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VolitionRx 收益报告的主要要点(2024 年 3 月)收入增长:第四季度收入:244,000 美元,同比增长 104% 全年收入:775,000 美元,同比增长 153% 预计 2024 年将出现强劲增长轨迹,尤其是 Nu。 Q Vet 癌症测试扩展Nu.Q Vet 癌症测试:与 Fujifilm Vet Systems、Heska 和 Antech 建立新的分销合作伙伴关系预计将带来现金收益,并可通过 Heska 和 Antech 作为内部诊断癌症检测开发:用于脓毒症诊断的 Nu.Q NET有前景的临床相关性Capture-PCR是一种突破性的液体活检方法,可从血液中分离出肿瘤来源的DNA公司展望:通过产品收入、里程碑付款、向外许可和非稀释性融资实现正收入的目标Nu.Q Discover预计将增长一倍以上2024 年收入重点通过非稀释来源和许可机会为 Nu.Q NET 提供资金 看涨亮点:对 Capture-PCR 许可的浓厚兴趣 Heska 许可协议的递延收入预计将于今年开始盈利 兽医和 Nu.Q Discover 收入流的毛利率强劲 看跌亮点:Nu.Q Discover 项目的收入由于项目性质和时间安排而难以预测兽医收入的增长取决于新经销商的推出
VolitionRx Limited (NYSE: VNRX) reported significant revenue growth in its fourth quarter and full year 2023 earnings call on March 26, 2024. The company's revenue for the quarter was $244,000, marking a 104% increase from the previous year's quarter. The full-year revenue reached $775,000, a 153% increase compared to the prior year.
VolitionRx Limited(纽约证券交易所股票代码:VNRX)于2024年3月26日召开的财报电话会议上报告称,其第四季度和2023年全年营收显着增长。该公司本季度营收为244,000美元,较上年同期增长104%。全年收入达到775,000美元,比上年增长153%。
VolitionRx is optimistic about its revenue growth trajectory, particularly with the anticipated acceleration in 2024 due to the expansion of its distribution network for the Nu.Q Vet cancer test. The company also highlighted its progress in the development of cancer detection methods, including Nu.Q NET for sepsis diagnosis and Capture-PCR for isolating tumor-derived DNA from blood.
VolitionRx 对其收入增长轨迹持乐观态度,特别是由于 Nu.Q Vet 癌症测试分销网络的扩展,预计 2024 年收入将加速增长。该公司还强调了其在癌症检测方法开发方面取得的进展,包括用于脓毒症诊断的 Nu.Q NET 和用于从血液中分离肿瘤衍生 DNA 的 Capture-PCR。
Key Takeaways
- Q4 revenue increased by 104% year-over-year to $244,000; full-year revenue up by 153% to $775,000.
- Nu.Q Vet cancer test to be rolled out countrywide through Fujifilm Vet Systems and available through Heska (NASDAQ:HSKA) and Antech.
- Nu.Q NET method for sepsis diagnosis showing promising clinical correlations; more data expected by year-end.
- Capture-PCR cancer detection method development progressing, with commercial discussions underway.
- Company targeting breakeven through product revenues, milestone payments, out-licensing, and non-dilutive funding.
- Veterinary sector revenue grew by 194% to $475,000; Nu.Q Discover generated $300,000 in revenue with over $1 million in pipeline projects.
Company Outlook
- Expectation of strong revenue growth from Nu.Q vet cancer test in 2024 and beyond.
- Nu.Q Discover revenue expected to double in 2024 with a project pipeline valued at over $1 million.
- Plans to achieve breakeven through a combination of revenue streams, including milestone payments and out-licensing.
- Nu.Q vet aimed to be cash positive; Nu.Q Discover projected to be profitable in 2025.
- Seeking $25 million in project funding for Nu.Q NET and exploring licensing opportunities for CTCF and Nu.Q cancer technologies.
Bearish Highlights
- Revenue from Nu.Q Discover projects difficult to forecast due to project nature and timing.
- Veterinary revenue ramp-up dependent on the launch of new distributors.
Bullish Highlights
- Significant interest in licensing the Capture-PCR technology.
- $23 million in deferred income from Heska license agreement expected to start earning out this year.
- Both veterinary and Nu.Q Discover revenue streams have good gross margins, with higher profitability expected at scale.
Misses
- No specific misses were discussed in the provided summary.
Q&A Highlights
- Company working with governmental agencies to secure funding for bedside cancer detection test.
- Open to divesting or spinning off veterinary side to fund human sepsis trials.
- Company focusing on larger, more prevalent cancers for detection technology.
- Optimizing solid tumor detection test for potential licensing deals.
VolitionRx emphasized its commitment to generating revenue through licensing and upfront milestone payments and expressed confidence in the potential of its technology to detect various types of cancer. The company also revealed cost-cutting measures totaling $2 million and expressed gratitude for positive feedback on its webinars. Plans to update investors in the coming months were mentioned, with a first-quarter earnings call scheduled for mid-May.
主要要点第四季度收入同比增长 104% 至 244,000 美元;全年收入增长 153%,达到 775,000 美元。Nu.Q Vet 癌症测试将通过 Fujifilm Vet Systems 在全国范围内推广,并可通过 Heska(纳斯达克股票代码:HSKA)和 Antech.Nu.Q NET 脓毒症诊断方法提供,显示出有希望的临床相关性;预计到年底会有更多数据。Capture-PCR 癌症检测方法开发正在进行,商业讨论正在进行中。公司的目标是通过产品收入、里程碑付款、向外许可和非稀释资金实现盈亏平衡。兽医部门收入增长 194%,达到475,000 美元; Nu.Q Discover 创造了 30 万美元的收入,有超过 100 万美元的管道项目。公司展望预计 2024 年及以后 Nu.Q 兽医癌症测试收入将强劲增长。Nu.Q Discover 的收入预计将在 2024 年翻一番,管道项目价值为超过 100 万美元。计划通过收入流组合实现收支平衡,包括里程碑付款和向外许可。Nu.Q vet 的目标是现金积极; Nu.Q Discover 预计将于 2025 年实现盈利。为 Nu.Q NET 寻求 2500 万美元的项目资金,并探索 CTCF 和 Nu.Q 癌症技术的许可机会。看跌亮点 Nu.Q Discover 项目的收入由于项目性质而难以预测兽医收入的增长取决于新经销商的推出。看涨亮点对 Capture-PCR 技术许可的浓厚兴趣。Heska 许可协议的 2300 万美元递延收入预计今年开始盈利。兽医和 Nu.Q 都发现收入流具有良好的毛利率,预计规模化盈利能力会更高。失误提供的摘要中没有讨论具体的失误。问答亮点公司与政府机构合作,确保床边癌症检测测试的资金。愿意剥离或分拆兽医方面以提供资金人类脓毒症试验。公司专注于更大、更普遍的癌症检测技术。优化实体瘤检测测试以获得潜在的许可交易。VolitionRx 强调其通过许可和预付款里程碑付款来创收的承诺,并对其检测技术的潜力表示信心各种类型的癌症。该公司还透露了总计 200 万美元的成本削减措施,并对网络研讨会的积极反馈表示感谢。他们提到了未来几个月向投资者通报最新情况的计划,第一季度财报电话会议定于五月中旬举行。
InvestingPro Insights
VolitionRx Limited's recent earnings report showcased impressive revenue growth, but a closer look at the company's financial health through InvestingPro data and insights reveals a more nuanced picture. Here's what potential investors should consider:
InvestingPro InsightsVolitionRx Limited 最近的收益报告显示了令人印象深刻的收入增长,但通过 InvestingPro 数据和见解仔细观察该公司的财务状况会发现更微妙的情况。潜在投资者应考虑以下事项:
InvestingPro Data:
投资专业数据:
- Revenue for the last twelve months as of Q4 2023: $0.78M USD
- Revenue growth for the last twelve months as of Q4 2023: 153.04%
- Gross Profit Margin for the last twelve months as of Q4 2023: 100%
InvestingPro Tips:
截至 2023 年第四季度的过去十二个月的收入:78 万美元 截至 2023 年第四季度的过去十二个月的收入增长:153.04% 截至 2023 年第四季度的过去十二个月的毛利率:100%InvestingPro 提示:
- Analysts forecast continued sales growth for VolitionRx in the current year, aligning with the company's positive outlook for its Nu.Q Vet cancer test and other diagnostic solutions.
- However, VolitionRx is quickly depleting its cash reserves, and its short-term obligations currently outweigh its liquid assets, which could pose financial risks if not managed properly.
For investors considering VolitionRx, these metrics and insights provide a deeper understanding of the company's performance and potential challenges. It's worth noting that, based on the InvestingPro platform, there are 9 additional InvestingPro Tips available for VolitionRx, which could further inform investment decisions. Users interested in gaining access to these tips and more detailed analytics can take advantage of an exclusive offer by using the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
分析师预测 VolitionRx 今年的销售额将持续增长,这与该公司对其 Nu.Q Vet 癌症测试和其他诊断解决方案的积极前景一致。然而,VolitionRx 正在迅速耗尽其现金储备,其短期债务目前超过了其现金储备流动资产,如果管理不当可能会带来财务风险。对于考虑 VolitionRx 的投资者来说,这些指标和见解可以让他们更深入地了解公司的业绩和潜在挑战。值得注意的是,基于 InvestingPro 平台,VolitionRx 还提供了 9 个额外的 InvestingPro Tips,可以进一步为投资决策提供信息。有兴趣了解这些技巧和更详细分析的用户可以使用优惠券代码 PRONEWS24 享受独家优惠,获得每年或每两年一次的 Pro 和 Pro+ 订阅额外 10% 的折扣。
Full transcript - Volitionrx Ltd (VNRX) Q4 2023:
Operator: Good morning, ladies and gentlemen, and thank you for standing by. Welcome to VolitionRx Limited Fourth Quarter and Full Year 2023 Earnings Conference Call. During today's presentation, all parties will be in a listen-only mode. Following the presentation, the conference call will be open for questions. [Operator Instructions]. This conference call is being recorded today, March 26, 2024. I would now like to turn the conference over to Louise Batchelor, Group Chief Marketing and Communications Officer. Please go ahead.
