−Removed: Management’s Discussion and Analysis of Financial Condition and Results
−Removed: of Operations.
−Removed: thousands, except for share amounts and per share data)
−Removed: should read the following discussion and analysis of our financial condition and results of operations together with our unaudited consolidated
−Removed: financial statements and related notes appearing in Part I, Item 1 of this Quarterly Report on Form 10-Q (the “Quarterly Report”), and with our audited financial
−Removed: statements and notes thereto for the year ended December 31, 2023, included in our prospectus dated September 16, 2024 (File Number:
−Removed: 333-274805)(the
−Removed: “Prospectus”).
+Added: Management’s Discussion and Analysis
+Added: of Financial Condition and Results of Operations.
+Added: (in thousands, except for share amounts and per share
+Added: You should read the following
+Added: discussion and analysis of our financial condition and results of operations (the “MD&A”) together with our unaudited
+Added: consolidated financial statements and related notes appearing in Part I, Item 1 of this Quarterly Report on Form 10-Q (the “Quarterly
+Added: Report”), and with our audited financial statements and notes thereto for the year ended December 31, 2024, included in our annual
+Added: report on Form 10-K filed with the Securities Exchange Commission (the “SEC”) on April 15, 2025, as amended (the “2024
+Added: Annual Report”) .
Note Regarding Forward-Looking Statements
−Removed: addition to historical information, some of the statements contained in this discussion and analysis or set forth elsewhere in this
−Removed: Quarterly Report, including information with respect to our plans and strategy for our business, constitute forward-looking
−Removed: statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange
−Removed: Act of 1934, as amended (the “Exchange Act”).
−Removed: We have based these forward-looking statements on our current expectations
−Removed: and any projections about future events.
−Removed: The following information and any forward-looking statements should be considered in light
−Removed: of factors discussed elsewhere in this Quarterly Report, along with the risks identified in the Prospectus under the title
−Removed: “Risk Factors” and in our other filings with the Securities Exchange Commission (the “SEC”).
−Removed: caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial
−Removed: condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements
−Removed: contained in this Quarterly Report.
−Removed: Statements made herein are as of the date of the filing of this Quarterly Report with the SEC and
−Removed: should not be relied upon as of any subsequent date.
−Removed: Even if our results of operations, financial condition and liquidity, and the development
−Removed: of the industry in which we operate are consistent with the forward-looking statements contained in this Quarterly Report, they may not
−Removed: be predictive of results or developments in future periods.
−Removed: We disclaim any obligation, except as specifically required by law and the
−Removed: rules of the SEC, to publicly update or revise any such statements to reflect any change in our expectations or in events, conditions
−Removed: or circumstances on which any such statements may be based or that may affect the likelihood that actual results will differ from those
−Removed: set forth in the forward-looking statements.
−Removed: are a clinical-stage biopharmaceutical company advancing therapeutics for cancer patients that are designed to overcome key hurdles in
−Removed: immune suppression and drug resistance.
−Removed: mission is to advance our portfolio of innovative therapeutics to reverse key mechanisms of therapeutic resistance and immune suppression
−Removed: and transform the way cancer is treated.
−Removed: We have leveraged molecular insights of the mechanisms of therapeutic resistance and immune
−Removed: suppression to develop a new class of novel drugs that we expect will target drug resistance and checkpoints of immune suppression.
−Removed: of the date of this Quarterly Report, our product candidates have not been approved as
−Removed: safe or effective by the Food and Drug Administration (“FDA”) or any other comparable foreign regulator.
−Removed: inception, our operations have focused on organizing and staffing our company, business planning, raising capital, acquiring and developing
−Removed: our technology, establishing our intellectual property portfolio, identifying potential product candidates and undertaking preclinical
−Removed: and clinical studies and manufacturing.
−Removed: We do not have any products approved for sale and have not generated any revenue from product
−Removed: inception, we have incurred significant operating losses.
−Removed: Our net losses were $1,623 and $1,812 for the nine months ended September 30,
−Removed: 2024 and for the year ended December 31, 2023, respectively.
−Removed: As of September 30, 2024, we had an accumulated deficit of $7,835.
−Removed: to continue to incur significant and increasing expenses and operating losses for the foreseeable future, as we advance our current and
−Removed: future product candidates through preclinical and clinical development, manufacture drug product and drug supply, seek regulatory approval
−Removed: for our current and future product candidates, maintain and expand our intellectual property portfolio, hire additional research and
−Removed: development and business personnel and operate as a public company.
−Removed: will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval
−Removed: for our product candidates.
−Removed: In addition, if we obtain regulatory approval for our product candidates and do not enter into a third-party
−Removed: commercialization partnership, we will likely incur significant expenses related to developing our commercialization capability to support
−Removed: product sales, marketing, manufacturing, and distribution activities.
−Removed: a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy.
−Removed: generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of public or private
−Removed: equity offerings and debt financings or other sources, such as potential collaboration agreements, strategic alliances and licensing
−Removed: arrangements.
−Removed: We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on acceptable
−Removed: terms, or at all.
−Removed: Our failure to raise capital or enter into such agreements as, and when needed, could have a material adverse effect
−Removed: on our business, results of operations and financial condition.
−Removed: report of our independent registered public accounting firm on our financial statements for the years ended December 31, 2022 and 2023
−Removed: included an explanatory paragraph indicating that there was substantial doubt about our ability to continue as a going concern.
−Removed: 1 to our annual financial statements appearing at the Prospectus for additional information on our assessment.
−Removed: September 30, 2024, the Company had cash on hand in the amount of $3,217.
−Removed: The ability to continue as a going concern is dependent on
−Removed: the Company attaining and maintaining profitable operations in the future and raising additional capital to meet its obligations and
−Removed: repay its liabilities arising from normal business operations when they come due.
−Removed: Since inception, the Company has funded its operations
−Removed: primarily through equity and debt financings and it expects to continue to rely on these sources of capital in the future.
−Removed: assurance can be given that any future financing will be available or, if available, that it will be on terms that are satisfactory to
+Added: In addition to historical information, some of
+Added: the statements contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect
+Added: to our plans and strategy for our business, constitute forward-looking statements within the meaning of Section 27A of the Securities
+Added: Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange
+Added: We have based these forward-looking statements on our current expectations and any projections about future events.
+Added: The following
+Added: information and any forward-looking statements should be considered in light of factors discussed elsewhere in this Quarterly Report,
+Added: along with the risks identified in the Prospectus under the title “Risk Factors” and in our other filings with the Securities
+Added: Exchange Commission (the “SEC”).
+Added: We caution you that forward-looking statements
+Added: are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development
+Added: of the industry in which we operate may differ materially from the forward-looking statements contained in this Quarterly Report.
+Added: made herein are as of the date of the filing of this Quarterly Report with the SEC and should not be relied upon as of any subsequent
+Added: Even if our results of operations, financial condition and liquidity, and the development of the industry in which we operate are
+Added: consistent with the forward-looking statements contained in this Quarterly Report, they may not be predictive of results or developments
+Added: in future periods.
+Added: We disclaim any obligation, except as specifically required by law and the rules of the SEC, to publicly update or
+Added: revise any such statements to reflect any change in our expectations or in events, conditions or circumstances on which any such statements
+Added: may be based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
+Added: We are a clinical-stage biopharmaceutical company
+Added: advancing therapeutics for cancer patients that are designed to overcome key hurdles in immune suppression and drug resistance.
+Added: Our mission is to advance our portfolio of innovative
+Added: therapeutics to reverse key mechanisms of therapeutic resistance and immune suppression and transform the way cancer is treated.
+Added: leveraged molecular insights of the mechanisms of therapeutic resistance and immune suppression to develop a new class of novel drugs
+Added: that we expect will target drug resistance and checkpoints of immune suppression.
