share_log

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

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

Palisade Bio公佈2024年第一季度財務業績並提供業務最新情況
Palisade Bio ·  05/14 00:00

– Company on track to commence Phase 1 human clinical study of lead product candidate, PALI-2108, for the treatment of Ulcerative Colitis (UC) before year end

— 公司有望在年底前開始對治療潰瘍性結腸炎(UC)的主要候選產品 PALI-2108 進行第一期人體臨床研究

– Sufficient cash on hand to execute on business plan and reach clinical and regulatory milestones into 2025

— 手頭有足夠的現金來執行業務計劃並在2025年之前達到臨床和監管里程碑

Carlsbad, CA, May 14, 2024 — 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, today reported its financial results for the first quarter 2024 and provided a business update.

加利福尼亞州卡爾斯巴德,2024 年 5 月 14 日 — Palisade Bio, Inc. 納斯達克股票代碼:PALI)(“Palisade”、“Palisade Bio” 或 “公司”)是一家專注於爲自身免疫、炎症和纖維化疾病患者開發和推進新療法的生物製藥公司,今天公佈了其2024年第一季度的財務業績並提供了業務最新情況。

Recent Highlights

近期亮點

  • Entered into a strategic collaboration with Strand Life Sciences that provides Palisade access to advanced bioinformatics tools vital for understanding complex disease pathways and predicting responses to phosphodiesterase-4 (PDE4) inhibitors;
  • Successfully completed an ex-vivo study to determine the effects of bioactivated PALI-2108 on TNF-α production in a whole blood assay;
  • Successfully completed an analysis evaluating ex-vivo bioactivation of PALI-2108 in study of healthy and UC patients' stool;
  • Appointed Wall Street and biotech industry veteran, Margery Fischbein, to its Board of Directors; and
  • In May 2024, extended cash runway with completion of a $4.0 million private placement.
  • 與Strand Life Sciences達成戰略合作,爲Palisade提供先進的生物信息學工具,這些工具對於了解複雜的疾病途徑和預測對磷酸二酯酶-4(PDE4)抑制劑的反應至關重要;
  • 成功完成了 ex-vivo 研究確定生物活化的 PALI-2108 對全血化驗中腫瘤壞死因子α生成的影響;
  • 成功完成分析評估 ex-vivo 在健康和 UC 患者糞便研究中對 PALI-2108 進行生物活化;
  • 任命華爾街和生物技術行業資深人士瑪格麗·菲施拜因爲董事會成員;以及
  • 2024年5月,延長了現金流道,完成了400萬澳元的私募配售。

"Our team remains focused on advancing PALI-2108 towards our first-in-human study, which is on track to start later this year. Our growing body of data, including the most recent data from two ex-vivo studies evaluating PALI-2108, coupled with our strategic partnership with Strand Life Sciences, further build our confidence in the robust anti-inflammatory potential of PALI-2108 in the treatment of UC. Most importantly, the data underscore its potential as a next-generation therapeutic option for patients with inflammatory bowel disease," commented J.D. Finley, Chief Executive Officer.

“我們的團隊仍然專注於將 PALI-2108 推向我們的首次人體研究,該研究有望在今年晚些時候開始。我們不斷增長的數據量,包括來自兩個的最新數據 ex-vivo 評估 PALI-2108 的研究,加上我們與 Strand Life Sciences 的戰略合作伙伴關係,進一步增強了我們對 PALI-2108 在治療UC方面的強大抗炎潛力的信心。最重要的是,這些數據突顯了其作爲炎症性腸病患者的下一代治療選擇的潛力。” 首席執行官J.D. Finley評論道。

PALI-2108 Development Program

PALI-2108 開發計劃

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.

該公司繼續將其治療中度至重度 UC 的牽頭項目 PALI-2108 推進到 1 期臨床研究。PALI-2108 是一種口服、局部作用的結腸特異性 PDE4 抑制劑前藥,正在開發中,適用於受 UC 影響的患者。

Upcoming Target Milestones

即將到來的目標里程碑

  • Complete ongoing IND/CTA-enabling tox studies by the end of the second quarter of 2024;
  • Complete nonclinical IND/CTA-enabling activities by the end of the third quarter of 2024;
  • Submit initial IND/CTA in the third quarter of 2024; and
  • Initiate Phase 1a/b prior to the end of 2024.
  • 在2024年第二季度末之前完成正在進行的支持IND/CTA的毒素研究;
  • 在2024年第三季度末之前完成非臨床IND/CTA支持活動;
  • 在 2024 年第三季度提交初始 IND/CTA;以及
  • 在 2024 年底之前啓動第 1a/b 階段。

Precision Medicine Approach

精準醫療方法

Additionally, the Company is in the process of developing a genetic- or biomarker-based precision medicine approach that, if developed, will aid physicians in selecting patients most likely to respond to PDE4-inhibitor therapy with PALI-2108. The Company is working with a strategic collaborator on development and has completed 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.

