Item 2. Management’s Discussion and Analysis
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
(in
thousands, except for share amounts and per share data)
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”) .
Special
Note Regarding Forward-Looking Statements
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 with the Securities Exchange Commission (the “SEC”).
We
caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial
condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements
contained in this Quarterly Report. Statements 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 date. Even if our results of operations, financial condition and liquidity, and the development
of the industry in which we operate are consistent with the forward-looking statements contained in this Quarterly Report, they may not
be predictive of results or developments in future periods. We disclaim any obligation, except as specifically required by law and the
rules of the SEC, to publicly update or revise any such statements to reflect any change in our expectations or in events, conditions
or circumstances on which any such statements may be based or that may affect the likelihood that actual results will differ from those
set forth in the forward-looking statements.
Overview
We
are a clinical-stage biopharmaceutical company advancing therapeutics for cancer patients that are designed to overcome key hurdles in
immune suppression and drug resistance.
Our
mission is to advance our portfolio of innovative therapeutics to reverse key mechanisms of therapeutic resistance and immune suppression
and transform the way cancer is treated. We have leveraged molecular insights of the mechanisms of therapeutic resistance and immune
suppression to develop a new class of novel drugs that are designed to target drug resistance and checkpoints of immune suppression. As
of the date of this Quarterly Report, our product candidates have not been approved as safe or effective by the FDA or any other comparable
foreign regulator.
18
Since
inception, our operations have focused on organizing and staffing our Company, business planning, raising capital, acquiring and developing
our technology, establishing our intellectual property portfolio, identifying potential product candidates, and undertaking preclinical
and clinical studies and manufacturing. We do not have any products approved for sale and have not generated any revenue from product
sales.
Since
inception, we have incurred significant operating losses. Our net losses were $2,684 and $2,603, respectively, for the six months ended June 30, 2025
and the year ended December 31, 2024. As of June 30, 2025, we had an accumulated deficit of $11,499. 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.
We
will not generate revenue from product sales unless and until we successfully complete our clinical trials and obtain regulatory approval
for our product candidates. In addition, if we obtain regulatory approval for our product candidates and do not enter into a third-party
commercialization partnership, we will likely incur significant expenses related to developing our commercialization capability to support
product sales, marketing, manufacturing, and distribution activities.
As
a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until we can
generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of public or private
equity offerings and debt financings and other sources, such as potential collaboration agreements, strategic alliances and licensing
arrangements. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on acceptable
terms, or at all. Our failure to raise capital or enter into such agreements as and when needed could have a material adverse effect
on our business, results of operations and financial condition. 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 stockholders,
in case of equity financing.
Recent
Developments
Equity
Line of Credit Agreement (ELOC)
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 are 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.
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.
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.
During
the three and six months ended June 30, 2025, in connection with the ELOC Agreement, the Company sold 510,000 shares of
our common stock to Helena for net proceeds of $210. The shares were issued to Helena during the three and six months ended June 30,
2025.
19
Subsequent
to June 30, 2025, in connection with the ELOC Agreement, the Company sold 3,000,000 shares of our common stock to Helena
for net proceeds of $3,693, excluding certain related costs. The shares were issued to Helena in July 2025.
As
of the date of this Quarterly Report on Form 10-Q, we have sold an aggregate of 3,510,000 shares of our common stock for net
proceeds of $3,903 under the ELOC Agreement. 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.
January
2025 PIPE Offering
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”).
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.
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.
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.
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.
Components
of Results of Operations
Net
Sales
We
have not generated any sales to date. No revenue was recorded from any sources during the six months ended June 30, 2025 and 2024.
Operating
Expenses
Our
operating expenses consist of (i) research and development expenses and (ii) general and administrative expenses.
Research
and Development Expenses
Dr.
Ramachandran Murali is our Vice President of Research and Development. Dr. Murali is a doctor and scientist at Cedars-Sinai Medical Center,
and is the inventor, with others, of three of the patented technologies that are subject to the Kairos-Cedars license agreements.
20
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.
