Commenced enrollment and dosing in Phase 1 clinical study of PALI-2108 for the treatment of moderate-to-severe Ulcerative Colitis (UC)
Carlsbad, CA, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) ("Palisade," "Palisade Bio" or the "Company"), a clinical-stage 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 third quarter of 2024 and provided a business update.
Recent Highlights
- Commenced enrollment and dosed first subjects in its Phase 1 human clinical study of PALI-2108 for the treatment of moderate-to-severe UC;
- Presented data from two translational studies demonstrating the ex vivo bioactivation of PALI-2108 in stool samples and whole blood at the ACG's 2024 Annual Scientific Meeting;
- Reported the completion of refined patient selection strategies based on PDE4-related biomarkers and disease characteristics to optimize clinical outcomes for patients with UC as part of its collaboration with Strand Life Sciences;
- Completed microbiome study confirming bacterial enzymes for local bioactivation of lead product candidate, PALI-2108, in development for Crohn's disease and UC;
- Expanded intellectual property portfolio of PALI-2108 and PALI-1908 with a notice to grant patent from the European Patent Office; and
- Completed the first Good Manufacturing Practice (GMP) batch of drug substance PALI-2108, an orally administered, locally acting colon-specific phosphodiesterase-4 (PDE4) inhibitor prodrug in development for patients affected by UC.
"I am extremely proud of the clinical progress our team has made over this past quarter. The initiation of our Phase 1 clinical trial and patient enrollment and dosing are important milestones in our clinical program," commented J.D. Finley, Chief Executive Officer of Palisade. "We continue to believe in the potential of PALI-2108 to provide a much-needed solution for UC patients still experiencing significant medical need."
About PALI-2108
PALI-2108 is an orally administered, locally acting colon-specific PDE4 inhibitor prodrug in development for patients affected by UC. The Company continued to progress development of PALI-2108 and recently commenced a Phase 1 single-center, double-blind, placebo-controlled study focused on safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers, alongside an open-label study involving a patient cohort with UC. The comprehensive data gathered will support Palisade Bio's precision medicine strategy, aimed at identifying patient responders for future clinical studies.
Upcoming Target Milestones
- Phase 1 topline data expected in the first half of 2025; and
- Initiate Phase 1b/2a in the second half of 2025.
For more information about the Phase 1 clinical study, visit clinicaltrials.gov and reference identifier NCT06663605.
Summary of Financial Results for the Quarter Ended September 30, 2024
As of September 30, 2024, the Company had cash and cash equivalents of $8.0 million. 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 September 30, 2024, compared to $3.6 million for the same period in 2023.
Research and development expenses of approximately $2.1 million were virtually flat compared to the three months ended September 30, 2023. In the current year period, higher expenses directly related to the joint development of our lead asset, PALI-2108, and higher drug manufacturing costs, were offset by a decrease in costs related to the Company's development of LB1148, which we ceased in August of 2023, a decrease in other employee-related costs, and the favorable impact of a non-cash gain associated with a decrease in the fair value of our contingent consideration liability.
General and administrative expenses decreased by $0.2 million, or 13%, from approximately $1.7 million for the three months ended September 30, 2023 to $1.5 million for the three months ended September 30, 2024. The decrease was primarily due to lower general corporate expenses, which were partially offset by higher consultant and contract labor.
About Palisade Bio
Palisade Bio is a clinical-stage 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; the timing and outcome of our current and anticipated applications and studies related to our product candidates; 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 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, and any Quarterly Reports on Form 10-Q or other SEC filings that were filed thereafter. 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
908-824-0775
PALI@jtcir.com
Palisade Bio, Inc.