此外,該公司正在開發一種基於遺傳或生物標誌物的精準醫療方法,該方法如果開發出來,將幫助醫生選擇最有可能對 PALI-2108 PDE4-抑制劑療法產生反應的患者。該公司正在與戰略合作伙伴合作進行開發,並已完成了包括1,600多名加州大學患者臨床和生物標誌物數據在內的管道的策劃,並且正在與潛在合作伙伴進行討論,以獲取更多患者數據,以支持美國食品藥品管理局批准的測試的開發。該公司計劃利用這種專業知識和基礎設施爲不斷增長的經過驗證和高度優先的自身免疫性、炎症和纖維化疾病候選產品提供燃料。

Summary of Financial Results for the First Quarter Ended March 31, 2024

截至2024年3月31日的第一季度財務業績摘要

As of March 31, 2024, the Company had cash and cash equivalents of $11.3 million. Subsequent to the end of the quarter, the Company completed a $4.0 million private placement. Including the recent financing, the Company believes it has sufficient cash to fund its currently planned operations through the first quarter of 2025.

截至2024年3月31日,該公司的現金及現金等價物爲1,130萬美元。在本季度末之後,公司完成了400萬澳元的私募配售。包括最近的融資,該公司認爲有足夠的現金爲其目前計劃在2025年第一季度之前的運營提供資金。

Net loss was $3.5 million for the three months ended March 31, 2024, up $1.2 million from a net loss of $2.3 million for the three months ended March 31, 2023.

截至2024年3月31日的三個月,淨虧損爲350萬美元,較截至2023年3月31日的三個月淨虧損230萬美元增加了120萬美元。

Research and development expenses for the three months ended March 31, 2024 were $2.2 million, an increase of approximately $1.0 million, or 78%, compared to $1.2 million for the three months ended March 31, 2023. The increase for the three months ended March 31, 2024 compared to the same period last year was attributable to approximately $1.6 million of expenses recognized that were directly related to the joint development of the Company's new lead asset, PALI-2108, partially offset by a decrease in costs directly related to the development of LB1148, which the Company ceased in August of 2023, and lower employee-related costs.

截至2024年3月31日的三個月,研發費用爲220萬美元,與截至2023年3月31日的三個月的120萬美元相比,增加了約100萬美元,增長了78%。截至2024年3月31日的三個月,與去年同期相比的增長歸因於約160萬美元的已確認支出,這些支出與公司新的主要資產 PALI-2108 的聯合開發直接相關,但部分被與公司於2023年8月停止開發 LB1148 直接相關的成本減少以及員工相關成本的減少所抵消。

General and administrative expenses remained virtually flat at approximately $1.5 million for both the three months ended March 31, 2024 and March 31, 2023.

在截至2024年3月31日和2023年3月31日的三個月,一般和管理費用幾乎保持在150萬美元左右。

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.

關於 Palisade Bio
Palisade Bio是一家生物製藥公司,專注於爲自身免疫、炎症和纖維化疾病患者開發和推進新型療法。該公司認爲,通過對新療法使用靶向方法,它將改變治療格局。欲了解更多信息,請前往 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; 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 the COVID-19 pandemic or 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. 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.

