On April 27, 2021 Leading BioSciences, Inc. a late-stage biopharma company advancing therapies for acute and chronic gastrointestinal (GI) complications, reported the closing of its previously announced merger transaction with Seneca Biopharma, Inc. ("Seneca") (Press release, Neuralstem, APR 27, 2021, View Source [SID1234578595]). Seneca shareholders previously approved the transaction. The combined, publicly traded company will operate under the name Palisade Bio, Inc. ("Palisade Bio" or the "Company"), and its common stock is expected to commence trading on the Nasdaq Capital Market on April 28, 2021, under the ticker symbol "PALI."
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In addition, the Company has announced the closing of the previously announced private placement led by Altium Capital that included $20.0 million in cash plus the cancelation of outstanding principal and interest pursuant to the notes previously issued to the investor.
"This merger marks a tremendous milestone for all stakeholders in the newly formed Palisade Bio, a now publicly listed company with a promising pipeline of oral therapies for GI complications," said Tom Hallam, Ph.D., chief executive officer of Palisade Bio. "We are thrilled to have the added financial flexibility provided by Seneca and the private placement financing as we advance our drugs through clinical development. Our lead asset, LB1148, has already demonstrated efficacy signals in clinical trials that we believe may support a potential paradigm shift in the restoration of post-operative GI function following a wide range of common surgeries. There are more than six million of these procedures annually in the U.S. Now, as the combined company, Palisade Bio, we plan to build on this momentum with multiple clinical data readouts planned over the next 12 to 18 months."
Leading BioSciences Inc.’s management team will lead the merged company, Palisade Bio, following completion of the merger transaction. Palisade Bio will focus on developing therapeutics for broad GI disorders and complications. The Company’s lead asset, LB1148, is a patent-protected oral formulation of a protease inhibitor that neutralizes the activity of digestive proteases released from the gut during surgery. LB1148 has demonstrated the potential to improve restoration of normal GI function following major surgery and reduce certain postoperative complications such as abdominal adhesions. The FDA has granted LB1148 Fast Track Designation for treating postoperative GI dysfunction in pediatric patients who undergo open-heart surgery based on its potential to treat this serious condition, positioning LB1148 for potential accelerated approval and priority review. Palisade expects to initiate a Phase 2/3 study of LB1148 for the treatment of postoperative GI dysfunction associated with pediatric cardiovascular surgery and report Phase 2 data read-outs in GI surgery by year-end 2021.
Conference Call and Webcast Details:
Management will host a conference call and webcast with slides at 11:00 AM Eastern Time on Wednesday, April 28, 2021, for investors regarding this announcement with details as follows:
About LB1148
LB1148 is an oral formulation of a broad-spectrum serine protease inhibitor designed to neutralize the activity of potent digestive proteases released from the gut during surgery. Evidence suggests that the release of digestive proteases contributes to the temporary loss of normal gastrointestinal function and formation of postoperative adhesions. By inhibiting the activity of these digestive proteases, LB1148 has the potential to prevent damage to GI tissues, accelerate the time to return of normal GI function, and shorten the duration of costly post-surgery hospital stays