Tranexamic Acid

Commenced enrollment and dosing in Phase 1 clinical study of PALI-2108 for the treatment of moderate-to-severe Ulcerative Colitis (UC) Carlsbad, CA, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade,” “Palisade Bio” or the “Company”), a clinical-stage biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, today reported its financial results for the third quarter of 2024 and provided a business update. Recent Highlights Commenced enrollment and dosed first subjects in its Phase 1 human clinical study of PALI-2108 for the treatment of moderate-to-severe UC;Presented data from two translational studies demonstrating the ex vivo bioactivation of PALI-2108 in stool samples and whole blood at the ACG’s 2024 Annual Scientific Meeting;Reported the completion of refined patient selection strategies based on PDE4-related biomarkers and disease characteristics to optimize clinical outcomes for patients with UC as part of its collaboration with Strand Life Sciences;Completed microbiome study confirming bacterial enzymes for local bioactivation of lead product candidate, PALI-2108, in development for Crohn’s disease and UC;Expanded intellectual property portfolio of PALI-2108 and PALI-1908 with a notice to grant patent from the European Patent Office; andCompleted 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. “I am extremely proud of the clinical progress our team has made over this past quarter. The initiation of our Phase 1 clinical trial and patient enrollment and dosing are important milestones in our clinical program,” commented J.D. Finley, Chief Executive Officer of Palisade. “We continue to believe in the potential of PALI-2108 to provide a much-needed solution for UC patients still experiencing significant medical need.” About PALI-2108 PALI-2108 is an orally administered, locally acting colon-specific PDE4 inhibitor prodrug in development for patients affected by UC. The Company continued to progress development of PALI-2108 and recently commenced a Phase 1 single-center, double-blind, placebo-controlled study focused on safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers, alongside an open-label study involving a patient cohort with UC. The comprehensive data gathered will support Palisade Bio's precision medicine strategy, aimed at identifying patient responders for future clinical studies. Upcoming Target Milestones Phase 1 topline data expected in the first half of 2025; andInitiate Phase 1b/2a in the second half of 2025. For more information about the Phase 1 clinical study, visit clinicaltrials.gov and reference identifier NCT06663605. Summary of Financial Results for the Quarter Ended September 30, 2024 As of September 30, 2024, the Company had cash and cash equivalents of $8.0 million. The Company believes it has sufficient cash to fund its currently planned operations through the first quarter of 2025. Net loss was $3.5 million for the three months ended September 30, 2024, compared to $3.6 million for the same period in 2023. Research and development expenses of approximately $2.1 million were virtually flat compared to the three months ended September 30, 2023. In the current year period, higher expenses directly related to the joint development of our lead asset, PALI-2108, and higher drug manufacturing costs, were offset by a decrease in costs related to the Company’s development of LB1148, which we ceased in August of 2023, a decrease in other employee-related costs, and the favorable impact of a non-cash gain associated with a decrease in the fair value of our contingent consideration liability. General and administrative expenses decreased by $0.2 million, or 13%, from approximately $1.7 million for the three months ended September 30, 2023 to $1.5 million for the three months ended September 30, 2024. The decrease was primarily due to lower general corporate expenses, which were partially offset by higher consultant and contract labor. About Palisade Bio Palisade Bio is a clinical-stage 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, and any Quarterly Reports on Form 10-Q or other SEC filings that were filed thereafter. 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, LLCJenene Thomas 908-824-0775PALI@jtcir.com Palisade Bio, Inc.Condensed Consolidated Balance Sheets (Unaudited)(in thousands, except share and per share amounts) September 30, December 31, 2024 2023 ASSETS Current assets: Cash and cash equivalents $8,040 $12,432 Prepaid expenses and other current assets 830 896 Total current assets 8,870 13,328 Restricted cash 26 26 Property and equipment, net 3 10 Operating lease right-of-use asset 113 198 Other noncurrent assets 324 490 Total assets $9,336 $14,052 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $366 $698 Accrued liabilities 1,509 831 Accrued compensation and benefits 449 778 Current portion of operating lease liability 122 121 Insurance financing debt 235 158 Total current liabilities 2,681 2,586 Warrant liability 2 2 Contingent consideration obligation 45 61 Operating lease liability, net of current portion — 90 Total liabilities 2,728 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 September 30, 2024 and December 31, 2023 2 2 Common stock, $0.01 par value; 280,000,000 shares authorized;1,198,516 and 618,056 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively 11 6 Additional paid-in capital 139,195 132,811 Accumulated deficit (132,600) (121,506)Total stockholders' equity 6,608 11,313 Total liabilities and stockholders' equity $9,336 $14,052 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, 2024 2023 2024 2023 License revenue $— $— $— $250 Operating expenses: Research and development 2,137 2,104 6,979 5,522 General and administrative 1,456 1,674 4,498 4,644 Total operating expenses 3,593 