完整文字记录 - Volitionrx Ltd (VNRX) 2023 年第 4 季度:操作员:早上好,女士们、先生们,感谢你们的支持。欢迎参加 VolitionRx Limited 2023 年第四季度和全年收益电话会议。在今天的演示过程中,各方都将处于仅听模式。演讲结束后,电话会议将开放供提问。 [操作员说明]。本次电话会议于今天(2024 年 3 月 26 日)进行录制。我现在将会议交给集团首席营销和传播官 Louise Batchelor。请继续。
Louise Batchelor: Thank you, and welcome, everyone to today's earnings conference call for VolitionRx Limited. Before we begin, I'd like to remind everyone that some of the information discussed on this conference call will include forward-looking statements covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on our beliefs as well as assumptions we have used based upon information currently available to us. Because these statements reflect our current views concerning future events, these statements involve risks, uncertainties and assumptions. Actual future results may vary significantly based on a number of factors that may cause the actual results or events to be materially different from future results, performance or achievements expressed or implied by these statements. We have identified various risk factors associated with our operations in our most recent annual report on Form 10-K, quarterly reports on Form 10-Q and other filings with the Securities and Exchange Commission. We do not undertake an obligation to update any forward-looking statements made during the course of this call. I am joined today by Mr. Cameron Reynolds, President and Group Chief Executive Officer, Mr. Terig Hughes, Group Chief Financial Officer Doctor, Dr. Tom Butera, Chief Executive Officer of our Volition Veterinary Subsidiary and Dr. Andrew Retter, currently Medical Consultant to Volition, which has recently announced due to join Volition n the role of Chief Medical Officer in April 2024. During the call, we will cover Volition's financial and operating results for the fourth quarter and full fiscal year of 2023, along with a discussion of our recent activities and upcoming milestones. Following our prepared remarks, we will open the conference call to a question-and-answer session. I'll now turn the call over to Cameron Reynolds. Cameron?
Louise Batchelor:谢谢并欢迎大家参加今天的 VolitionRx Limited 收益电话会议。在我们开始之前,我想提醒大家,本次电话会议讨论的一些信息将包括 1995 年《私人证券诉讼改革法案》安全港条款所涵盖的前瞻性陈述。这些陈述基于我们的信念以及我们根据当前可获得的信息使用的假设。由于这些陈述反映了我们目前对未来事件的看法,因此这些陈述涉及风险、不确定性和假设。未来的实际结果可能会因多种因素而显着不同,这些因素可能导致实际结果或事件与这些陈述中明示或暗示的未来结果、业绩或成就存在重大差异。我们在最近的 10-K 表年度报告、10-Q 表季度报告以及向美国证券交易委员会提交的其他文件中确定了与我们运营相关的各种风险因素。我们不承担更新本次电话会议期间所做的任何前瞻性陈述的义务。今天与我一起出席的还有总裁兼集团首席执行官 Cameron Reynolds 先生、集团首席财务官 Terig Hughes 先生、医生、Volition 兽医子公司首席执行官 Tom Butera 博士以及现任医疗顾问 Andrew Retter 博士Volition 最近宣布将于 2024 年 4 月加入 Volition,担任首席医疗官。在电话会议中,我们将介绍 Volition 的第四季度和 2023 年整个财年的财务和运营业绩,并讨论我们最近的活动和即将到来的里程碑。在我们准备好的发言之后,我们将在电话会议上进行问答环节。我现在将把电话转给卡梅伦·雷诺兹。卡梅伦?
Cameron Reynolds: Thanks Lou, and thank you, everyone, for joining Volition's fourth quarter and full year 2023 earnings call today. We appreciate your time given the busy annual 10-K filing season. We will commence the call with a financial report from our Group Chief Financial Officer, Terig Hughes, before moving on to a prerecorded update from Dr. Tom Butera, Chief Executive Officer of Volition Vet on the rollout of our Nu.Q vet cancer test. And I'm delighted to welcome Dr. Andy Retter to the call to provide an update on the Nu.Q NET and Capture-PCR. As was announced last week, Andy will be joining Volition as our Chief Medical Officer beginning April 1st. Many of you will have heard from Andy previously, but I'd like to formally share his credentials. Dr. Butera is an intensive care consultant at Guy's and St Thomas' NHS Foundation Trust in London, where he has worked as a consultant since 2014 and leads clinical governance in critical care. He specializes in the management of severe respiratory failure, ECMO and thrombosis. Dr. Butera is the only consultant in the UK to hold dual entry on the specialist register in Intensive Care and Hematology and provides national guidance on the management of complex hematology patients in clinical care. He will continue his clinical and research duties at Guy's and St Thomas' NHS Foundation Trust after joining Volition. Dr. Butera has worked with Volition in an advisory capacity since January of 2022. To help guide the product development and clinical utility of Nu.Q NET's, a CE-Marked routine blood test to detect disease associated with NETosis, such as sepsis. The whole team are absolutely delighted to be welcoming Andy more formally into Volition. As Chief Medical Officer, he will be vital to our success, ensuring the needs of the patient are placed at the heart of our research, development and commercialization activities. It's great to have you on board, Andy. And I must say your enthusiasm for our mission and platform really helps us to fully understand the great importance of the work we do. Following Andy's update, I will wrap up with my thoughts and upcoming milestones and discuss our overall strategy going forward. Without further ado, I'll hand you across to Terry for our financial report. Terry?
Cameron Reynolds:感谢 Lou,也感谢大家今天参加 Volition 的第四季度和 2023 年全年财报电话会议。鉴于每年繁忙的 10-K 申请季节,我们感谢您抽出宝贵的时间。我们将首先由集团首席财务官 Terig Hughes 提交财务报告,然后由 Volition Vet 首席执行官 Tom Butera 博士预先录制关于推出 Nu.Q 兽医癌症测试的最新情况。我很高兴欢迎 Andy Retter 博士参加电话会议,提供有关 Nu.Q NET 和 Capture-PCR 的最新信息。正如上周宣布的那样,Andy 将从 4 月 1 日开始加入 Volition,担任我们的首席医疗官。你们中的许多人以前都听说过安迪,但我想正式分享他的资历。 Butera 博士是伦敦盖伊和圣托马斯 NHS 基金会信托基金的重症监护顾问,自 2014 年以来一直担任顾问,领导重症监护的临床治理。他专门从事严重呼吸衰竭、ECMO 和血栓形成的治疗。 Butera 博士是英国唯一一位在重症监护和血液学专家名册上持有双重资格的顾问,并为临床护理中复杂血液病患者的管理提供国家指导。加入 Volition 后,他将继续在盖伊和圣托马斯 NHS 基金会信托基金担任临床和研究职务。 Butera 博士自 2022 年 1 月以来一直以顾问身份与 Volition 合作。帮助指导 Nu.Q NET 的产品开发和临床应用,Nu.Q NET 是一种具有 CE 标志的常规血液检测,用于检测与 NETosis 相关的疾病,例如败血症。整个团队非常高兴地欢迎 Andy 更正式地加入 Volition。作为首席医疗官,他对我们的成功至关重要,确保患者的需求成为我们研究、开发和商业化活动的核心。很高兴你能加入,安迪。我必须说,你们对我们的使命和平台的热情确实帮助我们充分理解了我们所做工作的重要性。在安迪更新后,我将总结我的想法和即将到来的里程碑,并讨论我们未来的总体战略。言归正传,我将把我们的财务报告交给特里。特里?
Terig Hughes: Thanks very much, Cameron, and thank you everyone for joining our earnings call today. I'll now provide a summary of the key financial results for the quarter ended December 31 full year 2023. From a revenue perspective, we recorded revenue of $244,000 for the quarter, a 104% increase over the same period last year. For the full year 2023, we recorded revenue of $775,000 an increase of 153% over the prior year. We believe that these results demonstrate steady progress, but not yet the ramp in revenues that we anticipate. We expect revenues to accelerate in 2024 as several additional distributors come online with our Nu.Q vet cancer test, in particular, Antech and FujiVet who are both about to launch and our Nu.Q discover pipeline continues to grow. 2023 full-year revenue of the Nu.Q Vet cancer test was $475,000 a year-on-year increase of 194%, mainly reflecting sales of reference kits through our agreement with IDEXX. Revenues in Nu.Q discover for 2023 was $300,000, which reflects 107% growth over 2022. Moving on to the balance sheet. We ended the year with cash and cash equivalents of approximately $20.7 million compared with $10.9 million at the end of 2022. Net cash generated from operating activities during the fourth quarter 2023 was approximately $6.4 million and reflected the receipt of $13 million in milestone payments from Heska Corporation in December. For the full year 2023, net cash used in operating activities was $18.1 million, compared to $15.3 million in the prior year. Net loss for fourth quarter 2023 was $8.8 million, compared to $7.3 million for the fourth quarter 2022 and for the full year, $35.7 million, compared to $30.6 million in 2022. This increase was primarily the result of increased Research & Development expenditures mainly reflecting the cost of our U.S. clinical trials which added $3.1 million to the P&L costs in 2023. To date, various European funding bodies and in particular, Belgian agencies have committed to the company over $21 million in non-dilutive funding in various forms, including cash grants and loans on favorable terms. In the fourth quarter, our Walloon institutional fund and regional government bodies of the Walloon region of Belgium committed additional funding to the company aggregating approximately $5.5 million of which approximately one half was in the form of a loan. We would like to publicly thank the various government agencies of Belgium for their continued support. We have also initiated efforts with respect to seeking non-dilutive funding in the U.S. Our aim is to fund some of our major programs through either non-dilutive or project financing, which we anticipate could be substantial over the next two years. As mentioned earlier, at the end of fourth quarter, we received $13 million in milestone payments from Heska Corporation, now an Antech company and part of Mars Petcare, one of the largest pet health companies in the world. And so, to recap, we ended the year with cash and cash equivalents of $20.7 million. With that said, I believe that we are well-placed to execute the plans the team have in place for 2024. And with that, I will pass over to Dr. Tom Butera, CEO of our Volition Veterinary subsidiary. Tom?
特里格·休斯:非常感谢卡梅伦,也感谢大家今天参加我们的财报电话会议。现在,我将提供截至 2023 年 12 月 31 日的季度的主要财务业绩摘要。从收入角度来看,我们该季度的收入为 244,000 美元,比去年同期增长 104%。 2023 年全年,我们的收入为 775,000 美元,比上一年增长 153%。我们相信这些结果表明了稳步进展,但收入尚未达到我们预期的增长。我们预计,随着更多分销商上线我们的 Nu.Q 兽医癌症测试,特别是即将推出的 Antech 和 FujiVet,并且我们的 Nu.Q 发现管道继续增长,我们预计 2024 年收入将加速增长。 Nu.Q Vet癌症检测2023年全年收入为475,000美元,同比增长194%,主要反映通过我们与IDEXX的协议销售参考试剂盒。 Nu.Q discovery 2023 年的收入为 300,000 美元,比 2022 年增长 107%。转向资产负债表。截至年底,我们的现金和现金等价物约为 2070 万美元,而 2022 年底为 1090 万美元。2023 年第四季度经营活动产生的现金净额约为 640 万美元,反映了从 Heska 收到的 1300 万美元的里程碑付款12月成立公司。 2023 年全年,经营活动使用的现金净额为 1,810 万美元,而上一年为 1,530 万美元。 2023 年第四季度的净亏损为 880 万美元,而 2022 年第四季度为 730 万美元;全年净亏损为 3,570 万美元,而 2022 年为 3,060 万美元。这一增长主要是由于研发支出增加,主要反映了我们的美国临床试验成本使 2023 年的损益成本增加了 310 万美元。迄今为止,各个欧洲资助机构,特别是比利时机构已承诺以各种形式向该公司提供超过 2100 万美元的非稀释性资金,包括现金补助以及优惠条件的贷款。第四季度,我们的瓦隆机构基金和比利时瓦隆地区政府机构承诺向该公司提供总计约 550 万美元的额外资金,其中约一半以贷款形式提供。我们要公开感谢比利时各政府机构的持续支持。我们还开始努力在美国寻求非稀释性资金。我们的目标是通过非稀释性融资或项目融资为我们的一些重大项目提供资金,我们预计这在未来两年内可能会很大。如前所述,第四季度末,我们从 Heska Corporation 收到了 1300 万美元的里程碑付款,Heska Corporation 现在是 Antech 公司,是世界上最大的宠物保健公司之一玛氏宠物护理公司的一部分。因此,回顾一下,我们年底的现金和现金等价物为 2070 万美元。话虽如此,我相信我们有能力执行团队为 2024 年制定的计划。接下来,我将把任务交给我们 Volition Veterinary 子公司的首席执行官 Tom Butera 博士。汤姆?
