Silexion (NASDAQ: SLXN) Q1 loss widens as SIL204 moves into Phase 2/3
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
Silexion Therapeutics reported first quarter 2026 results and highlighted progress for its lead RNAi candidate SIL204 in locally advanced pancreatic cancer. The Israeli Ministry of Health approved initiation of a Phase 2/3 clinical trial, and a Clinical Trial Application was submitted in Germany under the EU Clinical Trials Regulation, keeping trial initiation on track for the second quarter of 2026.
For the three months ended March 31, 2026, Silexion recorded a net loss of $2.7 million compared with $1.7 million a year earlier, driven by higher research and development expense of $1.4 million and general and administrative expense of $1.4 million. Cash and cash equivalents declined to $2.4 million from $6.0 million as of December 31, 2025, while shareholders’ equity fell to $0.3 million from $2.6 million, and a related party promissory note of $1.6 million was reclassified into current liabilities. Management noted warrant exercise inducements, at-the-market usage and shareholder approval for a prospective reverse share split as steps to support both clinical development and continued Nasdaq listing.
Positive
- None.
Negative
- None.
Insights
Regulatory progress for SIL204 offsets a weaker balance sheet.
Silexion Therapeutics moved SIL204 into Phase 2/3 development with Israeli approval and a German Clinical Trial Application under the EU Clinical Trials Regulation. This is a key step as the company targets KRAS-driven locally advanced pancreatic cancer.
The quarter shows higher operating spend, with research and development at $1.37M and general and administrative at $1.38M, producing a net loss of $2.73M. Cash fell to $2.41M and shareholders’ equity to $0.29M, while a related party promissory note of $1.55M now sits in current liabilities.
Management references warrant exercise inducements, at-the-market issuance and a planned reverse share split to help maintain Nasdaq Capital Market compliance, including shareholders’ equity requirements. Subsequent filings may clarify how these financing steps interact with the planned Phase 2/3 trial timing in Q2 2026.
8-K Event Classification
2 items: 2.02, 9.01
2 items
Item 2.02
Results of Operations and Financial Condition
Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
Cash and cash equivalents: $2,413 thousand
Total assets: $4,602 thousand
Net loss: $2,733 thousand
+5 more
8 metrics
Cash and cash equivalents
$2,413 thousand
As of March 31, 2026
Total assets
$4,602 thousand
As of March 31, 2026
Net loss
$2,733 thousand
Three months ended March 31, 2026
Research and development expense
$1,370 thousand
Three months ended March 31, 2026
General and administrative expense
$1,379 thousand
Three months ended March 31, 2026
Shareholders’ equity
$291 thousand
As of March 31, 2026
Loss per share
$0.85
Basic and diluted, Q1 2026
Ordinary shares outstanding
3,394,865 shares
As of March 31, 2026
Key Terms
Phase 2/3 clinical trial, RNA interference (RNAi), Clinical Trial Application, reverse share split, +2 more
6 terms
Phase 2/3 clinical trial medical
"approved the initiation of Silexion's Phase 2/3 clinical trial of SIL204 in locally advanced pancreatic cancer"
A phase 2/3 clinical trial is a single, combined study that first tests whether a treatment works and is safe in a modest number of patients, then expands seamlessly into a larger, confirmatory stage if early results are promising. Think of it like a prototype test that can quickly move into full production without starting over; for investors, it concentrates risk and time, because positive results can speed regulatory approval while negative results can be a major setback.
RNA interference (RNAi) medical
"a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers"
A natural cellular process in which small RNA molecules shut down the production of a specific protein by blocking the instructions that make it, like flipping a precise light switch to silence one appliance without affecting others. For investors, RNA interference is important because it underpins a class of highly targeted therapies and research tools that can create new drugs, shorten development paths, and change the potential market and regulatory risks for companies working on gene-based treatments.
Clinical Trial Application regulatory
"Clinical Trial Application subsequently submitted to Germany through the EU Clinical Trials Information System"
An application submitted to a regulatory authority requesting formal permission to begin testing a new drug, medical device, or treatment in humans. Like asking for a building permit before construction, it summarizes safety data, plans for how the study will be run, and monitoring procedures; investors watch these filings closely because approval lets a program move from lab research to clinical testing, reducing uncertainty and creating value-driving milestones.
