Oncternal Therapeutics Inc (ONCT) 2024 Q2 法說會逐字稿

Greetings, and welcome to the Oncternal Therapeutics second-quarter 2024 financial results call. (Operator Instructions) As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Richard Vincent, Chief Financial Officer. Thank you. You may begin.

您好，歡迎您參加 Oncternal Therapeutics 2024 年第二季財務業績電話會議。（操作員指示）謹此提醒，本次會議正在錄製中。現在我很高興向您介紹主持人，財務長理查德·文森特。謝謝。你可以開始了。

Thank you, Diego. Good afternoon, everyone, and thank you for joining us today. Joining me on the call this afternoon are our President and CEO, Dr. James Breitmeyer; and our CMO, Dr. Salim Yazji.

謝謝你，迭戈。大家下午好，感謝您今天加入我們。今天下午與我一起參加電話會議的是我們的總裁兼執行長 James Breitmeyer 博士；以及我們的首席行銷長 Salim Yazji 博士。

Today's call includes a business update and discussion of our second-quarter, ended June 30, 2024, financial results that were filed earlier today. Today's press release and a replay of today's call will be available on the Investor Relations section of Oncternal's website for at least the next 30 days.

今天的電話會議包括業務更新和對今天早些時候提交的截至 2024 年 6 月 30 日的第二季度財務業績的討論。今天的新聞稿和今天電話會議的重播將在至少未來 30 天內在 Oncternal 網站的投資者關係部分提供。

Please note that certain information discussed on today's call is covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act. We will be making forward-looking statements during this call about future events such as: our business and product development strategies, the timing of our clinical studies, planned interim data updates, regulatory filings, and our cash runway.

請注意，今天電話會議中討論的某些資訊受《私人證券訴訟改革法案》的安全港條款管轄。我們將在本次電話會議中就未來事件做出前瞻性陳述，例如：我們的業務和產品開發策略、臨床研究的時間表、計劃的中期數據更新、監管文件和我們的現金跑道。

Our actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with our business. These forward-looking statements should be considered in conjunction with, and are qualified by, the cautionary statements contained in today's press release and our SEC filings, including our Form 10-Q filed today and our previously filed Form 10-K for the full year ended December 31, 2023.

由於與我們業務相關的風險和不確定性，我們的實際結果可能與這些前瞻性陳述中明示或暗示的結果有重大差異。這些前瞻性陳述應與今天的新聞稿和我們向SEC 提交的文件（包括今天提交的10-Q 表格和之前提交的全年10-K 表格）中包含的警示性聲明結合起來考慮，並受到其限制。

This call contains time-sensitive information that is accurate only as of the date of this live broadcast, August 8, 2024. We undertake no obligation to revise or update any forward-looking statements to reflect events or circumstances occurring after the date of this call.

本次通話包含時間敏感訊息，僅截至本次直播之日（2024 年 8 月 8 日）準確。我們不承擔修改或更新任何前瞻性陳述以反映本次電話會議之後發生的事件或情況的義務。

With that, it is my pleasure to hand the call over to our CEO, Dr. Jim Breitmeyer.

至此，我很高興將電話轉交給我們的執行長 Jim Breitmeyer 博士。

Thank you, Rich, and good afternoon, everyone. At Oncternal, we are advancing two first-in-class clinical programs targeting cancers for patients with significant unmet medical needs. ONCT-534, our novel dual-action androgen receptor inhibitor, or DAARI, continues to advance through the dose escalation portion of the Phase 1/2 study, and we continue to see strong demand from investigators.

謝謝里奇，大家下午好。在 Oncternal，我們正在推動兩個針對癌症的一流臨床項目，以滿足醫療需求未滿足的患者的需求。ONCT-534 是我們的新型雙作用雄性激素受體抑制劑（DAARI），在 1/2 期研究的劑量遞增部分中繼續取得進展，我們繼續看到研究人員的強烈需求。

As a reminder, preclinical studies showed that ONCT-534 inhibited prostate cancer cells through both the ligand binding domain and the end terminal domain of the androgen receptor, and it also induced degradation of the androgen receptor. Thanks to this novel mechanism, we believe ONCT-534 may address key prostate cancer escape mechanisms from currently approved AR pathway inhibitors, such as enzalutamide and abiraterone, which include multiple LBD mutations as well as splice variants such as AR-V7.

提醒一下，臨床前研究表明，ONCT-534透過配體結合域和雄激素受體的末端域抑制前列腺癌細胞，並且還誘導雄激素受體的降解。由於這種新穎的機制，我們相信ONCT-534 可能會解決目前批准的AR 通路抑制劑（例如恩雜魯胺和阿比特龍）的關鍵前列腺癌逃脫機制，其中包括多個LBD 突變以及AR -V7 等剪接變異體。

The clinical trial is proceeding well. We have not observed any dose-limiting toxicities or other concerning side effects. And we recently announced that the sixth dosing cohort of the study is now fully enrolled. Patients in this cohort are receiving 1,200 milligrams of ONCT-534 administered orally once per day.

