– Company on track to commence Phase 1 human clinical study of lead product candidate, PALI-2108, for the treatment of Ulcerative Colitis (UC) before year end
– Sufficient cash on hand to execute on business plan and reach clinical and regulatory milestones into 2025
Carlsbad, CA, May 14, 2024 (GLOBE NEWSWIRE) — 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 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.
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 | ||||
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