Item 2. Management’s Discussion and Analysis
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Introductory
Note
The
following discussion and analysis of our financial condition and results of operations (this “ MD&A ”)
should be read in conjunction with the financial statements and the related notes included elsewhere in this quarterly report. Some of
the information contained in this discussion and analysis or set forth in this quarterly report, including information with respect to
our plans, objectives, expectations, projections, and strategy for our business and related financing, includes forward-looking statements
that involve risks and uncertainties. As a result of many factors, including those factors set out in “Part I— Item 1A. Risk
Factors” in our 2025 annual report, our actual results could differ materially from the results described in or implied by these
forward-looking statements. See also the section entitled “Cautionary Note Regarding Forward-Looking Statements” in this quarterly
report.
Unless
the context otherwise requires, references to “Silexion,” the “Company,” “we,” “us” and
“our” in this MD&A generally refer to Silexion Therapeutics Corp, a Cayman Islands exempted company. For periods prior
to the Business Combination, these terms refer to Silexion Israel, an Israeli company, through which our operations were conducted prior
to the Business Combination.
Overview
Overview
of Operations
We
are a clinical-stage biotechnology company developing, through our subsidiaries, RNA interference (RNAi) therapies for cancers driven
by mutations in the Kirsten rat sarcoma viral oncogene homolog (“ KRAS ”). Our approach
targets a significant unmet medical need, as treatment innovation for KRAS-driven cancers has historically lagged despite KRAS being one
of the most common oncogenic drivers across solid tumors. In pancreatic cancer, for example, approximately 92% of patients have this mutated
oncogene. While multiple pharmaceutical companies are pursuing strategies to inhibit KRAS and thereby limit its downstream signaling,
our approach is differentiated by targeting the root cause of oncogenic signaling; our lead product candidate, SIL204, is a second-generation
siRNA therapy that is engineered to suppress the KRAS oncogene itself, preventing the production of the oncogenic protein. We utilize
an integrated treatment approach that combines administering SIL204 both directly into the tumor and systemically via subcutaneous injection,
in combination with standard-of-care chemotherapy. In a previous Phase 2 clinical trial with our first-generation siRNA, the combination
of siRNA and standard-of-care chemotherapy demonstrated an overall survival benefit compared to standard-of-care chemotherapy alone. Building
on preclinical advancements and regimen optimization, we believe SIL204 has the potential to further improve clinical outcomes.
During
the second quarter of 2026, we received formal regulatory approvals— from the Israeli Ministry of Health (the “ Israeli
MoH ”) and Germany's Federal Institute for Drugs and Medical Devices (“ BfArM ”)
(in the case of BfArM, based on the positive opinion of the Ethics Committee of the North Rhine Medical Association — to initiate
our Phase 2/3 clinical trial for SIL204 in locally advanced pancreatic cancer subjects in Israel and Germany, respectively. Subsequent
to the end of the quarter covered by this report, in late July 2026, we initiated the trial at the Tel Aviv Sourasky Medical Center in
Tel Aviv, Israel (after having received the approval of the Helsinki Ethics Committee of Tel Aviv Sourasky Medical Center), with commencement
of patient screening expected within weeks thereafter and first patient dosing expected to follow. We furthermore expect, in the coming
months, that additional Israeli and German trial sites will complete customary site activation procedures, including contracting and budget
finalization, and will join the trial. The supply of our SIL204 product candidate for the clinical trials has been manufactured via current
good manufacturing practice (cGMP) by Catalent, Inc. at its facility in Limoges, France.
2
Overview
of Financing Activities
As
a clinical stage company, we have not realized any revenues to date, and have been solely reliant on financing transactions to fund our
operations.
Prior
to the Business Combination, as a private company, we financed our operations primarily with the net proceeds from private offerings of
our ordinary shares and convertible preferred shares, convertible financing agreements, and Simple Agreement for Future Equity (SAFE)
financings, as well as royalty-bearing grants from the Israeli Innovation Authority (the “ IIA ”).
Those grants totaled $5.8 million through June 30, 2026, all of which was received prior to the Business Combination. Since the Closing
of the Business Combination, we have primarily relied upon public offerings and private financings to finance our operations, specifically:
public offerings of ordinary shares and/or pre-funded warrants, together with ordinary warrants; sales of ordinary shares into the public
market in an ongoing manner under the ATM Agreement; and induced ordinary warrant exercise transactions.
Initially
as a public company, at the time of the Closing of the Business Combination, we raised $2.0 million via a private investment in public
entity (PIPE) financing, in which Moringa sold to Greenstar, LP, an affiliate of the Moringa sponsor, 148 newly issued Moringa ordinary
shares at a price of $13,500 per share. Those shares were converted into an equivalent number of Silexion ordinary shares at the Closing.
Also in connection with the Closing, we entered into an ordinary share purchase agreement, dated August 13, 2024 and effective as of August
15, 2024, with White Lion Capital, LLC, which provided us with an equity line of credit (the “ ELOC ”)
of up to $15.0 million. We utilized the ELOC for financings from time to time during the early periods following the Closing of the Business
Combination, having raised an aggregate of $3.1 million, all of which was raised prior to December 31, 2024. The ELOC expired on December
31, 2025.
Subsequent
to that initial period, we transitioned to alternative financing transactions. In January 2025, September 2025, and August 2026, we completed
public offerings in which we raised gross proceeds of approximately $5.0 million, $6.0 million and $2.5 million, respectively, before
deducting placement agent fees and other offering expenses. In connection with the January 2025 and September 2025 public offerings, investors
exercised ordinary warrants and Series B ordinary warrants, respectively,
which provided us with additional gross proceeds of $0.9 million and $1.78 million, respectively. As follow-up transactions to the January
2025 and September 2025 public offerings, we completed induced warrant exercise transactions in January 2025, August 2025, and May 2026,
which raised gross proceeds of approximately $3.3 million, $1.8 million, and $1.0 million, respectively, before deducting placement agent
fees and other offering expenses. H.C. Wainwright served as the exclusive placement agent for each of those public offerings and induced
warrant exercise transactions.
Recently,
we have been financing our operations on an ongoing basis via our ATM program with H.C. Wainwright, which we entered into in September
2025 and under which we may raise up to $13.17 million via sales of our ordinary shares into the open market. While we were unable to
effect any sales under the ATM during 2025, during the second and first quarters of 2026, we raised approximately $1.9 million and $0.08
million (in each case, net of sales agent fees and issuance costs), respectively, and in July 2026 and thus far in August 2026 (through
August 11, 2026), we have raised $0.3 million (net of sales agent fees), in the aggregate, from the sale of ordinary shares under the
ATM.
Please
see “ Liquidity and Capital Resources ” below in this MD&A for further detail regarding
our financing transactions.
Overview
of Financial Condition
Since
our inception, we have incurred significant operating losses. Our net losses were $6.3 million and $3.6 million for the six months and
three months ended June 30, 2026, respectively, and $11.9 million for the year ended December 31, 2025. As of June 30, 2026, we had an
accumulated deficit of $61.5 million.
3
We
expect to continue to incur significant expenses and operating losses for the foreseeable future. The net losses we incur may fluctuate
significantly from quarter to quarter. Our expenses will depend on many factors, including, among other matters: the timing and extent
of spending for our clinical trials, regulatory applications, and any further development activities, in each case related to SIL204;
the extent of our related research and development activities; our investments in potential additional pipeline products; and whether
and when we retain additional personnel to expand our operations. Our expenses will increase as and if we:
•
advance with our Phase
2/3 clinical trials seeking statistically significant results with respect to our SIL204 product candidate in locally advanced pancreatic
cancer subjects in Israel and Germany;
•
seek marketing approvals
for SIL204 in various territories;
•
apply for Orphan Drug
Designation in both the U.S. and EU for SIL204;
•
maintain, expand and
protect our intellectual property portfolio;
•
hire additional operational,
clinical, quality control and scientific personnel;
•
add additional product
candidates to our pipeline;
•
develop additional cancer
indications for SIL204;
•
add operational, financial
and management information systems and personnel, including personnel to support our product development, any future commercialization
efforts and our status as a public company; and
•
invest in research and
development and regulatory approval efforts in order to utilize our technology as a broader platform focused on the silencing of the KRAS
oncogene using RNA-interference therapeutics.