前瞻性陳述
就1995年《私人證券訴訟改革法》的安全港條款而言,本通信包含 “前瞻性” 陳述。前瞻性陳述包括有關公司意圖、信念、預測、前景、分析或當前預期的陳述,其中包括:我們的現金流範圍;我們成功開發許可技術的能力;對候選產品市場規模和增長潛力的估計,以及我們爲這些市場提供服務的能力,包括所產生的任何潛在收入;美國(美國)和外國未來的監管、司法和立法變化或發展,以及這些變化的影響;我們維持證券在納斯達克上市的能力;我們在美國和其他市場建立商業基礎設施的能力;我們在競爭激烈的行業中進行有效競爭的能力;我們識別和認證製造商提供原料藥和製造藥品的能力;我們簽訂商業供應協議的能力;已經或可能出現的競爭技術的成功;我們吸引和留住關鍵科學或管理人員的能力;我們有關估計的準確性支出、未來收入、資本要求和額外融資需求;我們獲得運營資金的能力;我們吸引合作者和戰略伙伴關係的能力;以及 COVID-19 疫情或任何全球事件對我們的業務、運營和供應的影響。本通信中包含的任何非歷史事實陳述的陳述均可被視爲前瞻性陳述。這些前瞻性陳述基於公司當前的預期。前瞻性陳述涉及風險和不確定性。由於這些風險和不確定性,公司的實際業績和事件發生時間可能與此類前瞻性陳述中的預期存在重大差異,其中包括但不限於公司推進其非臨床和臨床項目的能力、不確定和耗時的監管批准程序;以及公司獲得額外融資以資助其候選產品的未來運營和開發的能力。其他風險和不確定性可以在公司於2024年3月26日向美國證券交易委員會(“SEC”)提交的截至2023年12月31日財年的10-K表年度報告中找到。這些前瞻性陳述僅代表截至本文發佈之日,公司明確表示沒有義務或承諾公開發布此處包含的任何前瞻性陳述的任何更新或修訂,以反映公司對這些前瞻性陳述的預期的任何變化或任何此類陳述所依據的事件、條件或情況的任何變化。

Investor Relations Contact

投資者關係聯繫人

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

JTC Team, LLC
珍妮·托馬斯
833-475-8247
PALI@jtcir.com

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

Palisade Bio, Inc.
簡明合併資產負債表(未經審計)
(以千計,股票和每股金額除外)

March 31, December 31,
2024 2023
ASSETS
Current assets:
Cash and cash equivalents $ 11,276 $ 12,432
Prepaid expenses and other current assets 737 896
Total current assets 12,013 13,328
Restricted cash 26 26
Property and equipment, net 5 10
Operating lease right-of-use asset 170 198
Other noncurrent assets 438 490
Total assets $ 12,652 $ 14,052
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 459 $ 698
Accrued liabilities 1,670 831
Accrued compensation and benefits 213 778
Current portion of operating lease liability 125 121
Insurance financing debt 158
Total current liabilities 2,467 2,586
Warrant liability 2 2
Contingent consideration obligation 61 61
Operating lease liability, net of current portion 58 90
Total liabilities 2,588 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 March 31, 2024 and December 31, 2023 2 2
Common stock, $0.01 par value; 280,000,000 shares authorized; 851,302 and 618,056 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively 8 6
Additional paid-in capital 135,087 132,811
Accumulated deficit (125,033) (121,506)
Total stockholders' equity 10,064 11,313
Total liabilities and stockholders' equity $ 12,652 $ 14,052
3月31日 十二月三十一日
2024 2023
資產
流動資產:
現金和現金等價物 $ 11,276 $ 12,432
預付費用和其他流動資產 737 896
流動資產總額 12,013 13,328
受限制的現金 26 26
財產和設備,淨額 5 10
經營租賃使用權資產 170 198
其他非流動資產 438 490
總資產 $ 12,652 $ 14,052
負債和股東權益
流動負債:
應付賬款 $ 459 $ 698
應計負債 1,670 831
應計薪酬和福利 213 778
經營租賃負債的當前部分 125 121
保險融資債務 158
流動負債總額 2,467 2,586
認股權證責任 2 2
或有對價義務 61 61
經營租賃負債,扣除流動部分 58 90
負債總額 2,588 2,739
承付款和意外開支
股東權益:
A 系列可轉換優先股,面值0.01美元,已授權7,000,000股;截至2024年3月31日和2023年12月31日已發行和流通20萬股 2 2
普通股,面值0.01美元;授權2.8億股;截至2024年3月31日和2023年12月31日已發行和流通的股票分別爲851,302和618,056股 8 6
額外的實收資本 135,087 132,811
累計赤字 (125,033) (121,506)
股東權益總額 10,064 11,313
負債和股東權益總額 $ 12,652 $ 14,052

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

Palisade Bio, Inc.
簡明合併運營報表(未經審計)
(以千計,股票和每股金額除外)