Nasdaq Capital Market market
"maintenance of compliance with the continued listing requirements of the Nasdaq Capital Market"
The Nasdaq Capital Market is a platform where smaller, emerging companies can list their shares for trading by investors. It provides these companies with access to funding and visibility, helping them grow, much like a local marketplace where new vendors can introduce their products to potential customers. For investors, it offers opportunities to discover early-stage companies with growth potential.
Earnings Snapshot
Net loss: $2,733 thousand
Three months ended March 31, 2026
Net loss
$2,733 thousand
Loss per share, basic and diluted
$0.85
Research and development expense
$1,370 thousand
General and administrative expense
$1,379 thousand
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant
to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of report (Date of earliest event reported):
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Identification No.)
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(Address of principal executive offices)
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(Zip Code)
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-3-756-4999
(Registrant’s telephone number, including area code)
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(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if
the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
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Item 2.02
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Results of Operations and Financial Condition.
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On May 18, 2026, Silexion Therapeutics Corp issued a press release announcing its financial results for the first
quarter ended March 31, 2026. A copy of the press release is furnished as Exhibit 99.1 hereto and is incorporated by reference into this Item 2.02.
The information contained in this Item 2.02 and Exhibit 99.1 hereto shall not be deemed to be “filed” for the
purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of such section,
nor will such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or under the Exchange Act, except as may be expressly set forth by specific reference in such filing.
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Item 9.01
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Financial Statements and Exhibits
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(d) Exhibits
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99.1
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Press Release, dated
May 18, 2026, titled “Silexion Therapeutics Reports First Quarter 2026 Financial Results and Provides Business Update”
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be
signed on its behalf by the undersigned hereunto duly authorized.
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SILEXION THERAPEUTICS CORP
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Date: May 18, 2026
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By:
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/s/ Ilan Hadar
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Name:
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Ilan Hadar
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Title:
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Chief Executive Officer
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Exhibit 99.1
Silexion Therapeutics Reports First Quarter 2026 Financial Results and
Provides Business Update
Israeli Ministry of Health approved the initiation of Silexion's Phase 2/3 clinical trial of SIL204 in
locally advanced pancreatic cancer
Clinical Trial Application subsequently submitted to Germany through the EU Clinical Trials
Information System
Phase 2/3 clinical trial initiation remains on track for the second quarter of 2026
Grand Cayman, Cayman Islands, May 18, 2026 -- Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage biotechnology company pioneering RNA
interference (RNAi) therapies for KRAS-driven cancers, today provided an update on recent business developments following the release of its financial results for the first quarter ended March 31, 2026, which were reported on May 15, 2026.
Recent Milestones & Business Highlights
| • |
Israeli Ministry of Health Approval to Initiate Phase 2/3 Clinical
Trial of SIL204: On March 24, 2026, Silexion announced that it had received formal approval from the Israeli Ministry of Health to initiate its Phase 2/3 clinical trial evaluating the Company’s lead product candidate SIL204 for
the treatment of locally advanced pancreatic cancer. The approval represented a defining regulatory milestone for the Company, marking the transition of SIL204 into clinical-stage development of a next-generation siRNA therapy designed to
silence mutated KRAS - a driver present in approximately 90% of pancreatic cancers - and positioning Silexion as a clinical-stage biotechnology company focused on KRAS-driven cancers. The approval followed strong positive anti-tumor
activity demonstrated across multiple preclinical models, successful completion of two-species toxicology studies, and constructive regulatory engagement supporting the Phase 2/3 trial design.
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Phase 2/3 Clinical Trial Application Submitted to Germany: On
April 28, 2026, subsequent to quarter end, the Company announced the successful submission of a Clinical Trial Application (CTA) to Germany for the planned Phase 2/3 clinical trial of SIL204 in patients with locally advanced pancreatic
cancer. The CTA was submitted through the EU Clinical Trials Information System (CTIS), with Germany serving as the Reporting Member State leading the scientific assessment of the trial across the European Union. The submission was informed
by the positive written Scientific Advice received from Germany's Federal Institute for Drugs and Medical Devices (BfArM) in December 2025, and was supported by the Company's comprehensive regulatory and preclinical package, including
completed two-species toxicology studies.
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Phase 2/3 Trial Initiation Planned for the Second Quarter of 2026: The
planned Phase 2/3 clinical study is expected to begin in the second quarter of 2026 and will include an initial safety run-in cohort of approximately 18 patients, followed by expansion into a randomized cohort of approximately 166 patients.