臨床試驗進展順利。我們尚未觀察到任何劑量限制性毒性或其他相關副作用。我們最近宣布，該研究的第六個給藥隊列現已全部入組。該隊列中的患者每天口服一次 1,200 毫克 ONCT-534。

The decision to move to this dose level was made by the study's safety review committee after reviewing data from the patients treated to date, including the third dose level of 600 milligrams 534 daily. We plan to share an initial clinical data update for ONCT-534 later in the third quarter.

該研究的安全審查委員會在審查了迄今為止接受治療的患者的數據後做出了轉向這一劑量水平的決定，其中包括第三劑量水平 600 毫克 534 每天。我們計劃在第三季稍後分享 ONCT-534 的初始臨床數據更新。

Now switching gears to ONCT-808, our autologous ROR1 targeting CAR-T product. Our Phase 1/2 study in patients with relapsed or refractory aggressive B-cell lymphoma, including patients who have failed previous CD19 CAR-T treatment, is enrolling in treating patients.

現在轉向 ONCT-808，我們的自體 ROR1 靶向 CAR-T 產品。我們針對復發或難治性侵襲性 B 細胞淋巴瘤患者（包括先前 CD19 CAR-T 治療失敗的患者）進行的 1/2 期研究正在招募治療患者。

There have been no dose-limiting toxicities observed in the current dosing cohort. We expect to report updated clinical results, including data from patients treated with the new dosing schedule in the fourth quarter of 2024.

在目前的劑量組中尚未觀察到劑量限制性毒性。我們預計將報告更新的臨床結果，包括 2024 年第四季接受新給藥方案治療的患者的數據。

With this, I now turn the call back to our CFO, Rich Vincent. Rich?

現在，我將電話轉回給我們的財務長 Rich Vincent。富有的？

Thank you, Jim. Our revenue is currently derived from research and development grants received from the NIH. Our grant revenue was $0.8 million for the second quarter ended June 30, 2024. Our total operating expenses for the second quarter ended June 30, 2024, were $9.7 million, including $1.4 million in non-cash, stock-based compensation expense.

謝謝你，吉姆。我們目前的收入來自美國國立衛生研究院 (NIH) 的研發資助。截至 2024 年 6 月 30 日的第二季度，我們的贈款收入為 80 萬美元。截至 2024 年 6 月 30 日的第二季總營運費用為 970 萬美元，其中包括 140 萬美元的非現金股票補償費用。

Research and development expenses totaled $6.6 million and general and administrative expenses totaled $3.1 million. Net loss for the second quarter was $8.6 million, or a net loss of $2.89 per share basic and diluted.

研究與開發費用總計 660 萬美元，一般及管理費用總計 310 萬美元。第二季淨虧損為 860 萬美元，即每股基本虧損和稀釋後淨虧損為 2.89 美元。

As of June 30, 2024, we had approximately 3 million shares of common stock outstanding, $21.4 million in cash, cash equivalents, and short-term investments, and no debt. We believe these funds will be sufficient to support our operations into the first quarter of 2025.

截至 2024 年 6 月 30 日，我們擁有約 300 萬股已發行普通股、2,140 萬美元現金、現金等價物及短期投資，無負債。我們相信這些資金將足以支持我們到 2025 年第一季的營運。

With respect to upcoming milestones, we are looking forward to the following updates: for ONCT-534, our lead DAARI product candidate, we expect to present initial clinical data in the third quarter of 2024, with additional data readouts in the fourth quarter of 2024. For ONCT-808, our ROR1 autologous CAR-T, we expect to report a clinical data update in the fourth quarter of 2024.

對於即將到來的里程碑，我們期待以下更新：對於我們的主要 DAARI 產品候選產品 ONCT-534，我們預計將在 2024 年第三季提供初始臨床數據，並在 2024 年第四季公佈更多數據。對於我們的 ROR1 自體 CAR-T ONCT-808，我們預計將在 2024 年第四季報告臨床數據更新。

With that, I will turn things back over to the operator for the Q&A portion of this afternoon's call. Diego?

這樣，我將把今天下午電話的問答部分的事情轉交給接線員。迭戈？

(Operator Instructions) Carl Byrnes, Northland Capital Markets.

（操作員說明）Carl Byrnes，Northland Capital Markets。

Thanks for the question and congratulations on the progress. With respect to the clinical data update for 534 in the third quarter or late third quarter, to be specific, what's -- what do you expect -- what should we be expecting there?

感謝您的提問並祝賀您的進展。關於第三季或第三季末 534 的臨床數據更新，具體來說，您期望什麼 – 我們應該期待什麼？

So safety data, which would be inclusive of the 1,200 milligram dose? Would we be also potentially expecting PSA reduction numbers? And if so, would that be through the first cohorts or all the cohorts? And then I have a follow-up as well. Thanks.

