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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d)
of
the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): January 29, 2024
PALISADE
BIO, INC.
(Exact
name of Registrant as Specified in Its Charter)
| Delaware |
|
001-33672 |
|
52-2007292 |
(State
or Other Jurisdiction
of
Incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
7750
El Camino Real
Suite
2A |
|
|
| Carlsbad,
California |
|
92009 |
| (Address
of Principal Executive Offices) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: (858) 704-4900
N/A
(Former
name or former address, if changed since last report)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
| ☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| |
|
| ☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| |
|
| ☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| |
|
| ☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
| Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
| Common
Stock, par value $0.01 per share |
|
PALI |
|
Nasdaq
Capital Market |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item
7.01 Regulation FD Disclosure.
On
January 29, 2024, Palisade Bio, Inc. (the “Company”) made the following disclosures:
Informative
Video
The
Company posted an informative video with the Company’s Chief Executive Officer and Chief Medical Officer, discussing the Company’s
current developments.
A
link to the video may be found at https://www.virtualinvestorco.com/wtm-pali-positive-preclinical-data and is incorporated by reference
herein.
Press
Release and Poster presented at Crohn’s & Colitis Congress
The
Company also announced the presentation of positive preclinical data of its lead asset, PALI-2108, presented in a poster at the Crohn’s
& Colitis Congress held from January 25 through January 27, 2024, in Las Vegas, Nevada.
A
copy of the press release is attached hereto as Exhibit 99.1.
A
copy of the poster titled “Local Bioactivation and Efficacy of PALI-2108: a Promising PDE4 Inhibitor Prodrug for Ulcerative
Colitis Treatment” is available on the Company’s website on the Scientific Publications page at https://www.palisadebio.com/scientific-publications/.
The
information in this Item 7.01, including Exhibit 99.01, is being furnished and shall not be deemed “filed” for purposes of
Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities
of that Section, nor shall it be deemed incorporated by reference into any registration statement or other filing under the Securities
Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item
9.01 Financial Statement and Exhibits.
Forward-Looking
Statements
This
Current Report on Form 8-K contains forward-looking statements for purposes of the “safe harbor” provisions of the Private
Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding the Company’s intentions,
beliefs, projections, outlook, analyses or current expectations concerning, among other things: the extent of our cash runway; our ability
to successfully develop our licensed technologies; estimates about the size and growth potential of the markets for our product candidates,
and our ability to serve those markets, including any potential revenue generated; future regulatory, judicial, and legislative changes
or developments in the United States (U.S.) and foreign countries and the impact of these changes; our ability to maintain our Nasdaq
listing of our securities; our ability to build a commercial infrastructure in the U.S. and other markets; our ability to compete effectively
in a competitive industry; our ability to identify and qualify additional manufacturers to provide API and manufacture drug product;
our ability to enter into commercial supply agreements; the success of competing technologies that are or may become available; our ability
to attract and retain key scientific or management personnel; the accuracy of our estimates regarding expenses, future revenues, capital
requirements and needs for additional financing; our ability to obtain funding for our operations; our ability to attract collaborators
and strategic partnerships; and the impact of the COVID-19 pandemic on our business, and operations, and supply. Any statements contained
in this communication that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking
statements are based upon the Company’s current expectations. Forward-looking statements involve risks and uncertainties. The Company’s
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, which include, without limitation, the Company’s ability to advance its clinical programs, the
uncertain and time-consuming regulatory approval process; and the Company’s ability to achieve additional financing to fund future
operations. Additional risks and uncertainties can be found in the Company’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2022, filed with the Securities and Exchange Commission (“SEC”) on March 22, 2023 as well as the Company’s
Quarterly Report on Form 10-Q, for the nine month period ended September 30, 2023, filed with the SEC on November 9, 2023. These forward-looking
statements speak only as of the date hereof and the Company 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 the Company’s expectations with
regard thereto or any change in events, conditions or circumstances on which any such statements are based.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report on Form 8-K to be signed on its
behalf by the undersigned hereunto duly authorized.
| Date:
January 29, 2024 |
Palisade
Bio, Inc. |
| |
|
|
| |
By: |
/s/
J.D. Finley |
| |
|
J.D.
Finley |
| |
|
Chief
Executive Officer |
Exhibit
99.1
Palisade
Bio Announces Positive Preclinical Data of Lead Program
PALI-2108
at the 2024 Crohn’s & Colitis Congress
–
Preclinical data demonstrated PALI-2108 to be safe and well tolerated
–
PALI-2108 is orally delivered and colon activated allowing for local activity with low systemic exposure
–
Company advancing PALI-2108 for the treatment of moderate-to-severe ulcerative colitis (UC) toward Phase 1 clinical study, expected to
commence in 2024
Carlsbad,
CA – January 29, 2024 – Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”),
a biopharmaceutical company focused on developing novel therapeutics for serious chronic gastrointestinal (GI) diseases, today announced
the presentation of positive preclinical data of its lead asset, PALI-2108 at the Crohn’s & Colitis Congress, which
was held on January 25-27, 2024 in Las Vegas, NV.
The
preclinical data was presented in a poster titled, Local Bioactivation and Efficacy of PALI-2108: A Promising PDE4 Inhibitor Prodrug
for Ulcerative Colitis Treatment. PALI-2108 is the Company’s orally administered, locally acting colon-specific phosphodiesterase-4B
(PDE4B) inhibitor prodrug in development for patients affected by moderate-to-severely active ulcerative colitis (UC). The poster is
available on the Scientific Publications page of the Company’s website.
