PDS Biotechnology Corp (PDSB) 2026 Q1 法說會逐字稿

Greetings, and welcome to the PDS Biotech First Quarter 2026 Earnings Conference Call. (Operator Instructions)

各位好，歡迎參加 PDS Biotech 2026 年第一季財報電話會議。（接線員指示）

It is now my pleasure to introduce your host, [Dean Schwartz]. Thank you. You may begin.

現在我很榮幸介紹本次會議主持人，[Dean Schwartz]。謝謝。您可以開始了。

Thank you, operator. Good morning, everyone, and welcome to PDS Biotech's first-quarter 2026 results and clinical programs update call. I'm joined on the call today by the following members of the company's management team: Dr. Frank Bedu-Addo, Chief Executive Officer; Dr. Kirk Shepard, Chief Medical Officer; and Lars Boesgaard, Chief Financial Officer.

謝謝，接線員。各位早安，歡迎參加 PDS Biotech 2026 年第一季業績與臨床計畫更新電話會議。今天與我一同出席的公司管理團隊成員包括：Frank Bedu-Addo 博士，執行長；Kirk Shepard 博士，醫務長；以及 Lars Boesgaard，財務長。

Dr. Bedu-Addo and Dr. Shepard will provide an overview of the company's recent highlights in its clinical development program, and Mr. Boesgaard will review the financial results for the quarter ended March 31, 2026. Following management's prepared remarks, we will take questions from covering analysts.

Bedu-Addo 博士與 Shepard 博士將概述公司臨床開發計畫近期重點進展，Boesgaard 先生將回顧截至 2026 年 3 月 31 日止季度的財務結果。管理團隊的預先準備發言結束後，我們將接受追蹤本公司的分析師提問。

As a reminder, during this call, we will be making forward-looking statements, which are subject to various risks and uncertainties that could cause our actual results to differ materially from these statements. Any such statements should be considered in conjunction with cautionary statements in our press releases and risk factors discussed in our filings with the SEC, including our quarterly reports on Form 10-Q and annual report on Form 10-K and cautionary statements made during this call. We assume no obligation to update any of these forward-looking statements or information.

提醒各位，本次電話會議中我們將作出前瞻性陳述；此類陳述受多項風險與不確定性影響，可能導致實際結果與陳述內容出現重大差異。任何此類陳述均應結合我們新聞稿中的警示性聲明，以及我們向美國證券交易委員會（SEC）提交文件中所討論的風險因素一併考量，包括 Form 10-Q 季度報告與 Form 10-K 年度報告，以及本次電話會議中所作的警示性聲明。我們不承擔更新任何前瞻性陳述或資訊的義務。

Now I'd like to turn the call over to Dr. Bedu-Addo. Frank?

現在我想把電話交給 Bedu-Addo 博士。Frank？

Thank you, Dean, and good morning, everyone. It's our pleasure to speak with you again and to provide this brief update on our progress in advancing our clinical programs. This past quarter, our major focus was on advancing our clinical programs and we made significant progress. So I will hand the call over to our Chief Medical Officer, Dr. Kirk Shepard, to provide an update. Kirk?

謝謝你，Dean，各位早安。很高興再次與各位交流，並就我們推進臨床計畫的進展提供簡要更新。過去一季，我們的主要重點是推進臨床計畫，且取得了顯著進展。因此我將把電話交給我們的醫務長 Kirk Shepard 博士，請他提供最新進度。Kirk？

Thank you, Frank. During our first quarter, we adopted an amendment to our VERSATILE-003 trial, revising the design to incorporate progression-free survival as an interim primary endpoint which we believe has the potential to enable a more efficient path to accelerated approval. We also believe this amendment may shorten the trial's duration and reduce the overall costs, all while retaining overall survival as a basis for full approval in accordance with FDA requirements.

