Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade”, “Palisade Bio”
or the “Company”), a 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 first quarter 2024 and
provided a business update.
Recent Highlights
- Entered into a strategic
collaboration with Strand Life Sciences that provides Palisade
access to advanced bioinformatics tools vital for understanding
complex disease pathways and predicting responses to
phosphodiesterase-4 (PDE4) inhibitors;
- Successfully completed an ex-vivo
study to determine the effects of bioactivated PALI-2108 on TNF-α
production in a whole blood assay;
- Successfully completed an analysis
evaluating ex-vivo bioactivation of PALI-2108 in study of healthy
and UC patients’ stool;
- Appointed Wall Street and biotech
industry veteran, Margery Fischbein, to its Board of Directors;
and
- In May 2024, extended cash runway
with completion of a $4.0 million private placement.
“Our team remains focused on advancing PALI-2108
towards our first-in-human study, which is on track to start later
this year. Our growing body of data, including the most recent data
from two ex-vivo studies evaluating PALI-2108, coupled with our
strategic partnership with Strand Life Sciences, further build our
confidence in the robust anti-inflammatory potential of PALI-2108
in the treatment of UC. Most importantly, the data underscore its
potential as a next-generation therapeutic option for patients with
inflammatory bowel disease,” commented J.D. Finley, Chief Executive
Officer.
PALI-2108 Development
Program
The Company continues to advance its lead
program, PALI-2108, for the treatment of moderate-to-severe UC
toward a Phase 1 clinical study. PALI-2108 is an orally
administered, locally acting colon-specific 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 in the third
quarter 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 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
1,600 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
First Quarter Ended March 31, 2024
As of March 31, 2024, the Company had cash and
cash equivalents of $11.3 million. Subsequent to the end of the
quarter, the Company completed a $4.0 million private placement.
Including the recent financing, the Company believes it has
sufficient cash to fund its currently planned operations through
the first quarter of 2025.
Net loss was $3.5 million for the three months
ended March 31, 2024, up $1.2 million from a net loss of $2.3
million for the three months ended March 31, 2023.
Research and development expenses for the three
months ended March 31, 2024 were $2.2 million, an increase of
approximately $1.0 million, or 78%, compared to $1.2 million for
the three months ended March 31, 2023. The increase for the three
months ended March 31, 2024 compared to the same period last year
was attributable to approximately $1.6 million of expenses
recognized that were directly related to the joint development of
the Company’s new lead asset, PALI-2108, partially offset by a
decrease in costs directly related to the development of LB1148,
which the Company ceased in August of 2023, and lower
employee-related costs.
General and administrative expenses remained
virtually flat at approximately $1.5 million for both the three
months ended March 31, 2024 and March 31, 2023.
About Palisade
Bio Palisade Bio is a 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.Condensed Consolidated Balance Sheets
(Unaudited)(in thousands, except share and per
share amounts)
|
|
March 31, |
|
|
December 31, |
|
|
|
2024 |
|
|
2023 |
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
11,276 |
|
|
$ |
12,432 |
|
Prepaid expenses and other current assets |
|
|
737 |
|
|
|
896 |
|
Total current assets |
|
|
12,013 |
|
|
|
13,328 |
|
Restricted cash |
|
|
26 |
|
|
|
26 |
|
Property and equipment,
net |
|
|
5 |
|
|
|
10 |
|
Operating lease right-of-use
asset |
|
|
170 |
|
|
|
198 |
|
Other noncurrent assets |
|
|
438 |
|
|
|
490 |
|
Total assets |
|
$ |
12,652 |
|
|
$ |
14,052 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
459 |
|
|
$ |
698 |
|
Accrued liabilities |
|
|
1,670 |
|
|
|
831 |
|
Accrued compensation and benefits |
|
|
213 |
|
|
|
778 |
|
Current portion of operating lease liability |
|
|
125 |
|
|
|
121 |
|
Insurance financing debt |
|
|
— |
|
|
|
158 |
