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Enlivex Therapeutics Ltd. — Investor Relations & Filings

Ticker · ENLV ISIN · IL0011319527 TA Manufacturing
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Filings indexed 485 across all filing types
Latest filing 2023-02-23 Report Publication Anno…
Country IL Israel
Listing TA ENLV

About Enlivex Therapeutics Ltd.

https://enlivex.com/

Enlivex Therapeutics Ltd. is a clinical-stage macrophage reprogramming immunotherapy company. It is focused on developing Allocetra™, a universal, off-the-shelf cell therapy designed to treat immune system dysregulation. The therapy works by reprogramming macrophages to resolve hyper-inflammation. Enlivex is evaluating Allocetra™ in clinical trials for the treatment of multiple indications, including acute inflammatory diseases such as sepsis and chronic inflammatory conditions like osteoarthritis. The product candidate offers flexible administration options, including systemic intravenous infusion and targeted local injections.

Recent filings

Filing Released Lang Actions
Rceives Clearance From Spanish Agency of Medicines and Medical Devices For Treatment of Patients with Advanced Solid Malignancies in the Ongoing Allocetra Phase I/II Clinical Trial
Report Publication Announcement Classification · 1% confidence The document is very short (1767 characters) and explicitly states, "Attached hereto is a report on *6-k* *6k23022023_isa.pdf*". This structure—a brief announcement pointing to an attached or linked external report (in this case, a Form 6-K, which is a general report filed by foreign private issuers)—fits the definition of a Report Publication Announcement (RPA) according to the 'MENU VS MEAL' rule. It is announcing the publication of a filing rather than being the full filing itself. Since RPA is a specific category for such announcements, it is preferred over the general fallback RNS.
2023-02-23 English
וssuance of Israeli Patent Covering the Use of Allocetra™ to Prevent Cytokine Release Syndrome (CRS)
Regulatory Filings Classification · 1% confidence The document is explicitly identified as a "Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 under the Securities Exchange Act of 1934," filed on Form 6-K for the month of February 2023. Form 6-K is a general reporting requirement for foreign private issuers, often used to file material information that is required to be disclosed to shareholders in the home country or exchange, or information that is being distributed to shareholders. The content itself is a press release announcing the issuance of an Israeli patent for their drug Allocetra™. Since Form 6-K is a general regulatory filing that doesn't fit into the specific categories like 10-K (Annual Report), ER (Earnings Release), or IR (Interim Report), and it is a formal SEC filing, the most appropriate classification is the general regulatory filing category, RNS (Regulatory Filings), which serves as a fallback for miscellaneous SEC filings that are not covered by the more specific codes. Although it contains information about intellectual property, it is primarily structured as a Form 6-K submission.
2023-02-15 English
וssuance of Israeli Patent Covering the Use of Allocetra™ to Prevent Cytokine Release Syndrome (CRS)
Report Publication Announcement Classification · 1% confidence The document is extremely short (1773 characters) and explicitly states, "Attached hereto is a report on *6-k* *6k15032023v1_DC_isa.pdf*". This structure—a brief announcement referencing an attached or linked official filing (in this case, a Form 6-K, which is an 'other report' for foreign private issuers)—fits the definition of a Report Publication Announcement (RPA) under the 'MENU VS MEAL' rule. It is announcing the publication of a report rather than being the comprehensive report itself. Since RPA is a specific category for such announcements, it is preferred over the general fallback RNS.
2023-02-15 English
Enlivex Announces Positive DSMB Recommendation and IMOH Clearance to Continue Phase I/II Trial of Allocetra in Patients with Advanced Solid Tumors
Regulatory Filings Classification · 1% confidence The document is explicitly titled 'Form 6-K' and is filed with the 'UNITED STATES SECURITIES AND EXCHANGE COMMISSION'. Form 6-K is the standard SEC filing for a Foreign Private Issuer to report material information that is made public in their home country or required by their home country's exchange. The content is a press release announcing positive clinical trial data and regulatory clearance to continue the trial. This type of material, non-periodic disclosure by a foreign private issuer is best categorized under the general regulatory filing category, as it is not a specific periodic report (like 10-K or IR) or a specific event report (like DIV or DIRS). Since 'RNS' is defined as 'General regulatory announcements and fallback category for miscellaneous filings that do not neatly fit into other specific categories,' and Form 6-K is a general regulatory filing mechanism, RNS is the most appropriate classification, although it is a specific SEC form type not explicitly listed. Given the options, RNS serves as the best fit for a general, non-periodic regulatory disclosure.
2023-01-25 English
Enlivex Announces Positive DSMB Recommendation and IMOH Clearance to Continue Phase I/II Trial of Allocetra in Patients with Advanced Solid Tumors
Report Publication Announcement Classification · 1% confidence The document explicitly states it is an 'Immediate Report' filed under the regulations of the Israel Securities Authority and the Tel Aviv Stock Exchange. Crucially, it states: 'Attached hereto is a report on *6K* *6k25012023_DC_isa.pdf*'. The document itself is very short (1769 characters) and its primary function is to announce the attachment or publication of an external report (a Form 6-K, which is a US SEC filing often used by foreign private issuers). According to Rule 2, when a document is short and announces the publication of another report, it should be classified as a Report Publication Announcement (RPA).
2023-01-25 English
Receives Authorizations from French and Belgian Regulatory Agencies To Expand Its Phase II Sepsis Clinical Trial Into France and Belgium
Regulatory Filings Classification · 1% confidence The document is explicitly identified as a "Form 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 under the Securities Exchange Act of 1934" filed for the month of January 2023. Form 6-K is used by foreign private issuers to report material information that is made public in their home country or required to be filed with a foreign securities exchange. This type of filing is generally used to disseminate current material news, which often overlaps with an Earnings Release (ER) or a Regulatory Filing (RNS). However, the content itself is a press release announcing regulatory clearance and expansion of a clinical trial (Phase II sepsis trial). This is a material event announcement. Reviewing the definitions: - ER (Earnings Release): Initial announcement of *financial results* (key highlights only). This is about clinical trial progress, not financial results. - LTR (Legal Proceedings Report): This is about regulatory clearance/protocol amendment, not a lawsuit. - RNS (Regulatory Filings): General regulatory announcements and fallback. Since the document is a Form 6-K containing a press release about a significant clinical/regulatory update, it is a material event disclosure. While it is a specific SEC filing type (6-K), among the provided options, it functions most closely as a general regulatory announcement or a specific type of material event disclosure. Given the options, and recognizing that 6-K filings often contain material news that doesn't fit neatly into ER, IR, or CAP, the most appropriate general category for a material regulatory/clinical update that isn't a full report (like 10-K or IR) is RNS (Regulatory Filings), as it is a required filing disseminating material information. Alternatively, since it details clinical trial progress and regulatory milestones, it could be argued as an Investor Presentation (IP) if it were a presentation, or a Capital/Financing Update (CAP) if it involved funding, but it is primarily a regulatory update announcement. Given the structure (Form 6-K) and the content (announcement of regulatory clearance for a clinical trial), RNS is the best fit as the catch-all for required regulatory disclosures that aren't the core financial reports (10-K, IR) or specific announcements like DIV or DIRS. The document length (8822 chars) is substantial enough that it is not just a brief RPA.
2023-01-04 English

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