謝謝你，Frank。在第一季期間，我們採納了對 VERSATILE-003 試驗的修訂，調整試驗設計，將無惡化存活期（PFS）納入期中主要終點；我們相信此舉有望使加速核准的路徑更為高效。我們也認為，該修訂可能縮短試驗期間並降低整體成本，同時仍保留總存活期（OS）作為依據，以符合 FDA 對完全核准的要求。

Additionally, this approach may also accelerate the availability of this promising treatment to the rapidly growing population of HPV16-positive patients in dire need of effective treatment. For patients living with HPV16-positive head and neck cancer, a disease with significant and growing unmet need, we believe PDS0101 represents a promising treatment option, and we remain focused on advancing it as efficiently as possible.

此外，這種做法也可能加速讓這項具前景的治療，提供給快速成長且迫切需要有效治療的 HPV16 陽性患者族群。對於罹患 HPV16 陽性頭頸癌的患者而言，這是一種未被滿足醫療需求顯著且持續增加的疾病；我們相信 PDS0101 代表一項具前景的治療選擇，並將持續專注於以最高效率推進其開發。

PDS0101 in combination with KEYTRUDA or pembrolizumab is the only late-stage investigational head and neck squamous cell carcinoma therapy that requires only five doses and also the only subcutaneous therapy. These characteristics of PDS0101, together with the tolerability and survival data reported to date, make PDS0101 a potential compelling option for these patients. Key opinion leaders at institutions such as Mayo Clinic, Dana-Farber, and Yale Cancer Institute are involved in our trial.

PDS0101 與 KEYTRUDA（pembrolizumab）合併使用，是唯一一項處於後期開發階段、僅需五次給藥的頭頸部鱗狀細胞癌（HNSCC）研究中療法，同時也是唯一的皮下給藥療法。PDS0101 的這些特性，加上迄今所報告的耐受性與存活數據，使其成為這些患者可能極具吸引力的選擇。梅約診所（Mayo Clinic）、Dana-Farber 與耶魯癌症中心（Yale Cancer Institute）等機構的關鍵意見領袖亦參與我們的試驗。

HPV16-positive cancers are rapidly increasing in the US and EU due to poor uptake of the human papillomavirus vaccine and other factors. Along with the unique pathophysiology of HPV16 cancers and the absence of approved targeted therapies, there is a significant unmet need we believe that PDS0101 is uniquely positioned to address.

由於人類乳突病毒（HPV）疫苗接種率偏低及其他因素，HPV16 陽性癌症在美國與歐盟正快速增加。再加上 HPV16 癌症獨特的病理生理機制，以及缺乏已核准的標靶治療，存在顯著的未被滿足醫療需求；我們相信 PDS0101 具備獨特定位可加以因應。

Elsewhere in our program, we recently reported promising results from ongoing trials for the treatment of prostate and colorectal cancer with PDS01ADC, our novel investigational Interleukin-12 or IL-12 fused antibody drug conjugate that enhances the proliferation, potency and longevity of T cells in tumor microenvironment. In March, the Journal of Clinical Oncology, JCO, Oncology Advances published clinical and immunological biomarker data from Stage 1 of a Phase 2 trial, evaluating PDS01ADC in colorectal cancer with liver metastasis.

在我們計畫的其他部分，我們近期也公布了正在進行的試驗之令人鼓舞結果，該試驗以 PDS01ADC 治療攝護腺癌與大腸直腸癌。PDS01ADC 是我們新穎的研究用白介素-12（Interleukin-12，IL-12）融合抗體藥物複合體（ADC），可增強腫瘤微環境中 T 細胞的增殖、效力與持久性。3 月，《臨床腫瘤學期刊》（Journal of Clinical Oncology，JCO）旗下的 Oncology Advances 發表了第二期試驗第一階段的臨床與免疫生物標記資料，評估 PDS01ADC 用於合併肝轉移之大腸直腸癌。

We refer you to these press releases issued this morning. Earlier in our first quarter, we also announced early results from the NCI-led trial investigating PDS01ADC at the AACR special conference on prostate cancer research. In patients with metastatic castration-resistant prostate cancer, the majority of whom received this therapy as a third-line option, the combination of PDS01ADC and docetaxel demonstrated encouraging results included in our press release this morning.

