InMed Pharmaceuticals Inc (INM) 2022 Q4 法說會逐字稿

Good day and thank you for standing by. Welcome to the InMed Pharmaceuticals' fourth-quarter fiscal 2022 financial results and business update conference call. (Operator Instructions)

您好，感謝您的支持。歡迎參加 InMed Pharmaceuticals 2022 財年第四季財務業績和業務更新電話會議。 （操作員指令）

Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Colin Clancy, Vice President of Investor Relations.

請注意，今天的會議正在錄音。現在，我想將會議交給今天的發言人、投資者關係副總裁 Colin Clancy。

Thank you, Norma, and good day, ladies and gentlemen. My name is Colin Clancy, InMed's Vice President of Investor Relations. Welcome to InMed's fiscal year and 2022 financial results and business update conference call.

謝謝你，諾瑪。我叫 Colin Clancy，是 InMed 的投資人關係副總裁。歡迎參加 InMed 財年和 2022 年財務表現和業務更新電話會議。

Please note our speakers are joining today from remote locations, so we appreciate your patience if we encounter any unexpected technical challenges.

請注意，我們的演講者今天是從遠端地點加入的，因此如果我們遇到任何意外的技術挑戰，我們將感謝您的耐心。

Before we begin, we would like to go over our disclosure statements, followed by a progress report on our pharmaceutical drug development program, led by our President and CEO, Eric Adams, together with an update on our health and wellness commercial activities, which will be provided by Michael Woudenberg, our Chief Operating Officer. Ms. Brenda Edwards, our Interim Chief Financial Officer, will then review the financial results of operations. Following this, we will be available for question-and-answer session.

在開始之前，我們想先介紹一下我們的披露聲明，然後介紹一下由我們的總裁兼首席執行官 Eric Adams 領導的藥物開發計劃的進展報告，以及我們健康和保健商業活動的最新情況，這將由我們的營運長Michael Woudenberg 提供。我們的臨時財務長 Brenda Edwards 女士將審查財務營運結果。隨後，我們將進行問答環節。

Also joining us today to address your questions is Dr. Eric Hsu, Senior Vice President of Preclinical Research and Development.

今天與我們一起解答大家問題的還有臨床前研究與發展資深副總裁 Eric Hsu 博士。

Please be advised that certain statements in the following conference call, including expectations for InMed's business operations, clinical development, key personnel, contractual arrangements, regulatory approvals, revenue opportunities, financing and cash runway, all constitute forward-looking statements. Such statements are not historical facts, but rather predictions about the future, which inherently involve assumptions, risks, and uncertainties. Actual results may differ materially from those contained in the forward-looking statements. A description of these risks can be found in our latest disclosure document. InMed does not undertake any obligation to update any forward-looking statements made during this call.

請注意，以下電話會議中的某些聲明，包括對 InMed 的業務運營、臨床開發、關鍵人員、合約安排、監管批准、收入機會、融資和現金流量的預期，均構成前瞻性陳述。這些陳述不是歷史事實，而是對未來的預測，其中固有涉及假設、風險和不確定性。實際結果可能與前瞻性陳述中的結果有重大差異。這些風險的描述可以在我們最新的揭露文件中找到。 InMed 不承擔更新本次電話會議中任何前瞻性陳述的義務。

I would now like to turn over to InMed's President and CEO, Eric Adams. Eric?

現在我想把發言權交給 InMed 總裁兼執行長 Eric Adams。埃里克？

Thanks, Colin, and thank you to everyone for joining us today. Since our last earnings call, there have been several significant and eventful changes both in relation to operations and on the corporate level. We have seen several macro socio-economic issues in 2022, including increasing recessionary pressures, the largest inflation growth in decades, the ongoing war in Ukraine, as well as the slow emergence from the COVID pandemic. All of which have had a direct and considerable impact on many businesses as well as the global stock market. q

謝謝，科林，也謝謝大家今天的參加。自從我們上次召開財報電話會議以來，在營運和公司層面都發生了一些重大且多事的變化。 2022 年，我們看到了若干宏觀社會經濟問題，包括經濟衰退壓力加大、幾十年來通膨率創下最大增幅、烏克蘭戰爭持續不斷以及新冠疫情復甦緩慢。所有這些都對許多企業以及全球股市產生了直接而重大的影響。問

Specifically, in 2022, we've seen the worst stock market performance for biotech companies in decades, causing significant challenges in the capital markets, especially for small-cap pharmaceutical R&D companies that rely on investment to advance clinical development and other programs. InMed has not been immune to these overarching influences.