Nasdaq
Listing Compliance as Support for Financing Activities and Financial Condition
Our
financial condition depends on, and is supported by, our ability to fund our operations on an ongoing basis, including through equity
financings. Our Nasdaq listing facilitates that ability, as many potential investors or financing sources may be unwilling to consider
an investment in our company on reasonable terms— or at all— if our ordinary shares and warrants were to be delisted from
Nasdaq. Such a delisting would likely reduce the liquidity of our securities and increase volatility in our trading price.
As
of June 30, 2026, our shareholders’ equity was below the requisite $2.5 million level and totaled to $44 thousand. Nevertheless,
as a result of our consummation of our August 2026 Offering in which we raised approximately $2.5 million, and additional equity-increasing
transactions following the second quarter ended June 30, 2026, such as sales under the Company’s at-the-market (ATM) offering program
in an aggregate amount of $0.3 million, and the conversion of $0.8 million outstanding principal amount under the A&R Sponsor Promissory
Note into ordinary shares, we have restored our shareholders’ equity as of June 30, 2026, as adjusted to reflect the foregoing transactions,
above the $2.5 million level as of the date of this quarterly report, to approximately $3.2 million.
While
we believe we have successfully addressed all immediate compliance concerns, we must continue to maintain compliance with all Nasdaq Capital
Market listing standards. There can be no assurance that we will be able to maintain compliance with the shareholders’ equity requirement,
the minimum bid price requirement, or any other applicable standard for continued listing on the Nasdaq Capital Market on an ongoing basis.
Past
Remedy of Nasdaq Listing Deficiencies, Including Via Hearings Process
Our
current compliance with the continued listing requirements of the Nasdaq Capital Market reflects our remediation of deficiencies to which
we had been subject, both recently and also during the earlier stages of our history as a public company following the Business Combination.
Over the course of 2025, we underwent a hearings process with Nasdaq, which together with various remedial actions that we took (including
financing transactions and a reverse share split), restored our compliance with Nasdaq listing rules related to shareholders’ equity
and minimum bid price, thereby enabling us to avoid the delisting of our ordinary shares and public warrants from Nasdaq. As of September
25, 2025, we received confirmation from Nasdaq that we had restored our compliance with each such Nasdaq listing requirement, subject
to an ongoing mandatory panel monitoring period until September 23, 2026. To the extent we are found to once again be out of compliance
with the shareholders’ equity requirement during the monitoring period, we will be subject to an immediate delisting notice, without
entitlement to a cure or compliance period, subject to our right to request a new hearing before a hearings panel in order to prevent
a delisting of our securities from Nasdaq. The threat of an immediate delisting from Nasdaq materialized on May 22, 2025, when we received
a delisting notice from the Nasdaq Listing Qualifications Department in respect of two listing deficiencies that we had been unable to
remedy during the six-month cure period since we had initially been notified of those deficiencies, on November 19, 2024. The deficiencies
related to our failure to maintain (i) a minimum market value of listed securities of $50 million and (ii) a minimum market value of publicly
held shares of $15 million, in each case for continued listing on the Nasdaq Global Market (on which our securities were initially listed
upon completion of the Business Combination). We appealed the delisting notice to a Nasdaq hearings panel, and a hearing was held before
the panel on June 26, 2025. On July 7, 2025, we received a favorable decision from the hearings panel, granting our request to remain
listed on Nasdaq, subject to certain conditions. Pursuant to the favorable outcome, the listings of our ordinary shares and warrants were
transferred from the Nasdaq Global Market to the Nasdaq Capital Market.
4
Under
the terms of the decision reached by the hearings panel, the continued listing of our securities on the Nasdaq Capital Market was conditioned
on our fulfillment of the terms of the compliance plan that we had presented to the panel in connection with the June 26, 2025 hearing.
That plan was designed to enable us to achieve at least $2.5 million of shareholders’ equity and thereby comply with the Equity
Standard for listing on the Nasdaq Capital Market on a continued basis. The terms of the compliance plan required, in primary part, that
on or before September 19, 2025, we demonstrate in a report filed under the Exchange Act our restoration of compliance with, and our expected
long-term compliance with, the shareholders’ equity requirement, as to be demonstrated in a balance sheet not older than 60 days
to be included in such a filing. We demonstrated that restoration of compliance with the shareholders’ equity requirement in our
current report on Form 8-K that we filed with the SEC on September 15, 2025.
In
addition to becoming subject to, and remedying, a Nasdaq shareholders’ equity listing deficiency, we also became subject to, and
subsequently remedied, a Nasdaq minimum bid price deficiency. On July 18, 2025, we received a letter from Nasdaq notifying us that for
the 30 consecutive business days preceding the letter, the closing bid price of our ordinary shares was below the minimum $1.00 per share
bid price required for continued listing on Nasdaq. The letter indicated that the Nasdaq panel would consider the bid price deficiency
in its decision as to whether to enable us to remain listed on the Nasdaq Capital Market. Following shareholder approval at our reconvened
annual general meeting on July 14, 2025, we effected a 1-for-15 reverse share split on July 29, 2025, which raised the price of our ordinary
shares above $1.00, and we maintained a closing price above $1.00 for more than 10 consecutive trading days afterwards, thereby remedying
the minimum bid price deficiency.
As
a result of our remedy of each of the shareholders’ equity and minimum bid price deficiencies, on September 23, 2025, we received
a letter from Nasdaq confirming that we had demonstrated compliance with the requirements related to each such prior deficiency. As described
in that letter, we are subject to a mandatory panel monitoring period until September 23, 2026. If, during that one-year monitoring period,
the Nasdaq staff determines that our company is again out of compliance with the shareholders’ equity requirement, we would not
be permitted to submit a plan of compliance or be granted additional time to regain compliance, nor would we be afforded an applicable
cure or compliance period. Instead, the staff would issue a “Delist Determination Letter,” and we would have the opportunity
to request a new hearing before the same panel from our June 2025 hearing or, if that panel is unavailable, before a newly convened hearings
panel.
Authorized
Share Capital Increases as Support for Financing Activities and Financial Condition
Our
financing activities and our Nasdaq listing compliance are dependent on an ample supply of authorized share capital, which has sometimes
been depleted due to a combination of frequent financing transactions and declines in the price of our ordinary shares (the latter of
which necessitates the issuance of a greater number of shares to successfully complete the former). We have actively replenished our reserve
of ordinary shares twice recently, which under Cayman law and our amended and restated articles of association requires the approval of
our shareholders to an effective amendment to our memorandum of association. At extraordinary general meetings originally held on April
28, 2026 and (subsequent to the quarterly period covered by this quarterly report) July 13, 2026, which were reconvened on May 5, 2026
and July 20, 2026, respectively (the “May 2026 extraordinary general meeting” and “July 2026 extraordinary general meeting”,
respectively), our shareholders approved increases to our authorized share capital.
5
The
approval at the May 2026 extraordinary general meeting resulted in an increase in our authorized share capital from $121,500, divided
into 900,000 ordinary shares with a par value of $0.135 each, to $796,500, divided into 5,900,000 ordinary shares with a par value of
$0.135 each. The approval at the July 2026 extraordinary general meeting resulted in a further increase to our authorized share capital
from $796,500, divided into 5,900,000 ordinary shares of a par value of $0.135 each, to $2,146,500, divided into 15,900,000 ordinary shares
of a par value of $0.135 each.
These
increases have provided us with additional capacity to issue equity securities pursuant to financing transactions and other equity-enhancing
arrangements, including our May 2026 induced warrant exercise transaction, our August 2026 public offering, and our ongoing sales of ordinary
shares under the ATM program, which gained traction in the months of May, June, July and August 2026, thereby enhancing our ability to
maintain compliance with the Nasdaq minimum shareholders’ equity requirement.
Reverse
Share Splits as Support for Financing Activities and Financial Condition
In
addition to the increases to our authorized share capital, we have employed (both recently—in the second quarter of 2026—
and previously) other means to support our ability to finance our operations and maintain compliance with Nasdaq listing requirements.
