Veru Inc (VERU) 2024 Q3 法說會逐字稿

Good morning, ladies and gentlemen, and welcome to Veru Inc.'s investors conference call. (Operator Instructions) Please note 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）請注意此事件正在被記錄。

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

我現在將會議交給 Veru Inc. 投資者關係和企業傳播部執行董事 Sam Fisch 先生主持。請繼續。

Good morning. The 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. Such forward-looking statements are subject to known and unknown risks and uncertainties, and our actual results may differ significantly from those projected, 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.

早安.本次電話會議中的陳述可能是前瞻性陳述。前瞻性陳述可能包括但不限於公司有關其業務、營運、監管互動、財務和開發以及產品組合的計劃、目標、期望或意圖的陳述。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 Inc. 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, Chief Scientific Officer; Michele Greco, Chief Financial Officer and Chief Administrative Officer; Michael Purvis, the General Counsel and Executive Vice President of Corporate Strategy; and Sam Fisch, Executive Director of Investor Relations and Corporate Communications. Thank you for joining our Q3 fiscal year 2024 earnings call.

早安.與我一起參加今天早上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 Purvis，總法律顧問兼企業策略執行副總裁；以及投資者關係和企業傳播部執行董事 Sam Fisch。感謝您參加我們的 2024 財年第三季財報電話會議。

Veru is a late clinical stage biopharmaceutical company focused on developing innovative medicines for high-quality wave loss, oncology and acute respiratory distress syndrome. The company's drug development pipeline includes two late-stage novel oral small molecules in enobosarm and sepisabululin. In our weight loss pipeline, we have enobosarm, also known as Austria-MK-2866 GTX-024 and VR-024, which is an oral selective angio-receptor modulator, SARM for short. Enobosarm being developed as a treatment in combination with a weight loss drug like glucagon-like peptide-1 receptor agonist, also known as a GLP-1 receptor agonist to augment that loss and to avoid muscle locks and overweight or obese patients for chronic weight management.

Veru 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波缺失、腫瘤和急性呼吸窘迫症候群的創新藥物。該公司的藥物開發管線包括enobosarm和sepisabululin兩種處於後期階段的新型口服小分子。在我們的減重產品線中，我們有enobosarm，也稱為Austria-MK-2866 GTX-024和VR-024，它是一種口服選擇性血管受體調節劑，簡稱SARM。Enobosarm 正在開發與減肥藥物（如胰高血糖素樣勝肽-1 受體激動劑，也稱為GLP-1 受體激動劑）聯合使用的治療方法，以增強減肥效果，避免肌肉僵硬和超重或肥胖患者進行長期體重管理。

In our oncology pipeline and pending additional external funding or pharmaceutical partnership, we have a Enobosarm combination with abemaciclib as a second line treatment of angel receptor positive, estrogen receptor positive and human epidermal growth factor II negative metastatic breast cancer in our infectious and inflammatory disease pipeline and similarly pending additional external funding of pharmaceutical partnership, we have sabizabulin, a microtubule disruptor, which is a planned Phase 3 clinical trial for the treatment of hospitalized patients with viral-induced ARDS.

在我們的腫瘤學管道和待定的額外外部資金或製藥合作夥伴關係中，我們有Enobosarm 與abemaciclib 組合，作為我們感染和炎症性疾病管道中天使受體陽性、雌激素受體陽性和人類表皮生長因子II 陰性轉移性乳癌的二線治療同樣，我們還有sabizabulin（一種微管幹擾劑）正在等待額外的外部資金，這是一種微管幹擾劑，這是一項計劃中的3 期臨床試驗，用於治療病毒引起的ARDS 住院患者。

The company also has an FDA-approved commercial product, the FC2 female condom internal condom for dual protection against unplanned pregnancy and sexually transmitted infections. This morning, we'll provide an update on the current focus of our company, which is the development of enobosarm, an oral SARM in combination with Wegovy , which is semaglutide, a GLP-1 receptor agonist to preserve muscle glass and to augment fat loss for a potentially higher quality weight loss. We'll also provide financial highlights for our third quarter fiscal year 2024. Lipid receptor agonist, which included Ozempic, Sefone and Mounjaro, were very effective drugs that cause significant weight loss.

該公司還有FDA核准的商業產品FC2女用安全套內建保險套，可雙重保護意外懷孕和性傳染感染。今天早上，我們將提供有關我們公司當前重點的最新信息，即開發enobosarm，這是一種口服SARM 與Wegovy 的組合，Wegovy 是索馬魯肽，一種GLP-1 受體激動劑，可保護肌肉玻璃並增加脂肪潛在更高品質的減肥效果。我們也將提供 2024 財年第三季的財務亮點。脂質受體激動劑，包括 Ozempic、Sefone 和 Mounjaro，是非常有效的藥物，可顯著減輕體重。

Unfortunately, up to 50% of the total weight loss comes from muscle, which is problematic as muscle is necessary not only for strength and physical function, but also muscle with a metabolic tissue that may play a role in allowing a higher-quality wave-loss.

不幸的是，高達50% 的整體重減輕來自肌肉，這是有問題的，因為肌肉不僅是力量和身體功能所必需的，而且具有代謝組織的肌肉也可能在允許更高品質的波方面發揮作用。

To clarify this point, nose preservation may assist in high-quality weight loss in three ways. First, we need a drug that given in combination with GLP-1 receptor agonist will prevent the loss of muscle caused by GLP-1 receptor agonist to preserve physical function in older adults who had risk for muscle loss and who overweight and obese. According to the CDC, 42% of older adults have obesity in the United States and could benefit from Waveband medication. Up to 34% of obese patients over the age of 60 have sarcopenic obesity. Sarcopenia being age late loss of muscle.

為了澄清這一點，保留鼻子可能透過三種方式有助於高品質的減肥。首先，我們需要一種與 GLP-1 受體激動劑聯合使用的藥物，以防止 GLP-1 受體激動劑引起的肌肉損失，以保護有肌肉損失風險以及超重和肥胖的老年人的身體功能。據 CDC 稱，美國 42% 的老年人患有肥胖症，可以從 Waveband 藥物中受益。60歲以上的肥胖患者中高達34%患有肌肉減少性肥胖。肌少症是指年齡晚期肌肉喪失。

This large subpopulation of sarcopenic-obese patients is especially at risk when taking a Glucagon receptor drug 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 on glucagon-receptor agonist therapy for weight loss, glucagon receptor agonist drugs may accelerate the development of frailty and muscle weakness in Obese overweight elderly patients. Muscle weakness may lead to poor balance, decreased gate speed, mobility, disability, loss of independence and high-risk for falls and fractures.

當服用升糖素受體藥物減重時，這一大批肌肉減少症肥胖患者尤其面臨風險，因為由於與年齡相關的肌肉損失，他們的肌肉量可能已經非常低。由於肌肉流失的程度和速度，在使用胰高血糖素受體激動劑減重治療時，胰高血糖素受體激動劑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。肌肉無力可能導致平衡能力差、門速降低、活動能力下降、殘疾、喪失獨立性以及跌倒和骨折的高風險。

In fact, the safety section of the package insert for wegovy has been updated based on the recently reported select cardiovascular outcome clinical trial, which now highlights a 400% increase in pelvic and hip fractures that were observed in patients greater than the age of 75 years receiving VEGOVI compared to placebo patients, and that was 2.4% versus 0.6%. Practice of the hip and pelvis typically occur because of falls, which increased would decrease muscle mass. Second, for all patients who are overweight or obese, muscle preservation may prevent the GLP-1 receptor agonist weight loss plateau.