+Added: As of the date of this Annual Report, our product candidates
+Added: have not been approved as safe or effective by the FDA or any other comparable foreign regulator.
+Added: Since inception, our operations have focused on organizing
+Added: and staffing our Company, business planning, raising capital, acquiring and developing our technology, establishing our intellectual property
+Added: portfolio, identifying potential product candidates, and undertaking preclinical and clinical studies and manufacturing.
+Added: We do not have
+Added: any products approved for sale and have not generated any revenue from product sales.
+Added: Since inception, we have incurred significant operating
+Added: Our net losses were $1,262 and $2,603 for the three months ended March 31, 2025 and the year ended December 31, 2024, respectively.
+Added: As of March 31, 2025, we had an accumulated deficit of $10,077.
+Added: We expect to continue to incur significant and increasing expenses and
+Added: operating losses for the foreseeable future, as we advance our current and future product candidates through preclinical and clinical
+Added: development, manufacture drug product and drug supply, seek regulatory approval for our current and future product candidates, maintain
+Added: and expand our intellectual property portfolio, hire additional research and development and business personnel, and operate as a public
+Added: will not generate revenue from product sales unless and until we successfully complete our clinical trials and obtain
+Added: regulatory approval for our product candidates.
+Added: In addition, if we obtain regulatory approval for our product candidates and do not
+Added: enter into a third-party commercialization partnership, we will likely incur significant expenses related to developing our
+Added: commercialization capability to support product sales, marketing, manufacturing, and distribution activities.
+Added: As a result, we will need substantial additional funding
+Added: to support our continuing operations and pursue our growth strategy.
+Added: Until we can generate significant revenue from product sales, if
+Added: ever, we expect to finance our operations through a combination of public or private equity offerings and debt financings and other sources,
+Added: such as potential collaboration agreements, strategic alliances and licensing arrangements.
+Added: We may be unable to raise additional funds
+Added: or enter into such other agreements or arrangements when needed on acceptable terms, or at all.
+Added: Our failure to raise capital or enter
+Added: into such agreements as and when needed could have a material adverse effect on our business, results of operations and financial condition.
+Added: No assurance can be given that any future financing will be available or, if available, that it will be on terms that are satisfactory
+Added: to the Company.
Even if the Company is able to obtain additional financing, it may contain undue restrictions on our operations, in the
case of debt financing, or cause substantial dilution for our stockholders, in case of equity financing.
−Removed: Accounting Policies and Significant Judgments and Estimates
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations is based on our financial statements, which
−Removed: have been prepared in accordance with accounting principles generally accepted in the United States, or GAAP.
−Removed: The preparation of these
−Removed: financial statements requires us to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities,
−Removed: disclosure of contingent assets and liabilities as of the date of the balance sheets and the reported amounts of expenses during the
−Removed: reporting periods.
−Removed: In accordance with GAAP, we base our estimates on historical experience and on various other assumptions that we believe
−Removed: are reasonable under the circumstances at the time such estimates are made.
−Removed: Actual results may differ materially from our estimates and
−Removed: judgments under different assumptions or conditions.
−Removed: We periodically review our estimates in light of changes in circumstances, facts
−Removed: and experience.
−Removed: The effects of material revisions in estimates are reflected in our financial statements prospectively from the date
−Removed: of the change in estimate.
−Removed: define our critical accounting policies as those accounting principles that require us to make subjective estimates and judgments about
−Removed: matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as
−Removed: the specific manner in which we apply those principles.
−Removed: While our significant accounting policies are more fully described in Note 2
−Removed: to our unaudited financial statements appearing elsewhere in this Quartey
−Removed: Report, we believe the following are the critical accounting policies used in the preparation of our financial statements that require
−Removed: significant estimates and judgments.
−Removed: and Development Expenses
−Removed: and development expenses consist primarily of costs incurred in connection with the development of our product candidates.
−Removed: research and development costs as incurred.
−Removed: the end of each reporting period, we compare payments made to third-party service providers to the estimated progress toward completion
−Removed: of the applicable research or development objectives.
−Removed: Such estimates are subject to change as additional information becomes available.
−Removed: Depending on the timing of payments to the service providers and the progress that we estimate has been made as a result of the service
−Removed: provided, we may record net prepaid or accrued expenses relating to these costs.
−Removed: As of December 31, 2023, and September 30,
−Removed: 2024, we have not made any material adjustments to our prior estimates of accrued research and development expenses.
−Removed: Stock-Based Compensation
−Removed: The Company measures all stock
−Removed: options and other stock-based awards granted based on the fair value of the award on the date of the grant and recognizes compensation
−Removed: expense for those awards over the requisite service period, which is generally the vesting period of the respective award.
−Removed: has elected to recognize forfeitures as they occur.
−Removed: The reversal of compensation cost previously recognized for an award that is forfeited
−Removed: because of a failure to satisfy a service or performance condition is recognized in the period of the forfeiture.
−Removed: Generally, the Company
−Removed: issues stock options with only service-based vesting conditions and records the expense for these awards using the straight-line method
−Removed: over the requisite service period.
−Removed: The Company classifies stock-based
−Removed: compensation expense in its statements of operations in the same manner in which the award recipient’s payroll costs are classified
−Removed: or in which the award recipients’ service payments are classified.
−Removed: The Company was a private company
−Removed: until the completion of its IPO on September 17, 2024.
−Removed: The Company estimates the fair value of common stock using an appropriate valuation
−Removed: methodology, in accordance with the framework of the American Institute of Certified Public Accountants’ Technical Practice Aid,
−Removed: Valuation of Privately-Held Company Equity Securities Issued as Compensation.
−Removed: Each valuation methodology includes estimates and assumptions
−Removed: that require the Company’s judgment.
−Removed: These estimates and assumptions include a number of objective and subjective factors, including
−Removed: external market conditions, guideline public company information, the prices at which the Company sold its common stock to third parties
−Removed: in arms’ length transactions, the rights and preferences of securities senior to the Company’s common stock at the time, and
−Removed: the likelihood of achieving a liquidity event such as an initial public offering or sale.
−Removed: Significant changes to the assumptions used
−Removed: in the valuations could result in different fair values of stock options or warrants at each valuation date, as applicable.
−Removed: The fair value of each stock option or warrant grant is estimated using
−Removed: the Black-Scholes option-pricing model.
−Removed: The Company was a private company and lacked company-specific historical and implied volatility
−Removed: Therefore, it estimated its expected stock volatility based on the historical volatility of a publicly traded set of peer
−Removed: companies within the biotechnology industry with characteristics similar to the Company.
−Removed: The expected term of the Company’s stock
−Removed: options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options.
−Removed: The expected term of stock options granted to non-employees is equal to the contractual term of the option award.
−Removed: The risk-free interest
−Removed: rate is determined by reference to the U.S.
−Removed: Treasury yield curve in effect at the time of grant of the award for time periods approximately
−Removed: equal to the expected term of the award.
−Removed: Expected dividend yield is zero, based on the fact that the Company has never paid cash dividends
−Removed: and does not expect to pay any cash dividends in the foreseeable future.
−Removed: Sheet Arrangements
−Removed: the years ended December 31, 2022 and 2023, and the nine months ended September 30, 2024, we did not have, and we do not currently have,
−Removed: any off-balance sheet arrangements (as defined under SEC rules).
−Removed: Accounting Pronouncements
−Removed: a description of recently issued accounting standards that may have a material impact on our financial statements or will otherwise apply
−Removed: to our operations, please see Note 2 to our unaudited financial statements appearing elsewhere in this Quartey
−Removed: Emerging Growth
−Removed: Company Status
−Removed: As an “emerging growth company,” the Jumpstart Our Business
−Removed: Startups Act of 2012 permits us to take advantage of an extended transition period to comply with new or revised accounting standards
−Removed: applicable to public companies until those standards would otherwise apply to private companies.