具體而言，2022年，我們見證了生物科技公司幾十年來最糟糕的股市表現，為資本市場帶來了重大挑戰，尤其是對依賴投資推進臨床開發和其他項目的小型製藥研發公司而言。 InMed 也未能免於這些整體影響。

That said, InMed has managed to navigate these headwinds and gained positive momentum across our operations and continue to advance our preclinical and clinical programs, especially our Phase 2 clinical trial for the treatment of EB.

儘管如此，InMed 已成功克服這些不利因素，並在整個運作中獲得了積極的勢頭，並繼續推進我們的臨床前和臨床項目，特別是我們針對 EB 治療的 2 期臨床試驗。

On a corporate level, we have had several capital market-related events, including two recent financing to bolster our balance sheet to ensure we have sufficient capital to execute on our programs.

在公司層面，我們經歷了幾次與資本市場相關的事件，包括最近的兩次融資，以增強我們的資產負債表，確保我們有足夠的資本來執行我們的專案。

Let me start with discussing our pharmaceutical drug development programs, beginning with INM-755 for epidermolysis bullosa or EB. For those of you who are new to the study, InMed is evaluating the safety of INM-755 cannabinol cream and its preliminary efficacy in treating symptoms and wound healing over a 28-day treatment period in individuals diagnosed with EB.

讓我先討論一下我們的藥物開發計劃，首先是用於治療大皰性表皮鬆解症（EB）的 INM-755。對於剛參與研究的人來說，InMed 正在評估 INM-755 大麻酚乳膏的安全性及其在 28 天治療期內治療 EB 患者症狀和傷口癒合的初步療效。

The study is designed to enroll up to 20 patients and marks the first time that cannabinol, also known as CBN, has advanced into a Phase 2 clinical trial to be investigated as a therapeutic option to treat this specific disease.

該研究旨在招募多達 20 名患者，標誌著大麻酚（也稱為 CBN）首次進入 2 期臨床試驗，以研究其作為治療這種特定疾病的治療選擇。

InMed's Phase 2 clinical trial now has nine clinical trial sites fully activated to screen and enroll patients. Two more sites are expected to be fully activated soon. The clinical trial is taking place in seven countries, including Austria, Germany, Greece, France, Italy, Israel, and Spain.

InMed 的第 2 期臨床試驗目前已有 9 個臨床試驗地點全面啟動，以篩選和招募病患。預計另外兩個站點也將很快全面投入使用。臨床試驗在奧地利、德國、希臘、法國、義大利、以色列和西班牙等七個國家進行。

This Phase 2 clinical trial continues to progress. Since our last call, patient screening and enrollment continued, and nine patients have been enrolled and completed the study. Following a period of downtime during the summer months, patient screening and enrollment have now recommenced.

該2期臨床試驗正在持續進展中。自上次通話以來，患者篩選和招募工作仍在繼續，目前已有 9 名患者招募並完成了研究。經過夏季的一段時間的停工後，患者篩檢和登記現已重新開始。

In the fourth fiscal quarter, based on safety data of the first five adult patients who completed treatment, an independent data monitoring committee agreed it was safe to enroll adolescent patients defined as persons aged 12 to 17 into our trial. The first adolescent patient for EB has been enrolled into the clinical trial and has completed treatment at the clinical site in Greece during the summer.

在第四財季，根據前五名完成治療的成年患者的安全數據，獨立數據監測委員會同意將青少年患者（定義為 12 至 17 歲的人）納入我們的試驗是安全的。第一位 EB 青少年患者已參加臨床試驗，並於夏季在希臘臨床基地完成治療。

The company anticipates that the inclusion of adolescents will have a positive impact on the enrollment rate for the remainder of the clinical trial. As a result, we expect enrollment into the trial to complete during the calendar year 2021 and a data readout expected in the first quarter of calendar 2023.

該公司預計，青少年的加入將對臨床試驗剩餘部分的入組率產生正面影響。因此，我們預計試驗招募將於 2021 日曆年內完成，數據預計將於 2023 日曆年第一季讀取。

Now turning to INM-088. The company continues to advance its preclinical research on CBN as treatment for glaucoma. In the fourth fiscal quarter, the company completed three investigational new drug application discussions with the US Food and Drug Administration regarding manufacturing, preclinical studies, and early clinical development plans for INM-088.

現在轉向 INM-088。該公司繼續推進 CBN 治療青光眼的臨床前研究。在第四財季，該公司與美國食品藥物管理局完成了三項新藥研究申請討論，涉及INM-088的製造、臨床前研究和早期臨床開發計劃。

We gained alignment on the design of the initial Phase 1-2 clinical trial and gathered preliminary data on the safety and efficacy of INM-088 treatment for glaucoma. We continue to work towards completing the necessary preclinical studies in anticipation of an investigational new drug application filing in the first half of calendar year 2024, seeking regulatory permission to initiate a human clinical trial.

