Predictive Oncology Inc (POAI) 2024 Q2 法說會逐字稿

Good day, and thank you for standing by.

美好的一天，感謝您的支持。

Welcome to the Predictive Oncology Second Quarter 2024 Earnings Conference Call.

歡迎參加預測腫瘤學 2024 年第二季財報電話會議。

(Operator Instructions) Please be advised that today's conference is being recorded.

（操作員指示）請注意，今天的會議正在錄製中。

I would now like to hand the call over to your speaker, Mr. Glenn Garmont, Investor Relations.

現在我想將電話轉交給您的發言人、投資者關係部門的 Glenn Garmont 先生。

Thank you.

謝謝。

You may begin.

你可以開始了。

Welcome, and thank you, everyone, for dialing into the Predictive Oncology Second Quarter 2024 Financial Results Call.

歡迎並感謝大家撥打預測腫瘤學 2024 年第二季財務業績電話會議。

First, you'll hear from our Chief Executive Officer and Chairman of the Board, Raymond Vennare; and our Chief Financial Officer, Josh Blacher, who will review our financials.

首先，您將聽到我們的執行長兼董事會主席 Raymond Vennare 的講話；我們的財務長 Josh Blacher 將審查我們的財務狀況。

Certain matters discussed on this call contain forward-looking statements.

本次電話會議討論的某些事項包含前瞻性陳述。

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.

這些前瞻性陳述反映了我們目前對未來事件的預期和預測，並受到有關我們的營運和投資的重大風險、不確定性和假設的影響。

All statements other than statements of historical facts included in the call 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.

除電話會議中包含的有關我們的策略、未來營運、未來財務狀況、未來收入和財務業績、預計成本、前景、計劃和管理目標的歷史事實陳述外，所有陳述均為前瞻性陳述。

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.

預期、相信、估計、期望、打算、可能、計劃、將、目標和類似表達等詞語旨在識別前瞻性陳述，儘管並非所有前瞻性陳述都包含這些識別詞。

Our actual performance may materially differ from that contemplated by the forward-looking statements as a result of a variety of factors, including, among other things, factors discussed under the heading Risk Factors in our filings with the SEC.

由於多種因素的影響，我們的實際表現可能與前瞻性陳述中預期的表現有重大差異，其中包括我們向美國證券交易委員會提交的文件中「風險因素」標題下討論的因素。

Except as expressly required by law, the company disclaims any intent or obligation to update these forward-looking statements.

除非法律明確要求，否則本公司不承擔任何更新這些前瞻性聲明的意圖或義務。

Now I'd like to turn the call over to Raymond Vennare, Chief Executive Officer.

現在我想將電話轉給執行長 Raymond Vennare。

Raymond?

雷蒙？

Thank you, Glenn, and good morning, everyone.

謝謝格倫，大家早安。

I would like to begin this morning with a recap of a significant announcement that we made just a few weeks ago regarding the successful retrospective multiyear ovarian cancer study that we completed with UPMC Magee-Womens Hospital conducted over the past five years.

今天早上，我想先回顧我們幾週前發布的一項重要公告，內容涉及我們與 UPMC Magee-Womens 醫院在過去五年中成功完成的回顧性多年卵巢癌研究。

As a result of this study, the findings of which were presented at the American Society of Clinical Oncology Annual Meeting in June, we have expanded our artificial intelligence and machine learning offering to independently pursue the discovery of novel biomarkers that can predict patient outcomes and drug responses in oncology.

這項研究的結果已在 6 月的美國臨床腫瘤學會年會上公佈，我們擴展了人工智慧和機器學習產品，以獨立地探索能夠預測患者結果和藥物的新型生物標誌物的發現腫瘤學方面的反應。

With these capabilities, we are very well positioned to play a significant role, not only in validating biomarkers that have already been discovered by potential partners, but also in discovering our own unique biomarkers and playing a more active and direct role in drug discovery and development.

憑藉這些能力，我們完全有能力發揮重要作用，不僅可以驗證潛在合作夥伴已經發現的生物標誌物，還可以發現我們自己獨特的生物標誌物，並在藥物發現和開發中發揮更積極和直接的作用。

Please recall that the Magee study was designed to identify key features that drive overall survival endpoints in ovarian cancer, a very serious cancer type with a very high rate of recurrence.

