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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 2021-09-22 Regulatory Filings
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
Enlivex Doses First Patient in Placebo-Controlled Phase IIb Clinical Trial Evaluating Allocetra in Severe and Critical COVID-19 Patients with ARDS
Regulatory Filings Classification · 1% confidence The document explicitly states it is a 'Form 6-K' filed with the 'UNITED STATES SECURITIES AND EXCHANGE COMMISSION'. Form 6-K is a report filed by Foreign Private Issuers, typically containing material information that the company is required to disclose to its home country's regulators or stock exchange. The content is a press release announcing the initiation of dosing in a Phase IIb clinical trial for their drug AllocetraTM in COVID-19 patients. This type of material, non-periodic disclosure by a foreign private issuer is generally classified under the general regulatory filing category, as there is no specific code for a Form 6-K press release announcement among the provided definitions, and it is not a full Annual Report (10-K), Interim Report (IR), or Earnings Release (ER). Therefore, the most appropriate classification is the general Regulatory Filings category (RNS).
2021-09-22 English
Enlivex Doses First Patient in Placebo-Controlled Phase IIb Clinical Trial Evaluating Allocetra in Severe and Critical COVID-19 Patients with ARDS
Report Publication Announcement Classification · 1% confidence The document is very short (1767 characters) and explicitly states, "Attached hereto is a report on *6-k* *6k22092021_isa.pdf*". This structure—a brief announcement pointing to an attached or linked official filing (in this case, an SEC Form 6-K, which is a report filed by foreign private issuers)—fits the definition of a Report Publication Announcement (RPA). It is not the full 6-K report itself, but the notice of its publication. The presence of the ISA and TASE headers confirms it is a regulatory filing announcement.
2021-09-22 English
After Review of Phase II Data, Israeli Ministry of Health Authorizes Initiation of a Multi-Center, Randomized Phase IIb Clinical Trial Evaluating Allocetra in Severe and Critical COVID-19 Patients
Regulatory Filings Classification · 1% confidence The document explicitly states it is a "Form 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 under the Securities Exchange Act of 1934" for the month of August 2021. Form 6-K is a periodic report required for foreign private issuers, which generally contains information that the company is required to disclose to its home country's securities regulator or stock exchange, or information that it makes public in press releases. The content is a press release announcing the authorization to initiate a Phase IIb clinical trial for their drug AllocetraTM. While it contains financial reporting elements (being an SEC filing), the core purpose and structure align with a general regulatory disclosure for foreign issuers, often used for material news announcements not covered by specific US forms like 10-K or 10-Q. Given the provided classification options, this type of filing, which is a mandatory SEC submission containing material, non-financial news (a press release), fits best under the general regulatory/miscellaneous category, 'Regulatory Filings' (RNS), as it is not an Annual Report (10-K), Interim Report (IR), Earnings Release (ER), or a specific announcement like DIV or DIRS. However, Form 6-K is a specific SEC filing type. Since there is no specific code for Form 6-K, and it is a mandatory regulatory filing, RNS (Regulatory Filings) is the most appropriate fallback, although it is a very specific type of filing. Given the context of the provided definitions, RNS serves as the catch-all for regulatory announcements not explicitly defined elsewhere.
2021-08-15 English
After Review of Phase II Data, Israeli Ministry of Health Authorizes Initiation of a Multi-Center, Randomized Phase IIb Clinical Trial Evaluating Allocetra in Severe and Critical COVID-19 Patients
Report Publication Announcement Classification · 1% confidence The document is extremely short (1765 characters) and explicitly states, "Attached hereto is a report on *6k* *6k15082021_isa.pdf*". This structure indicates that the document itself is an announcement about the publication of another report (a Form 6-K, which is a general SEC filing for foreign private issuers, often used for material events). According to Rule 2, when a document is short and announces the availability of a report, it should be classified as a Report Publication Announcement (RPA). The presence of the Israel Securities Authority and Tel Aviv Stock Exchange context confirms it is a regulatory filing announcement, but RPA is more specific for this announcement format.
2021-08-15 English
Announces Second Quarter 2021 Financial Results and Provides a Business Update
Earnings Release Classification · 1% confidence The document is explicitly titled 'Form 6-K' and is filed by a 'Foreign Private Issuer' with the SEC. The content primarily consists of a press release dated August 9, 2021, announcing the company's financial results for the second quarter of 2021 and providing a business update, including clinical trial progress and corporate highlights. A Form 6-K is generally used to report material information that the company is required to disclose to its home country's regulators or stock exchange, or that it voluntarily discloses to the public. Since this filing contains the initial announcement of quarterly financial results and business updates, it aligns closely with the purpose of an Earnings Release (ER). However, the filing itself is the Form 6-K wrapper, which often contains the press release. Given the options, the content is a comprehensive update including financial results, which is more detailed than a typical 'ER' (which is usually just the highlights). The document structure (Form 6-K containing a press release detailing Q2 2021 results) strongly suggests it is an official periodic report submission. Since 'IR' (Interim/Quarterly Report) is defined as a *comprehensive* financial report for a shorter period, and this document contains the financial results summary and extensive business commentary, it fits the scope of an Interim Report, even though it is submitted via Form 6-K. If the document were *only* the press release announcing the results, 'ER' might be considered, but the inclusion of detailed financial figures and the formal SEC filing structure points towards a more comprehensive periodic filing. Revisiting the definitions: 'ER' is 'Initial announcement of quarterly/periodical financial results (key highlights only)'. 'IR' is 'Comprehensive financial report for a period shorter than a year (e.g., half-year)'. The document contains the full financial summary for Q2 2021 (Net Loss, R&D, G&A expenses, cash position) alongside extensive business updates. This level of detail suggests it is more than just 'key highlights' (ER) and functions as the comprehensive quarterly disclosure, making 'IR' the most appropriate fit for the *content* being disclosed, despite the *form* being 6-K. Q2 2021
2021-08-09 English
Announces Second Quarter 2021 Financial Results and Provides a Business Update
Report Publication Announcement Classification · 1% confidence The document is very short (1765 characters) and explicitly states, "Attached hereto is a report on*6k* *6k09082021_isa.pdf*". This structure indicates that the document itself is an announcement about the publication of another report (a Form 6-K, which is a general SEC filing for foreign private issuers, often used for material events). According to Rule 2, when a document is short and announces the attachment or publication of a report, it should be classified as a Report Publication Announcement (RPA). Since this is a regulatory filing announcement, RPA is the most appropriate specific code, rather than the general fallback RNS, as it clearly signals the release of a report.
2021-08-09 English

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