Veru Inc (VERU) 2024 Q2 法說會逐字稿

Good morning, ladies and gentlemen, and welcome to Veru Inc's investors conference call. (Operator Instructions) Please note that this event is being recorded.

早安，女士們先生們，歡迎參加 Veru Inc 的投資者電話會議。（操作員說明）請注意，該事件正在被記錄。

I would now like to turn the conference over to Sam, Mr. Sam Fisch, Veru Inc's, Executive Director, Investor Relations and Corporate Communications. Please go ahead.

現在我想將會議交給 Veru 公司投資者關係和企業傳播部執行董事 Sam Fisch 先生主持。請繼續。

Statements made on this conference call may be forward looking statements forward looking statements may include, but are not necessarily limited to statements of the company's plans, objectives, expectations or intentions regarding its business operations, regulatory interactions, finances and development and product portfolio.

本次電話會議上發表的聲明可能是前瞻性聲明。

Such forward-looking statements are subject to known and unknown risks and uncertainties, and our actual results may differ significantly from those projected or suggested or included in any forward-looking statements. Risks that may cause actual results or developments to differ materially are contained in our 10-Q and 10-K SEC filings as well as in our press releases from time to time.

此類前瞻性陳述受到已知和未知的風險和不確定性的影響，我們的實際結果可能與任何前瞻性陳述中預測、建議或包含的結果有顯著差異。可能導致實際結果或發展出現重大差異的風險包含在我們的 10-Q 和 10-K SEC 文件以及我們不時發布的新聞稿中。

I would now like to turn the conference call over to Dr. Mitchell Steiner, Veru Inc's, Chairman, CEO, and President.

我現在想將電話會議轉交給 Veru 公司董事長、執行長兼總裁 Mitchell Steiner 博士。

Good morning. With me on this morning's call are Dr. Gary Barnette, the Chief Scientific Officer; Michele Greco, Chief Financial Officer and Chief Administrative Officer; Michael Purviss, Executive Vice President, General Counsel and Corporate Strategy, and Sam Fisch, Executive Director of Investor Relations and Corporate Communications. Thank you, for joining our Q2 fiscal year 2024 earnings call.

早安.今天早上和我一起參加電話會議的是首席科學官加里·巴內特 (Gary Barnette) 博士。米歇爾‧格雷科 (Michele Greco)，財務長兼首席行政官； Michael Purviss，執行副總裁，總法律顧問和企業策略，Sam Fisch，投資者關係和企業傳播執行董事。感謝您參加我們的 2024 財年第二季財報電話會議。

Here is a late-stage clinical stage biopharmaceutical company focused on developing innovative medicines for high quality weight loss, oncology and acute respiratory distress syndrome company's drug development pipeline includes two late-stage novel oral small molecules, enobosarm and visibility in our weight-loss pipeline. We have enobosarm also known as Ostarine, MK two H. six six GTXO. two four and zero to four, which is an oral selective androgen receptor modulator.

這是一家後期臨床階段生物製藥公司，專注於開發用於高品質減肥、腫瘤學和急性呼吸窘迫綜合徵的創新藥物，該公司的藥物開發管道包括兩種後期新型口服小分子、enobosarm 和我們減肥管道中的可見性。我們有enobosarm也稱為Ostarine，MK二H.六六GTXO。二四和零四，這是一種口服選擇性雄性激素受體調節劑。

So on Novozymes is being developed as a treatment in combination with glucagon-like peptide one receptor agonist, which I'll be referring to is glucagon receptor agonist, which is a weight loss drug to augment a fat loss and to avoid muscle loss in overweight or obese patients for chronic weight management in oncology pipeline and pending additional external funding of pharma partnership.

因此，Novozymes 正在開發一種與胰高血糖素樣勝肽一受體激動劑聯合使用的治療方法，我將指的是胰高血糖素受體激動劑，它是一種減肥藥物，可增強脂肪減少並避免超重時的肌肉損失或肥胖患者在腫瘤學管道中進行長期體重管理，並等待製藥合作夥伴的額外外部資金。

We have enobosarm in combination with abemaciclib as a treatment of androgen receptor positive estrogen receptor positive and human epidermal growth factor receptor two negative metastatic breast cancer in the second-line setting in our infectious disease pipeline.

在我們的傳染病產品線中，enobosarm 與 abemaciclib 聯合用於治療雄性激素受體陽性、雌激素受體陽性和人類表皮生長因子受體二陰性轉移性乳癌的二線治療。

Similarly, pending additional external funding or pharma partnership, we have some visibility in microtubule disruptor, which is in a planned Phase 3 clinical trial for the treatment of hospitalized patients with viral induced ARDS company also has an FDA approved commercial products the FC2 Female Condom internal condom for dual protection against unplanned pregnancy and sexually transmitted infection.

同樣，在等待額外的外部資金或製藥合作夥伴關係之前，我們在微管破壞器方面有一定的知名度，該產品正處於計劃中的3 期臨床試驗中，用於治療病毒引起的ARDS 住院患者。該公司還擁有FDA 批准的商業產品FC2 女用避孕套內部避孕套具有雙重保護作用，防止意外懷孕和性傳染感染。

This morning we'll provide an update on the primary focus of our company through the development of enobosarm, an oral dose arm in combination with govies and semaglutide EQUIP one receptor agonist to avoid muscle loss and to augment that loss for potentially higher quality weight loss will also provide financial highlights for our second quarter fiscal to fiscal year 2024.

今天早上，我們將透過開發enobosarm 來介紹我們公司的主要關注點的最新情況，enobosarm 是一種口服劑量臂，與govies 和semaglutide EQUIP one 受體激動劑相結合，以避免肌肉損失並增加肌肉損失，從而可能實現更高品質的減肥還將提供 2024 財年第二季的財務亮點。

With one receptor agonist like aseptic govies shutdown, majority of very effective weight loss drugs, unfortunately, up to 50% of total weight loss comes from muscle, which is problematic as muscles necessary metabolism strength and physical function, lots of muscle. Maybe one of the reasons why patients on quick one receptor agonist drugs, which have weight loss plateau, meaning the rate of weight loss slows or stops while taking a glucagon receptor agonist drug.

隨著一種受體激動劑（如無菌Govies關閉）的出現，大多數非常有效的減肥藥物，不幸的是，高達50%的總體重減輕來自肌肉，這是有問題的，因為肌肉需要代謝強度和身體功能，大量的肌肉。這可能是患者服用快速一種受體激動劑藥物的原因之一，這種藥物會出現減重平台期，這意味著在服用胰高血糖素受體激動劑藥物時體重減輕速度減慢或停止。

According to the CDC 41.5% of older adults have obesity in the United States and could benefit from a weight loss medication up to 34.4% of obese patients over the age of 60 has sarcopenia obesity of this larger study population and sarcopenia could these patients is especially at risk when taken equip one receptor agonist for weight loss as they may already have critically low amounts of muscle due to age-related muscle loss because of the magnitude and speed of muscle loss, while glucagon receptor agonist therapy for weight loss with one receptor agonist drugs may accelerate the development of frailty and muscle weakness in obese overweight elderly patients.

根據CDC 的數據，在美國，41.5% 的老年人患有肥胖症，可以從減肥藥物中受益，在這個較大的研究人群中，高達34.4% 的60 歲以上肥胖患者患有肌肉減少症，而這些患者的肌肉減少症可能尤其嚴重服用一種受體激動劑進行減肥時存在風險，因為由於肌肉損失的幅度和速度，他們可能已經因與年齡相關的肌肉損失而擁有極低的肌肉量，而使用受體激動劑進行胰高血糖素受體激動劑減重治療藥物可能會加速肥胖超重老年患者的虛弱和肌肉無力的發展。

Muscle weakness may lead to poor balance decrease, gait speed, mobility, disability, loss of independence and higher risk of falls and fractures effects. The safety section of the package insert for Gobi has been updated based on the recently reported select cardiovascular outcomes clinical study, which now highlighted 400% increase in public and hip fractures that were observed in patients greater than 75 years of age receiving Wegovy compared to placebo at 2.4% versus 0.6%, which was statistically significant with a p-value of 0.0073 and a 500% increase in public and hip fractures and females of any age. That's 1% versus 0.2%, which was statistically significant at p-value 0.0005 fractures of the hip and pelvis typically occurred because of falls, which increase would decrease muscle mass.

肌肉無力可能導致平衡能力下降、步態速度加快、活動能力下降、殘疾、失去獨立性以及跌倒和骨折風險增加。Gobi 說明書的安全性部分已根據最近報告的精選心血管結果臨床研究進行了更新，該研究現在強調，與安慰劑相比，接受Wegovy 治療的75 歲以上患者中觀察到的公共骨折和髖部骨折增加了400% 2.4% 與 0.6% 相比，具有統計顯著性，p 值為 0.0073，公共骨折和髖部骨折以及任何年齡的女性增加了 500%。這個比例是 1% 與 0.2%，在 p 值為 0.0005 時具有統計顯著性。

Consequently, we believe there is an urgent unmet medical need for a drug given in combination with equivalent receptor agonist that could prevent the loss of muscle while preferentially reducing fat in not only our overweight or obese patients, but also for the large subpopulation of sarcopenia copies, overweight elderly patients who are at risk for developing muscle atrophy and muscle weakness leading to frailty.

因此，我們認為，迫切需要一種與等效受體激動劑聯合使用的藥物，這種藥物可以防止肌肉損失，同時優先減少超重或肥胖患者的脂肪，而且還可以減少大量肌肉減少症患者的脂肪。 ，超重的老年患者有發生肌肉萎縮和肌肉無力導致虛弱的風險。

We believe that Novoste, our novel oral selective androgen receptor modulator may be the best drug candidate to address this urgent unmet medical need data from our clinical trials and preclinical studies supported Novozymes potential knows arm as a once a day, oral dosing works through the androgen receptor, which is a well established mechanism, demonstrates tissue selectivity; for example, improves and preserves muscle mass and physical function directly cause it to break down effect and prevent storage of fat, resulting in a decrease in fat mass.

