PALI Palisade Bio Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
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LB1148 (PROFILE)
Reduction in adhesions following abdominal and pelvic surgery
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Phase 2
Phase 2
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LB1148
Gastrointestinal (GI) recovery in neonates
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Phase 2/3
Phase 2/3
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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LB1148 - (China trial)
Gastrointestinal (GI) surgery
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Phase 2
Phase 2
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Phase 2 data released July 29, 2021- statistically significant (p=0.0008) effect in accelerating the return of bowel function.
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Latest News
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CARLSBAD, Calif., Nov. 15, 2021 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (NASDAQ:PALI) ("Palisade" or the "Company"), a clinical stage biopharmaceutical company advancing oral therapies that help patients with acute and chronic gastrointestinal (GI) complications, today provides a business update and releases its financial results for the third quarter ended September 30, 2021.
Third Quarter Highlights:
- In July 2021, the Company released top line Phase 2 clinical trial results from its development partner, Newsoara, that showed a 1.1-day improvement in GI recovery in patients receiving LB1148 vs placebo.
- In July 2021, the Company entered a worldwide exclusive license with the University of California to patent rights covering certain engineered substrates and use in measuring degradative enzymes for disease conditions, including cancer.
- In August 2021, Yuma Regional Medical Center made a private investment of $5.2 million to help advance clinical development of LB1148.
Financial Summary:
- Research and development expenses increased from $412,000 for the three months ended September 30, 2020, to $624,000 for the three months ended September 30, 2021, primarily attributable to an increase in clinical trial activities as non-essential surgical procedures, which were virtually halted following the onset of the COVID-19 pandemic, have begun to return to pre-pandemic levels resulting in more patients enrolled in our clinical trial. The increase was offset partially by a decrease in share-based compensation expense.
- General and administrative expenses increased from $1.4 million for the three months ended September 30, 2020, to $2.4 million for the same period of 2021, primarily related to an increase in other general and administrative expenses associated with operating as a public company, including accounting and legal costs, offset partially by a decrease in share-based compensation expense.
- Cash and cash equivalents as of September 30, 2021, was $14.1 million, while outstanding debt was $568,000.
"The positive results from the Phase 2 study demonstrated that LB1148 accelerated return to bowel function in patients undergoing GI surgery compared to placebo. We're excited about the read outs of these Phase 2 data as they guide us towards a pathway for late-stage protocols," stated Tom Hallam, Ph.D., President and Chief Executive Officer of Palisade Bio. "Additionally, we are initiating studies based on technology under the UC license to measure blood protease activity in defined patient groups, with the goal of identifying new biomarkers and therapeutic targets to build our pipeline."
About Palisade Bio, Inc.
Palisade Bio is a clinical stage biopharmaceutical company advancing oral therapies that help patients with acute and chronic gastrointestinal complications stemming from post-operative digestive enzyme damage. Palisade Bio's innovative lead asset, LB1148, advancing towards Phase 3 is a protease inhibitor with the potential to both reduce abdominal adhesions and help restore bowel function following surgery. Positive data from Phase 2 trials of LB1148 demonstrated safety and tolerability as well as a statistically significant improvement in return to bowel function and decrease in length of stay in ICU and hospital compared to placebo. Palisade Bio believes that its investigational therapies have the potential to address the myriad of health conditions and complications associated with chronic disruption of the gastrointestinal epithelial barrier. For more information, please go to www.palisadebio.com.Forward Looking Statements
This communication contains "forward-looking" statements, including, without limitation, statements related to expectations regarding Palisade's plans for future clinical development of LB1148, plans for regulatory approvals of LB1148, and plans for building a pipeline of therapies in the future. 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 and the uncertain and time-consuming regulatory approval process. Additional risks and uncertainties can be found in Palisade Bio's Quarterly Report on Form 10-Q for the quarter ended September 30, 2021. 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:
Dawn Hofmeister
Manager of Investor and Public Affairs
[email protected]CORE IR
[email protected]Palisade Bio Media Relations Contact:
CORE IR
Jules Abraham
[email protected]
917-885-7378Palisade Bio, Inc.
