Kairos Pharma, LTD.
For the period ended Mar 31, 2026. Filed May 13, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2026 · Filed May 13, 2026
KAPA$0.49+7.3%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-14.
0001493152-25-023276
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-13.
0001493152-26-022796
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 67 previous paragraphs and 88 current paragraphs.
30 unchanged; 14 reworded; 44 added; 19 removed; 4 previous and 0 current paragraphs rearranged.
Tables are not compared: 7 previous and 8 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (44)
Current report
At the Market (ATM) Offering
Current report
On January 12, 2026, we entered into an ATM Agreement with HCW for the sale, from time to time, up to $4,524,949 shares of our common stock. We registered the common stock offered under the ATM Agreement pursuant to a prospectus supplement filed in conjunction with our shelf registration statement on Form S-3 (SEC File No. 333-292686), which was declared effective on January 23, 2026. Pursuant to the ATM Agreement, HCW is entitled to a placement agent fee of 3.0% of the gross sale price of shares sold under the ATM Agreement.
Current report
As a result of the ATM offering, during the three months ended March 31, 2026, the Company raised gross proceeds of $385 through the sale of 589,845 shares of its common stock. Net proceeds were $367 after the deduction of offering costs.
Current report
Common Stock Issued for Cash Upon Closing of the Company’s Private Financing
Current report
The pre-funded warrants have an exercise price of $0.001 per share and are immediately exercisable and will expire when exercised in full. The common warrants have an exercise price of $1.40 per share, will be exercisable six months from issuance and will expire five and a half years from the issuance date. During the year ended December 31, 2025, the investor exercised 2,500,000 shares of the pre-funded warrants and as of December 31, 2025, there were no pre-funded shares remaining unexercised.
Current report
Services Agreement with Brammer Bio MA, LLC
Current report
On May 11, 2026, the Company entered into a Pharmaceutical Development Services Agreement with Brammer Bio MA, LLC (“Patheon”), under which Patheon agrees to transfer and manufacture clinical supply of ENV-105 sterile liquid vials in compliance with applicable regulations and cGMP to support Phase II clinical trials. The agreement also covers related analytical and microbiology methods, stability studies, and regulatory support, and includes customary terms on confidentiality, intellectual property ownership, quality audits, fees and cancellation, term, and termination. The total amount committed by the Company under the agreement is $783.
Current report
Research and Development Expenses
Current report
Research and Development Expenses
Current report
Other Income
Current report
The Company has experienced recurring losses from operations since inception and incurred a net loss of $1,654 and used cash in operations of $1,036 during the three months ended March 31, 2026. These factors raise substantial doubt about the Company’s ability to continue as a going concern. The ability of the Company to continue as a going concern is dependent upon the Company’s ability to raise additional funds and implement its strategies. The financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.
Current report
As of March 31, 2026, the Company had cash and short-term investments of $3,675. Until the Company can generate sufficient product revenue to finance our cash requirements, which we may never do, we expect to finance our future cash needs through a combination of public or private equity offerings and debt financings, or other capital sources such as potential collaborations, strategic alliances, licensing arrangements and other arrangements. Based on our research and development plans, we expect that our existing cash balance may not enable us to fund our planned operating expenses and capital expenditure requirements for at least the next 12 months from the date of filing of this report. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. In addition, because the design and outcome of our anticipated and any future clinical trials is highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete the development and commercialization of our current products or any future product candidates. Additionally, although we have the ability to raise funds through our Form S-1 and S-3 registration statements filed in 2025 and 2026, we may not receive some or all of these available proceeds, due to certain factors. The failure to receive all or some of the proceeds would exhaust our available capital resources sooner than expected and will require us to obtain further funding to achieve our business objectives.
