Palisade Bio Reports Year End 2023 Financial Results and Provides Corporate Update
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Insights
The financial results reported by Palisade Bio indicate a strategic shift in focus towards autoimmune, inflammatory and fibrotic diseases, particularly with their lead asset PALI-2108. The company's liquidity position, with $12.5 million in cash and equivalents, appears to be robust enough to support operations into the first quarter of 2025. This is a positive sign for investors, as it suggests that the company won't need to seek additional funding in the immediate future, thereby avoiding potential dilution of existing shares.
However, the reported net operating loss of $13.1 million for 2023, while lower than the $15.7 million loss in 2022, still indicates that the company is in a pre-revenue phase and its ability to generate income is yet unproven. The increase in research and development expenses, albeit a modest 5%, reflects the company's investment in its lead program. The decrease in general and administrative expenses by 26% is indicative of successful cost-saving measures, which are important for a pre-revenue biotech to extend its cash runway.
The progression of PALI-2108 towards a Phase 1 clinical study is a significant milestone for Palisade Bio and the ulcerative colitis patient community. As a locally acting colon-specific PDE4 inhibitor prodrug, PALI-2108 represents a novel approach in the treatment of moderate-to-severe ulcerative colitis. The therapeutic landscape for UC has been evolving with an emphasis on precision medicine and Palisade Bio's focus on a genetic- or biomarker-based precision medicine approach could be a game-changer if successful. This could potentially lead to better patient outcomes and a competitive advantage in the market.
The establishment of a Clinical Advisory Board and the involvement of Key Opinion Leaders in the field are strategic moves that can lend credibility to the program and potentially facilitate smoother regulatory navigation. The support from the US Crohn's and Colitis Foundation through its IBD Ventures program underscores the potential impact of the therapy and could signal to investors the project's viability and possible future funding opportunities.
From a market perspective, Palisade Bio's advancement of PALI-2108 is entering a competitive space with several established players in the inflammatory bowel disease market. The company's approach to precision medicine could differentiate PALI-2108 from other treatments if they can successfully develop and approve a companion diagnostic test. The move towards personalized medicine is a growing trend in the industry and can lead to higher drug efficacy and market adoption.
Investors will be closely monitoring the company's ability to meet its stated milestones, especially the initiation of the Phase 1 study by the end of 2024. Meeting these milestones can be a critical driver of investor confidence and can affect the company's stock price. Additionally, the successful curation of a pipeline with over 1600 UC patient clinical and biomarker data points to a robust research foundation, which could expedite drug development and approval processes.
– Rapid advancement of PALI-2108 towards Phase 1 clinical study for the treatment of moderate-to-severe ulcerative colitis; On track to commence Phase 1 before year end
– Formation of Clinical Advisory Board
– Sufficient cash on hand to execute on business plan and achieve significant clinical milestones into 2025
Carlsbad, CA, March 27, 2024 (GLOBE NEWSWIRE) -- 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
Net operating loss was
Research and development expenses were
General and administrative expenses decreased from
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 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; 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, LLC
Jenene Thomas
833-475-8247
PALI@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, 7,000,000 shares authorized; 200,000 issued and outstanding at December 31, 2023 and December 31, 2022 | 2 | 2 | ||||||
Common stock, 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 |
FAQ
What is PALI-2108's development status for ulcerative colitis treatment?
What recent highlights were mentioned in the press release for Palisade Bio, Inc.?
What are the upcoming target milestones for PALI-2108 development?
What precision medicine approach is Palisade Bio, Inc. planning for PALI-2108?