−Removed: We have irrevocably elected to “opt
−Removed: out” of this provision and, as a result, we will comply with new or revised accounting standards when they are required to be adopted
−Removed: by public companies that are not emerging growth companies.
−Removed: of Results of Operations
−Removed: have not generated any sales to date.
−Removed: There was no revenue recorded from any sources during the year ended December 31, 2023,
−Removed: and the nine months ended September 30, 2024.
−Removed: operating expenses consist of (i) research and development expenses and (ii) general and administrative expenses.
−Removed: and Development Expenses
−Removed: Ramachandran Murali is our Vice President of Research and Development.
−Removed: Murali is a doctor and scientist at Cedars-Sinai Medical Center,
−Removed: and is the inventor, with others, of three of the patent technologies that are subject to the Kairos-Cedars license agreements.
−Removed: We are engaged in rolling out Phase 1 and Phase 2 clinical trials for ENV-105
−Removed: and a Phase 1 trial for KROS-201.
−Removed: we are continuously performing preclinical research including animal models of disease, medicinal chemistry laboratory studies, formulation,
−Removed: and toxicology and biodistribution studies.
−Removed: Our clinical development costs may vary significantly based on factors such as:
+Added: Recent Developments
+Added: Equity Line of Credit Agreement (ELOC)
+Added: November 12, 2024, we entered into an ELOC agreement (the “ELOC Agreement”) with Helena Global Investment Opportunities
+Added: I LTD (“Helena”), pursuant to which Helena agreed to purchase from the Company up to $30,000 of common stock (the
+Added: “ELOC Shares”).
+Added: The Company issued 670,641 shares of restricted common stock (the “Commitment Fee Shares”)
+Added: to Helena as a “Commitment Fee” for the ELOC Agreement.
+Added: The ELOC Agreement will be available for the Company’s
+Added: use at such time following the filing and effectiveness of a resale registration statement registering the ELOC Shares for resale.
+Added: At the time of effectiveness of the resale registration statement (the “Effective Date”), the Commitment Fee Shares will
+Added: be subject to a “true-up” pursuant to which, in the event the shares are valued at less than $900 on the Effective Date,
+Added: additional shares will be issued to Helena to bring the ELOC Shares to the full $900 value.
+Added: The ELOC Agreement will terminate upon the following
+Added: (i) the first day of the month next following the 36-month anniversary of the date of the ELOC Agreement or (ii) the date on which
+Added: Helena has purchased the full $30,000 of ELOC Shares.
+Added: The ELOC Agreement may be terminated by the Company
+Added: after its commencement, at the Company’s discretion, provided that there are no advance notices outstanding for which common stock
+Added: has yet to be issued, and the Company has paid all amounts owed to Helena under the ELOC Agreement, including the Commitment Fee shares.
+Added: January 2025 PIPE Offering
+Added: On January 14, 2025, the Company entered into a securities
+Added: purchase agreement (the “Purchase Agreement”) and registration rights agreement (the “Registration Rights Agreement”)
+Added: with the investor name therein (the “Investor”) for the sale and issuance of 2,500,000 units (the “Pre-Funded Units”),
+Added: with each Pre-Funded Unit consisting of a pre-funded warrant (the “Pre-Funded Warrant”) to purchase one share of common stock,
+Added: exercisable for $0.001 per share, and a common warrant (the “Common Warrant”) to purchase one and one half shares of common
+Added: stock, exercisable at $1.40 per share (the “January 2025 PIPE Offering”).
+Added: 16, 2025, the Company closed the January 2025 PIPE Offering for a total purchase price of $3,498 (or $1.399 per Pre-Funded Unit), with
+Added: an additional $2 payable upon the Investor’s exercise of the Pre-Funded Warrants in full.
+Added: In advance of closing, on January 16, 2025, the Company
+Added: and the Investor entered into an amendment and restatement to the Purchase Agreement (the “A&R Purchase Agreement”), which
+Added: amended the terms of the Purchase Agreement to include a requirement that the Company obtain shareholder approval prior to issuing in
+Added: excess of 19.99% of the Company’s common stock and also amended the Common Warrants to make them immediately exercisable and reduce
+Added: the exercise period from 5.5 years to five years.
+Added: Other terms of the Purchase Agreement and Common Warrants remained the same.
+Added: Boustead and D.
+Added: Boral Capital LLC (“D.
+Added: acted as co-placement agents for the January 2025 PIPE Offering.
+Added: In conjunction therewith, on January 16, 2025, the Company entered into
+Added: a Placement Agent Agreement with Boustead (the “Placement Agent Agreement”).
+Added: Under the terms of the Placement Agent Agreement,
+Added: at closing, the Company paid the Placement Agents (i) a cash commission equal to 8% of the gross proceeds (including a 1% non-accountable
+Added: expense fee) and (ii) warrants to purchase a total of 175,000 shares of common stock, exercisable at $1.40 per share, with the total cash
+Added: and warrant compensation split equally between Boustead and D.
+Added: On January 20, 2025, the Company obtained the approval
+Added: of 55.4% of the shareholders (the “Majority Shareholders”) for the issuance in excess of 19.99% of the Company’s common
+Added: stock at a price below market value, in compliance with Rule 713 of the NYSE American LLC Company Guide.
+Added: On February 10, 2025, the Company
+Added: filed the definitive Schedule 14C and the shareholder approval became effective on March 1, 2025.
+Added: Components of Results of Operations
+Added: We have not generated any sales to date.
+Added: was recorded from any sources during the three months ended March 31, 2025 and 2024.
+Added: Operating Expenses
+Added: Our operating expenses consist of (i) research and
+Added: development expenses and (ii) general and administrative expenses.
+Added: Research and Development Expenses
+Added: Ramachandran Murali is our Vice President of Research
+Added: and Development.
+Added: Murali is a doctor and scientist at Cedars-Sinai Medical Center, and is the inventor, with others, of three of the
+Added: patented technologies that are subject to the Kairos-Cedars license agreements.
+Added: are engaged in rolling out our Phase 1 and Phase 2 clinical trials for ENV 105 and a Phase 1 trial for KROS 201.
+Added: In addition, we
+Added: are continuously performing preclinical research including animal models of disease, medicinal chemistry laboratory studies,
+Added: formulation, and toxicology and biodistribution studies.
+Added: Our clinical development costs may vary significantly based on factors such
+Added: per patient trial costs;
the number of trials required for approval;
the number of sites included in the trials;
−Removed: the location where the trials are
+Added: where the trials are conducted;
the length of time required to enroll eligible patients;
−Removed: the number of patients that participate in the trials;
−Removed: of doses that patients receive;
+Added: the number of patients that participate in
+Added: the number of doses that patients receive;
the drop-out or discontinuation rates of patients;
−Removed: potential additional safety monitoring requested by
−Removed: regulatory agencies;
+Added: potential additional
+Added: safety monitoring requested by regulatory agencies;
the duration of patient participation in the trials and follow-up;
−Removed: the cost and timing of manufacturing our product
+Added: timing of manufacturing our product candidates;
the phase of development of our product candidates;
−Removed: and the efficacy and safety profile of our product candidates.
+Added: and the efficacy and safety
+Added: profile of our product candidates.
successful development and commercialization of product candidates is highly uncertain.
27 unchanged sentences
business interruptions to our operations, including the timing and enrollment of patients in our planned clinical trials, or to those
−Removed: of our manufacturers, suppliers, or other vendors resulting from the COVID-19 pandemic or similar public health crisis;
−Removed: and a continued
−Removed: acceptable safety profile of our therapies following approval.
−Removed: change in the outcome of any of these variables with respect to the development of our product candidates could significantly change
−Removed: the costs and timing associated with the development of that product candidate.
−Removed: We may never succeed in obtaining regulatory approval
−Removed: for any of our product candidates.