Current report
Contractual Obligations and Commitments
Current report
Kairos Exclusive License Agreements with Cedars-Sinai Medical Center (Cedars)
Current report
The Company has entered into four Exclusive License Agreements with Cedars, each of which grants the Company licensing rights with respect to certain patent rights owned by Cedars as follows:
Current report
For each of the exclusive license agreement in items 1, 2 and 3, the Company was required to pay an initial license fee of $5, reimburse Cedars for patent protection costs ranging from approximately $9 to $61, pay an annual maintenance fee of $10, and pay royalties based on 3.75% of net sales and pay other non-royalty sublicense fees ranging from 5% to 35% of sales of products. In addition, for items 1, 2 and 3, the Company is required to pay Cedars based on the following milestones:
Current report
For the exclusive license agreement in item 4, the Company is required to pay an initial license fee of $50 upon raising $500 in capital, pay an annual maintenance fee of $10, pay royalties based on 4.25% of patent product sales and 0.5% of other sales and pay other non-royalty sublicense fees ranging from 5% to 35%. In addition, the Company is required to pay Cedars based on the following milestones:
Current report
As of March 31, 2026, no amounts were due under the Exclusive License Agreements between Cedars and the Company.
Current report
Enviro Therapeutics
Current report
On June 2, 2021, the Company’s then-wholly owned subsidiary, Enviro, entered into two Exclusive License Agreements with Cedars, which granted Enviro exclusive licensing rights (which include the right to sublicense) with respect to certain patent rights owned by Cedars, as follows:
Current report
In exchange for each of the licenses, pursuant to the terms of the Exclusive License Agreements, Enviro was required to pay an upfront license fee in the mid four-figures and low-five figures, respectively. Enviro was also required to reimburse Cedars for the costs in the mid-to-high six figures incurred in the prosecution of the patent rights subject to the Enviro-Cedars License Agreements prior to the date of execution of such agreements, and certain costs and fees then outstanding aggregating in the low-six figures owed by Kairos pursuant to the Kairos-Cedars License Agreements. Pursuant to the Enviro-Cedars License Agreements, Cedars was also to receive royalty payments of a mid-single-digit percentage of net sales of products associated with the licensed patent right and less than one percent of net sales of other products derived from Cedars’ technical information, with a minimum annual royalty fee in the low five-digits due beginning on the third anniversary of the effective date of the Enviro-Cedars License Agreements. To the extent Enviro derived non-royalty sublicensing revenues, a high single-digit to low double-digit percentage of such revenues would be due and payable to Cedars, with the actual percentage of such revenues dependent on the stage of FDA authorization at the time the sublicense revenue is generated.
Current report
Enviro was also required to pay Cedars in connection with achieving the following Payment Milestones relating to products derived from the patent rights: successful completion of a Phase I clinical trial; successful completion of a Phase II clinical trial, receipt of FDA approval, and approval for a Phase III clinical trial; FDA approval of an NDA or BLA; cumulative net sales exceeding $50,000; and cumulative net sales exceeding $100,000. If all of these payment milestones are met among both of the Exclusive License Agreements, the required milestone payments would total in the mid-to-high seven-figures.
Current report
Pursuant to the Exclusive License Agreements, Enviro was obligated to meet the following Commercialization Milestones. Pursuant to the Enviro-Cedars License Agreement (Endoglin Antagonism), Enviro was obligated to (1) obtain an IND for a patent product within 1 year of the effective date of the agreement, (2) commence a Phase II trial within 2 years of the effective date of the agreement, and (3) submit an NDA or BLA to the FDA or equivalent regulatory agency in another jurisdiction within 7 years of the effective date of the agreement. Pursuant to the Enviro-Cedars License Agreement (Mitochondrial DNA), Enviro was obligated to (1) complete preclinical studies of a patent product within 2 years of the effective date of the agreement, (2) complete toxicology studies within 2.5 years of the effective date of the agreement, (3) obtain IND within 3 years of the effective date of the agreement, (4) begin a Phase I trial within 4 years of the effective date of the agreement, and (5) submit an NDA or BLA to the FDA or equivalent regulatory agency in another jurisdiction within 7 years of the effective date of the agreement. If the Commercialization Milestones are not met or extended, Cedars may convert the exclusive licenses into non-exclusive licenses or to a co-exclusive licenses or terminate the licenses.