那麼安全數據包括 1,200 毫克劑量嗎？我們是否也可能預期 PSA 數量會減少？如果是這樣，是透過第一批還是所有隊列？然後我也有後續行動。謝謝。

Go ahead, Salim.

繼續吧，薩利姆。

Yeah, Carl. So I mean with regards to what we would expect, we would expect to present a safety data for sure and plus some of the PSA parameters probably will be in early ones because based on the follow-up period will be not too long.

是的，卡爾。所以我的意思是，就我們的期望而言，我們肯定會期望提供安全數據，加上一些 PSA 參數可能會處於早期階段，因為基於追蹤期不會太長。

Great. And then the additional clinical data in the fourth quarter, what might that consist of? Thanks.

偉大的。那麼第四季的額外臨床數據可能包括哪些內容？謝謝。

So in the first quarter, the additional clinical data will be probably more of a longer follow-up, more cohorts, I mean if we have. So I think we'll be more advanced than what we're going to be showing in the third quarter.

因此，在第一季度，額外的臨床數據可能更多是更長的追蹤時間、更多的隊列，我的意思是，如果我們有的話。所以我認為我們將比第三季展示的更加先進。

Got it. And then finally, with respect to 808, how many patients, if you could disclose, have been enrolled in with the update that you anticipate in the fourth quarter, how many subjects might that be covered? Thanks.

知道了。最後，關於 808，如果您能透露的話，您預計第四季度的更新已登記了多少患者，可能會涵蓋多少科目？謝謝。

Carl, we haven't disclosed the enrollment on the CAR-T program yet. But I think as you know and as we show in our corporate deck, we have -- we revised the dosing regimen with the CAR-T, which we found were very active, very active T cells. And we have enrolled patients under the revised amended dosing scheme, and we're not seeing any dose-limiting toxicity.

Carl，我們還沒有透露 CAR-T 計畫的招募。但我認為正如你所知，正如我們在公司簡報中所展示的那樣，我們修改了 CAR-T 的給藥方案，我們發現 CAR-T 是非常活躍的 T 細胞。我們已經根據修訂後的劑量方案招募了患者，我們沒有看到任何劑量限制性毒性。

Great. Thanks again and congratulations on the progress.

偉大的。再次感謝並恭喜取得的進展。

Okay. Thank you.

好的。謝謝。

Kemp Dolliver, Brookline Capital Markets.

Kemp Dolliver，布魯克林資本市場。

Great. Thank you. With regard to 534 and this question is admittedly speculative but is there any possibility you would move to higher dosing cohorts after you get the data, particularly from the sixth cohort?

偉大的。謝謝。關於 534，這個問題無疑是推測性的，但在獲得數據後，您是否有可能轉向更高劑量的隊列，特別是來自第六隊列的數據？

So, Kemp, it's a great question. And so we're collecting a lot of data on these patients. And so we have pharmacokinetic data and we've got some interesting and novel biomarker work that we're doing, and then, of course, the efficacy and the safety. And so, decisions about dose levels for any additional cohorts will be made with the scientific review committee based on the totality of available data.

所以，坎普，這是一個很好的問題。因此，我們正在收集有關這些患者的大量數據。因此，我們有藥物動力學數據，我們正在進行一些有趣且新穎的生物標記工作，當然還有功效和安全性。因此，關於任何其他隊列的劑量水平的決定將由科學審查委員會根據現有數據的總體情況做出。

Okay. That's helpful. And then, again, on the same theme, are there any practical limits with regard to administration if you go to higher doses?

好的。這很有幫助。然後，同樣的主題，如果您服用更高的劑量，在給藥方面是否有任何實際限制？

So we have -- we're using a 200-milligram tablet and so it is perfectly feasible to give more than six tablets a day for -- if the data suggests that we should go higher.

因此，我們正在使用 200 毫克的片劑，因此，如果數據顯示我們應該增加劑量，那麼每天服用超過 6 片是完全可行的。

Great. That's all I have for the moment. Thank you.

偉大的。這就是我目前所擁有的一切。謝謝。

Thank you, Kemp.

謝謝你，坎普。

And there are no further questions at this time. I'll hand the floor back to Dr. James Breitmeyer for closing remarks.

目前沒有其他問題。我將把發言權交還給詹姆斯·布萊特邁耶博士作結束語。

Thank you, Diego. So, as you can tell, we remain encouraged with the Phase 1 results from our clinical programs and are looking forward to clinical data updates with you in the coming months. So I'd like to thank you for joining us today, and we look forward to updating you throughout this year. Thank you and good afternoon.

謝謝你，迭戈。因此，如您所知，我們對臨床計畫的第一階段結果仍然感到鼓舞，並期待在未來幾個月與您一起更新臨床數據。因此，我要感謝您今天加入我們，我們期待今年為您提供最新資訊。謝謝你，下午好。

This concludes today's conference. All parties may disconnect. Have a great evening.

今天的會議到此結束。所有各方都可以斷開連接。祝您有個美好的夜晚。