INFINITI
3 years ago
Filing of Certain Prospectuses and Communications in Connection With Business Combination Transactions (425)
Source: Edgar (US Regulatory)
Filed by Seneca Biopharma, Inc.
Pursuant to Rule 425 under the Securities Act of 1933, as
amended and deemed filed pursuant to Rule 14a-12
under the Securities Exchange Act of 1934, as amended
Subject Company: Seneca Biopharma, Inc.
(Commission File No. 001-33672)
To Our Valued Stockholders:
We are writing to reaffirm our strong belief that Seneca Biopharma’s proposed merger with Leading Biosciences (the “Merger”) is in the best interests of all stockholders and urge your support at the Company’s Special Meeting scheduled for April 9, 2021.
After a thorough review process that included an evaluation of multiple alternatives, Seneca’s Board ultimately concluded the Merger offers the most compelling opportunity for its stockholders. Seneca’s board recommends voting in favor of the proposals (including the reverse stock split) for the following reasons:
· The post-Merger combined company (to be re-named Palisade Bio) will be well-positioned to pursue Leading Biosciences’ pipeline of novel therapeutics
o LBS’s lead candidate, LB1148, has demonstrated efficacy signals in three clinical trials
o LB1148 is aimed at multiple indications each with large addressable markets
o FDA fast track designation has already been granted to expedite regulatory review of LB1148 based on its potential to treat serious conditions and fill unmet medical needs
o LB1148 has a clear regulatory approval pathway, including Phase 3 clinical trials scheduled to commence in 2021 with multiple potentially value-creating clinical data readouts over the following 12 to 18 months
o Attractive co-development and licensing agreement with Newsoara provides potential for approvals for and access to the Chinese market
o LBS plans to build a pipeline of new candidates on its integrated protease assay platform to diversify the company’s risk profile and create potential for multiple shots on goal
· Palisade Bio has capital support from a regional hospital system and Altium Capital and transaction has the endorsement of leading proxy advisory firm ISS
o After reviewing Seneca’s proposed Merger with LBS, Institutional Shareholder Services (“ISS”) has recommended stockholders vote FOR both the Merger and the reverse stock split
o LBS has raised in excess of $35 million from life sciences investors since inception, with a hospital system as its largest investor to date, helping to validate the market potential and benefits to hospitals
o Altium Capital has committed to investing $20.0 million in Palisade prior to the closing of the Merger
o Listing on Nasdaq will enable Palisade Bio to attract a broader range of stockholders, including institutional investors that are averse to companies not listed on a major exchange
· Accomplished and proven management team and Board of Directors
o Broad base of pharmaceutical expertise and successes
o Medical, clinical, and regulatory expertise leading to successes in clinical studies
· The Merger provides a compelling value proposition for Seneca’s stockholders
o Following the Merger, Seneca stockholders will own ~26% of Palisade Bio
o Seneca has negotiated a Contingent Value Right (“CVR”) that preserves the ability of its stockholders, and certain of its warrant holders, to potentially recognize additional value if Seneca's legacy assets are sold or licensed within 18 months of the merger closing. The CVR would entitle Seneca stockholders to 80% of the monetization of the company’s assets. However, only upon completion of the merger will the CVR be issued to Seneca stockholders of record as of the record date. If the merger is not completed, the CVR will not be created and Seneca stockholders will not receive one. If the merger is completed, Seneca will announce the timing and protocol for receiving the CVR.
As indicated in the Company’s proxy statement (link: https://www.sec.gov/Archives/edgar/data/0001357459/000117184321000977/f424b3_021121.htm), Seneca’s Board recommends stockholders vote FOR all proposals at the Special Meeting. Proposals #1 and #2 are critical because the Merger cannot be consummated without their approval. We therefore urge all stockholders to vote FOR the merger for the reasons outlined above, including proposal #1, the reverse stock split, which is a pre-requisite to close the merger and enables Palisade Bio to meet Nasdaq’s listing requirements.