Condensed Consolidated Balance Sheets (Unaudited)
(in thousands, except share and per share amounts)
| September 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 8,040 | $ | 12,432 | ||||
| Prepaid expenses and other current assets | 830 | 896 | ||||||
| Total current assets | 8,870 | 13,328 | ||||||
| Restricted cash | 26 | 26 | ||||||
| Property and equipment, net | 3 | 10 | ||||||
| Operating lease right-of-use asset | 113 | 198 | ||||||
| Other noncurrent assets | 324 | 490 | ||||||
| Total assets | $ | 9,336 | $ | 14,052 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 366 | $ | 698 | ||||
| Accrued liabilities | 1,509 | 831 | ||||||
| Accrued compensation and benefits | 449 | 778 | ||||||
| Current portion of operating lease liability | 122 | 121 | ||||||
| Insurance financing debt | 235 | 158 | ||||||
| Total current liabilities | 2,681 | 2,586 | ||||||
| Warrant liability | 2 | 2 | ||||||
| Contingent consideration obligation | 45 | 61 | ||||||
| Operating lease liability, net of current portion | - | 90 | ||||||
| Total liabilities | 2,728 | 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 September 30, 2024 and December 31, 2023 | 2 | 2 | ||||||
| Common stock, $0.01 par value; 280,000,000 shares authorized; 1,198,516 and 618,056 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively | 11 | 6 | ||||||
| Additional paid-in capital | 139,195 | 132,811 | ||||||
| Accumulated deficit | (132,600 | ) | (121,506 | ) | ||||
| Total stockholders' equity | 6,608 | 11,313 | ||||||
| Total liabilities and stockholders' equity | $ | 9,336 | $ | 14,052 | ||||
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, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| License revenue | $ | - | $ | - | $ | - | $ | 250 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 2,137 | 2,104 | 6,979 | 5,522 | ||||||||||||
| General and administrative | 1,456 | 1,674 | 4,498 | 4,644 | ||||||||||||
| Total operating expenses | 3,593 | 3,778 | 11,477 | 10,166 | ||||||||||||
| Loss from operations | (3,593 | ) | (3,778 | ) | (11,477 | ) | (9,916 | ) | ||||||||
| Other (expense) income: | ||||||||||||||||
| Interest expense | (6 | ) | (8 | ) | (9 | ) | (11 | ) | ||||||||
| Other income, net | 112 | 190 | 392 | 598 | ||||||||||||
| Total other income, net | 106 | 182 | 383 | 587 | ||||||||||||
| Net loss | $ | (3,487 | ) | $ | (3,596 | ) | $ | (11,094 | ) | $ | (9,329 | ) | ||||
| Net loss available to common stockholders | $ | (3,487 | ) | $ | (3,612 | ) | $ | (11,094 | ) | $ | (9,345 | ) | ||||
| Basic and diluted weighted average shares used in computing basic and diluted net loss per common share | 1,500,409 | 489,624 | 1,168,277 | 402,074 | ||||||||||||
| Basic and diluted net loss per common share | $ | (2.32 | ) | $ | (7.38 | ) | $ | (9.50 | ) | $ | (23.24 | ) | ||||
Palisade Bio, Inc.
Condensed Consolidated Statements of Cash Flows (Unaudited)
(in thousands, except share and per share amounts)
| Nine Months Ended September 30, | ||||||||
| 2024 | 2023 | |||||||
| Net loss | $ | (11,094 | ) | $ | (9,329 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation | 3 | 4 | ||||||
| Non-cash operating lease expense | 85 | 76 | ||||||
| Recurring fair value measurements of liabilities | (159 | ) | 153 | |||||
| Issuance of common stock to vendors | 124 | - | ||||||
| Loss on disposal of property and equipment | 4 | - | ||||||
| Stock-based compensation and related charges | 575 | 439 | ||||||
| Other | - | (108 | ) | |||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid and other current assets and other noncurrent assets | 542 | 596 | ||||||
| Accounts payable and accrued liabilities | 526 | (184 | ) | |||||
| Accrued compensation and benefits | (329 | ) | 43 | |||||
| Operating lease liabilities | (89 | ) | (77 | ) | ||||
| Net cash used in operating activities | (9,812 | ) | (8,387 | ) | ||||
| 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 insurance financing debt | (270 | ) | (290 | ) | ||||
| Proceeds from issuance of common stock and warrants | 4,000 | 9,419 | ||||||
| Proceeds from the exercise of warrants | 2,503 | 2,758 | ||||||
| Payment of warrant inducement issuance costs | (343 | ) | - | |||||
| Payment of equity issuance costs | (456 | ) | (567 | ) | ||||
| Proceeds from issuance of common stock under Employee Stock Purchase Plan | 11 | - | ||||||
| Shares withheld for payment of employee withholding tax liability | (25 | ) | - | |||||
| Net cash provided by financing activities | 5,420 | 11,320 | ||||||
| Net (decrease) increase in cash, cash equivalents and restricted cash | (4,392 | ) | 2,929 | |||||
| Cash, cash equivalents and restricted cash, beginning of year | 12,458 | 12,409 | ||||||
| Cash, cash equivalents and restricted cash, end of period | $ | 8,066 | $ | 15,338 | ||||
| Reconciliation of cash, cash equivalents and restricted cash to the balance sheets: | ||||||||
| Cash and cash equivalents | $ | 8,040 | $ | 15,312 | ||||
| Restricted cash | 26 | 26 | ||||||
| Total cash, cash equivalents and restricted cash | $ | 8,066 | $ | 15,338 | ||||
