Inhibikase Therapeutics Inc (IKT) 2023 Q2 法說會逐字稿

Good morning. Welcome to the Inhibikase Therapeutics second-quarter 2023 financial results conference call. All participants will be in listen-only mode.

早安.歡迎參加 Inhibikase Therapeutics 2023 年第二季財務業績電話會議。所有參與者將處於僅聽模式。

(Operator Instructions) Please note, this event is being recorded.

（操作員說明）請注意，正在記錄此事件。

I would now like to turn the conference over to Alex Lobo, Stern Investor Relations. Please go ahead.

我現在想將會議交給斯特恩投資者關係部的 Alex Lobo。請繼續。

Good morning, and welcome to Inhibikase Therapeutics second-quarter 2023 financial results conference call and audio webcast.

早安，歡迎來到 Inhibikase Therapeutics 2023 年第二季財務業績電話會議和音訊網路廣播。

With me today is Dr. Milton Werner, Chief Executive Officer; (technical difficulty), Chief Financial Officer. On Monday, August 14, 2023, Inhibikase issued a press release announcing financial results for the second quarter ended June 30, 2023.

今天與我在一起的是執行長 Milton Werner 博士； （技術難度），財務長。 2023年8月14日星期一，Inhibikase發布新聞稿，宣布截至2023年6月30日的第二季財務業績。

We encourage everyone to read yesterday's press release as well as Inhibikase's quarterly report on Form 10-Q, which has been filed with the SEC. The company's press releases -- press release and quarterly report are also available on Inhibikase's website at inhibikase.com.

我們鼓勵大家閱讀昨天的新聞稿以及 Inhibikase 已向 SEC 提交的 10-Q 表格季度報告。該公司的新聞稿—新聞稿和季度報告也可在 Inhibikase 的網站 inhibikase.com 上取得。

In addition, this conference call is being webcast through the Investor Relations' section of the company's website and will be archived there for future reference.

此外，本次電話會議正在透過公司網站的投資者關係部分進行網路直播，並將存檔以供日後參考。

Please note that certain information discussed on today's call is covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995.

請注意，今天電話會議中討論的某些資訊受 1995 年《私人證券訴訟改革法案》的安全港條款管轄。

Participants are cautioned that this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, August 15, 2023. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business.

請參與者註意，本次電話會議包含時間敏感信息，僅截至本次直播之日（2023 年8 月15 日）準確。由於風險和影響，實際結果可能與這些前瞻性聲明中明示或暗示的結果存在重大差異。與公司業務相關的不確定性。

Information on potential risks and uncertainties are set forth in our most recent public filings with the SEC at sec.gov. The company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this webcast, except as maybe required by applicable securities law.

有關潛在風險和不確定性的資訊已在我們最近向 SEC 提交的 sec.gov 公開文件中列出。本公司不承擔修改或更新任何前瞻性聲明以反映本網路廣播日期之後的事件或情況的義務，除非適用的證券法可能要求。

With that said, I would now like to turn the call over to Dr. Milton Werner. Milton, you may begin.

話雖如此，我現在想將電話轉給米爾頓·維爾納博士。米爾頓，你可以開始了。

Thank you, Alex, and thank you, everyone, for joining us today for Inhibikase Therapeutics second-quarter 2023 earnings call.

謝謝 Alex，也謝謝大家今天加入我們參加 Inhibikase Therapeutics 2023 年第二季財報電話會議。

We are pleased with the progress we have made across our clinical programs in the first half of this year. Our Phase 2 201 trial using IkT-148009 to treat Parkinson's disease is screening and enrolling patients across 22 of up to 35 planned sites with the first patient (technical difficulty) 12-week dosing regimen.

我們對今年上半年臨床計畫的進展感到高興。我們使用 IkT-148009 治療帕金森氏症的 2 201 期試驗正在篩選和招募多達 35 個計畫中心中的 22 個中心的患者，其中第一位患者（技術難度）接受 12 週的給藥方案。

Additionally, this quarter, we launched a public awareness campaign through the201trial.com that we believe will enable us to continue to drive enrollment in the trial. The trial website is being augmented with outreach to patient advocacy groups, caregiver networks, foundations, and social media advertising throughout the United States.