Condensed Consolidated Balance Sheets (Unaudited)
(in thousands, except share and per share amounts)September 30,
2021December 31,
2020ASSETS Current assets: Cash and cash equivalents $ 14,104 $ 713 Accounts receivable — 59 Prepaid expenses and other current assets 1,988 124 Total current assets 16,092 896 Restricted cash 26 26 Deferred transaction costs — 1,817 Right-of-use asset 153 275 Property and equipment, net 3 5 Total assets $ 16,274 $ 3,019 LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) Current liabilities: Accounts payable $ 1,383 $ 2,537 Accrued liabilities 722 2,740 Accrued compensation and benefits 89 1,590 Current portion of lease liability 158 168 Current portion of debt 387 578 Current portion of related party debt, net 181 469 Total current liabilities 2,920 8,082 Warrant liability 9,434 1,830 Non-current portion of debt — 94 Lease liability, net of current portion — 112 Total liabilities 12,354 10,118 Commitments and contingencies (Note 11) Series C convertible preferred stock, $0.001 par value; 0 and 33,594,625 shares authorized as of September 30, 2021 and December 31, 2020, respectively; 0 and 11,674,131 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively; liquidation preference of $10.4 million as of December 31, 2020 — 9,503 Stockholders' equity (deficit): Series A convertible preferred stock, 7,000,000 shares authorized, $0.01 par value; 200,000 and 0 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively 2 — Common stock, $0.01 par value; 300,000,000 and 6,797,500 shares authorized as of September 30, 2021 and December 31, 2020, respectively; 12,929,911 and 2,774,501 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively 130 28 Additional paid-in capital 99,503 51,396 Accumulated deficit (95,715 ) (68,026 ) Total stockholders' equity (deficit) 3,920 (16,602 ) Total liabilities, convertible preferred stock and stockholders' equity (deficit) $ 16,274 $ 3,019
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 30,2021 2020 2021 2020 Operating expenses: Research and development $ 624 $ 412 $ 1,630 $ 2,314 In-process research and development — — 30,117 — General and administrative 2,392 1,404 6,080 3,738 Total operating expenses 3,016 1,816 37,827 6,052 Loss from operations (3,016 ) (1,816 ) (37,827 ) (6,052 ) 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 12,764 — 17,939 — Gain on change in fair value of share liability 18 — 91 — Interest expense (26 ) (28 ) (2,393 ) (39 ) Other income 20 1 36 13 Loss on issuance of LBS Series 1 Preferred Stock — — (1,881 ) — Loss on issuance of warrants (1,673 ) — (3,247 ) — Total other income (expense) 11,103 (27 ) 10,138 (26 ) Net income (loss) $ 8,087 $ (1,843 ) $ (27,689 ) $ (6,078 ) Earnings (loss) per share: Basic $ 0.42 $ (0.66 ) $ (3.50 ) $ (2.19 ) Diluted $ 0.42 $ (0.66 ) $ (4.13 ) $ (2.19 ) Weighted average shares used in computing earnings (loss) per share: Basic 12,100,292 2,774,502 7,902,104 2,774,237 Diluted 12,106,771 2,774,502 7,952,998 2,774,237 Net income (loss) attributable to common shares - basic $ 5,118 $ (1,843 ) $ (27,689 ) $ (6,078 ) Net income (loss) attributable to common shares - diluted $ 5,119 $ (1,843 ) $ (32,808 ) $ (6,078 ) Palisade Bio, Inc.