我們相信，我們的新型口服選擇性雄激素受體調節劑Novoste 可能是解決這一緊迫的未滿足醫療需求的最佳候選藥物，我們的臨床試驗和臨床前研究數據支持Novozymes 的潛力，每天一次，口服劑量透過雄性激素發揮作用受體是一種成熟的機制，具有組織選擇性；例如，改善和保存肌肉質量和身體機能，直接導致其分解作用並阻止脂肪儲存，從而導致脂肪量減少。

This represents a different nonoverlapping mechanism of drug action to reduce fat that is distinct from glucagon one receptor agonist with one receptor agonist, suppress appetite to create low caloric state silver, Novozymes given fluids lip one receptor agonist, the combination utilizes a different mechanism to increase the launch effect, enobosarm builds and heals bone potential to treat bone loss, also known as osteoporosis to prevent fractures.

這代表了一種不同的非重疊藥物作用機制，以減少脂肪，這與胰高血糖素一種受體激動劑與一種受體激動劑不同，抑制食慾以產生低熱量狀態銀，Novozymes 給予液體唇一種受體激動劑，該組合利用不同的機制來增加透過發射效應，enobosarm 可以增強和治癒骨潛力，從而治療骨質流失（也稱為骨質疏鬆症），從而預防骨折。

Enobosarm has been previously studied in five clinical studies involving 968 older men, postmenopausal women, as well as older patients who have muscle wasting because of advanced cancer advanced cancer simulates a low calorie state because of loss of appetite with a significant unintentional loss or wasting of both muscle and fat mass similar to was observed with the glucagon receptor agonist treatment.

Enobosarm 先前已在五項臨床研究中進行研究，涉及968 名老年男性、停經後女性以及因晚期癌症而出現肌肉萎縮的老年患者。的無意損失或消耗肌肉和脂肪質量與胰高血糖素受體激動劑治療相似。

Totality of the clinical data from these five clinical trials demonstrate that notice on treatment leads to increases in muscle mass with improvements in physical function as well as significant reductions in fat mass. The expectation is that enobosarm in combination with one receptor agonist will potentially preserve muscle and augment the fat reduction by two different mechanisms resulting in higher-quality total weight loss.

這五項臨床試驗的臨床數據總體表明，注意治療可以增加肌肉質量，改善身體機能，並顯著減少脂肪量。預計enobosarm與一種受體激動劑相結合將有可能透過兩種不同的機制保留肌肉並增強脂肪減少，從而實現更高品質的整體減肥效果。

More importantly, enobosarm has a large safety database, which includes 27 clinical trials involving 1,581 men and women dose with Novus arm with some patients dosed for over two years. In this large safety database, enobosarm was generally well tolerated without mask utilizing effects in women. First of all, mild liver enzyme elevations have been reported, but no drug-induced liver injury has been observed in any of the clinical studies evaluating enobosarm.

更重要的是，enobosarm擁有龐大的安全資料庫，其中包括27項臨床試驗，涉及1,581名男性和女性服用Novus Arm，其中一些患者服用了兩年以上。在這個大型安全資料庫中，enobosarm 通常對女性具有良好的耐受性，無需使用面罩即可產生影響。首先，據報道，肝酵素輕度升高，但在任何評估enobosarm的臨床研究中均未觀察到藥物引起的肝損傷。

Furthermore, there were no increases in gastrointestinal side effects. This is important as there are as there are already significant and frequent gastrointestinal side effects with Glip one receptor agonist treatment alone.

此外，胃腸道副作用並沒有增加。這一點很重要，因為單獨使用 Glip 1 受體激動劑治療已經出現顯著且頻繁的胃腸道副作用。

Now turning to the enobosarm clinical program for high-quality weight loss Phase IIb, multicenter, double-blind, placebo-controlled, randomized dose-finding clinical study to evaluate the safety and efficacy of NovaStar three milligrams dose of six milligrams compared to placebo in combination with Wegovy.

現在轉向enobosarm高品質減肥臨床計劃IIb期、多中心、雙盲、安慰劑對照、隨機劑量探索臨床研究，以評估NovaStar 3毫克劑量至6毫克劑量與安慰劑相比的安全性和有效性與Wegovy的結合。

So at semaglutide which is the blue one receptor agonist in approximately 90 older patients over the age of 60 who are overweight or obese. Purpose of the Phase 2b clinical trial is to select the optimal dose of enobosarm in combination with equivalent receptor agonist that best preserves muscle and augments the reduction of fat mass with 16 weeks of treatment. The primary endpoint of the Phase 2b clinical trial will be the change in total lean body mass from baseline to 16 weeks.

索馬魯肽是一種藍色受體激動劑，用於治療約 90 名 60 歲以上超重或肥胖的老年患者。2b期臨床試驗的目的是選擇enobosarm與等效受體激動劑組合的最佳劑量，在16週的治療中最好地保留肌肉並增強脂肪量的減少。2b 期臨床試驗的主要終點是總去脂體重從基線到 16 週的變化。

Key secondary endpoints will be the change from baseline to 16 weeks and total fat mass insulin resistance to body weight and physical function as measured by stair climb test. We initiated the Phase 2b study rolling our first several patients in April of 2024 and the clinical studies planned to be conducted in approximately 15 clinical sites in the United States. The top line clinical results of the Phase 2b clinical trial are expected at the end of calendar year 2024.

關鍵的次要終點是從基線到 16 週的變化，以及爬樓梯測試測量的總脂肪量胰島素阻抗對體重和身體功能的影響。我們於 2024 年 4 月啟動了 2b 期研究，對首批幾名患者進行了滾動研究，並計劃在美國約 15 個臨床中心進行臨床研究。2b 期臨床試驗的主要臨床結果預計將於 2024 年底公佈。

We believe that assessing the effects of enobosarm on lean body mass and fat mass of 16 weeks should be adequate to demonstrate significant loss of muscle in the semaglutide placebo cohort part comes from the STEP 1 study reported by winding it down in the New England Journal of Medicine, STEP 1 study that evaluates semaglutide for weight loss in overweight and obese patients showed that 49% of the total weight loss and 68-week study occurred by week-16 and approximately 40% of the total weight was attributed to muscle loss.

我們認為，評估 enobosarm 對 16 週去脂體重和脂肪量的影響應該足以證明索馬魯肽安慰劑隊列中肌肉的顯著損失，該部分來自《新英格蘭雜誌》上報道的 STEP 1 研究。 ，評估索馬魯肽對超重和肥胖患者減肥效果的STEP 1 研究表明，68 週研究中總體重減輕的49% 發生在第16 週，總體重的約40% 歸因於肌肉損失。

Now after completing the 16-week efficacy dose-finding portion of the Phase IIb clinical trial participants would then continue until a blinded Phase 2b extension clinical trial were all patients will stop receiving the glucagon receptor agonists, but we'll continue taking the placebo. Enobosarm three milligrams were Novozymes six milligrams for an additional 12 weeks, blinded Phase 2b extension clinical trial will evaluate with enobosarm can maintain muscle and prevent fat in weight gain that occurs after discontinuing with one receptor agonists. The top-line results of the separate blinded Phase 2b extension clinical study are expected in calendar Q2 2025.

現在，在完成IIb 期臨床試驗的16 週療效劑量探索部分後，參與者將繼續進行盲法2b 期擴展臨床試驗，所有患者將停止接受胰高血糖素受體激動劑，但我們將繼續服用安慰劑。Enobosarm 為 3 毫克，Novozymes 為 6 毫克，持續 12 週，盲法 2b 期擴展臨床試驗將評估在停止使用一種受體激動劑後，使用enobosarm 可以維持肌肉並防止體重增加中的脂肪。單獨的盲法 2b 期擴展臨床研究的主要結果預計將於 2025 年第二季公佈。

Novozymes, a muscle drug that also burns fat. Our current Phase 2b clinical program is designed to provide clinical data to support the development of Novozymes for precision high quality weight loss by answering the following clinical questions related to muscle Fuji at risk older patients who are overweight or obese Cannon NovaStar and prevent the loss of muscle to preserve physical function, older patients who have or who may develop sarcopenia KBC that is they have both low muscle reserves and overweight or at high risk for accelerated development of frailty muscle weakness and physical function decline, both even with one receptor agonist.

Novozymes，一種也能燃燒脂肪的肌肉藥物。我們目前的 2b 期臨床計劃旨在提供臨床數據，透過回答以下與肌肉富士風險老年患者相關的臨床問題（超重或肥胖的 Cannon NovaStar）來支持 Novozymes 的精準高品質減重開發，並防止其損失患有或可能患有肌肉減少症KBC 的老年患者，即他們肌肉儲備低且體重超重，或加速出現虛弱肌無力和身體功能下降的風險很高，即使使用一種受體激動劑也是如此。

Second question for all patients who are overweight or obese can enobosarm preserve muscle to prevent the clip one with a weight loss plateau. The hypothesis is that loss of muscle creates a muscle deficit and that triggers an increasing appetite this increase in uptake counters, the hydrochloric benefit when drugs leading to weight loss plateau without deficit, flip one to ultimately potentially remove more fat and be able to maintain the hydrochloric state.

第二個問題是，所有超重或肥胖的患者是否可以使用enobosarm來保留肌肉，以防止減重平台期。假設是，肌肉損失會導致肌肉缺乏，並引發食慾增加，攝入計數器增加，當藥物導致減肥平台沒有缺乏時，鹽酸的好處，翻轉一個最終可能去除更多的脂肪，並能夠維持鹽酸狀態。

By the way, Novozymes has direct effects on fat to further increased fat loss. Third quarter for all patients who are overweight or obese can enobosarm maintain adequate muscle reserve when the glucagon receptor agonist drugs or discontinue to prevent the rebound we weight regain, which is almost backlogs are flat. We're excited that our Phase 2b clinical study has been initiated and is enrolling.

