Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade”, “Palisade Bio”
or the “Company”), a biopharmaceutical company focused on
developing novel therapeutics for serious chronic gastrointestinal
(GI) diseases, today reported its financial results for the third
quarter 2023 and provided a business outlook.
Recent Corporate
Developments
- Entered into an exclusive worldwide
licensing agreement with Giiant Pharma, Inc. for multiple oral drug
candidates targeting IBD;
- Appointed GI clinical expert and
biotech entrepreneur Mitch Jones, M.D., PhD as Chief Medical
Officer; and
- Bolstered cash runway with a $2
million, common-stock-only registered direct offering priced at
market under Nasdaq rules.
“The past quarter was marked by a transformative
transaction for Palisade. The IBD market is large, well
established, and expected to grow to $20 billion by 2031. We
believe that novel therapeutics which demonstrate safety and
efficacy have the potential to gain significant market share.
Palisade has the only PDE4 inhibitor prodrug under development for
the treatment of ulcerative colitis, our lead indication,”
commented J.D. Finley, Chief Executive Officer. “We are committed
to advancing the clinical development of PALI-2108 and expect to
launch our Phase 1 study in UC in 2024. Importantly, we have a
strong cash position to fund operations through value-driving
milestones and believe we are positioned to build shareholder value
in the near and long term.”
About PALI-2108
PALI-2108 is an orally administered, locally
acting colon-specific phosphodiesterase-4B (PDE4B) inhibitor
prodrug in development for patients affected by
moderate-to-severely active ulcerative colitis (UC).
Key Program Highlights
- Preferential enzymatic inhibition
of PDE4B limiting the potential for off-target effects;
- Isoenzyme inhibition profile
superior to other PDE4 inhibitors and comparable to marketed
anti-inflammatory and anti-fibrotic PDE4B selective
inhibitors;
- 20 times more potent at inhibiting
lipopolysaccharide (LPS)-induced tumor necrosis factor-α (TNF-α)
when compared to apremilast in human whole blood;
- Demonstrated PDE4B target
engagement comparable to apremilast in vivo;
- Shown to be locally bioactivated
within the colon in mouse studies and ex vivo in normal healthy
subjects and in ulcerative colitis patient fecal samples;
- Nonclinical data demonstrating
prodrug significantly limits systemic drug exposure;
- Nonclinical data demonstrating
complete prevention of emesis, a well-known side effect limiting
the use of PDE4 inhibitors in humans, at therapeutic doses of oral
prodrug and compared with the active PDE4 moiety only; and
- Shown to be effective and
demonstrated a dose response across multiple nonclinical colitis
studies.
Upcoming Milestones
- Ongoing IND/CTA-enabling tox
studies;
- 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 before the end
of 2024.
Summary of Financial Results for the
Third Quarter Ended September 30, 2023
As of September 30, 2023, the Company had cash
and cash equivalents of $15.3 million. The Company believes it has
sufficient cash to fund its currently planned operations into the
first quarter of 2025.
Net loss was $3.6 million for the three months
ended September 30, 2023, compared to $4.0 million for the same
period in 2022.
Research and development expenses for the three
months ended September 30, 2023, were $1.7 million, a decrease of
approximately $0.2 million, or 10%, compared to $1.9 million for
the same period last year. The decrease was primarily attributable
to the Company concluding its U.S. Phase 2 PROFILE study of LB1148
in early third quarter of 2023 and its completion of enrollment in
its dose-optimization study of LB1148 in the second quarter of
2023. The Company has subsequently concluded it will no longer
pursue the development of LB1148 and has closed its PROFILE study.
Comparatively, in the third quarter of 2022, the Company was
actively enrolling its U.S. Phase 2 PROFILE study and incurring
expenses while initiating its U.S. Phase 3 INTEGRITY study for the
accelerated return of bowel function following GI surgery.
Accordingly, drug-manufacturing related expenses decreased by
approximately $0.5 million, investigator site fees decreased by
approximately $0.2 million, and clinical trial consultants and
contract labor decreased by approximately $0.1 million in the three
months ended September 30, 2023, compared to the three months ended
September 30, 2022. Also contributing to the year-over-year
decrease was lower research and development salaries and benefits
by approximately $0.1 million in the three months ended September
30, 2023, compared to the three months ended September 30, 2022,
primarily due to a decrease in research and development employee
headcount.
