Revelation Biosciences, Inc. - REVB STOCK NEWS

Revelation Biosciences (NASDAQ: REVB) announced FDA acceptance of its investigational new drug (IND) application for Gemini. The company will initiate a US-based Phase 1b clinical study to evaluate Gemini as a preconditioning treatment in chronic kidney disease (CKD) patients. The study will enroll up to 40 subjects across 5 cohorts, focusing on safety and tolerability of a single Gemini dose. Positive results would enable a Phase 2 study targeting the reduction of acute kidney injury in patients undergoing coronary artery bypass graft and cardiac valve surgery.

Revelation Biosciences (NASDAQ: REVB) has completed the GMP manufacture of Gemini drug product for upcoming clinical studies in the United States. This manufacturing milestone is a key requirement for FDA's Investigational New Drug (IND) application. The current Gemini supply will support both the upcoming Phase 1b clinical trial in chronic kidney disease (CKD) patients and future Phase 2 studies. The company expects to report top-line results, including pharmacokinetic, pharmacodynamic, and safety data, in the first half of 2025.

Revelation Biosciences (NASDAQ: REVB) reported financial results for Q3 2024. The company ended the period with $6.5 million in cash and cash equivalents, down from $12.0 million at the end of 2023. Net loss for Q3 2024 was $2.2 million ($0.84 per share), compared to a $2.6 million loss in Q3 2023. For the nine months ended September 30, 2024, net loss was $13.3 million. The company received $3.8 million from warrant exercises in August 2024 and completed GMP manufacture of Gemini clinical drug supply. Management believes current cash position is sufficient to fund operations into 2025.

Revelation Biosciences (NASDAQ: REVB) announced statistically significant, dose-dependent increases of interleukin-10 (IL-10) in response to Gemini treatment, using a high sensitivity analysis. This follows the previously reported positive topline data from the Phase 1 clinical study. Key findings include:

- Gemini induced significant changes in circulatory IL-10 at 2 hours post-dose across all dose levels (p-value < 0.05)
- IL-10 increases were 27-fold, 162-fold, and 309-fold for low, mid, and high dose groups, respectively
- No significant increase in pro-inflammatory IL-1β and TNF-α was observed
- Results confirm TLR4 binding unique to Gemini and reprogramming of innate immune response
- Findings are consistent with prior preclinical studies

The company plans to move rapidly into a Phase 1b study in late 2024, focusing on potential benefits for patients, including prevention of AKI following cardiac surgery.

Revelation Biosciences Inc. (NASDAQ: REVB) has announced a definitive agreement for the immediate exercise of certain outstanding warrants. The exercise will result in $3.8 million in gross proceeds for the company. Key details include:

- Exercise of warrants to purchase up to 2,548,060 shares of common stock
- Reduced exercise price of $1.50 per share
- Issuance of new warrants in a private placement
- New warrants for up to 5,096,120 shares at $1.00 per share
- Five-year term for new warrants
- Roth Capital Partners acting as financial advisor

The company plans to file a resale registration statement within 20 days of closing to register the resale of shares underlying the new warrants.

Revelation Biosciences (NASDAQ: REVB), a clinical-stage biopharmaceutical company, reported its financial results for Q2 and H1 2024. Key highlights include:

- Completed dosing of first-in-human phase 1 clinical study of Gemini
- Announced positive phase 1 clinical data meeting primary safety endpoint
- Cash and cash equivalents of $12.1 million as of June 30, 2024
- Net loss of $8.4 million for Q2 2024, compared to $1.4 million in Q2 2023
- Net loss of $11.1 million for H1 2024, compared to net income of $4.7 million in H1 2023

The company believes its current cash position is sufficient to fund operations through 2024.

Revelation Biosciences announced that its Phase 1 clinical study of Gemini met its primary safety endpoint and showed statistically significant biomarker activity. The study, conducted with 40 healthy volunteers aged 18-55 in Australia, found that Gemini was safe and well-tolerated at pharmacologically active doses. Significant dose-dependent changes in key biomarkers, such as interleukin-1RA, neutrophil gelatinase lipocalin, C-reactive protein, and IL-6, were observed, indicating the drug's immunostimulatory effects. The Phase 1 results support further development across multiple indications, including acute kidney injury prevention and postoperative infection prevention. The maximum tolerated dose identified will guide the upcoming Phase 1b study in chronic kidney disease patients planned for late 2024.

Revelation Biosciences (NASDAQ: REVB) has completed enrollment and dosing of its first-in-human Phase 1 clinical study (RVL-HV02) for Gemini, conducted in Australia.

The study evaluated escalating doses of intravenously administered Gemini in 40 healthy individuals aged 18-55. The forthcoming top-line data will assess safety and tolerability, along with biomarkers to demonstrate immune response stimulation.

Positive data could support Gemini's future development for multiple indications, including reducing acute kidney injury and post-surgical infections.

Preclinical studies have shown promising results in reducing AKI severity and bacterial infections.

Revelation's CEO, James Rolke, highlighted the milestone's significance for addressing critical unmet needs.

Revelation Biosciences, Inc. (NASDAQ: REVB) announced its financial results for the three months ended March 31, 2024. The company reported $14.6 million in cash and cash equivalents, up from $12.0 million in December 2023. They stated that the current cash is enough to fund operations through 2024. However, they reported a net loss of $2.7 million for the quarter, with significant expenses related to GEM-AKI and GEM-SSI clinical studies impacting their financials.