– 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,
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
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
As of
Net loss was
Research and development expenses for the three months ended
General and administrative expenses remained virtually flat at approximately
About Palisade Bio
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
Investor Relations Contact
833-475-8247
PALI@jtcir.com
Condensed Consolidated Balance Sheets (Unaudited)
(in thousands, except share and per share amounts)
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, | 2 | 2 | ||||||
Common stock, | 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 |
Condensed Consolidated Statements of Operations (Unaudited)
(in thousands, except share and per share amounts)
Three Months Ended | ||||||||
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
Condensed Consolidated Statements of Cash Flows (Unaudited)
(in thousands, except share and per share amounts)
Three Months Ended | ||||||||
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 |
Source:
2024 GlobeNewswire, Inc., source