−Removed: and administrative expenses
−Removed: and administrative expenses consist primarily of salaries and related costs for personnel in executive, finance, corporate and business
−Removed: development, as well as administrative functions.
+Added: of our manufacturers, suppliers, or other vendors resulting from any pandemic or public health crisis;
+Added: and a continued acceptable safety
+Added: profile of our therapies following approval.
+Added: A change in the outcome of any of these variables
+Added: with respect to the development of our product candidates could significantly change the costs and timing associated with the development
+Added: of that product candidate.
+Added: We may never succeed in obtaining regulatory approval for any of our product candidates.
+Added: General and administrative expenses
+Added: General and administrative expenses consist primarily
+Added: of salaries and related costs for personnel in executive, finance, corporate and business development, as well as administrative functions.
General and administrative expenses also include legal fees relating to patent, corporate, IPO-related matters, and reporting matters;
−Removed: professional fees
−Removed: for accounting, auditing, tax and administrative consulting services;
+Added: professional fees for accounting, auditing, tax and administrative consulting services;
insurance costs;
administrative travel expenses;
−Removed: marketing expenses
−Removed: and other operating costs.
−Removed: anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support our business
−Removed: We also anticipate that we will incur increased accounting, audit, legal, regulatory, compliance and director and officer
−Removed: insurance costs, as well as investor and public relations expenses associated with being a public company.
−Removed: of Operations
−Removed: of the Three Months Ended September 30, 2024 and 2023
−Removed: following table summarizes our results of operations for the three months ended September 30, 2024 and 2023 (in thousands), respectively:
−Removed: and administrative
+Added: marketing expenses and other operating costs.
+Added: We anticipate that our general and administrative
+Added: expenses will increase in the future as we increase our headcount to support our business operations.
+Added: We also anticipate that we will
+Added: incur increased accounting, audit, legal, regulatory, compliance, and director and officer insurance costs, as well as investor and public
+Added: relations expenses associated with being a public company.
+Added: Results of Operations
+Added: Comparison of the Three Months Ended March 31,
+Added: 2025 and 2024
+Added: The following table summarizes our results of operations
+Added: for the three months ended March 31, 2025 and 2024:
+Added: Operating expenses:
+Added: Research and development
+Added: General and administrative
Total operating expenses
2 unchanged sentences
Interest expense
−Removed: Financing costs
−Removed: discount amortization
−Removed: Total other expenses
−Removed: and Development Expenses
−Removed: table below summarizes our research and development expenses for the three months ended September 30, 2024 and 2023 (in thousands), respectively:
−Removed: Development Expenses:
−Removed: and related expenses
−Removed: Total research and development
−Removed: and development expenses were $14 and $33 for the three months ended September 30, 2024 and 2023, respectively.
−Removed: There were no significant
−Removed: changes between periods.
−Removed: and Administrative Expenses
−Removed: table below summarizes our general and administrative expenses for the three months ended September 30, 2024 and 2023 (in thousands), respectively:
−Removed: Administrative Expenses:
−Removed: Patent related
−Removed: Stock compensation
−Removed: Accounting fees
−Removed: Other professional fees
−Removed: Fees relating to license
−Removed: Insurance expense
−Removed: Amortization expense
−Removed: Total general and administrative
−Removed: and administrative expenses were $369 and $254 for the three months ended September 30, 2024 and 2023, respectively.
−Removed: There were no significant
−Removed: changes between periods.
−Removed: expenses were $664 and $25 for the three months ended September 30, 2024 and 2023, respectively.
−Removed: The increase in 2024 was due to financing
−Removed: costs recorded during 2024 of $537 and the increase in debt discount amortization in 2024.
−Removed: of the Nine Months Ended September 30, 2024 and 2023
−Removed: following table summarizes our results of operations for the nine months ended September 30, 2024 and 2023 (in thousands), respectively:
−Removed: and administrative
−Removed: Total operating expenses
−Removed: Loss from operations
+Added: Debt discount amortization
+Added: Interest income
+Added: Total other expenses, net
+Added: Research and Development Expenses
+Added: The table below summarizes our research and development
+Added: expenses for the three months ended March 31, 2025 and 2024:
+Added: Research and Development Expenses:
+Added: Clinical and related expenses
+Added: Total research and development expenses
+Added: Research and development expenses were $493 and $165
+Added: for the three months ended March 31, 2025 and 2024, respectively.
+Added: The increase in R&D expenses in 2025 primarily related to our Phase
+Added: 2 trial in prostate cancer beginning in 2024.
+Added: General and Administrative Expenses
+Added: The table below summarizes our general and administrative
+Added: expenses for the three months ended March 31, 2025 and 2024:
+Added: General and Administrative Expenses:
+Added: Stock-related expenses
+Added: Officer compensation and wages
+Added: Patent related expenses
+Added: Legal expenses
+Added: Accounting expenses
+Added: Other professional service expenses and fees
+Added: Fees relating to license agreements
+Added: Insurance expenses
+Added: Vendor advances amortization expense
+Added: Intangible amortization expense
Other expenses
−Removed: Interest expense
−Removed: Financing costs
−Removed: discount amortization
−Removed: Total other expenses
−Removed: and Development Expenses
−Removed: table below summarizes our research and development expenses for the nine months ended September 30, 2024 and 2023 (in thousands), respectively:
−Removed: Development Expenses:
−Removed: and related expenses
−Removed: Total research and development
−Removed: and development expenses were $242 and $75 for the nine months ended September 30, 2024 and 2023, respectively.
−Removed: The increase in 2024
−Removed: primarily resulted from expenses relating to the beginning of our Phase 2 clinical trial for
−Removed: our lead product candidate ENV 105 .
−Removed: and Administrative Expenses
−Removed: table below summarizes our general and administrative expenses for the nine months ended September 30, 2024 and 2023 (in thousands), respectively:
−Removed: Administrative Expenses:
−Removed: Patent related
−Removed: Stock compensation
−Removed: Accounting fees
−Removed: Other professional fees
−Removed: Fees relating to license
−Removed: Insurance expense
−Removed: Amortization expense
−Removed: Total general and administrative
−Removed: and administrative expenses were $655 and $550 for the nine months ended September 30, 2024 and 2023, respectively.
−Removed: There were no significant
−Removed: changes between periods.
−Removed: expenses were $726 and $69 for the nine months ended September 30, 2024 and 2023, respectively.
−Removed: The increase in 2024 was due to financing
−Removed: costs recorded during 2024 of $537 and the increase in debt discount amortization in 2024.
−Removed: and Capital Resources
−Removed: the year ended December 31, 2023, the Company incurred a net loss of $1,812 and had a shareholders’ deficit of $2,078 as of December
−Removed: As reflected in the accompanying condensed consolidated financial statements, during the nine months ended September 30, 2024, the Company
−Removed: incurred a net loss of $1,623 and used cash in operations of $2,152.
−Removed: the nine months ended September 30, 2024, the Company closed its initial public offering (“IPO”) and received $5,524 of net
−Removed: proceeds from this offering, before deducting deferred offering costs.
−Removed: Due to the funds received through this offering, and the conversion
−Removed: of convertible notes payable and certain accounts payable upon the closing of the IPO, the Company had shareholders’ equity of
−Removed: $3,332 at September 30, 2024.
−Removed: The Company now expects its cash, totaling $3,217 at September 30, 2024, to last into the fourth quarter
−Removed: ability to continue as a going concern is dependent on the Company attaining and maintaining profitable operations in the future and
−Removed: raising additional capital to meet its obligations and repay its liabilities arising from normal business operations when they come due.
−Removed: Since inception, the Company has funded its operations primarily through equity and debt financings and it expects to continue to rely
−Removed: on these sources of capital in the future.
+Added: Total general and administrative expenses
+Added: General and administrative expenses were $773 and
+Added: $122 for the three months ended March 31, 2025 and 2024, respectively.