Condensed Consolidated Statements of Cash Flows (Unaudited)
(in thousands)Nine Months Ended
September 30,2021 2020 Net loss $ (27,689 ) $ (6,078 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 2 2 In-process research and development 30,117 — Noncash transaction costs shared with Seneca (135 ) — Noncash lease expense 122 105 Gain on forgiveness of PPP loan (279 ) — Accretion of debt discount and non-cash interest expense 2,334 32 Loss on issuance of LBS Series 1 Preferred Stock 1,881 — Loss on issuance of secured debt 686 — Loss on issuance of warrants 3,247 — Change in fair value of warrant liabilities (17,939 ) — Change in fair value of share liability (91 ) — Stock-based compensation 1,208 1,544 Accrued and unpaid interest — 7 Other 191 — Changes in operating assets and liabilities: Trade and other receivables 84 (53 ) Prepaid and other assets (1,264 ) 24 Accounts payable and accrued liabilities (2,527 ) 1,299 Accrued compensation (1,544 ) — Operating lease liabilities (122 ) (102 ) Net cash used in operating activities (11,718 ) (3,220 ) Cash flows from investing activities: Cash acquired in connection with the Merger 3,279 — Acquisition related costs paid (3,333 ) — Purchases of property and equipment — (5 ) Net cash used in investing activities (54 ) (5 ) Cash flows from financing activities: Payments on debt (949 ) — Proceeds from issuance of debt 1,250 379 Proceeds from issuance of LBS Series 1 Preferred Stock 19,900 — Proceeds from issuance of common stock and warrants 5,209 — Redemption of warrants (99 ) — Payment of debt issuance costs (148 ) — Net cash provided by financing activities 25,163 379 Net increase (decrease) in cash, cash equivalents and restricted cash 13,391 (2,846 ) Cash, cash equivalents and restricted cash, beginning of period 739 3,623 Cash, cash equivalents and restricted cash, end of period $ 14,130 $ 777 Reconciliation of cash, cash equivalents and restricted cash to the balance sheets: Cash and cash equivalents 14,104 751 Restricted cash 26 26 Total cash, cash equivalents and restricted cash $ 14,130 $ 777 Supplemental disclosure of cash flows: Interest paid $ 61 $ — Supplemental disclosures of non-cash investing and financing activities: Equity issuance costs included in accounts payable $ 67 $ — Transaction costs shared with Seneca $ 135 $ — Acquisition costs related to stock issuance $ 1,184 $ — Issuance of common stock to former Seneca stockholders $ 28,728 $ — Conversion of LBS Series C Preferred stock into common stock $ 9,503 $ — Net assets acquired in the Merger $ 2 $ — Acquisition related vesting of RSU's assumed in the Merger $ 41 $ — Acquisition related fair value change in warrant liability assumed in the Merger $ 51 $ — 
- In July 2021, the Company released top line Phase 2 clinical trial results from its development partner, Newsoara, that showed a 1.1-day improvement in GI recovery in patients receiving LB1148 vs placebo.
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CARLSBAD, Calif., Oct. 22, 2021 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (NASDAQ:PALI), a late-stage biopharma company advancing oral therapies that help patients with acute and chronic gastrointestinal (GI) complications, announces today that an early exercise option has led to the acquisition of the Seneca asset NSI-189, a neurogenic compound which was part of Seneca Biopharma's product portfolio at the time of the merger to form Palisade Bio and which is part of the Contingent Value Rights issued to the pre-merger Seneca shareholders. Prior to the merger (in December 2020) Seneca had exclusively out-licensed the NSI-189 program with a 3-year exercise option.
Under the terms of the agreement to acquire NSI-189, the purchaser will pay an upfront cash payment of approximately $400,000 with up to an additional $4.5 million contingent on certain clinical development milestones or a subsequent license or sale of the asset by the purchaser within a certain period.
About Palisade Bio.
Palisade Bio is a late-stage biopharma company advancing therapies that help patients with acute and chronic gastrointestinal complications stemming from post-operative digestive enzyme damage. Palisade Bio's innovative lead asset, LB1148, is a Phase 3-ready protease inhibitor with the potential to both reduce abdominal adhesions and help restore bowel function following surgery. Positive data from Phase 2 trials of LB1148 demonstrated safety and tolerability as well as a statistically significant improvement in return to bowel function and decrease in length of stay in ICU and hospital compared to placebo. Palisade Bio believes that its investigational therapies have the potential to address the myriad health conditions and complications associated with chronic disruption of the gastrointestinal epithelial barrier. For more information, please go to www.palisadebio.com.This communication contains "forward-looking" statements, including, without limitation, statements related to the potential for any future milestone payments under the asset acquisition agreement. 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, related to the Company's ability to advance its clinical programs and the uncertain and time-consuming regulatory approval process. Additional risks and uncertainties can be found in Palisade Bio's (formerly known as Seneca Biopharma, Inc.) Quarterly Report on Form 10-Q for the quarter ended June 30, 2021. 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:
Dawn Hofmeister
[email protected]Palisade Bio Media Relations Contact:
CORE IR
Jules Abraham
[email protected]
917-885-7378
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CARLSBAD, Calif., Sept. 09, 2021 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (NASDAQ:PALI) a late-stage biopharma company advancing therapies for acute and chronic gastrointestinal (GI) complications, announces today that Chief Executive Officer Tom Hallam, Ph.D. will present at the H.C. Wainwright Global Investment Conference, which is being held virtually from September 13- 15, 2021.
