in the January 2024 Offering.
+Added: The gross proceeds to the Company from the January
+Added: 2024 Offering were $3,500,000.
The Company incurred offering costs of $711,031.
−Removed: 2024 Bridge Note Financing
−Removed: May 31, 2024, the Company entered into a Note Purchase Agreement with an accredited investor (the “NPA”), and a Securities
−Removed: Purchase Agreement with three accredited investors (the “SPA”).
−Removed: Under the terms of the NPA, the investor provided the Company
−Removed: with a $1,000,000 cash subscription in exchange for the issuance of a senior secured note.
−Removed: As of December 31, 2024, a total of $1,176,470
−Removed: was repaid to the NPA investors.
−Removed: The difference between such note and the subscription amount, initially recorded as a discount on the
−Removed: notes, was the result of the discount factor included in the NPA of approximately 17.6%.
−Removed: the terms of the SPA, the three investors agreed to collectively provide the Company with a separate $1,000,000 cash subscription in
−Removed: exchange for the issuance of senior secured notes ($333,333 each), and the collective issuance of 1,451 shares of the Company’s
−Removed: common stock.
−Removed: The fair value of the common stock issued in connection with the SPA was $307,563.
−Removed: As of December 31, 2024, a total of
−Removed: $1,111,110 was repaid to the SPA investors.
−Removed: The difference between such notes and the subscription amounts, initially recorded as a discount
−Removed: on the notes, was the result of the discount factor included in the SPA of 11.11%.
−Removed: expense recorded on the NPA and SPAs was $807,797 for the year ended December 31, 2024, including debt issuance costs related to the
−Removed: NPA and SPA totaling $212,654.
−Removed: 2024 Offering
−Removed: June 28, 2024, the Company sold in a public offering ( the “June 2024 Offering”), (i) 11,541 common units (the “Common
−Removed: Units”), each consisting of one share of common stock, two Class C Warrants and one Class D Warrant and (ii) 95,815 prefunded warrants
−Removed: (the “Prefunded Units”), each consisting of one prefunded warrant to purchase one share of common stock (each, a “Prefunded
−Removed: Warrant”), two Class C Warrants and one Class D Warrant to purchase Common Shares.
+Added: May 2024 Bridge Note Financing
+Added: On May 31, 2024, the Company entered into a Note
+Added: Purchase Agreement with an accredited investor (the “NPA”), and a Securities Purchase Agreement with three accredited investors
+Added: Under the terms of the NPA, the investor provided the Company with a $1,000,000 cash subscription in exchange
+Added: for the issuance of a senior secured note.
+Added: As of December 31, 2024, a total of $1,176,470 was repaid to the NPA investors.
+Added: The difference
+Added: between such note and the subscription amount, initially recorded as a discount on the notes, was the result of the discount factor included
+Added: in the NPA of approximately 17.6%.
+Added: Under the terms of the SPA, the three investors
+Added: agreed to collectively provide the Company with a separate $1,000,000 cash subscription in exchange for the issuance of senior secured
+Added: notes ($333,333 each), and the collective issuance of 362 shares of the Company’s common stock.
+Added: The fair value of the common stock
+Added: issued in connection with the SPA was $307,563.
+Added: As of December 31, 2024, a total of $1,111,110 was repaid to the SPA investors.
+Added: The difference
+Added: between such notes and the subscription amounts, initially recorded as a discount on the notes, was the result of the discount factor
+Added: included in the SPA of 11.11%.
+Added: Interest expense recorded on the NPA and SPAs
+Added: was $807,797 for the year ended December 31, 2024, including debt issuance costs related to the NPA and SPA totaling $212,654.
+Added: June 2024 Offering
+Added: On June 28, 2024, the Company sold in a public
+Added: offering ( the “June 2024 Offering”), (i) 2,888 common units (the “Common Units”), each consisting of one share
+Added: of common stock, two Class C Warrants and one Class D Warrant and (ii) 23,953 prefunded warrants (the “Prefunded Units”),
+Added: each consisting of one prefunded warrant to purchase one share of common stock (each, a “Prefunded Warrant”), two Class C
+Added: Warrants and one Class D Warrant to purchase Common Shares.
Aegis Capital Corp.
−Removed: the “Underwriter”) partially exercised its over-allotment option in respect to 13,573 Class C Warrants and 6,787 Class D
−Removed: Warrants (the “Over-Allotment Warrants”).