順便說一句，Novozymes 對脂肪有直接作用，可進一步增加減脂效果。第三季對於所有超重或肥胖的患者來說，當胰高血糖素受體激動劑藥物或停藥以防止體重反彈時，enobosarm可以保持足夠的肌肉儲備，這幾乎與積壓持平。我們很高興我們的 2b 期臨床研究已經啟動並正在招募中。

We believe we have sufficient financial resources on hand, which include the recent financing of net proceeds of $35.2 million to complete and provide results in both the Phase 2b clinical trial in the Phase 2b extension clinical trial.

我們相信我們手頭上有足夠的財務資源，其中包括最近融資的淨收益 3520 萬美元，以完成 2b 期臨床試驗和 2b 期擴展臨床試驗並提供結果。

I will now turn the call over to Michele Greco, CFO and CAO, to discuss the financial highlights. Michelle?

我現在將把電話轉給財務長兼首席行政官 Michele Greco，討論財務亮點。米歇爾？

Thank you, Dr. Steiner. Let's start with the second quarter results. For the three months ended March 31, 2024, overall net revenues were $4.1 million compared to $6.6 million in the prior year second quarter, the Company's quarterly sales for its US prescription business decreased to $597,000 from $4.1 million in the prior year second quarter.

謝謝你，斯坦納博士。讓我們從第二季的業績開始。截至2024 年3 月31 日的三個月，整體淨收入為410 萬美元，而去年第二季為660 萬美元，該公司美國處方藥業務的季度銷售額從去年第二季的410 萬美元下降至597,000 美元。

The reduction in the prescription business net revenues is due to $3.9 million in revenues for sales to the Pill Club in the prior year period. We did not have any sales to the Pill Club in the current year period due to the pill clubs Chapter 11 bankruptcy filing in April 2023.

處方業務淨收入減少的原因是去年期間向 Pill Club 的銷售收入為 390 萬美元。由於 Pill Clubs 於 2023 年 4 月根據美國破產法第 11 章申請破產，我們本年度沒有向 Pill Club 進行任何銷售。

We recorded a provision for credit losses related to those sales in the prior year. Net revenues from the global public sector business for the quarter was $3.5 million compared to $2.4 million in the prior year's quarter. The increase in the public sector business is for increased shipments under our contracts with UNFPA. and USAD.

我們記錄了與上一年銷售相關的信用損失準備金。本季全球公共部門業務的淨收入為 350 萬美元，而去年同期為 240 萬美元。公共部門業務的增加是為了增加我們與人口基金合約下的出貨量。和美國農業部。

Overall gross profit was $678,000 or 16% of net revenues compared to $4.1 million or 62% of net revenues in the prior year quarter. The decrease in gross profit and gross margin is due primarily to the change in sales mix with the US prescription business, which has a higher profit margin, comprising a smaller percentage of total net revenues and an increase in our cost of sales due to a charge of $700,000 for an obsolete stock reserve related to inventory in the US prescription channel.

整體毛利潤為 678,000 美元，佔淨收入的 16%，而去年同期為 410 萬美元，佔淨收入的 62%。毛利和毛利率的下降主要是由於美國處方藥業務的銷售組合發生變化，該業務的利潤率較高，佔總淨收入的比例較小，並且由於收費而導致我們的銷售成本增加700,000 美元用於與美國處方通路庫存相關的過時庫存儲備。

Our operating expenses for the quarter decreased to $10.6 million compared to the prior year's quarter of $38.5 million. The decrease is primarily due to research and development costs, which decreased $14.9 million to $3 million compared to $17.9 million in the prior year. Quarter and a decrease in selling, general and administrative expenses of $ 5.3 million from $12.8 million in the prior year quarter to $7.6 million in the current quarter.

與去年同期的 3,850 萬美元相比，我們本季的營運費用減少至 1,060 萬美元。下降的主要原因是研發成本，與去年的 1,790 萬美元相比，減少了 1,490 萬美元至 300 萬美元。本季銷售、一般和管理費用減少 530 萬美元，從去年同期的 1,280 萬美元減少到本季的 760 萬美元。

The decrease in research and development costs and due to our drug development strategy to focus development efforts and those drug candidates with the best opportunity for long-term success and shareholder value creation while matching available funding. During the quarter, we prepared the IND submission for enobosarm for weight loss, clinical program and other drug programs have been paused due to reduced expenses.

研發成本的下降是由於我們的藥物開發策略集中了開發工作以及那些在匹配可用資金的同時最有機會實現長期成功和股東價值創造的候選藥物。本季度，我們準備了enobosarm用於減肥的IND提交，臨床項目和其他藥物項目由於費用減少而暫停。

The decrease in selling, general and administrative expenses is primarily due to significant costs incurred in the prior year related to preparation for the potential commercialization of the visibility for COVID-19 prior to the FDA's declination of the Company's EUA application and an increase in personnel-related costs in the prior year due to increased headcount for potential commercialization. This incremental headcount has now been reduced post the EUA declination.

銷售、一般和管理費用的減少主要是由於上一年在 FDA 拒絕公司 EUA 申請之前為 COVID-19 可見性的潛在商業化做準備以及人員增加而產生的大量成本。 ，導致上一年度的相關成本。在 EUA 被拒絕後，此增量人員數量現已減少。

In addition, during the prior year quarter, we recorded an impairment charge totaling $3.9 million related to in-process research and development assets recorded for the VisibiliT for prostate zuclomiphene. Because of the company's changes strategy. We also recorded a provision for credit losses of $3.9 million related to the total amount due from the Pill Club as a result of the uncertainty of their financial condition after they filed for Chapter 11 bankruptcy.

此外，在上一季度，我們記錄了與前列腺珠氯米芬 VisibiliT 記錄的正在進行的研發資產相關的總計 390 萬美元的減損費用。由於公司策略的改變。由於 Pill Club 申請美國破產法第 11 章後財務狀況的不確定性，我們也記錄了與 Pill Club 應付總額相關的 390 萬美元的信用損失準備金。

The operating loss for the quarter was $9.9 million compared to $34.4 million in the prior year quarter. Non-operating income was $45,000 compared to [$559,000] in the prior year's second quarter and primarily consisted of interest income and the change in the fair value of the derivative liabilities related to the FC. two synthetic royalty financing, partially offset by interest expense and the change in the fair value of the hand kinetics preferred stock received on October 3, 2023 related to a payment due from ON kinetics for the sale of entire fee.

本季營運虧損為 990 萬美元，去年同期營運虧損為 3,440 萬美元。營業外收入為 45,000 美元，而去年第二季為 [559,000 美元]，主要包括利息收入和與 FC 相關的衍生負債的公允價值變化。兩項合成特許權使用費融資，部分被利息費用和2023 年10 月3 日收到的Hand Kinetics 優先股公允價值變化所抵消，這些變化與ON Kinetics 因出售全部費用而應付的付款有​​關。

For the quarter, we recorded a tax expense of $182,000 compared to a tax benefit of $67,000 in the prior year second quarter. Bottom line result for the second quarter was a net loss of $10 million, or $0.07 per diluted common share compared to a net loss of $33.8 million or $0.42 per diluted common share in the prior year second quarter.

本季度，我們記錄的稅收支出為 182,000 美元，而去年第二季度的稅收優惠為 67,000 美元。第二季的底線結果是淨虧損 1,000 萬美元，或稀釋後普通股每股 0.07 美元，而去年第二季的淨虧損為 3,380 萬美元，或稀釋後普通股每股 0.42 美元。

Turning to the results for the six months ended March 31, 2024. For the first six months of fiscal 2024, total net revenues were $6.3 million compared to $9.1 million in the prior-year period. Net revenue from the U.S. prescription business was $1.2 million compared to $4.3 million in the prior year period.

轉向截至 2024 年 3 月 31 日止六個月的業績。2024 財年的前六個月，總淨收入為 630 萬美元，而去年同期為 910 萬美元。美國處方藥業務的淨收入為 120 萬美元，去年同期為 430 萬美元。

The reasons for the decrease in net revenues from the prescription business for the period are consistent with the quarter. Included in the net revenues for the prior period were $3.9 million for sales to the Pill Club net revenue from the global public sector business for the period was $5 million compared to $4.8 million in the prior year's period.

本期處方業務淨收入下降的原因與季度一致。上一期間的淨收入中包括向 Pill Club 銷售的 390 萬美元，該期間全球公共部門業務的淨收入為 500 萬美元，而去年同期為 480 萬美元。

Overall, gross profit was $1.8 million or 29% of net revenues compared to $4.8 million or 53% of net revenues in the prior-year period. The decrease in profit and gross margin is due primarily to the decrease in the US prescription business and the increase in cost of sales.

整體而言，毛利為 180 萬美元，佔淨收入的 29%，而上年同期毛利為 480 萬美元，佔淨收入的 53%。利潤和毛利率的下降主要是由於美國處方業務的減少和銷售成本的增加。

Operating expenses decreased by $56.2 million to $20.5 million compared to the prior year period of $76.7 million. The decrease is driven by a reduction in research and development costs of $33.8 million to $4.6 million from $38.4 million in the prior-year period and a reduction in selling, general and administrative expenses of $14.5 million from $30.4 million in the prior-year period to $15.9 million.

營運費用比去年同期的 7,670 萬美元減少了 5,620 萬美元，降至 2,050 萬美元。造成這一下降的原因是，研發成本從去年同期的 3,840 萬美元減少到 460 萬美元，銷售、一般和管理費用從去年同期的 3,040 萬美元減少到 460 萬美元，減少了 1,450 萬美元。 1590 萬美元。

Factors contributing to the decrease in research and development costs and selling, general and administrative expenses are the same as those described for the quarter. As I mentioned, during the prior year second quarter, we also recorded an impairment charge of $3.9 million related to in-process research and development costs and a provision for credit losses of $3.9 million related to receivables from the PerClot.

導致研發成本以及銷售、一般和管理費用下降的因素與本季所述的相同。正如我所提到的，在去年第二季度，我們還記錄了與正在進行的研發成本相關的 390 萬美元的減損費用，以及與 PerClot 應收帳款相關的 390 萬美元的信用損失撥備。

Operating loss for the period was $17.8 million compared to $71.9 million in the prior year period, a decrease of $54.1 million, which is primarily due to the reduction in operating expenses, nonoperating expenses were $421,000 compared to $763,000 in the prior-year period and primarily consisted of interest expense and the change in the fair value of the kinetics preferred shares received related to the sale of entire fee, partially offset by the change in the fair value of the derivative liabilities related to the Up-C to synthetic royalty financing and interest income.

本期營業虧損為 1,780 萬美元，較上年同期的 7,190 萬美元減少 5,410 萬美元，主要是由於營業費用減少，非營業費用為 421,000 美元，較上年同期的 763,000 美元減少，主要是由於包括利息支出和與出售全部費用相關的Kinetics 優先股公允價值變化，部分被與Up-C 相關的衍生負債公允價值變化所抵消，以合成特許權使用費融資和利息收入。

For the six month period, we recorded a tax expense of $110,000 compared to a tax benefit of $135,000 in the prior year period. Bottom line results for the first six months of fiscal 2024 was a net loss of $18.3 million or $0.15 per diluted common share compared to a net loss of $72.5 million, or $0.90 per diluted common share in the prior-year period.

在這六個月期間，我們記錄的稅收支出為 110,000 美元，而上一年期間的稅收優惠為 135,000 美元。2024 財年前六個月的底線表現為淨虧損 1,830 萬美元，即每股稀釋普通股 0.15 美元，而上年同期淨虧損 7,250 萬美元，即每股稀釋普通股 0.90 美元。

Net loss for the company decreased by $54.2 million for the current six-month period. The main reason for the decrease in the net loss relates to the Company's focus on drug candidates with the best opportunity for long-term success and shareholder value creation while missing available funding and elimination of the commercial team and related commercialization expenses for the potential loss of the visibility for COVID-19.

在目前六個月期間，公司淨虧損減少了 5,420 萬美元。淨虧損減少的主要原因與公司專注於具有最佳機會實現長期成功和股東價值創造的候選藥物有關，同時缺少可用資金以及消除商業團隊和相關商業化費用，以防止潛在的損失。可見度。

Now looking at the balance sheet. As of March 31, 2024, our cash balance was $34.7 million, and our accounts receivable were $2.8 million compared to a cash balance of $9.6 million and an accounts receivable balance of $4.5 million as of September 30, 2023.

現在看資產負債表。截至2024 年3 月31 日，我們的現金餘額為3,470 萬美元，應收帳款餘額為280 萬美元，而截至2023 年9 月30 日，現金餘額為960 萬美元，應收帳款餘額為450萬美元。

Our net working capital was $35.6 million on March 31, 2024, compared to $5.1 million on September 30, 2023. During the six months ended March 31, 2024, we used cash of $11.7 million for operating activities compared with $60.1 million used for operating activities in the prior period.

截至 2024 年 3 月 31 日，我們的淨營運資本為 3,560 萬美元，而 2023 年 9 月 30 日為 510 萬美元。截至 2024 年 3 月 31 日的六個月內，我們用於經營活動的現金為 1,170 萬美元，而上一期間用於經營活動的現金為 6,010 萬美元。

We generated cash from financing activities for the six months ended March 31, 2024 of $36.8 million compared to $3.8 million in the prior period. On December 18, 2023, we completed an underwritten public offering of our common stock, which included the exercise and full of the underwriter's option to purchase additional shares.

截至 2024 年 3 月 31 日的六個月，我們透過融資活動產生的現金為 3,680 萬美元，而上一期間為 380 萬美元。2023 年 12 月 18 日，我們完成了普通股的承銷公開發行，其中包括行使並全額承銷商購買額外股票的選擇權。

Net proceeds to the company from this offering were approximately $35.2 million after deducting underwriting discounts and commissions and costs incurred by the company all the shares sold in the offering were offered by the company.

扣除承銷折扣和佣金以及公司產生的成本後，本公司從本次發行中獲得的淨收益約為3520萬美元，本次發行中出售的所有股票均由公司發行。

We are working to increase the future FC2 net revenues in the U.S. prescription channel by growing awareness and driving demand of FC2 through increased marketing efforts for our own telehealth platform and pursuing additional distributors in the telehealth sector. We are starting to see increases in our global public sector business from efforts to increase FC2 market awareness in developing countries.

我們正在努力提高FC2 在美國處方管道的未來淨收入，方法是透過加強對我們自己的遠距醫療平台的營銷力度以及在遠距醫療領域尋找更多經銷商來提高人們對FC2 的認識並推動FC2 的需求。我們開始看到，由於努力提高發展中國家 FC2 市場意識，我們的全球公共部門業務有所成長。

We believe our current cash balance, along with cash expected to be generated from sales of FC2 will be adequate to fund planned operations of the company for at least the next 12 months as we continue to focus on developing enobosarm for high quality weight-loss over the years, we have had plenty of experience in managing our cash burn.

我們相信，我們目前的現金餘額以及預計銷售 FC2 產生的現金將足以為公司至少未來 12 個月的計劃運營提供資金，因為我們將繼續專注於開發 enobosarm，以實現高質量減肥多年來，我們在管理現金消耗方面擁有豐富的經驗。

And now I'd like to turn the call back to Dr. Steiner

現在我想把電話轉回斯坦納博士

Dr. Steiner, Michelle, all Glip one receptor agonist work, mainly by creating a low caloric starvation state that results in the non selective loss of muscle and fat tissues to cause weight loss using a muscle preserving chart that can also decreased fat mass like enobosarm in combination with the slip-on receptor agonists may potentially allow for the additive reduction of fat mass for a higher quality precision weight loss in that or not only in older patients who are overweight, overweight or obese, but also in our patients who are overweight or obese.

Steiner 博士、Michelle，所有Glip one 受體激動劑的作用，主要是透過創造一種低熱量飢餓狀態，導致肌肉和脂肪組織的非選擇性損失，從而使用肌肉保留圖表來減輕體重，該圖表也可以像enobosarm一樣減少脂肪量與Slip-On受體激動劑聯合使用可能會進一步減少脂肪量，從而實現更高質量的精確減肥，不僅適用於超重、超重或肥胖的老年患者，還適用於我們的超重患者或肥胖。

This is truly a new indication. We believe that Novozymes is the best investigational drug candidate to address the muscle loss caused by with one receptor agonist drugs for weight loss. Enobosarm is a first-in-class novel sign as it orally once a day dosing has demonstrated tissue selectivity utilizes a well established known mechanism of action, the androgen receptor to favorably change body composition, activation of the Andrew receptor increases, muscle mass, improved physical function and decreases fat mass to potentially achieve a higher quality way laws.

這確實是一個新的跡象。我們相信 Novozymes 是解決由一種受體激動劑減肥藥物引起的肌肉損失的最佳研究候選藥物。Enobosarm 是一流的新標誌，因為每天口服一次給藥已證明組織選擇性利用了眾所周知的作用機制，雄激素受體有利地改變身體成分，安德魯受體的激活增加，肌肉質量，改善身體機能和減少脂肪量有可能實現更高品質的方式法則。

No Sun has a favorable side effect profile is not expected to add to the gastrointestinal side effects that already observed with with one receptor agonist treatment alone. The global obesity and overweight drug market is projected by research analysts to be $100 billion by 2030.

No Sun 具有良好的副作用，預計不會增加單獨使用一種受體激動劑治療時已觀察到的胃腸道副作用。研究分析師預計，到 2030 年，全球肥胖和超重藥物市場將達到 1,000 億美元。

Accordingly, the combination of enobosarm with it with one receptor agonist also potentially represents a multi-billion dollar global opportunity. Very excited about the prospects of enobosarm to address this new and important unmet medical need.

因此，enobosarm 與其與一種受體激動劑的組合也可能代表著數十億美元的全球機會。對enobosarm解決這一新的、重要的未滿足的醫療需求的前景感到非常興奮。

And we are looking forward to quickly enrolling this important and timely Phase IIb clinical study. I should note that we also have new clinical conclusions that we've generated from re-examining the clinical data from some of the previous five clinicals muscle studies evaluating enobosarm. That's a further support potential for enobosarm for the preservation of total lean body mass and reduction of fat mass to improved body composition for potentially a higher-quality weight loss in patients who are obese overweight.

我們期待盡快啟動這項重要且及時的 IIb 期臨床研究。我應該指出的是，我們也透過重新檢查先前五項評估enobosarm的臨床肌肉研究中的一些臨床數據而得出了新的臨床結論。這進一步支持enobosarm保持總去脂體重和減少脂肪量以改善身體成分，從而為肥胖超重患者提供更高品質的減肥效果。

The company will be who will be presenting two late breaking abstract presentations at the American Association of Clinical Endocrinology 2024 Annual Meeting taking place May 9, to the 11 in New Orleans, Louisiana. The presentations are double-blind, multiple ascending dose safety, pharmacokinetic and body composition study of enobosarm in healthy young and old demand. Lead author is Dr. Jeffrey Crawford within Department of Medicine, Duke School of Medicine.

該公司將於 5 月 9 日至 11 日在路易斯安那州新奧爾良舉行的美國臨床內分泌學會 2024 年年會上發表兩篇最新的突破性摘要報告。演講內容是enobosarm在健康年輕人和老年人需求的雙盲、多次遞增劑量安全性、藥物動力學和身體組成研究。主要作者是杜克大學醫學院醫學系的 Jeffrey Crawford 博士。

Second abstract is potential to optimize weight loss with enobosarm, which is to augment reduction of fat mass while preserving muscle older patients with obesity. That lead authors also Dr. Jeffrey Crawford from the Department of Medicine at Duke School of Medicine.

第二個摘要是利用enobosarm優化減重的潛力，即增加脂肪量的減少，同時保留老年肥胖患者的肌肉。研究的主要作者還有杜克大學醫學院醫學系的 Jeffrey Crawford 博士。

With that and now open the call to questions. Operator?

現在開始提問。操作員？

(Operator Instructions)

（操作員說明）

Dennis Ding, Jefferies.

丹尼斯丁，傑弗里斯。

Good morning.

早安.

Thanks for taking our questions and thanks for the very us very comprehensive prepared remarks as well.

感謝您提出我們的問題，也感謝我們準備的非常全面的評論。

Maybe if I can just ask about your internal views around duration of therapy. And if you think that this would mean that enobosarm would be used over, let's say, 1224 52-week period and then patients are stopped? Or do you view this as more of a chronic therapy for the lifetime of a patient being on the on a quick one, a great question and so duration of therapy.

也許我可以詢問您對治療持續時間的內部看法。如果您認為這意味著 enobosarm 將使用超過 1224 個 52 週週期，然後停止治療患者？或者您認為這更像是一種對患者一生進行快速治療的慢性治療，這是一個很好的問題，因此治療持續時間也很長。

So we do believe our size is beginning and we do believe that will be used for chronic and chronic management of obesity or overweight patients. And the reason for that is if the Glip group one is being used or the clip. One GIPPGIPI. glucagon are being used that the body is moving into a negative net negative nitrogen balance that you want to protect and preserve muscle.

因此，我們確實相信我們的規模正在開始，我們確實相信它將用於肥胖或超重患者的長期管理。原因是是否使用了 Glip 群組或剪輯。一個吉普吉皮。胰高血糖素被用來表示身體正在進入負淨負氮平衡，您想要保護和保存肌肉。

So if you want to preserve muscle, we what you'll want to take notice. With that said, there could be reasons for using enobosarm to rescue patients that started and started taking a quick one, then muscle mass got low and they got into trouble. And the question is, how don't you how do you rescue them so they don't get that rebound, weight gain and which is our FAD.

因此，如果您想保留肌肉，我們會告訴您您需要注意的事項。話雖如此，使用enobosarm來拯救那些開始服用快速藥物的患者可能是有原因的，然後肌肉質量變低，他們陷入了麻煩。問題是，你如何不拯救他們，這樣他們就不會出現反彈、體重增加，而這正是我們的時尚。

So numbers are I'm going to use it potentially episodic there. But to answer the question directly, I think it's chronic management. Interestingly, if you look at the data supplemental data from the select cardiovascular outcome study, it's very interesting because when you look at weight loss and this is a big study that was done for 4.25 years. I think it was published in New England Journal of Medicine. And what it shows is that the patients lose 10% of the of the total weight, we basically by year-end call and call it six months to nine months and it stays at 10% for the next, you know, 3.5 years.

所以我可能會偶爾使用它。但直接回答這個問題，我認為這是長期管理。有趣的是，如果您查看精選心血管結果研究中的數據補充數據，您會發現它非常有趣，因為當您查看體重減輕時，這是一項為期 4.25 年的大型研究。我認為它發表在《新英格蘭醫學雜誌》上。它顯示的是，患者減掉了總體重的 10%，我們基本上到年底就稱其為 6 個月到 9 個月，並且在接下來的 3.5 年裡保持在 10%。

So it's amazing this plateaus real. And and so I think I think by having the ability to add something to the Group, one of potentially can add to the total weight loss that you can achieve and potentially modify that plateau. So I think the best answer at this point is the thinking is it will be used for chronic management, but there's a lot there's a lot to learn from our clinical study that will help us understand what are some of the other programmatic things that we can do, including quite frankly, I mentioned about the fractures. I mean, public fractures in older patients is it is, is that has a high mortality rate and that's a hard endpoint.

所以這個高原真實存在是令人驚訝的。因此，我認為，透過為集團添加一些東西的能力，其中之一可能會增加您可以實現的總減肥效果，並可能改變這個平台。因此，我認為目前最好的答案是，我們的想法是將其用於長期管理，但從我們的臨床研究中可以學到很多東西，這將幫助我們了解我們可以做的其他一些規劃性的事情確實如此，包括坦白說，我提到了骨折的問題。我的意思是，老年患者的公共骨折的死亡率很高，這是一個硬終點。

And Novus, I'm used to be called Ostarine because of the first things that we recognized about Novozymes, that bone potential to build cortical with wells, trabecular bone. And and that's why, for example, that's why males have less hip fractures and females because because of the androgenic component, they end up having stronger cortical bone.

Novus，我習慣被稱為 Ostarine，因為我們首先認識到 Novozymes，即透過孔、小梁骨建構皮質的骨骼潛力。這就是為什麼，例如，這就是為什麼男性髖部骨折較少，而女性則因為雄激素成分，最終擁有更堅固的皮質骨。

So other programmatic approach, ability to see whether or not the combination will ultimately affect the reduction in pelvic fractures or hip fractures. So so at this point now, again, chronic therapy is what we're thinking. But a lot of it depends on programmatically how we roll it out and all that depends on how the Phase 2b data comes out.

因此，其他程序化方法，能夠看看組合是否最終會影響骨盆骨折或髖部骨折的復位。所以現在我們再次考慮慢性治療。但這很大程度上取決於我們如何以程式設計方式推出它，而這一切都取決於第 2b 階段資料的結果。

Thank you.

謝謝。

Well, sorry, if I will let Mr. Ding.

好吧，抱歉，如果我能讓丁先生的話。

No, thank you.

不，謝謝。

William Bird, B. Riley Securities.

威廉·伯德，B.萊利證券。

Yes, thank you for your questions and congratulations on a nice quarter. So you're you've obviously started to enroll your Phase 2 trial on a steady you'll be looking at some functional endpoints, including stair climb on. I was curious if there were any plans to look at additional functional endpoints, possibly six minute time walk or grip strength or possibly others may be even reduced hip fracture, unlike we've seen in some of these other trials?

是的，感謝您的提問，並祝賀您度過了一個愉快的季度。因此，您顯然已經開始在穩定狀態下進行第二階段試驗，您將關註一些功能終點，包括爬樓梯。我很好奇是否有任何計劃來研究其他功能終點，可能是六分鐘步行時間或握力，或者其他可能甚至可以減少髖部骨折，與我們在其他一些試驗中看到的不同？

Yes. Great question. So first of all, functional endpoints. We have to understand that if you're trying to build muscle preserve muscle, then the functional endpoint is going to be a strength endpoint.

是的。很好的問題。首先，功能端點。我們必須明白，如果你想鍛鍊肌肉並保持肌肉，那麼功能終點將是力量終點。

Okay, not a duration end 0.66 minute walk test and anything related to ENDURANCE. I probably is not going to be very sensitive, which can be sensitive things related to strength first strain. So you're trying to measure quadriceps in arm strength. And interestingly, it's not just strength from a regulatory standpoint. The agency has taken it one step further. And this we've seen in writing from the FDA and that is a they do not like grip strength of chest press of late press.

好吧，不是持續時間結束 0.66 分鐘步行測試以及與耐力相關的任何內容。我可能不會很敏感，這可能是與力量第一應變相關的敏感事物。因此，您正在嘗試測量股四頭肌的手臂力量。有趣的是，這不僅僅是從監管角度來看的實力。該機構又向前邁出了一步。我們在 FDA 的書面文件中看到了這一點，他們不喜歡後期推胸時的握力。

So in the regulatory world that's not seen as a as a functional test as a strength test. So the reason I bring it up, I think it's very important that people focus on what is from a regulatory standpoint, except for physical function endpoint, stair climb, power stair climb test is one of those tests, and we've been very fortunate to have Dr. Charlie, we've seen that with one of our key members of the Scientific Advisory Board has done over 2000 patients with stair climb test. It is we've been working with them for many years first with GTX. and now can vary. But interestingly, in 1,000 patients in those five clinical studies by 925 of those patients, we did stair climb tests, FDA recognized stair climb test as a functional endpoint.

因此，在監管領域，這並不被視為功能測試，而是強度測試。所以我提出這個問題的原因是，我認為從監管的角度來看，人們關注什麼是非常重要的，除了物理功能終點之外，爬樓梯、動力爬樓梯測試就是其中之一，我們非常幸運有查理博士，我們看到我們科學顧問委員會的一位主要成員已經為超過2000名患者做過爬樓梯測試。我們多年來一直與他們合作，首先是 GTX。現在可能會有所不同。但有趣的是，在這五項臨床研究中，我們對其中 925 名患者的 1,000 名患者進行了爬樓梯測試，FDA 認可爬樓梯測試作為功能終點。

We can measure speed going up the steps and you can also measure power from a regulatory standpoint. You know, Tower Pharma had a drug approved for muscular dystrophy. And I think in the last three months that was based on a stair climb test.

我們可以測量台階的速度，您也可以從監管的角度測量功率。你知道，Tower Pharma 有一種藥物被批准用於治療肌肉萎縮症。我認為在過去的三個月裡，這是基於爬樓梯測試。

So measuring functional endpoints, we're going to focus on the functional endpoint that correlates well with, for example, like leg strength there's a lot of literature over the last 10 years, 12 years showing that stair climb power. You have still good stair climb power and in decreasing in time to go up the steps that correlates very nicely with like strengthen and the strength endpoints, which is how you want to measure eMedicine that goes after muscle.

因此，在測量功能終點時，我們將重點放在與腿部力量密切相關的功能終點，例如，過去 10 年、12 年有大量文獻顯示了爬樓梯力量。您仍然具有良好的爬樓梯能力，並且減少了爬樓梯的時間，這與強度和力量端點非常相關，這就是您想要測量肌肉的電子醫學的方式。

So so we're going to focus on stair climb power. It's a it's a it's not a primary endpoint. I mean, very clear, it's a it's really a secondary endpoint is the endpoint to allow us to power what we wanted to see in a Phase 3 setting and I met Dr. Gary Barnett, who's our Chief Scientific Officer, who's one of the pioneers of the stair climb test.

所以我們將專注於爬樓梯的力量。這不是主要終點。我的意思是，非常清楚，這確實是一個次要終點，是讓我們能夠在第三階段環境中實現我們想要看到的目標的終點，我遇到了加里·巴尼特博士，他是我們的首席科學官，也是先驅之一的爬樓梯測試。

Two comments yellows, Gary? Yes, this is right. That says we have to look at what's regulatorily from an FDA perspective reasonable and what's going to get us closer to two marketability and that stair climb power, a functional endpoint. Think about it. It's very functional, Brian, if you have a second peak obesity or you have depleted muscle being able to climb steps, lift yourself carrying groceries, et cetera, is very important and contributes to your quality of life and your ability to thrive.

兩則評論發黃，加里？是的，這是對的。這就是說，我們必須從 FDA 的角度考慮什麼是合理的監管，以及什麼會讓我們更接近兩個適銷性和爬樓梯能力（功能終點）。想一想。這是非常實用的，布萊恩，如果你有第二個肥胖高峰，或者你的肌肉已經耗盡，那麼能夠爬樓梯、舉起自己攜帶雜貨等等，是非常重要的，有助於提高你的生活品質和你的成長能力。

And that is exactly what we're going to be testing and the FDA recognizes that strength assessments like grip strength and like press, et cetera, aren't really functional just strength. There's a lot of other aspects of the body that has to be working to to allow a patient to have a better quality of life. So that's why we chose we choose a stair climb and stair climb power, and we'll continue doing that as a NovaStar has shown in basically every study we've tested and to benefit the patients compared to a blinded placebo control in this in this functional assessment.

這正是我們要測試的內容，FDA 意識到，握力和推舉等力量評估並不是真正有效的，只是力量而已。為了讓患者擁有更好的生活質量，身體的許多其他方面都必須努力。因此，這就是為什麼我們選擇爬樓梯和爬樓梯功率，我們將繼續這樣做，正如NovaStar 在我們測試過的基本上每項研究中所顯示的那樣，與盲法安慰劑對照相比，這將使患者受益。

And because you had that functions to head out to add one additional point. And that is it that the muscle has to do adding lean body mass it lean body mass component as muscle mindset or internal organs and and others other compartments are going to stay the same, which then changes muscle and that increasing lean body mass. It's good, but linked to increasingly Invitae massively the physical function means that the quality of the muscle is that's built or preserved is good-quality.

因為你有這個功能可以去增加一個額外的點。也就是說，肌肉必須增加去脂體重，它的去脂體重成分作為肌肉心態或內臟和其他隔間將保持不變，然後改變肌肉並增加去脂體重。這很好，但與越來越多的身體功能有關，意味著建造或保存的肌肉質量是優質的。

So that's why the functional endpoint is interesting. Now with that said, muscle alone has a metabolic tissue. So independent of function in patients that are not at risk for physical decline, might you go after all patients, a drug that can preserve muscle may not have consequences with function, for example, a 32-year-old male and female with who's obese and as a BCD because they can lose 25% to 40% of their muscle mass is still do pretty well, functionally at least initially. But the plateau is a real problem. As I mentioned in that select trial, I mean, imagine being at 10% weight loss were 4.25 years.

這就是功能端點有趣的原因。話雖如此，肌肉本身就有代謝組織。因此，對於沒有身體衰退風險的患者來說，與功能無關，您可能會追尋所有患者，一種可以保留肌肉的藥物可能不會對功能產生影響，例如，一名32歲的男性和女性患有肥胖症而作為 BCD，因為他們可能會失去 25% 到 40% 的肌肉質量，但仍然表現得很好，至少在功能上是這樣，至少在最初是這樣。但平台期是一個真正的問題。正如我在那次選擇性試驗中提到的，我的意思是，想像一下體重減輕 10% 需要 4.25 年。

And so that's why there's a lot of frustration and if you can break through that. So I think from a metabolic standpoint, showing that the muscles preserved muscle doesn't contribute to the A overheating or the or the increase in appetite as one of the mechanisms that's fighting the HyperCloud state by suppressing appetite will look one. So so so I think you have to think of it in two buckets bucket one, physical decline in patients at risk that the older patients sarcopenia competed two, the metabolic effects that can help manage appetite and other good things that you want muscles to do in patients that may not be a for physical decline but would benefit them from losing more weight and that hit that plateau.

這就是為什麼會有很多挫折感，如果你能突破它的話。因此，我認為從新陳代謝的角度來看，表明保留的肌肉不會導致過熱或食慾增加，作為透過抑制食慾對抗超雲狀態的機制之一。所以我認為你必須從兩方面來考慮：第一，老年患者肌少症患者面臨身體衰退的風險，第二，代謝作用可以幫助控制食慾和其他你希望肌肉做的好事患者可能不會因為身體下降而受益，但會因為減輕更多體重而受益，並且達到穩定狀態。

Got it. Very helpful. Thank you. Appreciate that extra color there.

知道了。很有幫助。謝謝。欣賞那裡額外的顏色。

On when I saw your quick question on, I know it's still a bit early, but I was curious if there's been any feedback on from investigators, possibly patients about enthusiasm towards your approach and the need to sort of maintain or the lean muscle loss off to a minimum in the Phase two trial has just started to get enrolling?

當我看到你的快速問題時，我知道現在還為時過早，但我很好奇是否有研究人員（可能是患者）對你的方法的熱情以及需要保持或減少瘦肌肉損失的反饋至少在第二階段試驗剛開始招募時？

So I mean, my doctor gave an answer to that question to persist, at least close to the clinical trial and be able to say my initial, my initial impression is that we've never seen such enthusiasm for a clinical trial that we've ever run. I mean there is tremendous enthusiasm in this space. And for this trial, particularly, we've been bombarded with phone calls and requests by patients to get into the study and by sites, I want to make sure they get patients in the study. But Gary, do you want to add to that now?

所以我的意思是，我的醫生對這個問題給出了堅持的答案，至少在接近臨床試驗的時候，並且能夠說出我最初的、我最初的印像是，我們從未見過對臨床試驗如此熱情，我們已經曾經跑過。我的意思是這個領域有巨大的熱情。特別是對於這項試驗，我們收到了來自患者的電話和要求參與研究的轟炸，我想確保他們讓患者參與研究。但是加里，你現在想補充嗎？

Yes, we're getting calls from patients and sites into our clinical trials number. I've been routine daily daily. We're talking 25 to 50 to 60 70 calls a day with interesting study. Of course, we have the Scientific Advisory Board and our investigators that are coming on that are extremely excited about the the opportunity to participate in the study. We recognize and most clinicians that use good point recognize the problem with that we're facing with the loss of muscle and the especially in the older patient population as much as I described. But we know we have a lot of calls coming in and we direct them to clinicaltrials.gov and encourage them to find the site but near them that they may participate in that study. So yes, there's a lot of enthusiasm for sure.

是的，我們接到了病患和研究中心的臨床試驗電話。我每天都過著例行公事。我們每天會接到 25 到 50 到 60 70 通電話，進行有趣的研究。當然，我們的科學顧問委員會和我們的研究人員對有機會參與這項研究感到非常興奮。我們認識到，並且大多數使用好點的臨床醫生都認識到我們面臨的肌肉損失問題，特別是在老年患者群體中，正如我所描述的那樣。但我們知道我們接到了很多電話，我們將他們引導至 ClinicalTrials.gov，並鼓勵他們找到該網站，但要靠近他們，以便他們可以參與研究。所以，是的，肯定有很大的熱情。

And you have to add to that. The other thing that I've never seen before is the common awareness that muscle loss is occurs with the clip ones. And then it doesn't matter what patient. But whatever group of this patient to investors and brokers are. I mean, it's understood that muscle loss occurs with weight loss when the coupon drugs and interesting variable bariatric surgery was the same case.

你還必須補充這一點。我以前從未見過的另一件事是，人們普遍意識到肌肉損失是由夾子造成的。然後什麼病人並不重要。但無論這群病人對投資人和經紀人來說是什麼。我的意思是，據了解，當優惠券藥物和有趣的可變減肥手術相同時，肌肉損失會隨著體重減輕而發生。

And then with the differences in bariatric surgery, which you'd see the same thing, you see that rapid weight loss, it plateaus and stays that way is the reason why the number of amount of attention was brought to his because he knows about 250,000 bariatric surgical cases done a year. And with Glip, once you are in millions of patients being effective just really has moved to the front burner.

然後，由於減肥手術的差異，你會看到同樣的事情，你會看到，體重迅速下降，體重趨於穩定並保持這種狀態，這就是他受到如此多關注的原因，因為他知道大約 250,000一年完成減肥手術個案。有了 Glip，一旦對數百萬患者有效，就真正成為人們關注的焦點。

And and so the question now becomes what we're excited that we have the weight loss will not exceed the weight loss include so much muscle and there's a lot of debate and discussion and what does it mean to have a tool like enobosarm that can specifically to increase muscle and decreased fat can answer other questions that can't be answered with the current ways that people are going after by just looking at muscle loss such as muscle loss is can you preserve we can add to it. And now what does that mean clinically?

所以現在的問題是，我們很高興我們的體重減輕不會超過包括這麼多肌肉的體重減輕，並且有很多爭論和討論，以及擁有像enobosarm這樣的工具意味著什麼，它可以專門增加肌肉和減少脂肪可以回答其他問題，而這些問題是人們目前所追求的僅通過觀察肌肉損失的方式無法回答的，例如肌肉損失是可以保留的，我們可以增加它。那麼這在臨床上意味著什麼呢？

Excellent. Thank you for the very clear response and on I appreciate it. Congrats on the quarter and thanks for taking our questions. I hope I can do.

出色的。感謝您非常明確的答复，我很感激。恭喜本季度，感謝您提出我們的問題。我希望我能做到。

Thank you.

謝謝。

Gary Nachman with Raymond James.

加里·納赫曼和雷蒙德·詹姆斯。

Hey, guys, good morning. This is Dennis on for Gary. Thanks for taking our question on. First, can you just walk through your current thinking of a potential Phase three? Do you think the FDA will require the trial to be used in combination with the various approved Quick ones within different cohorts? Or could you run a Phase three with just semaglutide similar to kind of how the Phase two is then I'm going to follow up after.

嘿，夥計們，早安。這是丹尼斯替加里發言。感謝您提出我們的問題。首先，您能簡單介紹一下您目前對潛在第三階段的想法嗎？您認為 FDA 是否會要求該試驗與不同隊列中各種已批准的 Quick 試驗結合使用？或者你可以只用索馬魯肽進行第三階段，類似於第二階段，然後我會跟進。

Yes. So I'm going to ask Dr. Bunn by now, who is our Chief Scientific Officer and also Head of Regulatory to take a stab at that question because at this point, we don't have feedback with them. What do you think, Gary?

是的。因此，我現在要請我們的首席科學官兼監管主管 Bunn 博士來回答這個問題，因為目前我們還沒有得到他們的回饋。你覺得怎麼樣，蓋瑞？

So I mean, however, we went for label to look at how we would we would design it. And right now we we are using only semaglutide in our in our Phase two. Obviously, as you might expect, limiting the the the cliff one to one group one is it decreases variability now what we would do in a clinical trial sites kind of trough where we opened up two, the approved performance at that point, what we would Stratify randomization so that the good one you intended to be used would be would be equally distributed across three groups are the two groups in that case. So I see, frankly, I would I would design it using all the data points at that point just because I think that's how the product will be used in clinic.

所以我的意思是，然而，我們選擇標籤是為了看看我們將如何設計它。現在我們在第二階段只使用索馬魯肽。顯然，正如您所期望的那樣，將懸崖限制為一對一組，它會減少變異性，現在我們會在臨床試驗地點做一些低谷，我們打開了兩個，當時批准的性能，我們會做什麼對隨機化進行分層，以便您打算使用的好隨機化將平均分佈在三個組中，即這種情況下的兩個組。所以我認為，坦白說，我會使用當時的所有數據點來設計它，因為我認為這就是該產品在臨床上的使用方式。

Yes, and to answer the question Phase two, why do we pick one full point for the Phase two? One is no. The decrease variability, of course, to is to is to come is to be able to power the study based on known information. And semaglutide has the best information in terms of what happens to muscle over time. And the other ones are either in progress or just to complete. It's just hard to say or we know, as I know every one of these good ones in combination type the once you use the two drugs or three drugs are on that kind of going after equip one GIP. or glucagon all have muscle loss. And we just don't know the time and we don't know the amount. So that's why we use semaglutide.

是的，為了回答第二階段的問題，為什麼我們為第二階段選擇一個滿分？一是沒有。當然，變異性的減少是為了能夠為基於已知資訊的研究提供動力。索馬魯肽擁有關於肌肉隨時間變化的最佳資訊。其他的要么正在進行中，要么剛剛完成。這很難說，或者我們知道，因為我知道這些好的藥物中的每一種都是組合型的，一旦你使用兩種藥物或三種藥物，就會在裝備一種 GIP 後出現這種情況。或胰高血糖素都有肌肉損失。我們只是不知道時間，也不知道金額。這就是我們使用索馬魯肽的原因。

With that said, I make one more comment. With that said, there's been information about well, some of them you lose 25% some you lose 40%, sometimes 50%, the not all the same.

話雖如此，我再發表一則評論。話雖如此，有一些資訊說，有些你會損失 25%，有些你會損失 40%，有時是 50%，但並不都是一樣的。

Well, in fairness, the mechanism is decreasing appetite, central, the creating a hydrochloric state. So basically starvation state and the bond is responding like you would in the wild. I mean, you're utilizing your glycogen from the liver and then glycogen from the muscle and they start hitting gluconeogenesis and muscle breaks down if that breaks down. So the body is not responding to a particular receptor is responding to a to a metabolic state. What I'm trying to say is I just don't know if we can actually pick out which one is better or less in terms of with muscle and muscle.

好吧，公平地說，該機制是降低食慾，核心是創造鹽酸狀態。所以基本上飢餓狀態和債券的反應就像你在野外一樣。我的意思是，您正在利用肝臟中的肝醣，然後利用肌肉中的肝醣，它們開始影響糖質新生，如果分解，肌肉就會分解。因此，身體不是對特定受體做出反應，而是對代謝狀態做出反應。我想說的是，我只是不知道我們是否能真正選出在肌肉和肌肉方面哪個更好或更差。

We've done head to head and done head to head. I think we'll find that muscle loss is going to be more related to the potency of the appetite suppression and and the duration that patients on the drug. And so so Gary's right. I mean, if you can get all of the quick ones and in this study and we stratify so that we minimize the ability, the ability of the potential for variability from arm to arm, that would be great. But I think what we'll do after we talk to the FDA with the Phase IIb results is the layout programmatically. What we're thinking because I because there are covenants in some endpoints that are interesting like hip fractures and topic factors that you make a difference in that that's almost like the cardiovascular SELECT trials showing cardiovascular benefit in the group ones.

我們已經進行過正面交鋒和正面交鋒。我認為我們會發現肌肉損失與食慾抑制的效力以及患者服用藥物的持續時間更相關。所以加里是對的。我的意思是，如果你能在這項研究中獲得所有快速的能力，並且我們進行分層，以便最大限度地減少能力，即手臂之間潛在變異的能力，那就太好了。但我認為，在我們與 FDA 討論 IIb 期結果後，我們要做的就是以程式設計方式進行佈局。我們在想什麼，因為我是因為在一些有趣的終點上有契約，例如髖部骨折和主題因素，你會產生影響，這幾乎就像心血管 SELECT 試驗顯示了團體中的心血管益處。

As you know, the good ones are not being paid for by Medicare until they showed an endpoint like that with a cardiovascular endpoints. So can you imagine a situation as we show in our program reduction in fractures, will that's going to feel a lot better and have more of a meaningful from a payer standpoint in fact, the payers now are paying for Wegovy because they show that the endpoints so more to come.

如您所知，好的藥物只有在顯示出與心血管終點類似的終點後才會由醫療保險支付。因此，您能想像一下我們在減少骨折的計劃中展示的情況嗎？顯示端點未來還會有更多。

That was very helpful. Thank you. And then just a quick follow-up. Not ever who is fully focused on enobosarm for weight loss. Can you just talk a little bit about how the FC. two business fits in within the overall company and kind of how you view the value that it provides you guys. Thanks a lot.

這非常有幫助。謝謝。然後進行快速跟進。從來沒有誰完全專注於enobosarm減肥。能簡單談談FC 的情況嗎？兩項業務適合整個公司，以及您如何看待它為您提供的價值。多謝。

I'm sorry, which business as well as a seasonal part of the year.

抱歉，該業務以及一年中的季節性部分。

FC2 business

FC2業務

Yes. So kind of the reason we first was a legacy product came from the Female Health Company that went through a very was a Aspen Park. Pharmaceuticals was acquired by a Female Health Company and ultimately what came out of that was very and the reason we did that initially was that we would have revenue and we would and we would be able to use that revenue and it was a high profit business to use it to pay for our clinical development.

是的。因此，我們首先是女性健康公司的遺留產品，該公司經歷了阿斯彭公園的考驗。製藥公司被一家女性健康公司收購，最終的結果是非常好的，我們最初這樣做的原因是我們將擁有收入，我們將能夠利用這些收入，這是一項高利潤業務用它來支付我們的臨床開發費用。

And over the last five years or so, I think it's generated something like $200 million in cash that we were able to use in clinical trials unlike five years and so achieve what we wanted to achieve. And now the business is kind of turnkey. It's in the background, we have a team that's involved with it that our main primary focuses is Foamix Pharmaceuticals, in particular, now enobosarm in obesity.

在過去五年左右的時間裡，我認為它產生了大約 2 億美元的現金，我們能夠將其用於臨床試驗，而不是五年，從而實現我們想要實現的目標。現在這項業務有點交鑰匙了。在後台，我們有一個團隊參與其中，我們的主要關注點是 Foamix Pharmaceuticals，特別是現在的 enobosarm 治療肥胖症。

So where we see right now is it the FC2 business. If it keeps generating cash for us, it's great. If we wanted to look for selling and into do sound like that, we can we have options to monetize it. But it clearly it's not I mean, our focus is a pharmaceutical company.

所以我們現在看到的是 FC2 業務。如果它繼續為我們創造現金，那就太好了。如果我們想尋求銷售並做到聽起來像這樣，我們可以選擇將其貨幣化。但顯然這不是我的意思，我們的重點是一家製藥公司。

Great. Thank you so much and congrats on the progress.

偉大的。非常感謝並祝賀取得的進展。

Thank you very much.

非常感謝。

(Operator Instructions)

（操作員說明）

Rohan Mathur, Oppenheimer. Please go ahead.

羅漢·馬圖爾，奧本海默。請繼續。

It's Roland on for Lee and commercial.

羅蘭為李主持廣告。

Thanks for taking my questions. On the topic of weight loss quality, there aren't very many studies being conducted to evaluate preservation of muscle mass and function, how do you how are you viewing the bar for success finding a better kind of function given the lack of competitors? And has the FDA provided any color here?

感謝您回答我的問題。關於減肥質量，目前還沒有很多研究來評估肌肉質量和功能的保存，在缺乏競爭對手的情況下，您如何看待成功找到更好的功能的標準？FDA 是否提供了任何顏色？

Yes. Great question. So part of the problem is we're trying to decide whether to use mass of the Club Car department. The field right now is trying to understand we understand the problem. And as you have loss of muscle significant loss of muscle, again, it's up to half of them of the way.