請記住，Magee 研究的目的是確定推動卵巢癌整體存活終點的關鍵特徵，這是一種非常嚴重的癌症類型，復發率非常高。

This study included data from 235 ovarian cancer patients from 2010 through 2016, a broad array of inputs, including patient data, whole-exome sequencing, whole-transcriptome sequencing, drug response profile and digital pathology profiles were used to train the 160 models that were included in the study.

這項研究包括2010 年至2016 年235 名卵巢癌患者的數據，使用了廣泛的輸入，包括患者數據、全外顯子組測序、全轉錄組測序、藥物反應圖譜和數字病理學圖譜來訓練160個模型，這些模型納入研究。

As we previewed during our first quarter conference call, we were able to obtain an end-of-life data that supports novel ovarian cancer biomarker discovery and development.

正如我們在第一季電話會議上預覽的那樣，我們獲得了支持新型卵巢癌生物標記發現和開發的臨終數據。

We are very pleased to report that we were able to deliver strong predictive models with high levels of accuracy, and our machine learning capabilities demonstrated the ability to identify prognostic subgroups within ovarian cancer patient population.

我們非常高興地報告，我們能夠提供高精度的強大預測模型，並且我們的機器學習能力證明了識別卵巢癌患者群體中的預後亞組的能力。

This progress represents a natural extension of our core artificial intelligence capabilities, where we employ our active machine learning and diverse patient tumor samples preserved in our extensive biobank to predict responses to drugs with a very high degree of accuracy.

這項進展代表了我們核心人工智慧能力的自然延伸，我們利用主動機器學習和廣泛生物庫中保存的多樣化患者腫瘤樣本來高度準確地預測對藥物的反應。

We are now taking this one step further by applying state-of-the-art deep learning approaches for biomarker discovery for both overall survival and drug responses.

我們現在更進一步，應用最先進的深度學習方法來發現整體生存和藥物反應的生物標記。

This includes our ability to extract differentiating features from our digitized pathology slides, which, in and of themselves, are potential biomarkers.

這包括我們從數位病理切片中提取差異特徵的能力，這些特徵本身就是潛在的生物標記。

Our platform now enables us to pursue deep learning as a methodology to accelerate the initial stages of biomarker discovery and stratify patient cohorts and further extend our capabilities, either independently or in partnership with our biopharma companies.

我們的平台現在使我們能夠將深度學習作為一種方法來加速生物標記發現的初始階段並對患者群體進行分層，並進一步擴展我們的能力，無論是獨立還是與我們的生物製藥公司合作。

Ovarian cancer represents a significant unmet need in oncology, with epithelial ovarian cancer being the deadliest of all gynecologic malignancies.

卵巢癌代表了腫瘤學中未滿足的重大需求，而上皮性卵巢癌是所有婦科惡性腫瘤中最致命的。

While these cancers are sensitive to front-line chemotherapy in approximately 75% of cases, these women will ultimately experience disease relapse in an equal percentage, which is incurable.

雖然這些癌症在大約 75% 的病例中對第一線化療敏感，但這些女性最終將以相同比例經歷疾病復發，這是無法治癒的。

Outside of primary chemotherapy, there is no universal treatment decision path to determine the agent, sequence and timing of the standard of care for chemotherapeutic agents.

除了主要化療之外，沒有通用的治療決策路徑來確定化療藥物的治療標準、順序和時間。

These capabilities extend well beyond ovarian cancer and can be used in the discovery of biomarkers for other cancer types as well as diseases outside of oncology.

這些功能遠遠超出了卵巢癌的範圍，可用於發現其他癌症類型以及腫瘤學以外疾病的生物標記。

External sources have valued the biomarker discovery market at more than $51 billion in 2024.

外部消息人士預計，到 2024 年，生物標記物發現市場的估值將超過 510 億美元。

So this is a very significant opportunity for us to leverage our unique set of assets and capabilities to play a role in the discovery of next-generation therapeutics, while creating enduring value for our shareholders.