Recent changes in how some brokerage firms cast votes on behalf of their clients has impacted voter turnout at Seneca and all public companies with a meaningful retail shareholder base. As a result, based on the higher vote requirement of a majority of all outstanding shares needed to approve the reverse stock split (compared to merely a majority of votes cast required for all other proposals), Seneca adjourned the Special Meeting until April 9, 2021 to enable additional time for stockholders to consider and vote on all proposals.
Seneca’s Board, as well as LBS and Altium, remains fully supportive of the Merger. We urge all stockholders to support it as well by voting FOR all proposals at the Special Meeting. Regardless of the number of shares of our common stock that you own, even if you no longer hold Seneca shares, your vote is very important and will be greatly appreciated. Thank you for your continued support, interest, and investment in Seneca Biopharma, Inc.
Sincerely,
Seneca Biopharma
TraderInvictus
3 years ago
News
Leading BioSciences Announces FDA Fast Track Designation Granted to LB1148 for the Treatment of Postoperative Gastrointestinal Dysfunction Associated with Pediatric Cardiovascular Surgery
LBS expects to initiate a pivotal trial in 2021
https://www.globenewswire.com/fr/news-release/2021/01/13/2157904/0/en/Leading-BioSciences-Announces-FDA-Fast-Track-Designation-Granted-to-LB1148-for-the-Treatment-of-Postoperative-Gastrointestinal-Dysfunction-Associated-with-Pediatric-Cardiovascular-.html
3 janv. 2021 08h30 HE | Source : Leading BioSciences
CARLSBAD, Calif., Jan. 13, 2021 (GLOBE NEWSWIRE) -- Leading BioSciences, Inc. (“LBS”), a privately held company that recently entered into a definitive agreement for a reverse merger with Seneca Biopharma, Inc. (Nasdaq: SNCA) to form Palisade Bio, Inc., announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to LB1148 for the treatment of postoperative gastrointestinal (GI) dysfunction associated with pediatric heart surgery.
“Even with high success rates of neonatal heart surgery, longer-term outcomes in pediatric patients are, to a great extent, dependent upon the speed of postoperative recovery of GI function,” said Dr. Michael Dawson, Chief Medical Officer of Leading BioSciences. “By awarding Fast Track Designation to LB1148 for the treatment of pediatric patients undergoing open-heart surgery, the FDA has recognized LB1148’s potential to accelerate return of bowel function and reduce the risk of serious and life-threatening complications associated with corrective surgeries for these patients, a condition for which no therapy currently exists. This is an important acknowledgement and will improve the frequency of our dialogue with the agency as we initiate our pivotal study.”
The FDA Fast Track program is intended to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. With Fast Track designation LBS is eligible for greater access to the FDA for the purpose of expediting clinical development and creates eligibility for accelerated approval and priority review of LB1148.
Previously, LBS announced positive topline data from a Phase 2, randomized, double-blind, placebo-controlled, study that enrolled 120 adult open-heart surgery patients. This trial evaluated return of bowel function in adult patients undergoing open-heart surgery with cardiopulmonary bypass. The LB1148-treated group demonstrated a statistically significant improvement of approximately 30% in the median time to return of normal bowel function as compared to the placebo treatment group (p<0.001). Generally, treatment with LB1148 was well tolerated. Adverse events were similar between the treatment groups and not unexpected for the subject population.
In addition to adult open-heart surgery patients, there is a tremendous unmet need for improving GI recovery in neonates undergoing heart surgery. By accelerating a return of GI function and full feeding following surgery, LB1148 may minimize the risk of developmental delays and other serious complications. LBS is planning to initiate a randomized, double-blind, placebo-controlled, multicenter Phase 3 clinical trial of LB1148 in neonatal patients undergoing elective on-pump open-heart surgery to correct congenital heart defects in 2021.
