Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade”, “Palisade Bio”
or the “Company”), a pre-clinical biopharmaceutical company focused
on developing and advancing novel therapeutics for patients living
with autoimmune, inflammatory, and fibrotic diseases, today
reported its financial results for the full year 2023 and provided
a corporate update.
Recent Highlights
- The Company formed its Clinical
Advisory Board and appointed preeminent Key Opinion Leaders, Bruce
Sands, MD, MS and Florian Rieder, MD;
- The exercise in February 2024, of
3,422,286 previously issued warrants to purchase common stock
resulting in gross cash proceeds to the Company of $2.5
million;
- Presentation of positive
preclinical data of its lead asset, PALI-2108 at the 2024 Crohn’s
& Colitis Congress; and
- Giiant Pharma, Inc., the Company’s
joint development partner, received the second milestone payment to
assist in funding PALI-2108 from the US Crohn’s and Colitis
Foundation, through its IBD Ventures program.
“2023 was a transformative year for Palisade Bio
as we strategically shifted into the autoimmune, inflammatory, and
fibrotic disease space, with the focus on our precision medicine
approach in inflammatory bowel disease,” commented J.D. Finley,
Chief Executive Officer. “As a result of the progress made by our
development team, we are on track to launch the Phase 1 study of
PALI-2108 by the end of 2024. We are looking forward to the
advancement of our lead program to bring our product candidates
into clinical trials and to increase our value for all
stakeholders.”
PALI-2108 Development
Program
The Company continues to advance its lead
program, PALI-2108, for the treatment of moderate-to-severe
ulcerative colitis (UC) toward a Phase 1 clinical study. PALI-2108
is an orally administered, locally acting colon-specific
phosphodiesterase-4 (PDE4) inhibitor prodrug in development for
patients affected by UC.
Upcoming Target Milestones
- Complete ongoing IND/CTA-enabling
tox studies by the end of the second quarter of 2024;
- Complete nonclinical
IND/CTA-enabling activities by the end of the third quarter of
2024;
- Submit initial IND/CTA prior to the
end of 2024; and
- Initiate Phase 1a/b prior to the
end of 2024.
Precision Medicine Approach
Additionally, the Company is in the process of
developing a genetic- or biomarker-based precision medicine
approach that, if developed, will aid patients and physicians in
selecting patients most likely to respond to PDE4 inhibitor therapy
with PALI-2108. The Company is working with a strategic
collaborator on development and has completed curation of a
pipeline including over 1600 UC patients clinical and biomarker
data and is in ongoing discussions with potential partners with
access to additional patient data to support development of an
FDA-approved test. The Company plans to leverage this expertise and
infrastructure to fuel a growing pipeline of validated and
high-priority autoimmune, inflammatory, and fibrotic disease
product candidates.
Summary of Financial Results for the
Year Ended December 31, 2023
As of December 31, 2023, the Company had cash,
cash equivalents and restricted cash of $12.5 million. The Company
believes it has sufficient cash to fund its currently planned
operations into the first quarter of 2025.
Net operating loss was $13.1 million for the
year ended December 31, 2023 compared to $15.7 million for the year
ended December 31, 2022. Included in the net operating loss for the
year ended December 31, 2023 was license revenue of $0.3 million,
of which there was none in 2022, and restructuring costs of $0.2
million in 2023, compared to restructuring costs of $0.4 million in
2022.
Research and development expenses were $6.9
million for the year ended December 31, 2023, an increase of $0.3
million, or approximately 5% compared to the year ended December
31, 2022. The year-over-year increase is attributable to increased
costs associated with the Giiant License Agreement, which we
entered into on September 1, 2023, as well an increase in
employee-related costs and employee recruiting costs, which were
partially offset by a decrease in costs directly related to our
development of LB1148, which we ceased in August of 2023.
General and administrative expenses decreased
from $8.8 million for the year ended December 31, 2022 to $6.2
million for the year ended December 31, 2023. The decrease of $2.6
million, or 26%, was primarily as a result of cost-saving
opportunities implemented by us in the third and fourth quarters of
2022, including those associated with the 2022 Cost-Reduction Plan.