The study is designed to evaluate SIL204 in combination with standard chemotherapy in patients with locally advanced pancreatic cancer using Silexion's dual-route administration approach - combining intratumoral delivery to target primary
tumors with systemic administration to address metastatic disease. The Company plans to conduct the trial at leading oncology centers in Germany and across additional EU member states, in parallel with previously announced Israeli sites led
by Sheba Medical Center.
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Ilan Hadar, Chairman and Chief Executive Officer of Silexion, commented: “The first quarter and the period since represented a defining
moment in Silexion's evolution. With the Israeli Ministry of Health approval to initiate our Phase 2/3 clinical trial of SIL204 in locally advanced pancreatic cancer, and our subsequent submission of a Clinical Trial Application to Germany under
the EU Clinical Trials Regulation, we have advanced SIL204 from a preclinical asset into clinical-stage development across two major regulatory jurisdictions. We remain on track to initiate the Phase 2/3 clinical trial in the second quarter of
2026, with the goal of bringing an RNAi-based approach to patients with KRAS-driven cancers who have limited treatment options today.”
Mirit Horenshtein Hadar, Chief Financial Officer of Silexion, added: “During the first quarter and subsequent to quarter end, we executed
a series of capital-raising and corporate actions designed to support our clinical development plan and our continued Nasdaq listing. These included our May 2026 warrant exercise inducement transaction, additional capital raised under our
at-the-market facility, and obtaining shareholder approval for a prospective reverse share split. We continue to evaluate financing alternatives as we work to support the advancement of SIL204 into the clinic in the second quarter of 2026.”
Financial Results for the Three Months Ended March 31, 2026
| • |
Research and development (“R&D”) expenses for the three
months ended March 31, 2026, were approximately $1.4 million, compared to approximately $0.6 million for the same period in 2025, an increase of 133.3%. The increase was primarily driven by approximately $0.7 million in higher subcontractor
and consultant expenses related to toxicology studies and product development required to support initiation of the planned human clinical trial expected in the second quarter of 2026, including GMP manufacturing of our drug product, as
well as approximately $0.1 million in non-cash share-based compensation expenses related to executive officer grants awarded in February 2026.
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General and administrative (“G&A”) expenses for the three
months ended March 31, 2026, were approximately $1.4 million, compared to approximately $1.1 million for the same period in 2025, an increase of 27.3%. The increase was primarily driven by approximately $0.26 million in higher professional
services costs, including legal, investor relations, director compensation, and other expenses associated with operating as a public company, as well as approximately $0.2 million in non-cash share-based compensation expenses related to
executive officer and director grants awarded in February 2026.
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| • |
Net loss for the three months ended March 31, 2026, was
approximately $2.7 million, compared to approximately $1.7 million for the same period in 2025, an increase of 58.8%. The increase was primarily attributable to higher research and development expenses, primarily related to preparations for
the human clinical trial, and higher general and administrative expenses.
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Balance Sheet Highlights
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Cash and cash equivalents were $2.4 million as of March 31, 2026, compared to $6.0 million as of December 31, 2025. The decrease primarily reflects ongoing operating
expenses supporting preclinical and clinical readiness activities for the planned initiation of the Phase 2/3 clinical trial of SIL204.
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Subsequent to quarter end, the Company strengthened its balance sheet through a May 2026 warrant exercise inducement transaction generating approximately $1.0
million in gross proceeds and through utilization of its at-the-market facility. The Company has reported that the May 2026 warrant exercise transaction, together with additional equity-increasing transactions effected on or about May 15,
2026, have raised its shareholders' equity above the $2.5 million minimum under the Nasdaq Capital Market continued listing requirements, which the Company believes constitutes restored compliance with those requirements.