+Added: Significant changes between periods consisted of a $132 increase
+Added: in stock-related and officer compensation expenses in 2025, relating to stock awards and cash compensation earned by our officers in 2025;
+Added: and the $240 increase in vendor advance amortization expense in 2025, relating to our vendor advances in 2025.
+Added: Other Income (Expenses)
+Added: Other income (expenses) were $4 and $(36) for the
+Added: three months ended March 31, 2025 and 2024, respectively.
+Added: In 2025, the other income was interest income earned from our money market account.
+Added: In 2024, the other expenses were interest expense of $16 and debt discount amortization of $20.
+Added: Liquidity and Capital Resources
+Added: accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization
+Added: of assets and the settlement of liabilities and commitments in the normal course of business.
+Added: the three months ended March 31, 2025, the Company incurred a net loss of $1,262 and used cash in operations of $714.
+Added: January 2025, the Company closed a private financing in which the Company received net proceeds of $3,145, and at March 31, 2025,
+Added: the Company had cash and cash equivalents totaling $3,616 and shareholders’ equity of $7,132.
+Added: The Company expects its
+Added: current cash reserves to fund the Company’s operations for at least 12 months from the date of this filing.
+Added: Company’s ability to continue as a going concern is dependent on the Company attaining and maintaining profitable operations
+Added: in the future, which will primarily be accomplished in the near term by raising additional capital to meet the Company’s
+Added: operating needs and repay liabilities arising from normal business operations when they come due.
+Added: Since inception, the Company
+Added: has funded its operations primarily through equity and debt financings and it expects to continue to rely on these sources of
+Added: capital in the future until it is able to generate revenues.
assurance can be given that any future financing will be available or, if available, that it will be on terms that are satisfactory to
−Removed: Even if the Company is able to obtain additional financing, it may contain undue restrictions on our operations, in the
−Removed: case of debt financing, or cause substantial dilution for our stockholders, in the case of equity financing.
−Removed: Cash Flows for the Nine Months Ended September 30, 2024 and 2023
−Removed: table below summarizes our cash flow activities for the nine months ended September 30, 2024 and 2023 (in thousands), respectively:
−Removed: months Ended September 30,
+Added: Even if the Company is able to obtain additional financing, such financing may contain undue restrictions on our operations,
+Added: in the case of debt financing, or cause substantial dilution for our stockholders, in the case of equity financing.
+Added: The table below summarizes our cash flow activities
+Added: for the three months ended March 31, 2025 and 2024:
Net cash provided by (used in):
2 unchanged sentences
Financing activities
−Removed: Net increase (decrease)
−Removed: the nine months ended September 30, 2023, we provided cash from operating activities of $15, compared to $2,152 used during the nine
−Removed: months ended September 30, 2024.
−Removed: During the nine months ended September 30, 2024, we incurred a net loss of $1,623 and had non-cash
−Removed: expenses of $845, compared to a net loss of $694 and non-cash expenses of $150 during the nine months ended September 30, 2023.
−Removed: primary non-cash expense incurred during both periods was amortization expense, totaling $120 during the nine months ended September
−Removed: 30, 2024 and 2023, respectively.
−Removed: The net change in assets and liabilities during the nine months ended September 30, 2023 provided
−Removed: cash of $559, compared to $1,374 used during the nine months ended September 30, 2024.
−Removed: The primary source of cash relating to the
−Removed: change in assets and liabilities for the nine months ended September 30, 2024 and 2023 was the increase in accounts payable and
−Removed: accrued expenses.
−Removed: The primary use of cash was the increase in vendor advances.
−Removed: was no cash used in investing activities for the nine months ended September 30, 2024 and 2023.
−Removed: cash (used in) provided by financing activities for the nine months ended September 30, 2024 and 2023 was 5,276 and $(353),
−Removed: respectively.
−Removed: For the nine months ended September 30, 2024 and 2023, cash used in financing activities consisted of payments of
−Removed: deferred offering costs of $390 and $353, respectively.
−Removed: For the nine months ended September 30, 2024, cash provided by financing
−Removed: activities consisted of $5,524 of proceeds from common stock issued in connection with the IPO and $142 from notes payable –
−Removed: from Related Parties
−Removed: the year ended December 31, 2021, shareholders of the Company, and a company whose principal stockholder is also a stockholder of the
−Removed: Company, advanced the Company $14, all of which was outstanding at December 31, 2021.
−Removed: The advances accrue no interest, are
−Removed: unsecured and are due on demand.
−Removed: As of December 31, 2021, $14 was owed on the advances.
−Removed: During the year ended December 31,
−Removed: 2022, the Company repaid $10 of the advances, and as of December 31, 2022 and 2023, and September 30, 2024, a total of $4 remained outstanding.
−Removed: Notes Payable
−Removed: the year ended December 31, 2022, the Company entered into several convertible note payable agreements with certain investors.
−Removed: The convertible notes accrue interest at 6% per annum, are unsecured and are due by April 2025.
−Removed: Company does not close an IPO transaction within 12 months following the date of issuance of the notes, the Company will have the choice
−Removed: of paying off the principal plus all accrued and unpaid interest, or the note’s principal balance will increase to 110% of its
−Removed: original balance.
−Removed: The notes are convertible at the option of the noteholders into shares of the Company’s common stock at a price
−Removed: per share as defined in the agreement or will automatically be converted into shares of the Company’s common stock at 60% of the
−Removed: IPO price per share upon the closing of the IPO.
−Removed: The convertible note offerings were completed pursuant to an exemption from registration under Rule 506(b)
−Removed: of the Securities Act.
−Removed: Boustead Securities, LLC acted as placement agent in each of the June and September 2022 private placements and
−Removed: received five-year warrants to purchase shares of common stock equal
−Removed: to 7.0% of the number of the conversion shares at an exercise price equal to the conversion price.
−Removed: As of September 30, 2024, $792 of
−Removed: principal was outstanding on the notes and $92 of accrued and unpaid interest, which automatically converted into 368,371 shares of the Company’s
−Removed: common stock upon the closing of the Company’s IPO.
−Removed: Payable - Officers
−Removed: the nine months ended September 30, 2024, the Company borrowed $142 from three of its officers.
−Removed: The loans accrue interest at
−Removed: 7.5% per annum, are unsecured and are due one year from the issuance date, with the due dates ranging from April 2025 to August 2025.
−Removed: Subsequent to September 30, 2024, the loans were repaid and the officers
−Removed: were granted 36,269 shares of the Company’s common stock.
−Removed: of Accounts Payable
−Removed: to December 31, 2023, we entered into agreements with Cedars-Sinai Medical Center (“Cedars”) under which Cedars agreed
−Removed: to convert $750 of the $988 total accounts payable due to them into 312,500 shares of our common stock, with such conversion to
−Removed: occur upon the closing of the Company’s IPO.
−Removed: The conversion price of the shares will be equal to 60% of the per share IPO
−Removed: Upon the closing of the Company’s IPO, the 312,500 shares were issued to Cedars and the $750 of debt was forgiven.
−Removed: of Amounts Due to Related Parties
−Removed: to December 31, 2023, two officers and shareholders agreed to convert the $4 due to them into 1,664 shares of the Company’s
−Removed: common stock, effective upon the closing of the Company’s IPO.
−Removed: The conversion price of the shares was equal to 60% of the per
−Removed: share IPO purchase price.
−Removed: During the three months ended September 30, 2024, the debt converted, and the 1,664 shares were
−Removed: of September 30, 2024, an officer converted $172 of accounts payable owed primarily for past services into 51,610
−Removed: shares of the Company’s common stock, effective upon the closing of the Company’s IPO.
−Removed: The conversion price of the shares
−Removed: was equal to the IPO per share purchase price times a multiple of 1.2, as per the officer’s employment agreement.