General and administrative expenses decreased by
approximately $0.4 million, or 19%, from $2.1 million for the three
months ended September 30, 2022, to $1.7 million for the three
months ended September 30, 2023, primarily because of a $0.3
million decrease in salaries and benefits and a $0.1 million
decrease in stock-based compensation expense.
In connection with the entering into the
research collaboration and license agreement with Giiant Pharma,
Inc., in the three months ended September 30, 2023, the
Company recognized In-process research and development expenses in
the amount of $0.4 million consisting of certain contingent
consideration obligations incurred as well as direct
transaction-related costs.
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 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, 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 months 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.
Investor Relations Contact
JTC Team, LLCJenene Thomas 833-475-8247PALI@jtcir.com
Source: Palisade Bio
Palisade Bio,
Inc.Condensed Consolidated Balance Sheets
(Unaudited)(in thousands, except share and per
share amounts)
|
|
September 30, |
|
December 31, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
15,312 |
|
|
$ |
12,383 |
|
Prepaid expenses and other current assets |
|
|
954 |
|
|
|
2,350 |
|
Total current assets |
|
|
16,266 |
|
|
|
14,733 |
|
Restricted cash |
|
|
26 |
|
|
|
26 |
|
Property and equipment, net |
|
|
10 |
|
|
|
10 |
|
Right-of-use asset |
|
|
224 |
|
|
|
300 |
|
Other noncurrent assets |
|
|
541 |
|
|
|
694 |
|
Total assets |
|
$ |
17,067 |
|
|
$ |
15,763 |
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
950 |
|
|
$ |
1,759 |
|
Accrued liabilities |
|
|
794 |
|
|
|
574 |
|
Accrued compensation and benefits |
|
|
529 |
|
|
|
486 |
|
Current portion of lease liability |
|
|
117 |
|
|
|
105 |
|
Debt |
|
|
259 |
|
|
|
88 |
|
Total current liabilities |
|
|
2,649 |
|
|
|
3,012 |
|
Warrant liability |
|
|
2 |
|
|
|
61 |
|
Contingent consideration
obligation |
|
|
212 |
|
|
|
— |
|
Lease liability, net of current
portion |
|
|
122 |
|
|
|
211 |
|
Total liabilities |
|
|
2,985 |
|
|
|
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
September 30, 2023 and December 31, 2022 |
|
|
2 |
|
|
|
2 |
|
Common stock, $0.01 par value; 280,000,000 shares
authorized;9,210,751 and 2,944,306 shares issued and outstanding at
September 30, 2023 and December 31, 2022,
respectively |
|
|
92 |
|
|
|
30 |
|
Additional paid-in capital |
|
|
132,523 |
|
|
|
121,637 |
|
Accumulated deficit |
|
|
(118,535 |
) |
|
|
(109,190 |
) |
Total stockholders' equity |
|
|
14,082 |
|
|
|
12,479 |
|
Total liabilities and stockholders' equity |
|
$ |
17,067 |
|
|
$ |
15,763 |
|
Palisade Bio,
Inc.Condensed Consolidated Statements of
Operations (Unaudited) (in thousands, except share
and per share amounts)
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
License revenue |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
250 |
|
|
$ |
— |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
1,742 |
|
|
|
1,928 |
|
|
|
5,160 |
|
|
|
4,204 |
|
In-process research and development |
|
|
362 |
|
|
|
— |
|
|
|
362 |
|
|
|
— |
|
General and administrative |
|
|
1,674 |
|
|
|
2,075 |
|
|
|
4,644 |
|
|
|
7,259 |