我們就初步 1-2 期臨床試驗的設計達成了一致，並收集了 INM-088 治療青光眼的安全性和有效性的初步數據。我們將繼續努力完成必要的臨床前研究，以期在 2024 年上半年提交新藥試驗申請，尋求監管部門的許可啟動人體臨床試驗。

I'd now like to speak to our work on neurodegenerative disease. As a pharma company, it is imperative that we continue to add to our pipeline. Therefore, I think it's important to point out that our pharmaceutical drug development program also includes exploring other rare cannabinoids and cannabinoid analogue for their therapeutic effects.

現在我想談談我們在神經退化性疾病方面的工作。作為一家製藥公司，我們必須繼續擴充我們的產品線。因此，我認為有必要指出，我們的藥物開發計劃還包括探索其他稀有大麻素和大麻素類似物的治療效果。

Last November, we filed an international patent application seeking commercial exclusivity for the potential treatment of important neurodegenerative diseases such as Alzheimer's disease, Parkinson's disease, Huntington's disease, and others by demonstrating neuroprotection and promotion of neurite growth in a population of affected neuronal cells using a different rare cannabinoid.

去年11 月，我們提交了一份國際專利申請，尋求商業獨佔權，用於治療阿茲海默症、帕金森氏症、亨廷頓氏症等重要的神經退化性疾病，透過使用一種藥物展示神經保護和促進受影響的神經元細胞群的神經突生長不同的稀有大麻素。

Since then, screening for this indication has yielded some meaningful analogue candidates, and we will continue with our plans to find an appropriate compound for continuing preclinical development.

自那時起，針對該適應症的篩選已經產生了一些有意義的類似物候選物，我們將繼續我們的計劃，尋找合適的化合物進行持續的臨床前開發。

Let's move over to our analogue strategy. Advancing the research and development of cannabinoid analogues remains a high priority for the company. In April, we announced the publication of a patent application in North America for several cannabinoid analogue. This patent application has broad claims directed to their molecular structure, uses, and methods of manufacturing. Such patent protection of the underlying molecule itself is an important component to ensure long-term commercial exclusivity as we continue to invest in R&D.

讓我們轉到我們的模擬策略。推進大麻素類似物的研究和開發仍然是該公司的首要任務。今年4月，我們宣佈在北美發布了幾種大麻素類似物的專利申請。該專利申請對其分子結構、用途和製造方法提出了廣泛的權利要求。在我們繼續投資研發的同時，對基礎分子本身進行這種專利保護是確保長期商業獨佔權的重要組成部分。

At the same time, we initiated an important research collaboration with Dr. Mauro Maccarrone at the University of L'Aquila in Italy. Dr. Maccarrone is international expert in cannabinoid research and a founding member of the European Cannabinoid Research Alliance. He is investigating the potential utility of a group of cannabinoid analogues in the treatment of ocular disease. Considering the enhanced commercial protections afforded with a proprietary patented analogue, this is an area where we intend to place additional focus in the coming years.

同時，我們與義大利拉奎拉大學的Mauro Maccarrone博士開展了重要的研究合作。 Maccarrone 博士是大麻素研究的國際專家，也是歐洲大麻素研究聯盟的創始成員。他正在研究一組大麻素類似物在治療眼部疾病的潛在用途。考慮到專有專利類似物所提供的增強的商業保護，我們打算在未來幾年將更多重點放在這一領域。

Now I'd like to hand over to our COO, Michael Woudenberg, who will provide an update on BayMedica's commercial activity. Mike?

現在，我想將麥克風交給我們的營運長 Michael Woudenberg，他將介紹 BayMedica 的商業活動的最新進展。麥克風？

Thanks, Eric. I'd like to take a few minutes to address our recent announcement on commercial operations. Since completing the acquisition of BayMedica in October 2021, our focus is launching new products and building our product portfolio of rare cannabinoids as well as developing cannabinoid analogues to support pharmaceutical drug development.

謝謝，埃里克。我想花幾分鐘談談我們最近關於商業營運的公告。自 2021 年 10 月完成對 BayMedica 的收購以來，我們的重點是推出新產品、建立我們的稀有大麻素產品組合以及開發大麻素類似物以支持藥物開發。

However, as we pointed out in the last quarterly update, rare cannabinoids in the health and wellness sector is still a nascent industry. For a variety of reasons, demand for rare cannabinoids has unfortunately not materialized as quickly as we anticipated, resulting in slower-than-expected revenue growth. In our assessments, some of the reasons include: recent overarching recessionary pressures and economic uncertainty has led to hesitation within the health and wellness sector to invest in and launch new rare cannabinoids products. The immature market is not ready for premium rare cannabinoids.

