Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the
“Company”), a biopharmaceutical company advancing therapies for
acute and chronic gastrointestinal (GI) complications, today
reported its financial results for the first quarter 2023 and
provided a corporate update.
“We are looking forward to the upcoming topline
data readout for our U.S. Phase 2 adhesions study. This Phase 2
data along with the results from our dose optimization study, which
enrolled its first patient earlier this week, will be integral in
determining the most expedient clinical pathway for LB1148. With
our cash runway extending past key near-term data endpoints under
our current clinical studies, the Company has never been
fundamentally stronger, and we are well-positioned to focus on the
advancement of our development pipeline,” commented J.D. Finley,
interim Chief Executive Officer.
Recent Company Highlights:
- Commenced enrollment and dosed
first patient in dose optimization study for all indications of
LB1148;
- Announced first patient enrolled in
our partner Newsoara’s Phase 3 study of LB1148 for the accelerated
return of bowel function indication;
- Received Canadian Patent covering
composition of LB1148; and
- Raised gross proceeds of $11.2
million since January 1, 2023 through registered direct offerings,
private placements, and exercises of common stock warrants,
extending cash runway through 2024.
The Company also announced today that its Chief
Operating Officer, Robert McRae will be transitioning to an
executive strategic consultant. In this capacity, Mr. McRae will
provide ongoing strategic counsel to the Palisade team related to
clinical development and operations, business development/licensing
and investor relations.
Summary of Financial
Results for the First Quarter
Ended March 31,
2023
As of March 31, 2023, the Company had cash and
cash equivalents of $13.3 million, which was supplemented by gross
proceeds of $6.0 million from a registered direct offering and
concurrent private placement completed in early April 2023. The
Company believes it has sufficient cash to fund its operations and
clinical programs through 2024.
Net loss was $2.3 million for the three months
ended March 31, 2023, down $1.9 million from the $4.2 million net
loss for the same period in 2022.
Research and development expenses for the three
months ended March 31, 2023 were $1.2 million, an increase of
approximately $0.3 million, or 29%, compared to the same period
last year. The increase was primarily attributable to the Company's
increased clinical trial activity related to the development of its
lead therapeutic candidate, LB1148.
General and administrative expenses for the
three months ended March 31, 2023, decreased approximately $1.4
million, or 47%, from $2.9 million for three months ended March 31,
2022, to $1.5 million for the three months ended March 31, 2023.
The decrease was primarily the result of cost-saving opportunities
implemented by the Company in the third and fourth quarters of
2022, including those associated with the cost-reduction plan
announced on September 9, 2022.
About Palisade Bio
Palisade Bio is a biopharmaceutical company
focused on developing therapeutics that protect the integrity of
the intestinal barrier. The Company utilizes over three decades of
research and established science that links the role of intestinal
barrier biology with human disease to advance novel therapeutics
that target and improve the integrity of the intestinal
barrier.
The Company’s lead program, LB1148, is a
broad-spectrum serine protease inhibitor that acts to neutralize
digestive enzymes, potentially reducing intestinal damage. In prior
clinical studies, LB1148 has demonstrated positive results in
reducing the incidence and severity of post-surgical abdominal
adhesions and potentially reducing the time to return of
postoperative bowel function. LB1148’s current U.S. Phase 2 study
is evaluating its effectiveness in reducing intra-abdominal
adhesions, accelerating return of gastrointestinal function, and
the prevention of post-operative ileus in subjects undergoing
elective bowel resection (PROFILE).