|
Total current liabilities |
|
|
2,467 |
|
|
|
2,586 |
|
Warrant liability |
|
|
2 |
|
|
|
2 |
|
Contingent consideration
obligation |
|
|
61 |
|
|
|
61 |
|
Operating lease liability, net
of current portion |
|
|
58 |
|
|
|
90 |
|
Total liabilities |
|
|
2,588 |
|
|
|
2,739 |
|
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 March 31,
2024 and December 31, 2023 |
|
|
2 |
|
|
|
2 |
|
Common stock, $0.01 par value; 280,000,000 shares authorized;
851,302 and 618,056 shares issued and outstanding at March 31,
2024 and December 31, 2023, respectively |
|
|
8 |
|
|
|
6 |
|
Additional paid-in capital |
|
|
135,087 |
|
|
|
132,811 |
|
Accumulated deficit |
|
|
(125,033 |
) |
|
|
(121,506 |
) |
Total stockholders’ equity |
|
|
10,064 |
|
|
|
11,313 |
|
Total liabilities and stockholders’ equity |
|
$ |
12,652 |
|
|
$ |
14,052 |
|
Palisade Bio,
Inc.Condensed Consolidated Statements of
Operations (Unaudited)(in thousands, except share
and per share amounts)
|
|
Three Months Ended March 31, |
|
|
|
2024 |
|
|
2023 |
|
License revenue |
|
$ |
— |
|
|
$ |
250 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
2,214 |
|
|
|
1,241 |
|
General and administrative |
|
|
1,459 |
|
|
|
1,538 |
|
Total operating expenses |
|
|
3,673 |
|
|
|
2,779 |
|
Loss from operations |
|
|
(3,673 |
) |
|
|
(2,529 |
) |
Other (expense) income: |
|
|
|
|
|
|
|
|
Interest expense |
|
|
(1 |
) |
|
|
— |
|
Other income |
|
|
147 |
|
|
|
189 |
|
Total other income, net |
|
|
146 |
|
|
|
189 |
|
Net loss |
|
$ |
(3,527 |
) |
|
$ |
(2,340 |
) |
|
|
|
|
|
|
|
|
|
Basic and diluted weighted
average shares used in computing basic and diluted net loss per
common share* |
|
|
768,137 |
|
|
|
287,702 |
|
Basic and diluted net loss per
common share* |
|
$ |
(4.59 |
) |
|
$ |
(8.13 |
) |
(*) Basic and diluted loss per common share and
basic and diluted weighted average share used in computing basic
and diluted loss per common share for the three months ended
March 31, 2023 has been adjusted to reflect the 1-for-15
reverse stock split effected on April 5, 2024.
Palisade Bio,
Inc.Condensed Consolidated Statements of Cash
Flows (Unaudited)(in thousands, except share and
per share amounts)
|
|
Three Months Ended March 31, |
|
|
|
2024 |
|
|
2023 |
|
|
|
|
|
Net loss |
|
$ |
(3,527 |
) |
|
$ |
(2,340 |
) |
Adjustments to
reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
|
|
Depreciation |
|
|
1 |
|
|
|
1 |
|
Non-cash operating lease expense |
|
|
28 |
|
|
|
25 |
|
Recurring fair value measurements of liabilities |
|
|
— |
|
|
|
(43 |
) |
Loss on disposal of property and equipment |
|
|
4 |
|
|
|
— |
|
Stock-based compensation and related charges |
|
|
118 |
|
|
|
93 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
— |
|
|
|
(250 |
) |
Prepaid and other current assets and other noncurrent assets |
|
|
174 |
|
|
|
278 |
|
Accounts payable and accrued liabilities |
|
|
615 |
|
|
|
(970 |
) |
Accrued compensation and benefits |
|
|
(565 |
) |
|
|
(295 |
) |
Operating lease liabilities |
|
|
(28 |
) |
|
|
(25 |
) |
Net cash used in operating activities |
|
|
(3,180 |
) |
|
|
(3,526 |
) |
Cash flows from
financing activities: |
|
|
|
|
|
|
|
|
Payments on insurance financing debt |
|
|
(158 |
) |
|
|
(88 |
) |
Proceeds from issuance of common stock and warrants |
|
|
— |
|
|
|
2,231 |
|
Proceeds from the exercise of warrants |
|
|
2,503 |
|
|
|
2,710 |
|
Payment of warrant inducement issuance costs |
|
|
(321 |
) |
|
|
— |
|
Payment of equity issuance costs |
|
|
— |
|
|
|
(413 |
) |
Net cash provided by financing activities |
|
|
2,024 |
|
|
|
4,440 |
|
Net (decrease) increase in
cash, cash equivalents and restricted cash |
|
|
(1,156 |
) |
|
|
914 |
|
Cash, cash equivalents and
restricted cash, beginning of year |
|
|
12,458 |
|
|
|
12,409 |
|
Cash, cash equivalents and
restricted cash, end of period |
|
$ |
11,302 |
|
|
$ |
13,323 |
|
Reconciliation of
cash, cash equivalents and restricted cash to the balance
sheets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
11,276 |
|
|
$ |
13,297 |
|
Restricted cash |
|
|
26 |
|
|
|
26 |
|
Total cash, cash equivalents and restricted cash |
|
$ |
11,302 |
|
|
$ |
13,323 |
|
Palisade Bio (NASDAQ:PALI)
Historical Stock Chart
From May 2024 to Jun 2024
Palisade Bio (NASDAQ:PALI)
Historical Stock Chart
From Jun 2023 to Jun 2024