然而，正如我們在上一季更新中指出的那樣，健康和保健領域的稀有大麻素仍然是一個新興產業。由於各種原因，對稀有大麻素的需求不幸沒有像我們預期的那樣迅速實現，導致收入成長低於預期。我們評估認為，原因包括：近期總體經濟衰退壓力和經濟不確定性導致衛生和保健領域對於投資和推出新的稀有大麻素產品猶豫不決。不成熟的市場還沒準備好接受優質的稀有大麻素。

BayMedica's competitive advantage of certified high-purity and reliable and consistent supply is not resonating with the industry product manufacturers, and additional downward pricing pressure for cannabinoids in the health and wellness sector in general.

BayMedica 經過認證的高純度和可靠且穩定的供應的競爭優勢並沒有引起行業產品製造商的共鳴，並且給整個健康和保健領域的大麻素帶來了額外的下行價格壓力。

We do continue to believe a significant opportunity in this market segment. However, the timing and demand and product sales is currently highly uncertain. As a result, we will be reducing our efforts in the BayMedica's commercial activities.

我們確實繼續相信這一領域存在著巨大的機會。然而，目前時機、需求和產品銷售都存在著很大的不確定性。因此，我們將減少在 BayMedica 商業活動中的力度。

Currently, we continue to reduce inventory through existing sales and new business opportunities as well as continuing to convert existing work-in-progress inventory into commercial product.

目前，我們繼續透過現有銷售和新業務機會減少庫存，並繼續將現有的在製品庫存轉化為商業產品。

The company will continue to pursue strategic discussions for structured supply agreements and partial collaborations that make economic sense for BayMedica's high-end differentiators of quality, purity, and scalability. In addition, the BayMedica's scientific team will continue to support pharmaceutical drug development by advancing the work on the generation of proprietary cannabinoid analogues, which was a major part of the rationale for the acquisition of BayMedica in October of 2021.

該公司將繼續進行結構化供應協議和部分合作的策略討論，這對 BayMedica 的品質、純度和可擴展性的高端差異化具有經濟意義。此外，BayMedica 的科學團隊將繼續支持藥物開發，推動專有大麻素類似物的生成工作，這也是 2021 年 10 月收購 BayMedica 的主要原因。

That concludes the commercial update. I'll now hand back the call to Eric.

商業更新到此結束。我現在將電話交還給埃里克。

Thanks, Mike. Finally, I'd like to speak to recent capital markets and financing activities as well as cost-saving initiatives.

謝謝，麥克。最後，我想談談最近的資本市場和融資活動以及節省成本的舉措。

As mentioned earlier, 2022 has seen significant challenges in the capital markets, especially in the biotech space, where we have seen many companies either close their doors or offer sub-optimal strategic alternatives merely to survive. As a result, to ensure the company has sufficient capital to maintain operations, we implemented significant cost-saving measures across all divisions.

如前所述，2022 年資本市場面臨重大挑戰，尤其是在生技領域，我們看到許多公司要么倒閉，要么提供次優的策略替代方案只是為了生存。因此，為了確保公司有足夠的資金維持運營，我們在所有部門實施了重大的成本節約措施。

These initiatives included a reduction in total headcount and voluntary salary reductions for several members of management, resulting in a reduction of approximately 25% of our current workforce. This reduction in headcount, along with other expense reduction initiatives, are expected to result in human resource expense savings of approximately 30% on an annualized basis.

這些舉措包括減少員工總數和部分管理階層自願減薪，最終導致我們現有員工人數減少約 25％。此次裁員以及其他削減費用的措施預計將使人力資源費用年度化節省約 30%。

As part of these reductions, and as the leader of this organization, I have undertaken a voluntary 20% reduction in salary as compared to the previous year. Also, as part of these initiatives, no employee received an annual performance bonus for the fiscal year 2022.

作為減薪的一部分，身為組織的領導者，我自願承諾比前一年減薪 20%。此外，作為這些措施的一部分，沒有員工獲得 2022 財年的年度績效獎金。

The company also successfully executed a series of financing events to support our ongoing development programs. In June 2022, the company closed a registered direct offering and concurrent private placement for total proceeds of approximately $5 million. In August, the company announced a share consolidation of 1 to 25 in order to regain compliance with NASDAQ's continued listing requirements and subsequently receive a notification of compliance from the Exchange on September 21.

公司也成功執行了一系列融資活動，以支持我們正在進行的發展計畫。 2022 年 6 月，該公司完成了註冊直接發行和同時進行的私募，總收益約為 500 萬美元。 8月份，該公司宣布將股票合併為1股至25股，以重新符合納斯達克的持續上市要求，並隨後於9月21日收到交易所的合規通知。

Also recently, on September 13, 2022, the company closed an additional $6 million private placement to two healthcare-focused institutional investors to further bolster our balance sheet.

此外，最近，在 2022 年 9 月 13 日，該公司向兩家專注於醫療保健的機構投資者完成了額外的 600 萬美元私募，以進一步增強我們的資產負債表。

In terms of the outlook, in summary, despite many challenges and difficult decisions, we have continued to make considerable progress on our core business and pharmaceutical drug development. Over the next several months, shareholders should expect to see the following catalysts: completion of the Phase 2 clinical trial with a data readout expected in first quarter of calendar 2023; complete the IND-enabling toxicology program in the INM- 088 program for glaucoma by end of calendar year 2023; candidate selection for the neurodegenerative disease category in the second quarter of 2023; further execution on our preclinical R&D and patent strategies for proprietary cannabinoid analogues; and we will remain opportunistic to business development in the pharmaceutical drug R&D arena to build shareholder wealth.

展望方面，總而言之，儘管面臨許多挑戰和艱難的決定，但我們在核心業務和藥物開發方面仍繼續取得長足進展。在接下來的幾個月裡，股東應該會看到以下催化劑：完成第 2 階段臨床試驗，預計在 2023 年第一季讀取數據；在 2023 年底前完成 INM-088 青光眼計畫中的 IND 支持毒理學計畫； 2023年第二季神經退化性疾病類別的候選人選拔；進一步執行我們的專有大麻素類似物的臨床前研發和專利策略；我們將繼續抓住機遇，在藥品研發領域拓展業務，為股東創造財富。

On that note, I'd like to turn the call over to our Interim CFO, Brenda Edwards, to provide more information on our fourth-quarter fiscal 2022 financial results. Brenda?

關於這一點，我想將電話轉給我們的臨時財務長 Brenda Edwards，以提供有關我們 2022 財年第四季財務業績的更多資訊。布倫達？

Thank you, Eric, and thank you all for joining the call. By way of a reminder, and as Colin noted at the beginning of the call, we have a fiscal year-end of June 30. So as a consequence, these figures represent our fiscal year-end 2022 results. Please also note that our 10-K is available on our website as well as on sec.gov.com (sic - "sec.gov").

謝謝你，艾瑞克，也謝謝大家參加這次電話會議。提醒一下，正如科林在電話會議開始時指出的那樣，我們的財政年度結束於 6 月 30 日。另請注意，我們的 10-K 可在我們的網站以及 sec.gov.com（「sec.gov」）上取得。

Overall, for the year ended June 30, 2022, the company recorded a net loss of $18.6 million or $33.17 a share compared with a net loss of $10.2 million or $37.96 per share for the previous year.

總體而言，截至 2022 年 6 月 30 日的財政年度，該公司淨虧損 1,860 萬美元，即每股 33.17 美元，而上一年的淨虧損為 1,020 萬美元，即每股 37.96 美元。

R&D and patent expenses were approximately $7.3 million for the year compared with $5.3 million for the same period last year. The increase was primarily due to the inclusion of BayMedica operating result following the acquisition date and due to increased activities related to the 755 Phase 2 clinical trials.

本年度的研發和專利費用約為 730 萬美元，而去年同期為 530 萬美元。成長的主要原因是收購日後納入了 BayMedica 經營業績，以及與 755 項 2 期臨床試驗相關的活動增加。

Turning now to general and admin expenses. G&A expenses were $6.9 million for the year, representing a 54% increase on the previous year. The increase is due to the inclusion of BayMedica operating result following the acquisition date from the combination of changes, including investor relation expenses, accounting fees and legal fees, and substantially higher insurance results from our listing on the NASDAQ capital market.

現在來談談一般費用和行政費用。全年一般及行政開支為 690 萬美元，較前一年增加 54%。成長的原因是 BayMedica 的經營業績納入了收購日期之後的一系列變化，包括投資者關係費用、會計費用和法律費用，以及我們在納斯達克資本市場上市後保險業績的大幅增長。

I would now like to comment on BayMedica revenue. The company realized sales of $1.1 million in our BayMedica segment for the year, the results of the manufacturing and distribution sales of bulk rare cannabinoid products. It is important to note the acquisition only closed in October 2021.

我現在想評論一下 BayMedica 的收入。該公司 BayMedica 部門今年實現了 110 萬美元的銷售額，這是大宗稀有大麻素產品的製造和分銷銷售的結果。值得注意的是，此次收購已於 2021 年 10 月完成。

As a result of management's decisions to refocus on our core business in pharmaceutical drug development area and reduce effort in BayMedica's commercial business, the company incurred a non-cash impairment of intangible assets and goodwill of $3.5 million in the BayMedica segment for the year ended June 30, 2022.

由於管理層決定將重點重新放在藥物開發領域的核心業務上，並減少對BayMedica 商業業務的投入，截至2019 年6 月的年度，公司在BayMedica 部門的無形資產和商譽發生了350 萬美元的非現金減損。

Turning now to our balance sheet. The company had cash and cash equivalents of $6.2 million as of June 30, 2022, combined with the approximate $5.4 million of net proceeds from a private placement, which closed on September 13. We forecast we will be sufficient to fund its operating expenses and capital expenditure requirements into the second half of fiscal 2023 and possibly into the first quarter of fiscal 2024, being the third quarter of calendar year 2023, depending on the level and timing of realized revenues from the sale of BayMedica inventory as well as the level and timing of company operating expenses.

現在來看看我們的資產負債表。截至 2022 年 6 月 30 日，該公司的現金和現金等價物為 620 萬美元，加上 9 月 13 日完成的私募淨收益約 540 萬美元。支出要求將計入2023 財年下半年，甚至可能計入2024 財年第一季度，即2023 日曆年的第三季度，具體取決於BayMedica 庫存銷售實現的收入水平和時間以及公司營運費用。

This runway, which will continue -- we will continue to monitor closely, could be reduced or extended by delays in any of our programs, exceeding our revenue expectations or scaling back on selected third-party research program.

這條跑道將會持續下去——我們將繼續密切監控，它可能會因為我們任何項目的延遲、超出我們的收入預期或縮減選定的第三方研究項目的規模而縮短或延長。

With that, I'd like to now turn it back to Colin for questions-and-answer session.

說完這些，我現在想把話題交還給柯林，讓他來進行問答環節。

As a reminder, Erik Hsu is available for questions.

提醒一下，Erik Hsu 可以回答您的問題。

(Operator Instructions) Scott Henry, ROTH Capital Partners.

（操作員指示）史考特‧亨利（Scott Henry），羅仕證券資本合夥公司（ROTH Capital Partners）。

Thank you and good afternoon. Just a couple of questions. First, on the INM-755 safety data, was there any efficacy data gleaned from that readout by the DSMB?

謝謝您，下午好。僅有幾個問題。首先，關於 INM-755 安全數據，是否從 DSMB 的讀數中收集到任何功效數據？

Hi, Scott. Thanks for the question. There may have been, but those results would not have been recorded to the company. So it was blinded to us. They simply review the data from the study and it provided the decision to move ahead with enrollment of adolescents. But we certainly didn't have any insight into any of the data.

你好，斯科特。謝謝你的提問。可能有，但這些結果不會記錄在公司。因此我們對此視而不見。他們只是審查了研究數據並做出了繼續招收青少年的決定。但我們確實沒有洞察任何數據。

Okay. Fair enough. And then with the readout of that trial, and it sounds like calendar year first-quarter 2023, at this point, what do you anticipate as the next step? Do you think you can file on that trial? Or do you think another trial would be necessary?

好的。很公平。然後根據該試驗的結果，聽起來像是 2023 年第一季度，此時，您預計下一步會怎麼樣？您認為您可以對該審判提起訴訟嗎？或者您認為有必要進行另一次審判？

I think another trial is going to be necessary. I don't think we'll be in a position to file exclusively on a 20-patient database. So yes, there's definitely, in our opinion, going to be additional trials required. The timing of those and the design of those are still TBD, pending the outcome of this first Phase 2 trial.

我認為有必要進行另一次審判。我認為我們無法僅根據 20 名患者的資料庫進行歸檔。所以是的，我們認為肯定需要進行額外的試驗。這些措施的具體時間和設計仍有待確定，需等待第一階段 2 試驗的結果。

Okay, great. And then final question, could you speak to what the current burn or the burn rate was in the last fiscal quarter? And where you would expect it to be two quarters down the road? Just trying to get a sense of where the burn was and where it is currently. Thank you.

好的，太好了。最後一個問題，您能說一下目前的燒錢狀況或是上個財政季度的燒錢率是多少嗎？您預計未來兩個季度它會達到什麼水平？只是想了解燒傷發生的位置以及目前的位置。謝謝。

Yes. Brenda, would you want to fill that one?

是的。布倫達，你想填寫這個嗎？

Sure. Thanks for the question. And in the last quarter, we were an all-in burn rate of around $900,000 a month, and we expect to be moving down to about $700,000 a month. But if you're just looking for operating expenses, then we're looking at probably around $500,000 a month.

當然。謝謝你的提問。上個季度，我們每個月的總消耗量約為 90 萬美元，我們預計這個數字將下降到每月約 70 萬美元。但如果您只考慮營運費用，那麼大約每月約為 50 萬美元。

Okay, great. Thank you for taking the questions.

好的，太好了。感謝您回答這些問題。

Thank you.

謝謝。

(Operator Instructions) Raghuram Selvaraju, H.C. Wainwright.

(操作員指示) Raghuram Selvaraju, H.C.溫賴特。

Hi. Thanks very much for taking my questions. These are primarily related to your various clinical development initiatives. Sort of in order of timing of release, I think, can you just give us a sense of what do you expect to be the most important efficacy takeaways from the October 2022 envisaged data set?

你好。非常感謝您回答我的問題。這些主要與您的各種臨床開發計劃有關。按照發佈時間的順序，我想，您能否讓我們了解一下，您認為 2022 年 10 月預計的資料集中最重要的功效要點是什麼？

Also, if you could give us a sense of what you expect to be the most important efficacy readout coming from the INM-755 proof-of-concept study?

此外，您能否告訴我們，您認為 INM-755 概念驗證研究中最重要的功效讀數是什麼？

And lastly, specific efficacy measures or visual acuity measures you expect to utilize in the context of the glaucoma candidate's development. That would be helpful. Thank you.

最後，您希望根據青光眼患者的發展採用特定的療效測量或視力測量。那將會很有幫助。謝謝。

Great. Thank you. So just for clarification, you referred to October 2022 readout. We don't have any readout, I believe, in October 2022. So could you clarify that question?

偉大的。謝謝。因此，只需澄清一下，您指的是 2022 年 10 月的讀數。我相信，我們在 2022 年 10 月沒有任何數據。

This is with specific regard to the Trokie collaboration.

這是關於 Trokie 合作的具體內容。

Oh, okay. Yes, thank you. Yes. So the Trokie collaboration, we were providing -- BayMedica was providing a high-purity Delta 9 THCV, which is a non-intoxicating cannabinoid, for a study.

哦好的。是的，謝謝。是的。因此，在與 Trokie 的合作中，我們為研究提供了 BayMedica 高純度 Delta 9 THCV，它是一種非致醉性的大麻素。

This is with a company called Radical. Radical conducts a number of consumer-driven investigations, looking at different cannabinoids and what their effects are in the real world at the consumer level. So they supply a certain cannabinoid in different formulations, different delivery formats. And then they track through an app what the patient's experiences with these different cannabinoids.

這是與一家名為 Radical 的公司合作的。 Radical 進行了一系列由消費者驅動的調查，研究不同的大麻素及其在消費者層面的現實世界中的影響。因此，他們以不同的配方和不同的輸送形式供應特定的麻素。然後他們透過應用程式追蹤患者對這些不同大麻素的體驗。

So for THCV, some of the readouts that we're looking for are whether they feel like they have an increased in mental acuity and their overall energy, and whether they feel there's any change to their appetite.

因此對於 THCV，我們正在尋找的一些讀數是他們是否感覺自己的精神敏銳度和整體能量有所提高，以及他們是否感覺食慾有所變化。

I may be missing one readout there, but this is a pretty -- I wouldn't call it a clinical trial, but it's certainly an investigation into the consumer's experience with these different cannabinoids. And they've done this with other cannabinoids in the past.

我可能遺漏了一個讀數，但這是一個非常——我不會稱之為臨床試驗，但它肯定是對消費者對這些不同大麻素的體驗的調查。他們過去也曾對其他大麻素進行過同樣的研究。

These are several -- you know, into the thousands of patients who report on this, and they did complete a very interesting CBD study about a year ago that gave a lot of feedback to the market in terms of where you may see these cannabinoids playing the role in the health and wellness marketplace.

你知道，在數千名報告此問題的患者中，他們在大約一年前完成了一項非常有趣的 CBD 研究，該研究為市場提供了大量反饋，說明這些大麻素可能發揮什麼作用在健康和保健市場中的作用。

Trokie is a company that we work with. They put our THCV into a lozenge format, and that's how that's being delivered then to the consumers. So there's nothing earth-shattering in terms of any statistically powered clinical trials. This is more of an experiential consumer-based study.

Trokie 是我們合作的公司。他們將我們的 THCV 製成錠劑形式，然後將其交付給消費者。因此，從任何有統計依據的臨床試驗來看，都沒有什麼驚天動地的事。這更像是一項以消費者為基礎的體驗式研究。

I think your second question was on the 755, and the kinds of things that we are looking for in terms of readouts. We are looking at the different measurements and some of these are patient reported. So we are looking at itch, that's related to both wound and non-wound areas. We're looking at inflammation, and this is a chronic inflammation, not an acute inflammation. We're looking at the impact on wound healing and we're looking at pain.

我認為您的第二個問題是關於 755 以及我們在讀數方面尋找的東西。我們正在研究不同的測量結果，其中一些是患者報告的。因此，我們正在研究瘙癢，這與傷口和非傷口區域都有關。我們正在觀察炎症，這是一種慢性炎症，而不是急性炎症。我們正在研究對傷口癒合的影響以及疼痛。

So in order to get into the -- to enroll in the clinical trial, you have to have one or more of these different symptoms. So not every patient is going to be the same. We're going to get a large range of what the patients are experiencing and which areas are getting treated. It's a really good protocol design, and that is matched area in that it's a matched area inpatient design. So the patient has to have two areas that have the similar symptomology, one of which will be treated with the active ingredient, one of which will be treated with a placebo.

因此，為了參加臨床試驗，您必須具有一種或多種不同的症狀。所以並不是每個病人的情況都是一樣的。我們將廣泛了解患者的治療經驗以及接受治療的部位。這是一個非常好的協議設計，並且是匹配區域，因為它是一個匹配區域住院設計。因此，患者必須有兩個具有相似症狀的區域，其中一個區域將以活性成分治療，另一個區域將以安慰劑治療。

So the design is very robust. It also makes it a little bit difficult to get in the trial because you have to have two areas, not just one. But we're very optimistic that we can finish enrollment and we will finish enrollment this calendar year.

因此設計非常穩健。這也讓參加試驗變得有點困難，因為你必須涵蓋兩個領域，而不只是一個。但我們非常樂觀地認為我們能夠完成招生，我們將在今年完成招生。

And then after a database lock and analysis, we'll have a readout sometime in the February-March timeframe so by the end of the first quarter.

然後在資料庫鎖定和分析之後，我們將在 2 月至 3 月期間的某個時間，也就是第一季末獲得一份讀數。

Did you have any other questions related to that?

您還有其他與此相關的問題嗎？

No, with respect to 755, no. Thank you for that color.

不，關於 755，沒有。謝謝你的色彩。

The last question was just pertaining to the visual acuity or other ocular function readouts that are likely to be most pertinent in the context of the glaucoma project development.

最後一個問題只是涉及視力或其他眼部功能讀數，這些讀數可能與青光眼項目開發最相關。

Sure. Let me turn that over to Dr. Eric Hsu who is in charge of that program.

當然。讓我把這個問題交給負責這個專案的 Eric Hsu 博士。

Thanks, Eric. Hi. So in the earlier of this year, we had pre-IND meeting with FDA. And the communication we had with the FDA is to move the glaucoma program into clinical trials. And the first trial -- in-human trial will be a Phase 1-2 trial. The primary readout for Phase 1-2 will be, of course, safety being the first, and IOP reduction being the secondary readout for that 1-2 trial.

謝謝，埃里克。你好。因此，今年早些時候，我們與 FDA 舉行了 IND 前會議。我們與 FDA 的溝通是將青光眼計畫推向臨床試驗。第一次試驗－人體試驗將是第 1-2 階段試驗。當然，第 1-2 階段的主要讀數是安全性第一，而眼壓降低是此 1-2 階段試驗的次要讀數。

And the other discussion we had was the possibility to move into a phase -- another Phase 2 after that trial to have neuroprotection readout. So those are what we're planning right now.

我們進行的另一個討論是，在該試驗之後進入另一個第二階段以讀取神經保護資料的可能性。這些就是我們現在的計劃。

Thank you. And at this time, I'm showing no further questions. I'd like to hand the conference back over to Mr. Adams for any closing remarks.

謝謝。此刻，我沒有其他問題。我想將會議交還給亞當斯先生，請他作最後發言。

Great. Thank you very much. So in closing, I just want to thank our shareholders for their continued support over the last year. We understand it's been a very difficult year for everyone involved in the industry, including investors and shareholders.

偉大的。非常感謝。最後，我只想感謝我們的股東在過去一年對我們的持續支持。我們理解，對於業內每個人來說，包括投資者和股東，今年都是非常艱難的一年。

We believe we've taken all the necessary steps to ensure that we have a positive 2023, and we are excited to execute on our plans. And I look forward to updating everyone on our continued progress and future milestones over the coming months.

我們相信，我們已經採取了一切必要措施，以確保 2023 年取得積極的進展，並且我們很高興執行我們的計劃。我期待在接下來的幾個月向大家通報我們持續的進展和未來的里程碑。

Thanks again and wish you a good weekend.

再次感謝並祝您週末愉快。

This concludes today's conference call. Thank you for participating. You may now disconnect. Everyone, have wonderful day.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。祝大家有美好的一天。