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About Silexion Therapeutics
Silexion Therapeutics is a pioneering clinical-stage, oncology-focused biotechnology company dedicated to the development of innovative treatments for unsatisfactorily treated solid tumor cancers which have the mutated KRAS oncogene, generally considered to be the most common oncogenic gene driver in human cancers. The Company conducted a Phase 2a clinical trial in its first-generation product, which showed a positive trend in comparison to the control of chemotherapy alone, and is currently advancing its lead, second-generation, product candidate, SIL204, a small interfering RNA (siRNA), towards clinical trials in Israel and the European Union. Silexion is committed to pushing the boundaries of therapeutic advancements in the field of oncology, and further developing its lead product candidate for locally advanced pancreatic cancer. For more information please visit: https://silexion.com
Notice Regarding Forward-Looking
Statements:
This press release contains forward-looking statements within the meaning of the federal securities laws. All statements other than statements of historical fact contained in this communication, including, for example, statements regarding the development of SIL204; the timing, design, conduct, and initiation of the planned Phase 2/3 clinical trial of SIL204 in locally advanced pancreatic cancer (including the expected commencement in the second quarter of 2026, the safety run-in and randomized cohort design, and patient enrollment); the timing, content, outcome, and review of regulatory submissions and interactions with regulatory authorities in Israel, Germany, the European Union, and other jurisdictions, including the expected scientific assessment under the EU Clinical Trials Regulation with Germany as Reporting Member State; the conduct of clinical trial activities in Germany; the Company's anticipated future financing activities; the Company’s planned reverse share split and the timing of its effectiveness; the Company's restoration and future maintenance of compliance with the continued listing requirements of the Nasdaq Capital Market, including the shareholders' equity requirement; the potential therapeutic benefits, mutation coverage, and clinical utility of SIL204 across multiple cancer types; Silexion's business strategy and development plans; and Silexion's future capital requirements and ability to raise additional capital, are forward-looking statements. These forward-looking statements are generally identified by terminology such as “may”, “should”, “could”, “might”, “plan”, “possible”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “prospective”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. Forward-looking statements involve a number of risks, uncertainties, and assumptions, and actual results or events may differ materially from those projected or implied in those statements. Important factors that could cause such differences include, but are not limited to: (i) whether Silexion will succeed at initiating and conducting clinical trials, including the Phase 2/3 trial of SIL204 in locally advanced pancreatic cancer; (ii) whether Silexion's strategy, future operations, financial position, projected costs, prospects, and plans will run as currently anticipated; (iii) the impact of the regulatory environment and compliance complexities; (iv) whether Silexion can establish future partnerships or other relationships with third parties; (v) Silexion's future capital requirements and sources and uses of cash, including its ability to obtain additional capital; (vi) whether Silexion can maintain its Nasdaq listing, including its ability to continue to satisfy the Nasdaq shareholders' equity and minimum bid price requirements; and (vii) other risks and uncertainties set forth in the documents filed by the Company with the SEC, including the Company's Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 17, 2026, and the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the SEC on May 15, 2026. Silexion cautions you against placing undue reliance on forward-looking statements, which reflect current beliefs and are based on information currently available as of the date a forward-looking statement is made. Forward-looking statements set forth herein speak only as of the date they are made. Silexion undertakes no obligation to revise forward-looking statements to reflect future events, changes in circumstances, or changes in beliefs, except as otherwise required by law.
Company Contact:
Silexion Therapeutics Corp
Ms. Mirit Horenshtein Hadar, CFO
mirit@silexion.com
Investor Relations
Arx Investor Relations
North American Equities Desk
silexion@arxhq.com
SILEXION THERAPEUTICS
CORP
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share data)
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share data)
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March 31,
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December 31,
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|||||||
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2026
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2025
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ASSETS
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CURRENT ASSETS:
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||||||||
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Cash and cash equivalents
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$
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2,413
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$
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5,991
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Restricted cash
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27
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27
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Prepaid expenses
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1,529
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570
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Other current assets
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96
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49
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TOTAL CURRENT ASSETS
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4,065
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6,637
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NON-CURRENT ASSETS:
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||||||||
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Restricted cash
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58
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57
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Long-term deposit and other non-current assets
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76
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84
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||||||
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Property and equipment, net
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23
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25
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||||||
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Operating lease right-of-use asset
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380
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412
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||||||
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TOTAL NON-CURRENT ASSETS
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537
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578
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||||||
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TOTAL ASSETS
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$
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4,602
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$
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7,215
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||||
SILEXION THERAPEUTICS CORP
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS (continued)
(U.S. dollars in thousands, except share data)
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS (continued)
(U.S. dollars in thousands, except share data)
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March 31,
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December 31,
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|||||||
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2026
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2025
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LIABILITIES AND SHAREHOLDERS' EQUITY (CAPITAL DEFICIENCY)
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||||||||
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CURRENT LIABILITIES:
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||||||||
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Trade payables
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$
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912
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$
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787
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||||