Dr. Hallam will deliver his corporate presentation, which will become available beginning on September 13 at 7:00 AM ET.
Investors can register here: www.hcwevents.com.
Dr. Hallam will also be available for one-on-one meetings throughout the conference.
About Palisade Bio, Inc.
Palisade Bio is a late-stage biopharma company advancing therapies that help patients with acute and chronic gastrointestinal complications stemming from post-operative digestive enzyme damage. Palisade Bio's innovative lead asset, LB1148, is a Phase 3-ready protease inhibitor with the potential to both reduce abdominal adhesions and help restore bowel function following surgery. Positive data from Phase 2 trials of LB1148 demonstrated safety and tolerability as well as a statistically significant improvement in return to bowel function and decrease in length of stay in ICU and hospital compared to placebo. Palisade Bio believes that its investigational therapies have the potential to address the myriad health conditions and complications associated with chronic disruption of the gastrointestinal epithelial barrier. For more information, please go to www.palisadebio.com.Forward Looking Statements
This communication contains "forward-looking" statements, including, without limitation, statements related to expectations regarding Palisade's plans for future clinical development of LB1148, plans for regulatory approvals of LB1148, plans for building a pipeline of therapies in the future, and plans for additional investor updates in the future. 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, related to the Company's ability to advance its clinical programs and the uncertain and time-consuming regulatory approval process. Additional risks and uncertainties can be found in Palisade Bio's (formerly known as Seneca Biopharma, Inc.) Quarterly Report on Form 10-Q for the quarter ended June 30, 2021. 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:
Dawn Hofmeister
[email protected]Palisade Bio Media Relations Contact:
CORE IR
Jules Abraham
[email protected]
917-885-7378
-
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CARLSBAD, Calif., Aug. 24, 2021 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (NASDAQ:PALI) ("Palisade" or the "Company"), a late-stage biopharma company advancing therapies for acute and chronic gastrointestinal (GI) complications, today provides a business update and releases its financial results for the second quarter ending June 30, 2021.
Recent Corporate Highlights:
- Announced positive topline results from Phase 2 study of LB1148 by partner Newsoara demonstrating accelerated return of bowel function after gastrointestinal surgery
- Entered into worldwide in-licensing agreement with University of California for technology to support target identification, drug discovery, and clinical development
- Launched a Clinical Steering Committee to provide strategic guidance over late-stage clinical program development for its lead investigational drug LB1148
- Hosted a key opinion leader (KOL) webinar on LB1148 with Drs. Steven Wexner, M.D., Cleveland Clinic and Mark A. Talamini, M.D., Northwell Health
- Received FDA Fast Track Designation for LB1148 for reduction of adhesions following abdominal and pelvic surgery
- Closed a $5.2M private investment by the Yuma Regional Medical Center to help advance clinical development of LB1148
Financial Summary:
- R&D expenses declined from $650,000 for the three months ended June 30, 2020 to $314,000 in the three months ended June 30, 2021, primarily due to higher trailing enrollment in the prior period before the COVID-19 pandemic, as well as due to a general decrease in personnel-related costs and stock-based compensation in the current period.
- General and administrative expenses increased from $1.2 million in the quarter ended June 30, 2020 to $2.4 million in the same period of 2021, primarily due to increased compensation and stock compensation expenses, as well as other general and administrative expenses associated with operating as a public company.
- In-process R&D for the quarter ended 2021 was $30.1 million, as compared to $0 in the same period of 2020, and reflects the allocation of the merger price to in-process R&D projects acquired with no alternative future use.
- Cash and cash equivalents as of June 30, 2021 was $12.7 million, while outstanding debt was $1.1 million.
