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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公布2024年第一季度财务业绩并提供业务最新情况
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

— 公司有望在年底前开始对治疗溃疡性结肠炎(UC)的主要候选产品 PALI-2108 进行第一期人体临床研究

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

— 手头有足够的现金来执行业务计划并在2025年之前达到临床和监管里程碑

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.

加利福尼亚州卡尔斯巴德,2024 年 5 月 14 日 — Palisade Bio, Inc. 纳斯达克股票代码:PALI)(“Palisade”、“Palisade Bio” 或 “公司”)是一家专注于为自身免疫、炎症和纤维化疾病患者开发和推进新疗法的生物制药公司,今天公布了其2024年第一季度的财务业绩并提供了业务最新情况。

Recent Highlights

近期亮点

  • 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.
  • 与Strand Life Sciences达成战略合作,为Palisade提供先进的生物信息学工具,这些工具对于了解复杂的疾病途径和预测对磷酸二酯酶-4(PDE4)抑制剂的反应至关重要;
  • 成功完成了 ex-vivo 研究确定生物活化的 PALI-2108 对全血化验中肿瘤坏死因子α生成的影响;
  • 成功完成分析评估 ex-vivo 在健康和 UC 患者粪便研究中对 PALI-2108 进行生物活化;
  • 任命华尔街和生物技术行业资深人士玛格丽·菲施拜因为董事会成员;以及
  • 2024年5月,延长了现金流道,完成了400万澳元的私募配售。

"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.

“我们的团队仍然专注于将 PALI-2108 推向我们的首次人体研究,该研究有望在今年晚些时候开始。我们不断增长的数据量,包括来自两个的最新数据 ex-vivo 评估 PALI-2108 的研究,加上我们与 Strand Life Sciences 的战略合作伙伴关系,进一步增强了我们对 PALI-2108 在治疗UC方面的强大抗炎潜力的信心。最重要的是,这些数据突显了其作为炎症性肠病患者的下一代治疗选择的潜力。” 首席执行官J.D. Finley评论道。

PALI-2108 Development Program

PALI-2108 开发计划

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.

该公司继续将其治疗中度至重度 UC 的牵头项目 PALI-2108 推进到 1 期临床研究。PALI-2108 是一种口服、局部作用的结肠特异性 PDE4 抑制剂前药,正在开发中,适用于受 UC 影响的患者。

Upcoming Target Milestones

即将到来的目标里程碑

  • 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进行的支持IND/CTA的毒素研究;
  • 在2024年第三季度末之前完成非临床IND/CTA支持活动;
  • 在 2024 年第三季度提交初始 IND/CTA;以及
  • 在 2024 年底之前启动第 1a/b 阶段。

Precision Medicine Approach

精准医疗方法

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,该公司正在开发一种基于遗传或生物标志物的精准医疗方法,该方法如果开发出来,将帮助医生选择最有可能对 PALI-2108 PDE4-抑制剂疗法产生反应的患者。该公司正在与战略合作伙伴合作进行开发,并已完成了包括1,600多名加州大学患者临床和生物标志物数据在内的管道的策划,并且正在与潜在合作伙伴进行讨论,以获取更多患者数据,以支持美国食品药品管理局批准的测试的开发。该公司计划利用这种专业知识和基础设施为不断增长的经过验证和高度优先的自身免疫性、炎症和纤维化疾病候选产品提供燃料。

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

截至2024年3月31日的第一季度财务业绩摘要

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,该公司的现金及现金等价物为1,130万美元。在本季度末之后,公司完成了400万澳元的私募配售。包括最近的融资,该公司认为有足够的现金为其目前计划在2025年第一季度之前的运营提供资金。

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日的三个月,净亏损为350万美元,较截至2023年3月31日的三个月净亏损230万美元增加了120万美元。

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日的三个月,研发费用为220万美元,与截至2023年3月31日的三个月的120万美元相比,增加了约100万美元,增长了78%。截至2024年3月31日的三个月,与去年同期相比的增长归因于约160万美元的已确认支出,这些支出与公司新的主要资产 PALI-2108 的联合开发直接相关,但部分被与公司于2023年8月停止开发 LB1148 直接相关的成本减少以及员工相关成本的减少所抵消。

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日的三个月,一般和管理费用几乎保持在150万美元左右。

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.

关于 Palisade Bio
Palisade Bio是一家生物制药公司,专注于为自身免疫、炎症和纤维化疾病患者开发和推进新型疗法。该公司认为,通过对新疗法使用靶向方法,它将改变治疗格局。欲了解更多信息,请前往 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.