因此，這對我們來說是一個非常重要的機會，可以利用我們獨特的資產和能力，在下一代療法的發現中發揮作用，同時為我們的股東創造持久的價值。

We look forward to further validating these capabilities through development collaborations with leading biopharmaceutical partners and health care networks.

我們期待透過與領先的生物製藥合作夥伴和醫療保健網路的開發合作來進一步驗證這些能力。

Also, during the second quarter, in addition to our biomarker discovery initiative, we launched a novel organ-specific 3D cell culture technology that more closely mimics human tissue architecture than 2D assays.

此外，在第二季度，除了我們的生物標記發現計劃之外，我們還推出了一種新型器官特異性 3D 細胞培養技術，該技術比 2D 檢測更接近模仿人體組織結構。

It does this by preserving critical interactions between a tumor and its cellular and extracellular surroundings and creates a more representative method for in vivo clinical testing for drug candidates.

它透過保留腫瘤與其細胞和細胞外環境之間的關鍵相互作用來實現這一點，並為候選藥物的體內臨床測試創建更具代表性的方法。

This allows for more robust predictions of clinical outcomes and can be used to optimize candidate selection for subsequent clinical development.

這可以對臨床結果進行更可靠的預測，並可用於優化後續臨床開發的候選藥物選擇。

The potential benefits to drug developers are numerous.

對藥物開發商的潛在好處有很多。

They decrease the cost of new drug development and the time to market, but also reducing the need for animal testing and time-consuming iterations during clinical trials.

它們降低了新藥開發的成本和上市時間，同時也減少了臨床試驗期間動物測試和耗時的迭代的需要。

The 3D cell market is estimated by third parties to grow 14% annually from $1.4 billion in 2022 to $5.3 billion in 2032.

第三方估計 3D 細胞市場每年將以 14% 的速度成長，從 2022 年的 14 億美元成長到 2032 年的 53 億美元。

Also worth mentioning is the progress that we have made with our Accelerating Compound Exploration program, otherwise known as the ACE initiative.

另外值得一提的是我們在加速化合物探索計劃（也稱為 ACE 計劃）方面取得的進展。

This program, as you may remember, is geared toward novel discovery through partnerships with universities and academic institutions and was created to provide early-stage academic development groups access to Predictive Oncology's artificial intelligence platform, which, as you also know, leverages our extensive and diverse biobank of heterogenous tumor samples.

您可能還記得，該計劃旨在透過與大學和學術機構的合作來實現新發現，旨在為早期學術發展團體提供訪問預測腫瘤學人工智慧平台的機會，正如您所知，該平台利用了我們廣泛且異質腫瘤樣本的多樣化生物庫。

The ACE program is designed to enable academic investigators to evaluate their drug compounds and facilitate more informed selections of drug tumor type combinations to increase the probability of future clinical success by efficiently addressing tumor heterogeneity earlier in development.

ACE 計劃旨在使學術研究人員能夠評估他們的藥物化合物，並促進更明智地選擇藥物腫瘤類型組合，從而透過在開發早期有效解決腫瘤異質性來增加未來臨床成功的可能性。

This program, which we have been nurturing for more than a year, has resulted in our first collaboration with the University of Michigan.

這個計畫經過我們一年多的培育，最終促成了我們與密西根大學的首次合作。

The library created by University of Michigan's Natural Products Discovery Core is one of the largest collections of pharmaceutically viable extracts in the United States.

該圖書館由密西根大學天然產品發現核心創建，是美國最大的藥學上可行的萃取物收藏之一。

This library, which has been meticulously constructed over the past decade, in the laboratory of Dr. David H. Sherman at the University of Michigan's Life Sciences Institute, is comprised of strains from Asia Pacific, Middle East, South America, North America and the Antarctic.

這個文庫是在密西根大學生命科學研究所 David H. Sherman 博士的實驗室中經過十年精心構建的，由來自亞太地區、中東、南美、北美和中東地區的菌株組成。

Most importantly, this collaboration represents Predictive Oncology's foray into true drug discovery.

最重要的是，這次合作代表了預測腫瘤學進軍真正的藥物發現領域。

With the addition of University of Michigan's natural products and drug candidates, we are very well positioned to expand our small molecule capabilities to include development of large molecule models using our proprietary AI and ML platform.