Current report
The Exclusive License Agreements will, unless sooner terminated, continue in effect on a country-by-country basis until the last of the patents covering the patent rights or future patent rights expires. Under the terms of the Enviro-Cedars License Agreements, unless waived by Cedars, the agreements would automatically terminate: (a) if Enviro ceases, dissolves or winds up its business operations; (b) if performance by either party jeopardizes the licensure, accreditation or tax exempt status of Cedars or the agreement is deemed illegal by a governmental body; (c) within 30 days for non-payment of royalties or if Enviro fails to undertake commercially reasonable efforts to exploit the patent rights or future patent rights; (d) within 60 days of Cedars’ failure to cure any breach or default of a material obligation under the agreements; (e) within 90 days of Enviro’s failure to cure any breach or default of a material obligation under the agreements; or (f) upon mutual written agreement of the parties.
Current report
Novation Agreements
Current report
On October 1, 2025, the Board of Directors approved the entry of Kairos and Enviro into a novation agreement (the “Cedars Novation Agreement”) with Cedars. The Cedars Novation Agreement was entered into on October 1, 2025, but effective as of April 17, 2025, for purposes of transferring the exclusive license of two patents from Enviro, as the original licensee, to Kairos, as the new licensee. As the new licensee of the two patents, Kairos accepted and assumed all obligations and liabilities that may arise under the Exclusive License Agreements from Enviro and Enviro is relieved of all of its liabilities and obligations under the license agreements.
Current report
In addition, on October 1, 2025, the Board approved the Company’s entry into a novation agreement (the “Tracon Novation Agreement”) with Tracon Pharmaceuticals, Inc. (“Tracon”) and Enviro pursuant to which Enviro’s rights and obligations under the license and supply agreement between Tracon, Enviro and Kairos, originally dated May 21, 2021, as amended to date (the “Tracon License Agreement”), were transferred from Enviro to Kairos and Enviro was relieved of any further liabilities or obligations under the license and supply agreement. Under the Tracon License Agreement, Tracon had granted Enviro exclusive access to its TRC105 and CD105 technologies, which Kairos has now assumed pursuant to the Tracon Novation Agreement.
Current report
Agreements with Lonza Sales AG
Current report
On November 12, 2025, the Company entered into an amendment (the “Lonza Amendment”) to the sales agreement with Lonza Sales AG (“Lonza”), originally dated February 14, 2008, pursuant to which the Company agreed to purchase and Lonza agreed to testing of standards and the preparation to manufacture ENV105 antibody to be used in the Company’s Phase 2 clinical trial. The Company agreed to pay a total of $1,143 in consideration, which will be paid over time as each of the 13 stages of the Lonza Amendment are completed.
Current report
On March 27, 2026, the Company entered into an additional statement of work to the sales agreement with Lonza pursuant to which the Company agreed to pay an additional amount of approximately $2,000, which will also be paid over time as each of the 13 stages of the Lonza Amendment are completed. As of March 31, 2026, Lonza’s testing and preparation of the ENV105 antibody had begun but had yet to be completed and the Company had yet to make any payments to Lonza. Subsequent to March 31, 2026, the Company made a payment of $160 to Lonza under the amended agreement.
Current report
Agreement with Celyn Therapeutics, Inc.
Current report
On March 2, 2026, the Company entered into a binding term sheet with Celyn Therapeutics, Inc., a privately held biotechnology company, regarding a proposed asset acquisition of CL-273, an investigational, reversible, wild type sparing pan EGFR small molecule inhibitor being developed by Eilean Therapeutics for EGFR mutant non-small cell lung cancer. Pursuant to the term sheet, the Company will receive 100% of the development, manufacturing, commercialization rights, patent prosecution and patent filing rights worldwide to CL-273 in exchange for upfront payment of 16.5% of the Company’s outstanding capital stock, with such stock to be issued in the form of Common Stock or convertible preferred stock, and milestone payments of (i) $15 million payable at NDA or BLA FDA, with such payment to be made in combination of cash and stock and (ii) 2% royalties from net revenue generated from sales in the U.S. for the life of the intellectual property. Closing is subject to satisfactory completion of due diligence and negotiation of a definitive acquisition agreement.