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Current maturities of operating lease liability
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185
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182
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||||||
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Employee related obligations
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560
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879
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||||||
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Other account payable
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850
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910
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||||||
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Private warrants to purchase ordinary shares (including $* due to related party as of March 31, 2026 and December 31, 2025)
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*
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*
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||||||
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Related Party Promissory Note
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1,553
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—
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||||||
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TOTAL CURRENT LIABILITIES
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4,060
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2,758
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||||||
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NON-CURRENT LIABILITIES:
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||||||||
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Long-term operating lease liability
|
251
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286
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||||||
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Related Party Promissory Note
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—
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1,568
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||||||
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TOTAL NON-CURRENT LIABILITIES
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$
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251
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$
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1,854
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||||
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TOTAL LIABILITIES
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$
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4,311
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$
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4,612
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||||
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SHAREHOLDERS' EQUITY (CAPITAL DEFICIENCY):
|
||||||||
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Ordinary shares ($0.0135 par value per share, 9,000,000 shares authorized as of March 31, 2026 and December 31, 2025; 3,394,865
and 3,126,651 shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively)
|
46
|
42
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||||||
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Additional paid-in capital
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58,144
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57,727
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||||||
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Accumulated deficit
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(57,899
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)
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(55,166
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)
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||||
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TOTAL SHAREHOLDERS' EQUITY (CAPITAL DEFICIENCY)
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$
|
291
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$
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2,603
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||||
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TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY (CAPITAL DEFICIENCY)
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$
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4,602
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$
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7,215
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||||
* Represents an amount less than $1.
SILEXION THERAPEUTICS CORP
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
|
Three months ended March 31,
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2026
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2025
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OPERATING EXPENSES:
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||||||||
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Research and development (including $130 and $0 from related parties for the three-month periods ended March 31, 2026 and 2025,
respectively)
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$
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1,370
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$
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590
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||||
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General and administrative (including $215 and $21 from related parties for the three-month periods ended March 31, 2026 and
2025, respectively)
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1,379
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1,060
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||||||
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TOTAL OPERATING EXPENSES
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2,749
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1,650
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||||||
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OPERATING LOSS
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2,749
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1,650
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||||||
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Financial expense (income), net (including $(15) and $32 from related parties for the three-month periods ended March 31, 2026
and 2025, respectively)
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(16
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)
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85
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|||||
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LOSS BEFORE INCOME TAX
|
$
|
2,733
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$
|
1,735
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||||
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INCOME TAX
|
*
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*
|
||||||
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NET LOSS
|
$
|
2,733
|
$
|
1,735
|
||||
|
LOSS PER SHARE, BASIC AND DILUTED
|
$
|
0.85
|
$
|
3.84
|
||||
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WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE
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3,230,378
|
451,990
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||||||
All share and per share amounts reflect (in the case of the three months ended March 31, 2025, on a retroactive basis) a 1-for-15 reverse share split effected in July 2025, as discussed in Note 1(e) to the Company’s condensed consolidated financial statements included in the Company’s quarterly report on Form 10-Q for the quarter ended March 31, 2026
* Represents an amount less than $1.
FAQ
How did Silexion Therapeutics (SLXN) perform financially in Q1 2026?
Silexion reported a Q1 2026 net loss of $2.73 million, compared with $1.74 million in Q1 2025. Operating expenses rose to $2.75 million, reflecting higher research and development and general and administrative spending as the company advances its oncology pipeline.
What is the status of Silexion’s SIL204 clinical program as of Q1 2026?
SIL204 has advanced into Phase 2/3 development in locally advanced pancreatic cancer. The Israeli Ministry of Health approved trial initiation, and a Clinical Trial Application was submitted in Germany under the EU Clinical Trials Regulation, with trial start still targeted for the second quarter of 2026.
What were Silexion Therapeutics’ cash and total assets at March 31, 2026?
At March 31, 2026, Silexion held $2.41 million in cash and cash equivalents and had total assets of $4.60 million. This compares with $5.99 million in cash and $7.22 million in total assets as of December 31, 2025.
What capital and corporate actions did Silexion undertake around Q1 2026?
Silexion’s CFO highlighted a warrant exercise inducement transaction, additional capital raised under an at-the-market facility, and shareholder approval for a prospective reverse share split. These steps are intended to support clinical development plans and help maintain the company’s Nasdaq listing requirements.