3,778 11,477 10,166 Loss from operations (3,593) (3,778) (11,477) (9,916)Other (expense) income: Interest expense (6) (8) (9) (11)Other income, net 112 190 392 598 Total other income, net 106 182 383 587 Net loss $(3,487) $(3,596) $(11,094) $(9,329) Net loss available to common stockholders $(3,487) $(3,612) $(11,094) $(9,345)Basic and diluted weighted average shares used in computing basic and diluted net loss per common share 1,500,409 489,624 1,168,277 402,074 Basic and diluted net loss per common share $(2.32) $(7.38) $(9.50) $(23.24) Palisade Bio, Inc.Condensed Consolidated Statements of Cash Flows (Unaudited)(in thousands, except share and per share amounts) Nine Months Ended September 30, 2024 2023 Net loss $(11,094) $(9,329)Adjustments to reconcile net loss to net cash used in operating activities: Depreciation 3 4 Non-cash operating lease expense 85 76 Recurring fair value measurements of liabilities (159) 153 Issuance of common stock to vendors 124 — Loss on disposal of property and equipment 4 — Stock-based compensation and related charges 575 439 Other — (108)Changes in operating assets and liabilities: Prepaid and other current assets and other noncurrent assets 542 596 Accounts payable and accrued liabilities 526 (184)Accrued compensation and benefits (329) 43 Operating lease liabilities (89) (77)Net cash used in operating activities (9,812) (8,387)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 (270) (290)Proceeds from issuance of common stock and warrants 4,000 9,419 Proceeds from the exercise of warrants 2,503 2,758 Payment of warrant inducement issuance costs (343) — Payment of equity issuance costs (456) (567)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 5,420 11,320 Net (decrease) increase in cash, cash equivalents and restricted cash (4,392) 2,929 Cash, cash equivalents and restricted cash, beginning of year 12,458 12,409 Cash, cash equivalents and restricted cash, end of period $8,066 $15,338 Reconciliation of cash, cash equivalents and restricted cash to the balance sheets: Cash and cash equivalents $8,040 $15,312 Restricted cash 26 26 Total cash, cash equivalents and restricted cash $8,066 $15,338

SCHAUMBURG, Ill.--( BUSINESS WIRE )--Avenacy, a specialty pharmaceutical company focused on supplying critical medications, looks forward to celebrating its first year of growth and success since launching in October 2023. Backed by a robust global network of development and FDA-inspected contract manufacturing partners, Avenacy has already brought 13 injectable products to the U.S. market to address key gaps in the drug supply chain. “We are incredibly proud of the achievements and progress we have made at Avenacy since launching nearly a year ago as a trusted partner and provider of critical injectable medicines for the U.S. healthcare system,” said Jeff Yordon, Co-Founder and CEO of Avenacy. “We have acted swiftly and decisively to bring over a dozen medications to the U.S. market to help meet the needs of patients, strengthened our financial position with the addition of esteemed pharmaceutical investor and businessman, Dr. Patrick Soon-Shiong, and built out our infrastructure and leadership to support scaling up our business. As we look to usher in the next phase of growth for Avenacy, we will remain steadfast in our goal of enhancing patient care and enabling access to safe, high-quality essential medications.” Through a rigorous and optimized selection process, Avenacy has launched thirteen products in the U.S. market, including: Melphalan Hydrochloride for Injection Bivalirudin for Injection Fosaprepitant for Injection Fulvestrant Injection Furosemide for Injection Desmopressin Acetate for Injection Eptifibatide for Injection Magnesium Sulfate in Water for Injection Isoproterenol Hydrochloride Injection, USP Tranexamic Acid Injection, USP Prochlorperazine Edisylate Injection, USP Palonosetron Hydrochloride Injection, USP Metoclopramide Injection, USP The Company is well-positioned to continue expanding its differentiated portfolio to meet the needs of today’s dynamic drug supply chain while ensuring quality of care to patients. All of Avenacy’s products feature unique packaging and labeling designed to assist healthcare providers with accurate medication selection, thereby supporting a reduction in administration errors and improper dosing. The Company also utilizes ready-to-use formulations of essential medications to help address dosing inaccuracies, enhance patient safety, and streamline efficiency – all with the ultimate goal of improving patient care. Avenacy will be sharing its first year progress, differentiated business model, and diverse partner network at this year’s CPHI 2024 Conference, taking place in Milan from October 8-10. During this time, the Company will be hosting meetings with potential partners, customers, and investors, as it seeks to expand its global presence and portfolio of critical injectable medicines. About Avenacy Avenacy is a U.S.-based specialty pharmaceutical company focused on supplying critical injectable medications used to treat patients in various medically supervised settings, from acute care hospitals to outpatient clinics and physician offices. Through a rigorous and optimized selection process, the Company is building out a pipeline of high-quality FDA approved injectable products in order to ensure a resilient portfolio that can meet the needs of today’s dynamic drug supply chain. With an experienced team, commitment to quality and reliability, and product offerings intended to facilitate safe and efficient patient care, Avenacy strives to be a trusted partner for essential medications. Avenacy was launched in 2023 and is headquartered in Schaumburg, IL. For more information, please visit http://www.avenacy.com/ .