Mitchell
Jones, M.D., Ph.D., Chief Medical Officer of Palisade Bio, commented, “PALI-2108 continues to demonstrate promise as a novel therapy
for UC, with colon-selective bioactivation, an expanded therapeutic window, reduced CNS toxicity, potent PDE4 inhibitory activity, and
impressive efficacy in preclinical models. We are pleased with our growing body of evidence, including support for a precision medicine
approach and the selection of potential responders, which validate the continued development of this program. We are working diligently
to launch our Phase 1 study later this year, and we are eager to continue to gain experience on the potential of this groundbreaking
PDE4 inhibitor prodrug therapy. The journey ahead holds great promise for advancing UC treatment, and we are committed to making a meaningful
impact for patients.”
The
results presented at the Crohn’s and Colitis Foundation include several preclinical studies of PALI-2108, a novel oral PDE4 inhibitor
prodrug designed for the treatment of ulcerative colitis (UC). The Company’s research has focused on addressing the limitations
of current PDE4 inhibitors, such as CNS toxicity and systemic distribution, which often lead to therapy discontinuation.
In
preclinical studies, PALI-2108 demonstrated promising outcomes. In a DSS-induced UC mouse model, researchers observed a significant reduction
in disease activity index (DAI) score over time compared to the control group. Notably, body weight loss was attenuated in specific dosage
groups, showcasing the potential for targeted efficacy.
PALI-2108’s
unique design, incorporating a galactose-derived sugar moiety, allows for minimal absorption until cleaved by the colonic bacterium enzyme
β-glucuronidase. This feature ensures localized bioactivation, leading to colon-specific distribution with limited systemic exposure,
as confirmed by a tissue distribution study. The colon/plasma AUC ratio exceeding 200 further highlights PALI-2108’s preference
for the colon.
In
addition, the Company’s research demonstrates colon-selective bioactivation in oxazolone colitis-induced mice, negligible plasma
levels in duodenal and ileal tissue, and comparable target engagement with other PDE4 inhibitors. As well, a tolerated dose study in
dogs revealed no CNS toxicity or emesis over effective doses, addressing a critical concern associated with oral administration.
“PALI-2108
is emerging as a promising candidate for UC therapy, offering localized bioactivation, expanded therapeutic window, and potent PDE4 inhibitory
activity. We believe this innovative approach has the potential to revolutionize UC treatment and enhance patient outcomes,” added
Dr. Jones.
In
summary, results of the Company’s preclinical studies showed that PALI-2108 demonstrated:
| |
● |
Local bioactivation; |
| |
● |
Colon-specific distribution; |
| |
● |
Similar target engagement to other PDE4 inhibitors; |
| |
● |
Dose-dependent efficacy in a mouse UC model; and |
| |
● |
No systemic toxicity in dogs and large therapeutic window due to local activation. |
Inflammatory
bowel disease (IBD) represents a multi-billion-dollar market opportunity in need of innovative approaches, with current therapies achieving
a clinical remission rate of less than 20% on average.
About
Palisade Bio
Palisade
Bio is a biopharmaceutical company focused on developing novel therapeutics for serious chronic gastrointestinal diseases. The Company
believes that by using a targeted approach with its novel therapeutics it will transform the treatment landscape. For more information,
please go to www.palisadebio.com.
Forward
Looking Statements
This
communication contains “forward-looking” statements for purposes of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. Forward-looking statements include statements regarding the Company’s intentions, beliefs, projections,
outlook, analyses or current expectations concerning, among other things: the extent of our cash runway; our ability to successfully
develop our licensed technologies; estimates about the size and growth potential of the markets for our product candidates, and our ability
to serve those markets, including any potential revenue generated; future regulatory, judicial, and legislative changes or developments
in the United States (U.S.) and foreign countries and the impact of these changes; our ability to maintain the Nasdaq listing of our
securities; our ability to build a commercial infrastructure in the U.S. and other markets; our ability to compete effectively in a competitive
industry; our ability to identify and qualify manufacturers to provide API and manufacture drug product; our ability to enter into commercial
supply agreements; the success of competing technologies that are or may become available; our ability to attract and retain key scientific
or management personnel; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for additional
financing; our ability to obtain funding for our operations; our ability to attract collaborators and strategic partnerships; and the
impact of the COVID-19 pandemic or any global event on our business, and operations, and supply. Any statements contained in this communication
that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements are based
upon the Company’s current expectations. Forward-looking statements involve risks and uncertainties. The Company’s 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, which include, without limitation, the Company’s ability to advance its nonclinical and clinical programs,
the uncertain and time-consuming regulatory approval process; and the Company’s ability to secure additional financing to fund
future operations and development of its product candidates. Additional risks and uncertainties can be found in the Company’s Annual
Report on Form 10-K for the fiscal year ended December 31, 2022, filed with the Securities and Exchange Commission (“SEC”)
on March 22, 2023, as well as the Company’s Quarterly Report on Form 10-Q, for the three and nine month periods ended September
30, 2023, filed with the SEC on November 9, 2023. These forward-looking statements speak only as of the date hereof and the Company 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 the Company’s expectations with regard thereto or any change in events, conditions or circumstances on
which any such statements are based.
Investor
Relations Contact
JTC
Team, LLC
Jenene
Thomas
833-475-8247
PALI@jtcir.com
Source:
Palisade Bio
v3.24.0.1
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