事實上，wegovy 包裝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試驗進行了更新，該試驗現在強調在 75 歲以上患者中觀察到的骨盆和髖部骨折增加了 400%接受VEGOVI治療的患者與安慰劑患者相比，這一比例分別為2.4% 和0.6%。髖部和骨盆的運動通常是因為跌倒而發生，增加會減少肌肉質量。其次，對於所有超重或肥胖的患者，保留肌肉可能會阻止 GLP-1 受體激動劑減重平台期。

Significant depletion of muscle mass may be one of the may also be one of the reasons where patients with GLP-1 receptor agonist drugs retailors plateau, meaning the rate of well slows or stops while taking the GLP-1 receptor agonist drug. The hypothesis is that loss of muscle creates a muscle deficit that causes low energy balance and triggers in the brain to signal to increase appetite that counters the inhibition of appetite. GLP-1 receptor agonist drugs thus leading to the weight loss plateau.

肌肉量的顯著減少可能是 GLP-1 受體激動劑藥物患者恢復平穩的原因之一，這意味著在服用 GLP-1 受體激動劑藥物時，恢復速度會減慢或停止。這個假設認為，肌肉損失會造成肌肉缺陷，導致能量平衡低下，並觸發大腦發出增加食慾的信號，從而對抗食慾的抑制。GLP-1受體激動劑藥物進而導致減肥平台期。

Without a muscle deficit clip-on drug may maintain the loss of appetite and reduction of calorie consumption, which may potentially be moved more fat mass with greater weight loss. Third, for all patients who overweight obese, muscle depletion may trigger the overeating that occurs when the patient discontinues glucagon receptor agonist, resulting in a rebound weight gain that is that we gained their original weight.

如果沒有肌肉缺陷，夾式藥物可能會維持食慾不振並減少卡路里消耗，這可能會移動更多的脂肪，從而減輕更多的體重。第三，對於所有超重肥胖的患者來說，當患者停止使用胰高血糖素受體激動劑時，肌肉消耗可能會引發暴飲暴食，從而導致體重增加反彈，即我們增加了原來的體重。

But now the regained way is composed almost all of that. Having a drug that maintains adequate muscle reserve when the Glucagon receptor drug is discontinued and prevent this rebound weight gain and help with the maintenance of weight loss. We believe that enobosarm, or novel oral selective and receptor modulator may be the best drug candidate to address this urgent unmet medical need to preserve muscle in patients receiving a glucagon receptor agonist for weight loss. Data from our clinical trials and preclinical support studies enobosarm's potential. Enobosarm is given as a once-a-day oral dose and enobosarm works through the androgen receptor in a well-established mechanism.

但現在恢復的道路幾乎全部由這些組成。當升糖素受體藥物停用時，使用一種可以維持足夠肌肉儲備的藥物，可以防止體重反彈並有助於維持體重減輕。我們相信，enobosarm 或新型口服選擇性受體調節劑可能是解決接受胰高血糖素受體激動劑減肥的患者保留肌肉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支持數據研究了enobosarm的潛力。Enobosarm 以每日一次口服劑量給藥，enobosarm 以完善的機制透過雄激素受體發揮作用。

Enobosarm demonstrates tissue selectivity as it improves and preserves lean body mass, muscle mass and physical function. In addition, enobosarm also directly causes a breakdown of fat and prevents storage of fat, resulting in a decrease in fat mass. This represents a different nonoverlapping mechanism of drug action to reduce fab that's distinct from a GLP-1 receptor agonist, which suppress suppresses appetite, resulting in a low caloric state. Therefore, if enobosarm is given with the GLP-1 receptor agonist, the combination utilizes two different mechanisms to increase the loss of fat.

Enobosarm 表現出組織選擇性，因為它可以改善和維持去脂體重、肌肉質量和身體功能。此外，eno​​bosarm還直接導致脂肪分解並阻止脂肪儲存，從而導致脂肪量減少。這代表了一種不同的非重疊藥物作用機制，以減少 fab，與 GLP-1 受體激動劑不同，GLP-1 受體激動劑抑制食慾，導致低熱量狀態。因此，如果enobosarm與GLP-1受體激動劑一起使用，則該組合利用兩種不同的機制來增加脂肪的減少。

Also, enobosarm builds and heals bone, providing another potential benefit to treat bone loss, which is also known as osteoporosis to prevent fractures. The enobosarm has been previously studied in 5 clinical studies that measure muscle as an endpoint, involving 960-day older men and post-menopausal women as well as older patients who have muscle wasting because of advanced cancer. An advanced cancer population is relevant as advanced cancer causes a loss of appetite, resulting in significant unintentional loss or wasting of both muscle and fat mass similar to what's observed with the GLP-1 receptor agonist treatment. The totality of the clinical data from these five clinical trials demonstrate that enobosarm treatment leads to increases in muscle glass with improvement in physical function as well as significant reduction in fat mass.

此外，eno​​bosarm 可以建造和治癒骨骼，為治療骨質流失（也稱為骨質疏鬆症）提供另一個潛在益處，以預防骨折。enobosarm 先前已在 5 項以肌肉測量為終點的臨床研究中進行研究，涉及 960 天老年男性和停經後女性以及因晚期癌症而出現肌肉萎縮的老年患者。晚期癌症族群具有相關性，因為晚期癌症會導致食慾不振，導致肌肉和脂肪量顯著無意損失或浪費，類似於 GLP-1 受體激動劑治療中觀察到的情況。這五項臨床試驗的全部臨床數據表明，enobosarm 治療可增加肌肉玻璃，改善身體功能，並顯著減少脂肪量。

The expectation is that enobosarm in combination with glucagon receptor agonist with both preserved muscle and augment fat reduction, resulting in a higher quality total weight loss. Furthermore, enobosarm has a large safety database, which includes 27 clinical trials solving 1,581 men and women dosed with enobosarm with some patients dosed for over two years.

預計enobosarm與胰高血糖素受體激動劑結合，既能保留肌肉，又能減少脂肪，從而實現更高品質的整體減肥效果。此外，eno​​bosarm擁有龐大的安全資料庫，其中包括27項臨床試驗，解決了1,581名男性和女性服用enobosarm的問題，其中一些患者服用了兩年以上。

In this large safety database, enobosarm is generally well tolerated without masculinizing effects in women. Reversible mild liver enzyme elevations have been reported, which are mostly grade 1 adverse events, there were no grade 3 or grade 4 adverse events. To be clear, no drug-induced liver injury has been observed for any of the 27 clinical studies evaluating enobosarm.

在這個大型安全資料庫中，enobosarm 通常具有良好的耐受性，不會對女性產生男性化作用。已有通報出現可逆性輕度肝酵素升高，其中大部分為 1 級不良事件，沒有 3 級或 4 級不良事件。需要明確的是，在評估enobosarm的27項臨床研究中，並沒有觀察到藥物引起的肝損傷。

Furthermore, there were no increases in gastrointestinal side effects compared to placebo. This is important as there is already significant and frequent gastrointestinal side effects with a GLP-1 receptor agonist treatment alone. Now turning to our enobosarm clinical program for high-quality weight loss. We're conducting the Phase 2b quality clinical trials of Qualtiname the trial, which is a multicenter, double-blind, placebo-controlled, randomized dose-finding study to evaluate the safety and efficacy of enobosarm 3 milligrams, enobosarm 6 milligrams compared to placebo in combination with the wegovy with is semaglutide cliff receptor agonist and approximately 150 older patients greater than the age of 60 who are overweight or obese.