Current report
Funding Requirements
Current report
We expect our expenses to increase substantially in connection with our ongoing research activities, particularly as we pursue the advancement of our product candidates through clinical trials. In addition, we expect to incur additional costs associated with operating as a public company. The timing and amount of our operating expenditures will depend on numerous variables, including: the initiation, progress, timing, costs and results of the clinical trials for our product candidates or any future product candidates we may develop; the initiation, progress, timing, costs and results of nonclinical studies for our product candidates or any future product candidates we may develop; our ability to maintain our relationships with key collaborators; the outcome, timing and cost of seeking and obtaining regulatory approvals from the FDA and comparable foreign regulatory authorities, including the potential for such authorities to require that we perform more nonclinical studies or clinical trials than those that we currently expect or change their requirements on studies that had previously been agreed to; the cost to establish, maintain, expand, enforce and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with licensing, preparing, filing, prosecuting, defending and enforcing any patents or other intellectual property rights; the effect of competing technological and market developments; the costs of continuing to grow our business, including hiring key personnel and maintain or acquiring operating space; market acceptance of any approved product candidates, including product pricing, as well as product coverage and the adequacy of reimbursement by third-party payors; the cost of acquiring, licensing or investing in additional businesses, products, product candidates and technologies; the cost and timing of selecting, auditing and potentially validating a manufacturing site for commercial-scale manufacturing; the cost of establishing sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval and that we determine to commercialize; and our need to implement additional internal systems and infrastructure, including financial and reporting systems.
Current report
We expect that we will continue to require additional funding to complete the clinical development and commercialization of our product candidates, if we receive regulatory approval, and pursue in-licenses or acquisitions of other product candidates. If we receive regulatory approval for our product candidates, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on where we choose to commercialize ourselves.
Current report
Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity and debt financings, collaborations, strategic alliances, and marketing, distribution or licensing arrangements with third parties. To the extent that we raise additional capital through the sale of equity or convertible debt securities, ownership interest may be materially diluted, and the terms of such securities could include liquidation or other preferences that adversely affect the rights of our current common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include restrictive covenants that limit our ability to take specified actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, reduce or eliminate our product development or future commercialization efforts, or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Current report
Commitments and Contingencies
Current report
From time to time, we may have certain contingent liabilities that arise in the ordinary course of business. We evaluate the likelihood of an unfavorable outcome in legal or regulatory proceedings to which we are a party and record a loss contingency on an undiscounted basis when it is probable that a liability has been incurred and the amount of the loss can be reasonably estimated. These judgments are subjective and based on the status of such legal proceedings, the merits of our defenses, and consultation with legal counsel. Actual outcomes of these legal proceedings may differ materially from our estimates. We estimate accruals for legal expenses when incurred as of each balance sheet date based on the facts and circumstances known to us at that time.
Current report
Off-Balance Sheet Arrangements
Current report
During the three months ended March 31, 2026 and 2025, we did not have, and we do not currently have, any off-balance sheet arrangements (as defined under SEC rules).
Showing the first 40 of 44 passages. Open the source sections for the rest.
Removed paragraphs (19)
Previous report
Equity Line of Credit Agreement (ELOC)
Previous report
On November 12, 2024, we entered into an ELOC agreement (the “ELOC Agreement”) with Helena Global Investment Opportunities I LTD (“Helena”), pursuant to which Helena agreed to purchase from the Company up to $30,000 of common stock (the “ELOC Shares”), which the Company may exercise at any time following effectiveness of a registration statement at a price equal to the 95% of the lowest trading price during the three days following the Company’s notice to Helena to exercise the ELOC Agreement. The Company issued 670,641 shares of restricted common stock (the “Commitment Fee Shares”) to Helena as a “Commitment Fee” for the ELOC Agreement. The ELOC Agreement became available for the Company’s use following the filing and effectiveness of a resale registration statement registering the ELOC Shares for resale. Following effectiveness of the resale registration statement (the “Effective Date”), the Commitment Fee Shares were subject to a “true-up” pursuant to which, as the shares were valued at less than $900 on the Effective Date, additional shares were issued to Helena to bring the ELOC Shares to the full $900 value.
