Silexion Therapeutics Corp (NASDAQ: SLXN) experienced a dramatic rally on Wednesday, with shares closing up 96.95% at $0.5298 following news that Israel's Ministry of Health had approved a pivotal Phase 2/3 clinical trial for its lead drug candidate, SIL204. The stock had closed at $0.269 the prior day. However, the gains partially reversed in after-hours trading, with shares falling 9.5% as investors weighed the company's ongoing financial and listing challenges.
Trading volume exploded to over 325 million shares, a massive spike for the micro-cap biotech, as retail and institutional traders piled into the name. The move came after the regular Nasdaq session had closed, with after-hours activity extending through 8:00 p.m. Eastern. The broader market also provided a tailwind, with the Nasdaq Composite rising 1.55%, the S&P 500 gaining 1.08%, and the Dow Jones Industrial Average adding 1.31% on the day.
Clinical Milestone for SIL204
Silexion announced on May 18 that Israeli regulators had given the green light to initiate a Phase 2/3 study of SIL204 in patients with locally advanced pancreatic cancer. The company also disclosed that it had filed a clinical trial application in Germany under the European Union's regulatory framework. The trial design includes a safety run-in phase of approximately 18 patients, followed by a randomized main cohort of about 166 patients, who will receive SIL204 in combination with standard chemotherapy.
SIL204 utilizes RNA interference (RNAi) technology, employing small RNA molecules to silence gene expression. The drug targets the KRAS gene, a mutation found in a significant proportion of pancreatic tumors. CEO Ilan Hadar stated in an update that the company remains on track to commence the trial in the second quarter of 2026.
Financial Pressures Mount
Despite the positive clinical news, Silexion's balance sheet remains a source of concern. The company reported a first-quarter net loss of approximately $2.7 million, widening from a $1.7 million loss in the same period last year. Cash and cash equivalents dwindled to $2.4 million as of March 31, down sharply from $6.0 million at the end of 2025.
In May, the company raised approximately $1 million in gross proceeds through the exercise of warrants, with nearly 2 million warrants exercised at a reduced cash price of $0.50 per share. The warrant exercise also resulted in the issuance of new warrants for up to roughly 4 million additional shares, increasing the potential for future dilution. CFO Mirit Horenshtein Hadar noted that the company is "evaluating financing alternatives" to support the advancement of SIL204.
Nasdaq Compliance and Reverse Split
Silexion is also racing to meet Nasdaq's minimum bid price requirement. The stock has traded below $1 for most of May, putting its listing at risk. The company has announced a 1-for-10 reverse stock split, expected to take effect in late May or early June. Reverse splits are a common tactic to boost share prices above exchange minimums, but they also reduce the number of outstanding shares and can signal financial distress.
As of May 14, Silexion had 4,189,954 ordinary shares outstanding. The reverse split, combined with potential further dilution from warrants and equity lines, adds uncertainty for existing shareholders.
Competitive Landscape Heats Up
The pancreatic cancer treatment space is becoming increasingly competitive. Revolution Medicines recently reported that its RAS-targeting drug daraxonrasib nearly doubled median survival compared to chemotherapy in late-stage pancreatic cancer. J.P. Morgan analyst Brian Cheng described the data as strong enough to position daraxonrasib as "the next standard of care" for pancreatic ductal adenocarcinoma.
Other KRAS-targeted therapies, such as Amgen's Lumakras and Bristol Myers Squibb's Krazati, are already approved for certain indications, though they are used in different patient populations. The FDA cleared Lumakras in combination with Vectibix for some KRAS G12C-mutated colorectal cancer patients last year, and Bristol Myers' Krazati received a similar approval for colorectal cancer the year prior.
For Silexion, the path forward is fraught with risk. The company must successfully launch and manage the Phase 2/3 trial, secure additional financing to fund operations, and maintain compliance with Nasdaq listing standards. Any delay or setback could quickly unwind the gains seen on Wednesday, underscoring the volatile nature of this stock.