Tom Butera: Thanks very much, Terig, and good morning everybody. In 2023, we supplied kits and components for over 58,000 tests, 5 times the number in the prior year. This growth demonstrates solid progress to date and we certainly expect more growth to come as additional companies fully launch our product at home in the United States and around the world. By the end of 2023, the Nu.Q Vet cancer test was available in the United States, the United Kingdom, and Ireland, Portugal, Singapore, Taiwan and Italy. 2023 was a breakthrough year for Volition Veterinary gaining such wide distribution and with such respected companies, so kudos to the team and a special thanks to our legal department. We have also learned a great deal, launching and introducing a new product in veterinary medicine, especially early cancer detection in dogs takes a tremendous amount of education to teach veterinarians how to incorporate this early cancer dialogue into their routine wellness visits. Our Nu.Q test also requires an additional cost to the client, which is part of our educational conversation in teaching doctors how to easily make this part of their wellness office visit Additionally, we are always emphasizing the affordable cost of our test and encouraging doctors to keep the test at very reasonable margins. The fact is clearly related to the very large number of dogs that they will be screened for early cancer detection. All-in-all, I believe our Volition team will look back on 2023 as a proud pivotal moment in the burgeoning field of early canine cancer detection, setting the stage to improve and extend the lives of millions of dogs in the months years to come. We have also launched the Nu.Q test with IDEXX, one of the world's leading veterinary diagnostic companies and now Heska, an Antech company and part of Mars Petcare, another leading veterinary company in completing the exciting tech transfer onto the Heska Element I+ in-house diagnostic platform. More recently, as you will have seen in an announcement just last week, we have signed a supply agreement with Fujifilm Vet Systems for our Nu.Q Vet Cancer Test in Japan. Indeed, I have prerecorded my update for today's call as I am currently over in Japan with our colleagues from Fuji and Wow! What an incredible event this last week. We were delighted to be deeply engaged with our Fuji colleagues at their veterinary booth located at the World Veterinary Cancer Congress in Tokyo. This event also provided a significant exposure to numerous veterinary cancer specialists from around the world. We believe that Japan is a considerable market opportunity for Volition as we seek to expand our Nu.Q Vet Cancer Test offering in Asia and Fuji is a great partner with us. Fujifilm Vet Systems as Japan's leading veterinary diagnostic laboratory service with a network of 10 laboratories serving more than 90% of the 12,000 veterinary clinics and hospitals nationwide in Japan. As a reminder, our test is a simple, affordable, easy to use blood-screening test that can be easily integrated into preventive care programs and used alongside other routine blood work during regular wellness visits. We had an incredibly busy time at the Fuji booth and have been excited not only to see the response to the test, but also to hear about the exciting marketing plans Fuji has in place to drive the adoption of Nu.Q. Heather also had the privilege of presenting a poster about the Nu.Q Vet Cancer Test at the Congress. It's been a busy few days and we look forward to working alongside Fujifilm Vet Systems as they roll out our test countrywide across their extensive diagnostic laboratory network. We are also incredibly excited that the Nu.Q Vet cancer test will soon be available as an in-house diagnostic via Heska and Antech company. We understand preorders are currently being processed and the test will be rolled out fully at their upcoming national sales meeting at the end of this month. Soon veterinarians will have accurate in hospital fast test results in under eight minutes, so that they can discuss findings with pet owners and hopefully develop an action plan before the patient even goes home. Antech is initially pricing the test at $35 to the veterinarian and we really believe that the relatively low cost combined with the effectiveness of our test will help drive adoption of the test not only as a screening test, but also in time as an important monitoring tool for disease progression and remission. So, to quote Cameron, very exciting times indeed. That's a quick update for me given our packed agenda today. I will now with absolute great pleasure hand over to our incoming Chief Medical Officer, Dr. Andrew Retter. Andy is a fabulous addition to our leadership team. Andy, over to you for an update on Nu.Q NET.
Tom Butera:非常感谢,Terig,大家早上好。 2023 年,我们为超过 58,000 次测试提供了套件和组件,是上一年的 5 倍。这一增长表明迄今为止取得了坚实的进展,随着更多公司在美国和世界各地全面推出我们的产品,我们当然预计会出现更多增长。到 2023 年底,Nu.Q Vet 癌症检测已在美国、英国、爱尔兰、葡萄牙、新加坡、台湾和意大利推出。 2023 年对于 Volition Veterinary 来说是突破性的一年,获得了如此广泛的分销和如此受人尊敬的公司,因此我们的团队值得赞扬,并特别感谢我们的法律部门。我们还学到了很多东西,推出和推出兽医医学新产品,特别是狗的早期癌症检测,需要大量的教育来教导兽医如何将这种早期癌症对话纳入他们的日常健康访问中。我们的 Nu.Q 测试还需要客户支付额外费用,这是我们教育对话的一部分,教导医生如何轻松地将这一部分纳入他们的健康办公室访问此外,我们始终强调我们的测试成本可承受,并鼓励医生将测试保持在非常合理的范围内。这一事实显然与大量狗将接受早期癌症检测筛查有关。总而言之,我相信我们的 Volition 团队将回顾 2023 年,将其视为犬类早期癌症检测这一新兴领域的一个令人自豪的关键时刻,为在未来几个月改善和延长数百万只狗的生命奠定了基础。我们还与 IDEXX(世界领先的兽医诊断公司之一)以及现在的 Heska(Antech 公司和另一家领先的兽医公司 Mars Petcare 的一部分)一起启动了 Nu.Q 测试,完成了令人兴奋的技术转移到 Heska Element I+ in-房屋诊断平台。最近,正如您在上周的公告中看到的那样,我们与 Fujifilm Vet Systems 签署了一份供应协议,为我们在日本的 Nu.Q Vet 癌症测试提供服务。事实上,我已经预先录制了今天电话会议的最新情况,因为我目前正在日本与 Fuji 和 Wow! 的同事一起。上周发生了多么令人难以置信的事件啊。我们很高兴能在东京世界兽医癌症大会的兽医展位上与富士同事进行深入交流。此次活动还为来自世界各地的众多兽医癌症专家提供了重要的接触机会。我们相信,日本对于 Volition 来说是一个巨大的市场机会,因为我们寻求在亚洲扩展我们的 Nu.Q 兽医癌症检测产品,而富士是我们的绝佳合作伙伴。 Fujifilm Vet Systems 是日本领先的兽医诊断实验室服务公司,拥有 10 个实验室网络,为日本全国 12,000 家兽医诊所和医院中的 90% 以上提供服务。提醒一下,我们的测试是一种简单、经济实惠、易于使用的血液筛查测试,可以轻松整合到预防保健计划中,并在定期健康就诊期间与其他常规血液检查一起使用。我们在富士展台度过了一段非常忙碌的时光,不仅很高兴看到测试的反应,而且还听到富士为推动 Nu.Q 的采用而制定的令人兴奋的营销计划。 Heather 还荣幸地在大会上展示了有关 Nu.Q 兽医癌症测试的海报。这几天很忙碌,我们期待与 Fujifilm Vet Systems 合作,通过其广泛的诊断实验室网络在全国范围内推出我们的测试。我们还非常兴奋的是,Nu.Q Vet 癌症测试很快将通过 Heska 和 Antech 公司作为内部诊断提供。据我们了解,预订单目前正在处理中,测试将在本月底即将举行的全国销售会议上全面展开。很快,兽医将在八分钟内获得准确的医院快速测试结果,以便他们可以与宠物主人讨论结果,并有望在患者回家之前制定行动计划。 Antech 最初给兽医的测试定价为 35 美元,我们坚信相对较低的成本加上我们测试的有效性将有助于推动该测试的采用,不仅作为筛查测试,而且及时作为重要的监测工具用于疾病进展和缓解。所以,用卡梅伦的话来说,这确实是非常激动人心的时刻。鉴于我们今天的议程排得满满的,这对我来说是一个快速的更新。现在,我非常高兴地将工作移交给我们即将上任的首席医疗官安德鲁·雷特 (Andrew Retter) 博士。安迪是我们领导团队的出色补充。 Andy,请您了解 Nu.Q NET 的最新情况。
Andrew Retter: Thank you very much for those kind words, Tom, and good morning, everybody. I'd just like to take a moment to start by thanking Cameron, Jake and the Board of Directors for working with me and inviting me to join the Volition team at such an important time. I've really enjoyed working with Volition for the last two years, and I'm really excited about leaning into and contributing to delivery of our mission purpose in the years to come. We really hope to have an impact to improve the lives and quality of lives of millions of people worldwide. I'd like to update you this morning on some of the significant progress we've made with Nu.Q NET and our new breakthrough cancer detection method, which we now call Capture-PCR. So first, starting with NETosis and sepsis. Sepsis, as you've heard me say before, is one of the leading of causes of death worldwide with almost 50 million cases annually and around 11 million deaths. Physicians made significant progress trying to address these issues in 2023, and I'd just like to recap a few highlights. In September, Volition hosted a key opinion leader roundtable event in Athens, Greece. The workshop held over the course of two days focused exclusively on sepsis and the potential role of Nu.Q NET is attended by some of the world's leading experts. Many of the attendees are operating under the umbrella of our Center of Excellence program with Nu.Q NET and have firsthand experience using assay now. The sense from the group was that Nu.Q NET potentially represents one of the biggest breakthroughs in the diagnosis and monitoring of sepsis in the last 30 years. We're moving forward with this group and I'm now working on a review article with the intention to submit it for peer review and publication in a journal towards the end of the year. Continuing in the theme of publication, shortly after our Canadian opinion leader event and subsequent to quarter end in October, the first clinical paper from our clinical excellence group was published. Professor Gila Monterrey's team in Leon published data demonstrating the correlation of the Nu.Q NET level