Company has sufficient cash expected to fund operations through 2024
Carlsbad, CA, May 12, 2023 (GLOBE NEWSWIRE) -- 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, LLC
Jenene Thomas
833-475-8247
PALI@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 | ||||