−Removed: The Common Units were sold at a price of $81.50 per unit and the Prefunded Warrants
−Removed: were sold at a price of $81.495 per unit.
+Added: (“Aegis” or, the “Underwriter”)
+Added: partially exercised its over-allotment option in respect to 3,393 Class C Warrants and 1,696 Class D Warrants (the “Over-Allotment
+Added: The Common Units were sold at a price of $326.00 per unit and the Prefunded Warrants were sold at a price of $325.98
As of December 31, 2024, all Prefunded Warrants have been exercised in full.
−Removed: 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
−Removed: equal to 8.5% of the gross proceeds received in the June 2024 Offering.
−Removed: gross proceeds to the Company from the June 2024 Offering were $8,569,075.
+Added: Pursuant to an engagement letter dated June 6,
+Added: 2024, by and between the Company and Aegis, the Company paid Aegis a total cash fee of $743,750 equal to 8.5% of the gross proceeds received
+Added: in the June 2024 Offering.
+Added: The gross proceeds to the Company from the June
+Added: 2024 Offering were $8,569,075.
The Company incurred offering costs of $1,133,419.
−Removed: Accounting Policies and Estimates
−Removed: of our critical accounting policies require us to make difficult, subjective or complex judgments or estimates.
−Removed: An accounting estimate
−Removed: is considered to be critical if it meets both of the following criteria:
−Removed: (i) the estimate requires assumptions about matters that
−Removed: are highly uncertain at the time the accounting estimate is made, and (ii) different estimates reasonably could have been used,
−Removed: or changes in the estimate that are reasonably likely to occur from period to period may have a material impact on the presentation of
−Removed: our financial condition, changes in financial condition or results of operations.
−Removed: an emerging growth company, we have elected to opt-in to the extended transition period for new or revised accounting standards.
−Removed: As a result, our consolidated financial statements may not be comparable to those of companies that comply with public company effective
+Added: April 2025 Private Placement
+Added: On April 7, 2025, the Company entered into inducement
+Added: letter agreements with certain existing holders of the Company’s Class C Warrants, pursuant to which such holders agreed to purchase
+Added: an aggregate of 271,277 shares of the Company’s common stock (or, to the extent the applicable holder would have exceeded a specified
+Added: beneficial ownership limitation, prefunding the future exercise of such warrants, other than a remaining $0.0004 per share exercise price).
+Added: The Class C Warrants were originally issued on June 28, 2024 for an exercise price of $392.00 per share and were subsequently reduced
+Added: to $65.20 per share pursuant to stockholder approval on August 21, 2024.
+Added: Pursuant to the inducement letter agreements, the applicable
+Added: holders agreed to exercise their Series C Warrants at a reduced exercise price of $13.68 per share, and to purchase an equivalent number
+Added: of new Class E Warrants for an additional $0.50 per share.
+Added: The Class E Warrants have an exercise price of $13.68 per share and expire
+Added: on April 8, 2030.
+Added: The transaction closed on April 8, 2025.
+Added: of the Class C Warrants resulted in the Company issuing 170,551 shares of common stock at closing pursuant to the inducement letters,
+Added: and the exercise price of 100,726 of the Class C Warrants being amended to 0.0004 per share.
+Added: As of December 31, all such reduced exercise
+Added: price Class C Warrants had been exercised.
+Added: The gross proceeds to the Company from the exercise
+Added: of the Class C Warrants and the sale of the new Class E Warrants were $3,846,692 million.
+Added: The Company incurred total offering costs of
+Added: $464,670, including a 10% financial advisory fee to Aegis Capital Corp.
+Added: The modification of the terms or conditions of
+Added: the Class C Warrants in this transaction is treated as an exchange of the original instrument for a new instrument.
+Added: Using the Black Scholes
+Added: option pricing model, the fair value of the Series C Warrants immediately prior to the inducement transaction was $479,299 and immediately
+Added: after the inducement transaction was $1,590,930.
+Added: In addition, Series E Warrants with a fair value of $1,730,652 were provided as part
+Added: of the inducement transaction for a purchase price of $135,638.
+Added: The Company recorded additional equity issuance costs of $2,706,645 related
+Added: to the modification of the Series C Warrants and issuance of Series E Warrants related to the inducement transaction.