−Removed: expect our expenses to increase substantially in connection with our ongoing research activities, particularly as we pursue the advancement
−Removed: of our product candidates through clinical trials.
−Removed: In addition, we expect to incur additional costs associated with operating as a public
−Removed: The timing and amount of our operating expenditures will depend on numerous variables, including:
−Removed: the initiation, progress,
−Removed: timing, costs and results of the clinical trials for our product candidates or any future product candidates we may develop;
−Removed: the initiation,
−Removed: progress, timing, costs and results of nonclinical studies for our product candidates or any future product candidates we may develop;
−Removed: our ability to maintain our relationships with key collaborators;
−Removed: the outcome, timing and cost of seeking and obtaining regulatory approvals
−Removed: from the FDA and comparable foreign regulatory authorities, including the potential for such authorities to require that we perform more
−Removed: nonclinical studies or clinical trials than those that we currently expect or change their requirements on studies that had previously
−Removed: been agreed to;
−Removed: the cost to establish, maintain, expand, enforce and defend the scope of our intellectual property portfolio, including
−Removed: the amount and timing of any payments we may be required to make, or that we may receive, in connection with licensing, preparing, filing,
−Removed: prosecuting, defending and enforcing any patents or other intellectual property rights;
−Removed: the effect of competing technological and market
−Removed: developments;
−Removed: the costs of continuing to grow our business, including hiring key personnel and maintain or acquiring operating space;
−Removed: market acceptance of any approved product candidates, including product pricing, as well as product coverage and the adequacy of reimbursement
−Removed: by third-party payors;
−Removed: the cost of acquiring, licensing or investing in additional businesses, products, product candidates and technologies;
−Removed: the cost and timing of selecting, auditing and potentially validating a manufacturing site for commercial-scale manufacturing;
−Removed: of establishing sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval
−Removed: and that we determine to commercialize;
−Removed: and our need to implement additional internal systems and infrastructure, including financial
−Removed: and reporting systems.
−Removed: believe that our existing cash, plus the net proceeds from the IPO, will enable us to fund our operating expenses and capital expenditure
−Removed: requirements for at least the next 12 months.
−Removed: We have based this estimate on assumptions that may prove to be wrong, and we could exhaust
−Removed: our available capital resources sooner than we expect.
−Removed: We expect that we will require additional funding to complete the clinical development
−Removed: and commercialize our product candidates, if we receive regulatory approval, and pursue in-licenses or acquisitions of other product
−Removed: If we receive regulatory approval for our product candidates, we expect to incur significant commercialization expenses related
−Removed: to product manufacturing, sales, marketing and distribution, depending on where we choose to commercialize ourselves.
−Removed: such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity
−Removed: and debt financings, collaborations, strategic alliances, and marketing, distribution or licensing arrangements with third parties.
−Removed: the extent that we raise additional capital through the sale of equity or convertible debt securities, ownership interest may be materially
−Removed: diluted, and the terms of such securities could include liquidation or other preferences that adversely affect the rights of our current common stockholder.
−Removed: Debt financing and
−Removed: preferred equity financing, if available, may involve agreements that include restrictive covenants that limit our ability to take specified
−Removed: actions, such as incurring additional debt, making capital expenditures or declaring dividends.
−Removed: If we raise funds through collaborations,
−Removed: strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights
−Removed: to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable
−Removed: If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required
−Removed: to delay, reduce or eliminate our product development or future commercialization efforts, or grant rights to develop and market product
−Removed: candidates that we would otherwise prefer to develop and market ourselves.
−Removed: Obligations and Commitments
−Removed: Agreement with Prevail Infoworks, Inc.
+Added: Net increase (decrease) in cash
+Added: Operating Activities
+Added: During the three months ended March 31, 2025, we used
+Added: cash from operating activities of $714, compared to $36 provided during the three months ended March 31, 2024.
+Added: During the three months
+Added: ended March 31, 2025, we incurred a net loss of $1,262 and had non-cash expenses of $116, compared to a net loss of $323 and non-cash
+Added: expenses of $60 during the three months ended March 31, 2024.
+Added: The primary non-cash expense during both periods was stock-related expenses
+Added: totaling $76 and $20 during the three months ended March 31, 2025 and 2024, respectively.
+Added: The net change in operating assets and liabilities
+Added: during the three months ended March 31, 2025, provided cash of $432, compared to $299 provided during the three months ended March 31,
+Added: The primary source of cash relating to operating assets and liabilities during the three months ended March 31, 2025 was the decrease
+Added: in vendor advances of $636.
+Added: The primary source of cash during the three months ended March 31, 2024 was the increase in accounts payable
+Added: and accrued expenses of $310.
+Added: Financing Activities
+Added: During the three months ended March 31, 2025, we provided
+Added: cash from financing activities of $3,058, compared to $89 used during the three months ended March 31, 2024.
+Added: For the three months ended
+Added: March 31, 2025, cash provided by financing activities consisted of gross proceeds from our private financing of $3,500.
+Added: Net cash used
+Added: in 2025 and 2024 consisted of the payment of deferred offering costs of $442 and $89, respectively.
+Added: We expect our expenses to increase substantially in
+Added: connection with our ongoing research activities, particularly as we pursue the advancement of our product candidates through clinical
+Added: In addition, we expect to incur additional costs associated with operating as a public company.
+Added: The timing and amount of our operating
+Added: expenditures will depend on numerous variables, including:
+Added: the initiation, progress, timing, costs and results of the clinical trials
+Added: for our product candidates or any future product candidates we may develop;
+Added: the initiation, progress, timing, costs and results of nonclinical
+Added: studies for our product candidates or any future product candidates we may develop;
+Added: our ability to maintain our relationships with key
+Added: collaborators;
+Added: the outcome, timing and cost of seeking and obtaining regulatory approvals from the FDA and comparable foreign regulatory
+Added: authorities, including the potential for such authorities to require that we perform more nonclinical studies or clinical trials than
+Added: those that we currently expect or change their requirements on studies that had previously been agreed to;
+Added: the cost to establish, maintain,
+Added: expand, enforce and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be
+Added: required to make, or that we may receive, in connection with licensing, preparing, filing, prosecuting, defending and enforcing any patents
+Added: or other intellectual property rights;
+Added: the effect of competing technological and market developments;
+Added: the costs of continuing to grow
+Added: our business, including hiring key personnel and maintain or acquiring operating space;
+Added: market acceptance of any approved product candidates,
+Added: including product pricing, as well as product coverage and the adequacy of reimbursement by third-party payors;
+Added: the cost of acquiring,
+Added: licensing or investing in additional businesses, products, product candidates and technologies;
+Added: the cost and timing of selecting, auditing
+Added: and potentially validating a manufacturing site for commercial-scale manufacturing;
+Added: the cost of establishing sales, marketing and distribution
+Added: capabilities for any product candidates for which we may receive regulatory approval and that we determine to commercialize;
+Added: to implement additional internal systems and infrastructure, including financial and reporting systems.
+Added: believe that our existing cash, including the net proceeds we received from the IPO and the January 2025 PIPE Offering, will enable
+Added: us to fund our operating expenses and capital expenditure requirements for at least the next 12 months.
+Added: We have based this estimate
+Added: on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.
+Added: that we will continue to require additional funding to complete the clinical development and commercialization of our product
+Added: candidates, if we receive regulatory approval, and pursue in-licenses or acquisitions of other product candidates.
+Added: If we receive
+Added: regulatory approval for our product candidates, we expect to incur significant commercialization expenses related to product
+Added: manufacturing, sales, marketing and distribution, depending on where we choose to commercialize ourselves.
+Added: Until such time, if ever, as we can generate substantial
+Added: product revenue, we expect to finance our cash needs through a combination of equity and debt financings, collaborations, strategic alliances,
+Added: and marketing, distribution or licensing arrangements with third parties.