|
Restructuring costs |
|
|
— |
|
|
|
410 |
|
|
|
— |
|
|
|
410 |
|
Total operating expenses |
|
|
3,778 |
|
|
|
4,413 |
|
|
|
10,166 |
|
|
|
11,873 |
|
Loss from operations |
|
|
(3,778 |
) |
|
|
(4,413 |
) |
|
|
(9,916 |
) |
|
|
(11,873 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
Interest expense |
|
|
(8 |
) |
|
|
(4 |
) |
|
|
(11 |
) |
|
|
(10 |
) |
Other income |
|
|
190 |
|
|
|
426 |
|
|
|
598 |
|
|
|
2,453 |
|
Loss on issuance of warrants |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(1,110 |
) |
Total other income, net |
|
|
182 |
|
|
|
422 |
|
|
|
587 |
|
|
|
1,333 |
|
Net loss |
|
$ |
(3,596 |
) |
|
$ |
(3,991 |
) |
|
$ |
(9,329 |
) |
|
$ |
(10,540 |
) |
Basic and diluted net loss per
common share |
|
$ |
(0.49 |
) |
|
$ |
(4.10 |
) |
|
$ |
(1.55 |
) |
|
$ |
(18.40 |
) |
Basic and diluted weighted
average shares used in computing basic and diluted net loss per
common share |
|
|
7,344,351 |
|
|
|
974,197 |
|
|
|
6,031,099 |
|
|
|
572,684 |
|
Palisade Bio,
Inc.Condensed Consolidated Statements of Cash
Flows (Unaudited) (in thousands)
|
|
Nine Months Ended September 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
Net loss |
|
$ |
(9,329 |
) |
|
$ |
(10,540 |
) |
Adjustments to reconcile
net loss to net cash used in operating activities: |
|
|
|
|
Depreciation and amortization |
|
|
4 |
|
|
|
1 |
|
Noncash lease expense |
|
|
76 |
|
|
|
140 |
|
Loss on issuance of warrants |
|
|
— |
|
|
|
1,110 |
|
Fair value of contingent consideration obligation |
|
|
212 |
|
|
|
— |
|
Change in fair value of warrant liabilities |
|
|
(59 |
) |
|
|
(2,403 |
) |
Stock-based compensation and related charges |
|
|
439 |
|
|
|
946 |
|
Other |
|
|
(108 |
) |
|
|
(213 |
) |
Changes in operating
assets and liabilities: |
|
|
|
|
Prepaid and other assets and other noncurrent assets |
|
|
596 |
|
|
|
744 |
|
Accounts payable and accrued liabilities |
|
|
(184 |
) |
|
|
706 |
|
Accrued compensation |
|
|
43 |
|
|
|
(418 |
) |
Operating lease liabilities |
|
|
(77 |
) |
|
|
(127 |
) |
Net cash used in operating activities |
|
|
(8,387 |
) |
|
|
(10,054 |
) |
Cash flows from investing
activities: |
|
|
|
|
Purchases of property and equipment |
|
|
(4 |
) |
|
|
— |
|
Net cash used in investing activities |
|
|
(4 |
) |
|
|
— |
|
Cash flows from financing
activities: |
|
|
|
|
Payments on debt |
|
|
(290 |
) |
|
|
(524 |
) |
Proceeds from issuance of common stock and warrants |
|
|
9,419 |
|
|
|
14,401 |
|
Proceeds from the exercise of warrants |
|
|
2,758 |
|
|
|
— |
|
Payment of equity issuance costs |
|
|
(567 |
) |
|
|
(333 |
) |
Net cash provided by financing activities |
|
|
11,320 |
|
|
|
13,544 |
|
Net increase (decrease) in cash,
cash equivalents and restricted cash |
|
|
2,929 |
|
|
|
3,490 |
|
Cash, cash equivalents and
restricted cash, beginning of period |
|
|
12,409 |
|
|
|
10,521 |
|
Cash, cash equivalents and
restricted cash, end of period |
|
$ |
15,338 |
|
|
$ |
14,011 |
|
Reconciliation of cash,
cash equivalents and restricted cash to the balance
sheets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
15,312 |
|
|
$ |
13,985 |
|
Restricted cash |
|
|
26 |
|
|
|
26 |
|
Total cash, cash equivalents and
restricted cash |
|
$ |
15,338 |
|
|
$ |
14,011 |
|
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