此外，本季度，我們透過 the201Trial.com 發起了一項公眾意識活動，我們相信這將使我們能夠繼續推動試驗的註冊人數。該試驗網站正在透過向美國各地的患者倡導團體、護理人員網路、基金會和社交媒體廣告進行宣傳來擴大。

In June, we completed the pivotal phase of the 501 trial evaluating bioequivalence between IkT-001Pro commercial 400 milligram imatinib mesylate. Following agreements with the FDA, we are contemplating to evaluate the bioequivalent does between IkT-001Pro and high-dose 600 milligram imatinib mesylate to further explore the potential safety benefit of IkT-001Pro delivery of imatinib. High dose imatinib mesylate is in common use for the treatment of CML, but poorly tolerated by most patients, a shortcoming that IkT-001Pro may overcome.

6 月，我們完成了 501 試驗的關鍵階段，評估 IkT-001Pro 商用 400 毫克甲磺酸伊馬替尼之間的生物等效性。在與 FDA 達成協議後，我們正在考慮評估 IkT-001Pro 和高劑量 600 毫克甲磺酸伊馬替尼之間的生物等效劑量，以進一步探索 IkT-001Pro 輸送伊馬替尼的潛在安全益處。高劑量甲磺酸伊馬替尼常用於治療 CML，但大多數患者耐受性差，IkT-001Pro 可以克服此缺點。

We plan to release the full data description from the pivotal phase of our 501 trial in the near term. Upon completion of the study, we plan on engaging the FDA to discuss the parameters of drug approval under the 505(b)(2) regulatory pathway.

我們計劃在近期發布 501 試驗關鍵階段的完整資料描述。研究完成後，我們計劃與 FDA 合作討論 505(b)(2) 監管途徑下藥物核准的參數。

In addition to these clinical accomplishments, we continue to expand our expertise in drug delivery, not only with IkT-001Pro, but also now with IkT-148009. The development of a commercial tablet formulation of IkT-009 -- IkT-148009 has nearly doubled the efficiency of drug delivery for IkT-148009, providing the opportunity to lower the therapeutic dose and improved safety as well as consistently deliver the dose each and every day to ensure continuous therapeutic benefit from once daily dosing.

除了這些臨床成就之外，我們還繼續擴大我們在藥物傳遞方面的專業知識，不僅是 IkT-001Pro，現在還包括 IkT-148009。 IkT-009——IkT-148009商業片劑配方的開發使IkT-148009的藥物遞送效率幾乎翻倍，提供了降低治療劑量和提高安全性以及每次持續遞送劑量的機會日，以確保每天一次給藥的持續治療效果。

Before I turn the call over to Joe to review our financial results, I would like to touch on our preclinical efforts and other neurodegenerative diseases.

在我打電話給喬審查我們的財務表現之前，我想談談我們的臨床前工作和其他神經退化性疾病。

Multiple system atrophy or MSA is a rare Parkinson's related disease that is rapidly progressive -- that is a rapidly progressive neurodegenerative movement disorder of central and autonomic nervous systems. Currently, we are evaluating MSA in two models. One that measures the ability of IkT-148009 to block progression earlier in the course of MSA, an effective model that evaluates the therapeutic potential to correct functional loss and neurodegeneration late in the course of the disease.

多系統萎縮症（MSA）是一種罕見的帕金森氏症相關疾病，進展迅速，是一種中樞和自主神經系統快速進展的神經退化性運動障礙。目前，我們正在評估兩種模型的 MSA。此模型測量 IkT-148009 在 MSA 病程早期阻斷進展的能力，這是一種有效的模型，可評估矯正病程後期功能喪失和神經退化的治療潛力。

The first MSA model study is nearing completion and has demonstrated that treatment with IkT-148009 for 20 weeks prevented functional loss and preserved neural anatomy in mice when IkT-148009 is given orally once daily. Functional benefit in this model was accomplished by substantial reduction in the underlying alpha-synuclein pathology. Evaluation of the effective IkT-148009 when treatment begins late in the course of disease remains ongoing, and we expect to complete that study by the end of 2023.