Three Months Ended March 31,
2024 2023
License revenue $ $ 250
Operating expenses:
Research and development 2,214 1,241
General and administrative 1,459 1,538
Total operating expenses 3,673 2,779
Loss from operations (3,673) (2,529)
Other (expense) income:
Interest expense (1)
Other income 147 189
Total other income, net 146 189
Net loss $ (3,527) $ (2,340)
Basic and diluted weighted average shares used in computing basic and diluted net loss per common share* 768,137 287,702
Basic and diluted net loss per common share* $ (4.59) $ (8.13)
截至3月31日的三個月
2024 2023
許可證收入 $ $ 250
運營費用:
研究和開發 2,214 1,241
一般和行政 1,459 1,538
運營費用總額 3,673 2,779
運營損失 (3,673) (2,529)
其他(支出)收入:
利息支出 (1)
其他收入 147 189
其他收入總額,淨額 146 189
淨虧損 $ (3,527) $ (2,340)
計算每股普通股基本虧損和攤薄淨虧損時使用的基本和攤薄後的加權平均股數* 768,137 287,702
普通股每股基本虧損和攤薄淨虧損* $ (4.59) $ (8.13)

(*) 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 months ended March 31, 2023 has been adjusted to reflect the 1-for-15 reverse stock split effected on April 5, 2024.

(*) 對截至2023年3月31日的三個月中用於計算普通股基本虧損和攤薄後每股虧損的基本和攤薄後每股虧損以及基本和攤薄後的加權平均股進行了調整,以反映2024年4月5日生效的15股反向股票拆分。

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

Palisade Bio, Inc.
簡明合併現金流量表(未經審計)
(以千計,股票和每股金額除外)

Three Months Ended March 31,
2024 2023
Net loss $ (3,527) $ (2,340)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation 1 1
Non-cash operating lease expense 28 25
Recurring fair value measurements of liabilities (43)
Loss on disposal of property and equipment 4
Stock-based compensation and related charges 118 93
Changes in operating assets and liabilities:
Accounts receivable (250)
Prepaid and other current assets and other noncurrent assets 174 278
Accounts payable and accrued liabilities 615 (970)
Accrued compensation and benefits (565) (295)
Operating lease liabilities (28) (25)
Net cash used in operating activities (3,180) (3,526)
Cash flows from financing activities:
Payments on insurance financing debt (158) (88)
Proceeds from issuance of common stock and warrants 2,231
Proceeds from the exercise of warrants 2,503 2,710
Payment of warrant inducement issuance costs (321)
Payment of equity issuance costs (413)
Net cash provided by financing activities 2,024 4,440
Net (decrease) increase in cash, cash equivalents and restricted cash (1,156) 914
Cash, cash equivalents and restricted cash, beginning of year 12,458 12,409
Cash, cash equivalents and restricted cash, end of period $ 11,302 $ 13,323
Reconciliation of cash, cash equivalents and restricted cash to the balance sheets:
Cash and cash equivalents $ 11,276 $ 13,297
Restricted cash 26 26
Total cash, cash equivalents and restricted cash $ 11,302 $ 13,323
截至3月31日的三個月
2024 2023
淨虧損 $ (3,527) $ (2,340)
爲使淨虧損與經營活動中使用的淨現金相一致而進行的調整:
折舊 1 1
非現金運營租賃費用 28 25
負債的經常性公允價值計量 (43)
處置財產和設備損失 4
股票薪酬和相關費用 118 93
運營資產和負債的變化:
應收賬款 (250)
預付資產和其他流動資產以及其他非流動資產 174 278
應付賬款和應計負債 615 (970)
應計薪酬和福利 (565) (295)
經營租賃負債 (28) (25)
用於經營活動的淨現金 (3,180) (3,526)
來自融資活動的現金流:
保險融資債務的付款 (158) (88)
發行普通股和認股權證的收益 2,231
行使認股權證的收益 2,503 2,710
支付認股權證激勵發行費用 (321)
支付股票發行成本 (413)
融資活動提供的淨現金 2,024 4,440
現金、現金等價物和限制性現金淨增加(減少) (1,156) 914
現金、現金等價物和限制性現金,年初 12,458 12,409
現金、現金等價物和限制性現金,期末 $ 11,302 $ 13,323
現金、現金等價物和限制性現金與資產負債表的對賬:
現金和現金等價物 $ 11,276 $ 13,297
受限制的現金 26 26
現金、現金等價物和限制性現金總額 $ 11,302 $ 13,323

Primary Logo

声明:本內容僅用作提供資訊及教育之目的,不構成對任何特定投資或投資策略的推薦或認可。 更多信息
    搶先評論