Palisade Bio Reports Second Quarter 2024 Financial Results and Provides Business Update

Rhea-AI Summary

Palisade Bio (Nasdaq: PALI) reported Q2 2024 financial results and provided a business update. Key highlights include:

1. Progress towards Phase 1 clinical study of PALI-2108 for Ulcerative Colitis (UC) before year-end
2. Completed microbiome study and nonclinical IND/CTA-enabling studies
3. Expanded global IP portfolio with European patent grant
4. Completed first GMP batch of PALI-2108
5. Advanced collaboration with Strand Life Sciences on PDE4-related biomarkers
6. Received Canadian patent allowance for PALI-2108

Financial results: $11.4M cash on hand, sufficient through Q1 2025. Net loss of $4.1M, up from $3.4M in Q2 2023. R&D expenses increased 21% to $2.6M, while G&A expenses rose 11% to $1.6M.

Positive

• Progress towards Phase 1 clinical study of PALI-2108 for UC before year-end
• Completed first GMP batch of PALI-2108
• Expanded global IP portfolio with European and Canadian patent grants
• Sufficient cash ($11.4M) to fund operations through Q1 2025

Negative

• Net loss increased to $4.1M from $3.4M in Q2 2023
• R&D expenses increased 21% to $2.6M
• G&A expenses rose 11% to $1.6M

Financial Analyst

Palisade Bio's Q2 2024 results reveal a mixed financial picture. While the company's $11.4 million cash position appears sufficient to fund operations through Q1 2025, the increased net loss of $4.1 million (up from $3.4 million in Q2 2023) raises concerns. The 21% increase in R&D expenses to $2.6 million reflects investment in PALI-2108, but also contributes to the widening losses. The 11% rise in G&A expenses to $1.6 million further pressures the bottom line. Investors should monitor the burn rate closely as Palisade approaches critical clinical milestones.

Medical Research Analyst

Palisade Bio's progress with PALI-2108 for Ulcerative Colitis (UC) is promising. The completion of microbiome studies and IND/CTA-enabling studies are important steps towards clinical trials. The GMP batch production of PALI-2108 and the expanding patent portfolio strengthen the company's position. The collaboration with Strand Life Sciences on PDE4-related biomarkers could lead to more targeted treatments. However, investors should note that despite these advancements, PALI-2108 is still in early stages and success in preclinical stages doesn't guarantee clinical efficacy or regulatory approval.

Market Research Analyst

Palisade Bio's focus on developing PALI-2108 as a first-in-class PDE4 inhibitor for UC positions them in a potentially lucrative market. The global UC therapeutics market is projected to grow significantly, driven by increasing prevalence and demand for effective treatments. The company's precision medicine approach, including biomarker-based patient selection, could provide a competitive edge. However, the UC market is highly competitive with established players and emerging therapies. Palisade's success will depend on PALI-2108's efficacy, safety profile and ability to differentiate from existing treatments in upcoming clinical trials.

– Continued progress toward commencement of Phase 1 human clinical study of lead product candidate, PALI-2108, for the treatment of Ulcerative Colitis (UC) before year end

– Company continues to establish growing body of preclinical data for PALI-2108 and global patent estate

– Sufficient cash on hand to execute on current business plan and reach clinical and regulatory milestones through first quarter of 2025

Carlsbad, CA, Aug. 13, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade”, “Palisade Bio”, or the “Company”), a biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, reported its financial results for the second quarter of 2024 and provided a business update.

Recent Highlights

• Completed microbiome study confirming bacterial enzymes for local bioactivation of lead product candidate, PALI-2108, in development for Crohn’s disease and UC;
• Completed nonclinical IND/CTA-enabling studies;
• Expanded global intellectual property portfolio for PALI-2108 and PALI-1908 with a notice to grant patent from the European Patent Office;
• Completed the first Good Manufacturing Practice (GMP) batch of drug substance PALI-2108, an orally administered, locally acting colon-specific phosphodiesterase-4 (PDE4) inhibitor prodrug in development for patients affected by UC;
• Progressed on previously announced strategic collaboration with Strand Life Sciences including identification of promising PDE4-related biomarkers associated with UC pathology, providing valuable insights for targeted therapeutic interventions;
• Received notice of allowance for Canadian patent covering the proprietary composition of PALI-2108 titled, “Gut Microbiota Bioactivated PDE4 Inhibitor Precursors”; and
• Presented positive preclinical data from PALI-2018 demonstrating it to be safe, effective and well tolerated in mouse models at Digestive Disease Week (DDW) 2024.
  