此外，與安慰劑相比，胃腸道副作用並沒有增加。這一點很重要，因為單獨使用 GLP-1 受體激動劑治療已經出現顯著且頻繁的胃腸道副作用。現在轉向我們的enobosarm 臨床計劃，以實現高品質的減肥。我們正在進行Qualtiname 試驗的2b 期品質臨床試驗，這是一項多中心、雙盲、安慰劑對照、隨機劑量探索研究，旨在評估enobosarm 3 毫克、enobosarm 6 毫克與安慰劑相比的安全性和有效性與 semaglutide Cliff 受體激動劑聯用，約 150 名 60 歲以上超重或肥胖的老年患者接受了治療。

Purpose of the Phase 2b clinical trial is to select the optimal dose of enobosarm in combination with equipment receptor agonist that best preserves muscle and augments a reduction in fat mass for a better body composition at 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 and key secondary endpoints will be the change in baseline to 16 weeks in total fat mass, total body weight and physical function as measured by the serocime test.

2b期臨床試驗的目的是選擇enobosarm與設備受體激動劑組合的最佳劑量，以最好地保留肌肉並增加脂肪量的減少，從而在治療16週時獲得更好的身體組成。2b 期臨床試驗的主要終點將是總去脂體重從基線到 16 週的變化，關鍵次要終點將是從基線到 16 週的總脂肪量、總體重和身體功能的變化（透過測量）血清毒試驗。

After completing the 16-week efficacy dose-finding portion of the Phase 2b clinical trial, participants will then continue into a blinded Phase 2b extension clinical trial, while all patients will stop receiving equip receptor agonist, but we'll continue taking placebo, enobosarm 3 milligrams or Enobosarm 6 milligrams for an additional 12 weeks. The blinded Phase 2b extension clinical trial will evaluate the maintenance of weight loss, meaning whether enobosarm can maintain muscle and prevent the fats and weight gain that occurs after discontinuing the lion receptor agonist.

在完成2b期臨床試驗的16週療效劑量探索部分後，參與者將繼續進入盲法2b期擴展臨床試驗，同時所有患者將停止接受equip受體激動劑，但我們將繼續服用安慰劑，enobosarm 3毫克或Enobosarm 6 毫克，持續12 週。盲法2b期擴展臨床試驗將評估體重減輕的維持情況，這意味著enobosarm是否可以維持肌肉並防止停用lion受體激動劑後出現的脂肪和體重增加。

We believe that assessing the effects of enobosarm in lean body mass and fat master 16 weeks' time point should be adequate to demonstrate significant loss of muscle in the semaglutide and placebo cohort. Support comes from the STEP-1 study reported by Wilding at all in the New England Journal of Medicine. The STEP-1 study that evaluated semaglutide for weight loss and overweight and obese patients showed that 49% of the total weight loss that's lost in that 68-week study occurred by week 16. Approximately 40% of the total weight loss was attributed to muscle loss.

我們認為，評估 enobosarm 在 16 週時間點對瘦體重和脂肪大師的影響應該足以證明索馬魯肽和安慰劑組中肌肉的顯著損失。支持來自 Wilding at alling 在《新英格蘭醫學雜誌》上報導的 STEP-1 研究。STEP-1 研究評估了索馬魯肽對體重減輕以及超重和肥胖患者的作用，結果表明，在為期 68 週的研究中，第 16 週時體重減輕總量減少了 49%。大約 40% 的總體重減輕歸因於肌肉損失。

As Novosarm a muscle drug that also burns fat, our current Phase 2b clinical program is designed to provide body composition clinical data to support the Phase 3 clinical development of novosarm for precision high-quality weight loss by answering the following clinical questions related to muscle. For risk older adults who are overweight or obese, can novosarm prevent loss of muscle to preserve physical function. For all patients who are overweight obese can a novosarm or preserve muscle to prevent the Glucagon receptor agonist, weight loss plateau. And for all patients who overweight obese can novosarm maintain adequate muscle reserve when GLP-1 receptor agonists are discontinued to prevent the rebound weight gain, which is almost all fat.

由於 Novosarm 是一種同時燃燒脂肪的肌肉藥物，我們目前的 2b 期臨床計劃旨在提供身體組成臨床數據，透過回答以下與肌肉相關的臨床問題來支持 Novosarm 的精準高品質減肥的 3 期臨床開發。對於超重或肥胖的高風險老年人，novosarm 可以防止肌肉流失以維持身體功能。對於所有超重肥胖患者，可以使用 novosarm 或保留肌肉，以防止胰高血糖素受體激動劑出現減重平台期。而對於所有超重肥胖的患者，當停用GLP-1受體激動劑時，novosarm可以維持足夠的肌肉儲備，以防止體重增加反彈，而體重增加幾乎全是脂肪。

I'm proud of our team as they have expeditiously executed the novosarm Phase 2b quality clinical program. We prioritized the company's clinical development activities to address this new important unmet need in November of 2023. We filed the IND with the FDA in January of 2024. We received FDA clearance on the IND in February of 2024. We made a strategic decision to upsize the size of the trial to 150 patients to increase the power of the study.

我為我們的團隊感到自豪，因為他們迅速執行了 novosarm 2b 期品質臨床計劃。我們在 2023 年 11 月優先考慮公司的臨床開發活動，以解決這一新的重要的未滿足需求。我們於 2024 年 1 月向 FDA 提交了 IND 申請。我們於 2024 年 2 月獲得了 FDA 的 IND 批准。我們做出了一項策略決定，將試驗規模擴大到 150 名患者，以增強研究的效能。

We initiated this Phase 2b quality study in April of 2024. Clinical studies being conducted in 14 clinical sites in the United States. This morning, I'm pleased to report that we have completed the greater than 150 patient enrollment for the Phase 2b quality study. can now anticipate that the last patient to complete the Phase 2b quality study will be in December of 2024 with top line clinical results of the Phase 2b clinical study expected in January of 2025.

我們在 2024 年 4 月啟動了這項 2b 階段品質研究​​。臨床研究正在美國 14 個臨床中心進行。今天早上，我很高興地向大家報告，我們已經完成了 2b 期品質研究超過 150 名患者的入組工作。現在可以預計，最後一位完成 2b 期品質研究的患者將於 2024 年 12 月完成，2b 期臨床研究的頂線臨床結果預計將於 2025 年 1 月獲得。

Furthermore, the top line results of the separate blinded Phase 2b extension clinical study may now be expected in the second calendar quarter of 2025. We believe we have sufficient financial resources on hand with cash of $29.2 million at the end of June 2024 to complete and provide results on both the Phase 2b quality clinical trial and the Phase 2b extension clinical trial. I will now turn the call over to Michele Greco, CFO, COO, to discuss the financial highlights. Michele?

此外，單獨的盲法 2b 期擴展臨床研究的主要結果現在預計將在 2025 年第二季公佈。我們相信，截至 2024 年 6 月，我們手​​頭上有足夠的財務資源和 2,920 萬美元的現金來完成 2b 期品質臨床試驗和 2b 期擴展臨床試驗並提供結果。我現在將把電話轉給財務長兼營運長 Michele Greco，討論財務亮點。米歇爾？

Thank you, Dr. Steiner. Let's start our highlights with the third quarter results for the three months ended June 30, 2024. Overall, net revenues were $4 million compared to $3.3 million in the prior year's third quarter. The company's quarterly sales for its US.

謝謝你，斯坦納博士。讓我們從截至 2024 年 6 月 30 日止三個月的第三季業績開始重點介紹。總體而言，淨收入為 400 萬美元，而去年第三季的淨收入為 330 萬美元。該公司在美國的季度銷售額。

prescription business were $552,000 compared to $863,000 in the prior year's third quarter. Net revenue from the Global Public Sector business for the quarter was $3.4 million compared to $2.5 million in the prior year's quarter. The increase in the public sector business is for increased shipments under our contracts with UNFPA and USAID. Overall, gross profit was $1.3 million or 34% of net revenues compared to $1.2 million or 37% of net revenues in the prior year quarter.