and sepsis. There is a clear mortality signal. What does that mean? The higher patients Nu.Q NET level unfortunately the more likely they are to die. We've also seen in a longitudinal fashion that Nu.Q NET level tracks very well with the severity of the patient's illness. We've been using something called the sepsis score, the sequential organ failure assessment score to calibrate and check Nu.Q NET levels. It's brilliant that we've got the first paper out and I'm really looking forward to publishing and sharing with you more data from our centers of excellence as we go through 2024 and 2025. Over in the U.S., I'm pleased to report that Volition completed the Q sub process with the U.S. Food and Drug Administration. The FDA has confirmed that we can continue to follow a traditional 5, 10-K pathway. I'm also delighted to confirm that my own hospital guidance and Thomas has started using Nu.Q NET in our first study. In a similar theme, we're trying to identify and track patients and monitor the severity of sepsis. This is a large study, we're aiming to enroll around 500 patients and compare patients with sepsis to healthy patients undergoing cardiac surgery. This should give us really good data to try and split the patients apart and understand differences between them. For those that might have missed the recent Edison webinar on sepsis or indeed their thematic report, I wanted to highlight a couple of ongoing studies, which we hope will continue to reinforce and strengthen our clinical utility case. We have ongoing analysis of two large retrospective sepsis cohorts in Europe. The first is with the German sepsis group and the second is with the team at UMC Amsterdam. In total, these studies will examine the outcome and trajectory of over 2,500 patients with sepsis. They involve the processing of over 8,000 Nu.Q NET samples. It's an unbelievably rich data source for us. And we're really excited about this data. But we're really excited about presenting it and submitting it for publication by the end of 2024. These studies will be a rich source of insight using Nu.Q NET on a really large scale and should enable us to sharpen and improve it as we move forward to again bringing into the clinical arena. Our project with key opinion leader, Professor De Carli Annan [ph] in France is progressing really well. De Carl is involved in the consortium project with an ongoing prospective study of which Volition is a member. Again, it's longitude in nature and large scale and is aiming to recruit 1,500 patients. We've also extended our study with [indiscernible] in the U.S. We have refocused this study to concentrate on the sickest patients admitted from the emergency room rather than simply including intensive care patients. This is expanding the population of patients in which we're using Nu.Q and that's really exciting. We hope to close out the study by the end of second quarter and we'll share the results as soon as we can. We're confident that we will have significantly strengthened our data within the confidential data room for ongoing commercial discussions by the middle of the year. From a publication perspective, all eyes and our focus will be on the European Society of Intensive Care meeting in October later this year. We anticipate a number of the studies I've just mentioned will report at ESICM. We're also really proud to be sponsoring our first satellite symposium session at the Congress. More details will follow, but it's going to be a really busy year ahead for Nu.Q NET and sepsis. I'd now like to take just a few more minutes to discuss Volition's potentially breakthrough cancer detection method, which we first presented at the European Society of Medical Oncology Congress Press in 2023. Cancer, as we all know, affects the lives of millions around the world each year. Unfortunately, the number of new cases of cancer diagnosed each year is continuing to grow. Like many diseases, early diagnosis when the cancer is smaller and hasn't spread leads to a better outcome for patients that's less surgery, less chemotherapy and just needs better and improved outcomes. Sadly, cancer is often a silent disease, it's asymptomatic and people don't realize they have it until really quite late. In the UK, we're a perfect example about that, where around 45% in cancers are diagnosed at the later stages Stage 3 and Stage 4. Our test focuses around detecting circulating tumor DNA, ctDNA. Detecting ctDNA is really difficult because the levels of DNA in blood are relatively low and circulating tumor DNA compromises only about 0.01% of the circulating cell-free DNA. While the challenge is compounded as most of the detect cancer DNA looks almost identical or is indeed exactly the same as normal DNA. Volition has developed a novel method of liquid biopsy involving the first reported physical isolation of tumor-derived DNA fragments from blood. The cancer-derived circulating tumor DNA fragments are then extracted after removal of all normal background DNA and then they are sequenced using a low-cost PCR test. We're calling this technique Capture-PCR. Volition's proof-of-concept data was presented at ESMA 2023, demonstrating the isolation of tumor-derived ctDNA fragments from plasma. Volition tested the new method in a small clinical experiment and detected a range of liquid and solid organ cancers, including early stage disease, Stage 1 disease. These early assays were developed from our initial leukemia model, but to our surprise, we were also able to detect many other cancers. In particular, we were able to detect colorectal cancer. We're really excited about the potential for Capture-PCR going forward. My colleague, Dr. Jake Micalle and team have presented a number of cancer specific conferences such as prostate cancer and liver cancer conferences. They have been sharing their data with important key opinion leaders and we've received really valuable feedback and positive feedback as we go forward. The team have also continued to identify other potential markers and other potential targets associated with the PCR test and we very much look forward to sharing this data in particular in solid organ cancers throughout this year and beyond. Last but certainly no means least, Jake is working hard on completing the manuscript to submit this breakthrough method for peer review publication. This is going to be incredibly important paper and is intrinsically aligned with Felicia's core ethos and purpose of bringing a low-cost diagnostic test to millions of people around the world. Understandably, there will be ongoing commercial discussions throughout the year. Enjoying to a close, and so I can hand back over to Cameron, I'd just like to take a moment and I hope it's come across from me talking here to express how personally excited I am to be joining the company. I really believe in Volition's ethos and purpose and I'll hand you back to Cameron for his closing remarks. Thank you ever so much.
Andrew Retter:非常感谢您的客气话,汤姆,大家早上好。首先,我想花一点时间感谢 Cameron、Jake 和董事会与我合作,并邀请我在如此重要的时刻加入 Volition 团队。过去两年我非常享受与 Volition 的合作,并且对于在未来几年致力于实现我们的使命目标并为其做出贡献感到非常兴奋。我们真诚地希望能够对改善全世界数百万人的生活和生活质量产生影响。今天早上我想向您介绍我们在 Nu.Q NET 和我们新的突破性癌症检测方法(现在称为 Capture-PCR)方面取得的一些重大进展。首先,从 NETosis 和脓毒症开始。正如您之前听我说过的,脓毒症是全球主要死亡原因之一,每年有近 5000 万例病例,约 1100 万人死亡。 2023 年,医生们在努力解决这些问题方面取得了重大进展,我只想回顾一下一些亮点。 9 月,Volition 在希腊雅典举办了关键意见领袖圆桌会议活动。研讨会为期两天,专门讨论脓毒症和 Nu.Q NET 的潜在作用,一些世界领先的专家参加了研讨会。许多与会者都在我们的 Nu.Q NET 卓越中心计划的保护下开展工作,并且现在拥有使用检测的第一手经验。该小组认为,Nu.Q NET 可能代表过去 30 年来脓毒症诊断和监测方面的最大突破之一。我们正在与这个小组一起推进,我现在正在撰写一篇评论文章,打算在年底提交该文章进行同行评审并在期刊上发表。继续发表主题,在我们的加拿大意见领袖活动后不久和十月份季度末,我们的临床卓越小组发表了第一篇临床论文。 Gila Monterrey 教授在莱昂的团队发表的数据证明了 Nu.Q NET 水平与败血症的相关性。有明显的死亡信号。这意味着什么?不幸的是,患者的 Nu.Q NET 水平越高,他们死亡的可能性就越大。我们还以纵向方式看到 Nu.Q NET 水平与患者疾病的严重程度密切相关。我们一直在使用脓毒症评分(即序贯器官衰竭评估评分)来校准和检查 Nu.Q NET 水平。很高兴我们已经发表了第一篇论文,我真的很期待在 2024 年和 2025 年期间发布和与您分享来自我们卓越中心的更多数据。在美国,我很高兴向您报告Volition 与美国食品和药物管理局完成了 Q 子流程。 FDA 已确认我们可以继续遵循传统的 5、10-K 途径。我也很高兴地确认我自己的医院指导和 Thomas 已开始在我们的第一项研究中使用 Nu.Q NET。在类似的主题中,我们正在尝试识别和跟踪患者并监测脓毒症的严重程度。这是一项大型研究,我们的目标是招募约 500 名患者,并将脓毒症患者与接受心脏手术的健康患者进行比较。这应该为我们提供非常好的数据来尝试将患者分开并了解他们之间的差异。对于那些可能错过了最近的爱迪生脓毒症网络研讨会或其主题报告的人,我想重点介绍几项正在进行的研究,我们希望这些研究将继续加强和加强我们的临床实用案例。我们正在对欧洲的两个大型回顾性脓毒症队列进行分析。第一个是与德国脓毒症小组合作,第二个是与 UMC 阿姆斯特丹团队合作。总的来说,这些研究将检查 2,500 多名脓毒症患者的结果和轨迹。它们涉及超过 8,000 个 Nu.Q NET 样本的处理。对于我们来说,这是一个令人难以置信的丰富数据源。我们对这些数据感到非常兴奋。但我们非常高兴能够在 2024 年底之前展示它并提交出版。这些研究将成为大规模使用 Nu.Q NET 的丰富见解来源,并且应该使我们能够在我们的研究过程中不断完善和改进它。再次迈向临床领域。我们与法国关键意见领袖 De Carli Annan 教授的项目进展非常顺利。 De Carl 参与了该联盟项目,正在进行一项前瞻性研究,Volition 是该项目的成员。同样,它的性质是经度和大规模的,目标是招募 1,500 名患者。我们还在美国扩展了我们的研究[音频不清晰]。我们重新调整了这项研究的重点,将重点放在从急诊室收治的病情最严重的患者,而不是简单地包括重症监护患者。