Predictive Oncology Reports First Quarter 2024 Financial Results and Provides Business Update
Predictive Oncology Reports First Quarter 2024 Financial Results and Provides Business Update
Company to host investor call and webcast today, May 15th, at 8:30am EDT
公司将于今天，美国东部时间5月15日上午 8:30 举办投资者电话会议和网络直播
PITTSBURGH, May 15, 2024 (GLOBE NEWSWIRE) -- Predictive Oncology (Nasdaq: POAI), a science driven company leveraging its proprietary artificial intelligence and machine learning capabilities, extensive biorepository of tumor samples, CLIA laboratory and GMP facility, to accelerate oncologic drug discovery and enable drug development, today reported financial and operating results for the quarter ended March 31, 2024, and provided a corporate update. The company reported a net loss of approximately $4.2 million on total revenue of approximately $0.4 million for the quarter.
匹兹堡，2024年5月15日（GLOBE NEWSWIRE）——预测肿瘤学（纳斯达克股票代码：POAI）是一家以科学为导向的公司，利用其专有的人工智能和机器学习能力、庞大的肿瘤样本生物库、CLIA实验室和GMP设施，加速肿瘤药物的发现和药物开发，今天公布了截至2024年3月31日的季度财务和经营业绩，并提供了公司最新情况。该公司报告净亏损约420万美元，本季度总收入约为40万美元。
Q1 2024 and Recent Highlights:
2024 年第一季度及近期亮点：
- Announced that an abstract detailing results of the recent study that Predictive Oncology completed in collaboration with UPMC Magee-Womens Hospital in Pittsburgh, PA, has been accepted as a poster presentation at the American Society for Clinical Oncology (ASCO) Annual Meeting, which is being held May 31-June 4 in Chicago.
- The study utilized multi-omic machine learning models to identify molecular features that better correlate to short- and long-term survival outcomes among women diagnosed with high grade serous ovarian cancer (HGSC) as compared to clinical data alone.
- Models hold potential as decision support tools to be incorporated into daily clinical practice to tailor therapies to individual patients and may also be used to identify novel biomarkers to advance the development of next-generation cancer therapeutics.
- Presentation is scheduled for Monday, June 3rd, 9:00am – 12:00pm CDT (10:00am-1:00pm EDT).
- Announced a collaboration and co-marketing agreement with Fujifilm to reduce protein interference in bacterial endotoxin testing of biopharmaceutical products, thereby improving drug safety. Per the terms of the agreement, Predictive Oncology will utilize its novel EndoPrep sample treatment technology, together with Fujifilm's PYROSTAR bacterial endotoxin detection reagent, to detect residual endotoxins more accurately in biopharmaceuticals by eliminating protein interference from the drug product in the detection assay.
- Reported meaningful progress with its FluGen collaboration designed to bring a first-of-its-kind intranasal flu vaccine to market, as part of a $6.2 million Phase 2b grant awarded by the U.S. Department of Defense (DoD), a portion of which will be received indirectly by Predictive Oncology, as subcontractor for FluGen, over multiple years. Per the terms of the collaboration, Predictive Oncology will play a key role in making FluGen's M2SR flu vaccine more stable and sustainable in a refrigerated state as it advances through clinical trials.
- Successful accomplishment of the solubility and stability goals in this collaboration – which would commercially validate the Company's ability to solubilize and stabilize a whole live attenuated virus – may lead to future contracts with FluGen for other vaccine projects, as well as potentially other pharmaceutical companies.
- Successful accomplishment of the solubility and stability goals in this collaboration – which would commercially validate the Company's ability to solubilize and stabilize a whole live attenuated virus – may lead to future contracts with FluGen for other vaccine projects, as well as potentially other pharmaceutical companies.