“Our team has made great progress this past quarter. Our growing body of encouraging data coupled with the successful completion of our first GMP batch for PALI-2108 has positioned us for some exciting momentum as we prepare for the initiation of our Phase 1 clinical trial. Based on the preclinical data demonstrated to date, we believe PALI-2108 has the potential to be the first approved PDE4 inhibitor for UC and importantly, provide a much-needed solution for patients,” commented J.D. Finley, Chief Executive Officer.

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 analysis of ongoing IND/CTA-enabling tox studies by the end of the third quarter 2024;
• Submit initial IND/CTA prior to the end of the third quarter of 2024; and
• Initiate Phase 1a with UC patient cohort prior to the end of 2024.

Precision Medicine Approach

Additionally, the Company is in the process of developing a genetic- or biomarker-based patient selection approach that, if developed, will aid clinicians in identifying patients who may respond to therapy with a locally acting PDE4-inhibitor such as PALI-2108. The Company is working with a strategic collaborator on development and has completed the 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 Quarter Ended June 30, 2024

As of June 30, 2024, the Company had cash and cash equivalents of $11.4 million. The Company believes it has sufficient cash to fund its currently planned operations through the first quarter of 2025.

Net loss was $4.1 million for the three months ended June 30, 2024, up $0.7 million from a net loss of $3.4 million for the three months ended June 30, 2023.

Research and development expenses for the three months ended June 30, 2024 were $2.6 million, a 21% increase compared to $2.2 million for the three months ended June 30, 2023. The increase is attributable to higher expenses recognized for the three months ended June 30, 2024 that were directly related to the development of the Company’s lead asset, PALI-2108, and higher share-based compensation expense, partially offset by a decrease in costs directly related to our development of LB1148, which Palisade ceased in August of 2023, and lower other employee-related costs.

General and administrative expenses increased by $0.2 million, or 11%, from $1.4 million for the three months ended June 30, 2023 to $1.6 million for the three months ended June 30, 2024.

About Palisade Bio 
Palisade Bio is a biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases. The Company believes that by using a targeted approach with its novel therapeutics it will transform the treatment landscape. 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: the extent of our cash runway; our ability to successfully develop our licensed technologies; the timing and outcome of our current and anticipated applications and studies related to our product candidates; 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 the United States (U.S.) and foreign countries and the impact of these changes; our ability to maintain the Nasdaq listing of our securities; our ability to build a commercial infrastructure in the U.S. and other markets; our ability to compete effectively in a competitive industry; our ability to identify and qualify manufacturers to provide API and manufacture drug product; our ability to enter into commercial supply agreements; the success of competing technologies that are or may become available; our ability to attract and retain key scientific or management personnel; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for additional financing; our ability to obtain funding for our operations; our ability to attract collaborators and strategic partnerships; and the impact of any global event on our business, and operations, and supply. 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 nonclinical and clinical programs, the uncertain and time-consuming regulatory approval process; and the Company’s ability to secure additional financing to fund future operations and development of its product candidates. Additional risks and uncertainties can be found in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 26, 2024, Form 10-Q for the three months ended June 30, 2024, filed with the SEC on August 12, 2024. These forward-looking statements speak only as of the date hereof and the Company 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 the Company’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

Investor Relations Contact

JTC Team, LLC
Jenene Thomas
833-475-8247
PALI@jtcir.com

Palisade Bio, Inc.
Condensed Consolidated Balance Sheets (Unaudited)
(in thousands, except share and per share amounts)

		June 30,				December 31,
		2024				2023
ASSETS
Current assets:
Cash and cash equivalents		$	11,353			$	12,432
Prepaid expenses and other current assets			959				896
Total current assets			12,312				13,328
Restricted cash			26				26
Property and equipment, net			4				10
Operating lease right-of-use asset			142				198
Other noncurrent assets			387				490
Total assets		$	12,871			$	14,052
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable		$	514			$	698
Accrued liabilities			1,555				831
Accrued compensation and benefits			288				778
Current portion of operating lease liability			130				121
Insurance financing debt			349				158
Total current liabilities			2,836				2,586
Warrant liability			2				2
Contingent consideration obligation			60				61
Operating lease liability, net of current portion			24				90
Total liabilities			2,922				2,739
Commitments and contingencies
Stockholders' equity:
Series A Convertible Preferred Stock, $0.01 par value, 7,000,000 shares authorized; 200,000 issued and outstanding at June 30, 2024 and December 31, 2023			2				2
Common stock, $0.01 par value; 280,000,000 shares authorized; 966,345 and 618,056 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively			9				6
Additional paid-in capital			139,051				132,811
Accumulated deficit			(129,113	)			(121,506	)
Total stockholders' equity			9,949				11,313
Total liabilities and stockholders' equity		$	12,871			$	14,052

