Financial Performance - The net loss for the three months ended June 30, 2024, was $3.096 million, compared to a net loss of $6.792 million for the same period in 2023, indicating an improvement of about 54%[6] - The net loss for the six months ended June 30, 2024, was $7,236 thousand, compared to a net loss of $14,010 thousand for the same period in 2023[11] - The company reported operating loss of $2.986 million for the three months ended June 30, 2024, compared to an operating loss of $6.649 million for the same period in 2023, reflecting a reduction of about 55%[6] - Basic and diluted loss per share improved to $(0.16) for the three months ended June 30, 2024, compared to $(0.37) for the same period in 2023[6] Assets and Liabilities - As of June 30, 2024, total assets decreased to $31.902 million from $36.831 million as of December 31, 2023, representing a decline of approximately 13.5%[4] - Total current liabilities decreased to $2.841 million from $6.061 million, a reduction of approximately 53%[4] - Total shareholders' equity decreased to $28.562 million from $30.084 million, a decline of approximately 5.1%[4] - The company reported total accrued expenses and other liabilities of $2,538,000 as of June 30, 2024, down from $4,001,000 as of December 31, 2023, indicating a reduction of about 37%[34] Cash Flow and Financing - Cash and cash equivalents increased significantly to $3.747 million from $0.813 million, marking a growth of over 360%[4] - The company reported a net cash used in operating activities of $6,307 thousand for the six months ended June 30, 2024, down from $12,807 thousand in the prior year[11] - Cash and cash equivalents at the end of the period were $4,166 thousand, an increase from $3,862 thousand at the end of June 30, 2023[11] - The company raised $4,943 thousand from the issuance of shares and warrants during the six months ended June 30, 2024[11] Research and Development - Research and development expenses for the three months ended June 30, 2024, were $1.999 million, down from $5.035 million in the same period of 2023, a decrease of approximately 60%[6] - Research and development expenses for the three months ended June 30, 2024, were $145 thousand, compared to $122 thousand for the same period in 2023, reflecting an increase of approximately 18.9%[56] Share-Based Compensation - The company incurred share-based compensation expenses of $771 thousand for the six months ended June 30, 2024[11] - For the three months ended June 30, 2024, the company recognized share-based compensation expenses of $388 thousand, compared to $511 thousand for the same period in 2023, reflecting a decrease of approximately 24%[56] - For the six months ended June 30, 2024, total share-based compensation expenses amounted to $771 thousand, down from $1,144 thousand in the same period of 2023, indicating a decline of about 32.5%[56] Future Outlook - The company expects to continue incurring losses for the foreseeable future and will need to raise additional financing to support its development activities[16] - The company plans to finance its operations through equity securities issuances and, in the longer term, revenues[17] - The company’s management believes that current financial resources will be sufficient for at least twelve months following the filing of the financial statements[17] Other Financial Information - The company has not generated any revenues or product sales and has not achieved profitable operations since its inception[15] - The company has not paid any royalties to the Israeli Innovation Authority as of June 30, 2024, despite receiving approximately $9.9 million in grants[38] - The company entered into a securities purchase agreement on May 27, 2024, for the issuance of 2,060,000 Ordinary Shares at a price of $1.40 per share[39] - The total unrecognized estimated compensation cost related to outstanding non-vested stock options was $1,061 thousand, expected to be recognized over a weighted average period of 1.36 years[50]

First patient dosed with AllocetraTM in thumb osteoarthritis, a degenerative, debilitating and progressive disease that affects millions of people Thumb osteoarthritis currently has no FDA-approved therapy and no effective long-term treatments Ness-Ziona, Israel, June 24, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (NASDAQ:ENLV, the "Company"))), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the first patient has been dosed in an investigator-initiated, randomi ...

Ness-Ziona, Israel, June 20, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (NASDAQ:ENLV, the "Company" or "Enlivex"))), a clinical-stage macrophage reprogramming immunotherapy company, is pleased to invite investors to a webinar on June 25, 2024, at 4:15 p.m. ET. The event, hosted by RedChip Companies, will feature Enlivex's Chief Executive Officer, Dr. Oren Hershkovitz, who will share insight into the Company's leading product candidate, Allocetra™. Enlivex's Chief Executive Officer will discuss the r ...

Ness-Ziona, Israel, June 17, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company, today released a positive interim data readout from a Phase I/II investigator-initiated clinical trial of AllocetraTM in patients with endstage knee osteoarthritis who had been indicated for knee replacement surgery. During the three-month period post injection of AllocetraTM, only a single patient (1/9, 11%) decided to move forward w ...

Key Highlights Enrolled patients with severe knee osteoarthritis who were indicated for knee-replacement surgery received a single local injection of AllocetraTM into the knee as a "last resort" Three-month data readout showed a significant reduction in pain and a favorable safety profile Pain reduction: patients reported an average pain reduction of 64% from baseline Complete Pain Resolution: 33% of patients reported complete pain relief, from an average pain level of 9 to a pain level of 0; pain scale use ...

Core Insights - Enlivex Therapeutics has received authorization from the Israeli Ministry of Health to initiate a Phase I/II trial for Allocetra™ targeting thumb osteoarthritis, a condition with no FDA-approved therapies [1][4] - The trial will be led by Dr. Amir Oron, focusing on the role of macrophages in osteoarthritis and the potential of Allocetra™ as a disease-modifying treatment [2][4] - Allocetra™ is designed to reprogram macrophages into their homeostatic state, potentially addressing unmet medical needs in various diseases [5][8] Company Overview - Enlivex Therapeutics is a clinical-stage company specializing in macrophage reprogramming immunotherapy, with Allocetra™ as its primary product [8] - The company aims to develop novel therapies that can improve the quality of life for patients suffering from osteoarthritic conditions [4] Trial Details - The Phase I/II trial will recruit up to 46 patients, consisting of a safety run-in phase followed by a randomized, placebo-controlled stage [3] - The primary safety endpoint will assess adverse events, while efficacy will be measured through changes in pain and function over 12 months [3] Disease Context - Basal thumb osteoarthritis is a chronic condition that significantly impacts daily activities, with a prevalence of 5.8% in 50-year-old males and 7.3% in females, increasing to 33.1% and 39.0% in those aged 80 [6][7] - Current treatments for thumb osteoarthritis are limited, and the condition often progresses despite conservative management [7]

The potential gross proceeds from the warrants, if fully exercised on a cash basis, will be approximately $10.0 million. No assurance can be given that any of the warrants will be exercised. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes. H.C. Wainwright & Co. acted as the exclusive placement agent for the offering. The securities described above were offered and sold by the Company in a registered direct offering pursuant to a "shelf" regist ...

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein or any other securities, nor shall there be any sale of the securities described herein or any other securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. Nes-Ziona, Israel, May 29, 2024 (GLOBE NEWSWIRE) -- Enlive ...

Single healthcare-focused institutional investor $5 million upfront with up to an additional $10 million of gross proceeds upon the exercise in full of clinical milestone-linked warrants Nes-Ziona, Israel, May 28, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company, today announced that it has entered into a definitive agreement with a single healthcare-focused institutional investor for the issuance and sale in a ...

Nes-Ziona, Israel, May 28, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company, today announced that it has entered into a definitive agreement with a single healthcare-focused institutional investor for the issuance and sale in a registered direct offering of an aggregate of 3,571,429 ordinary shares (or ordinary share equivalents in lieu thereof) and clinical milestone-linked warrants, composed of Series A warran ...