Our completion of a 1-for-10 reverse share split in May 2026 proactively bolstered the trading market for our ordinary shares by proportionately
increasing (initially) the trading price of our shares. That increase has enhanced the attractiveness of our ordinary shares to a larger
pool of potential investors who would not invest in a company with a share price slightly above or below $1.00, while also supporting
our compliance with the Nasdaq minimum bid price requirement (which requires the trading price of our ordinary shares to close at or above
$1.00 on an ongoing basis). As with the increases to our authorized share capital, the 1-for-10 reverse share split required, under Cayman
Islands law and our articles of association, the approval of our shareholders (and, subsequently, implementation by our board of directors).
Our shareholders approved that reverse share split at the May 2026 extraordinary general meeting, following which our board of directors
effected the 1-for-10 reverse share split of all issued and outstanding, and authorized but unissued, ordinary shares after the close
of business on May 28, 2026. Our ordinary shares began trading on a reverse split-adjusted basis on the Nasdaq Capital Market under the
existing ticker symbol “SLXN” at the market open on May 29, 2026. As a result of the reverse share split, our authorized share
capital remained at the time at $796,500 (prior to our July 2026 increase), but was adjusted, at the time, to consist of 5,900,000 ordinary
shares with a par value of $0.135 per share instead of 59,000,000 ordinary shares with a par value of $0.0135 per share.
As
described above (under “ Overview of Nasdaq Listing Compliance — Past
Remedy of Nasdaq Listing Deficiencies, Including Via Hearings Process ”), previously, in July 2025 (as well as, at a time
that predated the three-month and six-month periods in 2026 and 2025 covered by this quarterly report, in November 2024), we had effected
a reverse share split to achieve the same objectives— support for our financing activities and maintenance of our compliance with
the $1.00 minimum bid price requirement of Nasdaq. That prior reverse share split was effected on July 28, 2025 at a ratio of 1-for-15
(and, during a period preceding the periods covered by this quarterly report, on November 27, 2024 at a ratio of 1-for-9), and was reflected
in the market price of the ordinary shares pre-market on July 29, 2025 (and November 29, 2024), after having been approved by our shareholders
at an extraordinary general meeting held (following adjournment) on July 14, 2025 (and November 19, 2024).
Because
of our reverse share split on May 28, 2026, if our share price were to close below $1.00 for 30 consecutive trading days prior to the
end of the one-year period following that reverse share split (i.e., prior to May 29, 2027), we would be subject to immediate delisting
proceedings, subject to our ability to appeal any delisting determination to a Nasdaq hearings panel.
6
Components
of our Results of Operations
Operating
Expenses
Research
and Development Expenses
Research
and development expenses include costs directly attributable to the conduct of research and development programs, and consist primarily
of the cost of payroll and related expenses, payroll taxes and other employee benefits including share-based compensation related to employees,
subcontractors costs, preclinical and clinical trials costs and consulting fees.
We
expect to continue to invest in research and development to develop SIL204, including, subject to our financial capacity, hiring additional
employees and continuing the research and development of that product candidate. As a result, we expect that our research and development
expenses will continue to increase in the future.
General
and Administrative Expenses
General
and administrative expenses consist primarily of personnel costs, including share-based compensation related to directors and employees,
patent application fees, office space rental costs, and maintenance expenses, external professional service costs, including legal, accounting,
audit, insurance, human resource services, travel expenses and other consulting fees.
Our
general and administrative expenses have increased, and we expect that— subject to our financial capacity— they will continue
to increase in the future, as we fund our continued research and development activities, primarily due to increased headcount to support
anticipated growth in the business and due to incremental costs associated with operating as a public company, including costs to comply
with the rules and regulations applicable to public companies, such as costs related to compliance and reporting obligations pursuant
to the rules and regulations of the SEC and Nasdaq listing standards, investor relations, insurance and professional services.
Financial
expenses, net
Finance
expenses consist primarily of changes in fair value of financial liabilities measured at fair value, interest expenses (income), and exchange
rate differences expenses.
Results
of Operations
We
are providing within this section a discussion and analysis of our historical statement of operations data in accordance with accounting
principles generally accepted in the United States of America (“ GAAP ”). Our financial
statements included elsewhere in this quarterly report, as well as the financial data and related discussion and analysis contained in
this MD&A, relate to our financial condition and results of operations as of, and for the three-month and six-month periods ended,
June 30, 2026, as compared to the corresponding information as of, and for the three-month and six-month periods ended, June 30, 2025.
7
Comparison
of six-month periods ended June 30, 2026 and 2025
The
following table summarizes our results of operations for the six-month periods ended June 30, 2026 and 2025:
Six-month
period ended
June
30,
2026
2025
(U.S.
dollars, in thousands)
Operating
expenses:
Research and development
$
3,582
$
1,608
General and administrative
2,847
2,326
Total operating expenses
6,429
3,934
Operating
loss
6,429
3,934
Financial expenses (income),
net
(145
)
301
Loss
before income tax
6,284
4,235
Income tax
*
3
Net
loss
$
6,284
$
4,238
* Represents
an amount less than $1
Research
and Development Expenses
The
following table summarizes our research and development expenses for the six-month periods ended June 30, 2026 and 2025:
Six-month
period ended
June
30,
2026
2025
(U.S.
dollars, in thousands)
Payroll and related expenses
$
774
$
854
Share-based compensation
expenses
230
-
Subcontractors and consultants
2,429
598
Rent and maintenance
106
95
Other
43
61
Total research and development
expenses
$
3,582
$
1,608
Research
and development expenses increased by approximately $2.0 million, or 125.0%, to $3.6 million for the six-month period ended June 30, 2026,
compared to $1.6 million for the six-month period ended June 30, 2025. The increase resulted mainly from an increase in subcontractors’
and consultants’ expenses in an aggregate amount of $1.8 million, reflecting our operational ramp-up and preparations, required
to support the initiation of our Phase 2/3 human clinical trial, which was initiated in July 2026. These expenses primarily arose from
toxicology studies costs, product development costs, GMP manufacturing costs of our product candidate, regulatory approval expenses,
and contract research organization (“CRO”) setup costs.
General
and Administrative Expenses
The
following table summarizes our general and administrative expenses for the six-month periods ended June 30, 2026 and 2025:
Six-month
period ended
June
30,
2026
2025
(U.S.
dollars, in thousands)
Payroll and related expenses
$
661
$
739
Share-based compensation
expenses
312
58
Professional service
1,571
1,111
Depreciation
5
7
Rent and maintenance
94
85
Patent registration
10
51
Travel expenses
37
91
Other
157
184
Total general and administrative
expenses
$
2,847
$
2,326
8
General
and administrative expenses increased by approximately $0.5 million, or 21.7%, to $2.8 million for the six-month period ended June 30,
2026, compared to $2.3 million for the six-month period ended June 30, 2025. The increase resulted mainly from an increase in professional
services costs in an amount of $0.5 million, primarily related to legal, consultants, and other expenses associated with the costs of
operating as a public company.
Financial
expenses, net
Financial
expenses (income), net decreased by approximately $0.4 million, to $(0.1) million of financial income for the six-month period ended June
30, 2026, compared to $0.3 million of financial expenses for the six-month period ended June 30, 2025. The decrease was mainly due to
the revaluation of financial instruments (mainly promissory notes).
Net
loss
Net
loss increased by approximately $2.1 million, or 50.0%, to $6.3 million for the six-month period ended June 30, 2026, compared to $4.2
million for the six-month period ended June 30, 2025. The increase was mainly due to an increase in our research and development expenses
(mainly related to preparations for the human clinical trial, initiated in July 2026) and an increase to our general and administrative
expenses. This increase was partly offset by a decrease in financial expenses, net, due to the revaluation of financial instruments.