請參閱我們今天上午發布的新聞稿。在第一季稍早，我們也於 AACR 攝護腺癌研究特別會議上，公布由 NCI 主導、研究 PDS01ADC 的試驗初步結果。在轉移性去勢抗性攝護腺癌患者中，多數患者將此療法作為第三線治療選項；PDS01ADC 與 docetaxel 的合併治療展現令人鼓舞的結果，相關內容已收錄於我們今天上午的新聞稿中。

The results from these two trials reinforce the potential of PDS01ADC to enhance the efficacy of existing therapies across multiple solid tumor types. We remain focused on advancing PDS01ADC as a key component of our immuno-oncology pipeline.

這兩項試驗的結果進一步強化了 PDS01ADC 在多種實體腫瘤類型中提升既有療法療效的潛力。我們仍專注於推進 PDS01ADC，使其成為我們免疫腫瘤產品線的關鍵組成。

I will now hand the call back to Frank.

現在我把電話交回給 Frank。

Thank you, Kirk. Finally, during our first quarter, we also strengthened the intellectual property estate for PDS0101 with new patents granted in the United States and Japan. The new US patent, combined with anticipated biologics exclusivity for PDS0101, extends our market protection into the 2040s. The Japanese patent adds broad composition of matter claims to existing protections across major markets.

謝謝你，Kirk。最後，在第一季期間，我們也透過在美國與日本取得新核准專利，強化了 PDS0101 的智慧財產權布局。新的美國專利，加上預期可取得的 PDS0101 生物製劑市場獨占期，將我們的市場保護延伸至 2040 年代。日本專利則在主要市場既有保護的基礎上，新增廣泛的物質組成（composition of matter）權利要求。

Now I will turn it over to Lars for a review of our results for the 2026 first quarter. Lars?

現在我把電話交給 Lars，請他回顧我們 2026 年第一季的業績。Lars？

Thanks, Frank, and good morning, everyone. We reported a net loss for the quarter ended March 31, 2026, of approximately $7.3 million or $0.13 per basic and diluted share. That compares to a net loss of $8.5 million or $0.21 per basic and diluted share for the quarter ended March 31, 2025.

謝謝你，Frank，各位早安。我們公布截至 2026 年 3 月 31 日止季度的淨損約為 730 萬美元，或每股基本及稀釋淨損 0.13 美元。相較之下，截至 2025 年 3 月 31 日止季度的淨損為 850 萬美元，或每股基本及稀釋淨損 0.21 美元。

Research and development expenses for the first quarter were $3.5 million compared to $5.8 million for the prior year period. Decrease was primarily due to lower clinical and manufacturing costs.

第一季研發費用為 350 萬美元，較去年同期的 580 萬美元下降。下降主要由於臨床與製造成本較低。

General and administrative expenses for the first quarter were $3.1 million compared to $3.3 million for the prior year period. The decrease was primarily due to lower professional fees. Total operating expenses for the first quarter were $6.5 million compared to $9.1 million for the prior year period. Net interest expense for the first quarter were $0.8 million compared to $0.6 million for the prior year period. The company's cash balance, as of March 31, 2026, was $21.7 million.

第一季一般及行政費用為 310 萬美元，較去年同期的 330 萬美元下降。下降主要由於專業服務費用較低。第一季總營運費用為 650 萬美元，較去年同期的 910 萬美元下降。第一季淨利息費用為 80 萬美元，較去年同期的 60 萬美元增加。截至 2026 年 3 月 31 日，公司現金餘額為 2,170 萬美元。

And with that, operator, we can open the call to questions from analysts.

接線員，以上就是我們的內容，現在可以開放分析師提問。

(Operator Instructions)

（接線員指示）

Mayank Mamtani, B. Riley Securities.