这扩大了我们使用 Nu.Q 的患者群体,这确实令人兴奋。我们希望在第二季度末之前完成这项研究,我们将尽快分享结果。我们相信,到今年年中,我们将显着增强机密数据室内的数据,以便进行持续的商业讨论。从出版的角度来看,所有的目光和我们的焦点将集中在今年 10 月晚些时候举行的欧洲重症监护学会会议上。我们预计我刚才提到的一些研究将在 ESICM 上报告。我们也非常自豪能够在大会上赞助我们的第一届卫星研讨会。更多细节将随之而来,但对于 Nu.Q NET 和败血症来说,未来的一年将是非常忙碌的一年。我现在想再花几分钟讨论 Volition 潜在突破性的癌症检测方法,该方法是我们于 2023 年在欧洲肿瘤内科学会大会出版社首次提出的。众所周知,癌症影响着数百万人的生活每年的世界。不幸的是,每年诊断出的新癌症病例数量仍在持续增长。与许多疾病一样,当癌症较小且尚未扩散时进行早期诊断可以为患者带来更好的结果,减少手术、化疗,只需要更好和改善的结果。可悲的是,癌症通常是一种无声的疾病,它没有症状,人们直到很晚才意识到自己患有这种疾病。在英国,我们就是一个完美的例子,大约 45% 的癌症是在第三阶段和第四阶段的晚期阶段被诊断出来的。我们的测试重点是检测循环肿瘤 DNA,ctDNA。检测 ctDNA 确实很困难,因为血液中的 DNA 水平相对较低,循环肿瘤 DNA 只占循环游离 DNA 的约 0.01%。然而,由于大多数检测到的癌症 DNA 看起来与正常 DNA 几乎相同或实际上完全相同,因此挑战变得更加复杂。 Volition 开发了一种新的液体活检方法,首次报道了从血液中物理分离肿瘤来源的 DNA 片段。去除所有正常背景 DNA 后,提取源自癌症的循环肿瘤 DNA 片段,然后使用低成本 PCR 测试对其进行测序。我们将这种技术称为“Capture-PCR”。 Volition 的概念验证数据已在 ESMA 2023 上展示,证明了从血浆中分离肿瘤来源的 ctDNA 片段。 Volition 在一项小型临床实验中测试了这种新方法,并检测到了一系列液体和固体器官癌症,包括早期疾病、一期疾病。这些早期检测方法是根据我们最初的白血病模型开发的,但令我们惊讶的是,我们还能够检测到许多其他癌症。特别是,我们能够检测出结直肠癌。我们对 Capture-PCR 的未来潜力感到非常兴奋。我的同事 Jake Micalle 博士和团队在许多癌症特定会议上发表了演讲,例如前列腺癌和肝癌会议。他们一直在与重要的关键意见领袖分享他们的数据,在我们前进的过程中,我们收到了非常有价值的反馈和积极的反馈。该团队还继续确定与 PCR 测试相关的其他潜在标记物和其他潜在目标,我们非常期待在今年及以后分享这些数据,特别是实体器官癌症的数据。最后但同样重要的是,杰克正在努力完成手稿,以提交这一突破性方法以供同行评审出版。这将是一篇极其重要的论文,本质上符合 Felicia 的核心精神和为世界各地数百万人提供低成本诊断测试的目的。可以理解的是,全年都会有持续的商业讨论。愉快的结束了,所以我可以把时间交还给卡梅伦,我想花一点时间,希望我在这里讲话能表达我个人对加入公司的兴奋之情。我真的相信 Volition 的精神和宗旨,我会将您交还给卡梅伦,让您听他的结束语。真的非常感谢你。
Cameron Reynolds: Thanks very much, Andy, for providing those insights, and thanks as always to Terry and Tom for their reports. It is a real sign of the varied expertise we now have at Volition. 2023 was certainly transformational for Volition and a year we can look back on with pride. The commercialization of our transformational Nu.Q vet cancer test within the companion animal healthcare sector has led to agreements with several new global and regional partners, including last week with Fujifilm Vet Systems, Japan's leading veterinary diagnostic service provider and looking just around the corner, the Nu.Q vet cancer test will soon be available as an in-house diagnostic test through Heska and Antech company. We strongly suspect we will see very good revenue growth from Nu.Q vet through 2024 and beyond. I'm also absolutely delighted in the progress made in our Nu.Q NET's pillar, and in particular, in determining our regulatory pathway forward with the U.S. FDA, a key milestone for the company and in having a number of large-scale clinical studies due for publication later this year. Thirdly, and as we always seem to run low on time, I won't cover too much, but I would like to quickly mention Nu.Q Discover, which recorded revenue of $300,000 in 2023 and now has a pipeline of projects valued at over $1 million As a reminder, Nu.Q Discover is a complete solution to profiling nucleosomes, drug developers and scientists can work with us, access our state-of-the-art proprietary assays and realize their long term drug development needs. In this way, Nu.Q Discover is able to unlock value from Volition's IP portfolio by helping us commercialize the areas we are not going to focus on ourselves. As I mentioned, revenue in 2023 was $300,000 and we expect it to more than double in 2024 and be as profitable as early as 2025. And finally, I'm absolutely also delighted with our potential breakthrough CTCF cancer detection method, Capture-PCR, which we had a poster in the Q4 at ESMO. We believe this is a true breakthrough moment. The first reported physical isolation of a class of tumor derived cell free DNA fragments from blood. We expect that this method obviates expensive and time-consuming DNA sequencing and bioinformatics, allowing for a rapid cost-effective detection in a routine blood test. This method could become a must have technology. Given its significance, we are very much open to licensing this technology. We have been tremendously encouraged by the level of interest thus far. It has been and will continue to be a busy few months ahead of discussions and negotiations, not only now on Capture-PCR, but as we build out the data room for Nu.Q NET through the second quarter of this year, we anticipate more active discussions on that front as well. It is an exciting time for us as a Company and we look forward to sharing further updates and milestones with you over the coming quarters as we continue to adapt such changing times and conditions, deliver on what we believe to be revolutionary technologies. Given the current macroeconomic conditions, we are focusing on getting each pillar to support itself, either through product revenues, milestone payments, out licensing, or other non-dilutive funding in the coming year. We are making every attempt to ensure as little dilution as possible to reach breakeven as a company with a mix of non-dilutive funding, revenue and milestone payments from our licensing as we have achieved in Vet. As we've described before, we are currently targeting the following. Firstly, we expect Nu.Q vet to be overall cash positive from existing milestone payments and the expected revenue ramp as more partners launch and existing partners expand into new territories. We're also working on a range of new products to drive revenue growth and hopefully new out licensing and milestone payments in future years from Vet. Secondly, we expect Nu.Q Discover to more than double revenue in 2024 and to become profitable as a unit starting in 2025, with over $1 million in the current pipeline and growing strongly. Thirdly, we have begun the strategy to fund, as Terig alluded to earlier, our Nu.Q net pillar through non-dilutive and or project funding with an aim of $25 million. We have targeted a range of governmental agencies and are also preparing the background work aimed at attracting a large player to either out license or invest in this product directly. We have made strong progress through the first quarter of 2024 in getting the data required, and our aim is to get the first payments in the next 12 months from either corporate or governmental sources. Lastly, as discussed by Gael Forterre, our Chief Commercialization Officer in our recent webinar, there has been a lot of external interest in our CTCF and Nu.Q cancer technologies. Our strategy is to license this out to one or more large companies as a commercial undertaking of this size is likely beyond our current capabilities. If successful, we believe this strategy could provide us with ongoing royalties and very meaningful milestone payments in the next 12 months. In drawing to a close, I would like to thank you all for joining the call today. We very much appreciate it, given how much there is to digest across all of our pillars. We are now happy to answer questions. Operator?
卡梅伦·雷诺兹:非常感谢安迪提供这些见解,并一如既往地感谢特里和汤姆的报告。这是我们 Volition 目前拥有的各种专业知识的真实标志。 2023 年对于 Volition 来说无疑是变革性的一年,我们可以自豪地回顾这一年。我们的变革性 Nu.Q 兽医癌症测试在伴侣动物医疗保健领域的商业化已导致与多个新的全球和区域合作伙伴达成协议,包括上周与日本领先的兽医诊断服务提供商 Fujifilm Vet Systems 达成的协议,并且指日可待, Nu.Q 兽医癌症测试很快将通过 Heska 和 Antech 公司作为内部诊断测试提供。我们强烈怀疑,到 2024 年及以后,我们将看到 Nu.Q vet 的收入增长非常好。我也对我们的 Nu.Q NET 支柱取得的进展感到非常高兴,特别是在确定我们与美国 FDA 的监管路径方面,这是公司的一个关键里程碑,并且进行了许多大规模临床研究将于今年晚些时候出版。第三,由于我们的时间似乎总是不够,我不会介绍太多,但我想快速提一下 Nu.Q Discover,该公司在 2023 年的收入为 300,000 美元,现在拥有价值超过 300,000 美元的项目管道100 万美元 提醒一下,Nu.Q Discover 是分析核小体的完整解决方案,药物开发人员和科学家可以与我们合作,访问我们最先进的专有检测方法并实现他们的长期药物开发需求。通过这种方式,Nu.Q Discover 能够帮助我们将我们不关注的领域商业化,从而释放 Volition 知识产权组合的价值。正如我提到的,2023 年的收入为 30 万美元,我们预计 2024 年将增加一倍以上,并最早在 2025 年实现盈利。最后,我对我们潜在的突破性 CTCF 癌症检测方法 Capture-PCR 感到非常高兴,我们在 ESMO 第四季度有一张海报。我们相信这是一个真正的突破时刻。首次报道从血液中物理分离一类肿瘤来源的无细胞 DNA 片段。我们希望这种方法能够避免昂贵且耗时的 DNA 测序和生物信息学,从而能够在常规血液检测中进行快速且经济高效的检测。这种方法可能成为一项必备技术。鉴于其重要性,我们非常愿意许可这项技术。迄今为止,我们对人们的兴趣程度感到极大鼓舞。在讨论和谈判之前的几个月里,我们已经并将继续忙碌,不仅是在 Capture-PCR 方面,而且随着我们在今年第二季度为 Nu.Q NET 建立数据室,我们预计会有更多在这方面也进行了积极的讨论。对于我们公司来说,这是一个激动人心的时刻,我们期待在未来几个季度与您分享进一步的更新和里程碑,因为我们将继续适应不断变化的时代和条件,交付我们认为是革命性的技术。鉴于当前的宏观经济状况,我们的重点是让每个支柱在来年通过产品收入、里程碑付款、许可或其他非稀释性资金来支持自身。我们正在尽一切努力确保尽可能少的稀释,以实现盈亏平衡,作为一家公司,通过我们的许可获得非稀释性资金、收入和里程碑付款,就像我们在 Vet 中所实现的那样。正如我们之前所描述的,我们目前的目标如下。首先,随着更多合作伙伴的推出以及现有合作伙伴扩展到新领域,我们预计 Nu.Q vet 将从现有的里程碑付款和预期收入增长中获得整体现金收益。我们还致力于开发一系列新产品,以推动收入增长,并希望在未来几年从 Vet 获得新的许可和里程碑付款。其次,我们预计 Nu.Q Discover 的收入将在 2024 年增加一倍以上,并从 2025 年开始作为一个部门实现盈利,目前的收入超过 100 万美元,并且增长强劲。第三,正如 Terig 之前提到的,我们已经开始通过非稀释性和/或项目融资为我们的 Nu.Q 净支柱提供资金的战略,目标是 2500 万美元。我们已针对一系列政府机构,并正在准备旨在吸引大型参与者直接投资该产品的背景工作。截至 2024 年第一季度,我们在获取所需数据方面取得了巨大进展,我们的目标是在未来 12 个月内从企业或政府来源获得第一笔付款。最后,正如我们的首席商业化官 Gael Forterre 在最近的网络研讨会上所讨论的,外部对我们的 CTCF 和 Nu.Q 癌症技术非常感兴趣。我们的策略是将其授权给一家或多家大公司,因为这种规模的商业企业可能超出了我们目前的能力。如果成功,我们相信这一策略可以在未来 12 个月内为我们提供持续的特许权使用费和非常有意义的里程碑付款。最后,我要感谢大家参加今天的电话会议。考虑到我们所有的支柱都有很多东西需要消化,我们对此非常感激。我们现在很乐意回答问题。操作员?