第一項 MSA 模型研究已接近完成，並證明每天口服一次 IkT-148009 後，以 IkT-148009 治療 20 週可防止小鼠功能喪失並保留神經解剖結構。此模型中的功能益處是透過顯著減少潛在的 α-突觸核蛋白病理學來實現的。在病程晚期開始治療時 IkT-148009 的有效性的評估仍在進行中，我們預計在 2023 年底之前完成研究。

These studies will form the basis of our planned Phase 2 clinical study of IkT-148009 in MSA. We look forward to providing further updates on these studies and potential timing of the planned Phase 2 trial in the coming quarters.

這些研究將構成我們計劃的 IkT-148009 在 MSA 中的 2 期臨床研究的基礎。我們期待在未來幾季提供這些研究的進一步更新以及計劃的第二階段試驗的可能時間表。

I will now turn it over to our Chief Financial Officer, Joe Frattaroli, to review our financial results for the quarter. Joe?

我現在將把它交給我們的財務長 Joe Frattaroli，以審查我們本季的財務表現。喬？

Thank you, Milton. Before I review our financial results, I'd like to highlight that we recently received notice from the listing qualification staff of the Nasdaq stock market, indicating that we had regained full compliance with the minimum bid price requirement of $1 per share on the Nasdaq Listing Rule 5550(a)(2). Regaining compliance allows us to move forward and work to generate meaningful clinical data that will ultimately drive value for our shareholders.

謝謝你，米爾頓。在回顧我們的財務表現之前，我想強調的是，我們最近收到了納斯達克股票市場上市資格工作人員的通知，表明我們已完全符合納斯達克上市每股 1 美元的最低投標價格要求規則5550(a)(2)。重新獲得合規性使我們能夠繼續前進並努力產生有意義的臨床數據，最終為我們的股東帶來價值。

Now let me review our financial results for the three months ended June 30, 2023. For the second-quarter 2023, we reported a net loss of $5.8 million or $1.11 per share compared to a net loss of $4.6 million or $1.10 per share in the quarter ended June 30, 2022.

現在讓我回顧一下我們截至2023 年6 月30 日的三個月的財務業績。對於2023 年第二季度，我們報告的淨虧損為580 萬美元，即每股1.11 美元，而2023 年第二季度的淨虧損為460 萬美元，即每股1.10 美元。截至 2022 年 6 月 30 日的季度。

Research and development expenses were $4.5 million for the quarter ended June 30, 2023, compared to $3 million for the quarter ended June 30, 2022. The increase was primarily due to the company's ongoing Phase 2 201 PD clinical trial costs and IkT-001Pro for CML programs.

截至2023 年6 月30 日的季度研發費用為450 萬美元，而截至2022 年6 月30 日的季度研發費用為300 萬美元。這一增長主要是由於該公司正在進行的2 期201 PD 臨床試驗成本以及IkT-001Pro 的CML 程式。

Selling, general, and administrative expenses were $1.8 million for the quarter ended June 30, 2023, compared to $1.7 million for the quarter ended June 30, 2022. The increase was driven by a net increase in normal selling, general, and administrative expenses.

截至2023 年6 月30 日的季度，銷售、一般和管理費用為180 萬美元，而截至2022 年6 月30 日的季度為170 萬美元。這一增長是由正常銷售、一般和管理費用淨增長推動的。

As of June 30, 2023, we had approximately $20.9 million in cash and cash equivalents. We expect that existing cash and cash equivalents will be sufficient to fund operations into the fourth quarter of 2024.

截至 2023 年 6 月 30 日，我們擁有約 2,090 萬美元的現金及現金等價物。我們預計現有現金和現金等價物將足以為 2024 年第四季的營運提供資金。

That concludes our review of our financial statements. I'd like to hand the call back over to Milton for closing remarks.