The
successful development and commercialization of product candidates is highly uncertain. This is due to the numerous risks and uncertainties
associated with product development and commercialization, including the following: the timing and progress of nonclinical and clinical
development activities; the number and scope of nonclinical and clinical programs we decide to pursue; raising necessary additional funds;
the progress of the development efforts of parties with whom we may enter into collaboration arrangements; our ability to maintain our
current development program and to establish new ones; our ability to establish new licensing or collaboration arrangements; the successful
initiation and completion of clinical trials with safety, tolerability and efficacy profiles that are satisfactory to the FDA or any
comparable foreign regulatory authority; the receipt and related terms of regulatory approvals from applicable regulatory authorities;
the availability of drug substance and drug product for use in production of our product candidate; establishing and maintaining agreements
with third-party manufacturers for clinical supply for our clinical trials and commercial manufacturing, if our product candidates are
approved; our ability to obtain and maintain patents, trade secret protection and regulatory exclusivity, both in the United States and
internationally; our ability to protect our rights in our intellectual property portfolio; the commercialization of our product candidates,
if and when approved; obtaining and maintaining third-party insurance coverage and adequate reimbursement; the acceptance of our product
candidate, if approved, by patients, the medical community and third-party payors; competition with other products; the impact of any
business interruptions to our operations, including the timing and enrollment of patients in our planned clinical trials, or to those
of our manufacturers, suppliers, or other vendors resulting from any pandemic or public health crisis; and a continued acceptable safety
profile of our therapies following approval.
A
change in the outcome of any of these variables with respect to the development of our product candidates could significantly change
the costs and timing associated with the development of that product candidate. We may never succeed in obtaining regulatory approval
for any of our product candidates.
General
and administrative expenses
General
and administrative expenses consist primarily 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 SEC reporting matters; professional fees for accounting, auditing, tax and
administrative consulting services; insurance costs; administrative travel expenses; marketing expenses and other operating
costs.
We
anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support our business
operations. We also anticipate that we will incur increased accounting, audit, legal, regulatory, compliance, and director and officer
insurance costs, as well as investor and public relations expenses associated with being a public company.
21
Results
of Operations
Comparison
of the Three Months Ended June 30, 2025 and 2024
The
following table summarizes our results of operations for the three months ended June 30, 2025 and 2024:
June 30,
2025
June 30,
2024
Revenues
$ -
$ -
Operating expenses:
Research and development
496
63
General and administrative
960
159
Total operating expenses
1,456
222
Loss from operations
(1,456 )
(222 )
Other expenses:
Interest expense
-
(12 )
Debt discount amortization
-
(19 )
Interest income
34
-
Total other income (expenses)
34
(31 )
Net loss
(1,422 )
(253 )
Research
and Development Expenses
The
table below summarizes our research and development expenses for the three months ended June 30, 2025 and 2024:
Research and Development Expenses:
June 30,
2025
June 30,
2024
Clinical and related expenses
$ 496
63
Total research and development expenses
$ 496
63
Research
and development expenses were $496 and $63 for the three months ended June 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.
General
and Administrative Expenses
The
table below summarizes our general and administrative expenses for the three months ended June 30, 2025 and 2024:
General and Administrative Expenses:
June 30,
2025
June 30,
2024
Stock-related expenses
$ 60
$ -
Officer compensation and wages
59
-
Patent related expenses
31
1
Legal expenses
78
1
Accounting expenses
93
50
Other professional service expenses and fees
98
26
Fees relating to license agreements
-
32
Insurance expenses
98
9
Vendor advances amortization expense
265
-
Intangible amortization expense
40
40
Other expenses
138
-
Total general and administrative expenses
$ 960
$ 159
General
and administrative expenses were $960 and $159 for the three months ended June 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.
22
Other
Income (Expenses)
Other
income (expenses) was $34 and $(31) for the three months ended June 30, 2025 and 2024, respectively. In 2025, other income consisted
of interest income earned from our money market account. In 2024, other expenses consisted of interest expense of $12 and debt
discount amortization of $19.
Comparison
of the Six Months Ended June 30, 2025 and 2024
The
following table summarizes our results of operations for the six months ended June 30, 2025 and 2024:
June 30,
2025
June 30,
2024
Revenues
$ -
$ -
Operating expenses:
Research and development
989
228
General and administrative
1,733
286
Total operating expenses
2,722
514
Loss from operations
(2,722 )
(514 )
Other expenses:
Interest expense
-
(23 )
Debt discount amortization
-
(39 )
Interest income
38
-
Total other expenses, net
38
(62 )
Net loss
$ (2,684 )
$ (576 )
Research
and Development Expenses
The
table below summarizes our research and development expenses for the six months ended June 30, 2025 and 2024:
Research
and Development Expenses:
June
30,
2025
June
30,
2024
Clinical
and related expenses
$
989
228
Total
research and development expenses
$
989
228
Research
and development (“R&D”) expenses were $989 and $228 for the six months ended June 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.