- 宣布，一份详细介绍预测肿瘤学会与宾夕法尼亚州匹兹堡的UPMC Magee-Womens医院合作完成的最新研究结果的摘要已作为海报展示在5月31日至6月4日在芝加哥举行的美国临床肿瘤学会（ASCO）年会上被接受。
- 与单独的临床数据相比，该研究使用多组学机器学习模型来识别与被诊断患有高级别浆液性卵巢癌（HGSC）的女性的短期和长期存活结果更相关的分子特征。
- 模型有可能作为决策支持工具，将其纳入日常临床实践，为个体患者量身定制疗法，还可用于鉴定新的生物标志物，以推进下一代癌症疗法的开发。
- 演讲定于6月3日星期一举行第三方，中部夏令时间上午9点至中午12点（美国东部时间上午10点至下午1点）。
- 宣布与富士胶片签订合作和联合营销协议，以减少生物制药产品细菌内毒素测试中的蛋白质干扰，从而提高药物安全性。根据协议条款，Predictive Oncology将利用其新的EndoPrep样本处理技术以及富士胶片的PYROSTAR细菌内毒素检测试剂，通过消除检测分析中药物产品的蛋白质干扰，更准确地检测生物制药中残留的内毒素。
- 报告称，其FluGen合作旨在将首款鼻内流感疫苗推向市场，这是美国国防部（DoD）授予的620万美元2b期拨款的一部分，其中一部分将在多年内由作为FluGen分包商的预测肿瘤学间接获得。根据合作条款，随着临床试验的进展，预测肿瘤学将在使FluGen的M2SR流感疫苗在冷藏状态下更加稳定和可持续方面发挥关键作用。
- 成功实现此次合作的溶解度和稳定性目标——这将对该公司溶解和稳定整个减毒活病毒的能力进行商业验证——可能会导致未来与FluGen签订其他疫苗项目的合同，并可能与其他制药公司签订合同。
- 成功实现此次合作的溶解度和稳定性目标——这将对该公司溶解和稳定整个减毒活病毒的能力进行商业验证——可能会导致未来与FluGen签订其他疫苗项目的合同，并可能与其他制药公司签订合同。
"Our first quarter 2024 and subsequent results reflect the breadth and versatility of our technology, from the development of AI-driven machine learning models that can accelerate and de-risk early drug discovery, to our suite of biologics formulations and manufacturing capabilities that support leading biopharmaceutical drug developers and improve their chances of clinical success," said Raymond F. Vennare, Chief Executive Officer and Chairman of Predictive Oncology. "Our recent announcements of projects with Fujifilm and FluGen, in particular, suggest that demand for our biologics solutions is strong while we continue to advance discussions with UPMC Magee-Womens Hospital and others on next steps following recent successful PEDAL engagements."
预测肿瘤学首席执行官兼董事长雷蒙德·文纳雷表示：“我们的2024年第一季度及其后的业绩反映了我们技术的广度和多功能性，从开发可以加速和降低早期药物发现风险的人工智能驱动的机器学习模型，到我们的一系列生物制剂配方和制造能力，为领先的生物制药药物开发商提供支持，提高他们获得临床成功的机会。”“我们最近宣布的与富士胶片和FluGen合作的项目尤其表明，对我们的生物制剂解决方案的需求强劲，与此同时，继最近成功参与PEDAL之后，我们将继续推进与UPMC Magee-Womens Hospital和其他机构就下一步措施的讨论。”
"Just a few weeks ago, we announced that an abstract detailing results from a retrospective study that we completed with UPMC Magee has been accepted for presentation at the prestigious ASCO 2024 Annual Meeting. This study, in which we successfully developed active machine learning models capable of accurately predicting survival outcomes among ovarian cancer patients, has broad implications. In addition to the potential use of these models as decision support tools to be used in daily clinical practice to tailor therapies to individual patients, we see an opportunity to identify novel biomarkers which may allow us, or a licensing partner, to develop new cancer therapies on our own."