General and administrative employee compensation costs for the year
ended December 31, 2023 decreased by approximately $1.4 million
compared to the year ended December 31, 2022, primarily due to an
approximately $0.9 million decrease in salaries and benefits and an
approximately $0.5 million decrease in stock-based compensation
expense. Other decreases in general and administrative expenses for
the year ended December 31, 2023 compared to the year ended
December 31, 2022 include: (i) an approximately $0.3 million
decrease in professional fees, including accounting and legal fees
and financial printing costs, (ii) an approximately $0.3 million
decrease in investor and public relations costs and shareholder
services costs, (iii) an approximately $0.2 million decrease in
consultants and contract labor costs, (iv) an approximately $0.2
million decrease in general and administrative employee recruiting
costs, and (v) an approximately $0.2 million decrease in insurance
costs.
About Palisade
Bio Palisade Bio is a pre-clinical biopharmaceutical
company focused on developing and advancing novel therapeutics for
patients living with autoimmune, inflammatory, and fibrotic
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 StatementsThis
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, 2023, filed
with the Securities and Exchange Commission (“SEC”) on March 26,
2024. 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, LLCJenene Thomas 833-475-8247PALI@jtcir.com
Palisade Bio,
Inc.Consolidated Balance Sheets
(Unaudited)(in thousands, except share and per
share amounts)
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
12,432 |
|
|
$ |
12,383 |
|
Prepaid expenses and other current assets |
|
|
896 |
|
|
|
2,350 |
|
Total current assets |
|
|
13,328 |
|
|
|
14,733 |
|
Restricted cash |
|
|
26 |
|
|
|
26 |
|
Property and equipment,
net |
|
|
10 |
|
|
|
10 |
|
Operating lease right-of-use
asset |
|
|
198 |
|
|
|
300 |
|
Other noncurrent assets |
|
|
490 |
|
|
|
694 |
|
Total assets |
|
$ |
14,052 |
|
|
$ |
15,763 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
698 |
|
|
$ |
1,759 |
|
Accrued liabilities |
|
|
831 |
|
|
|
574 |
|
Accrued compensation and benefits |
|
|
778 |
|
|
|
486 |
|
Current portion of operating lease liability |
|
|
121 |
|
|
|
105 |
|
Insurance financing debt |
|
|
158 |
|
|
|
88 |
|
Total current liabilities |
|
|
2,586 |
|
|
|
3,012 |
|
Warrant liability |
|
|
2 |
|
|
|
61 |
|
Contingent consideration
obligation |
|
|
61 |
|
|
|
— |
|
Operating lease liability, net
of current portion |
|
|
90 |
|
|
|
211 |
|
Total liabilities |
|
|
2,739 |
|
|
|
3,284 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
|
|
Series A Convertible Preferred Stock, $0.01 par value, 7,000,000
shares authorized; 200,000 issued and outstanding at
December 31, 2023 and December 31, 2022 |
|
|
2 |
|
|
|
2 |
|
Common stock, $0.01 par value; 280,000,000 shares
authorized;9,270,894 and 2,944,306 shares issued and outstanding at
December 31, 2023 and December 31, 2022,
respectively |
|
|
93 |
|
|
|
30 |
|
Additional paid-in capital |
|
|
132,724 |
|
|
|
121,637 |
|
Accumulated deficit |
|
|
(121,506 |
) |
|
|
(109,190 |
) |
Total stockholders' equity |
|
|
11,313 |
|
|
|
12,479 |
|
Total liabilities and stockholders' equity |
|
$ |
14,052 |
|
|
$ |
15,763 |
|
Palisade Bio,
Inc.Consolidated Statements of Operations
(Unaudited)(in thousands, except share and per
share amounts)
|