23
General
and Administrative Expenses
The
table below summarizes our general and administrative expenses for the six months ended June 30, 2025 and 2024:
General and Administrative Expenses:
June 30,
2025
June 30,
2024
Stock-related expenses
$ 136
-
Officer compensation and wages
115
-
Patent related expenses
53
9
Legal expenses
78
2
Accounting expenses
160
72
Other professional service expenses and fees
136
32
Fees relating to license agreements
-
64
Insurance expenses
203
21
Vendor advances amortization expense
505
-
Intangible amortization expense
80
80
Other expenses
267
6
Total general and administrative expenses
$ 1,733
286
General
and administrative expenses were $1,733 and $286 for the six months ended June 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.
Other
Income (Expenses)
Other
income (expenses) was $38 and $(62) for the six months ended June 30, 2025 and 2024, respectively. In 2025, other income consisted
of interest income earned from our money market account. In 2024, other expenses consisted of interest expense of $23 and debt
discount amortization of $39.
Liquidity
and Capital Resources
During
the six months ended June 30, 2025, the Company incurred a net loss of $2,684 and used cash in operations of $1,519. During that
period, the Company closed a private financing in which the Company received net proceeds of $3,058 and closed two financings from
the Equity Line of Credit (“ELOC”) for net proceeds of $223. At June 30, 2025, the Company had cash and cash equivalents
totaling $3,034 and shareholders’ equity of $5,997. Subsequent to June 30, 2025, the Company closed an additional financing
from the ELOC totaling net proceeds of $3,693. The Company expects our current cash reserves to fund the Company’s operations
for at least 12 months from the date of this filing.
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 our operating needs and repay our
liabilities arising from normal business operations when they come due. Since inception, the Company has funded our operations
primarily through equity and debt financings and we expect to continue to rely on these sources of capital in the future until it
is able to generate revenues.
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 for our stockholders, in the case of equity financing.
Cash
Flows
The
table below summarizes our cash flow activities for the six months ended June 30, 2025 and 2024:
June 30,
June 30,
Net cash provided by (used in):
2025
2024
Operating activities
$ (1,519 )
$ (132 )
Investing activities
-
-
Financing activities
3,281
60
Net increase (decrease) in cash
$ 1,762
$ (72 )
24
Operating
Activities
During
the six months ended June 30, 2025, we used cash from operating activities of $1,519, as compared to $132 used during the six months
ended June 30, 2024. During the six months ended June 30, 2025, we incurred a net loss of $2,684 and had non-cash expenses of
$1,531, as compared to a net loss of $576 and non-cash expenses of $119 during the six months ended June 30, 2024. The primary
non-cash expense in 2025 was the amortization of vendor advances of $1,298.
The
net change in operating assets and liabilities during the six months ended June 30, 2025 used cash of $366, as compared to $325
provided during the six months ended June 30, 2024. The primary use of cash relating to operating assets and liabilities during the
six months ended June 30, 2025, was the decrease in accounts payable and accrued expenses. The primary source of cash during the six
months ended June 30, 2024, was the increase in accounts payable and accrued expenses.
Financing
Activities
During
the six months ended June 30, 2025, we provided cash from financing activities of $3,281, as compared to $60 provided during the six
months ended June 30, 2024. For the six months ended June 30, 2025, cash provided by financing activities consisted of proceeds from
our private financing of $3,058 and proceeds of $223 from our ELOC. Net cash provided in 2024 was from proceeds from notes payable
– officers of $102. Net cash used in 2024 consisted of the payment of deferred offering costs of $42.
Funding
Requirements
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.
We
believe that our existing cash, including the net proceeds we received from the IPO and the January 2025 PIPE Offering, will enable us
to fund our operating expenses and capital expenditure requirements for at least the next 12 months. 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. 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.
25
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.
Contractual
Obligations and Commitments
Kairos
Agreement with Prevail Infoworks, Inc.
In
August 2024, the Company entered into a master service and technology agreement with Prevail Infoworks, Inc. (“Prevail”),
pursuant to which Prevail agreed to provide certain clinical research services to the Company. As part of the agreement, the Company
was required to make an advance payment of $900 to Prevail before they begin their services. At such time as we notify Prevail to engage
their services related to the relevant clinical trial, or six months from the date of the agreement, we will be required to pay approximately
$80 per month during the time Prevail performs such clinical research services. The agreement with Prevail is subject to cancellation
at any time upon 30 days’ written notice to the other party. The Company made the advance payment to Prevail in October 2024.
Kairos
Agreement with PreCheck Health Services, Inc.