Tom Hallam, Ph.D., Chief Executive Officer of Leading BioSciences added, “There are currently no therapies available to treat GI dysfunction in pediatric patients undergoing open-heart surgery. We are thrilled that the FDA granted Fast Track designation to LB1148 for this indication. We believe this recognizes LB1148’s potential to demonstrate meaningful improvements in bowel recovery that are commensurate with the improvements demonstrated in our Phase 2 study in adult heart surgery patients.”
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.
About Leading BioSciences, Inc.
Leading BioSciences is developing novel therapeutics designed to improve human health through therapeutic protection of the gastrointestinal mucosal barrier. LBS’ initial focus is combatting the interruption of GI function (ileus) following major surgery in order to reduce recovery times and shorten the duration of patient hospital stays. Additionally, LBS believes that its investigational therapies have the potential to prevent the formation of postoperative adhesions (reducing hospital re-admissions and additional surgeries), as well as to address the myriad health conditions and complications associated with chronic disruption of the gastrointestinal mucosal barrier. As of December 2020, Leading BioSciences has entered into a definitive agreement with Seneca Biopharma, Inc. under which a wholly owned subsidiary of Seneca will merge with Leading BioSciences in an all-stock transaction. The combined company is expected to operate under the name Palisade Bio, Inc. (Nasdaq: PALI), upon completion of the merger.
No Offer or Solicitation:
This communication will not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor will there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities in connection with the proposed merger shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.
Important Additional Information Will be Filed with the SEC
In connection with the proposed transactions between LBS and Seneca, Seneca filed a registration statement on Form S-4 that contained a proxy statement and prospectus with the Securities Exchange Commission (“SEC”) on December 23, 2020, but the registration statement has not yet become effective. This communication is not a substitute for the registration statement or the proxy statement or any other documents that Seneca may file with the SEC or send to its stockholders in connection with the proposed transactions. BEFORE MAKING ANY VOTING DECISION, SENECA URGES INVESTORS AND STOCKHOLDERS TO READ THESE MATERIALS CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT SENECA, THE PROPOSED TRANSACTION AND RELATED MATTERS.
You may obtain free copies of the registration statement, proxy statement and all other documents filed or that will be filed with the SEC regarding the proposed transaction at the website maintained by the SEC at www.sec.gov. The registration statement is available free of charge on Seneca’s website at www.senecabio.com, by contacting Seneca’s Investor Relations by phone at (301) 366-4960, or by electronic mail at investor@senecabio.com. Investors and stockholders are urged to read the registration statement, proxy statement, prospectus and the other relevant materials when they become available before making any voting or investment decision with respect to the proposed transaction.
Participants in the Solicitation
Seneca and LBS, and each of their respective directors and executive officers and certain of their other members of management and employees, may be deemed to be participants in the solicitation of proxies in connection with the proposed transaction. Information about Seneca’s directors and executive officers is included in Seneca’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on March 27, 2020, and the proxy statement for Seneca’s 2020 annual meeting of stockholders, filed with the SEC on June 24, 2020. Additional information regarding these persons and their interests in the transaction is included in the proxy statement relating to the transaction. These documents can be obtained free of charge from the sources indicated above.
Cautionary Statement Regarding Forward-Looking Statements
This communication contains “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements related to the timing and results of clinical trials, and other statements that are not historical facts. Any statements contained in this communication that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as “expect,” “intend,” “plan,” “anticipate,” “believe,” “will,” and similar expressions and their variants. These forward-looking statements are based upon LBS’s current expectations. Forward-looking statements involve risks and uncertainties, and actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. Except as required by law, LBS expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in LBS’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
Leading BioSciences Media Relations Contact:
Darren Opland, Ph.D.
LifeSci Communications
darren@lifescicomms.com
Leading BioSciences Investor Relations Contact:
Corey Davis, Ph.D.
LifeSci Advisors
cdavis@lifesciadvisors.com
Corporate Contact:
Justin Stege, Ph.D.
justin.stege@leadingbiosciences.com
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