隨著密西根大學天然產物和候選藥物的加入，我們完全有能力擴展我們的小分子能力，包括使用我們專有的人工智慧和機器學習平台開發大分子模型。

Several publications will definitely come out of this drug discovery initiative.

這項藥物發現計劃肯定會發表幾篇出版物。

To ensure that we remain nimble and able to capitalize on this and other new opportunities that continue to emerge, we announced more recently that we implemented a comprehensive and strategic cost reduction initiative aimed at streamlining our operations and extending our cash runway.

為了確保我們保持靈活性並能夠利用這一機會以及不斷出現的其他新機會，我們最近宣布實施一項全面的策略性成本削減計劃，旨在簡化我們的營運並擴大我們的現金跑道。

As a key part of this initiative, we made the challenging decision to consolidate our Birmingham operations, which houses our Biologics business, into Pittsburgh, which, as you know, also serves as our corporate headquarters.

作為這項計畫的關鍵部分，我們做出了一項具有挑戰性的決定，將生物製品業務所在的伯明罕業務整合到匹茲堡，正如您所知，匹茲堡也是我們的公司總部。

From a strategic perspective, it is important to understand the context of this action.

從策略角度來看，了解這項行動的背景非常重要。

First and foremost, it is incumbent on the company to remain laser focused on its core capabilities with respect to the application of artificial intelligence to drive drug discovery.

首先也是最重要的是，公司有責任繼續專注於其在應用人工智慧推動藥物發現方面的核心能力。

Second, the very thing that enables our ability to model and predict drug tumor responses identify biomarkers and predict outcomes with such accuracy is the quality of the tumor samples in our biobank and the significance of the pristine longitudinal data that has been generated from those samples.

其次，使我們能夠建模和預測藥物腫瘤反應、識別生物標記並如此準確地預測結果的能力在於我們生物庫中腫瘤樣本的品質以及從這些樣本生成的原始縱向數據的重要性。

This has now been externally validated and was presented at the Association of Surgical Oncology.

該結果現已獲得外部驗證，並已提交給腫瘤外科協會。

The ability to deliver on the accuracy of our predictions and relevance of our models requires constant sequencing, characterizing, curating and digitization of tissue samples, drug response data and pathology slides.

為了實現預測的準確性和模型的相關性，需要對組織樣本、藥物反應資料和病理切片進行持續的定序、表徵、整理和數位化。

This is an ongoing effort and one which drives the precision with which our AI-generated models are perfected.

這是一項持續的努力，它推動了我們的人工智慧生成模型的完善精度。

In the absence of these silent endeavors, we cannot possibly distinguish ourselves in the marketplace.

如果沒有這些默默的努力，我們不可能在市場上脫穎而出。

All of this requires dedicated resources and in this case, the reallocation of those resources from Birmingham to Pittsburgh.

所有這些都需要專門的資源，在這種情況下，需要將這些資源從伯明罕重新分配到匹茲堡。

Lastly, innovation perpetuates value creation, and adding value to the company impacts valuation of the company.

最後，創新可以持續創造價值，為公司增加價值會影響公司的估值。

By adding value, we are signaling our relevance to the market with respect to the significance of our core assets.

透過增加價值，我們表明我們的核心資產與市場的相關性。

This initiative, once fully implemented in Q4 of this year, is expected to reduce our run rate for cash used in operating activities by approximately $2.5 million annually, which equates to roughly 20% of our cash burn based on our stated 2023 cash used in operating activities of $13.2 million.

該措施一旦於今年第四季全面實施，預計將每年將我們用於經營活動的現金運行率降低約250 萬美元，這相當於我們根據2023 年所述的經營活動現金消耗量計算的約20% 。

As a point of reference, the Birmingham segment generated a net loss of $2.0 million in 2023 and $1.8 million in 2022, with de-minimis-supporting revenue.

作為參考，伯明罕部門在 2023 年產生了 200 萬美元的淨虧損，在 2022 年產生了 180 萬美元的淨虧損，但收入也達到了微乎其微的水平。

Moreover, since Birmingham has become essential to our core focus in Pittsburgh over time, and in light of its lack of profitability, this simply became the right decision for the company and the shareholders moving forward.