On
September 20, 2024, the Company entered into a bioassay services agreement (the “Bioassay Services Agreement”) with PreCheck
Health Services, Inc., a Florida-based corporation (“PreCheck”). Pursuant to the Bioassay Services Agreement, PreCheck will
provide certain biomarker screening services for the Company’s ongoing carotuximab (ENV 105) clinical trials in order to assist
the Company in identifying lung and prostate cancer patients suitable to the Company’s ongoing Phase 1 clinical trials for lung
cancer patients and Phase 2 trials for patients with castrate resistant prostate cancer. In order to identify biomarkers for patient
screening and therapy monitoring using carotuximab (ENV 105), PreCheck will utilize its SolidTumorCheck+ platform for the somatic gene
expression analysis of biopsy tissue samples derived from patients with lung and prostate cancer, as part of the Company’s ongoing
clinical trials. In furtherance of these efforts, PreCheck will develop a companion diagnostic to support its identification of such
patients with a three gene PCR analysis or other genetic analysis, which diagnostic test will then be developed and submitted to the
FDA for castrate-resistant prostate cancer patients and for lung cancer patients on Tagrisso. In exchange for PreCheck’s services,
and according to the terms of the Bioassay Services Agreement, the Company paid $900 to PreCheck as an advance for the future laboratory
services to be performed. The term of the agreement is one year from the effective date.
Kairos
Agreement with CEO.CA Technologies Ltd.
On
September 23, 2024, the Company entered into an advisory and consulting services agreement (the “CEO.CA Agreement”) with
CEO.CA Technologies Ltd., a Canadian company (“CEO.CA”), pursuant to which CEO.CA will provide certain internet-based financial
information and communications services for a period of one year for a services fee of $250. The service fee is an advance on future
services to be performed. The CEO.CA Agreement includes such services as strategic news placement, news releases, interviews, monthly
analytics and a video launch. The CEO.CA Agreement contains other customary clauses, including representations and warranties, indemnification
clauses and governing law clauses.
26
Kairos
Agreement with Belair Capital Advisors Inc.
On
September 23, 2024, the Company entered into a strategic advisory agreement (the “Strategic Advisory Agreement”) with Belair
Capital Advisors Inc. (“BCA”). BCA, a venture capital and corporate finance advisory firm, has been a long-term investor
and advisor to the Company and frequently works with early-stage pharmaceutical companies. The strategic advisory services consist of
corporate strategy, market positioning and long-term growth plans within the pharmaceutical sector, digital marketing and engagement,
market research analysis and business development assistance, among other things. During the one-year term of the Strategic Advisory
Agreement, in exchange for its services, the Company will pay BCA $365 fee and will issue BCA 50,000 RSUs, which will vest at the end
of six months.
Kairos
Agreement with Cross Current Capital LLC
On
October 1, 2024, the Company entered into a consulting agreement (the “Consulting Agreement”) with Cross Current Capital
LLC, a limited liability company organized under the laws of Puerto Rico (“Cross Current”), and Alan Masley (the “Advisor”),
pursuant to which Cross Current agreed to provide certain financial and business consulting services to the Company including, but not
limited, to (a) help drafting a public company competitive overview, (b) help preparing and/or reviewing a valuation analysis, (c) help
in drafting marketing materials and presentations, (d) reviewing the Company’s business requirements and discuss financing and
businesses opportunities, (e) investor marketing, (f) investor relations introductions, (g) legal counsel introductions, (h) auditor
introductions, (i) investment banking and research introductions, (j) M&A canvassing and ways to grow the business organically, and
(k) stand by capital markets advisory services. For the services rendered thereunder, 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 stock, issuable under the Company’s
2023 Equity Inventive Plan, in an amount equal to $500,000 (the “Shares”), which Shares shall vest at the end of six months
after issuance. The term of the Consulting Agreement is 24 months and can be extended for another 12 months upon the written consent
of both parties. The Company made the $200 payment in October 2024.
Exclusive
License Agreements with Cedars
We
have entered into four Exclusive License Agreements with Cedars which grants us licensing rights with respect to certain patent rights
owned by Cedars as follows:
1.
Methods
of use of compounds that bind to RelA of NFkB;
2.
Composition
and methods for treating fibrosis;
3.
Compositions
and methods for treating cancer and autoimmune diseases; and
4.
Method
of generating activated T cells for cancer therapy.
On
June 2, 2021, our 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:
●
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; and
●
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.
27
Item
3. Quantitative and Qualitative Disclosures about Market Risks.
As
a “smaller reporting company,” we are not required to provide the information required by this Item.
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.