Comparison
of three-month periods ended June 30, 2026 and 2025
The
following table summarizes our results of operations for the three-month periods ended June 30, 2026 and 2025:
Three-month
period ended
June
30,
2026
2025
(U.S.
dollars, in thousands)
Operating
expenses:
Research and development
$
2,212
$
1,018
General and administrative
1,468
1,266
Total operating expenses
3,680
2,284
Operating
loss
3,680
2,284
Financial expenses (income),
net
(129
)
216
Loss
before income tax
3,551
2,500
Income tax
*
3
Net
loss
$
3,551
$
2,503
* Represents
an amount less than $1
9
Research
and Development Expenses
The
following table summarizes our research and development expenses for the three-month periods ended June 30, 2026 and 2025:
Three-month
period ended
June
30,
2026
2025
(U.S.
dollars, in thousands)
Payroll and related expenses
$
511
$
485
Share-based compensation
expenses
100
-
Subcontractors and consultants
1,538
442
Rent and maintenance
51
55
Other
12
36
Total research and development
expenses
$
2,212
$
1,018
Research
and development expenses increased by approximately $1.2 million, or 120%, to $2.2 million for the three-month period ended June 30, 2026,
compared to $1.0 million for the three-month period ended June 30, 2025. The increase resulted mainly from an increase in subcontractors’
and consultants’ expenses in an aggregate amount of $1.1 million reflecting our operational ramp-up and preparations, required to
support the initiation of our Phase 2/3 human clinical trial, which was initiated in July 2026. These expenses primarily arose from toxicology
studies costs, product development costs, GMP manufacturing costs of our product candidate, regulatory approval expenses and CRO setup
costs.
General
and Administrative Expenses
The
following table summarizes our general and administrative expenses for the three-month periods ended June 30, 2026 and 2025:
Three-month
period ended
June
30,
2026
2025
(U.S.
dollars, in thousands)
Payroll and related expenses
$
420
$
407
Share-based compensation
expenses
97
37
Professional service
788
586
Depreciation
3
3
Rent and maintenance
45
55
Patent registration
2
47
Travel expenses
37
37
Other
76
94
Total general and administrative
expenses
$
1,468
$
1,266
General
and administrative expenses increased by approximately $0.2 million, or 15.4%, to $1.5 million for the three-month period ended June 30,
2026, compared to $1.3 million for the three-month period ended June 30, 2025. The increase resulted mainly from an increase in professional
services costs in an amount of $0.2 million, primarily related to consultants, and other expenses associated with the costs of operating
as a public company.
Financial
expenses, net
Financial
expenses (income), net decreased by approximately $0.3 million, to $(0.1) million of financial income, net, for the three-month period
ended June 30, 2026, compared to $0.2 million of financial expenses, net, for the three-month period ended June 30, 2025. The decrease
was mainly due to the revaluation of financial instruments (mainly promissory notes).
Net
loss
Net
loss increased by approximately $1.1 million, or 44.0%, to $3.6 million for the three-month period ended June 30, 2026, compared to $2.5
million for the three-month period ended June 30, 2025. The increase was mainly due to an increase in our research and development expenses
mainly related to preparations for the human clinical trial initiated in July 2026, and general and administrative expenses. This increase
was partly offset by a decrease in financial expenses, net, due to the revaluation of financial instruments.
10
Liquidity
and Capital Resources
Overview
Our
capital requirements depend on many factors, including the scale and pace at which our Phase 2/3 clinical trials with respect to SIL204
proceed, and the timing and extent of spending to support any and all of the following: further development of SIL204 (if and as necessary);
further research and development efforts; investments in potential additional pipeline products; and (to the extent our financial resources
enable) increased overall compensation as we continue to hire additional personnel. For the six months and three months ended June 30,
2026, we had net losses of $6.3 million and $3.6 million, respectively. As of June 30, 2026, our cash and cash equivalents totaled $2.2
million.
To
date, our principal sources of liquidity have evolved together with our progression as a company. As a private company, we (i.e., Silexion
Israel) raised proceeds from private offerings of our ordinary shares and convertible preferred shares, grants from the Israeli Innovation
Authority, issuance of convertible financing agreements (CFA), and SAFE financings. Upon the Closing of the Business Combination, we raised
$2.0 million from a PIPE in which Greenstar, LP, an affiliate of the Moringa sponsor, purchased Moringa ordinary shares that converted
automatically into Silexion ordinary shares, and we put into place an ELOC, under which we raised an aggregate of $3.1 million (all of
which was raised during the year ended December 31, 2024). Following the Closing, as a public company with ordinary shares and warrants
registered under the Exchange Act and trading on Nasdaq, we have obtained financings in various manners, primarily the following, which
are described in greater detail below:
•
registered public offerings
of ordinary shares and pre-funded warrants, along with ordinary warrants, in January 2025, September 2025 and August
2026 (as described below under “ Public
Offerings via H.C. Wainwright”) ;
•
induced warrant exercise
transactions, which were completed in January 2025, August 2025, and May 2026 (as described below under “ Induced
Warrant Exercise Transactions”);
•
additional warrant exercises,
such as in connection with the January 2025 and September 2025 public offerings, when investors exercised following the closing of those
offerings ordinary warrants and Series B ordinary warrants issued in those respective offerings, yielding $0.9 million and $1.78 million
of gross proceeds, respectively; and
•
ongoing financings via
the ATM Agreement, under which we have raised approximately $0.08 million and $1.9 million during the first and second quarters of 2026,
respectively (net of fees and issuance costs), and an additional $0.3 million (net of sales agent fees) following the end of the second
quarter of 2026 up until the filing date of this quarterly report.
We
furthermore anticipate additional ongoing financings via the ATM pursuant to the ATM Agreement with H.C. Wainwright, which provides for
the potential sale of up to $13.17 million of our ordinary shares under our shelf registration statement on Form S-3, of which approximately
$10.9 million remains available for future sales of ordinary shares as of the filing date of this quarterly report.
Based
on our current business plan, we believe our current cash and cash equivalents, and anticipated cash flow from operations, will not be
sufficient to meet our anticipated cash requirements for the next 12 months from the filing date of this quarterly report, but rather
through the fourth quarter of 2026 under our current business plan,. We will need to raise additional capital to finance our operations,
expand our business and pipeline, maintain our compliance with the Nasdaq shareholders’ equity requirement, or for other reasons.
Assumption
Regarding Going Concern
Note
1(e) to our unaudited consolidated financial statements for the three-month and six-month periods ended June 30, 2026 included in this
quarterly report and Note 1(e) to our audited consolidated financial statements for the year ended December 31, 2025 included in the 2025
annual report describe the substantial doubt about our ability to continue as a going concern as of those respective dates. Additionally,
in its report accompanying our audited consolidated financial statements included in the 2025 annual report, our independent registered
public accounting firm included an explanatory paragraph stating that our recurring losses from operations and our cash outflows from
operating activities raise substantial doubt as to our ability to continue as a going concern. That means that our management and independent
registered public accounting firm have expressed substantial doubt about our ability to continue our operations without an additional
infusion of capital from external sources. Our unaudited consolidated financial statements included herein have been prepared on a going
concern basis and do not include any adjustments that may be necessary should we be unable to continue as a going concern. If we are unable
to finance our operations, our business would be in jeopardy and we might not be able to continue operations and might have to liquidate
our assets. In that case, investors might receive less than the value at which those assets are carried on our consolidated balance sheets
as of June 30, 2026, and it is likely that investors would lose part or all of their investment in our company.
11
Contractual
Obligations; Off-Balance sheet Arrangements
We
have lease obligations and other contractual obligations and commitments as part of our ordinary course of business. See “ Note
5— Leases ” and “ Note 7— Commitments and Contingent Liabilities”
to our consolidated financial statements for the year ended December 31, 2025 included in our 2025 annual report for information about
our lease obligations.
We
did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements involving commitments or obligations,
including contingent obligations, arising from arrangements with unconsolidated entities or persons that have or are reasonably likely
to have a material current or future effect on our financial condition, results of operations, liquidity, cash requirements or capital
resources.
