Ensysce Biosciences Inc (ENSC) 2022 Q3 法說會逐字稿

Good morning and welcome to the Ensysce Biosciences, Inc. corporate update call. As a reminder, this conference is being recorded. Your hosts today are Dr. Lynn Kirkpatrick, Chief Executive Officer, Dr. Bill Schmidt, Chief Medical Officer, and Dave Humphrey, Chief Financial Officer.

早上好，歡迎來到 Ensysce Biosciences, Inc. 公司更新電話。提醒一下，這次會議正在錄製中。今天的主持人是首席執行官 Lynn Kirkpatrick 博士、首席醫療官 Bill Schmidt 博士和首席財務官 Dave Humphrey。

Before we begin the formal presentation, I would like to remind everyone that statements made on the call and webcast may include predictions, estimates or other information that might be considered forward-looking. While these forward-looking statements represent our current judgment on what the future holds, they are subject to risks and uncertainties that could cause actual results to differ materially. You're cautioned not to place undue reliance on these forward-looking statements, which reflect our opinions only as of the date of this presentation. Please keep in mind that we are not obligating ourselves to revise or publicly release the results of any revision to these forward-looking statements in light of new information or future events.

在我們開始正式介紹之前，我想提醒大家，在電話會議和網絡廣播中發表的聲明可能包括預測、估計或其他可能被視為前瞻性的信息。雖然這些前瞻性陳述代表了我們目前對未來的判斷，但它們受到可能導致實際結果大不相同的風險和不確定性的影響。請注意不要過分依賴這些前瞻性陳述，這些陳述僅反映我們截至本演示文稿之日的意見。請記住，我們沒有義務根據新信息或未來事件修改或公開發布對這些前瞻性陳述的任何修改結果。

Throughout today's discussion, we will attempt to present some important factors relating to our business that may affect our predictions. You should also review our most recent Forms 10-Q and 10-K for a more complete discussion of these factors and other risks, particularly under the heading Risk Factors.

在今天的討論中，我們將嘗試介紹一些與我們的業務相關的可能影響我們預測的重要因素。您還應該查看我們最近的 10-Q 和 10-K 表格，以更全面地討論這些因素和其他風險，尤其是在風險因素標題下。

At this time, I'd like to turn the call over to Chief Executive Officer, Dr. Lynn Kirkpatrick, Lynn?

在這個時候，我想把電話轉給首席執行官 Lynn Kirkpatrick 博士，Lynn？

Thank you, operator, and good morning, everyone. Thank you for joining us. I am pleased to welcome you to today's corporate update conference call. Although some of you are familiar with in size, I've historically kept off these calls spending a few minutes reviewing our technology platforms and overall company focus for those of you new to our story. First, we are a clinical-stage biotech company using sophisticated chemistry to improve drug safety and performance. Our technology platforms, TAAP and MPAR are designed to improve delivery and reduce abuse and overdose of prescription drugs with a goal of creating new classes of prescription medicines that are intended to be both powerful and safe.

謝謝接線員，大家早上好。感謝您加入我們。我很高興歡迎您參加今天的公司更新電話會議。儘管你們中的一些人對規模很熟悉，但我過去一直不接這些電話，而是花幾分鐘時間回顧我們的技術平台和公司對我們故事的新關注點。首先，我們是一家臨床階段的生物技術公司，使用複雜的化學技術來提高藥物的安全性和性能。我們的技術平台 TAAP 和 MPAR 旨在改善處方藥的交付並減少處方藥的濫用和過量服用，目標是創造出既有效又安全的新型處方藥。

Our first effort is to bring to market the next-generation G6 for strong pain relief. I will review our two technology platforms to offer background before we review recent clinical trial results, TAAP stands for trypsin activated abuse protection. TAAP is simply a chemical modification that makes a drug in active until it is swallowed and reaches a small intestine, whereas it�s exposed to an enzyme called trypsin.

我們的第一項努力是將下一代 G6 推向市場，以有效緩解疼痛。在我們回顧最近的臨床試驗結果之前，我將回顧我們的兩個技術平台以提供背景，TAAP 代表胰蛋白酶激活濫用保護。 TAAP 只是一種化學修飾，它使藥物在被吞嚥並到達小腸之前處於活性狀態，同時它會暴露在一種叫做胰蛋白酶的酶中。

Trypsin is only found in the small intestine where it is responsible for digesting the proteins and meats we eat. This exposure to trypsin allows our own body to turn on our TAAP Drives by starting the release process. TAAP allows us to deliver medicines orally, and we refer to it as sophisticated chemistry since we can use the chemical modification to fine tune how quickly or slowly a drug is released. TAAP can be applied to most types of medicines to either make them safer or actually perform better. We have applied TAAP to opioid products in an attempt to reduce recreational drug abuse.

胰蛋白酶僅存在於小腸中，負責消化我們吃的蛋白質和肉類。接觸胰蛋白酶可以讓我們自己的身體通過啟動釋放過程來打開我們的 TAAP 驅動器。 TAAP 允許我們口服藥物，我們將其稱為複雜化學，因為我們可以使用化學修飾來微調藥物釋放的速度或速度。 TAAP 可應用於大多數類型的藥物，以使其更安全或實際上表現更好。我們已將 TAAP 應用於阿片類產品，以減少消遣性藥物濫用。

Our second technology platform MPAR stones for multi pill abuse resistance. MPAR is a smart overdose protection technology designed to be combined with our TAAP products to prevent patients or abusers from overdosing, TAAP turned off the release of the active ingredient in an overdose situation. This protection from oral overdose is designed to activate only when more than the prescribed dose is taken. As mentioned, we have applied these transformative technologies initially to opioid products to produce the next-generation analgesics to treat severe pain. Now a stress severe pain, which is what an opioid is indicated for, there are many types of pains where opioids are not appropriate and not the focus of our current programs.

我們的第二個技術平台 MPAR stones 用於防止多藥丸濫用。 MPAR 是一種智能過量保護技術，旨在與我們的 TAAP 產品結合使用，以防止患者或濫用者過量服用，TAAP 在過量情況下關閉活性成分的釋放。這種防止口服過量的保護措施僅在服用超過規定劑量時才會激活。如前所述，我們最初將這些變革性技術應用於阿片類藥物產品，以生產用於治療劇烈疼痛的下一代止痛藥。現在是一種壓力性劇烈疼痛，這是阿片類藥物的適應症，阿片類藥物不適用於許多類型的疼痛，這不是我們當前計劃的重點。

As an example, there are those individuals who may require an opioid to control pain on a limited basis after major surgery such as hip or knee replacement therapy, whereby controlling pain in these situations appropriately may prevent one from developing chronic pain and needing opioids long term, the CDC has just released guidelines for the clinical practice of prescribing opioids, recognizing the need for these medications for severe pain when other therapies are contraindicated are likely to be ineffective.

例如，有些人在髖關節或膝關節置換治療等大手術後可能需要阿片類藥物來有限地控制疼痛，因此在這些情況下適當控制疼痛可以防止人們發展為慢性疼痛和長期需要阿片類藥物, CDC 剛剛發布了阿片類藥物處方的臨床實踐指南，認識到當其他療法可能無效時，需要使用這些藥物來治療劇烈疼痛。

We do know that in certain stances, such as severe traumatic injuries or invasive surgeries, having pain is inevitable, but we feel suffering from severe pain should be optional, and that is a role for PF614. We also know past opioid use has less to lead to a crisis yet our TAAP and MPAAR technologies have been developed to address and reduce both abuse and overdose of these prescription pain products, something that other marketed abuse deterrent formulations of opioids have failed to achieve. It is important to note that although we are focused on developing our lead product, PF614, both our TAAP and MPAR technologies can be applied to many more prescription drugs, therefore, providing us with ongoing opportunities.

我們確實知道在某些情況下，例如嚴重的外傷或侵入性手術，疼痛是不可避免的，但我們覺得遭受劇烈疼痛應該是可選的，這就是 PF614 的作用。我們也知道過去使用阿片類藥物很少會導致危機，但我們的 TAAP 和 MPAAR 技術已經開發出來以解決和減少這些處方止痛產品的濫用和過量服用，這是其他市售的阿片類藥物濫用威懾製劑未能實現的。值得注意的是，儘管我們專注於開發我們的主導產品 PF614，但我們的 TAAP 和 MPAR 技術都可以應用於更多的處方藥，因此為我們提供了持續的機會。

As our pipeline shows, we have applied to chemical modification to a number of OPOs as well as drugs to treat ADHD and we have a discovery program focused our novel TAAP agents for treatment of opioid use disorder. Our main focus today is to update you on our lead program, PF614 and oxycodone and TAAP products, which is designed to replace oxycodone in the marketplace. TAAP has received fast-track status for use in chronic pain from the FDA, demonstrating that the agency feels PF614 may fulfill an unmet therapeutic need. We continue to make significant strides in bringing our lead product to market, and we recently reported the PF614 was shown to be bioequivalent commercially available oxycodone and come that may provide a shorten path to registration and commercialization through the 505(b)(2) regulatory process.

正如我們的管道所示，我們已經對許多 OPO 以及治療 ADHD 的藥物進行了化學修飾，並且我們有一個發現計劃專注於我們用於治療阿片類藥物使用障礙的新型 TAAP 藥物。我們今天的主要重點是向您介紹我們的主導項目 PF614 以及羥考酮和 TAAP 產品，這些產品旨在取代市場上的羥考酮。 TAAP 已從 FDA 獲得用於慢性疼痛的快速通道狀態，表明該機構認為 PF614 可以滿足未滿足的治療需求。我們在將我們的主導產品推向市場方面繼續取得重大進展，我們最近報告稱 PF614 被證明與市售羥考酮具有生物等效性，並且可能通過 505(b)(2) 監管提供更短的註冊和商業化途徑過程。

For those unfamiliar, bioequivalence is the clinical comparison of two dosage forms or active ingredient, showing that they provide similar blood concentration levels, therefore, resulting in the same therapeutic effect. In other words, the data from this study means that PF614 will be as effective in treating severe pain as oxycodone. The advantages of PF614, however, is that PF614 has a longer half-life, meaning pain relief should last longer than oxycodone and products possibly be a true twice-a-day pain medications.

對於那些不熟悉的人，生物等效性是兩種劑型或活性成分的臨床比較，表明它們提供相似的血藥濃度水平，因此產生相同的治療效果。換句話說，這項研究的數據意味著 PF614 在治療劇烈疼痛方面與羥考酮一樣有效。然而，PF614 的優勢在於 PF614 具有更長的半衰期，這意味著止痛效果應該比羥考酮更持久，並且產品可能是真正的一天兩次的止痛藥。

Additionally we believe PF614 has subsidiary superior abuse-deterrent properties and also can be supplied with overdose protection as with PF614 MPAR products. Our extensive early discovery programs provided us with over 100 patents issued in 25 countries. We have built a strong team to assist in achieving the milestones we have set for each program and we have been advancing our lead products through clinical development in an attempt to bring our lead programs to market as quickly as possible. Just this week on Monday, we announced we received guidance from the FDA that an acute pain indication may be appropriate for PF614.

此外，我們相信 PF614 具有輔助的卓越防濫用特性，並且還可以像 PF614 MPAR 產品一樣提供過量保護。我們廣泛的早期發現計劃為我們提供了在 25 個國家頒發的 100 多項專利。我們已經建立了一支強大的團隊來協助實現我們為每個項目設定的里程碑，並且我們一直在通過臨床開發推進我們的領先產品，以盡快將我們的領先項目推向市場。就在本週的周一，我們宣布我們收到了 FDA 的指導，即急性疼痛適應症可能適用於 PF614。

While not binding, the FDA guidance is encouraging and states that our proposed clinical development approach of conducting at least two adequate and well-controlled clinical trials in two different pain models comparing PF614 to placebo and to another immediate release or IR opioids such as IRX Oxy codon appears to be reasonable to support a new drug application for PF614 for an acute pain indication.

雖然沒有約束力，但 FDA 指南令人鼓舞，並指出我們提出的臨床開發方法是在兩種不同的疼痛模型中進行至少兩項充分且控制良好的臨床試驗，將 PF614 與安慰劑和另一種速釋或速釋阿片類藥物（如 IRX Oxy）進行比較密碼子似乎可以合理支持 PF614 用於急性疼痛適應症的新藥申請。

Now this guidance is important since the development path for an acute pain indication should be less costly and have a shorter path to commercialization than that for chronic pain. The FDA advice letter also provided additional guidance with respect to the nonclinical studies and the clinical trials we have planned. As a result of the FDA guidance, we now intend to initially pursue clinical development of PF614 for an acute pain indication while we continue with our chronic pain development program, we believe that the longer half-life of PF614 compared to oxycodone may ultimately prevent acute pain from becoming chronic pain by better controlling severe pain on a day-to-day basis.

現在這一指南很重要，因為急性疼痛適應症的開發路徑應該比慢性疼痛的開發路徑成本更低，並且商業化路徑更短。 FDA 建議書還提供了關於我們計劃的非臨床研究和臨床試驗的額外指導。由於 FDA 的指導，我們現在打算在繼續我們的慢性疼痛開發計劃的同時，初步尋求 PF614 的急性疼痛適應症的臨床開發，我們相信，與羥考酮相比，PF614 的半衰期更長，最終可能會預防急性疼痛通過在日常基礎上更好地控制劇烈疼痛，避免疼痛變成慢性疼痛。

Now for the primary purpose of our call today, while Dave will later touch on our recent financial results at a high level, I'm pleased to turn the call over to Dr. Bill Schmidt, our Chief Medical Officer, to review the recently reported positive data from our PF614 103 human abuse potential clinical study. BILL?

現在，為了我們今天電話會議的主要目的，雖然 Dave 稍後將在高層談到我們最近的財務業績，但我很高興將電話轉交給我們的首席醫療官 Bill Schmidt 博士，以審查最近報告的我們的 PF614 103 人類虐待潛在臨床研究的積極數據。賬單？

Thank you, Bill. I'd like to again say how pleased we are with the positive top line results of the nasal HAP studies. I know Dr. Schmidt line was poor, so I'd like to repeat some of the data, specifically the top line results from this study which compared the inter nasal administration of PF614 powder to crushed Oxy cotton oxycodone immediate release tablet that was recently announced. These top line results showed that PF614 had significantly lower peak drug liking and significantly less appeal to take drug again in nondependent recreational opioid users where are we at a total of 26 subjects. Specifically the primary endpoint of the study drug liking at this moment was measured up to 24 hours after dosing using the visual assessment scale VAS scale.

謝謝你，比爾。我想再次表示，我們對鼻部 HAP 研究的積極頂線結果感到非常高興。我知道 Schmidt 博士的產品線很差，所以我想重複一些數據，特別是這項研究的主要結果，該研究將 PF614 粉末的鼻內給藥與最近宣布的壓碎的 Oxy 棉羥考酮速釋片進行了比較.這些頂級結果表明，PF614 對非依賴性消遣性阿片類藥物使用者的藥物喜好峰值顯著降低，再次吸毒的吸引力顯著降低，我們共有 26 名受試者。具體而言，使用視覺評估量表 VAS 量表在給藥後 24 小時內測量此時研究藥物喜好的主要終點。

As mentioned in the study, PF614 powder produced significantly lower drug liking liking when compared with intranasal crushed IR oxycodone with a P value of 0.0133 using the full 26 subject population. Furthermore, analyzing a smaller group of subjects following their exposure to the first drug, they were administered called the first period analysis.

正如該研究中提到的，與鼻內壓碎的 IR 羥考酮相比，PF614 粉末對 26 名受試者的藥物偏好顯著降低，P 值為 0.0133。此外，在接觸第一種藥物後分析一小部分受試者，他們被稱為第一階段分析。

A similarly strong difference was noted between PF614 in eight subjects and crushed higher oxycodone in 10 subjects with a P value of zero a 0.0175 even with this small cohort of subjects. Similar findings were noted with the second endpoint we evaluated where we ask subjects if they like the drug enough to want to take the drug again.

在 8 名受試者的 PF614 和 10 名受試者的壓碎高羥考酮之間也發現了類似的強烈差異，即使對於這一小群受試者，P 值為零和 0.0175。在我們評估的第二個終點中也注意到了類似的發現，我們詢問受試者是否足夠喜歡該藥物以再次服用該藥物。

The study showed a statistically significant difference with a lower wish to take PF614 again I guess, versus crushed IR oxycodone with a P-value which was even lower at 0.0001, also using a smaller group of subjects in the first period analysis. That's a highly significant value in a small group of subjects speak to the difference between PF614 and oxycodone for those who wish to use drug recreationally.

該研究顯示出統計學上的顯著差異，我猜想再次服用 PF614 的意願較低，而壓碎的 IR 羥考酮的 P 值甚至更低，為 0.0001，在第一階段分析中也使用了較小的受試者組。對於那些希望消遣性吸毒的人來說，這是一個非常重要的價值。

During the last quarter, we also initiated a second human abuse potential study, which we designate PF 614-104 to evaluate the oral abuse potential of PF614 in subjects and subject dosing is continuing. This study is designed to test and confirm that PF614 will have less potential for drug liking versus immediate release oxycodone adequate equivalent doses when taken orally.

在上個季度，我們還啟動了第二項人類濫用可能性研究，我們將其指定為 PF 614-104，以評估 PF614 在受試者中的口服濫用可能性，並且受試者給藥仍在繼續。本研究旨在測試和確認 PF614 與口服足夠等效劑量的速釋羥考酮相比，吸毒的可能性更小。

We are looking forward to reporting the data from this part trial, and we expect data to be released in the first half of 2023. We'd like to reiterate why these HAP studies are important milestones. They are key for gaining abuse-deterrent labeling for PF614, the studies help us further understand the tendencies for drug abusers to like the effects achieved after taking PF614 either orally or nasally compared to that of similar products, for example, crushed oxycodone.

我們期待報告這部分試驗的數據，我們預計數據將在 2023 年上半年發布。我們想重申為什麼這些 HAP 研究是重要的里程碑。它們是獲得 PF614 濫用威懾標籤的關鍵，這些研究幫助我們進一步了解藥物濫用者喜歡口服或鼻腔服用 PF614 與類似產品（例如，壓碎的羥考酮）相比取得的效果的傾向。

I will now briefly comment on the initial clinical data from our overdose protection product PF 614 MPAR that we reported in May. We believe that this data for the PF614 MPAR study where we combine PF614 and the trypsin inhibitor in the thermostat provided the first evidence of a product that would prevent fact from an overdose, the results also provided the first human data to show PF614 when absorbed into the bloodstream does not convert to oxycontin supporting our contention. But it tends to use PF614 by direct injection should be unsuccessful. We are continuing PF614 MPAR study to find our drug product profile.

我現在將簡要評論我們在 5 月份報告的過量保護產品 PF 614 MPAR 的初步臨床數據。我們相信，我們在恆溫器中將 PF614 和胰蛋白酶抑製劑結合使用的 PF614 MPAR 研究數據提供了產品可以防止過量服用的第一個證據，結果還提供了第一個顯示 PF614 被吸收到人體中的人類數據血液不會轉化為支持我們論點的奧施康定。但它傾向於通過直接注入使用PF614 應該是不成功的。我們正在繼續 PF614 MPAR 研究以找到我們的藥品概況。

Additional data from this part of the study is expected before the end of this year and will allow us to test the concept of overdose protection by delivering increase in doses of PF614 MPAR in the final part three of this study in the first half of 2023. During the quarter, we announced that this study is being undertaken in partnership with quotient sciences using their integrated translational pharmaceutical platform for the clinical testing appears six months for MPAR. Our findings from this study are important because the MPAR combination technology is the first approach we expect may prevent all four forms of abuse, injecting chewing, inhaling and importantly, oral overdose.

這部分研究的更多數據預計將在今年年底之前提供，這將使我們能夠通過在 2023 年上半年本研究的最後第三部分中增加 PF614 MPAR 的劑量來測試過量保護的概念。在本季度，我們宣布這項研究正在與 quotient sciences 合作進行，使用他們的集成轉化藥物平台進行臨床測試，出現六個月的 MPAR。我們從這項研究中得出的結果很重要，因為 MPAR 組合技術是我們預期可以防止所有四種形式的濫用、注射咀嚼、吸入以及重要的是口服過量的第一種方法。

Looking ahead at the milestones through the remainder of the year, I summarize them as follows. We expect to report data from the oral human abuse potential study PF614-104 during the first half of 2023, we expect the full data from PF614 MPAR part two to be reported before the end of this year, 2022, and data from the final part three of the study in the first part of next year. I will now welcome our CFO, Dave Humphrey, for a short financial summary. Dave?

展望今年剩餘時間的里程碑，我將它們總結如下。我們預計將在 2023 年上半年報告人類口腔虐待潛在研究 PF614-104 的數據，我們預計 PF614 MPAR 第二部分的完整數據將在今年年底之前報告，即 2022 年，最後一部分的數據將報告三的研究在明年的第一部分。我現在歡迎我們的首席財務官 Dave Humphrey 提供簡短的財務摘要。戴夫？

Thanks Lynn. As of September 30, remaining funding available from federal grants included $3.3 million to support our OUD research program and another $2.6 million to support the third part of the ongoing Phase 1 clinical trial evaluating the MPAR platform. With this non-dilutive government grant funding and our September 30 cash balance of $4.5 million, we are on track to advance the development of our highly unique TAAP MPAR technologies through the end of this year. I'll now turn the call back to Lynn for closing remarks and questions. Lynn?

謝謝林恩。截至 9 月 30 日，來自聯邦撥款的剩餘資金包括用於支持我們的 OUD 研究計劃的 330 萬美元和用於支持正在進行的評估 MPAR 平台的第一階段臨床試驗的第三部分的另外 260 萬美元。憑藉這筆非稀釋性政府補助資金和我們 9 月 30 日的 450 萬美元現金餘額，我們有望在今年年底之前推進我們高度獨特的 TAAP MPAR 技術的開發。我現在將電話轉回 Lynn，請其作結束語和提問。林恩？

Thanks, Dave. And before I turn the call over to the operator for Q&A. I wanted to take a moment and acknowledge all our company constituents as we forge ahead on our mission to provide patients in severe pain, a unique therapeutic option. Developing any new drug involves the complicated and sometimes torturous path.

謝謝，戴夫。在我將電話轉給接線員進行問答之前。我想花點時間感謝我們所有的公司成員，因為我們正在朝著我們的使命前進，為患有嚴重疼痛的患者提供一種獨特的治療選擇。開發任何新藥都涉及復雜且有時是曲折的過程。

And we are pleased that the FDA has provided us its recent feedback that will allow us to finalize our path toward commercialization in the coming months. We believe our recent clinical data that we highlighted today point to the potential for PF614 to be it safer pain medication and a highly novel option for those who experienced severe pain. Operator, we will now take question.

我們很高興 FDA 向我們提供了最近的反饋，這將使我們能夠在未來幾個月內最終確定我們的商業化道路。我們相信我們今天強調的最新臨床數據表明 PF614 有可能成為更安全的止痛藥，並且對於那些經歷過劇烈疼痛的人來說是一種非常新穎的選擇。接線員，我們現在開始提問。

(Operator Instructions) Thomas Flaten, Lake Street Capital.

（操作員說明）Thomas Flaten，Lake Street Capital。

Good morning. Appreciate you guys taking the questions. Hey Lynn, I was wondering if you could provide some context for the interaction you had with FDA that generated the guidance around the acute indication here. What was the question you were asking, were you surprised by the by the outcome? I'm just hoping you can kind of set the stage for how we ended up with the press release you put out this week?

早上好。感謝你們回答問題。嘿 Lynn，我想知道你是否可以提供一些背景信息，說明你與 FDA 的互動，這些互動產生了這里關於急性適應症的指南。你問的是什麼問題，你對結果感到驚訝嗎？我只是希望你能為我們如何結束你本週發布的新聞稿做好準備？

Sure. And thanks, Tomas. We have been interacting with the agency now for almost a year and considering various options for PF614 in an attempt to understand how we may be able to bring PF614 to the market in a way, I guess, a more direct path. As you know, with the COVID and supply chain issues, a lot of things have been delayed and in order to potentially expedite some of the activity we had asked the agency whether an acute pain indication may be appropriate, which potentially would have a reduced timeline for us, both for the nonclinical activities as well as the clinical path.

當然。謝謝，托馬斯。我們已經與該機構進行了將近一年的互動，並考慮了 PF614 的各種選擇，以試圖了解我們如何能夠以一種更直接的方式將 PF614 推向市場。如您所知，由於 COVID 和供應鏈問題，很多事情都被推遲了，為了有可能加快一些活動，我們已經詢問該機構急性疼痛適應症是否合適，這可能會縮短時間表對我們來說，既適用於非臨床活動，也適用於臨床路徑。

We began our discussion about December of last year, we had additional questions for the agency last March, and we were very pleased with our back and forth that they have agreed that a potential clinical development path for PF614 in acute pain as well as chronic pain would be appropriate. So this will allow us now to move really build on the answers, identify specifically the clinical program we intend to utilize over the next few years and hopefully bring the product to market more quickly than we could in the acute pain space.

我們從去年 12 月開始討論，去年 3 月我們向該機構提出了其他問題，我們很高興我們反复討論他們同意 PF614 在急性疼痛和慢性疼痛中的潛在臨床開發路徑將是適當的。因此，這將使我們現在能夠真正以答案為基礎，具體確定我們打算在未來幾年內使用的臨床計劃，並希望比我們在急性疼痛領域更快地將產品推向市場。

Great. And did they render an opinion about the chronic pain indication or was this specifically to get them to agree to acute, just to confirm? Yes, we've always intended and we still intend to do develop PF614 because this is an extended release product in the acute pain space or in the chronic pain space. But this was specifically to address whether or not it might be appropriate for this type of agent, which has a delayed onset and an extended-release profile to be used for acute pain and really the CDC guidelines that has broken pain down really into three subcategories now: acute sub-acute and chronic, defines where our clinical trials may be most appropriate.

偉大的。他們是否對慢性疼痛的適應症發表了意見，或者這是專門為了讓他們同意急性疼痛，只是為了確認？是的，我們一直打算並且仍然打算開發 PF614，因為這是急性疼痛領域或慢性疼痛領域的緩釋產品。但這是專門為了解決它是否適合這種類型的藥物，這種藥物具有延遲起效和緩釋特性，可用於急性疼痛，實際上 CDC 指南已將疼痛分為三個子類別現在：急性亞急性和慢性，定義了我們的臨床試驗可能最合適的地方。

Got it. And in terms of upcoming interactions with FDA to move towards an acute development plan, what's on the horizon there? I'm assuming you're going to wait till you have the HAP studies done and be able to report those out. But can you kind of lay out for us what happens next?

知道了。就即將與 FDA 進行互動以製定一項敏銳的發展計劃而言，那裡的地平線上有什麼？我假設您會等到完成 HAP 研究並能夠報告這些研究。但是你能為我們介紹一下接下來會發生什麼嗎？

We are currently meeting with our Clinical Advisory Board to continue the discussions of exactly what our clinical programs will be so we can develop our protocols. We anticipate providing updates to the agency next June discussing them and as they indicated, two well-controlled studies and for acute pain, I do need to do both and bony and soft tissue study would be considered appropriate for an NDA in this indication. So we will be discussing those protocols with the agency in the coming months.

我們目前正在與我們的臨床顧問委員會開會，繼續討論我們的臨床計劃究竟是什麼，以便我們可以製定我們的協議。我們預計明年 6 月向該機構提供更新，討論它們，正如他們指出的那樣，兩項控制良好的研究和急性疼痛，我確實需要做這兩項研究，骨和軟組織研究將被認為適合該適應症的新藥申請。因此，我們將在未來幾個月與該機構討論這些協議。

And then final question, if I might, any adjudication on the 505 (b)(2) two question or was that in part of the discussion was reasonable. (technical difficulty)

然後是最後一個問題，如果可以的話，關於 505 (b)(2) 兩個問題的任何裁決，或者在部分討論中是否合理。 （技術難度）

Good question questions were submitted much, much longer before we had the data, but that will be certainly in our upcoming discussion. Understood. Appreciate you guys taking the question. Thanks so much.

在我們獲得數據之前提交好問題的時間要長得多，但這肯定會出現在我們即將進行的討論中。明白了。感謝你們提出問題。非常感謝。

Hunter Diamond, Diamond Equity.

獵人鑽石，鑽石股票。

Hello, congratulations on the quarter so far. I was wondering in terms of the recent top line results for intranasal administration of PF615 can you say why the field data supports advantages over currently marketed products?

您好，祝賀本季度到目前為止。我想知道關於 PF615 鼻內給藥的最新頂級結果，您能說說為什麼現場數據支持優於目前上市產品的優勢嗎？

Bill, would you like to take that question?

比爾，你願意回答這個問題嗎？

Sure. It's PF614, and we compare this directly to crushed oxycodone HCL, which would be known commercially as oxycodone. We used equivalent operate equivalent doses of both products. And when the subjects slaughtered the [Roxy code on] product, they got the expected we�d expect from doing maize deflation of an opioid product. They liked it, some even hit our 100, on 1 to 100 scale in terms of how much they liked it and whether they would take the drug again.

當然。它是 PF614，我們將其直接與壓碎的鹽酸羥考酮進行比較，後者在商業上被稱為羥考酮。我們使用兩種產品的等效操作等效劑量。當受試者屠宰 [Roxy code on] 產品時，他們得到了我們對阿片類藥物產品進行玉米通縮所期望的預期效果。他們喜歡它，有些人甚至達到了我們的 100，根據他們喜歡它的程度以及他們是否會再次服用這種藥物，比例為 1 到 100。

Those who do insulated placebo, and this was on a blind basis, they didn't know what they were getting it just looked like white powder, those who insulated placebo had very neutral scores indicate that they neither liked it nor disliked it, it didn't have a burst of properties. When they got to PF614, the liking scores were very muted, they were substantially less than the scores that any of the individuals had recorded when they had supported authentic oxycodone CL.

那些服用絕緣安慰劑的人，這是盲目的，他們不知道他們得到的是什麼，只是看起來像白色粉末，那些服用絕緣安慰劑的人得分非常中性，表明他們既不喜歡也不不喜歡它，它沒有有爆屬性。當他們到達 PF614 時，喜歡的分數非常低，它們大大低於任何人在支持真正的羥考酮 CL 時記錄的分數。

When we looked at this and for take drug again, the scores were awful on the PF614 side compared to the oxycodone HCL side. We believe that this is because they actually received exposure to less oxycodone derived from PF614 when they snorted it because it only parts of the day and we'll convert to oxycodones, they swallowed on the back of their throat.

當我們查看這個並再次服用藥物時，PF614 方面的分數與鹽酸羥考酮方面相比非常糟糕。我們認為這是因為他們在吸食 PF614 時實際上接觸到的羥考酮較少，因為它只是一天中的部分時間，我們會轉化為羥考酮，他們吞嚥在喉嚨後部。

Previous studies have shown that that's only a percent of what goes up their nose. So it would be the equivalent of taking a say, a 100 milligram tablet of OxyContin, which could be a three-month dose, but a prudent another persisted for at 40 milligrams, which was the actual dose of oxycodone HCL, if you reduce that to four milligrams so that's percent of impulsive oxycodone probably wouldn't engender very much liking or target. Again, it's probable that the recreation user would be looking for somebody else if they really wanted to be a high. And that's what we showed in this study that given an alternative would not take PF614 again, look for some other drug products.

以前的研究表明，這只是他們鼻子上的東西的百分之一。所以這相當於服用 100 毫克 OxyContin 片劑，這可能是三個月的劑量，但謹慎的另一個人堅持服用 40 毫克，這是鹽酸羥考酮的實際劑量，如果你減少它到四毫克，所以這個百分比的衝動性羥考酮可能不會產生非常多的喜好或目標。同樣，如果娛樂用戶真的想成為一名高手，他們很可能會尋找其他人。這就是我們在這項研究中展示的，如果有替代方案，則不會再次服用 PF614，而是尋找其他一些藥物產品。

Great, thank you. And can you provide some color on how investors should view the acute pain indication for PF614, what exactly is the speed our market it was? I mean, I cover and understand the overall market opportunity, but what's the speed here to market?

太好了謝謝。您能否提供一些關於投資者應如何看待 PF614 的急性疼痛指示的顏色，我們的市場速度到底是多少？我的意思是，我涵蓋並了解整體市場機會，但上市速度如何？

Thanks, Hunter. The advantage of us moving into the acute pain space means that we are not required to undertake some of the nonclinical studies which are required for chronic pain with it take up to two years to complete some of the carcinogenicity studies, that is eliminated from our development path. Additionally, in the chronic pain space, we would be required to have subjects exposed to PF614 for up to a year.

謝謝，獵人。我們進入急性疼痛領域的優勢意味著我們不需要進行一些慢性疼痛所需的非臨床研究，而完成一些致癌性研究需要長達兩年的時間，這些研究已從我們的開發中消除小路。此外，在慢性疼痛領域，我們需要讓受試者接觸 PF614 長達一年。

So the clinical development path is also reduced. We have not identified our ultimate timelines to date. We hope to provide more clarity. But we believe this opportunity although on a market basis is a smaller market, it will be adding to the overall market when we are able to commercialize both for acute as well as chronic pain and initially bring the product to market more quickly. So we're anticipating significant reduction in time and cost, and we'll be providing more guidance on our expected commercialization date probably in the coming months. Thank you so much. Appreciate it.

因此臨床開發路徑也減少了。迄今為止，我們尚未確定最終時間表。我們希望提供更多的清晰度。但我們相信這個機會雖然在市場基礎上是一個較小的市場，但當我們能夠將急性和慢性疼痛商業化並最初將產品更快地推向市場時，它將會增加整個市場。因此，我們預計時間和成本會大幅減少，我們可能會在未來幾個月內就預期的商業化日期提供更多指導。太感謝了。欣賞它。

Thank you. At this time, I would now like to turn the call back over to Dr. Lynn Patrick for closing remarks.

謝謝。此時，我想將電話轉回給 Lynn Patrick 博士以作結束語。

Thank you, operator. And I would like to thank you each of you for joining our earnings conference call today. I look forward to continuing to update you on our ongoing progress in the coming year. I wish everyone a lovely holiday season and look forward to updating you in our next call. Thank you very much.

謝謝你，運營商。我要感謝你們每個人今天參加我們的收益電話會議。我期待在來年繼續向您通報我們的最新進展。祝大家度過一個愉快的假期，並期待在我們的下一次通話中為您更新。非常感謝。

Thank you. This will conclude today's conference. You may disconnect your lines at this time. Thank you for your participation.

謝謝。今天的會議到此結束。此時您可以斷開線路。感謝您的參與。