前瞻性陈述
就1995年《私人证券诉讼改革法》的安全港条款而言,本通信包含 “前瞻性” 陈述。前瞻性陈述包括有关公司意图、信念、预测、前景、分析或当前预期的陈述,其中包括:我们的现金流范围;我们成功开发许可技术的能力;对候选产品市场规模和增长潜力的估计,以及我们为这些市场提供服务的能力,包括所产生的任何潜在收入;美国(美国)和外国未来的监管、司法和立法变化或发展,以及这些变化的影响;我们维持证券在纳斯达克上市的能力;我们在美国和其他市场建立商业基础设施的能力;我们在竞争激烈的行业中进行有效竞争的能力;我们识别和认证制造商提供原料药和制造药品的能力;我们签订商业供应协议的能力;已经或可能出现的竞争技术的成功;我们吸引和留住关键科学或管理人员的能力;我们有关估计的准确性支出、未来收入、资本要求和额外融资需求;我们获得运营资金的能力;我们吸引合作者和战略伙伴关系的能力;以及 COVID-19 疫情或任何全球事件对我们的业务、运营和供应的影响。本通信中包含的任何非历史事实陈述的陈述均可被视为前瞻性陈述。这些前瞻性陈述基于公司当前的预期。前瞻性陈述涉及风险和不确定性。由于这些风险和不确定性,公司的实际业绩和事件发生时间可能与此类前瞻性陈述中的预期存在重大差异,其中包括但不限于公司推进其非临床和临床项目的能力、不确定和耗时的监管批准程序;以及公司获得额外融资以资助其候选产品的未来运营和开发的能力。其他风险和不确定性可以在公司于2024年3月26日向美国证券交易委员会(“SEC”)提交的截至2023年12月31日财年的10-K表年度报告中找到。这些前瞻性陈述仅代表截至本文发布之日,公司明确表示没有义务或承诺公开发布此处包含的任何前瞻性陈述的任何更新或修订,以反映公司对这些前瞻性陈述的预期的任何变化或任何此类陈述所依据的事件、条件或情况的任何变化。

Investor Relations Contact

投资者关系联系人

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

JTC Team, LLC
珍妮·托马斯
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.
简明合并资产负债表(未经审计)
(以千计,股票和每股金额除外)

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
资产
流动资产:
现金和现金等价物 $ 11,276 $ 12,432
预付费用和其他流动资产 737 896
流动资产总额 12,013 13,328
受限制的现金 26 26
财产和设备,净额 5 10
经营租赁使用权资产 170 198
其他非流动资产 438 490
总资产 $ 12,652 $ 14,052
负债和股东权益
流动负债:
应付账款 $ 459 $ 698
应计负债 1,670 831
应计薪酬和福利 213 778
经营租赁负债的当前部分 125 121
保险融资债务 158
流动负债总额 2,467 2,586
认股权证责任 2 2
或有对价义务 61 61
经营租赁负债,扣除流动部分 58 90
负债总额 2,588 2,739
承付款和意外开支
股东权益:
A 系列可转换优先股,面值0.01美元,已授权7,000,000股;截至2024年3月31日和2023年12月31日已发行和流通20万股 2 2
普通股,面值0.01美元;授权2.8亿股;截至2024年3月31日和2023年12月31日已发行和流通的股票分别为851,302和618,056股 8 6
额外的实收资本 135,087 132,811
累计赤字 (125,033) (121,506)
股东权益总额 10,064 11,313
负债和股东权益总额 $ 12,652 $ 14,052

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

Palisade Bio, Inc.
简明合并运营报表(未经审计)
(以千计,股票和每股金额除外)

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日的三个月
2024 2023
许可证收入 $ $ 250
运营费用:
研究和开发 2,214 1,241
一般和行政 1,459 1,538
运营费用总额 3,673 2,779
运营损失 (3,673) (2,529)
其他(支出)收入:
利息支出 (1)
其他收入 147 189
其他收入总额,净额 146 189
净亏损 $ (3,527) $ (2,340)
计算每股普通股基本亏损和摊薄净亏损时使用的基本和摊薄后的加权平均股数* 768,137 287,702
普通股每股基本亏损和摊薄净亏损* $ (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.

(*) 对截至2023年3月31日的三个月中用于计算普通股基本亏损和摊薄后每股亏损的基本和摊薄后每股亏损以及基本和摊薄后的加权平均股进行了调整,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.
简明合并现金流量表(未经审计)
(以千计,股票和每股金额除外)

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日的三个月
2024 2023
净亏损 $ (3,527) $ (2,340)
为使净亏损与经营活动中使用的净现金相一致而进行的调整:
折旧 1 1
非现金运营租赁费用 28 25
负债的经常性公允价值计量 (43)
处置财产和设备损失 4
股票薪酬和相关费用 118 93
运营资产和负债的变化:
应收账款 (250)
预付资产和其他流动资产以及其他非流动资产 174 278
应付账款和应计负债 615 (970)
应计薪酬和福利 (565) (295)
经营租赁负债 (28) (25)
用于经营活动的净现金 (3,180) (3,526)
来自融资活动的现金流:
保险融资债务的付款 (158) (88)
发行普通股和认股权证的收益 2,231
行使认股权证的收益 2,503 2,710
支付认股权证激励发行费用 (321)
支付股票发行成本 (413)
融资活动提供的净现金 2,024 4,440
现金、现金等价物和限制性现金净增加(减少) (1,156) 914
现金、现金等价物和限制性现金,年初 12,458 12,409
现金、现金等价物和限制性现金,期末 $ 11,302 $ 13,323
现金、现金等价物和限制性现金与资产负债表的对账:
现金和现金等价物 $ 11,276 $ 13,297
受限制的现金 26 26
现金、现金等价物和限制性现金总额 $ 11,302 $ 13,323

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