Palisade Bio, Inc.
Condensed Consolidated Statements of Operations (Unaudited)
(in thousands, except share and per share amounts)

		Three Months Ended June 30,								Six Months Ended June 30,
		2024				2023				2024				2023
License revenue		$	—			$	—			$	—			$	250
Operating expenses:
Research and development			2,628				2,177				4,842				3,418
General and administrative			1,583				1,432				3,042				2,970
Total operating expenses			4,211				3,609				7,884				6,388
Loss from operations			(4,211	)			(3,609	)			(7,884	)			(6,138	)
Other (expense) income:
Interest expense			(2	)			(3	)			(3	)			(3	)
Other income, net			133				219				280				408
Total other income, net			131				216				277				405
Net loss		$	(4,080	)		$	(3,393	)		$	(7,607	)		$	(5,733	)
Basic and diluted weighted average shares used in computing basic and diluted net loss per common share*			1,228,453				427,862				1,000,367				357,572
Basic and diluted net loss per common share*		$	(3.32	)		$	(7.93	)		$	(7.60	)		$	(16.03	)

(*) 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 and six months ended June 30, 2023 has been adjusted to reflect the 1-for-15 reverse stock split effected on April 5, 2024.

Palisade Bio, Inc.
Condensed Consolidated Statements of Cash Flows (Unaudited)
(in thousands, except share and per share amounts)

		Six Months Ended June 30,
		2024				2023
Net loss		$	(7,607	)		$	(5,733	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation			2				3
Non-cash operating lease expense			56				50
Recurring fair value measurements of liabilities			5				(59	)
Issuance of common stock to vendors			73				—
Loss on disposal of property and equipment			4				—
Stock-based compensation and related charges			480				237
Other			—				(108	)
Changes in operating assets and liabilities:
Prepaid and other current assets and other noncurrent assets			349				497
Accounts payable and accrued liabilities			506				(367	)
Accrued compensation and benefits			(490	)			(195	)
Operating lease liabilities			(57	)			(50	)
Net cash used in operating activities			(6,679	)			(5,725	)
Cash flows from investing activities:
Purchases of property and equipment			—				(4	)
Net cash used in investing activities			—				(4	)
Cash flows from financing activities:
Payments on insurance financing debt			(158	)			(138	)
Proceeds from issuance of common stock and warrants			4,000				7,681
Proceeds from the exercise of warrants			2,503				2,758
Payment of warrant inducement issuance costs			(343	)			—
Payment of equity issuance costs			(388	)			(552	)
Proceeds from issuance of common stock under Employee Stock Purchase Plan			11				—
Shares withheld for payment of employee withholding tax liability			(25	)			—
Net cash provided by financing activities			5,600				9,749
Net (decrease) increase in cash, cash equivalents and restricted cash			(1,079	)			4,020
Cash, cash equivalents and restricted cash, beginning of year			12,458				12,409
Cash, cash equivalents and restricted cash, end of period		$	11,379			$	16,429
Reconciliation of cash, cash equivalents and restricted cash to the balance sheets:
Cash and cash equivalents		$	11,353			$	16,403
Restricted cash			26				26
Total cash, cash equivalents and restricted cash		$	11,379			$	16,429

FAQ

What is the current status of Palisade Bio's PALI-2108 development for Ulcerative Colitis?

Palisade Bio is progressing towards initiating a Phase 1 clinical study of PALI-2108 for Ulcerative Colitis before the end of 2024. They have completed microbiome studies, nonclinical IND/CTA-enabling studies, and the first GMP batch of the drug substance.

How much cash does Palisade Bio (PALI) have on hand as of Q2 2024?

As of June 30, 2024, Palisade Bio (PALI) reported cash and cash equivalents of $11.4 million, which they believe is sufficient to fund their planned operations through the first quarter of 2025.

What were Palisade Bio's (PALI) financial results for Q2 2024?

Palisade Bio (PALI) reported a net loss of $4.1 million for Q2 2024, up from $3.4 million in Q2 2023. Research and development expenses increased 21% to $2.6 million, while general and administrative expenses rose 11% to $1.6 million.

What are the upcoming milestones for Palisade Bio's (PALI) PALI-2108 program?

Palisade Bio (PALI) aims to complete analysis of IND/CTA-enabling tox studies by Q3 2024, submit initial IND/CTA before the end of Q3 2024, and initiate a Phase 1a study with UC patient cohort before the end of 2024.