Public
Offerings via H.C. Wainwright
On
January 15, 2025 and January 17, 2025, and again on September 11, 2025 and September 12, 2025 , and on August 11, 2026 and
August 13, 2026, we priced and closed, respectively,
registered public offerings in which we offered and sold, on a best efforts basis, ordinary shares, pre-funded warrants and ordinary warrants,
with H.C. Wainwright as the sole placement agent (the “ January 2025 Offering ”, “ September 2025 Offering” ,
and “August 2026 Offering ”
collectively , the “ HCW Offerings ”):
•
in the January 2025 Offering,
(i) 14,309 ordinary shares, (ii) 10,386 pre-funded warrants to purchase up to 10,386 ordinary shares and (iii) 24,695 ordinary warrants
to purchase up to 24,695 ordinary shares, at purchase prices of $202.50 per ordinary share and accompanying ordinary warrant, and $202.50
per pre-funded warrant and accompanying ordinary warrant;
•
in the September 2025
Offering, (i) 139,225 ordinary shares, (ii) 10,775 pre-funded warrants to purchase up to 10,775 ordinary shares, (iii) 150,000 Series
A ordinary warrants, each to purchase one ordinary share, and (iv) 150,000 Series B ordinary warrants, each to purchase one ordinary share
(the Series A ordinary warrants and Series B ordinary warrants are collectively referred to as “ ordinary
warrants ”), at a purchase price of $40.00 per share and accompanying two ordinary warrants, and $39.99 per pre-funded warrant
and accompanying two ordinary warrants.
•
in the August 2026 Offering, (i)
2,028,619 ordinary shares, (ii) 1,817,542 pre-funded warrants to purchase up to 1,817,542 ordinary shares and (iii) 3,846,161 Series E
ordinary warrants to purchase up to 3,846,161 ordinary shares, at purchase prices of $0.65 per ordinary share and accompanying Series
E ordinary warrant, and $0.6499 per pre-funded warrant and accompanying Series E ordinary warrant;
Aggregate
gross proceeds from the January 2025 Offering, September 2025 Offering and August 2026 Offering
(without taking into account any proceeds from any future exercises of warrants) were approximately $5.0 million, $6.0 million, and $2.5
million, respectively.
The
pre-funded warrants from the HCW Offerings were immediately exercisable at exercise prices of $0.015, $0.001, and $0.0001 per ordinary
share, for the January 2025 Offering, September 2025 Offering, and August 2026 Offering, respectively, and did not expire until exercised
in full. The ordinary warrants from the January 2025 Offering, September 2025 Offering and August 2026 Offering had exercise prices of
$202.50, $40.00 and $0.65 per underlying ordinary share, respectively, and were immediately exercisable. The ordinary warrants from the
January 2025 Offering, Series A ordinary warrants from the September 2025 Offering, and Series E ordinary warrants from the August 2026
Offering could be exercised for five years from issuance, while the Series B ordinary warrants from the September 2025 Offering could
be exercised for a period of 12 months from issuance.
12
Holders
of the pre-funded and ordinary warrants do not have the right to exercise any portion of the warrants if the holder (together with parties
whose beneficial ownership of ordinary shares would be aggregated with the holder’s) would beneficially own ordinary shares in excess
of 4.99% (or, at the election of the holder, 9.99%) of the outstanding ordinary shares following exercise.
Certain
investors in the HCW Offerings entered into definitive securities purchase agreements with us, under which we agreed to abide by certain
customary standstill restrictions for periods of 60 days following the closing of those offerings (in the case of the August 2026 Offering,
a period of 30 days only). In addition, subject to limited exceptions, the agreements provided that for a period of one year following
the closing of the respective HCW Offerings, we will not effect or enter into an agreement to effect a “variable rate transaction”,
as defined in the agreements.
In
accordance with our engagement agreement with H.C. Wainwright, we paid to H.C. Wainwright aggregate cash placement agent fees equal to
7.0% of the gross proceeds received by us in the HCW Offerings, as well as management fees equal to 1.0% of the gross proceeds raised
in the HCW Offerings. We also reimbursed H.C. Wainwright for certain of its expenses in connection with the offerings. Pursuant to the
engagement agreement, we also issued to H.C. Wainwright (or its designees) 1,729, 10,500 and 269,231 placement agent warrants to purchase
up to 1,729, 10,500 and 269,231 ordinary shares, respectively, in the three HCW Offerings, representing 7.0% of the sum of the shares
and pre-funded warrants sold in the offerings. Those placement agent warrants have exercise prices of $253.13, $50.00 and $0.8125, respectively,
per ordinary share (representing 125% of the public offering price per ordinary share and accompanying ordinary warrant(s) in the respective
offerings), are exercisable for five years from the date of the commencement of sales in the HCW Offerings, and otherwise reflect substantially
the same terms as the ordinary warrants sold in the HCW Offerings.
The
net proceeds to us from the HCW Offerings were approximately $4.25 million, $5.20 million and $2.1 million, before deducting estimated
offering expenses payable by us. We have used and will continue to use the proceeds from the HCW Offerings to advance our pre-clinical
and clinical studies, and for general corporate purposes.
Induced
Warrant Exercise Transactions
On
January 29, 2025, July 31, 2025, and May 15, 2026, we entered into inducement offer letter agreements with holders of 14,810, 15,211,
and 199,510, respectively, of our existing ordinary warrants. Those warrants had been issued in the January 2025 Offering, the January
2025 induced warrant exercise transaction, the July 31/August 1, 2025 induced warrant exercise transaction, and the September 2025 Offering.
Under the warrant inducement offer letter agreements, on January 30, 2025, August 1, 2025, and May 18, 2026, the holders exercised those
warrants for cash and purchased 14,810, 15,211, and 199,510 ordinary shares, respectively, at cash exercise prices of $202.50, $115.70
and $5.00 per share, respectively, and in consideration of our issuance to them of new ordinary warrants to purchase up to an aggregate
of 14,810, 30,422, and 399,020 ordinary shares, respectively, at exercise prices of $225.00, $113.20, and $5.00, respectively, per share.
In the January 2025 induced warrant exercise transaction, the exercising holders also paid us an additional $18.80 per new ordinary warrant
issued to them. We received aggregate gross proceeds of approximately $3.3 million, $1.8 million, and $1.0 million from the exercise of
the existing warrants by the holders in January 2025, August 2025, and May 2026, respectively, before deducting placement agent fees and
other offering expenses payable by us.
We
engaged H.C. Wainwright to act as our exclusive placement agent in connection with the transactions contemplated by the inducement letters
and paid H.C. Wainwright cash fees equal to 7.0% of the aggregate gross proceeds received from the holders’ exercise of their existing
ordinary warrants, as well as management fees equal to 1.0% of the gross proceeds from the exercise of those warrants. We also issued
to H.C. Wainwright or its designees placement agent warrants to purchase up to 1,037, 1,065, and 13,966 ordinary shares, respectively
(representing 7.0% of the existing ordinary warrants that were exercised in the respective transactions), which have the same terms as
the new warrants issued in the transactions, except that the placement agent warrants have exercise prices equal to $276.60 per share,
$144.60, and $5.00 per share, respectively (125% of (i) the sum of the exercise price of the existing warrants exercised, and the additional
$18.80 paid per new ordinary warrant, in the January 2025 transaction, (ii) the $115.70 exercise price of the existing warrants exercised,
in the August 2025 transaction, and (iii) the $5.00 exercise price of the existing warrants exercised, in the May 2026 transaction).
13
Similar
to the new ordinary warrants issued to investors in these transactions, the placement agent warrants became exercisable either immediately
from the date of issuance (in the case of the January 2025 warrant exercise transactions), upon approval by our shareholders of an increase
in our authorized share capital, which occurred on August 19, 2025 at our reconvened extraordinary general meeting (in the case of the
August 2025 induced warrant exercise transaction), or upon approval by our shareholders of the exercisability of the new ordinary warrants
and placement agent warrants, which occurred on July 20, 2026 at our reconvened extraordinary general meeting (in the case of the May
2026 induced warrant exercise transaction). All new warrants and placement agent warrants issued in these transactions remain exercisable
until the 24-month anniversary of the effective date of the resale registration statements filed to cover the resale of shares underlying
the new warrants and placement agent warrants (except for the new ordinary warrants issued in the May 2026 induced warrant exercise transaction,
of which 204,500 warrants, along with all placement agent warrants, have an exercise period of five years and 194,520 warrants have an
exercise period of 24 months (in each case, from the later of the initial exercise date and the effective date of the resale registration
statement). We also paid certain fees and expenses in connection with the induced warrant exercise transactions.
