Palisade Bio Reports First Quarter 2022 Financial Results and Provides Corporate Update
Phase 3 study of LB1148 in lead indication for postoperative return of bowel function on track to commence Q2 2022
Ongoing Phase 2 study of LB1148 for the prevention of post-surgical abdominal adhesions
Additionally, the Company provided a clinical program update for its lead asset in development, LB1148, an oral formulation of a broad-spectrum serine protease inhibitor designed to neutralize the activity of potent digestive proteases released from the gut during surgery.
Recent Highlights
- Extended cash runway with a
$2.0 million registered direct offering. Received National Medical Products Administration (NMPA) clearance to commence Phase 3 clinical trial inChina evaluating LB1148 to accelerate the return of bowel function following abdominal surgery.- Received “Study May Proceed” letter from the
U.S. Food and Drug Administration (FDA) for Phase 3 clinical trial evaluating LB1148 to accelerate the return of bowel function following abdominal surgery. - Presented data from a pooled-analysis of studies LBS-IST-POI-101 and LBS-POI-201-CN (PROFILE-CN) demonstrating LB1148 reduced the extent and severity of post-surgical intraabdominal adhesions by 93% at the
Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) 2022 Annual Meeting. - Appointed
Robert McRae as Senior Vice President, Operations and Strategic Development.
“We have made exciting progress on the operational, clinical, and regulatory fronts over the course of the past quarter and are poised to execute on our near-term milestones. With the clearance from the FDA, as well as the NMPA, to proceed with our Phase 3 program in
Clinical Program Update
LB1148 is a novel oral liquid formulation of the well-characterized digestive enzyme inhibitor, tranexamic acid (“TXA”), with potential to both reduce abdominal adhesions and help restore bowel function following surgery. The therapy is being developed for administration prior to surgeries that are at risk of disrupting the intestinal epithelial barrier. Evidence suggests that the release of digestive proteases contributes to the temporary loss of normal gastrointestinal function and the formation of postoperative adhesions. By inhibiting the activity of these digestive proteases, LB1148 has the potential to prevent damage to GI tissues, accelerate the time to the return of normal GI function, and shorten the duration of costly post-surgery hospital stays.
Postoperative Return of Bowel Function: GI Surgery
In
Additionally, in
The expected timelines are management’s current forecasts and will be updated as enrollment progresses.
Expected Upcoming Milestones
- Q2 2022:
U.S. Phase 3 study initiation - 2H 2022:
U.S. Phase 3 study first patient enrolled
Prevention of Post-Surgical Abdominal Adhesions: GI Surgery
Digestive enzymes can escape the intestine during abdominal surgery and cause damage to the intestines and surrounding organs resulting in the formation of scar tissue known as adhesions. Adhesion prevalence has historically reported to be >90% in patients who undergo abdominal surgery and represents a potentially significant contribution to serious complications. Adhesions can be the cause of chronic pain and may prevent normal organ function, including bowel obstructions of the intestine. Adhesions can increase the difficulty of subsequent surgeries causing complications and are the leading cause of secondary infertility in women. In some cases, adhesions require a second corrective surgical procedure. There are currently no approved medications to prevent or treat adhesions.
The Company previously reported data on three patients who had been assessed for adhesions following GI surgery. In the Company’s recent data presentation at the
The Company is conducting an ongoing randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase 2 clinical trial of LB1148 in up to 200 patients undergoing elective bowel resection surgery in
Expected Upcoming Milestones
- Q4 2022: Phase 2 enrollment completion
- 1H 2023: Phase 2 study completion
- 2H 2023: Report Phase 2 topline results
Postoperative Return of Bowel Function: Cardiovascular Surgery
The Company previously announced positive topline data from its Phase 2 trial demonstrating LB1148 achieved its primary endpoint with statistically significant improvement in return of bowel function following cardiovascular (CV) surgery. The Phase 2 clinical trial was a randomized, double-blind, parallel, placebo-controlled trial in 120 subjects undergoing coronary artery bypass grafting (CABG) and/or heart valve replacement surgery requiring cardiopulmonary bypass (CPB) with patients randomized to receive LB1148 or placebo in conjunction with surgery. LB1148 provided a 30% improvement in the time to normal bowel function following cardiovascular surgery (p<0.001) compared to placebo. This improvement resulted in a 1.1-day reduction in average length of stay in the ICU and a 1.0-day reduction in average hospital length of stay. LB1148 was also shown to be safe and well-tolerated in the trial. The Company plans to initiate additional CV surgery studies with LB1148 after the completion of the studies to accelerate the return of bowel function in patients undergoing gastrointestinal surgery.