處方藥業務為 552,000 美元，而去年第三季為 863,000 美元。本季全球公共部門業務的淨收入為 340 萬美元，而去年同期為 250 萬美元。公共部門業務的成長是為了增加我們與聯合國人口基金和美國國際開發署簽訂的合約下的出貨量。整體而言，毛利為 130 萬美元，佔淨收入的 34%，而去年同期毛利為 120 萬美元，佔淨收入的 37%。

Gross profit increased due to an increase in units sold. The decrease in gross margin is due 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. Operating expenses for the quarter decreased to $12.4 million compared to the prior year's quarter of $19.7 million. The decrease is primarily due to research and development costs, which decreased to $4.9 million compared to $8.8 million in the prior year quarter and the decrease in selling, general and administrative expenses of $3.4 million from $10.9 million in the prior year quarter to $7.5 million in the current quarter.

由於銷量增加，毛利增加。毛利率下降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，但佔總淨收入的比例較小。本季營運費用從去年同期的 1,970 萬美元減少至 1,240 萬美元。下降的主要原因是研發成本從去年同期的 880 萬美元減少至 490 萬美元，銷售、一般和管理費用從去年同期的 1,090 萬美元減少到去年同期的 750 萬美元，減少了 340 萬美元。 。

The decrease in research and development costs is due to our drug development strategy to focus development efforts on those drug candidates with the best opportunity for long-term success and shareholder value creation while matching available funding. During the quarter, we initiated the Phase 2b quality clinical study. 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 sabizabulin for COVID-19 prior to the FDA's declination of the company's EUA application and an increase in personnel costs in the prior year due to increased headcount for the potential commercialization. These additional costs and incremental headcount have now been reduced post the EUA declination. On April 19, 2023, we sold our entified product to an kinetics for $20 million.

研發成本的下降是由於我們的藥物開發策略將開發工作重點放在那些最有機會實現長期成功和股東價值創造同時匹配可用資金的候選藥物上。本季度，我們啟動了 2b 期品質臨床研究。銷售、一般和管理費用的減少主要是由於上一年在 FDA 拒絕該公司的 EUA 申請之前為準備用於 COVID-19 的沙比沙布林的潛在商業化而產生的大量成本以及人員成本的增加上一年由於潛在商業化的人員增加。EUA 被拒絕後，這些額外成本和增量人員現已減少。2023 年 4 月 19 日，我們以 2000 萬美元的價格將我們的授權產品出售給 Kinetics。

We received $6 million at closing and promissory notes of $14 million, which are recognized as additional gain on the sale when nonrefundable consideration is received. During the current quarter, we recognized an additional gain on sale of $110,000 compared to the gain on sale of $4.7 million in the prior period. The operating loss for the quarter was $10.9 million compared to $13.7 million in the prior quarter. Nonoperating income was $132,000 compared to $1.3 million in the prior year's quarter.

我們在成交時收到了 600 萬美元和 1400 萬美元的期票，這些在收到不可退還對價時被確認為銷售的額外收益。在本季度，我們確認了 11 萬美元的額外銷售收益，而上一季的銷售收益為 470 萬美元。本季營運虧損為 1,090 萬美元，上一季營運虧損為 1,370 萬美元。非營業收入為 132,000 美元，而去年同期為 130 萬美元。

The reduction is primarily due to the change in the fair value of the derivative liabilities related to the FC2 synthetic royalty financing. For the quarter, we recorded a tax expense of $162,000 compared to $58,000 in the prior year's quarter. The bottom-line results for the third quarter was a net loss of $11 million or $0.07 per diluted common share compared to a net loss of $12.5 million or $0.14 per diluted common share in the prior year's quarter. During the third quarter, we used cash of $5.6 million for operating activities. Now turning to the results for the nine months ended June 30, 2024.

減少的主要原因是與 FC2 合成特許權使用費融資相關的衍生負債的公允價值變化。本季度，我們記錄的稅費為 162,000 美元，而去年同期為 58,000 美元。第三季的底線業績為淨虧損 1,100 萬美元，即稀釋後普通股每股 0.07 美元，去年同期淨虧損為 1,250 萬美元，即稀釋後普通股每股 0.14 美元。第三季度，我們使用現金 560 萬美元用於經營活動。現在就來看看截至 2024 年 6 月 30 日止九個月的業績。

For the first nine months of fiscal 2024, total net revenues were $10.2 million compared to $12.4 million in the prior year period. Net revenues from the US prescription business were $1.8 million compared to $5.2 million in the prior year period. Included in the net revenues for the prior period were $3.9 million for sales to the Pico.

2024 財年的前 9 個月，總淨收入為 1,020 萬美元，而上年同期為 1,240 萬美元。美國處方藥業務的淨收入為 180 萬美元，去年同期為 520 萬美元。上一期間的淨收入包括 390 萬美元的 Pico 銷售收入。

The reduction of prescription business net revenues is due to not having any revenues from the Pill Club in the current period due to the fact the Pill Club's Chapter 11 bankruptcy filing in the prior year. Net revenues from the Global Public Sector business for the period were $8.4 million compared to $7.2 million in the prior year's period.

處方業務淨收入減少的原因是，由於 Pill Club 於上一年申請破產法第 11 章，導致本期 Pill Club 沒有任何收入。該期間全球公共部門業務的淨收入為 840 萬美元，而去年同期為 720 萬美元。

Overall, gross profit was $3.2 million or 31% of net revenues compared to $6 million or 48% of net revenues in the prior year period. The decrease in gross profit and gross margin is due to the change in the 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 $1.2 million for an obsolete stock reserve related to inventory in the US prescription channel. Operating expenses decreased by $63.4 million to $32.9 million compared to the prior year of $96.4 million.

整體而言，毛利為 320 萬美元，佔淨收入的 31%，而去年同期毛利為 600 萬美元，佔淨收入的 48%。毛利和毛利率的下降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120 萬美元用於與美國處方通路庫存相關的過時庫存儲備。營運費用比前一年的 9,640 萬美元減少了 6,340 萬美元，達到 3,290 萬美元。

The decrease is driven by a reduction in research and development costs of $37.7 million to $9.5 million from $47.3 million in the prior year and a reduction in selling, general and administrative expenses of $17.9 million from $41.3 million in the prior year to $23.4 million.

這一下降的原因是研發成本從上一年的4,730 萬美元減少了3,770 萬美元至950 萬美元，銷售、一般和管理費用從上一年的4,130 萬美元減少到2,340 萬美元，減少了1,790 萬美元。

The 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. During the prior year, 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 the receivables from the Pico. During the nine months, we recorded a gain on the sale of entity of $1 million compared to $4.7 million in the prior year period.

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。去年，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 Pico 應收帳款相關的 390 萬美元的信用損失撥備。在這 9 個月中，我們記錄了出售實體的收益 100 萬美元，而去年同期為 470 萬美元。

Operating loss for the period was $28.7 million compared to $85.6 million in the prior year, a decrease of $56.9 million, which is primarily due to the reduction in operating expenses. Nonoperating expenses were $289,000 compared to operating income of $508,000. For the nine months, we recorded a tax expense of $272,000 compared to a tax benefit of $77,000 in the prior year.

本期營業虧損為 2,870 萬美元，較上年同期的 8,560 萬美元減少 5,690 萬美元，主要是因為營業費用減少。非營業費用為 289,000 美元，營業收入為 508,000 美元。在這 9 個月中，我們記錄的稅收支出為 272,000 美元，而前一年的稅收優惠為 77,000 美元。

The bottom-line results for the first nine months of fiscal 2024 was a net loss of $29.3 million or $0.22 per diluted common share compared to a net loss of $85 million or $0.012 per diluted common share in the prior year. The net loss for the company decreased by $55.7 million for the nine-month period.