"The recently announced topline Phase 2 data with our partner Newsoara showing LB1148 brought an accelerated return to bowel function in patients following surgery is yet another building block in our efforts to get LB1148 approved for GI treatments. Across our trials to date in both animals and humans, there is a consistent theme that the drug is both safe and effective in accelerating return of bowel function," stated Tom Hallam, Ph.D., President and CEO of Palisade Bio. "Assuming positive future clinical results that are consistent with our trials to date, we see pathways to regulatory approval for LB1148. Moreover, we expect to build a pipeline of therapies based on our recently announced license agreement with the Regents of the University of California. We are now diligently planning our next strategic activities and look forward to providing additional investor updates as our corporate and clinical progress unfolds."
About Palisade Bio, Inc.
Palisade Bio is a late-stage biopharma company advancing therapies that help patients with acute and chronic gastrointestinal complications stemming from post-operative digestive enzyme damage. Palisade Bio's innovative lead asset, LB1148, is a Phase 3-ready protease inhibitor with the potential to both reduce abdominal adhesions and help restore bowel function following surgery. Positive data from two Phase 2 trials of LB1148 demonstrated safety and tolerability as well as a statistically significant improvement in return to bowel function and decrease in length of stay in ICU and hospital compared to placebo. Palisade Bio believes that its investigational therapies have the potential to address the myriad health conditions and complications associated with chronic disruption of the gastrointestinal epithelial barrier. For more information, please go to www.palisadebio.com.Forward Looking Statements
This communication contains "forward-looking" statements, including, without limitation, statements related to expectations regarding Palisade's plans for future clinical development of LB1148, plans for regulatory approvals of LB1148, plans for building a pipeline of therapies in the future, and plans for additional investor updates in the future. 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, related to the Company's ability to advance its clinical programs and the uncertain and time-consuming regulatory approval process. Additional risks and uncertainties can be found in Palisade Bio's (formerly known as Seneca Biopharma, Inc.) Quarterly Report on Form 10-Q for the quarter ended June 30, 2021. 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:
CORE IR
[email protected]Palisade Bio Media Relations Contact:
CORE IR
Jules Abraham
[email protected]
917-885-7378Palisade Bio, Inc. Condensed Consolidated Balance Sheets (in thousands, except share and per share amounts) June 30,
2021December 31,
2020(Unaudited) ASSETS Current assets: Cash and cash equivalents $ 12,653 $ 713 Accounts receivable 59 59 Prepaid expenses and other current assets 2,013 124 Total current assets 14,725 896 Restricted cash 26 26 Deferred transaction costs - 1,817 Right-of-use asset 195 275 Property and equipment, net 3 5 Total assets $ 14,949 $ 3,019 LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) Current liabilities: Accounts payable $ 1,406 $ 2,537 Accrued liabilities 955 2,740 Accrued compensation and benefits 164 1,590 Current portion of lease liability 184 168 Current portion of debt 696 578 Current portion of related party debt, net 445 469 Total current liabilities 3,850 8,082 Warrant liability 20,526 1,830 Non-current portion of debt - 94 Lease liability, net of current portion 17 112 Total liabilities 24,393 10,118 Series C convertible preferred stock, $0.001 par value; 0 and 33,594,625 shares authorized as of June 30, 2021 and December 31, 2020, respectively; 0 and 11,674,131 shares issued and outstanding at June 30, 2021 and December 31, 2020; liquidation preference of $10.4 million as of December 31, 2020 - 9,503 Stockholders' deficit: Series A convertible preferred stock, 7,000,000 shares authorized, $0.01 par value; 200,000 and 0 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively 2 - Common stock, $0.01 par value; 300,000,000 and 6,797,500 shares authorized as of June 30, 2021 and December 31, 2020, respectively; 11,398,698 and 2,774,502 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively 114 28 Additional paid-in capital 94,242 51,396 Accumulated deficit (103,802 ) (68,026 ) Total stockholders' deficit (9,444 ) (16,602 ) Total liabilities, convertible preferred stock and stockholders' equity (deficit) $ 14,949 $ 3,019 Palisade Bio, Inc. Condensed Statements of Operations (in thousands, except share and per share amounts) (Unaudited) Three Months Ended Six Months Ended June 30, June 30, 2021 2020 2021 2020 Operating expenses: Research and development $ 314 $ 650 $ 1,006 $ 1,902 In-process research and development 30,117 - 30,117 - General and administrative 2,427 1,191 3,688 2,334 Total operating expenses 32,858 1,841 34,811 