Palisade Bio Reports Third Quarter 2022 Financial Results and Provides Business Update
Carlsbad, CA,
Clinical Program Update for LB1148
Advancement of
The Company is conducting an ongoing randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase 2 clinical trial of LB1148 in patients undergoing elective bowel resection surgery in
To date, the Company has enrolled 31 of an expected 70 patients in its
Status of Palisade Bio’s Return of Bowel Function
In
In
Given the foregoing, as well as the financial resources available to the Company at this time, the Company believes it is in its stakeholders’ best interests to pause enrollment in the
J.D. Finley, interim CEO of Palisade, commented, “Our number one priority is advancing the
Notwithstanding this review and the pausing of the trial, the Company remains optimistic as to the efficacy of LB1148 for the return of bowel function based on the Company’s co-development partner’s Phase 2 data and its plan to continue its Phase 3 study in
Summary of Financial Results for Third Quarter 2022
As of
Net loss was
Research and development expenses were
General and administrative expenses decreased from
The Company recognized restructuring costs of
About
The Company’s lead program, LB1148, is a broad-spectrum serine protease inhibitor which acts to neutralize digestive enzymes, potentially reducing intestinal damage. In clinical studies, LB1148 has demonstrated positive results in accelerating the time to return of postoperative bowel function, and the Company recently presented analysis that LB1148 reduced the incidence and severity of post-surgical abdominal adhesions. LB1148 is currently being evaluated in a Phase 2 study for the prevention of post-surgical abdominal adhesions.
The Company believes that addressing the disruption of the intestinal barrier can fundamentally change the way diseases are treated and establish new standards of patient care. 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: progress of studies, including opening additional clinical trial sites, timing of results or data, progress and completion of patient enrollment, including timing thereof and the Company’s co-development partner’s expectation to complete enrollment; regulatory progress and strategy, including potential registration and commercialization of LB1148; the extent of the cash runway; the closing of the underwritten public offering; and expected proceeds from financings. 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 clinical programs, the uncertain and time-consuming regulatory approval process; the Company’s ability to achieve additional financing to fund future operations and the Company’s ability to comply with the continued listing requirements for Nasdaq. Additional risks and uncertainties can be found in the Company’s Annual Report on Form 10-K for the fiscal year ended
Investor Relations Contact
833-475-8247
PALI@jtcir.com
Source:
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)
| 2022 | 2021 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 13,985 | $ | 10,495 | ||||
| Prepaid expenses and other current assets | 1,173 | 1,011 | ||||||
| Total current assets | 15,158 | 11,506 | ||||||
| Restricted cash | 26 | 26 | ||||||
| Right-of-use asset | 324 | 109 | ||||||
| Other noncurrent assets | 746 | 868 | ||||||
| Property and equipment, net | 12 | 3 | ||||||
| Total assets | $ | 16,266 | $ | 12,512 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,725 | $ | 1,323 | ||||
| Accrued liabilities | 1,242 | 463 | ||||||
| Accrued compensation and benefits | 93 | 511 | ||||||
| Current portion of lease liability | 101 | 112 | ||||||
| Debt | 352 | 87 | ||||||
| Total current liabilities | 3,513 | 2,496 | ||||||
| Warrant liability | 84 | 2,651 | ||||||
| Lease liability, net of current portion | 239 | — | ||||||
| Total liabilities | 3,836 | 5,147 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Series A Convertible Preferred Stock, 7,000,000 shares authorized, par value; 200,000 issued and outstanding at |
2 | 2 | ||||||
| Common stock, authorized as of 77,080,169 and 14,239,177 shares issued and outstanding at |
771 | 143 | ||||||
| Additional paid-in capital | 116,839 | 101,862 | ||||||
| Accumulated deficit | (105,182 | ) | (94,642 | ) | ||||
| Total stockholders' equity | 12,430 | 7,365 | ||||||
| Total liabilities and stockholders' equity | $ | 16,266 | $ | 12,512 | ||||
(in thousands, except share and per share amounts)
| Three Months Ended |
Nine Months Ended |
|||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 1,928 | $ | 624 | $ | 4,204 | $ | 1,630 | ||||||||