“就在几周前，我们宣布，一份详细介绍我们与UPMC Magee完成的回顾性研究结果的摘要已获准在久负盛名的ASCO 2024年年会上公布。在这项研究中，我们成功开发了能够准确预测卵巢癌患者存活结果的主动机器学习模型，具有广泛的意义。除了有可能将这些模型用作决策支持工具，用于日常临床实践，为个体患者量身定制疗法外，我们还看到了发现新型生物标志物的机会，这可能使我们或许可合作伙伴能够自行开发新的癌症疗法。”
"Since we implemented our new strategic vision for the company at the beginning of 2023, we have continued to refine our business development efforts, and we are making steady progress conveying to current and prospective partners the unique blend of assets and capabilities that we possess. Our message is resonating, as we are in late-stage discussions on a number of engagements, across both of our businesses, that we believe will continue to elevate awareness of our company among leading cancer drug developers worldwide. I look forward to accelerating contracting momentum as we progress through 2024," concluded Mr. Vennare.
“自从我们在2023年初为公司实施新的战略愿景以来，我们一直在完善业务发展工作，我们正在稳步取得进展，向现有和潜在合作伙伴传达我们所拥有的独特资产和能力组合。我们的信息引起了共鸣，因为我们正在就两家业务的多项合作进行后期讨论，我们相信这将继续提高全球领先的抗癌药物开发商对我们公司的认识。随着2024年的进展，我期待加快收缩势头。” 文纳雷先生总结道。
Q1 2024 Financial Summary:
2024 年第一季度财务摘要：
- Concluded the first quarter of 2024 with $5.2 million of cash, compared to $8.7 million as of December 31, 2023, and $4.1 million in stockholders' equity, compared to $8.3 million as of December 31, 2023.
- Basic and diluted net loss per common share for the quarter ended March 31, 2024, was $(1.04), compared to $(0.86) for the quarter ended March 31, 2023.
- 2024年第一季度结束时现金为520万美元，而截至2023年12月31日为870万美元，股东权益为410万美元，而截至2023年12月31日为830万美元。
- 截至2024年3月31日的季度，普通股每股基本亏损和摊薄后净亏损为1.04美元，而截至2023年3月31日的季度为0.86美元。
Q1 2024 Financial Results:
2024 年第一季度财务业绩：
- The company recorded revenue of $419,646 for the first quarter of 2024, compared to $239,895 for the comparable period in 2023. Revenues for the quarter ended March 31, 2024, and March 31, 2023, were primarily derived from the Company's Eagan operating segment.
- Cost of sales was $187,415 and $120,139 for the three months ended March 31, 2024, and 2023, respectively. Gross profit margin was approximately 55% and 50% for the three months ended March 31, 2024, and 2023, respectively. The improvement in gross profit margin was primarily due to a change in sales mix, with increased sales of STREAMWAY systems in the three months ended March 31, 2024.
- General and administrative expenses increased to $2,627,076 in the first quarter of 2024 from $2,335,984 in the first quarter of 2023. The increase was primarily due to increased professional fees including audit and consultant fees as well as increased business taxes, offset by decreased employee compensation as well as decreased depreciation due to fully depreciated assets.
- Operations expenses increased to $1,102,193 in the first quarter of 2024 compared to $878,518 in the first quarter of 2023. The increase was primarily due to increased employee compensation associated with our research and development efforts.
- Sales and marketing expenses increased to $739,734 in the first quarter of 2024 from $370,237 in the first quarter of 2023. The increase was primarily due to severance related to a former executive.
- Net cash used in operating activities was $3,416,021 in the first quarter of 2024 compared to net cash used of $3,427,761 in the first quarter of 2023. The increase in the Company's net loss was primarily offset by an increase in cash provided by changes in working capital, resulting from higher accounts payable and accrued expenses.