Operator: [Operator Instructions]. Our first question is from Tim Moore with EF. Tim, please proceed.
操作员:[操作员指令]。我们的第一个问题来自 EF 的 Tim Moore。蒂姆,请继续。
Tim Moore: Thank you. That was very informative prepared remarks. It was nice to hear that there's a lot of different levers being pulled and good optionality. Maybe I just want to start out with IDEXX. You mentioned there were revenues, it sounds like the end of the year that could start to come through. I'm just kind of wondering if you can talk a little bit about, it seems like have they finally finished kind of getting their standard operating procedures and best practices in place for the marketing launch? And if you can remind me, is it something like $10 per kit you're getting on those because you're assembling the full kit and shipping them?
蒂姆·摩尔:谢谢。这是准备好的、内容丰富的发言。很高兴听到有很多不同的杠杆被拉动并且有很好的选择性。也许我只是想从 IDEXX 开始。你提到有收入,听起来今年年底可能会开始实现。我只是想知道您是否可以谈谈,他们似乎终于完成了为营销启动制定标准操作程序和最佳实践的工作?如果您能提醒我,您是否会因为组装完整的套件并运送它们而获得每个套件 10 美元的费用?
Cameron Reynolds: Yes, yes, it is. That's correct. So yes, IDEXX have been great partners for the last year and a half and I think that we're putting a lot of work into really try to get the sales growing. So, I think there's an absolutely huge need for the test worldwide. And certainly, to get to where we need to get to, there's had to be some education of the customers. It's a completely disruptive technology. So, when it comes into the market, it's obviously a whole new thing for the vets as well as for the company. And so, we've been working closely with them to really get sales moving. And I think as it was mentioned several times, there were 58,000 tests this last year sold, so we sold the components for. So, it's getting adoption and obviously it's a very disruptive test. And I think also when the new platform comes through, which is actually starting on the first of next month, having it available in the lab as well as a point of care, I think will be absolutely huge to getting adoption out there. I think the more groups out there selling it whether that's IDEXX or Heska or Fuji, it really helps to generate awareness and education and getting vets used to a disruptive new technology. As we discussed, there's been nothing available in the cancer space before. So yes, and $10 a test is correct.
卡梅伦·雷诺兹:是的,是的,确实如此。这是正确的。所以,是的,IDEXX 在过去的一年半里一直是很好的合作伙伴,我认为我们正在投入大量工作来真正尝试让销售额增长。所以,我认为全世界对测试的需求绝对巨大。当然,为了达到我们需要达到的目标,必须对客户进行一些教育。这是一项完全颠覆性的技术。因此,当它进入市场时,对于兽医和公司来说显然都是一个全新的事物。因此,我们一直与他们密切合作,以真正推动销售。我认为正如多次提到的那样,去年售出 58,000 次测试,因此我们出售了组件。因此,它正在被采用,显然这是一个非常具有颠覆性的测试。我还认为,当新平台推出时(实际上将于下个月一号开始),在实验室和护理点提供该平台,我认为对于推广应用来说绝对是巨大的。我认为越多的团体出售它,无论是 IDEXX、Heska 还是 Fuji,它确实有助于提高认识和教育,并让兽医习惯颠覆性的新技术。正如我们所讨论的,之前在癌症领域还没有任何可用的东西。所以是的,一次测试 10 美元是正确的。
Tim Moore: Thanks for that really good Japan Fujifilm Vet Systems update. That was terrific news. And actually, I had a question about feline tests. Do you think that's still maybe on track to launch maybe late this year? And when would you think you would receive the $5 million milestone payment timing?
蒂姆·摩尔:感谢日本 Fujifilm Vet Systems 的精彩更新。这是个好消息。事实上,我有一个关于猫科动物测试的问题。您认为该产品仍有可能在今年晚些时候推出吗?您认为您什么时候会收到 500 万美元的里程碑付款?
Cameron Reynolds: Good question. and the first point, Fuji have done a huge amount of work before the launch. They're very organized. They're the biggest vet company in Japan. There's 60,000 vets in Japan and 12,000 fed hospitals. I didn't realize it was that big a market. It's obviously a large country and quite a rich country. So, as you probably heard from Tom and the team, the enthusiasm from the vet conference there has been very large. So, it's extremely good to get enthusiasm coming through and have a good new market. Yes, so the feline five we've been doing some work on with a range of other products looking to launch in the vet space. We're looking to get it working in cat 5th year. So, it's certainly possible this year or in the first half of next year that that payment will be made. As we talked about, an overall part of our strategy is to get as much funding as we can from non-dilutive and milestones and that would be the last of the payments due to us from Heska, the 23 million we've got so far plus this 5 million. So yes, it's definitely still in process and it's a reasonable thing to still have on the books.
卡梅伦·雷诺兹:好问题。而第一点,富士在推出之前就做了大量的工作。他们很有组织性。他们是日本最大的兽医公司。日本有 60,000 名兽医和 12,000 家医院。我没想到市场这么大。这显然是一个大国,也是一个相当富裕的国家。因此,正如您可能从汤姆和团队那里听到的那样,兽医会议的热情非常高。因此,获得热情并拥有良好的新市场是非常好的。是的,所以我们一直在与一系列其他产品一起开发猫科五种产品,希望在兽医领域推出。我们希望在第五年让它发挥作用。因此,这笔款项肯定有可能在今年或明年上半年支付。正如我们所讨论的,我们战略的总体部分是从非稀释性和里程碑中获得尽可能多的资金,这将是 Heska 应付给我们的最后一笔付款,迄今为止我们已收到 2300 万美元再加上这500万。所以是的,它肯定仍在进行中,并且仍然保留在账本上是合理的事情。
Tim Moore: My last set of questions is tied to sepsis. I mean, such a huge catalyst, gigantic market, number one killer in the hospitals. So, you have talked before about the traditional, 5, 10-K regulatory pathway. And if you can remind me, you're trying to demonstrate substantially equivalent performance and characteristics of a device already at the FDA cleared in the U.S., right? Can you can you kind of walk us through that? And I know it's theoretical, but what is the time line? I get a lot of questions from investors about, when do you think, if it does work out and you get approved, when do you think you can maybe start achieving revenues on the sepsis side?
蒂姆·摩尔:我的最后一组问题与败血症有关。我的意思是,如此巨大的催化剂,巨大的市场,医院的头号杀手。所以,您之前谈到了传统的 5、10-K 监管途径。如果您能提醒我,您正试图证明已在美国 FDA 批准的设备具有基本相同的性能和特性,对吗?您能引导我们完成这个过程吗?我知道这是理论上的,但时间线是多少?我从投资者那里收到了很多问题,你认为,如果它确实有效并且获得批准,你认为你什么时候可以开始在脓毒症方面实现收入?
Cameron Reynolds: Very good question. So, there's obviously, it's a product which has shown tremendous promise as you said. And the two things we've proven so far, what publications have shown, that's closely correlated with intensive care mortality and sepsis score, which is obviously both of which is incredibly important. As we talked about, there's a range of studies we're doing now, which will put a mountain of data, an avalanche of data coming out in thousands and thousands of patients and tens of thousands of samples beginning this month and all the way through the rest of the year with a big crescendo kind of in June. They're looking to show correlation with the sepsis III score, which sepsis is now defined as a dysregulated immune response, which is exactly what we measure. So, it's actually obviously incredibly useful. Disease severity, correlation with 28-day mortality, the duration of organ support and the length of stay in hospital. So, all of those are incredibly important to the clinician, which I think is why Andy and all the other clinicians we've been working with are so keen on them. With regards to the exact 510(k) pass, probably best get it from Andy. He was the key person in those trials. I don't want to make a mistake on that. There are quite a few predictive products, none of which measure what we measure, but there are products which have the ability to do some of this. That's why we were very lucky to get the 510(k) pass and I'm sure he can outline. I think he might be available on some later calls to go through the predicates as they were discussed. But that is something we're incredibly excited about. And I think it's if it continues to go well and every bit of day we've seen so far has been outstanding. And because the test is low cost can be run on any platform, it could be a bedside test, it can be a lab test, it could be a lateral flow test and doing it through a 510(k), which is as you know is the easier path through the FDA is very important. Now as to timing, obviously we're doing everything we can to preserve cash. So, we're working with large governmental agencies to see if they can take a large part of the funding in the U.S. as well as Europe. We're also getting the data ready so that we can get industry partners involved. So that's coming to a head in June when we'll start to open up a data room to look to get as much funded as possible from outside sources. For obvious reasons, the market is what it is at the moment, so we're doing everything we can not to spend money. And after that, our product would be at least a couple of years. But don't forget, our model has always been to make as much money as we can from licensing and upfront milestone payments. In the last two years, we've got 23 million just from Heska alone, which is obviously very, very meaningful in what we do. So, I wouldn't just think of it as revenue which is obviously a few years away, but as we have invested getting large chunks of money in the meantime from large industry partners and/or government agencies and I think there's certainly our aim and I think it's a very reasonable chance that we'll get some licensing or milestone revenues from either or both transcription factors and the sepsis side in the next 12 months. And if you look at the level of payments we've got in the vet side, it's a very important test in the vet. But I think the Nu.Q NET test is a whole level of importance for humanity. So, we'd be expecting some very significant payments in that sort of timescale. Does that answer your question?
卡梅伦·雷诺兹:非常好的问题。所以,很明显,正如你所说,这是一种显示出巨大前景的产品。到目前为止,我们已经证明的两件事,即出版物所表明的,与重症监护死亡率和脓毒症评分密切相关,这显然两者都非常重要。正如我们所说,我们现在正在进行一系列研究,从本月开始一直到整个过程,我们都会收集大量数据,来自成千上万名患者和数以万计的样本。今年剩下的时间里,六月会出现一个大的渐强。他们希望显示与脓毒症 III 评分的相关性,脓毒症现在被定义为免疫反应失调,这正是我们所测量的。所以,它实际上显然非常有用。疾病严重程度、与 28 天死亡率、器官支持持续时间和住院时间的相关性。因此,所有这些对临床医生来说都非常重要,我认为这就是为什么安迪和我们合作过的所有其他临床医生都对它们如此热衷。关于确切的 510(k) 通行证,可能最好从 Andy 那里得到。他是那些试验的关键人物。我不想在这一点上犯错误。有相当多的预测产品,它们都不能衡量我们所衡量的内容,但有些产品有能力做到其中一些。这就是为什么我们非常幸运地获得了 510(k) 通行证,我相信他能概述一下。我认为他可能会在以后的一些电话中检查所讨论的谓词。但这是我们非常兴奋的事情。我认为,如果一切继续顺利,并且迄今为止我们所看到的每一天都非常出色的话。而且由于该测试成本低廉,可以在任何平台上运行,它可以是床边测试,可以是实验室测试,也可以是侧流测试并通过 510(k) 进行,正如您所知通过 FDA 的更简单途径非常重要。至于时机,显然我们正在尽一切努力保存现金。因此,我们正在与大型政府机构合作,看看他们是否可以在美国和欧洲获得大部分资金。我们还在准备数据,以便让行业合作伙伴参与进来。因此,到了六月份,这个问题就到了紧要关头,届时我们将开始开放一个数据室,以寻求从外部来源获得尽可能多的资金。出于显而易见的原因,市场就是目前的情况,所以我们正在尽一切努力不花钱。在那之后,我们的产品将至少存在几年。但不要忘记,我们的模式一直是从许可和预付款中赚取尽可能多的钱。在过去的两年里,我们仅从 Heska 就获得了 2300 万美元,这对于我们所做的事情显然非常非常有意义。因此,我不会仅仅将其视为显然需要几年时间的收入,但由于我们同时从大型行业合作伙伴和/或政府机构那里获得了大量资金,我认为这肯定是我们的目标和目标我认为这是一个非常合理的机会,我们将在未来 12 个月内从转录因子和败血症方面中的一个或两个获得一些许可或里程碑收入。如果你看看我们在兽医方面的支付水平,就会发现这是对兽医的一个非常重要的测试。但我认为 Nu.Q NET 测试对于人类来说具有整体重要性。因此,我们预计在这样的时间内会收到一些非常大的付款。这是否回答你的问题?