The Company believes that addressing the
disruption of the intestinal barrier can fundamentally change the
way diseases are treated and establish new standards of patient
care. 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;
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 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. 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)
|
|
March 31, |
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
13,297 |
|
|
$ |
12,383 |
|
Accounts receivable |
|
|
250 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
|
762 |
|
|
|
2,350 |
|
Total current assets |
|
|
14,309 |
|
|
|
14,733 |
|
Restricted cash |
|
|
26 |
|
|
|
26 |
|
Property and equipment,
net |
|
|
9 |
|
|
|
10 |
|
Right-of-use asset |
|
|
275 |
|
|
|
300 |
|
Other noncurrent assets |
|
|
643 |
|
|
|
694 |
|
Total assets |
|
$ |
15,262 |
|
|
$ |
15,763 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
706 |
|
|
$ |
1,759 |
|
Accrued liabilities |
|
|
309 |
|
|
|
574 |
|
Accrued compensation and benefits |
|
|
191 |
|
|
|
486 |
|
Current portion of lease liability |
|
|
109 |
|
|
|
105 |
|
Debt |
|
|
— |
|
|
|
88 |
|
Total current liabilities |
|
|
1,315 |
|
|
|
3,012 |
|
Warrant liability |
|
|
18 |
|
|
|
61 |
|
Lease liability, net of
current portion |
|
|
182 |
|
|
|
211 |
|
Total liabilities |
|
|
1,515 |
|
|
|
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 March 31,
2023 and December 31, 2022 |
|
|
2 |
|
|
|
2 |
|
Common stock, $0.01 par value; 280,000,000 shares
authorized;4,563,977 and 2,944,306 shares issued and outstanding at
March 31, 2023 and December 31, 2022, respectively |
|
|
46 |
|
|
|
30 |
|
Additional paid-in capital |
|
|
125,229 |
|
|
|
121,637 |
|
Accumulated deficit |
|
|
(111,530 |
) |
|
|
(109,190 |
) |
Total stockholders’ equity |
|
|
13,747 |
|
|
|
12,479 |
|
Total liabilities and stockholders’ equity |
|
$ |
15,262 |
|
|
$ |
15,763 |
|
Palisade Bio,
Inc.Condensed Consolidated Statements of
Operations (Unaudited)
(in thousands, except
share and per share amounts)
|
|
Three Months Ended March 31, |
|
|
|
2023 |
|
|
2022 |
|
License revenue |
|
$ |
250 |
|
|
$ |
— |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
1,241 |
|
|
|
959 |
|
General and administrative |
|
|
1,538 |
|
|
|
2,929 |
|
Total operating expenses |
|
|
2,779 |
|
|
|
3,888 |
|
Loss from operations |
|
|
(2,529 |
) |
|
|
(3,888 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
Interest expense |
|
|
— |
|
|
|
(1 |
) |
Other income |
|
|
189 |
|
|
|
794 |
|
Loss on issuance of warrants |
|
|
— |
|
|
|
(1,110 |
) |
Total other income (expense),
net |
|
|
189 |
|
|
|
(317 |
) |
Net loss |
|
$ |
(2,340 |
) |
|
$ |
(4,205 |
) |
Basic and diluted loss per
common share |
|
$ |
(0.54 |
) |
|
$ |
(12.96 |
) |
Basic and diluted weighted
average shares used in computing loss per common share |
|
|
4,315,526 |
|
|
|
324,473 |
|
Palisade Bio,
Inc.Condensed Consolidated Statements of Cash
Flows (Unaudited) (in
thousands)
|
|
Three Months Ended March 31, |
|
|
|
2023 |
|
|
2022 |
|
|
|
|
|
Net loss |
|
$ |
(2,340 |
) |
|
$ |
(4,205 |
) |
Adjustments to
reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
1 |
|
|
|
1 |
|
Noncash lease expense |
|
|
25 |
|
|
|
45 |
|
Loss on issuance of warrants |
|
|
— |
|
|
|
1,110 |
|
Change in fair value of warrant liabilities |
|
|
(43 |
) |
|
|
(793 |
) |
Stock-based compensation |
|
|
93 |
|
|
|
358 |
|
Changes in operating
assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
(250 |
) |
|
|
— |
|
Prepaid and other assets and other noncurrent assets |
|
|
278 |
|
|
|
265 |
|
Accounts payable and accrued liabilities |
|
|
(970 |
) |
|
|
(59 |
) |
Accrued compensation |
|
|
(295 |
) |
|
|
(439 |
) |
Operating lease liabilities |
|
|
(25 |
) |
|
|
(47 |
) |
Net cash used in operating activities |
|
|
(3,526 |
) |
|
|
(3,764 |
) |
Cash flows from
financing activities: |
|
|
|
|
|
|
|
|
Payments on debt |
|
|
(88 |
) |
|
|
(87 |
) |
Proceeds from issuance of common stock and warrants |
|
|
2,231 |
|
|
|
— |
|
Proceeds from the exercise of warrants |
|
|
2,710 |
|
|
|
— |
|
Payment of equity issuance costs |
|
|
(413 |
) |
|
|
— |
|
Net cash provided by (used in) financing activities |
|
|
4,440 |
|
|
|
(87 |
) |
Net increase (decrease) in
cash, cash equivalents and restricted cash |
|
|
914 |
|
|
|
(3,851 |
) |
Cash, cash equivalents and
restricted cash, beginning of year |
|
|
12,409 |
|
|
|
10,521 |
|
Cash, cash equivalents and
restricted cash, end of period |
|
$ |
13,323 |
|
|
$ |
6,670 |
|
Reconciliation of
cash, cash equivalents and restricted cash to the balance
sheets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
13,297 |
|
|
$ |
6,644 |
|
Restricted cash |
|
|
26 |
|
|
|
26 |
|
Total cash, cash equivalents
and restricted cash |
|
$ |
13,323 |
|
|
$ |
6,670 |
|
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