Mayank Mamtani，B. Riley Securities。

I appreciate the updates. On the VERSATILE-003 restart enrollment activity, could you remind us what remains sort of pending there? And is there a consideration also maybe of including subcu KEYTRUDA as a combination partner. And I don't, I think, fully follow what would be the procurement of KEYTRUDA considerations that were there last year versus what do you have today for VERSATILE-003. And then I have a follow-up.

感謝更新。關於 VERSATILE-003 重新啟動收案的活動，能否提醒我們目前還有哪些事項算是仍在等待中？另外，是否也在考慮把皮下給藥的 KEYTRUDA 納入作為合併用藥夥伴？還有，我不太確定我是否完全理解：去年在 KEYTRUDA 的採購（procurement）方面有哪些考量，與今天你們針對 VERSATILE-003 所具備的情況相比有何不同？然後我還有一個追問。

Mayank, thanks a lot for your questions. I'll hand over to Kirk. Kirk, why don't you go ahead?

Mayank，非常感謝你的提問。我把時間交給 Kirk。Kirk，你接著說吧？

Thank you, Frank. Yes, regarding the enrollment, now that we have alignment with the FDA that we are going through the procedures of amending the protocol and going back to the sites to begin the study in the near future. We're happy to say that the sites all stayed with us during that period of a pause while we did the amendment and discussed it with the FDA. So we're very happy that we still have the momentum with us.

謝謝你，Frank。是的，關於入組方面，現在我們已與 FDA 達成一致，正依程序進行方案修訂，並將回到各研究中心，預計在不久的將來重新啟動研究。我們很高興地表示，在我們進行修訂並與 FDA 討論、研究暫停的這段期間，各研究中心都一直與我們保持合作。因此，我們非常高興仍能延續目前的動能。

Regarding the possibilities of using the drug with the subcu pembrolizumab in the future, that's something that would be a possibility, but it's certainly not the target now of our research. Our research is with the pembrolizumab given IV in the usual amount that it has been in the past, but that option would remain open in the future for an entirely subcu regimen.

至於未來將本藥物與皮下（subcu）pembrolizumab 併用的可能性，這確實是可行的選項，但目前並非我們研究的重點。我們目前的研究是使用以往慣常劑量、以靜脈注射（IV）方式給予的 pembrolizumab；不過，未來若要採用全皮下給藥方案，這個選項仍會保留。

And then on the landscape external to you within HPV16-positive head and neck, it still seems like a relatively open white space or swim lane. Are there any emerging updates you've seen recently or you're expecting particularly from the EGFR bispecific class that you might be watching for?

另外，就你們以外、在 HPV16 陽性頭頸癌領域的外部競爭態勢來看，似乎仍相對是一個開放的空白區域或賽道。你們最近是否看到任何新出現的更新，或特別是來自 EGFR 雙特異性（bispecific）類別、你們正在關注或預期會出現的動態？

And then I also noticed the colorectal cancer cohort Stage 2 is now fully enrolled and you obviously published data from the Stage 1 cohort. Maybe just remind us when do you expect to have the next data update for Cohort 2. That would be very helpful.

此外，我也注意到結直腸癌隊列第 2 階段現在已完成全部入組，而你們也已公布第 1 階段隊列的數據。能否請你們再提醒一下，預計何時會有隊列 2 的下一次數據更新？這會非常有幫助。

Mayank, I'll start and I'll hand over to Kirk to add anything to it. But in terms of the HPV16 landscape, you're correct, we know that BioNTech is also in the Phase 3 trial. But both PDS and BioNTech remain the two late-stage studies in the space. So you are correct. There are very few potential opportunities for these patients at this present time.