+Added: To the extent that we raise additional capital through the sale
+Added: of equity or convertible debt securities, ownership interest may be materially diluted, and the terms of such securities could include
+Added: liquidation or other preferences that adversely affect the rights of our current common stockholder.
+Added: Debt financing and preferred equity
+Added: financing, if available, may involve agreements that include restrictive covenants that limit our ability to take specified actions, such
+Added: as incurring additional debt, making capital expenditures or declaring dividends.
+Added: If we raise funds through collaborations, strategic
+Added: alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies,
+Added: future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us.
+Added: unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, reduce
+Added: or eliminate our product development or future commercialization efforts, or grant rights to develop and market product candidates that
+Added: we would otherwise prefer to develop and market ourselves.
+Added: Contractual Obligations and Commitments
+Added: Kairos Agreement with Prevail Infoworks, Inc.
August 2024, the Company entered into a master service and technology agreement with Prevail Infoworks, Inc.
−Removed: pursuant to which Prevail agreed to provide certain clinical research services to the Company.
−Removed: As part of the agreement, the Company
−Removed: must make an advance payment of $900 to Prevail before they begin their services and, at such time as we notify Prevail to engage their
−Removed: services related to the relevant clinical trial, or six months from the date of the agreement, pay approximately $80 per month during
−Removed: the time Prevail performs clinical research services for the Company’s Phase 2 ENV 105 prostate and Phase 1 ENV 105 lung clinical
−Removed: The agreement with Prevail is subject to cancellation at any time upon 30 days’ written notice to the other party.
−Removed: Company made the advance payment to Prevail in October 2024.
−Removed: Agreement with PreCheck Health Services, Inc.
−Removed: September 20, 2024, the Company entered into a bioassay services agreement (the “Bioassay Services Agreement”) with PreCheck
−Removed: Health Services, Inc., a Florida-based corporation (“PreCheck”).
−Removed: Pursuant to the Bioassay Services Agreement, PreCheck will
−Removed: provide certain biomarker screening services for the Company’s ongoing carotuximab (ENV105) clinical trials in order to assist
−Removed: the Company in identifying lung and prostate cancer patients suitable to the Company’s ongoing Phase 1 clinical trials for lung
−Removed: cancer patients and Phase 2 trials for patients with castrate resistant prostate cancer.
−Removed: In order to identify biomarkers for patient
−Removed: screening and therapy monitoring using carotuximab (ENV105), PreCheck will utilize its SolidTumorCheck+ platform for the somatic gene
−Removed: expression analysis of biopsy tissue samples derived from patients with lung and prostate cancer, as part of the Company’s ongoing
−Removed: clinical trials.
−Removed: In furtherance of these efforts, PreCheck will develop a companion diagnostic to support its identification of such
−Removed: patients with a three gene PCR analysis or other genetic analysis, which diagnostic test will then be developed and submitted to the
−Removed: FDA for castrate-resistant prostate cancer patients and for lung cancer patients on Tagrisso.
−Removed: In exchange for PreCheck’s services,
−Removed: and according to the terms of the Bioassay Services Agreement, the Company paid $900 to PreCheck as an advance for the future laboratory
−Removed: services to be performed.
−Removed: The payment of $900 is included in vendor advances on the accompanying balance sheet as of September
−Removed: The term of the agreement is one year from the effective date.
−Removed: Agreement with CEO.CA Technologies Ltd.
−Removed: September 23, 2024, the Company entered into an advisory and consulting services agreement (the “CEO.CA Agreement”) with
−Removed: CEO.CA Technologies Ltd., a Canadian company (“CEO.CA”), pursuant to which CEO.CA will provide certain internet-based financial
−Removed: information and communications services for a period of one year for a services fee of $250.
−Removed: The service fee is an advance on future
−Removed: services to be performed.
−Removed: The CEO.CA Agreement includes such services as strategic news placement, news releases, interviews, monthly
−Removed: analytics and a video launch.
−Removed: The CEO.CA Agreement contains other customary clauses, including representations and warranties, indemnification
−Removed: clauses and governing law clauses.
−Removed: The payment of $250 is included in vendor advances on the accompanying balance sheet as of September 30,
−Removed: Agreement with Belair Capital Advisors Inc.
−Removed: September 23, 2024, the Company entered into a strategic advisory agreement (the “Strategic Advisory Agreement”) with Belair
−Removed: Capital Advisors Inc.
−Removed: BCA, a venture capital and corporate finance advisory firm, has been a long-term investor
−Removed: and advisor to the Company and frequently works with early-stage pharmaceutical companies.
−Removed: The strategic advisory services consist of
−Removed: corporate strategy, market positioning and long-term growth plans within the pharmaceutical sector, digital marketing and engagement,
−Removed: market research analysis and business development assistance, among other things.
−Removed: During the one-year term of the Strategic Advisory
−Removed: Agreement, in exchange for its services, the Company will pay BCA a $365 fee and will issue BCA 50,000 RSUs, which will vest at the end of six months.
−Removed: of $365 is included in vendor advances on the accompanying balance sheet as of September 30, 2024.
−Removed: Company valued the 50,000 shares of common stock at $100 based on the Company’s closing stock price on the effective date of the
−Removed: The fair value will be amortized over the one-year term of the agreement.
+Added: (“Prevail”), pursuant to which Prevail agreed to provide certain clinical research services to the Company.
+Added: the agreement, the Company was required to make an advance payment of $900 to Prevail before they begin their services.
+Added: as we notify Prevail to engage their services related to the relevant clinical trial, or six months from the date of the agreement,
+Added: we will be required to pay approximately $80 per month during the time Prevail performs such clinical research services.
+Added: The agreement with Prevail is subject to
+Added: cancellation at any time upon 30 days’ written notice to the other party.
+Added: The Company made the advance payment to Prevail in
+Added: October 2024.
+Added: Kairos Agreement with PreCheck Health Services,
+Added: September 20, 2024, the Company entered into a bioassay services agreement (the “Bioassay Services Agreement”) with
+Added: PreCheck Health Services, Inc., a Florida-based corporation (“PreCheck”).
+Added: Pursuant to the Bioassay Services Agreement,
+Added: PreCheck will provide certain biomarker screening services for the Company’s ongoing carotuximab (ENV 105) clinical trials in
+Added: order to assist the Company in identifying lung and prostate cancer patients suitable to the Company’s ongoing Phase 1
+Added: clinical trials for lung cancer patients and Phase 2 trials for patients with castrate resistant prostate cancer.
+Added: identify biomarkers for patient screening and therapy monitoring using carotuximab (ENV 105), PreCheck will utilize its
+Added: SolidTumorCheck+ platform for the somatic gene expression analysis of biopsy tissue samples derived from patients with lung and
+Added: prostate cancer, as part of the Company’s ongoing clinical trials.
+Added: In furtherance of these efforts, PreCheck will develop a
+Added: companion diagnostic to support its identification of such patients with a three gene PCR analysis or other genetic analysis, which
+Added: diagnostic test will then be developed and submitted to the FDA for castrate-resistant prostate cancer patients and for lung cancer
+Added: patients on Tagrisso.
+Added: In exchange for PreCheck’s services, and according to the terms of the Bioassay Services Agreement, the
+Added: Company paid $900 to PreCheck as an advance for the future laboratory services to be performed.
+Added: The term of the agreement is one
+Added: year from the effective date.
+Added: Kairos Agreement with CEO.CA Technologies Ltd.
+Added: On September 23, 2024, the Company entered into an
+Added: advisory and consulting services agreement (the “CEO.CA Agreement”) with CEO.CA Technologies Ltd., a Canadian company (“CEO.CA”),
+Added: pursuant to which CEO.CA will provide certain internet-based financial information and communications services for a period of one year
+Added: for a services fee of $250.
+Added: The service fee is an advance on future services to be performed.