The
Summary of Financial Results for First Quarter 2022
Net loss was
Research and development expenses were
General and administrative expenses for the three months ended
As of
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 Palisade’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the expected commencement date for a Phase 3 study, expected near-term Phase 2 milestones, the use of proceeds from the financing, expectations regarding regulatory submissions, the potential for LB1148 to transform the current standard of care, if approved, and the ability for the Company to unlock value for our stakeholders. 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 Palisade’s current expectations. Forward-looking statements involve risks and uncertainties. Palisade’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 clinical programs, the uncertain and time-consuming regulatory approval process, and the Company's ability to achieve additional financing to fund future operations and to comply with the continued listing requirements of the applicable stock exchange. Additional risks and uncertainties can be found in Palisade Bio’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2022. Palisade 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 Palisade’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
Palisade Bio Investor Relations Contact:
ir@palisadebio.com
Investor Relations Contact
833-475-8247
PALI@jtcir.com
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)
| 2022 | 2021 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 6,644 | $ | 10,495 | ||||
| Prepaid expenses and other current assets | 1,614 | 1,879 | ||||||
| Total current assets | 8,258 | 12,374 | ||||||
| Restricted cash | 26 | 26 | ||||||
| Right-of-use asset | 64 | 109 | ||||||
| Property and equipment, net | 2 | 3 | ||||||
| Total assets | $ | 8,350 | $ | 12,512 | ||||
| LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,147 | $ | 1,323 | ||||
| Accrued liabilities | 580 | 463 | ||||||
| Accrued compensation and benefits | 72 | 511 | ||||||
| Current portion of lease liability | 65 | 112 | ||||||
| Current portion of debt | — | 87 | ||||||
| Total current liabilities | 1,864 | 2,496 | ||||||
| Warrant liability | 1,694 | 2,651 | ||||||
| Total liabilities | 3,558 | 5,147 | ||||||
| Commitments and contingencies (Note 9) | ||||||||
| Stockholders' equity: | ||||||||
| Series A Convertible Preferred Stock, 7,000,000 shares authorized, |
2 | 2 | ||||||
| Common stock, |
183 | 143 | ||||||
| Additional paid-in capital | 103,454 | 101,862 | ||||||
| Accumulated deficit | (98,847 | ) | (94,642 | ) | ||||
| Total stockholders' equity | 4,792 | 7,365 | ||||||
| Total liabilities and stockholders' equity | $ | 8,350 | $ | 12,512 | ||||
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(Unaudited)
| Three Months Ended |
||||||||
| 2022 | 2021 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 959 | $ | 692 | ||||
| General and administrative | 2,929 | 1,262 | ||||||
| Total operating expenses | 3,888 | 1,954 | ||||||
| Loss from operations | (3,888 | ) | (1,954 | ) | ||||
| Other income (expense): | ||||||||
| Gain on forgiveness of PPP loan | — | 279 | ||||||
| Loss on issuance of secured debt | — | (686 | ) | |||||
| Gain on change in fair value of warrant liability | 793 | 42 | ||||||
| Interest expense | (1 | ) | (1,711 | ) | ||||
| Other income | 1 | — | ||||||
| Loss on issuance of warrants | (1,110 | ) | — | |||||
| Total other expense | (317 | ) | (2,076 | ) | ||||
| Net loss | $ | (4,205 | ) | $ | (4,030 | ) | ||
| Basic and diluted loss per common share | $ | (0.26 | ) | $ | (1.45 | ) | ||
| Weighted average shares used in computing basic and diluted loss per common share | 16,223,656 | 2,774,502 | ||||||
Condensed Consolidated Statements of Cash Flows
(in thousands)
| Three Months Ended |
||||||||
| 2022 | 2021 | |||||||
| Net loss | $ | (4,205 | ) | $ | (4,030 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization | 1 | 1 | ||||||
| Noncash lease expense | 45 | 39 | ||||||
| Gain on forgiveness of PPP loan | — | (279 | ) | |||||
| Accretion of debt discount and non-cash interest expense | — | 1,590 | ||||||
| Loss on issuance of secured debt | — | 686 | ||||||
| Loss on issuance of warrants | 1,110 | — | ||||||
| Change in fair value of warrant liabilities | (793 | ) | (42 | ) | ||||
| Stock-based compensation | 358 | 569 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Trade and other receivables | — | 59 | ||||||
| Prepaid and other assets | 265 | 21 | ||||||
| Accounts payable and accrued liabilities | (59 | ) | 183 | |||||
| Accrued compensation | (439 | ) | (8 | ) | ||||
| Operating lease liabilities | (47 | ) | (39 | ) | ||||
| Net cash used in operating activities | (3,764 | ) | (1,250 | ) | ||||
| Cash flows from financing activities: | ||||||||
| Payments on debt | (87 | ) | (11 | ) | ||||
| Proceeds from issuance of debt | — | 1,250 | ||||||
| Payment of debt issuance costs | — | (87 | ) | |||||
| Net cash (used in) provided by financing activities | (87 | ) | 1,152 | |||||
| Net decrease in cash, cash equivalents and restricted cash | (3,851 | ) | (98 | ) | ||||
| Cash, cash equivalents and restricted cash, beginning of period | 10,521 | 739 | ||||||
| Cash, cash equivalents and restricted cash, end of period | $ | 6,670 | $ | 641 | ||||