此外，隨著時間的推移，伯明翰已經成為我們匹茲堡核心業務的重要組成部分，並且鑑於其缺乏盈利能力，這對於公司和股東的前進來說是一個正確的決定。

We would be remiss not to extend our gratitude to our partners in Birmingham, especially Dr. Larry DeLucas, Senior Vice President of Biologics, for his years of leadership and dedication.

如果我們不向伯明罕的合作夥伴表示感謝，尤其是生物製劑高級副總裁 Larry DeLucas 博士多年來的領導和奉獻，那就是我們的失職。

Thank you, Larry.

謝謝你，拉里。

To further strengthen our financial position, we've announced over the last few months a couple of significant capital raises, $5.0 million in total, that also helped to bolster our cash balance sheet and extend our runway.

為了進一步加強我們的財務狀況，我們在過去幾個月宣布了幾次重大融資，總計 500 萬美元，這也有助於增強我們的現金資產負債表並擴大我們的跑道。

In May, the company raised $3.7 million, net of $0.6 million of issuance costs or $3.1 million in net proceeds through its at-the-market facility through the issuance of 1.6 million shares.

5 月份，該公司透過發行 160 萬股股票籌集了 370 萬美元，扣除 60 萬美元的發行成本或 310 萬美元的淨收益。

And in July, the company raised an additional $1.3 million in gross proceeds through the exercise of 958,000 warrants through our warrant inducement transaction.

7 月份，公司透過我們的認股權證誘導交易行使 958,000 張認股權證，籌集了額外 130 萬美元的總收益。

And now I would like to turn this call over to Josh Blacher, our Chief Financial Officer, to review our second quarter financials in detail.

現在我想將這個電話轉給我們的財務長喬許·布萊徹（Josh Blacher），以詳細審查我們第二季的財務狀況。

Josh?

喬許？

Thank you, Raymond.

謝謝你，雷蒙德。

We concluded the second quarter of 2024 with $5.3 million in cash and cash equivalents 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.

截至2024 年第二季度，我們的現金及現金等價物為530 萬美元，而截至2023 年12 月31 日為870 萬美元；股東權益為410 萬美元，而截至2023 年12 月31 日為830 萬美元。

Note that our cash balance as of June 30, 2024, includes net proceeds of $3.1 million that we raised from our ATM facility in May, but excludes amounts raised subsequent to the end of the second quarter from the warrant inducement transaction that Raymond described earlier.

請注意，截至2024 年6 月30 日，我們的現金餘額包括我們5 月份從ATM 設施籌集的310 萬美元淨收益，但不包括雷蒙德之前描述的第二季度末後從認股權證激勵交易中籌集的金額。

Our net loss per share for the second quarter of 2024 was $0.68 per basic and diluted share as compared to $0.98 per basic and diluted share for the second quarter of 2023.

我們 2024 年第二季的每股淨虧損為每股基本和稀釋每股 0.68 美元，而 2023 年第二季基本和稀釋每股淨虧損為 0.98 美元。

The company recorded revenues of $279,000 for the second quarter of 2024 compared to $490,000 for the comparable period in 2023.

該公司 2024 年第二季的營收為 27.9 萬美元，而 2023 年同期營收為 49 萬美元。

Revenues for the quarter ended June 30, 2024, and June 30, 2023, were primarily derived from the company's Egan operating segment.

截至2024年6月30日及2023年6月30日的季度營收主要來自該公司的伊根營運部門。

General and administrative expenses primarily consist of management salaries, professional fees, consulting fees, administrative fees and general office expenses.

一般及行政費用主要包括管理人員薪資、專業費用、諮詢費、行政費用及一般辦公費用。

G&A expenses decreased by $567,000 to $2.1 million in the three months ended June 30, 2024, compared to $2.7 million in the comparable period 2023.

截至 2024 年 6 月 30 日的三個月，一般管理費用減少 567,000 美元，至 210 萬美元，而 2023 年同期為 270 萬美元。

The decrease was primarily due to lower employee compensation and decreased investor relation costs, offset by increased consulting fees.