- 该公司在2024年第一季度的收入为419,646美元，而2023年同期为239,895美元。截至2024年3月31日和2023年3月31日的季度收入主要来自公司的伊根运营板块。
- 截至2024年3月31日和2023年3月31日的三个月，销售成本分别为187,415美元和120,139美元。截至2024年3月31日和2023年3月31日的三个月，毛利率分别约为55％和50％。毛利率的提高主要是由于销售结构的变化，在截至2024年3月31日的三个月中，STREAMWAY系统的销售额有所增加。
- 一般和管理费用从2023年第一季度的2335,984美元增加到2024年第一季度的2627,076美元。增长的主要原因是包括审计和顾问费在内的专业费用增加，以及营业税的增加，但被员工薪酬减少以及资产完全折旧导致的折旧减少所抵消。
- 运营支出从2023年第一季度的878,518美元增至2024年第一季度的1,102,193美元。增长的主要原因是与我们的研发工作相关的员工薪酬增加。
- 销售和营销费用从2023年第一季度的370,237美元增加到2024年第一季度的739,734美元。增长主要是由于与一位前高管有关的离职费。
- 2024年第一季度用于经营活动的净现金为3,416,021美元，而2023年第一季度使用的净现金为3,427,761美元。公司净亏损的增加主要被应付账款和应计费用增加所产生的营运资金变动所产生的现金增加所抵消。
Conference Call and Webcast Details:
电话会议和网络直播详情：
Predictive Oncology management will host an investor conference call and webcast today, May 15th, 8:30 am EDT.
预测肿瘤学管理层将于今天（5月15日）主持投资者电话会议和网络直播第四，美国东部时间上午 8:30。
To participate in the call, investors and analysts should dial 1-877-407-3982 (domestic) or 1-201-493-6780 (international) and reference conference ID 13746389.
要参与电话会议，投资者和分析师应拨打1-877-407-3982（国内）或1-201-493-6780（国际），参考会议编号为13746389。
To access the Call Me feature, which eliminates the need to wait for a call operator, please click here.
要访问无需等待呼叫接线员的 “给我打电话” 功能，请单击 这里。
The live webcast of the call can be accessed here.
可以观看电话会议的网络直播 这里。
Forward-Looking Statements:
前瞻性陈述：
Certain matters discussed in this release contain forward-looking statements. These forward-looking statements reflect our current expectations and projections about future events and are subject to substantial risks, uncertainties and assumptions about our operations and the investments we make. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, future financial position, future revenue and financial performance, projected costs, prospects, plans and objectives of management are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "would," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Our actual future performance may materially differ from that contemplated by the forward-looking statements as a result of a variety of factors including, among other things, the risks related to the success of our collaboration arrangements, commercialization activities and product sales levels by our collaboration partners, and other factors discussed under the heading "Risk Factors" in our filings with the SEC. Except as expressly required by law, the Company disclaims any intent or obligation to update these forward-looking statements.