+Added: The CEO.CA Agreement includes such services
+Added: as strategic news placement, news releases, interviews, monthly analytics and a video launch.
+Added: The CEO.CA Agreement contains other customary
+Added: clauses, including representations and warranties, indemnification clauses and governing law clauses.
+Added: Kairos Agreement with Belair Capital Advisors
+Added: On September 23, 2024, the Company entered into a
+Added: strategic advisory agreement (the “Strategic Advisory Agreement”) with Belair Capital Advisors Inc.
+Added: a venture capital and corporate finance advisory firm, has been a long-term investor and advisor to the Company and frequently works with
+Added: early-stage pharmaceutical companies.
+Added: The strategic advisory services consist of corporate strategy, market positioning and long-term
+Added: growth plans within the pharmaceutical sector, digital marketing and engagement, market research analysis and business development assistance,
+Added: among other things.
+Added: During the one-year term of the Strategic Advisory Agreement, in exchange for its services, the Company will pay BCA
+Added: $365 fee and will issue BCA 50,000 RSUs, which will vest at the end of six months.
Agreement with Cross Current Capital LLC
−Removed: October 1, 2024, the Company entered into a consulting agreement (the “Consulting Agreement”) with Cross Current Capital
−Removed: LLC, a limited liability company organized under the laws of Puerto Rico (“Cross Current”), and Alan Masley (the “Advisor”),
−Removed: pursuant to which Cross Current agreed to provide certain financial and business consulting services to the Company including, but not
−Removed: limited, to (a) help drafting a public company competitive overview, (b) help preparing and/or reviewing a valuation analysis, (c) help
−Removed: in drafting marketing materials and presentations, (d) reviewing the Company’s business requirements and discuss financing and
−Removed: businesses opportunities, (e) investor marketing, (f) investor relations introductions, (g) legal counsel introductions, (h) auditor
−Removed: introductions, (i) investment banking and research introductions, (j) M&A canvassing and ways to grow the business organically, and
−Removed: (k) stand by capital markets advisory services.
−Removed: For the services rendered thereunder, the Company agreed to pay Cross Current $200,000
−Removed: in cash and agreed to issue to the Advisor restricted shares of the Company’s common stock, issuable under the Company’s
−Removed: 2023 Equity Inventive Plan, in an amount equal to $500,000 (the “Shares”), which Shares shall vest at the end of six months
−Removed: after issuance.
−Removed: The term of the Consulting Agreement is 24 months and can be extended for another 12 months upon the written consent
−Removed: of both parties.
+Added: On October 1, 2024, the Company entered into a consulting
+Added: agreement (the “Consulting Agreement”) with Cross Current Capital LLC, a limited liability company organized under the laws
+Added: of Puerto Rico (“Cross Current”), and Alan Masley (the “Advisor”), pursuant to which Cross Current agreed to provide
+Added: certain financial and business consulting services to the Company including, but not limited, to (a) help drafting a public company competitive
+Added: overview, (b) help preparing and/or reviewing a valuation analysis, (c) help in drafting marketing materials and presentations, (d) reviewing
+Added: the Company’s business requirements and discuss financing and businesses opportunities, (e) investor marketing, (f) investor relations
+Added: introductions, (g) legal counsel introductions, (h) auditor introductions, (i) investment banking and research introductions, (j) M&A
+Added: canvassing and ways to grow the business organically, and (k) stand by capital markets advisory services.
+Added: For the services rendered thereunder,
+Added: the Company agreed to pay Cross Current $200,000 in cash and agreed to issue to the Advisor restricted shares of the Company’s common
+Added: stock, issuable under the Company’s 2023 Equity Inventive Plan, in an amount equal to $500,000 (the “Shares”), which
+Added: Shares shall vest at the end of six months after issuance.
+Added: The term of the Consulting Agreement is 24 months and can be extended for another
+Added: 12 months upon the written consent of both parties.
The Company made the $200 payment in October 2024.
−Removed: License Agreements with Cedars
−Removed: have entered into four Exclusive License Agreements with Cedars which grants us licensing rights with respect to certain patent rights
−Removed: owned by Cedars as follows:
−Removed: of use of compounds that bind to RelA of NFkB;
−Removed: and methods for treating fibrosis;
−Removed: and methods for treating cancer and autoimmune diseases;
−Removed: of generating activated T cells for cancer therapy.
−Removed: June 2, 2021, our wholly owned subsidiary, Enviro, entered into two Exclusive License Agreements
−Removed: with Cedars, which granted Enviro exclusive licensing rights (which include the right to sublicense) with respect to certain patent rights
−Removed: owned by Cedars, as follows:
−Removed: Exclusive License Agreement (the “Enviro-Cedars License Agreement (Mitochondrial DNA)”) for Enviro to develop, manufacture,
−Removed: use and sell products utilized or derived from patent rights worldwide related to the “Compositions and Methods for Treating
−Removed: Diseases and Conditions by Depletion of Mitochondrial DNA from Circulation and for Detection of Mitochondrial DNA” invented
+Added: Exclusive License Agreements with Cedars
+Added: We have entered into four Exclusive License Agreements
+Added: with Cedars which grants us licensing rights with respect to certain patent rights owned by Cedars as follows:
+Added: Methods of use of compounds that bind to RelA of NFkB;
+Added: Composition and methods for treating fibrosis;
+Added: Compositions and methods for treating cancer and autoimmune diseases;
+Added: Method of generating activated T cells for cancer therapy.
+Added: On June 2, 2021, our wholly owned subsidiary, Enviro,
+Added: entered into two Exclusive License Agreements with Cedars, which granted Enviro exclusive licensing rights (which include the right to
+Added: sublicense) with respect to certain patent rights owned by Cedars, as follows:
+Added: an Exclusive License Agreement (the “Enviro-Cedars License Agreement (Mitochondrial DNA)”) for Enviro to develop, manufacture, use and sell products utilized or derived from patent rights worldwide related to the “Compositions and Methods for Treating Diseases and Conditions by Depletion of Mitochondrial DNA from Circulation and for Detection of Mitochondrial DNA” invented by Dr.
Neil Bhowmick and others;
−Removed: Exclusive License Agreement, (the “Enviro-Cedars License Agreement (Endoglin Antagonism)” and, collectively with the
−Removed: Enviro-Cedars License Agreement (Mitochondrial DNA), the “Enviro-Cedars License Agreements”) for Enviro to develop, manufacture,
−Removed: use and sell products utilized or derived from the patent rights and technical information worldwide related to the “Sensitization
−Removed: of Tumors to Therapies Through Endoglin Antagonism” invented by Dr.
+Added: an Exclusive License Agreement, (the “Enviro-Cedars License Agreement (Endoglin Antagonism)” and, collectively with the Enviro-Cedars License Agreement (Mitochondrial DNA), the “Enviro-Cedars License Agreements”) for Enviro to develop, manufacture, use and sell products utilized or derived from the patent rights and technical information worldwide related to the “Sensitization of Tumors to Therapies Through Endoglin Antagonism” invented by Dr.
Neil Bhowmick and others.
−Removed: with former Chief Financial Officer
−Removed: have an agreement with our former Chief Financial Officer that requires us to pay $50 upon the completion of raising more than $900
−Removed: in a debt or an equity financing.
−Removed: No amount was owed at December 31, 2022 or 2023, but $50 was owed as of September 30, 2024.
−Removed: addition, on September 27, 2023, we entered into an employment agreement with our current Chief Financial Officer, which became
−Removed: effective upon completion of the Company’s IPO.
−Removed: Quantitative and Qualitative Disclosures about Market Risks.
−Removed: As a “smaller reporting company,” we are not
−Removed: required to provide the information required by this Item.
+Added: Quantitative and Qualitative Disclosures
+Added: about Market Risks.
+Added: As a “smaller reporting company,” we are
+Added: not required to provide the information required by this Item.
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.