4,236 Loss from operations (32,858 ) (1,841 ) (34,811 ) (4,236 ) Other income (expense): Gain on forgiveness of debt - - 279 - Loss on issuance of secured debt - - (686 ) - Change in fair value of warrant liability 5,133 - 5,175 - Change in fair value of share liability 73 - 73 - Interest expense (655 ) (11 ) (2,367 ) (11 ) Other income 16 1 16 12 Loss on issuance of LBS Series 1 Preferred Stock (1,881 ) - (1,881 ) - Issuance cost of warrants (1,574 ) - (1,574 ) - Total other income (expense) 1,112 (10 ) (965 ) 1 Net loss $ (31,746 ) $ (1,851 ) $ (35,776 ) $ (4,235 ) Loss per share: Basic $ (3.59 ) $ (0.67 ) $ (6.17 ) $ (1.53 ) Diluted $ (4.10 ) $ (0.67 ) $ (6.96 ) $ (1.53 ) Weighted average shares used in computing loss per share: Basic 8,831,517 2,774,296 5,803,010 2,274,237 Diluted 8,984,198 2,774,296 5,879,351 2,774,237 Net loss attributable to common stockholders - basic $ (31,746 ) $ (1,851 ) $ (35,776 ) $ (4,235 ) Change in fair value of warrants $ (5,119 ) $ - $ (5,119 ) $ - Net loss attributable to common stockholders - diluted $ (36,865 ) $ (1,851 ) $ (40,895 ) $ (4,235 ) Palisade Bio, Inc. Condensed Consolidated Statements of Cash Flows Operations (in thousands) Six Months Ended June 30, 2021 2020 (unaudited) Net loss $ (35,776 ) $ (4,235 ) Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: Depreciation and amortization 2 1 In-process research and development 30,117 - Noncash transaction costs shared with Seneca (135 ) - Noncash lease expense 80 3 Gain on forgiveness of PPP loan (279 ) - Accretion of debt discount and non-cash interest expense 2,203 12 Loss on issuance of LBS Series 1 Preferred Stock 1,881 - Loss on issuance of debt 686 - Issuance cost allocated to warrant 1,574 - Change in fair value of warrant liabilities (5,175 ) - Change in fair value of share liability (73 ) - Stock-based compensation 1,064 880 Write off of accounts payable 183 - RSU vesting expense 41 - Changes in operating assets and liabilities: Trade and other receivables 25 (53 ) Prepaid and other assets (1,294 ) 43 Accounts payable and accrued liabilities (2,499 ) 998 Accrued compensation (1,518 ) - Operating lease liabilities (79 ) - Net cash used in operating activities (8,972 ) (2,351 ) Cash flows from investing activities: Cash acquired in connection with the Merger 3,279 - Acquisition related costs paid (2,985 ) - Purchases of property and equipment - (6 ) Net cash provided by (used in) investing activities 294 (6 ) Cash flows from financing activities: Payments on debt (285 ) - Proceeds from issuance of debt 1,250 279 Proceeds from issuance of LBS Series 1 Preferred Stock 19,900 - Redemption of warrants (99 ) - Payment of debt issuance costs (148 ) - Net cash provided by financing activities 20,618 279 Net increase (decrease) in cash, cash equivalents and restricted cash 11,940 (2,078 ) Cash, cash equivalents and restricted cash, beginning of period 739 3,623 Cash, cash equivalents and restricted cash, ending of period 12,679 1,545 Reconciliation of cash, cash equivalents and restricted cash to the balance sheets: Cash and cash equivalents 12,653 1,519 Restricted cash 26 26 Total cash, cash equivalents and restricted cash 12,679 1,545 Supplemental disclosure of cash flows: Interest paid $ 50 $ - Supplemental disclosures of non-cash investing and financing activities: Transaction costs shared with Seneca $ 135 $ - Acquisition related costs included in accounts payable and accrued liabilities $ 367 $ - Acquisition costs related stock issuance $ 1,184 $ - Issuance of common stock to former Seneca stockholders $ 28,728 $ - Conversion of LBS Series C Preferred stock into common stock $ 9,503 $ - Net assets acquired in the Merger $ 2 $ - Acquisition related vesting of RSU's assumed in the Merger $ 41 $ - Acquisition related fair value change in warrant liability assumed in the Merger $ 51 $ - 
- Announced positive topline results from Phase 2 study of LB1148 by partner Newsoara demonstrating accelerated return of bowel function after gastrointestinal surgery
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- $5.2M invested at $3.45 stock price
- Funds to be used to advance clinical development of LB1148
- Investment driven by Phase 2 clinical data that the medical center believes may lead to LB1148 being used as standard of care for the protection and healing of the GI tract in surgical patients if approved by the FDA
CARLSBAD, Calif., Aug. 20, 2021 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (NASDAQ:PALI) ("Palisade Bio" or the "Company"), a late‐stage biopharma company advancing therapies for acute and chronic gastrointestinal (GI) complications, today announces a new private investment of approximately $5.2 million from the Yuma Regional Medical Center ("YRMC"), an Arizona‐based, not‐for‐profit hospital providing high‐quality, patient‐centered care. The funds will be used to advance the clinical development of Palisade's lead oral liquid drug candidate LB1148, which is being developed to accelerate the return of bowel function after surgery and to reduce post‐surgical adhesions.
