– 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
– Sufficient cash on hand to execute on business plan and achieve significant clinical milestones into 2025
Carlsbad, CA,
Recent Highlights
- The Company formed its
Clinical Advisory Board and appointed preeminent Key Opinion Leaders,Bruce Sands , MD, MS andFlorian 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 andColitis Foundation , through itsIBD Ventures program.
“2023 was a transformative year for
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
As of
Net operating loss was
Research and development expenses were
General and administrative expenses decreased from
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
Consolidated Balance Sheets (Unaudited)
(in thousands, except share and per share amounts)
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 | 2 | 2 | ||||||
Common stock, 9,270,894 and 2,944,306 shares issued and outstanding at | 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 |
Consolidated Statements of Operations (Unaudited)
(in thousands, except share and per share amounts)
Year Ended | ||||||||
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 | ) |
Consolidated Statements of Cash Flows (Unaudited)
(in thousands, except share and per share amounts)
Year Ended | ||||||||
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 |
Source:
2024 GlobeNewswire, Inc., source