Upon
exercise for cash of any new warrants issued to investors in the transactions, in certain circumstances, we will (i) pay to H.C. Wainwright
a cash fee of 7.0% of the aggregate gross exercise price, and a cash management fee of 1.0% of the aggregate gross exercise price, and
(ii) issue to H.C. Wainwright warrants representing 7.0% of the ordinary shares issued to the investors upon such cash exercise of the
new warrants.
We
have been using the net proceeds from these transactions for general corporate purposes, R&D activities, and (in the case of the May
2026 induced warrant exercise transaction) to support our Phase 2/3 clinical trial for SIL204 that was initiated in July 2026.
Other
Warrant Exercises
In
addition to induced warrant exercise transactions, we have also raised funds via additional exercises of ordinary warrants. On January
30, 2025, in connection with the closing of the January 2025 Offering, investors exercised an aggregate of 4,268 ordinary warrants issued
in that offering and we issued 4,270 underlying ordinary shares. The gross proceeds to our company from those warrant exercises was $0.9
million. On September 12, 2025, in connection with the closing of the September 2025 Offering, investors exercised an aggregate of 44,500
Series B ordinary warrants issued in that offering and we issued 44,500 underlying ordinary shares. The gross proceeds to our company
from those warrant exercises was $1.78 million.
At-The-Market
Offering Agreement
We
have been raising additional capital on an ongoing basis under our ATM program. On September 26, 2025, we entered into the ATM Agreement
with H.C. Wainwright, as sales agent or principal, providing for the offer and sale from time to time of up to $13.17 million of our ordinary
shares under the ATM, which ATM offering was registered under our shelf registration statement on Form S-3. No sales were made under the
ATM Agreement during the third or fourth quarters of 2025, in part due to (i) customary standstill restrictions on subsequent offerings
imposed upon us in connection with our September 2025 public offering, and (ii) low trading volumes for our ordinary shares, which made
our use of the ATM impractical. During the second quarter and first quarter of 2026, we raised approximately $1.9 million and $0.08 million
(net of sales agent fees and issuance costs), respectively, in the aggregate, from the sale of 443,671 ordinary shares and 6,408 ordinary
shares, respectively under the ATM, reflecting average sales prices per share of $13.4 and $4.71, respectively, during those periods. Subsequent
to the end of the second quarter of 2026 (up until the date of this quarterly report), we have furthermore raised an additional $0.3 million
(net of sales agent fees), in the aggregate, from the sale of 130,249 ordinary shares under the ATM, reflecting an average sales prices
per share of $2.1. As of the date of this quarterly report, approximately $10.9 million remains available for future sales of ordinary
shares by us under the ATM program.
14
Issuance
of, and Conversions Under, A&R Sponsor Promissory Note
Effective
as of the Closing, we issued to the Moringa sponsor, and the Moringa sponsor accepted, in amendment and restatement, and replacement,
in their entirety, of all existing promissory notes issued by Moringa to the Moringa sponsor from Moringa’s initial public offering
until the Closing (and as to which the obligations of Moringa were assigned to Silexion upon the Closing), the A&R Sponsor Promissory
Note in an amount of $3.433 million, which reflected the total amount owed by Moringa to the sponsor through the Closing Date. The maturity
date of the A&R Sponsor Promissory Note is the 30-month anniversary of the Closing Date (i.e., February 15, 2027).
Amounts
outstanding under the A&R Sponsor Promissory Note may be repaid (unless otherwise decided by us) only by way of conversion into ordinary
shares in accordance with the terms set forth in the form of A&R Sponsor Promissory Note. Each of Silexion and the Moringa sponsor
may also convert amounts outstanding under the A&R Sponsor Promissory Note at the price per share at which we conduct equity financings
following the Closing, subject to a minimum conversion amount of $100,000, in an amount of ordinary shares constituting up to thirty percent
(30%) of the number of ordinary shares issued and sold by us in such equity financing. The sponsor may also elect to convert amounts of
principal outstanding under the note into ordinary shares at any time following the 24-month anniversary of the date of the Closing, subject
to a minimum conversion of $10,000, at a price per share equal to the volume weighted average price of the ordinary shares on the principal
market on which they are traded during the 20 consecutive trading days prior to the conversion date.
On
September 15, 2025, in connection with the September 2025 Offering, we converted $1.8 million of principal outstanding under
the A&R Sponsor Promissory Note into 45,000 ordinary shares that we issued to the Moringa sponsor. During the second quarter ended
June 30, 2026, we converted an aggregate of $0.6 million of the outstanding principal amount under the A&R Sponsor Promissory Note
into 153,320 ordinary shares that we issued to the Moringa sponsor, which conversions were effected in connection with the May 2026 induced
warrant exercise transaction and sales of ordinary shares under our ATM program. In the period subsequent to June 30, 2026 up until the
date of this quarterly report, we have furthermore converted an additional $0.1 million and $0.75 million of the principal amount of the
A&R Sponsor Promissory Note into 38,926 ordinary shares and 1,153,848 ordinary shares that we have issued to the Moringa sponsor,
which conversions have been effected in connection with sales of ordinary shares under our ATM facility and the closing of the August
2026 Offering, respectively. As of the date of this quarterly report, an aggregate of approximately $0.2 million remains outstanding under
the A&R Sponsor Promissory Note
The
Moringa sponsor (which is controlled by our former director, Ilan Levin) has notified us that it disputes the conversions into ordinary
shares under the terms of the A&R Sponsor Promissory Note and has filed a claim against us demanding repayment of the note in full.
We believe that the conversions were carried out in strict compliance with the substantive and procedural requirements of the note, and
reject any claim to the contrary. Please see “ Part II— Other Information, Item 1— Legal
Proceedings ” in this quarterly report for more information.
Settlement
of Amounts Due Under Marketing Agreement with EarlyBird
Prior
to the Closing of the Business Combination, Moringa reached agreement with EarlyBirdCapital, Inc., the representative of the underwriters
of Moringa’s initial public offering (“EarlyBird ” or “ EBC ”)
on the reduction, to $1.6 million, in the aggregate, of the fee payable to EBC under the Business Combination Marketing Agreement, dated
February 16, 2021, entered into by Moringa with EarlyBird in connection with Moringa’s initial public offering (the “ Marketing
Agreement ”). Pursuant to the final invoice provided by EBC under the Marketing Agreement, at the Closing, Moringa paid $350,000
of cash to EBC from Moringa’s trust account (in which remaining proceeds from Moringa’s IPO had been maintained), and we issued
to EBC a convertible note (the “ EarlyBird Convertible Note ”), which was a convertible
promissory note, due December 31, 2025, in an amount of $1.25 million to be paid by us to EBC in cash and/or via conversion of outstanding
amounts into ordinary shares.
The
EarlyBird Convertible Note bore interest at a rate of 6% per annum and by its terms was to mature on December 31, 2025. Through January
31, 2025, we made aggregate payments of $407,556 to EBC in respect of some of the amounts due from us under the EarlyBird Convertible
Note as a result of amounts raised by us under the ELOC and the January 2025 Offering.
15
On
March 13, 2025, we entered into a letter agreement with EBC, pursuant to which we paid to EBC an additional amount of $400,000 (plus $15,000
for EBC’s legal expenses) (the “ Settlement Prepayment Amount ”) and EBC agreed
to the partial conversion and retirement of all remaining amounts due under the EarlyBird Convertible Note. Under that letter agreement,
EBC agreed that the $880,202 principal and interest amount outstanding under the note as of the date of the letter agreement (the “ Outstanding
Amount ”) would be retired in consideration of: (i) our payment in cash of the Settlement Prepayment Amount; (ii) EBC’s
conversion of a certain amount of the principal and interest due under the EarlyBird Convertible Note (the “ Conversion
Amount ”) via the issuance by us to EBC of 1,852 ordinary shares (the “ EBC Settlement
Shares ”), which Conversion Amount would equal the net proceeds to be received by EBC from the sale of the EBC Settlement
Shares; and (iii) the payment in cash by us to EBC of any remaining amount due under the EarlyBird Convertible Note after deducting the
Settlement Prepayment Amount and the Conversion Amount from the Outstanding Amount (the “ Remaining
Amount ”). The resale by EBC of the EBC Settlement Shares was registered under our effective registration statement on Form
S-1 (SEC file number 333-282556) as required by the EarlyBird Convertible Note.