Tim Moore: It does, it does. It's terrific color and granularity. And I have one last little related topic question. You kind of already addressed this. There could be potential for project financing. You can come from the corporate rev, government, both milestones. One question I get from investors a lot was, as things go well on the vet side and maybe that becomes positive free cash flow and self-funding two years from now, hopefully. Would you consider divesting the vet side or spinning it out to maybe cash flow fund the human sepsis trials?
蒂姆·摩尔:确实如此,确实如此。它的颜色和颗粒度都很棒。我还有最后一个相关主题的小问题。你已经解决了这个问题。可能存在项目融资的潜力。你可以来自公司牧师、政府,这两个里程碑。我经常从投资者那里得到的一个问题是,随着兽医方面的进展顺利,也许两年后会变成正的自由现金流和自筹资金。您会考虑剥离兽医部门或将其分拆出来,为人类败血症试验提供现金流资金吗?
Cameron Reynolds: Yes, absolutely. So obviously, at the moment, it is actually not from revenue because you've seen what that is, but from the milestone payments and the other payments we're getting, it's actually cash flow positive at the moment from all those other payments. $23 million obviously has been a lot from those sides. Yes, we would absolutely look to corporatize and then have it run as a separate entity, because this is just the very first test on what should be a very long pathway of products we can launch in the vet space. We mentioned feline as well. Obviously, sepsis happens in dogs and every other animal as it does in humans. And also, the human transcription factor work, we have every reason to believe it would work in animals just as well as humans and then all the other animals. So, I think going forward, our business model has been very much to develop the technology and then prove it works, get a product launch like we have in vet, like we're about to in NETosis and then make revenue from licensing it out. But I think the final step on that path would be to make it to the vet itself. And I think that's something which could well happen in the next couple of years. And actually, there's obviously been some interest from other groups. We're the only cancer detection company out there at the moment which has a product in the market. So, I think it's going to be a very attractive one. But we want to get that value curve kind of pushed up the curve by pruning felines and/or sepsis and/or transcription factors in the next 12 months. So, it's probably a two-year target for that.
卡梅伦·雷诺兹:是的,绝对如此。显然,目前它实际上不是来自收入,因为你已经看到了收入是什么,但从里程碑付款和我们收到的其他付款来看,目前所有其他付款实际上都是正现金流。 2300 万美元对于双方而言显然是一笔巨款。是的,我们绝对会寻求公司化,然后将其作为一个独立的实体运行,因为这只是我们在兽医领域推出的产品的第一个测试,这应该是一个很长的产品路径。我们也提到了猫科动物。显然,败血症发生在狗和其他所有动物身上,就像发生在人类身上一样。而且,人类转录因子起作用,我们有充分的理由相信它对动物也起作用,就像人类一样,然后是所有其他动物。所以,我认为展望未来,我们的商业模式主要是开发技术,然后证明它的有效性,像我们在 vet 中那样推出产品,就像我们在 NETosis 中那样,然后通过授权获得收入。但我认为这条道路的最后一步是去看兽医。我认为这很可能在未来几年内发生。事实上,其他团体显然也对此感兴趣。我们是目前市场上唯一一家拥有产品的癌症检测公司。所以,我认为这将是一个非常有吸引力的。但我们希望通过在未来 12 个月内修剪猫科动物和/或脓毒症和/或转录因子来推高价值曲线。因此,这可能是一个两年目标。
Operator: Our next question is from Ilya Zubkov with Freedom Broker. Please proceed.
接线员:我们的下一个问题来自 Freedom Broker 的 Ilya Zubkov。请继续。
Ilya Zubkov: Good morning, and congrats for the progress in Q4. I have a question on the oncology test. Talking about Capture-PCR technology, what types of cancer are currently considered as the most promising for detection according to studies and your expectation?
Ilya Zubkov:早上好,祝贺第四季度取得的进展。我有一个关于肿瘤学测试的问题。谈到Capture-PCR技术,根据研究和您的期望,目前哪些类型的癌症被认为最有希望检测?
Cameron Reynolds: That’s a very good question. So, transcription factors are actually indicative of all types of cancer because, they are, it's an epigenetic signal, which is in all the cancers. So, we've done some work in a varied range of cancers, including lung and colorectal and the blood cancers. And initially, we'll focus on the larger cancers, the more prevalent ones particularly, of course, like we have in the past, in lung and colorectal and the blood cancers because that's where we did the first work. But it certainly holds the promise of -- it's definitely going to be low cost, very easy to run, as easy to run as a proven test in blood, but certainly potential for every single type of cancer. But you would probably not develop a test for every single type of cancer. You'd probably develop the top five types or seven types, which between them account for the majority of cancer cases.
卡梅伦·雷诺兹:这是一个非常好的问题。因此,转录因子实际上预示着所有类型的癌症,因为它们是一种表观遗传信号,存在于所有癌症中。因此,我们在多种癌症方面做了一些工作,包括肺癌、结直肠癌和血癌。最初,我们将重点关注较大的癌症、更常见的癌症,当然,就像我们过去所做的那样,在肺癌、结直肠癌和血癌中,因为这是我们开展第一项工作的领域。但它确实具有这样的前景——它肯定成本低廉,非常容易运行,就像经过验证的血液测试一样容易运行,而且肯定对每种类型的癌症都有潜力。但您可能不会为每种类型的癌症开发一种测试方法。您可能会发现前五种或七种类型,它们占癌症病例的大多数。
Ilya Zubkov: Thank you. That's helpful. And one more from me. The case test has demonstrated strong sensitivity in leukemia detection. And I'm wondering has any progress been made in its diagnostic performance for detection of solid tumors since October last year? And do you see the opportunity for improvement?
伊利亚·祖布科夫:谢谢。这很有帮助。还有我的另一封信。病例试验显示了白血病检测的高度敏感性。我想知道自去年10月以来,其实体瘤检测的诊断性能有什么进展吗?您是否看到了改进的机会?
Cameron Reynolds: Do you mean any in solid tumors with capture PCR?
Cameron Reynolds:您是指采用捕获 PCR 技术治疗实体瘤吗?
Ilya Zubkov: Yes.
伊利亚·祖布科夫:是的。
Cameron Reynolds: Yes. We've done a lot of work. The first thing we've been doing has been optimizing the process to make it as quick as easy as possible and on discovery on a wide range of different targets. So yes, we've been making progress. I think Andy alluded to a paper that's in process of being published and also to make the process as quickly -- the process we announced was a prototype. We've been developing as much as we can to make it quicker, easier and cheaper and also on a broad range of solid tumors as well as the liquid tumor. And yes, we're making very good progress, and we're aiming to publish in the next few or submit it soon in the next few months and also work heavily on out-licensing. We've discussed several times on public calls that we think is a complete breakthrough. And if we continue to show selection or concentration of tumor-derived DNA it's going to have to be a must-have for anyone in the liquid biopsy business. So, we've been very pleasantly surprised with the level of excitement and the interest from a range of driven groups. And those active discussions are going on as well. And we expect to have some news on that in the coming months and quarters as well because again, we want to license it out and get upfront payments as well as a share of the upside going forward. So, expect to keep an eye on all of that in the next few months and the next few quarters.
卡梅伦·雷诺兹:是的。我们已经做了很多工作。我们所做的第一件事就是优化流程,使其尽可能快速、简单,并在广泛的不同目标上进行发现。所以是的,我们一直在取得进展。我认为安迪提到了一篇正在发表的论文,也是为了尽快完成这个过程——我们宣布的过程是一个原型。我们一直在尽可能地进行开发,使其更快、更容易、更便宜,并且适用于广泛的实体瘤和液体肿瘤。是的,我们正在取得非常好的进展,我们的目标是在接下来的几年内发布或在接下来的几个月内很快提交,并且还在对外许可方面进行了大量工作。我们已经在公开电话中讨论过多次,我们认为这是一个彻底的突破。如果我们继续展示肿瘤来源 DNA 的选择或浓缩,它将成为液体活检行业任何人的必备品。因此,我们对一系列受驱动团体的兴奋程度和兴趣感到非常惊喜。这些积极的讨论也在进行中。我们预计在未来几个月和几个季度也会有一些相关消息,因为我们再次希望获得许可并获得预付款以及未来收益的份额。因此,预计在接下来的几个月和接下来的几个季度中密切关注所有这些。
Louise Batchelor: Yes. And Cameron, if I can just ask, this is Lou actually here, I can just add. we've also presented at a number of conferences this year cancer-specific conferences. So, we've been at a prostate cancer conference, liver cancer conference and then just this last weekend, a lung cancer conference with cancer-specific posters with the CTC, capture PCR technology. And we've then got breast and CRC to come in the second quarter. So there has been some additional data presented and then we've got some as come and says further down the line with the Generation two.
路易丝·巴彻勒:是的。卡梅伦,如果我可以问一下,这是卢,我可以补充一下。今年我们还在许多会议上介绍了癌症专题会议。所以,我们参加了前列腺癌会议、肝癌会议,然后就在上周末,我们参加了肺癌会议,其中有 CTC 的癌症特异性海报,捕获 PCR 技术。然后我们将在第二季度推出乳腺癌和结直肠癌。因此,我们提供了一些额外的数据,然后我们得到了一些数据,并进一步说明了第二代的情况。
Operator: Our next question is from Bruce Jackson with the Benchmark Company. Please proceed.
接线员:我们的下一个问题来自 Benchmark 公司的 Bruce Jackson。请继续。
Bruce Jackson: Hi, good morning, and thanks for taking my question. So, my first question is for Andrew. With the 500-patient study that you've just initiated is could that be ready in time for the conference in October?
布鲁斯·杰克逊:嗨,早上好,感谢您提出我的问题。所以,我的第一个问题是问安德鲁的。您刚刚启动的 500 名患者研究能否及时为 10 月份的会议做好准备?