2024 財年前九個月的底線表現為淨虧損 2,930 萬美元，即每股稀釋普通股 0.22 美元，而前一年的淨虧損為 8,500 萬美元，即每股稀釋普通股 0.012 美元。該公司前 9 個月的淨虧損減少了 5,570 萬美元。

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 matching available funding and elimination of the commercial team and related commercialization expenses for the potential launch of sabizabulin for COVID-19. Now looking at the balance sheet. As of June 30, 2024, our cash balance was $29.2 million and accounts receivable were $1.6 million compared to a cash balance of $9.6 million and accounts receivable balance of $4.5 million as of September 30, 2023. Our net working capital was $27.9 million on June 30, 2024, compared to $5.1 million on September 30, 2023.

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，同時匹配可用資金以及消除商業團隊和相關商業化費用，以便可能推出沙比沙布林用於治療COVID-19。現在看資產負債表。截至2024 年6 月30 日，我們的現金餘額為2,920 萬美元，應收帳款餘額為160 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。截至 2024 年 6 月 30 日，我們的淨營運資本為 2,790 萬美元，而 2023 年 9 月 30 日為 510 萬美元。

During the nine months ended June 30, 2024, we used cash of $17.3 million for operating activities compared with $78.5 million used for operating activities in the prior period. We generated cash from financing activities for the nine months ended June 30, 2024, of $36.8 million compared to $9 million in the prior period. On December 18, 2023, we completed an underwritten public offering of our common stock, which included the exercise in full of the underwriter's option to purchase additional shares. 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.

截至 2024 年 6 月 30 日的九個月中，我們用於經營活動的現金為 1,730 萬美元，而上一期間用於經營活動的現金為 7,850 萬美元。截至 2024 年 6 月 30 日止的九個月，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 900 萬美元。2023 年 12 月 18 日，我們完成了普通股的承銷公開發行，其中包括全額行使承銷商購買額外股票的選擇權。扣除承銷折扣、佣金以及公司產生的成本後，公司此次發行的淨收益約為 3,520 萬美元。

All the shares sold were offered by the company. We are working to increase the future FC2 net revenues in the US prescription channel by growing awareness and driving demand of FC2 through increased marketing efforts for our own telehealth platform. We're starting to see increases in our global public sector business from efforts to increase FC2 market awareness in developing countries. Now I'd like to turn the call back to Dr. Steiner. Dr. Steiner?

所有出售的股份均由公司發售。我們正在努力透過增加我們自己的遠距醫療平台的營銷力度來提高人們對 FC2 的認識並推動 FC2 的需求，從而增加未來 FC2 在美國處方管道的淨收入。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。現在我想把電話轉回斯坦納醫生。斯坦納博士？

Thank you, Michele. All of the GLP-1 receptor agonist was mainly by creating a low caloric starvation state by reducing appetite that results in the nonselective loss in both muscle and fat tissues to cause weight loss. Using a muscle preserving drug that can also decrease fat mass like enobosarm in combination with the glucagon receptor agonists may allow for the enhanced reduction of fat mass higher-quality precision weight loss in not only older patients who are overweight or obese, but also for all patients who overweight Orbis. This is truly an unmet medical need. We believe that enobosarm the best investigational drug candidate to address the muscle loss caused by glucagon receptor agonist drugs.

謝謝你，米歇爾。所有GLP-1受體激動劑主要是透過降低食慾造成低熱量飢餓狀態，導致肌肉和脂肪組織非選擇性流失，從而達到減肥的目的。使用也可以減少脂肪量的肌肉保存藥物（如依諾波沙姆）與胰高血糖素受體激動劑聯合使用，可以增強脂肪量的減少，從而實現更高質量的精確減肥，不僅適用於超重或肥胖的老年患者，而且適用於所有患者Orbis 超重的​​患者。這確實是一個未被滿足的醫療需求。我們認為，enobosarm 是解決胰高血糖素受體激動劑藥物引起的肌肉損失的最佳研究候選藥物。

Enobosarm the first in class arm has a once-a-day oral dosing has demonstrated tissue selectivity, utilizes a well-known mechanism of action to antigen receptor to favorably change by the composition. Activation of the ante receptor increases muscle mass, improves physical function and decreases fat mass to potentially achieve a higher quality of weight loss.

Enobosarm是同類中第一個每天一次口服給藥的藥物，已證明具有組織選擇性，利用眾所周知的作用機制對抗原受體進行有利的改變。ante 受體的活化可以增加肌肉質量，改善身體功能並減少脂肪量，從而有可能實現更高品質的減肥。

Enobosarm has a favorable safety profile and would not add to the gastrointestinal side effects that are already observed with a glucagon-receptor agonist treatment alone. The global obesity and overweight drug market is projected by many research analysts to be $100 billion annually by 2030. The combination of enobosarm with glucagon receptor agonist potentially represents a multibillion-dollar opportunity.

Enobosarm 具有良好的安全性，不會增加單獨使用胰高血糖素受體激動劑治療時已觀察到的胃腸道副作用。許多研究分析師預計，到 2030 年，全球肥胖和超重藥物市場每年將達到 1,000 億美元。enobosarm 與胰高血糖素受體激動劑的組合可能代表著數十億美元的機會。

I should note that we also have new clinical data that we generated from reexamination of the clinical data from some of the previous five clinical muscle studies evaluating enobosarm that further support the potential of enobosarm for the preservation of total lean body mass and the reduction of fat mass to improve body composition for higher-quality weight loss in patients who obese overweight.

我應該指出的是，我們還獲得了新的臨床數據，這些數據是透過重新審查先前五項評估enobosarm的臨床肌肉研究中的一些臨床數據而產生的，這些數據進一步支持了enobosarm在保持總去脂體重和減少脂肪方面的潛力體重以改善身體組成，從而為肥胖超重患者提供更高品質的減肥效果。

The company will be presenting an abstract of the obesity week 2024, and that's in November 2 through 6 in San Antonio, Texas. Furthermore, we've been invited to present keynote lectures at the fourth edition of the World Obesity and Wake Management Congress being held October 24 to 26 in Baltimore, Maryland, in the 17th International Conference of the Society of sarcopenia, cachexia-wasting disorders being held December 6, 8 in Washington, D.C.

該公司將於 11 月 2 日至 6 日在德克薩斯州聖安東尼奧發布 2024 年肥胖週摘要。此外，我們也受邀在10 月24 日至26 日在馬裡蘭州巴爾的摩舉行的第四屆世界肥胖和覺醒管理大會上發表主題演講，並在第17 屆肌少症協會國際會議上發表主題演講，惡病質消耗性疾病是12月6日至8日在華盛頓特區舉行

I've also been invited to co-chair a session entitled body composition changes induced by glycine receptor agonist and obesity therapy at the International Conference of the society and sarcopenia cachexia and wasting disorders. We are very excited about the prospects of enobosarm to address this new and important unmet medical need, and we are looking forward to the top line results of this important and timely Phase 2b quality clinical study.

我還受邀在該協會國際會議上共同主持題為“甘氨酸受體激動劑和肥胖治療引起的身體組成變化以及肌肉減少症惡病質和消耗性疾病”的會議。我們對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，我們期待著這項重要且及時的2b期品質臨床研究的頂線結果。

With that, I'll now open the call to questions. Operator?

現在，我將開始提問。操作員？

(Operator Instructions) Yi Chen, H.C. Wainwright.

（操作員指示） Yi Chen, H.C.溫賴特。

Thank you for taking my questions. Assuming positive results coming out of the Phase 2b quality study, how soon can you advance the candidate to the next step and whether you plan to find a partnership for a potential registration study.