我們對財務報表的審查到此結束。我想將電話轉回米爾頓做總結發言。

Thank you, Joe. We continue to demonstrate the value of c-Abl ambition of therapeutic paradigm for treatment of neurodegenerative disease and the safety profile of our lead c-Abl inhibitor IkT-148009 remains promising.

謝謝你，喬。我們繼續證明 c-Abl 治療神經退化性疾病治療範式的價值，並且我們的主要 c-Abl 抑制劑 IkT-148009 的安全性仍然充滿希望。

We look forward to reporting the outcomes of 201 trial and to share our plans for future trials in Parkinson's disease and multiple system atrophy.

我們期待報告 201 項試驗的結果，並分享我們未來帕金森氏症和多系統萎縮試驗的計劃。

We'd like to thank our site investigators, our partners, and our shareholders for their continued support as we seek to transform the treatment paradigm for neurodegenerative diseases.

我們要感謝我們的現場調查人員、合作夥伴和股東在我們尋求改變神經退化性疾病治療模式時給予的持續支持。

I'd now like to open the call to questions. Operator?

我現在想開始提問。操作員？

(Operator Instructions) Ed White, H.C. Wainwright.

（操作員說明）Ed White, H.C.溫賴特。

So on the Phase 2 201 trial, you said screening is ongoing at 22 sites. How many sites have enrolled patients so far? And can you just tell us about the screening process? Is the number of patients coming in meeting your expectations?

因此，在第 2 201 階段試驗中，您說篩檢正在 22 個地點進行。到目前為止，有多少個網站已經招募了病人？您能告訴我們篩選過程嗎？前來就診的患者數量符合您的預期嗎？

Well, so first of all, this is a challenging patient population, the untreated Parkinson patients, since the advent of COVID in United States, has driven many patients who are diagnosed with Parkinson's disease into telehealth appointments, and that has led physicians to start treatment much earlier than they had previously done often much sooner than patients actually require when other medical interventions such as exercise and the physical therapy with better benefit patients during the course of the disease.

嗯，首先，這是一個具有挑戰性的患者群體，自從新冠病毒在美國出現以來，未經治療的帕金森患者已經促使許多被診斷患有帕金森氏症的患者進行遠距醫療預約，這導致醫生開始治療比他們以前做的要早得多，通常比患者實際需要的要早得多，因為其他醫療幹預措施（例如運動和物理治療）在疾病過程中可以更好地使患者受益。

So we've not yet provided guidance on the enrollment rate for the number of sites that enrolling patients because we want to see how that the implementation of all of our patient outreach activities over the last six weeks and into the fall really bear fruit. I think we've guided that we will be providing that guidance closer to the next quarterly report.

因此，我們尚未提供有關註冊患者的站點數量的註冊率指導，因為我們希望了解過去六週和秋季之前所有患者外展活動的實施如何真正取得成果。我認為我們已經指導我們將在接近下一個季度報告時提供該指導。

Okay. Thanks, Milton. And on the 501 trial for IkT-001Pro, you had stated that following discussions with the FDA, you are considering a high dose bioequivalence cohort. Maybe you can just review some of the pros and cons that you are considering when thinking about running that cohort?

好的。謝謝，米爾頓。在 IkT-001Pro 的 501 試驗中，你們曾表示，在與 FDA 討論後，你們正在考慮進行高劑量生物等效性隊列。也許您可以回顧一下在考慮管理該群體時所考慮的一些優點和缺點？

Well, so we had to have a discussion with the FDA related to safety, so that the norm in the oncology division of FDA these days is often to do Phase 1 studies in the target population because many agents to treat cancer are quite toxic, unlike IkT-001Pro. And so it takes some work with the FDA to have them agree to do these studies in healthy subjects.

嗯，所以我們必須與 FDA 進行有關安全性的討論，所以現在 FDA 腫瘤學部門的規範往往是在目標人群中進行 1 期研究，因為許多治療癌症的藥物具有相當大的毒性，不像IkT-001Pro 。因此，需要與 FDA 進行一些合作才能讓他們同意在健康受試者中進行這些研究。

We have agreement with the agency to do things as single doses. We did that in both the dose escalation and pivotal trials in the 501 study so far. And the FDA has agreed to allow us to do the same in the next cohort for a limited number of patients.