Previous report
The ELOC Agreement will terminate upon the following events: (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 Helena has purchased the full $30,000 of ELOC Shares. The ELOC Agreement may also be terminated by the Company after its commencement, at the Company’s discretion, provided that there are no advance notices outstanding for which common stock has yet to be issued, and the Company has paid all amounts owed to Helena under the ELOC Agreement, including the Commitment Fee shares.
Previous report
At the Company’s annual meeting of shareholders on June 10, 2025, a majority of the Company’s shareholders approved the issuance in excess of 19.99% of the Company’s common stock at a price below market value, in accordance with the terms of the ELOC Agreement and in compliance with Rule 713 of the NYSE American LLC Company Guide.
Previous report
During the nine months ended September 30, 2025, in connection with its ELOC agreement with Helena, the Company sold 3,510,000 shares of its common stock to Helena for net proceeds of $3,205. The shares were issued to Helena during the nine months ended September 30, 2025.
Previous report
Boustead Securities LLC (“Boustead”) and D. Boral Capital LLC (“D. Boral”) acted as placement agents (the “Placement Agents”) in the ELOC offering and, following each exercise, are entitled to cash compensation of 7%, 1% non-accountable fees and warrants equal to 7%. To date, the Placement Agents have received total cash compensation equal to $313,225 and a total of 245,750 warrants to purchase common stock, exercisable at exercise prices of $0.40, $0.46 and $1.2308 per share, which warrants will expire five years from the date of grant.
Previous report
January 2025 PIPE Offering
Previous report
On January 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 an additional $2 payable upon the Investor’s exercise of the Pre-Funded Warrants in full.
Previous report
In advance of closing, on January 16, 2025, the Company and the Investor entered into an amended and restated Purchase Agreement (the “A&R Purchase Agreement”), which amended the terms of the Purchase Agreement to include a requirement that the Company obtain shareholder approval prior to issuing in excess of 19.99% of the Company’s common stock and also amended the Common Warrants to make them immediately exercisable and reduce the exercise period from 5.5 years to five years. Other terms of the Purchase Agreement and Common Warrants remained the same.
Previous report
Boustead and D. Boral acted as co-placement agents for the January 2025 PIPE Offering. In conjunction therewith, on January 16, 2025, the Company entered into a Placement Agent Agreement with Boustead (the “Placement Agent Agreement”). Under the terms of the Placement Agent Agreement, at closing, the Company paid the Placement Agents (i) a cash commission equal to 8% of the gross proceeds (including a 1% non-accountable 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 and warrant compensation split equally between the Placement Agents.
Previous report
On January 20, 2025, the Company obtained the approval of 55.4% of the shareholders (the “Majority Shareholders”) for the issuance in excess of 19.99% of the Company’s common stock at a price below market value, in compliance with Rule 713 of the NYSE American LLC Company Guide. On February 10, 2025, the Company filed the definitive Schedule 14C and the shareholder approval became effective on March 1, 2025.
Previous report
Other Income (Expenses)
Previous report
Comparison of the Nine months Ended September 30, 2025 and 2024
Previous report
General and Administrative Expenses
Previous report
General and administrative expenses were $2,560 and $655 for the nine months ended September 30, 2025 and 2024, respectively. Significant changes between periods consisted of the increase in vendor advance amortization expense in 2025, relating to our vendor advances in 2025; and the increase in insurance costs in 2025, relating to our increased costs of directors and officers liability insurance as a public company.
Previous report
Other Income (Expenses)
Previous report
Other income (expenses) was $75 and $(726) for the nine months ended September 30, 2025 and 2024, respectively. In 2025, other income was interest income earned from our money market account. In 2024, other expenses were interest expense of $35, financing costs of $537 and debt discount amortization of $154.