Mayank，我先回答，然後再請 Kirk 補充。就 HPV16 的競爭格局而言，你說得沒錯，我們知道 BioNTech 也在進行第 3 期試驗。不過，在這個領域中，PDS 與 BioNTech 仍是兩項處於後期階段的研究。因此你判斷正確：目前對這些患者而言，可選擇的機會非常有限。

And in terms of the colorectal cancer, yes, you are correct that we have completed enrollment into that colorectal cancer cohort of that study. And we are anticipating that by the end of the year, we should have some additional data on the full population of patients in the colorectal cancer study. Kirk, anything you want to add to that?

至於結直腸癌方面，是的，你說得沒錯，我們已完成該研究中結直腸癌隊列的入組。我們預期在今年年底前，應可取得結直腸癌研究全體患者的更多數據。Kirk，你要補充什麼嗎？

No, I would just refer them again to the article that was just published in our press release, but also we're very encouraged by the Stage 1 of the Phase 2 trial with the NCI. So we're anxious to move it on to the next trial, a controlled trial, with this therapy.

沒有，我只想再次請大家參考我們新聞稿中剛發布的那篇文章；同時，我們也對與 NCI 合作的第 2 期試驗第 1 階段結果感到非常振奮。因此，我們迫不及待想把這項療法推進到下一個試驗，也就是一項對照試驗。

Joe Pantginis, HC Wainwright.

Joe Pantginis，HC Wainwright。

Great to see the recent amendment. So I wanted to actually dive into that a little bit. If you could talk about maybe a little more color on the benefits here. Obviously, Kirk, you mentioned about acceleration of the clinical time lines. I'm hoping you could hit that a little more with regard to attracting patients, anecdotes you may be getting from doctors to be able to quickly get to those reenrolling quicker.

很高興看到最近的修訂。所以我其實想更深入談一下。如果可以的話，能否多提供一些關於這些變更帶來益處的細節？顯然，Kirk，你提到臨床時程的加速。我希望你能就吸引患者入組、以及你們可能從醫師那邊聽到的軼事回饋多談一些，說明如何更快讓患者重新入組。

And then next, sort of the second part of that is from Lars' standpoint, what do you believe the financial impact positively for these changes could be? And obviously, would you then look to put -- keep that money towards the filing path or put it towards a pathway sort of the ADC platform?

接著，第二部分是從 Lars 的角度，你認為這些變更可能帶來哪些正面的財務影響？另外，你們是否會考慮把省下來的資金用於申報路徑，或是投入到某種路徑，例如 ADC 平台？

Yes. Thank you for your question. Regarding the amendments, as far as the protocol, of course, this all started when we did our final data cut back in September of last year. And we were very encouraged by those results. If anything, though, we needed to consider how long the trial will take because the median overall survival, I think you know, increased from around 30 months out to almost 40 months and the trial would take a long time to complete.

是的。謝謝你的提問。關於方案修訂，就試驗方案而言，這一切當然始於我們在去年 9 月完成最終數據截點（data cut）。我們對那些結果感到非常鼓舞。不過，我們需要考量的是試驗需要多久才能完成，因為中位總生存期（median overall survival），我想你也知道，從約 30 個月提高到接近 40 個月，這會使試驗完成所需時間變得很長。

At the same time, too, we saw the robustness of our PFS. So we went to the FDA to discuss the possibility of a co-primary, which we have right now, having the PFS as a co-primary along with the median overall survival, which would be needed for full approval. But we'd have a chance for an accelerated review with the PFS. So we're very happy with that as far as the trial design that has come as a result of the latest results as well as discussions with the FDA.

同時，我們也看到了無惡化生存期（PFS）的穩健性。因此我們與 FDA 討論是否採用共同主要終點（co-primary）。目前我們的設計就是將 PFS 與中位總生存期一同作為共同主要終點；其中，中位總生存期將用於取得完全核准（full approval），而 PFS 則讓我們有機會獲得加速審查（accelerated review）。因此，對於這項試驗設計——它是最新結果以及與 FDA 討論後的產物——我們感到非常滿意。

Joe, this is Lars here. So to answer your question about the potential financial impact, the way we expect the amendment to the protocol to affect really the financial requirements for the trial is one, in terms of time and in terms of time to the interim readout in particular, so that we expect that to reduce cost, both external costs, but also our internal operating expenses simply due to that shorter time period.