下降的主要原因是員工薪酬下降和投資者關係成本下降，但被諮詢費增加所抵消。

Operation expenses primarily consist of expenses related to product development and prototyping and testing.

營運費用主要包括與產品開發、原型設計和測試相關的費用。

Operations expenses decreased by $100,000 to $893,000 for the three months ended June 30, 2024, compared to $993,000 in the comparable period in 2023.

截至 2024 年 6 月 30 日的三個月營運費用減少了 10 萬美元，至 89.3 萬美元，而 2023 年同期為 99.3 萬美元。

The decrease was primarily due to decreased cloud computing expenses related to our Pittsburgh operating segment.

減少的主要原因是與匹茲堡營運部門相關的雲端運算費用減少。

We expect these types of savings to continue going forward.

我們預計這些類型的節省將繼續下去。

Sales and marketing expenses consist of expenses required to market and sell our products, including staff-related expenses, for individuals performing such work.

銷售和行銷費用包括行銷和銷售我們的產品所需的費用，包括執行此類工作的個人的與員工相關的費用。

Sales and marketing expenses decreased by $145,000 to $284,000 for the three months ended June 30, 2024, compared to $429,000 in the comparable period in 2023.

截至 2024 年 6 月 30 日的三個月，銷售和行銷費用減少了 145,000 美元，至 284,000 美元，而 2023 年同期為 429,000 美元。

The decrease was primarily due to lower employee compensation, including sales commissions.

下降的主要原因是員工薪酬（包括銷售佣金）下降。

As a part of the cost savings initiative, we've taken a hard look at marketing spending in general as it relates to ROI hurdles, so you can expect that such reductions will continue going forward.

作為成本節約計劃的一部分，我們總體上認真審視了與投資回報率障礙相關的行銷支出，因此您可以預期此類削減將繼續下去。

Net cash used in operating activities was $6.6 million for the six months ended June 30, 2024, down from $7.0 million for the comparable period in 2023.

截至 2024 年 6 月 30 日的六個月，經營活動使用的現金淨額為 660 萬美元，低於 2023 年同期的 700 萬美元。

The company incurred net losses of $3.2 million and $3.9 million for the quarters ended June 30, 2024, and June 30, 2023, respectively.

該公司截至2024年6月30日和2023年6月30日的季度分別產生淨虧損320萬美元和390萬美元。

As of June 30, 2024, the company had an accumulated deficit of $175 million as compared to $168 million as of December 31, 2023.

截至2024年6月30日，該公司累計赤字為1.75億美元，截至2023年12月31日為1.68億美元。

That concludes the financial overview.

財務概覽到此結束。

We will now open the call up for questions.

我們現在將開始提問徵集。

Operator?

操作員？

(Operator Instructions) Mr. Vennare, I'd like to turn the floor back to you and close the question-and-answer session.

（操作員指示）Vennare 先生，我想將發言權轉回給您，並結束問答環節。

Thank you very much, and thanks, everyone, for being on the call.

非常感謝你們，也感謝大家的來電。

So that concludes our call for today.

我們今天的呼籲到此結束。

We hope that you take away from this call that we are extremely excited to actively pursue novel biomarker discovery and play a more direct role in the discovery and development of next-generation therapies, either independently or with a partner.

我們希望您從這次電話會議中了解到，我們非常高興能夠獨立或與合作夥伴積極追求新穎的生物標記發現，並在下一代療法的發現和開發中發揮更直接的作用。

This represents a tremendous opportunity for us to bring new hope to millions of patients worldwide in cancer and other high-need indications, while creating long-lasting value for our shareholders.

這對我們來說是一個巨大的機會，可以為全球數百萬癌症和其他高需求適應症患者帶來新的希望，同時為我們的股東創造持久的價值。

Thank you again for your support and your patience, and I look forward to the next quarterly update in November.

再次感謝您的支持和耐心，我期待 11 月的下一個季度更新。

Have a great day.

祝你有美好的一天。

Thank you.

謝謝。

This concludes today's conference call.

今天的電話會議到此結束。

You may disconnect your lines at this time.

此時您可以斷開線路。

Thank you for your participation.

感謝您的參與。