+Added: As this equity issuance
+Added: cost was a non-cash transaction, the Company recorded an increase to additional paid-in capital to offset the expense.
+Added: October 2025 Private Placement
+Added: On October 9, 2025, the Company entered
+Added: into a securities purchase agreement with two institutional investors pursuant to which the Company sold in a private placement (i) an
+Added: aggregate of 43,750 shares of common stock and prefunded warrants to purchase up to 518,750 shares of common stock (the “October
+Added: 2025 Prefunded Warrants”), and (ii) Series F warrants (the “Series F Warrants”) to purchase up to 1,125,000 shares of
+Added: common stock.
+Added: The combined price of the securities sold in the private placement was $8.00 per share of common stock (or prefunded warrant
+Added: in lieu thereof, in which case such price was reduced by $0.0004) and accompanying Series F Warrants to acquire two shares of common stock.
+Added: The October 2025 Prefunded Warrants, were exercisable for shares of common stock at an exercise price of $0.0004 per share and were immediately
+Added: exercisable, have all been fully exercised as of the date hereof.
+Added: The Series F Warrants are exercisable for shares of common stock at
+Added: an exercise price of $7.00 per share, are immediately exercisable and expire five and one-half years from the date of issuance.
+Added: The transaction closed on October 10, 2025.
+Added: gross proceeds to the Company from the sale of the securities sold in the private placement were approximately $4.5 million.
+Added: incurred total offering costs of $787,755, including a 8% financial advisory fee to Rodman and Renshaw LLC (“Rodman”), the
+Added: placement agent, of approximately $360,000.
+Added: Under the terms of the Company’s engagement letter with Rodman, the Company issue Rodman’s
+Added: designees warrants to purchase up to 45,000 of common stock at an exercise price of $10.00 per share, which expire 5.5 years from the
+Added: date of issuance (the “October 2025 Placement Agent Warrants”).
+Added: In connection with this private placement, the
+Added: Company filed a registration statement on Form S-3, which became effective on November 26, 2025, to register 1,732,500 shares of common
+Added: stock (including any shares of common stock issued in the future pursuant to the Series F Warrants or October 2025 Placement Agent Warrants)
+Added: for resale in public markets.
+Added: Critical Accounting Policies and Estimates
+Added: Some of our critical accounting policies require
+Added: us to make difficult, subjective or complex judgments or estimates.
+Added: An accounting estimate is considered to be critical if it meets both
+Added: of the following criteria:
+Added: (i) the estimate requires assumptions about matters that are highly uncertain at the time the accounting
+Added: estimate is made, and (ii) different estimates reasonably could have been used, or changes in the estimate that are reasonably likely
+Added: to occur from period to period may have a material impact on the presentation of our financial condition, changes in financial condition
+Added: or results of operations.
+Added: As an emerging growth company, we have elected
+Added: to opt-in to the extended transition period for new or revised accounting standards.
+Added: As a result, our consolidated financial statements
+Added: may not be comparable to those of companies that comply with public company effective dates.
See Note 2 to consolidated financial statements for a summary of significant
accounting policies.
−Removed: Adopted Accounting Standards
−Removed: Note 2 to consolidated financial statements (under the caption “Recently Issued Accounting Standards”).
−Removed: Issued Accounting Standards
−Removed: Note 2 to consolidated financial statements (under the caption “Recently Issued Accounting Standards”).
+Added: Recently Adopted Accounting Standards
+Added: See Note 2 to consolidated financial statements
+Added: (under the caption “Recently Adopted Accounting Standards”).
+Added: Recently Issued Accounting Standards
+Added: See Note 2 to consolidated financial statements
+Added: (under the caption “Recently Issued Accounting Standards”).
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
−Removed: requested by this Item is not applicable as we are electing scaled disclosure requirements available to Smaller Reporting Companies with
−Removed: respect to this Item.
+Added: Information requested by this Item is not applicable
+Added: as we are electing scaled disclosure requirements available to Smaller Reporting Companies with respect to this Item.
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
−Removed: Consolidated Financial Statements and The Report of Independent Registered Public Accounting Firm are included in this Form 10-K
−Removed: on pages F-1 through F-19.
−Removed: CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
+Added: Our Consolidated Financial Statements and The
+Added: Report of Independent Registered Public Accounting Firm are included in this Form 10-K on pages F-1 through F-22.
+Added: CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS
+Added: 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.