Joe，我是 Lars。回答你關於潛在財務影響的問題：我們預期方案修訂對試驗財務需求的影響，第一是在時間上，特別是到期中分析讀出（interim readout）的時間；我們預期這將降低成本，包括外部成本，也包括我們的內部營運費用，主要是因為時程縮短。

And another aspect to bear in mind, Joe, is that we did -- as part of the amendment, we changed the randomization and the ratio from 2:1 to 1:1. And so that also allowed us to essentially lower the number of patients from approximately 350 to approximately 250 patients. So that also in and of itself will drive lower external costs associated with completing the trial.

另外一點也請記住，Joe，作為修訂的一部分，我們調整了隨機分配與比例，從 2:1 改為 1:1。這也使我們能將患者人數從約 350 人降低到約 250 人。因此，僅此一項也會帶動完成試驗所需的外部成本下降。

Helpful detail. And then just a quick follow-up question. So look, things are late stage. They're progressing, right, very quickly. Can you talk about your manufacturing needs for Versamune and the pipeline in the near term and then heading beyond potential early commercialization?

這些細節很有幫助。接著再追問一個簡短問題：你看，現在已是後期階段，進展也很快。你能談談 Versamune 在近期的製造需求與產線規劃，以及在潛在早期商業化之後的規劃嗎？

Yes, Joe, I can talk a little bit about that. So as you know, we have a pretty straightforward manufacturing process. So in terms of scale-up and commercialization, some scale-up has been done already by the commercialization. Commercial process is already established. And so what we anticipate doing is one in parallel with the Phase 3 doing the traditional CMC activities, which involve validation of those processes.

可以，Joe，我可以稍微談一下。如你所知，我們的製造流程相當直接。因此在放大生產與商業化方面，部分放大工作已經完成；商業化製程也已建立。我們預期會做的是：一方面在第 3 期試驗進行的同時，並行推進傳統的 CMC 工作，包含對這些製程進行驗證。

There may be some additional scale-up required. But since the process is now fixed and established, we would look at the validation process. We need to do a number of those validation budgets heading into the BLA filing. So those are really the major CMC activities remaining for the program. But in terms of manufacturing itself, the processes are completed and established. So pretty straightforward path to the BLA filing as pertains to the manufacturing specifically.

可能仍需要一些額外的放大生產。不過，由於製程目前已固定並建立，我們將著重於驗證流程。我們需要在 BLA 申報前完成多項驗證批次（validation batches）。因此，這些就是該計畫剩餘的主要 CMC 工作。但就製造本身而言，流程已完成並建立，所以就製造面向而言，通往 BLA 申報是一條相當直接的路徑。

We have reached the end of the question-and-answer session. I would like to turn the floor back to Frank Bedu-Addo for closing remarks.

我們已到達問答環節的結束。我想把時間交回給 Frank Bedu-Addo 作結語。

Thank you, operator. Combined with early data from our PDS01ADC program and expanded patent protection extending into the 2040s for PDS0101, we believe we have meaningful opportunities ahead as we continue to execute against our priorities for 2026. We look forward to updating you on our progress, and thank you very much again. Have a great day.

謝謝你，接線員。結合我們 PDS01ADC 計畫的早期數據，以及將 PDS0101 的專利保護延伸至 2040 年代的擴大專利布局，我們相信在持續推進 2026 年優先事項的同時，前方仍有具實質意義的機會。我們期待向各位更新我們的進展，也再次非常感謝。祝各位有美好的一天。

Thank you. This concludes today's conference, and you may disconnect your lines at this time. We thank you for your participation.

謝謝。今天的電話會議到此結束，您現在可以掛斷電話線。感謝各位的參與。