感謝您回答我的問題。假設 2b 期品質研究取得正面結果，您多久可以將候選人推進到下一步，以及您是否計劃為潛在的註冊研究尋找合作夥伴。

Thank you. So assuming we have a positive study, which means that now that we have complete enrollment, we can now have a little bit more certainty, have a lot more certainty in terms of how the trial will progress in terms of information. So the expectation is the last patient will complete the study, the 16-week portion of the study in December give us some time here to clean up the data and look at the data and get the top line results, call it, January. So in January of 2025, we will have the Phase 2b quality clinical trial data. The reason I say that way is the extension trial is not required for us to move forward with talking to the FDA on potentially talking to partners.

謝謝。因此，假設我們有一項積極的研究，這意味著現在我們已經完成了註冊，我們現在可以有更多的確定性，就試驗將如何在資訊方面取得進展有更多的確定性。因此，預計最後一名患者將完成研究，12 月為期 16 週的研究部分給了我們一些時間來清理數據、查看數據並獲得最重要的結果，稱之為 1 月。所以在2025年1月，我們將擁有2b期優質臨床試驗數據。我之所以這麼說，是因為我們不需要延期試驗就可以繼續與 FDA 就可能與合作夥伴進行的談判。

So really, it's the data that we get in January that will start to borrow rolling from a standpoint of moving forward. So moving forward, means collect the information, go back to the FDA and start having further discussions now with real data in hand. I mean this data really represents the first muscle drug, and we have competition with, for example, myostatin inhibitors, but this data will be the first muscle drug to be given in combination of GLP-1 to see what the results look like. I mean all these other drugs pretty much have no clinical data in combination with GLP-1 and the data that they use to move forward to the Phase 2s just like us is data showing muscle preservation reduction in fat and other conditions, not in combination with GLP-1 so with that said, we have a real opportunity to meet with the FDA and understand what the Phase 3 clinical program will look like. With that said, also, this is also an ideal time with data on hand to begin to have discussions for potential partnerships.

事實上，從前進的角度來看，我們在一月獲得的數據將開始滾動。因此，向前邁進，意味著收集信息，返回 FDA 並開始利用手頭上的真實數據進行進一步的討論。我的意思是，這些數據確實代表了第一種肌肉藥物，我們與例如肌肉生長抑制素抑制劑競爭，但該數據將是第一種與GLP-1 聯合使用的肌肉藥物，以觀察結果如何。我的意思是，所有這些其他藥物幾乎都沒有與GLP-1 結合的臨床數據，而且它們用來進入2 期的數據就像我們一樣，是顯示肌肉保存、減少脂肪和其他條件的數據，而不是與GLP-1 結合使用的數據。話雖如此，這也是掌握現有數據並開始討論潛在合作關係的理想時機。

As I mentioned in previous calls, we have talked to the major players. As you would expect, the expectation is for us to get this study done so we'll have real data, so we can have real discussions. And so that's the way to think of it is after January, it gives the company an opportunity to begin moving on the regulatory front and moving on the partnership front.

正如我在之前的電話中提到的，我們已經與主要參與者進行了交談。正如您所期望的那樣，我們希望完成這項研究，這樣我們就能獲得真實的數據，這樣我們就可以進行真正的討論。因此，在一月之後，公司就有機會開始在監管方面和合作夥伴方面採取行動。

Got it. That's helpful. Thank you.

知道了。這很有幫助。謝謝。

Thank you.

謝謝。

Leland Gershell, Oppenheimer.

利蘭·格謝爾，奧本海默。

Hey, Mitch. Thanks for taking the question. Just a question actually on safety. In the trials that you referenced in the five studies that you referenced with the enobosarm, I think the high dose was 3 milligrams. I know you're testing up to 6 in the current quality study. Just wanted to ask kind of what gives you confidence that you'll be okay to expect to liver at 6? And are there any considerations with respect to the types of patients in the study, i.e., overlay obese, therefore, may have bad accumulation in the liver could that put them in for the risk of having tiering? And also, is there any provision for our alcohol cessation during the study, which also could be affected.

嘿，米奇。感謝您提出問題。其實只是一個關於安全的問題。在您提到的 enobosarm 的五項研究中，我認為高劑量是 3 毫克。我知道您在目前的品質研究中測試了多達 6 個。只是想問一下，是什麼讓您有信心在 6 歲就可以正常肝臟？對於研究中的患者類型，是否有任何考慮因素，即，過度肥胖，因此可能在肝臟中積聚不良，這可能會使他們面臨分層的風險？另外，是否有任何規定可以讓我們在研究期間戒酒，這也可能會受到影響。

Yes, thank you. So the answer to the first, I'm going to answer a couple of those questions and then I'm going to ask Dr. Gary Bird, our Chief Scientific Officer, to answer some of those questions. So as it relates to the database, you're absolutely right, the database that we have for muscle as an end point goes up to 3 milligrams. Of course, we have a single ascending dose and multiple ascending dose studies that were done at much higher doses as high as 100 milligrams. But I need to remind everybody that we also have done almost 250 patients at 9 milligrams or 18 milligrams in our breast cancer program.

是的，謝謝。因此，對於第一個問題，我將回答其中幾個問題，然後我將請我們的首席科學官加里·伯德博士回答其中一些問題。因此，當它與資料庫相關時，你絕對是對的，我們以肌肉為終點的資料庫高達 3 毫克。當然，我們有單次劑量遞增和多次劑量遞增研究，這些研究的劑量要高得多，高達 100 毫克。但我需要提醒大家的是，在我們的乳癌計畫中，我們已經對近 250 名患者進行了 9 毫克或 18 毫克的治療。

And some patients have been taking those doses for as high as long as two-year loss. So we do have data for safety above the 6 milligram and again, with no evidence of liver toxicity defined as drug-induced liver injury. As it relates to triglycerides, one of the things that we did see in a different patient population, the older patients, men over the age of 60 and women postmenopausal is we did see about a 30% reduction in triglyceride.

有些患者服用這些劑量的時間長達兩年。因此，我們確實有超過 6 毫克的安全性數據，而且沒有證據表明肝毒性被定義為藥物引起的肝損傷。就三酸甘油酯而言，我們在不同患者群體（老年患者、60 歲以上的男性和停經後女性）中確實看到的情況之一是，我們確實看到三酸甘油酯下降了約 30%。

So one of the mechanisms for if you worry about overweight patients or these patients that may have fatty liver, we may be able to reduce the triglycelides, which is the source of the fatty liver. As it relates to alcohol, I'm going to have to ask Dr. Gary Barnette what we're doing in a clinical protocol.

因此，如果您擔心超重患者或這些可能患有脂肪肝的患者，我們的機制之一可能是減少三酸甘油酯，這是脂肪肝的來源。由於它與酒精有關，我必須詢問加里·巴內特博士我們在臨床方案中正在做什麼。

Yes. We are not excluding alcohol. We do monitor the alcohol history in the alcohol intake as we go forward. Of course, we're excluding patients with alcohol-associated cirrhosis, alcohol associated hepatitis, alcohol-associated sodaliver. If we know those things, they're excluded from the study. But we don't exclude the intake of alcohol during the study, but we do monitor that.

是的。我們不排除酒精。隨著我們的前進，我們會監測酒精攝取量的酒精歷史。當然，我們排除了酒精性肝硬化、酒精性肝炎、酒精性肝病患者。如果我們知道這些事情，他們就會被排除在研究之外。但我們並不排除研究期間飲酒，但我們確實對其進行了監測。

Got it. Thank you very much for the color and look forward to the top-line results.

知道了。非常感謝您的顏色並期待最終的結果。

Great. Thank you.