本新闻稿中讨论的某些事项包含前瞻性陈述。这些前瞻性陈述反映了我们当前对未来事件的预期和预测，并受有关我们的运营和投资的重大风险、不确定性和假设的影响。除历史事实陈述外，本新闻稿中有关我们的战略、未来运营、未来财务状况、未来收入和财务业绩、预计成本、前景、计划和管理目标的所有陈述，均为前瞻性陈述。“预期”、“相信”、“估计”、“期望”、“打算”、“可能”、“计划”、“将”、“目标” 等词语和类似表述旨在识别前瞻性陈述，尽管并非所有前瞻性陈述都包含这些识别词。由于多种因素，包括与我们的合作安排成功相关的风险、合作伙伴的商业化活动和产品销售水平，以及我们向美国证券交易委员会提交的文件中在 “风险因素” 标题下讨论的其他因素，我们的实际未来表现可能与前瞻性陈述所设想的存在重大差异。除非法律明确要求，否则公司不承担任何更新这些前瞻性陈述的意图或义务。
Investor Relations Contact:
Tim McCarthy, CFA
LifeSci Advisors, LLC
tim@lifesciadvisors.com
投资者关系联系人：
蒂姆·麦卡锡，特许金融分析师
LifeSci 顾问有限公司
tim@lifesciadvisors.com
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PREDICTIVE ONCOLOGY INC. CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) | ||||||||
|
March 31, 2024 |
December 31, 2023 |
|||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash | $ | 5,197,235 | $ | 8,728,660 | ||||
| Accounts receivable | 509,445 | 333,697 | ||||||
| Inventories | 441,718 | 494,374 | ||||||
| Prepaid expense and other assets | 412,925 | 521,700 | ||||||
| Total current assets | 6,561,323 | 10,078,431 | ||||||
| Property and equipment, net | 1,087,718 | 1,233,910 | ||||||
| Intangibles, net | 245,594 | 252,457 | ||||||
| Lease right-of-use assets | 2,582,456 | 2,728,355 | ||||||
| Other long-term assets | 124,096 | 124,096 | ||||||
| Total assets | $ | 10,601,187 | $ | 14,417,249 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,729,126 | $ | 1,342,027 | ||||
| Note payable | 38,036 | 150,408 | ||||||
| Accrued expenses and other liabilities | 1,904,612 | 1,631,702 | ||||||
| Derivative liability | 367 | 1,376 | ||||||
| Contract liabilities | 304,320 | 308,091 | ||||||
| Lease liability | 540,200 | 517,427 | ||||||
| Total current liabilities | 4,516,661 | 3,951,031 | ||||||
| Other long-term liabilities | 3,507 | 5,459 | ||||||
| Lease liability – net of current portion | 2,027,348 | 2,188,979 | ||||||
| Total liabilities | 6,547,516 | 6,145,469 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Preferred stock, 20,000,000 shares authorized inclusive of designated below | ||||||||
| Series B Convertible Preferred Stock, $.01 par value, 2,300,000 shares authorized, 79,246 shares outstanding as of March 31, 2024, and December 31, 2023 | 792 | 792 | ||||||
| Common stock, $.01 par value, 200,000,000 shares authorized, 4,062,853 shares outstanding as of March 31, 2024, and December 31, 2023 | 40,629 | 40,629 | ||||||
| Additional paid-in capital | 175,992,976 | 175,992,242 | ||||||
| Accumulated deficit | (171,980,726) | (167,761,883) | ||||||
| Total stockholders' equity | 4,053,671 | 8,271,780 | ||||||
| Total liabilities and stockholders' equity | $ | 10,601,187 | $ | 14,417,249 | ||||
| 预测肿瘤学公司 简明的合并资产负债表 （未经审计） | ||||||||
| 3月31日 2024 |
十二月三十一日 2023 |
|||||||
| 资产 | ||||||||
| 流动资产： | ||||||||
| 现金 | $ | 5,197,235 | $ | 8,728,660 | ||||
| 应收账款 | 509,445 | 333,697 | ||||||
| 库存 | 441,718 | 494,374 | ||||||