On
March 17, 2025, EBC sold all 1,852 EBC Settlement Shares under the foregoing Form S-1 registration statement for a Conversion Amount of
$344,204, and on March 18, 2025, we paid the Remaining Amount of $135,998 that was due to EBC, resulting in the retirement of the EarlyBird
Convertible Note on March 18, 2025.
Government
Grants
Our
research and development efforts have been financed, in part, through royalty-bearing grants from the Israeli Innovation Authority (the
“ IIA ”). As of June 30, 2026, we had received IIA royalty-bearing grants totaling approximately
$5.8 million (all of which was received from grants prior to the Closing of the Business Combination).
We
are committed to pay royalties to the IIA at a rate of approximately 3.0% to 5.0% of the sales of all of our product candidates and other
related revenues generated from such projects, that were developed, in whole or in part, using the IIA royalty-bearing grants we received
under IIA programs up to the total amount of royalty-bearing grants received, linked to the U.S. dollar and bearing annual interest at
rates prescribed by the IIA’s rules and guidelines.
We
may in the future apply to receive additional grants from the IIA. However, we cannot predict whether we will be entitled to any future
grants, or the amounts of any such grants.
Under
the Israeli Innovation Law, research and development programs that meet specified criteria and are approved by a committee of the IIA
are eligible for grants. A company that receives a royalty-bearing grant from the IIA is typically required to pay royalties to the IIA
on income generated from products incorporating IIA-funded know-how (including income derived from services associated with such products
and from IIA-funded know-how), up to 100% of the U.S. dollar-linked royalty-bearing grant amount plus interest.
The
obligation to pay royalties is contingent on actual income generated from such products and services. In the absence of such income, no
payment of royalties is required.
As
of June 30, 2026, the total royalty amount that may be payable by our company is approximately $5.8 million ($6.8 million, including interest).
16
Cash
Flows
Cash
flows for the six-month periods ended June 30, 2026 and 2025
The
following table summarizes our cash flows for the six-month periods ended June 30, 2026 and 2025:
Six-month
period ended
June
30,
2026
2025
(U.S.
dollars, in thousands)
Cash
and cash equivalents and restricted cash at beginning of the period
$
6,075
$
1,270
Net cash used in operating
activities
(6,571
)
(4,960
)
Net cash used in investing
activities
(1
)
(7
)
Net cash provided by
financing activities
2,823
7,237
Net
decrease in cash and cash equivalents and restricted cash
$
(3,749
)
$
2,270
Translation
adjustments on cash and cash equivalents and restricted cash
(6
)
4
Cash
and cash equivalents and restricted cash at end of the period
$
2,320
$
3,544
Cash
Used in Operating Activities
Net
cash used in operating activities increased by approximately $1.6 million, or 32%, to $6.6 million for the six-month period ended June
30, 2026, compared to $5.0 million for the six-month period ended June 30, 2025. This increase was mainly due to a higher volume of invoices
received and a corresponding increase in accounts payable and accrued liabilities related to clinical trial activities, reflecting the
Company's operational ramp-up and preparations for the commencement of its Phase 2/3 human clinical trial, which was initiated in July
2026.
Cash
Provided by Financing Activities
Net
cash provided by financing activities decreased by approximately $4.4 million, or 61.1%, to approximately $2.8 million for the six-month
period ended June 30, 2026, compared to $7.2 million for the six-month period ended June 30, 2025. This decrease was mainly due to our
having raised approximately $1.9 million (net of sales agent fees and issuance costs) of cash under the ATM and approximately $0.8 million
(net of issuance costs) from the May 2026 induced warrant exercise transaction in the six-month period ended June 30, 2026, as opposed
to our having raised cash proceeds of (i) $5.0 million (offset in part by $0.7 million of issuance costs) in the January 2025 Offering,
(ii) $0.9 million from the exercise of warrants in connection with the January 2025 Offering, and (iii) $3.3 million from the January
2025 induced warrant exercise transaction (offset in part by $0.4 million of transaction expenses), as described above under “ Public
Offerings via H.C. Wainwright ”, “ Other Warrant Exercises ” and “ Induced
Warrant Exercise Transactions ”, respectively, in this “ Liquidity and Capital Resources ”
section, offset in part by $0.7 million of cash payments (the Settlement Prepayment Amount and the Remaining Amount) that we made under
the EarlyBird Convertible Note, in the six-month period ended June 30, 2025.
17
Cash
flows for the three-month periods ended June 30, 2026 and 2025
The
following table summarizes our cash flows for the three-month periods ended June 30, 2026 and 2025:
Three-month
period ended
June
30,
2026
2025
(U.S.
dollars, in thousands)
Cash
and cash equivalents and restricted cash at beginning of the period
$
2,498
$
6,233
Net cash used in operating
activities
(2,925
)
(2,507
)
Net cash used in investing
activities
(1
)
(1
)
Net cash provided by
(used in) financing activities
2,740
(195
)
Net
increase (decrease) in cash and cash equivalents and restricted cash
$
(186
)
$
(2,703
)
Translation
adjustments on cash and cash equivalents and restricted cash
8
14
Cash
and cash equivalents and restricted cash at end of the period
$
2,320
$
3,544
Cash
Used in Operating Activities
Net
cash used in operating activities increased by approximately $0.4 million, or 16.0%, to $2.9 million for the three-month period ended
June 30, 2026, compared to approximately $2.5 million for the three-month period ended June 30, 2025. This increase was mainly due to
a higher volume of invoices received and a corresponding increase in accounts payable and accrued liabilities related to clinical trial
activities, reflecting the Company's operational ramp-up and preparations for the commencement of its Phase 2/3 human clinical trial,
which was initiated in July 2026.
Cash
Provided by (Used in) Financing Activities
Net
cash provided by financing activities increased by approximately $2.9 million, or 1,450%, to approximately $2.7 million for the three-month
period ended June 30, 2026, compared to $0.2 million of cash used in financing activities for the three-month period ended June 30, 2025.
This increase in cash provided by financing activities was due to our having raised approximately $1.9 million (net of sales agent fees
and issuance costs) of cash under the ATM and approximately $0.8 million (net of issuance costs) from the May 2026 induced warrant exercise
transaction during the three-month period ended June 30, 2026, as opposed to our having used approximately $0.2 million for cash issuance
costs related to our January 2025 Offering that were paid during the three-month period ended June 30, 2025. Please see “ At-The-Market
Offering Agreement ”, “ Induced Warrant Exercise Transactions ” and “ Public
Offerings via H.C. Wainwright ” in this “ Liquidity and Capital Resources ”
section for a description of those financing transactions.
Funding
Requirements
We
expect to devote substantial financial resources to our ongoing and planned activities, particularly further development of SIL204 as
we conduct our current and future clinical trials.
Conducting
clinical trials, identifying additional potential product candidates and engaging in pre-clinical testing with respect to those additional
potential product candidates, are time-consuming, expensive, and uncertain processes that take years to complete, and we may never generate
the necessary data or results required to obtain marketing approval and achieve product sales (either for SIL204 or any other additional
potential product candidate). In addition, our product candidates, if approved, may not achieve commercial success. For additional information,
please refer to “ Part I, Item 1A. Risk Factors ”
in our 2025 annual report, including “ Risks Related to Our Financial Condition and Capital Requirements —
We have never generated any revenue from product sales and may never be profitable” and “Risks
Related to the Research and Development of Silexion’s Product Candidates— We are heavily dependent on the success of our product
candidates ...”.
We
expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance our clinical trials
for SIL204. In addition, if we obtain marketing approval for SIL204 in any indication or for any other product candidate we are developing
or may develop in the future, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing,
and distribution. Furthermore, following the Closing of the Business Combination, we have been incurring, and expect to continue to incur,
additional costs associated with operating as a public company. Accordingly, we will need to obtain substantial additional funding.
18
Our
future capital requirements will depend on many factors, including:
•
materials costs;
•
regulatory pathway; and
•
human clinical trial
costs.
As
of June 30, 2026, we had cash and cash equivalents of $2.2 million. Based on our current cash balance, as well as our history of operating
losses and negative cash flows from operations, combined with our anticipated use of cash to, among other things, (i) fund the clinical
development of SIL204, (ii) identify and develop new product candidates, and (iii) seek approval for SIL204 and any other product candidates
we may develop, our management has concluded that we do not have sufficient cash to fund our operations for 12 months from the issuance
date of our consolidated financial statements for the three-month and six-month periods ended June 30, 2026 included in this quarterly
report, but rather, under our current business plan, through the fourth quarter of 2026 and, as a result, there is substantial doubt
about our ability to continue as a going concern.
In
making this determination, applicable accounting standards prohibited us from considering the potential mitigating effect of plans that
have not been fully implemented as of the date of our consolidated financial statements for the three-month and six-month periods ended
June 30, 2026, including, without limitation, plans to raise additional capital. Our financial information throughout this quarterly report,
and our financial statements for the three-month and six-month periods ended June 30, 2026 contained herein, have been prepared on a basis
that assumes that we will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities
and commitments in the normal course of business. This financial information and our consolidated financial statements for the three-month
and six-month periods ended June 30, 2026 do not include any adjustments that might result from the outcome of this uncertainty.
We
have based these estimates and expectations on assumptions that may prove to be wrong, and our operating plan may change as a result of
many factors currently unknown to us. We could not, as of the June 30, 2026 balance sheet date of the unaudited financial statements for
the three-month and six-month periods ended June 30, 2026, determine the exact level of funds that will be available to us upon potential
equity financings. Our expected use of funds represents our intentions based upon our current plans and business condition, which could
change in the future as our plans and business condition evolve and the level of funding available to us becomes clearer. In addition,
changing circumstances could cause us to consume capital significantly faster than we currently anticipate, and we may need to spend more
than currently expected because of circumstances beyond our control. As a result, we could deplete our capital resources sooner than we
currently expect. In addition, because the successful development of SIL204 and any studies or other product candidates that we may pursue
is highly uncertain, at this time we cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary
to complete the development of any such product candidate.
Until
such time, if ever, as we can generate substantial revenues from product sales, we expect to finance our cash needs through a combination
of public and private equity offerings, including registered public offerings similar to the HCW Offerings completed in January 2025,
September 2025, and August 2026, induced warrant exercise transactions similar to those completed in late January 2025, early August 2025,
and May 2026, ordinary-course sales of ordinary shares into the market pursuant to the ATM, strategic alliances, collaborations, and marketing,
distribution, or licensing arrangements. However, adequate additional financing may not be available to us on acceptable terms, or at
all, and the availability of such financing may be impacted by the economic climate and market conditions.
19
Reliance
on public offerings, warrant exercise inducement transactions, the ATM, or other similar types of equity financing as a source of ongoing
funding for our operations have in the past involved, and could again in the future involve, significant issuances of ordinary shares
by us that could cause the following impacts (among others):
•
significant dilution
to the equity interests of our current shareholders;
•
a deemed change of control
of our company due to the issuance of a substantial number of ordinary shares, which may affect, among other things, our ability to use
our net operating loss carry forwards, if any, and could result in a change in the officers and directors of our company relative to our
current officers and directors, to the extent any shareholders build up significant beneficial ownership from ordinary shares issued pursuant
to public offerings, warrant exercises, the ATM, or conversions under the A&R Sponsor Promissory Note;
•
delaying or preventing
a change of control of our company by diluting the share ownership or voting rights of a person seeking to obtain control; and
•
an adverse effect on
prevailing market prices for our ordinary shares or warrants.
Critical
Accounting Policies and Estimates
For
a description of our significant accounting policies, see Note 2 to our consolidated financial statements for the year ended December
31, 2025 included in the 2025 annual report and Note 2 to our unaudited condensed consolidated financial statements for the three-month
and six-month periods ended June 30, 2026 included in this quarterly report.
The
preparation of our unaudited condensed consolidated financial statements for the three-month and six-month periods ended June 30, 2026
and our consolidated financial statements for the year ended December 31, 2025 in conformity with U.S. GAAP required our management to
make estimates and assumptions in certain circumstances that affect the amounts reported in the accompanying unaudited condensed consolidated
financial statements for the three-month and six-month periods ended June 30, 2026 and the consolidated financial statements for the year
ended December 31, 2025, and in related footnotes. Actual results may differ from these estimates. We base our judgments on our experience
and on various assumptions that we believe to be reasonable under the circumstances.
Of
our policies, the following are considered critical to an understanding of our unaudited condensed consolidated financial statements for
the three-month and six-month periods ended June 30, 2026 and consolidated financial statements for the year ended December 31, 2025,
as they require the application of subjective and complex judgment, involving critical accounting estimates and assumptions impacting
our unaudited condensed consolidated financial statements for the three-month and six-month periods ended June 30, 2026 and consolidated
financial statements for the year ended December 31, 2025.
The
critical accounting estimates relate to the following:
Valuation
of Promissory Notes
As
part of the Business Combination, we issued to the Moringa sponsor, as well as EarlyBird, promissory notes, which we irrevocably designated
to be measured at fair value. The EarlyBird Convertible Note was retired on March 18, 2025. In 2025, the fair value of the A&R Sponsor
Promissory Note was measured using a discount rate based on a B rated US dollar zero-coupon discount curve, plus a credit spread of 7.56%.
The discount rate was determined with reference to benchmark interest rates of secured loans reported by venture capitals, which were
then used to extract our entity-specific credit spread. Since the A&R Sponsor Promissory Note is not senior secured, one notch downgrade
was applied. The expected timing of conversion or redemption of the note has been determined using our management’s forecast. In
2026, the valuation technique for the A&R Sponsor Promissory Note was changed to a Monte Carlo simulation framework to model the expected
conversion price at the A&R Sponsor Promissory Note’s maturity date, when applicable,
which is based on a contractual 20-day average closing price mechanism.
20
Recent
Accounting Pronouncements
See
Note 2 on page F-18 to our financial statements for the year ended December 31, 2025 included in the 2025 annual report for a description
of recent accounting pronouncements applicable to our financial statements for the three-month and six-month periods ended June 30, 2026
and the year ended December 31, 2025.
Smaller
Reporting Company Status
We
are a “smaller reporting company,” meaning that the market value of our ordinary shares held by non-affiliates is less than
$700 million and our annual revenue was less than $100 million during the most recently completed fiscal year. We will continue to be
a smaller reporting company if either (i) the market value of our shares held by non-affiliates is less than $250 million or (ii) our
annual revenue was less than $100 million during the most recently completed fiscal year and the market value of our shares held by non-affiliates
is less than $700 million. As a smaller reporting company, we may choose to present only the two most recent fiscal years of audited financial
statements and we have reduced disclosure obligations regarding executive compensation.
Emerging
Growth Company Status
Section
102(b)(1) of the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, exempts emerging growth companies from being required to
comply with new or revised financial accounting standards until private companies are required to comply with the new or revised financial
accounting standards. The JOBS Act provides that a company can choose not to take advantage of the extended transition period and comply
with the requirements that apply to non-emerging growth companies, and any such election to not take advantage of the extended transition
period is irrevocable.
We
are an “emerging growth company” as defined in Section 2(a) of the Securities Act, and have elected to take advantage of the
benefits of the extended transition period for new or revised financial accounting standards. We will remain an emerging growth company
until the earliest of (i) the last day of the fiscal year in which the market value of ordinary shares that are held by non-affiliates
exceeds $700 million as of the end of that year’s second fiscal quarter, (ii) the last day of the fiscal year in which we have total
annual gross revenue of $1.235 billion or more during such fiscal year (as indexed for inflation), (iii) the date on which we have issued
more than $1.0 billion in non-convertible debt in the prior three-year, or (iv) December 31, 2029. We expect to continue to take advantage
of the benefits of the extended transition period, although it may decide to early adopt such new or revised accounting standards to the
extent permitted by such standards. This may make it difficult or impossible to compare our financial results with the financial results
of another public company that is either not an emerging growth company or is an emerging growth company that has chosen not to take advantage
of the extended transition period exemptions because of the potential differences in accounting standards used.
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.