Previous report
During the nine months ended September 30, 2025, the Company incurred a net loss of $4,082 and used cash in operations of $2,357. During that period, the Company closed a private financing in which the Company received net proceeds of $3,058 and closed three financings from our ELOC for net proceeds of $3,602. At September 30, 2025, the Company had cash and cash equivalents totaling $5,575 and shareholders’ equity of $7,664. The Company expects its current cash reserves to fund the Company’s operations for at least 12 months from the date of this filing.
Previous report
The Company’s ability to continue as a going concern is dependent on the Company attaining and maintaining profitable operations in the future, which will primarily be accomplished by raising additional capital to meet its operating needs and repay its liabilities arising from normal business operations when they come due. Since inception, the Company has funded its operations primarily through equity and debt financings and the Company expects to continue to rely on these sources of capital until such time as it is able to generate revenue.
Reworded paragraphs (14)
Previous wording
You should read the following discussion and analysis of our financial condition and results of operations (the “MD&A”) together with our unaudited consolidated 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 statements and notes thereto for the year ended December 31, 2024 included in our annual report on Form 10-K initially filed with the Securities Exchange Commission (the “SEC”) on April 15, 2025, as amended on April 29, 2025 and July 28, 2025 (the “2024 Annual Report”).
Current wording
You should read the following discussion and analysis of our financial condition and results of operations (the “MD&A”) together with our unaudited consolidated 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 statements and notes thereto for the year ended December 31, 2025, included in our annual report on Form 10-K filed with the Securities Exchange Commission (the “SEC”) on March 31, 2026 (the “2025 Annual Report”).
Previous wording
In addition to historical information, some of the statements contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business, constitute forward-looking 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 Act of 1934, as amended (the “Exchange Act”). We have based these forward-looking statements on our current expectations and any projections about future events. The following information and any forward-looking statements should be considered in light of factors discussed elsewhere in this Quarterly Report, along with the risks identified under the “Part I – Item 1A” in our 2024 Annual Report and in our other filings made with the Securities Exchange Commission (the “SEC”).
Current wording
In addition to historical information, some of the statements contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business, constitute forward-looking 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 Act of 1934, as amended (the “Exchange Act”). We have based these forward-looking statements on our current expectations and any projections about future events. The following information and any forward-looking statements should be considered in light of factors discussed elsewhere in this Quarterly Report, the “Risk Factor” section in the 2025 Annual Report, and in our other filings with the Securities Exchange Commission (the “SEC”).
Previous wording
Since inception, we have incurred significant operating losses. Our net losses were $4,082 and $2,603, respectively, for the nine months ended September 30, 2025 and the year ended December 31, 2024. As of September 30, 2025, we had an accumulated deficit of $12,897. We expect to continue to incur significant and increasing expenses and operating losses for the foreseeable future, as we advance our current and future product candidates through preclinical and clinical development, manufacture drug product and drug supply, seek regulatory approval for our current and future product candidates, maintain and expand our intellectual property portfolio, hire additional research and development and business personnel, and operate as a public company.
Current wording
Since inception, we have incurred significant operating losses. Our net losses were $1,654 and $1,262 for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, we had an accumulated deficit of $15,916. We expect to continue to incur significant and increasing expenses and operating losses for the foreseeable future, as we advance our current and future product candidates through preclinical and clinical development, manufacture drug product and drug supply, seek regulatory approval for our current and future product candidates, maintain and expand our intellectual property portfolio, hire additional research and development and business personnel, and operate as a public company.
Previous wording
On January 14, 2025, the Company entered into a securities purchase agreement (the “Purchase Agreement”) and registration rights agreement (the “Registration Rights Agreement”) with the investor name therein (the “Investor”) for the sale and issuance of 2,500,000 units (the “Pre-Funded Units”), with each Pre-Funded Unit consisting of a pre-funded warrant (the “Pre-Funded Warrant”) to purchase one share of common stock, exercisable for $0.001 per share, and a common warrant (the “Common Warrant”) to purchase one and one half shares of common stock, exercisable at $1.40 per share (the “January 2025 PIPE Offering”).