"There are almost seven million surgeries each year in the United States where patients may benefit from LB1148. The surgical community is still looking for safe therapeutics to improve postoperative bowel function and reduce abdominal adhesions," said Tom Hallam, Ph.D., CEO of Palisade Bio. "If approved, LB1148 may provide an easy‐to‐adopt solution to help surgical patients return to GI normalcy faster and help these patients spend less time in the hospital. Investments from end‐users like YRMC help validate the excitement for this treatment and its potential impact on patient lives."
Under the terms of the agreement, YRMC purchased 1,509,896 unregistered common shares at a purchase price of $3.45 per share. In addition, YRMC received a five‐year warrant to purchase an additional 377,474 common shares at $3.45 per share. The Company is required to register the common shares and the shares underlying the warrants within 60 days.
Dr. Bob Trenschel, D.O., M.P.H., Yuma Regional Medical Center's President and CEO added, "With the recent announcement of positive topline Phase 2 data, we are encouraged by the prospects that LB1148 presents to patients, caregivers, and hospitals as a simple and effective way to accelerate GI recovery after surgery. Delayed postsurgical recovery can affect quality of life and increase healthcare costs. As LB1148 has consistently been shown to accelerate the return of GI function in clinical studies with a favorable safety profile, we believe LB1148 may one day be the standard of care for patients undergoing major surgery. This investment is a continuation of our long‐standing dedication to clinical research. Our support of Palisade Bio is a testament to a shared commitment to advancing care for patients as the company brings forth new treatment through clinical development."
About LB1148
LB1148 is 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. Evidence suggests that the release of digestive proteases contributes to the temporary loss of normal gastrointestinal function and 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 return of normal GI function, and shorten the duration of costly post‐ surgery hospital stays.About Palisade Bio, Inc.
Palisade Bio is a late‐stage biopharma company advancing therapies that help patients with acute and chronic gastrointestinal complications stemming from post‐operative digestive enzyme damage. Palisade Bio's innovative lead asset, LB1148, is a Phase 3‐ready protease inhibitor with the potential to both reduce abdominal adhesions and help restore bowel function following surgery. Positive data from two Phase 2 trials of LB1148 demonstrated safety and tolerability as well as a statistically significant improvement in return to bowel function and decrease in length of stay in ICU and hospital compared to placebo. Palisade Bio believes that its investigational therapies have the potential to address the myriad health conditions and complications associated with chronic disruption of the gastrointestinal epithelial barrier. For more information, please go to www.palisadebio.com.Forward Looking Statements
This communication contains "forward‐looking" statements, including, without limitation, statements related to expectations regarding future clinical development and potential regulatory approval of LB1148 and the potential for LB1148 to be the standard of care for patients undergoing major surgery. 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, related to the Company's ability to advance LB1148 through clinical development and the uncertain and time‐consuming regulatory approval process. Additional risks and uncertainties can be found in Palisade Bio's (formerly known as Seneca Biopharma, Inc.) Quarterly Report on Form 10‐Q for the quarter ended March 31, 2021. 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:
CORE IR
[email protected]Palisade Bio Media Relations Contact:
CORE IR
Jules Abraham
[email protected]
917‐885‐7378