是的。很好的問題。因此，部分問題是我們正在嘗試決定是否使用 Club Car 部門的大部分資源。目前該領域正在試圖了解我們所理解的問題。當你的肌肉流失時，肌肉也會大量流失，同樣，最多會失去一半的肌肉。

Did you lose muscle the exchange rate again, humor me for a moment, the exchange rate is if we lose [GBP2], half of its muscle have it's fat. So you have to sacrifice a pound of muscle for pound effect and you can see how you can get to a point where somebody's [GBP400] and they lose 10% of the weight in our three 60 store base still have problems that are still overweight in the stock.

你又失去肌肉了嗎？所以你必須犧牲一磅肌肉來換取磅效應，你可以看到如何達到這樣一個地步：某人的[GBP400] 並且他們在我們的3 個60 商店基地中減掉了10% 的體重，但仍然存在超重的問題股票。

So I think there's a whole whole area that should be looked at and we're looking at in our Phase two, and that is changing body composition trying to show that we can reduce more fat with the combination so that we can get clues about how we will handle with 52 weeks later.

因此，我認為應該關注整個領域，我們在第二階段正在關注，那就是改變身體成分，試圖表明我們可以透過組合減少更多脂肪，以便我們可以獲得有關如何減少脂肪的線索。後處理。

You've got a situation where you preserve muscle and you keep losing fat loss of fat is what's going to lead to the increase in weight loss as it relates to muscle function function really has to be a function with enhanced focus on the older patient population. And if you look at our five five clinical trials, 948 patients, something like that almost 1,000 patients, almost all of those patients were older patients, so over the age of 60 of postmenopausal women.

你遇到的情況是，你保留了肌肉，但你不斷失去脂肪，脂肪的減少會導致體重減輕，因為它與肌肉功能有關，功能確實必須是一種更加關注老年患者群體的功能。如果你看一下我們的五、五項臨床試驗，有 948 名患者，差不多有 1000 名患者，幾乎所有這些患者都是老年患者，所以都是 60 歲以上的停經後女性。

So we have a lot of experience and whether it looks like for somebody who's not obese what and whether or not there's a benefit in muscle and fat and function. And so we have that under our belt, which I think is great. And so now the LEAP is going from that information to the obese and overweight patient population. And again, our anchor to that, our surrogate to that is one of us one of the studies that we do within the lung cancer patients on chemo.

所以我們有很多經驗，以及它對不肥胖的人來說是否看起來像什麼，以及是否對肌肉、脂肪和功能有好處。所以我們已經掌握了這一點，我認為這很棒。因此，現在 LEAP 正在將這些資訊應用於肥胖和超重患者群體。再說一次，我們的錨點，我們的替代物是我們在肺癌化療患者中進行的研究之一。

And these lung cancer patients have no reduction and appetite. And so it's almost like a blip one because the local or state and we're able to show in that state, we didn't build muscle. In other words, we're not creating body builders, but what we did do can you maintain muscle and preserve muscle and that and that correlated and that could and that was the day before and that correlated with function and and and ultimately by time got to week 21, there is no greater loss of weight in obese patients. So we feel we feel that we've got some interesting information.

而這些肺癌患者的食慾並沒有減少。所以這幾乎就像曇花一現，因為當地或州，我們能夠在那個州展示，我們沒有增強肌肉。換句話說，我們不是在創造健美運動員，而是我們所做的可以讓你維持肌肉並保留肌肉，並且那個和那個相關並且那個可以並且那是前一天並且那個與功能相關並且最終通過時間得到到第21週，肥胖患者的體重並沒有出現更大的下降。所以我們覺得我們得到了一些有趣的資訊。

As you know, there's no company you brought the point up, it has muscle data or any data in combination with the muscle drug in humans. So so so the the big categories, myostatin inhibitors that IV at least some of the Phase twos and others have reached that point yet to see an increase in diarrhea. But you know, to see direct Glip one to raise questions about the combination put that aside for a moment. So so the naphtha focusing on function necessarily, we're focusing on the on the first bucket, which is the metabolic tissue. If you keep them out of our tissue, can you see greater weight loss FDA is now is not going to be happy with just shown you have muscle unless there's some some some benefit for the patients or the benefits going to be additional weight loss, incremental weight loss with the combination that's meaning clinically meaningful or didn't have the shelf function.

如您所知，您提出的觀點沒有一家公司擁有肌肉數據或任何與人類肌肉藥物結合的數據。就大類而言，肌肉生長抑制素抑制劑IV至少有一些第二階段和其他階段已經達到這一點，但尚未看到腹瀉增加。但你知道，看到直接 Glip 一個提出關於組合的問題就暫時放在一邊。因此，石腦油必然關注功能，我們關注第一個桶，即代謝組織。如果你把它們排除在我們的組織之外，你能看到更大的體重減輕嗎FDA 現在不會對剛剛顯示的你有肌肉感到滿意，除非對病人有一些好處，或者好處是額外的體重減輕、增量具有臨床意義或不具貨架功能的組合的減肥效果。

And so the so that so function needs to be done in patients that are informative, meaning that you take the older patient that's already has low muscle. That's an exponentially get into trouble. And we know that they can have accelerated loss of muscle of accelerated frailty. And that's a patient that you can see you can take up the stairs and then show with an agent like ours that by maintaining muscle stopping the physical decline that you can, you can separate out stair climb, power and speed because you're not going to see the floor ceiling effect that happens sometimes reduce exercise functional endpoints.

因此，需要在資訊豐富的患者中完成這樣的功能，這意味著您需要接受肌肉已經較低的老年患者。這會帶來指數級的麻煩。我們知道，他們可能會加速肌肉流失，加速虛弱。這是一個病人，你可以看到你可以爬樓梯，然後向像我們這樣的代理人展示，透過保持肌肉阻止身體衰退，你可以將爬樓梯、力量和速度分開，因為你不會走觀察有時會發生的地板天花板效應會降低運動功能終點。

So I think, again, our Phase IIb is designed in a way that none of the others are at this point because first, we're adding patients and putting patients on that at risk and it can be informative. So we can understand how to design the Phase three with the information that we get from the from the Phase IIb. Again, the FDA's caution us it grip strength and like Preston just press and that kind of stuff strength endpoints here will not mix, not knock into functional endpoints. So that's why we focus so much on muscle that muscle drug in this Phase IIb phase will allow us to branch out and programmatically approach the different things that muscle can be involved with again, metabolic or function.

因此，我再次認為，我們的 IIb 期臨床試驗的設計方式是其他臨床試驗目前所沒有的，因為首先，我們正在增加患者，並將患者置於危險之中，這可以提供資訊。因此，我們可以利用從第二階段b 獲得的資訊來了解如何設計第三階段。再次，FDA 警告我們握力，就像普雷斯頓一樣，只需按壓，這種東西的強度終點不會混合，不會影響功能終點。這就是為什麼我們如此關注肌肉，IIb 期的肌肉藥物將使我們能夠分支並以編程方式處理肌肉可以再次參與的不同事物，代謝或功能。

Thanks. And I just as a follow-up, when you think about potential paths forward, how do you think about targeting other populations that could also benefit from these enormous platforms?

謝謝。我作為一個跟進者，當您考慮潛在的前進道路時，您如何考慮針對也可以從這些巨大平台中受益的其他人群？

Yes. So So right now, the Phase IIb is folks out of patients, but the Phase three programs are going to be all comers.

是的。所以現在，IIb 期計畫已經沒有病人了，但第三期計畫將會全部到來。

Sure. And then we'll embed special populations and maybe understand how we want to roll out the functional part of it. So there's still still thinking we have to do based on the Phase IIb that will help us understand programmatically how we want to go out to us. The immunome, what's interesting is our file and follow the money.

當然。然後我們將嵌入特殊人群，也許了解我們希望如何推出其中的功能部分。因此，我們仍然認為我們必須基於 IIb 階段進行工作，這將幫助我們以程式設計方式理解我們想要如何為我們提供服務。免疫組，有趣的是我們的檔案和追蹤金錢。

So wherever the good ones go, we go so for example, they start using flip lenses, sleep apnea using coupons for cardiovascular outcomes in the plans for inflammation, sustainment and problem. That is I do see a reduction in weight and energy reduction muscle being a big part of that weight so that that will also help us understand where we need to go.

因此，無論好的人去哪裡，我們都會去，例如，他們開始使用翻轉鏡片，睡眠呼吸暫停，在發炎、維持和問題計劃中使用心血管結果優惠券。也就是說，我確實看到體重的減少和能量減少肌肉是體重的重要組成部分，因此這也將幫助我們了解我們需要去哪裡。

Ladies and gentlemen, this concludes our question and answer session. I would like to turn the conference call back over to Dr. Mitchell Steiner for any closing remarks.

女士們先生們，我們的問答環節到此結束。我想將電話會議轉回給米切爾·施泰納博士，讓​​其發表結束語。

Appreciate everyone who's joined us on today's call, and I look forward to updating all of you on our progress in our next investor call. Thank you again.

感謝參加今天電話會議的每一個人，我期待在下次投資者電話會議上向大家通報我們的最新進展。再次感謝你。

The digital replay of the conference call will be available beginning approximately noon Eastern time today. May eighth by dialing one eight seven seven three four four seven five two nine in the US and one four one two three one seven zero zero eight eight. Internationally. You will be prompted to enter the replay access code, which will be eight eight six one six nine two. Please record your name and company when joining.

電話會議的數位重播將於東部時間今天中午左右開始提供。五月八號，在美國撥打一八七七三四四七五二九，以及一四一二三一七零八八。國際上。系統將提示您輸入重播存取代碼，代碼為八八六一六九二。加盟時請備註您的姓名和公司。

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

電話會議現已結束。感謝您參加今天的演講。您現在可以斷開連線。