Current wording
On January 14, 2025, the Company entered into a securities purchase agreement (“SPA”) and registration rights agreement with an investor for the sale and issuance of 2,500,000 units (the “Pre-Funded Units”), with each Pre-Funded Unit consisting of a pre-funded warrant to purchase one share of common stock, exercisable for $0.001 per share, and a common warrant to purchase one and one half shares of common stock (an aggregate of 3,750,000), exercisable at $1.399 per share. On January 16, 2025, the Company closed on the sale of the Pre-Funded Units for a total purchase price of $3,500 (or $1.40 per Pre-Funded Unit). Net proceeds received by the Company relating to the financing, and subsequent exercise of prefunded warrants was $3,058.
Previous wording
We have not generated any sales to date. No revenue was recorded from any sources during the nine months ended September 30, 2025 and 2024.
Current wording
We have not generated any sales to date. No revenue was recorded from any source during the three months ended March 31, 2026 and 2025.
Previous wording
We are engaged in rolling out our Phase 1 and Phase 2 clinical trials for ENV105 and a Phase 1 trial for KROS201. In addition, we are continuously performing preclinical research including animal models of disease, medicinal chemistry laboratory studies, formulation, and toxicology and biodistribution studies. Our clinical development costs may vary significantly based on factors such as: per patient trial costs; the number of trials required for approval; the number of sites included in the trials; the location where the trials are conducted; the length of time required to enroll eligible patients; the number of patients that participate in the trials; the number of doses that patients receive; the drop-out or discontinuation rates of patients; potential additional safety monitoring requested by regulatory agencies; the duration of patient participation in the trials and follow-up; the cost and timing of manufacturing our product candidates; the phase of development of our product candidates; and the efficacy and safety profile of our product candidates.
Current wording
We are engaged in rolling out our Phase 1 and Phase 2 clinical trials for ENV 105 and a Phase 1 trial for KROS 201. In addition, we are continuously performing preclinical research including animal models of disease, medicinal chemistry laboratory studies, formulation, and toxicology and biodistribution studies. Our clinical development costs may vary significantly based on factors such as: per patient trial costs; the number of trials required for approval; the number of sites included in the trials; the location where the trials are conducted; the length of time required to enroll eligible patients; the number of patients that participate in the trials; the number of doses that patients receive; the drop-out or discontinuation rates of patients; potential additional safety monitoring requested by regulatory agencies; the duration of patient participation in the trials and follow-up; the cost and timing of manufacturing our product candidates; the phase of development of our product candidates; and the efficacy and safety profile of our product candidates.
Previous wording
Research and development expenses were $608 and $14 for the three months ended September 30, 2025 and 2024, respectively. The increase in R&D expenses in 2025 primarily related to our Phase 2 trial in prostate cancer beginning in 2024.
Current wording
Research and development expenses were $684 and $493 for the three months ended March 31, 2026 and 2025, respectively. The increase in R&D expenses in the first quarter of 2026 primarily related to our Phase 2 trial in prostate cancer beginning in 2024.
Previous wording
General and administrative expenses were $827 and $369 for the three months ended September 30, 2025 and 2024, respectively. Significant changes between periods consisted of the increase in vendor advance amortization expense in 2025 relating to our vendor advances in 2025.
Current wording
General and administrative expenses were $1,006 and $773 for the three months ended March 31, 2026 and 2025, respectively. Significant changes between periods consisted of the increase in other professional service expenses and fees in 2026, primarily related to being a publicly traded company.
Previous wording
Other income (expenses) was $37 and $(664) for the three months ended September 30, 2025 and 2024, respectively. In 2025, other income was interest income earned from our money market account. In 2024, other expenses were interest expense of $12, financing costs of $537 and debt discount amortization of $115.
Current wording
Other income was $36 and $4 for the three months ended March 31, 2026 and 2025, respectively. In both periods, other income was interest income earned from our money market account.