Cameron Reynolds: I'm sorry, Andy, is actually don't answer a question but he's in clinic.
卡梅伦·雷诺兹:我很抱歉,安迪,实际上没有回答问题,但他在诊所。
Louise Batchelor: Just important into clinic. The full study won't have been finished Bruce by over this year, but we are hoping that we might potentially have some interim analyses available but we will have the results from several large-scale studies that will be presented at the October conference. So, the UMC in Amsterdam study and also the German Sepsis Group Study will be presented in October. But potentially, there might just be an interim analysis of hepatitis.
Louise Batchelor:对临床来说很重要。完整的研究布鲁斯今年还没有完成,但我们希望我们可能有一些可用的中期分析,但我们将获得几项大规模研究的结果,这些结果将在十月的会议上公布。因此,UMC 阿姆斯特丹研究以及德国败血症组研究将于 10 月推出。但有可能,可能只是对肝炎进行中期分析。
Cameron Reynolds: One is the perspective, Bruce, so the retrospective ones, UMC Amsterdam and the German study will be presented, we believe, but not the perspective that will be a bit slower, of course.
卡梅伦·雷诺兹:布鲁斯,一个是视角,所以我们相信,回顾性的、阿姆斯特丹大学医学中心和德国研究将被呈现,但当然不是会慢一点的视角。
Bruce Jackson: Okay. And then a question on the burn rate. Is it going to stay where it was last year, roughly? How is that going to develop over the course of this year and 2025.
布鲁斯·杰克逊:好的。然后是关于燃烧率的问题。大概会保持去年的水平吗?从今年到 2025 年,这种情况将如何发展?
Cameron Reynolds: Terig?
卡梅伦·雷诺兹:特里格?
Terig Hughes: Good question. Bruce. So, as we mentioned just now, we ended the year with cash of $20.7 million in the bank. And we used net cash in operating activities last year of $18.1 million. So that was partly offset -- or costs were partly offset by the $13 million that we received in licensing fees last year. And what we can expect is that our costs this year will be slightly lower than they were last year. And that's partly the result of the cost-saving actions that we took at the back end of last year saving a little over $2 million on a full year basis. And our focus this year is on achieving our next licensing deals in the human space, as Cameron mentioned. So, we've also initiated efforts with respect to seeking nondilutive funding in the U.S. And again, as Cameron mentioned, we're looking at getting each leg to support itself. What we're focusing on is bringing in those licensing deal so that we can achieve upfront payments and milestone payments. And we do expect to make good progress on those by the end of the year. I would expect that we've achieved one or more licensing deals by the end of the year. And so, I'm pretty confident with the resources that we've got available to us with some additional non-dilutive funding that we're working on at the moment that we'll be able to achieve those milestones that we've got planned for this year.
特里格·休斯:好问题。布鲁斯.因此,正如我们刚才提到的,年底我们在银行存有 2070 万美元的现金。去年我们在经营活动中使用的净现金为 1810 万美元。所以这被部分抵消了——或者说成本被我们去年收到的 1300 万美元的许可费部分抵消了。我们可以预期的是,今年我们的成本将略低于去年。这在一定程度上是我们去年年底采取的成本节约行动的结果,全年节省了略高于 200 万美元的成本。正如卡梅伦提到的,我们今年的重点是在人类领域达成下一个许可协议。因此,我们还开始努力在美国寻求非稀释性资金。正如卡梅伦提到的,我们再次考虑让每一条腿都支持自己。我们关注的是引入这些许可协议,以便我们能够实现预付款和里程碑付款。我们确实希望在今年年底之前在这些方面取得良好进展。我预计到今年年底我们将达成一项或多项许可协议。因此,我对我们可用的资源以及我们目前正在努力的一些额外的非稀释性资金非常有信心,我们将能够实现我们已经取得的这些里程碑今年计划。
Operator: Our next question is from Steven Ralston with Zacks. Please proceed.
接线员:我们的下一个问题来自 Zacks 的 Steven Ralston。请继续。
Steven Ralston: You certainly have a lot of irons in the fire right now, more than I've seen in the past. And despite the progress you made in your R&D efforts in cancer and sepsis, I'm trying to get a better handle on your two developing revenue streams. When I look at the -- you have product categories, product and service listed and the revenue streams are in the vet and Discover areas. Could you delineate those a little better, so I can better model the company?
史蒂文·罗尔斯顿:你现在确实有很多事情要做,比我过去见过的还要多。尽管你们在癌症和脓毒症方面的研发工作取得了进展,但我仍在努力更好地处理你们两个正在发展的收入来源。当我查看时,您列出了产品类别、产品和服务,收入来源位于兽医和发现领域。您能否更好地描述一下这些内容,以便我可以更好地为公司建模?
Cameron Reynolds: Terig?
卡梅伦·雷诺兹:特里格?
Terig Hughes: Yes, sure. So -- what -- in terms of our vet revenue, we achieved about $475,000 of net revenue last year. That was up 194%. And that does not yet ramp but we expect it to start ramping this year as we bring online the two new distributors. So, we've got Antech and Fuji Vet, who are both about to launch both aggressively pricing the test in the market at under $40, both having aggressive plans for marketing and launching of the test. So, looking ahead, I think we'll see a decent ramp starting in Q2 and going into the second half of the year. So, on Nu.Q Discover, we did about $300,000 of earned revenue last year. We've also got a very good pipeline building of over $1 million of opportunities. And that's a bit more difficult to forecast quarter-to-quarter because it's very lumpy in nature because of a number of projects of different sizes and then the timing is somewhat [indiscernible] difficult to estimate. But I do expect to see strong growth over the next year and for the year as a whole. So, I think we can look forward to further strong growth in the Nu.Q discover projects. Did that answer your question?
特里格·休斯:是的,当然。那么,就我们的兽医收入而言,去年我们实现了约 475,000 美元的净收入。增长了 194%。这还没有增加,但我们预计随着我们将两个新经销商上线,它会在今年开始增加。因此,我们有 Antech 和 Fuji Vet,他们都即将在市场上积极推出将测试价格定在 40 美元以下的产品,并且都制定了积极的营销和推出测试计划。因此,展望未来,我认为我们将在第二季度开始并进入今年下半年看到一个不错的增长。因此,去年我们在 Nu.Q Discover 上获得了约 30 万美元的收入。我们还拥有一个非常好的管道建设,价值超过 100 万美元的机会。逐季度预测有点困难,因为它本质上非常不稳定,因为有许多不同规模的项目,而且时间安排有些[难以辨别]难以估计。但我确实预计明年和全年都会出现强劲增长。因此,我认为我们可以期待 Nu.Q 发现项目进一步强劲增长。这回答了你的问题吗?
Steven Ralston: I think so. In other words, some of the Discover revenue is -- well, discover revenue is classified both under product and service categories.
史蒂文·罗尔斯顿:我想是的。换句话说,一些发现收入 - 嗯,发现收入分为产品和服务类别。
Terig Hughes: That's right. It is. So, we -- it's probably slightly more weighted towards the service than the product.
特里格·休斯:没错。这是。所以,我们可能更注重服务而不是产品。
Steven Ralston: Is it too early in the process to determine the relative profitability between Discover and Vet?
Steven Ralston:现在确定 Discover 和 Vet 之间的相对盈利能力是否为时过早?
Terig Hughes: So, both are highly profitable in terms of gross margin. Vet, I would say, is probably higher or more highly profitable once we get it to scale and Discover although highly profitable, there's a service element there and that makes it slightly less profitable, but still we have very, very good gross margins on both products.
Terig Hughes:所以,就毛利率而言,两者都是高利润的。我想说的是,一旦我们扩大规模,兽医的利润可能会更高或更高,并且发现虽然利润很高,但其中有一个服务元素,这使得它的利润略低,但我们在这两个方面仍然有非常非常好的毛利率产品。
Steven Ralston: Also, is there a corporate model of when to capture your deferred revenue? I know it's a long tail and a very large market, and it might be too early to determine that, but you are generating some sales in that and therefore, some miniscule percentage of the deferred revenue should be coming over through the bottom line, well, being put into the top line to come
Steven Ralston:另外,是否有一个企业模型来确定何时获取递延收入?我知道这是一个长尾和一个非常大的市场,现在确定这一点可能还为时过早,但你正在其中产生一些销售额,因此,递延收入的一小部分应该通过底线来实现,好吧,被放入顶线来
Terig Hughes: Yes, that's a good point. And I'm glad you brought that up because as you know, we've received about $23 million so far in payments related to the license agreement with Heska now Antech. And that's currently classified as deferred income on the balance sheet. And I do expect that to start earning out this year because it's linked to when the point of care or in-house diagnostic test launches with Heska, which is, as we said, is imminent. And so, I do expect to start to see some of that burning this year, but is a long tail over the lifetime of the agreement, which is 20 years.
特里格·休斯:是的,这是一个很好的观点。我很高兴您提出这个问题,因为如您所知,到目前为止,我们已收到与 Heska(现为 Antech)的许可协议相关的约 2300 万美元付款。目前,这在资产负债表上被归类为递延收入。我确实预计今年会开始盈利,因为这与 Heska 推出护理点或内部诊断测试的时间有关,正如我们所说,这即将到来。因此,我确实预计今年会开始看到其中一些燃烧,但在协议的有效期(20 年)中,这是一个长尾。
Steven Ralston: Thank you. Just two comments. I'd like to thank you for those informative webinars on cancer and sepsis. I've listened to them several times. Every time I listen to them, I get more out of it. and also, that the $2 million cost cutting was not unnoticed, it came all below my expectations with the lower cost.
史蒂文·罗尔斯顿:谢谢。只有两条评论。我要感谢您举办有关癌症和败血症的信息丰富的网络研讨会。我听过他们好几次了。每次我听他们讲话,我都能从中得到更多。而且,200 万美元的成本削减也引起了人们的注意,成本降低后,一切都低于我的预期。
Operator: We have reached the end of our question-and-answer session. I would like to turn the conference back over to Cameron for closing remarks.
接线员:我们的问答环节已经结束了。我想将会议转回卡梅伦致闭幕词。
Cameron Reynolds: Thank you, everyone, for attending our call. We really appreciate it. And we look forward to updating you with all the developments that we've outlined over the next few months and on the first quarter earnings call, which is, of course, due in mid-May. So, thank you very much, and have a great day. Thank you.
卡梅伦·雷诺兹:谢谢大家参加我们的电话会议。我们真的很感激。我们期待向您通报我们在未来几个月和第一季度财报电话会议上概述的所有进展情况,当然,第一季度财报电话会议将于 5 月中旬举行。所以,非常感谢您,祝您有美好的一天。谢谢。
Operator: Thank you. This will conclude today's conference. You may disconnect your lines at this time, and thank you for your participation.
接线员:谢谢。今天的会议到此结束。此时您可以断开线路,感谢您的参与。
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