偉大的。謝謝。

Gary Nachman, Raymond James.

加里·納赫曼，雷蒙德·詹姆斯。

Hi, guys. (inaudible) on for Gary. Congrats on the quarter. So my first question is, can you just talk about how you're expecting the Phase 2b to progress now that you're fully enrolled? And if we should expect any incremental updates before you report top line in January? And on that safety question, are you pleased with everything you're seeing with the safety committee thus far in that current trial? And then I also have a follow-up.

嗨，大家好。 （聽不清楚）加里。恭喜本季。所以我的第一個問題是，既然您已經完全註冊，您能談談您對第 2b 階段的進展有何期望嗎？在您一月份報告營收之前，我們是否應該期待任何增量更新？關於安全問題，您對安全委員會迄今為止在當前試驗中看到的一切感到滿意嗎？然後我還有一個後續行動。

Yes. So as it relates to the Phase 2 and what to expect. So as I promised, we would announce when we fully enrolled the study. And so that's probably the last announcement in terms of progress because the last patient out will be December. And so the next report will be the actual top line data. As it relates to safety, we're pleased with what we're seeing so far. But we enrolled 150 patients in three months. And so many of these patients are still just starting their part of their first month. So it's still early times.

是的。因為它與第二階段和預期有關。因此，正如我所承諾的，我們將在完全註冊該研究時宣布。因此，這可能是最後一次宣布進展情況，因為最後一位患者出院將是 12 月。因此，下一份報告將是實際的頂線數據。由於它涉及安全，我們對迄今為止所看到的情況感到滿意。但我們在三個月內招募了 150 名患者。其中許多患者才剛開始第一個月的生活。所以現在還為時過早。

But again, the 3 milligram dose we've used in in five clinical trials and other trials, and we've used 9 milligrams and 18 milligram. So we're not expecting anything strange, but that's why we run the study, and that's where we're going to follow. And so it's hard to say much more about safety at this point, except there's no surprises. And then as it relates to I think we're going to ask you another question after that, you said

但同樣，我們在五項臨床試驗和其他試驗中使用了 3 毫克劑量，我們使用了 9 毫克和 18 毫克。所以我們並不期待任何奇怪的事情，但這就是我們進行這項研究的原因，也是我們將要遵循的方向。因此，目前很難對安全性進行更多討論，除非沒有任何意外的情況。然後，因為它涉及到，我想我們會問你另一個問題，你說

Yes. I just wanted to ask a little bit more about some of the secondary endpoints in the Phase 2b? And then how do you take them to trend? And specifically on the home IR. Can you talk a bit more about the significance of that and what you're hoping to show?

是的。我只是想多問一些有關 2b 階段的一些次要終點的問題？那麼你要如何將它們帶入流行趨勢呢？特別是在家庭紅外線方面。您能多談談這一點的意義以及您希望展示的內容嗎？

Yes. So home IR, we have mistakenly put on our slide that we will be measuring home IR in this patient population. We have measured homeware in previous patient populations and show the benefit of insulin resistance. For this Phase 2, given how short it is, we've decided to move the home IR into the next study to the Phase 3 study. So that won't be one of the data points that you'll see.

是的。因此，家庭 IR，我們錯誤地將我們將在該患者群體中測量家庭 IR 的幻燈片放在幻燈片上。我們測量了先前患者群體的家居用品，並展示了胰島素阻抗的好處。對於第二階段，鑑於其時間很短，我們決定將家庭 IR 轉移到第三階段研究的下一個研究。所以這不會是您將看到的數據點之一。

You will see, again, the body mass, fat mass, which will be the body composition endpoints. We'll have total weight, body weight, so we'll see that. And then from a functional endpoint, we'll be measuring physical function by Steroclime. The reason that's important is to sterling power Steroclime test is a sensitive measure of Quadriceps strength and sensitive to testosterone and androgen anabolic stimulation. And it's also a test that the FDA told us in writing is the acceptable function endpoint.

您將再次看到體重、脂肪量，這將是身體組成端點。我們會有總重、體重，所以我們會看到的。然後從功能終點出發，我們將透過 Steroclime 測量身體功能。之所以重要，是因為 Steroclime 測試是衡量股四頭肌力量的敏感指標，並且對睪固酮和雄性激素合成代謝刺激敏感。這也是 FDA 書面告訴我們可接受的功能終點的測試。

To pause for a moment, as you know, there are many of you may have heard, like Grip strength and leg press and Chess press, the FDA told us those are not acceptable functional endpoints. So the functional endpoint that we've chosen in the study, Seraphim Power is accepted by FDA. In fact, TavoPharma with F had the muscular dystrophy drug approved. I guess about six months ago, and so I think that's key. The other thing that's key in those five clinical studies that we did in almost 968 patients, about 900 of those patients, we did sterclimb. So we know how to do stair-climb we've learned a lot on how to execute on that endpoint.

暫停一下，正如你們所知，你們很多人可能都聽說過，例如握力、腿舉和國際象棋推舉，FDA 告訴我們這些不是可接受的功能終點。因此，我們在研究中選擇的功能終點 Seraphim Power 已被 FDA 接受。事實上，TavoPharma 的 F 型肌肉營養不良症藥物已獲得批准。我猜大約是六個月前，所以我認為這是關鍵。在我們對近 968 名患者（其中約 900 名患者）進行的五項臨床研究中，另一件關鍵的事情是我們進行了 sterclimb。所以我們知道如何爬樓梯，我們已經學到了很多關於如何在該端點上執行的知識。

Dr. Barnett, do you want to add to anything to that?

Barnett 博士，還有什麼要補充的嗎？

No. Yes, that's exactly right. And we're looking for changes in lean mass. We're looking for maintenance of lean mass in our treated group versus a loss in mass in the placebo group, and we're looking to assess how much we can offer it to fat loss. That's the main focus of this study.

不。是的，完全正確。我們正在尋找瘦體重的變化。我們正在尋找治療組中瘦體重的維持與安慰劑組中體重損失的比較，我們正在評估我們可以為減脂提供多少幫助。這是本研究的主要焦點。

Thanks for that color, guys.

謝謝你的顏色，夥計們。

Thank you.

謝謝。

William Wood, B. Riley Securities.

威廉·伍德，B.萊利證券。

Appreciate you taking my questions and congratulations on the quarter. Just looking for a little extra color here on what we might expect in January for the top line data. Is this going to be like simply lean mass loss being reported? Or will you provide any extra details on the body weight loss and/or the fat loss war specifically the functional improvements?

感謝您回答我的問題並對本季表示祝賀。只是在這裡尋找一些額外的顏色來了解我們對 1 月份頂線數據的預期。這就像報告的瘦體重損失一樣嗎？或者您能提供有關體重減輕和/或減脂戰爭的任何額外細節，特別是功能改進嗎？

Yes. Great question. So the question because you're a little garbled, but I think the basic question is that I heard is that when you report in January, what can we expect in terms of top line data and the kinds of top line data that we'll get. And the answer is, for sure, and I say it this way because the rock depends on or concern that if you report too much information, then all of a sudden now you can't get all the societies and stuff you don't want you to, I mean, you have to have a scientific meeting with new information. So with that said, the most important thing about the trial is reporting out on body composition.