Previous wording
No assurance can be given that any future financing will be available or, if available, that it will be on terms that are satisfactory to the Company. Even if the Company is able to obtain additional financing, such financing may contain undue restrictions on our operations, in the case of debt financing, or cause substantial dilution to our stockholders, in the case of equity financing.
Current wording
No assurance can be given that any future financing will be available or, if available, that it will be on terms that are satisfactory 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 shareholders, in the event of an equity financing.
Previous wording
The table below summarizes our cash flow activities for the nine months ended September 30, 2025 and 2024:
Current wording
The table below summarizes our cash flow activities for the three months ended March 31, 2026 and 2025:
Previous wording
During the nine months ended September 30, 2025, we used cash from operating activities of $2,357, compared to $2,152 used during the nine months ended September 30, 2024. During the nine months ended September 30, 2025, we incurred a net loss of $4,082 and had non-cash expenses of $2,301, compared to a net loss of $1,623 and non-cash expenses of $845 during the nine months ended September 30, 2024. The primary non-cash expense in 2025 was the amortization of vendor advances of $1,958.
Current wording
During the three months ended March 31, 2026, we used cash from operating activities of $1,036, compared to $714 used during the three months ended March 31, 2025. During the three months ended March 31, 2026, we incurred a net loss of $1,654 and had non-cash expenses of $519, compared to a net loss of $1,262 and non-cash expenses of $116 during the three months ended March 31, 2025. The primary non-cash expense in the first three months of 2026 was the amortization of vendor advances of $220 and the fair value of vested restricted stock units of $259. The primary non-cash expense in the same period of 2025 was the fair value of vested restricted stock units of $76.
Previous wording
The net change in operating assets and liabilities during the nine months ended September 30, 2025 used cash of $576, compared to $1,374 used during the nine months ended September 30, 2024. The primary use of cash relating to operating assets and liabilities during the nine months ended September 30, 2025, was the decrease in accounts payable and accrued expenses. The primary use of cash during the nine months ended September 30, 2024, was the increase in vendor advances.
Current wording
The net change in operating assets and liabilities during the three months ended March 31, 2026 provided cash of $99, compared to $432 provided during the three months ended March 31, 2025. The primary source of cash relating to operating assets and liabilities during the three months ended March 31, 2026, was the increase in accounts payable and accrued expenses. The primary source of cash during the three months ended March 31, 2025, was the decrease in vendor advances.
Previous wording
During the nine months ended September 30, 2025, we provided cash from financing activities of $6,660, compared to $5,276 provided during the nine months ended September 30, 2024. For the nine months ended September 30, 2025, cash provided by financing activities consisted of proceeds from our private financing of $3,058 and proceeds of $3,602 from our ELOC. Net cash provided in 2024 was from net proceeds from our IPO of $5,524 and proceeds from notes payable – officers of $142. Net cash used in 2024 consisted of the payment of deferred offering costs of $390.
Current wording
During the three months ended March 31, 2026, we provided cash from financing activities of $220, compared to $3,058 provided during the three months ended March 31, 2025. For the three months ended March 31, 2026, cash provided by financing activities consisted of proceeds from our ATM offering of $385. Net cash provided in the same period of 2025 was from net proceeds from the sale and exercise of prefunded warrants of $3,058. Net cash used in the first three months of 2026 consisted of the payment of deferred offering costs of $165.
Rearranged previous paragraphs (4)
Previous report — wording carried elsewhere
The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024:
Previous report — wording carried elsewhere
The table below summarizes our research and development expenses for the nine months ended September 30, 2025 and 2024:
Previous report — wording carried elsewhere
Research and development expenses were $1,597 and $242 for the nine months ended September 30, 2025 and 2024, respectively. The increase in R&D expenses in 2025 primarily related to our Phase 2 trial in prostate cancer beginning in 2024.
Previous report — wording carried elsewhere
The table below summarizes our general and administrative expenses for the nine months ended September 30, 2025 and 2024: