Revelation Biosciences - REVB STOCK NEWS

Revelation Biosciences (NASDAQ: REVB) has announced a 1-for-16 reverse stock split effective January 28, 2025, following stockholder approval on January 17, 2025. The stock will continue trading under the symbol 'REVB' with a new CUSIP number 76135L606.

The reverse split aims to increase the market price per share to regain compliance with Nasdaq Capital Market's minimum bid listing requirements. Proportionate adjustments will be made to conversion and exercise prices of warrants, restricted stock units, stock options, and shares under equity incentive plans.

The company also announced the start of its Prime Phase 1b clinical study of Gemini in CKD patients, with dosing to begin in Mid-February 2025 and topline data expected Mid-Year.

Revelation Biosciences (NASDAQ: REVB) has initiated its PRIME (PReconditioning IMmunostimulatory Evaluation) Phase 1b clinical study for Gemini in patients with Stage 3 and 4 Chronic Kidney Disease (CKD). The study will evaluate escalating doses of intravenously administered Gemini across five cohorts, enrolling up to forty patients in a US-based multi-site placebo-controlled trial.

Dosing is scheduled to begin in mid-February, with topline data expected by mid-year. The results will include safety, tolerability, and biomarkers of target activity. The data from this PRIME clinical study will support future development in both the GEM-CKD and GEM-AKI programs.

Revelation Biosciences (NASDAQ: REVB) has announced a special meeting of stockholders scheduled for January 17, 2025. The key focus is on Proposal 2, which involves redomiciling the company from Delaware to Nevada, potentially saving the company over $200,000 annually in franchise tax fees.

The Board of Directors recommends shareholders vote in favor of all proposals. The meeting will be held virtually via Zoom videoconference, with telephone participation options available. Shareholders can vote by contacting Advantage Proxy at the provided toll-free numbers.

Revelation Biosciences (NASDAQ: REVB) has secured continued listing on the Nasdaq Stock Market following a decision by the Nasdaq Hearings Panel. The company must maintain its stock price at or above $1.00 for at least ten consecutive trading days by February 14, 2025. The Panel also confirmed REVB's compliance with the Equity Requirement of Listing Rule 5550(b)(1), addressing a previous delisting notice from August 14, 2024.

Recent developments include a successful $4 million warrant exercise on December 3, 2024, and FDA acceptance of the Gemini IND on December 2, 2024. The company plans to initiate a Phase 1b clinical study for chronic kidney patients in the first half of 2025, following the successful GMP manufacture of the Gemini drug product for clinical trials.

Revelation Biosciences (NASDAQ: REVB) announced a definitive agreement for the immediate exercise of outstanding warrants to purchase up to 4,064,040 shares of common stock at $1.00 per share, generating $4 million in gross proceeds. The exercising holders will receive new warrants in a private placement: Class F warrants for up to 4,064,040 shares and Class G warrants for up to 6,096,060 shares, both at $1.00 per share. Class F warrants have a 2-year term while Class G warrants have a 5-year term. Roth Capital Partners is acting as financial advisor for this transaction.

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.