我們與該機構達成協議，以單一劑量的方式進行操作。到目前為止，我們在 501 研究的劑量遞增和關鍵試驗中都做到了這一點。 FDA 已同意允許我們在下一個隊列中對有限數量的患者進行同樣的操作。

The 600-milligram dose is generally in wide use by many clinicians who are treating patients for CML, but it's also very poorly tolerated. And so the agency has agreed to design that similar to what we did in the dose escalation phase, eight subjects, single dose with a full PK description, and a full safety description.

600 毫克劑量通常被許多治療 CML 患者的臨床醫生廣泛使用，但其耐受性也很差。因此，該機構同意設計類似於我們在劑量遞增階段所做的那樣，八名受試者，單劑量，具有完整的 PK 描述和完整的安全性描述。

And so that's what we're contemplating the addition of. We're just going through all of the nuances and details of the safety profile from the 31 subject pivotal trial that has been completed as has the pharmacokinetic analysis. We should be releasing those results very shortly in detail.

這就是我們正在考慮添加的內容。我們只是從 31 名受試者的關鍵試驗中回顧安全性的所有細微差別和細節，該試驗已完成，藥物動力學分析也已完成。我們應該很快就會詳細發布這些結果。

Okay. Thanks, Milton. And my last question is just on expenses. How should we be thinking of R&D expenses into the second half of the year where you have patients enrolling in the 201 trial, and then the potential for this IkT-001Pro high-dose cohort?

好的。謝謝，米爾頓。我的最後一個問題只是關於費用。我們應該如何考慮下半年的研發費用，當您有患者參加 201 試驗時，以及 IkT-001Pro 高劑量隊列的潛力？

Well, all of our current activities are part of our existing budget. So we don't have a concern that the burn rate will increase and exceed our current resources. So that's the question you're asking. I don't know, Joe, if you have additional color you want to add.

嗯，我們目前的所有活動都是現有預算的一部分。因此，我們不擔心燃燒率會增加並超過我們目前的資源。這就是你問的問題。我不知道，喬，您是否還有想要添加的其他顏色。

Yeah, I mean that's exactly it. All of the budgeted items are contemplated in our present cash forecast. When it will flow out will be dependent in part on the rate of enrollment, right, which we are still assessing.

是的，我的意思是就是這樣。我們目前的現金預測中考慮了所有預算項目。它何時流出將部分取決於入學率，對吧，我們仍在評估。

Okay, great. Thanks for taking my question.

好的，太好了。感謝您提出我的問題。

Sure. Thanks, Ed.

當然。謝謝，艾德。

Thanks, Ed.

謝謝，艾德。

This concludes our question-and-answer session. I would like to turn the conference back over to Dr. Milton Werner for any closing remarks.

我們的問答環節到此結束。我想將會議轉交米爾頓·沃納博士發表閉幕詞。

Thank you, everyone, for participating in our earnings call for the second quarter. This is obviously a challenging time in the public markets. Our financial picture remains strong and consistent, and we remain on track with our overall goals of reading out the current trial work in 501 shortly and in the 201 trial in the coming year and look forward to how those outcomes will further inform our ability to control neurodegenerative diseases and other diseases that can be treated by c-Abl kinase inhibitors.

感謝大家參加我們第二季的財報電話會議。對於公開市場來說，這顯然是一個充滿挑戰的時期。我們的財務狀況仍然強勁且一致，我們仍然在實現我們的總體目標，即短期內宣讀當前的 501 試驗工作和來年的 201 試驗，並期待這些結果將如何進一步告知我們的控制能力神經退化性疾病和其他可以透過c-Abl 激酶抑制劑治療的疾病。

Thank you for your attention.

感謝您的關注。

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

會議現已結束。感謝您參加今天的演講。您現在可以斷開連線。