|
Year Ended December 31, |
|
|
|
2023 |
|
|
2022 |
|
License revenue |
|
$ |
250 |
|
|
$ |
— |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
6,893 |
|
|
|
6,547 |
|
General and administrative |
|
|
6,202 |
|
|
|
8,764 |
|
Restructuring costs |
|
|
225 |
|
|
|
410 |
|
Total operating expenses |
|
|
13,320 |
|
|
|
15,721 |
|
Loss from operations |
|
|
(13,070 |
) |
|
|
(15,721 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
Interest expense |
|
|
(15 |
) |
|
|
(13 |
) |
Other income |
|
|
785 |
|
|
|
2,584 |
|
Loss on issuance of warrants |
|
|
— |
|
|
|
(1,110 |
) |
Total other income, net |
|
|
770 |
|
|
|
1,461 |
|
Net loss |
|
$ |
(12,300 |
) |
|
$ |
(14,260 |
) |
|
|
|
|
|
|
|
|
|
Net loss available to common
stockholders |
|
$ |
(12,316 |
) |
|
$ |
(14,548 |
) |
Basic and diluted weighted
average shares used in computing basic and diluted net loss per
common share |
|
|
6,840,213 |
|
|
|
880,311 |
|
Basic and diluted net loss per
common share |
|
$ |
(1.80 |
) |
|
$ |
(16.53 |
) |
Palisade Bio,
Inc.Consolidated Statements of Cash Flows
(Unaudited)(in thousands, except share and per
share amounts)
|
|
Year Ended December 31, |
|
|
|
2023 |
|
|
2022 |
|
|
|
|
|
Net loss |
|
$ |
(12,300 |
) |
|
$ |
(14,260 |
) |
Adjustments to
reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
|
|
Depreciation |
|
|
4 |
|
|
|
3 |
|
Noncash operating lease expense |
|
|
102 |
|
|
|
164 |
|
Loss on issuance of warrants |
|
|
— |
|
|
|
1,110 |
|
Fair value of contingent consideration obligation |
|
|
204 |
|
|
|
— |
|
Change in fair value of warrant liabilities |
|
|
(59 |
) |
|
|
(2,426 |
) |
Stock-based compensation and related charges |
|
|
624 |
|
|
|
1,032 |
|
Other |
|
|
(108 |
) |
|
|
(233 |
) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Prepaid and other current assets and other noncurrent assets |
|
|
705 |
|
|
|
1,027 |
|
Accounts payable and accrued liabilities |
|
|
(492 |
) |
|
|
399 |
|
Accrued compensation |
|
|
292 |
|
|
|
(25 |
) |
Operating lease liabilities |
|
|
(105 |
) |
|
|
(151 |
) |
Net cash used in operating activities |
|
|
(11,133 |
) |
|
|
(13,360 |
) |
Cash flows from
investing activities: |
|
|
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(4 |
) |
|
|
(10 |
) |
Net cash used in investing activities |
|
|
(4 |
) |
|
|
(10 |
) |
Cash flows from
financing activities: |
|
|
|
|
|
|
|
|
Payments on insurance financing debt |
|
|
(391 |
) |
|
|
(790 |
) |
Proceeds from issuance of common stock and warrants |
|
|
9,419 |
|
|
|
14,401 |
|
Proceeds from the exercise of warrants |
|
|
2,758 |
|
|
|
2,274 |
|
Payment of equity issuance costs |
|
|
(617 |
) |
|
|
(627 |
) |
Proceeds from issuance of common stock under Employee Stock
Purchase Plan |
|
|
17 |
|
|
|
— |
|
Net cash provided by financing activities |
|
|
11,186 |
|
|
|
15,258 |
|
Net increase in cash, cash
equivalents and restricted cash |
|
|
49 |
|
|
|
1,888 |
|
Cash, cash equivalents and
restricted cash, beginning of year |
|
|
12,409 |
|
|
|
10,521 |
|
Cash, cash equivalents and
restricted cash, end of year |
|
$ |
12,458 |
|
|
$ |
12,409 |
|
Reconciliation of
cash, cash equivalents and restricted cash to the balance
sheets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
12,432 |
|
|
$ |
12,383 |
|
Restricted cash |
|
|
26 |
|
|
|
26 |
|
Total cash, cash equivalents
and restricted cash |
|
$ |
12,458 |
|
|
$ |
12,409 |
|
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