| 预付费用和其他资产 | 412,925 | 521,700 | ||||||
| 流动资产总额 | 6,561,323 | 10,078,431 | ||||||
| 财产和设备，净额 | 1,087,718 | 1,233,910 | ||||||
| 无形资产，净值 | 245,594 | 252,457 | ||||||
| 租赁使用权资产 | 2,582,456 | 2,728,355 | ||||||
| 其他长期资产 | 124,096 | 124,096 | ||||||
| 总资产 | $ | 10,601,187 | $ | 14,417,249 | ||||
| 负债和股东权益 | ||||||||
| 流动负债： | ||||||||
| 应付账款 | $ | 1,729,126 | $ | 1,342,027 | ||||
| 应付票据 | 38,036 | 150,408 | ||||||
| 应计费用和其他负债 | 1,904,612 | 1,631,702 | ||||||
| 衍生责任 | 367 | 1,376 | ||||||
| 合同负债 | 304,320 | 308,091 | ||||||
| 租赁责任 | 540,200 | 517,427 | ||||||
| 流动负债总额 | 4,516,661 | 3,951,031 | ||||||
| 其他长期负债 | 3,507 | 5,459 | ||||||
| 租赁负债——扣除当期部分 | 2,027,348 | 2,188,979 | ||||||
| 负债总额 | 6,547,516 | 6,145,469 | ||||||
| 承付款和意外开支 | ||||||||
| 股东权益： | ||||||||
| 优先股，授权的20,000,000股股票，包括以下指定股票 | ||||||||
| B系列可转换优先股，面值0.01美元，已授权2,300,000股，截至2024年3月31日和2023年12月31日已发行79,246股 | 792 | 792 | ||||||
| 普通股，面值0.01美元，已授权2亿股，截至2024年3月31日和2023年12月31日已发行4,062,853股 | 40,629 | 40,629 | ||||||
| 额外的实收资本 | 175,992,976 | 175,992,242 | ||||||
| 累计赤字 | (171,980,726) | (167,761,883) | ||||||
| 股东权益总额 | 4,053,671 | 8,271,780 | ||||||
| 负债和股东权益总额 | $ | 10,601,187 | $ | 14,417,249 | ||||
|
PREDICTIVE ONCOLOGY INC. CONDENSED CONSOLIDATED STATEMENTS OF NET LOSS (Unaudited) | ||||||||
|
Three Months Ended March 31, |
||||||||
| 2024 | 2023 | |||||||
| Revenue | $ | 419,646 | $ | 239,895 | ||||
| Cost of sales | 187,415 | 120,139 | ||||||
| Gross profit | 232,231 | 119,756 | ||||||
| Operating expenses: | ||||||||
| General and administrative expense | 2,627,076 | 2,335,984 | ||||||
| Operations expense | 1,102,193 | 878,518 | ||||||
| Sales and marketing expense | 739,734 | 370,237 | ||||||
| Total operating expenses | 4,469,003 | 3,584,739 | ||||||
| Total operating (loss) | (4,236,772) | (3,464,983) | ||||||
| Other income | 18,657 | 42,228 | ||||||
| Other expense | (1,737) | - | ||||||
| Gain on derivative instruments | 1,009 | 953 | ||||||
| Net (loss) | $ | (4,218,843) | $ | (3,421,802) | ||||
| Net (loss) per common share – basic and diluted | $ | (1.04) | $ | (0.86) | ||||
| Weighted average shares used in computation – basic and diluted | 4,062,853 | 3,968,099 | ||||||
| 预测肿瘤学公司 简明合并净亏损表 （未经审计） | ||||||||
| 三个月已结束 3月31日 |
||||||||
| 2024 | 2023 | |||||||
| 收入 | $ | 419,646 | $ | 239,895 | ||||
| 销售成本 | 187,415 | 120,139 | ||||||
| 毛利 | 232,231 | 119,756 | ||||||
| 运营费用： | ||||||||
| 一般和管理费用 | 2,627,076 | 2,335,984 | ||||||
| 运营费用 | 1,102,193 | 878,518 | ||||||
| 销售和营销费用 | 739,734 | 370,237 | ||||||
| 运营费用总额 | 4,469,003 | 3,584,739 | ||||||
| 营业总额（亏损） | (4,236,772) | (3,464,983) | ||||||
| 其他收入 | 18,657 | 42,228 | ||||||
| 其他费用 | (1,737) | - | ||||||
| 衍生工具的收益 | 1,009 | 953 | ||||||
| 净额（亏损） | $ | (4,218,843) | $ | (3,421,802) | ||||
| 每股普通股净（亏损）——基本股和摊薄后 | $ | (1.04) | $ | (0.86) | ||||
| 计算中使用的加权平均份额——基本份额和摊薄后份额 | 4,062,853 | 3,968,099 | ||||||
译文内容由第三方软件翻译。