| In-process research and development | — | — | — | 30,117 | ||||||||||||
| General and administrative | 2,075 | 2,392 | 7,259 | 6,080 | ||||||||||||
| Restructuring costs | 410 | — | 410 | — | ||||||||||||
| Total operating expenses | 4,413 | 3,016 | 11,873 | 37,827 | ||||||||||||
| Loss from operations | (4,413 | ) | (3,016 | ) | (11,873 | ) | (37,827 | ) | ||||||||
| 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 | 385 | 12,764 | 2,403 | 17,939 | ||||||||||||
| Gain on change in fair value of share liability | — | 18 | — | 91 | ||||||||||||
| Interest expense | (4 | ) | (26 | ) | (10 | ) | (2,393 | ) | ||||||||
| Other income | 41 | 20 | 50 | 36 | ||||||||||||
| Loss on issuance of LBS Series 1 Preferred Stock | — | — | — | (1,881 | ) | |||||||||||
| Loss on issuance of warrants | — | (1,673 | ) | (1,110 | ) | (3,247 | ) | |||||||||
| Total other income (expense) | 422 | 11,103 | 1,333 | 10,138 | ||||||||||||
| Net (loss) income | $ | (3,991 | ) | $ | 8,087 | $ | (10,540 | ) | $ | (27,689 | ) | |||||
| (Loss) income per common share: | ||||||||||||||||
| Basic | $ | (0.08 | ) | $ | 0.42 | $ | (0.37 | ) | $ | (3.50 | ) | |||||
| Diluted | $ | (0.08 | ) | $ | 0.42 | $ | (0.37 | ) | $ | (4.13 | ) | |||||
| Weighted average shares used in computing (loss) income per common share: | ||||||||||||||||
| Basic | 48,709,846 | 12,100,292 | 28,634,209 | 7,902,104 | ||||||||||||
| Diluted | 48,709,846 | 12,106,771 | 28,634,209 | 7,952,998 | ||||||||||||
| Net (loss) income attributable to common shares - basic | $ | (3,991 | ) | $ | 5,118 | $ | (10,540 | ) | $ | (27,689 | ) | |||||
| Net (loss) income attributable to common shares - diluted | $ | (3,991 | ) | $ | 5,119 | $ | (10,540 | ) | $ | (32,808 | ) | |||||
Condensed Consolidated Statements of Cash Flows (Unaudited)
(in thousands)
| Nine Months Ended |
||||||||
| 2022 | 2021 | |||||||
| Net loss | $ | (10,540 | ) | $ | (27,689 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization | 1 | 2 | ||||||
| In-process research and development | — | 30,117 | ||||||
| Noncash transaction costs shared with Seneca | — | (135 | ) | |||||
| Noncash lease expense | 140 | 122 | ||||||
| Gain on forgiveness of PPP loan | — | (279 | ) | |||||
| Accretion of debt discount and non-cash interest expense | — | 2,334 | ||||||
| Loss on issuance of LBS Series 1 Preferred Stock | — | 1,881 | ||||||
| Loss on issuance of secured debt | — | 686 | ||||||
| Loss on issuance of warrants | 1,110 | 3,247 | ||||||
| Change in fair value of warrant liabilities | (2,403 | ) | (17,939 | ) | ||||
| Change in fair value of share liability | — | (91 | ) | |||||
| Stock-based compensation | 946 | 1,208 | ||||||
| Other | (213 | ) | (191 | ) | ||||
| Changes in operating assets and liabilities: | ||||||||
| Other receivables | — | 84 | ||||||
| Prepaid and other assets and other noncurrent assets | 744 | (1,264 | ) | |||||
| Accounts payable and accrued liabilities | 706 | (2,145 | ) | |||||
| Accrued compensation | (418 | ) | (1,544 | ) | ||||
| Operating lease liabilities | (127 | ) | (122 | ) | ||||
| Net cash used in operating activities | (10,054 | ) | (11,718 | ) | ||||
| Cash flows from investing activities: | ||||||||
| Cash acquired in connection with the Merger | — | 3,279 | ||||||
| Acquisition related costs paid | — | (3,333 | ) | |||||
| Net cash used in investing activities | — | (54 | ) | |||||
| Cash flows from financing activities: | ||||||||
| Payments on debt | (524 | ) | (949 | ) | ||||
| Proceeds from issuance of debt | — | 1,250 | ||||||
| Proceeds from issuance of LBS Series 1 Preferred Stock | — | 19,900 | ||||||
| Proceeds from issuance of common stock and warrants | 14,401 | 5,209 | ||||||
| Redemption of warrants | — | (99 | ) | |||||
| Payment of equity issuance costs | (333 | ) | — | |||||
| Payment of debt issuance costs | — | (148 | ) | |||||
| Net cash provided by financing activities | 13,544 | 25,163 | ||||||
| Net (decrease) increase in cash, cash equivalents and restricted cash | 3,490 | 13,391 | ||||||
| Cash, cash equivalents and restricted cash, beginning of period | 10,521 | 739 | ||||||
| Cash, cash equivalents and restricted cash, end of period | $ | 14,011 | $ | 14,130 | ||||
| Reconciliation of cash, cash equivalents and restricted cash to the balance sheets: | ||||||||
| Cash and cash equivalents | 13,985 | 14,104 | ||||||
| Restricted cash | 26 | 26 | ||||||
| Total cash, cash equivalents and restricted cash | $ | 14,011 | $ | 14,130 | ||||
Source: Palisade Bio, Inc.