是的。很好的問題。所以這個問題是因為你有點混亂，但我認為基本的問題是，我聽到的是，當你在一月份報告時，我們對頂線數據有何期望以及我們將獲得的頂線數據類型得到。答案是肯定的，我這樣說是因為岩石取決於或擔心如果你報告太多信息，那麼突然之間你就無法獲得所有你不想要的社團和東西我的意思是，你必須召開一次包含新信息的科學會議。話雖如此，試驗中最重要的事情是報告身體組成。

So certainly, the primary endpoint of lean body mass and total fat mass. So you have a clear understanding of our dose response or the right dose to pick for the right preservation of muscle and reduction of fat compared to placebo. So we'll have that for sure. And then we'll just we'll just have to see how the societies and additional scientific meetings and that kind of stuff, what we can report. But as you know, in the spring time in the winter time, there are a lot of meetings that will be going on. So it's not right on the top line data happening in January, it'd be shortly thereafter in one of the major meetings.

當然，主要終點是去脂體重和總脂肪量。因此，與安慰劑相比，您可以清楚地了解我們的劑量反應或選擇正確的劑量來正確保存肌肉和減少脂肪。所以我們肯定會做到這一點。然後我們只需看看學會和其他科學會議以及諸如此類的事情如何，我們可以報告什麼。但如你所知，在春天和冬天，會有很多會議舉行。因此，一月份發生的頂線數據並不正確，而是不久之後的一次主要會議上的數據。

Got it. Very helpful. And maybe actually just a quick question. I believe you mentioned that you're going to have a presentation at obesity week. You mentioned the abstract. Is this going to be, I would say, unseen data from past clinical trials? Or is it going to be a little bit of what we've been seeing or potentially what we've seen already?

知道了。非常有幫助。也許其實只是一個簡單的問題。我相信你提到你將在肥胖週上發表演講。你提到了摘要。我想說，這是否是過去臨床試驗中看不見的數據？或者它會是我們已經看到的或可能已經看到的一些內容嗎？

It will be additional data that you have not seen. It's another analysis looking at data. So it's not repeat data that we've already shown. So it will be new data from the old studies.

這將是您沒有看到的額外數據。這是另一種針對數據的分析。所以這不是我們已經顯示的重複數據。所以這將是來自舊研究的新數據。

Okay. Helpful. That's it. I'll jump back in queue. Thank you so much.

好的。有幫助。就是這樣。我會插回隊列。太感謝了。

Thank you. Appreciate it.

謝謝。欣賞它。

(Operator Instructions) Dennis Ding, Jefferies.

（操作員說明）Dennis Ding，Jefferies。

Hi, this is [Anthea] on for Dennis. Thanks for taking our questions, two from us. On Star claim Power, could you talk a little bit about what the MCID is for the measure and what would be a successful outcome in Phase 2? And on the Phase 3, you've spoken previously about moving forward in elderly patients only versus the broader obesity population. Can you just let us know your thinking there and how the Phase two informed that decision.

大家好，我是丹尼斯的 [Anthea]。感謝您提出我們的問題，我們提出了兩個問題。關於 Star Claim Power，您能否談談該措施的 MCID 是什麼以及第二階段的成功結果是什麼？在第三階段，您之前曾談到僅針對老年患者與更廣泛的肥胖族群進行治療。您能否讓我們知道您的想法以及第二階段如何影響該決定。

Great. So I'm going to take the second question first and then Dr. Barnette will talk about Star Claim Power in terms of what's deemed a success. So in terms of the study, so to be very clear, the FDA has told us that the Phase 3 program that they're looking forward to us having the opportunity to develop the drug in all patients that have obesity or overweight. So in other words, all comers. And their belief is that a muscle preservation drug will have benefit in older, it has benefited all the patients will have benefit in younger patients, too. And so that's a positive sign that the FDA is well aware of body composition and how they're thinking about it. The FDA also said that one way forward would be to look for incremental weight loss, and this is now to about Phase 3 programs now, incremental weight loss the combination versus the GLP alone.

偉大的。因此，我將首先回答第二個問題，然後 Barnette 博士將根據什麼被視為成功來談論明星宣稱力量。因此，就這項研究而言，需要非常明確的是，FDA 告訴我們，他們期待我們有機會在 3 期計畫中為所有肥胖或超重患者開發該藥物。換句話說，所有人都來了。他們相信，肌肉保存藥物將對老年人有益，它使所有患者受益，也將使年輕患者受益。因此，這是一個積極的跡象，表明 FDA 非常了解身體組成以及他們對此的看法。FDA 也表示，前進的方向之一是尋求漸進式減肥，目前已進入第 3 階段計劃，漸進式減肥組合與單獨的 GLP 相比。

The incremental weight loss, the FDA did not commit to how much weight loss, incremental weight loss you should demonstrate because their position is that because you have a muscle preservation drug that may benefit in other ways such as physical function, home IR, Gary Nachman brought up. There are other things, other benefits of having a muscle preservation drug that's beyond just the adding muscle or preserving muscle just for the sake of doing it. So showing function is important.

增量減重，FDA沒有承諾你應該證明減重多少，增量減重，因為他們的立場是，因為你有肌肉保存藥物，可能會在其他方面受益，例如身體功能，家庭IR，Gary Nachman撫養長大。使用肌肉保存藥物還有其他一些好處，不僅是為了增加肌肉或為了保持肌肉而保存肌肉。所以展示功能很重要。

And so in a Phase 3 program, having those endpoints as key secondary endpoints and the primary endpoint wave loss allows the FDA to look at the totality of the data for clinical benefit and clinical meaningfulness, which is good because at one point it was a direct cutoff on weight, and that was it. But now it's much more totality of the data.

因此，在第 3 階段計劃中，將這些終點作為關鍵次要終點和主要終點波損失使 FDA 能夠查看全部數據的臨床效益和臨床意義，這很好，因為在某一時刻它是直接的體重限制，僅此而已。但現在數據更加全面。

So what will inform us in this study, the Phase 2 is not whether we're going to go after an older patient population. This study is meant to ask a question in an informative patient population, meaning doesn't it make sense that if you want to show a benefit in physical function, you pick patients that already have muscle loss and may already have functional limitations.

因此，在這項研究中，第二階段告訴我們的不是我們是否要針對老年患者族群。這項研究的目的是在資訊豐富的患者群體中提出一個問題，這意味著如果你想顯示身體功能的益處，你選擇已經出現肌肉損失並且可能已經出現功能限制的患者，這是否有意義。

And if you treat them with an anabolic agent, selective anabolic agent like enobosarm that you show a benefit in physical function. So you're going to more likely show that in older patient population, which, by the way, in the 950 some-odd patients, we've done five clinical studies, they were older patients. So we have experience with all the patients and older patients with at least certainly with the 3 milligram dose totality of the data shows that we hit function. So that would make sense.

如果你用合成代謝劑治療它們，選擇性合成代謝劑如enobosarm，你會顯示出對身體功能的好處。所以你更有可能表明，在老年患者群體中，順便說一句，在 950 名奇怪的患者中，我們已經做了五項臨床研究，他們都是老年患者。因此，我們對所有患者和老年患者的經驗至少可以肯定，3 毫克劑量的整體數據表明我們達到了功能。所以這是有道理的。

As you start thinking about a Phase 3 program, again, the totality of the whole approach would be to go for all comers. And so Gary, if you don't mind, can you comment on success, Gary Barnette, our Chief Scientific Officer. Can you comment on the success? What would be considered success with StarClient power? And then second, how we're thinking about the Phase 3, the development program as it relates to all comers, but also having the subgroup for the older patients.

當您開始考慮第三階段計畫時，再次強調，整個方法的整體內容將適用於所有參與者。加里，如果您不介意的話，您能否對我們的成功發表評論，加里·巴尼特，我們的首席科學官。您能評論一下成功嗎？StarClient 的強大功能如何才算是成功？其次，我們如何考慮第三階段，即與所有參與者相關的開發計劃，但也有針對老年患者的小組。

So in the Phase 2 study, I would believe the success really is being able to power and inform the design of the Phase 3. That's the success. And success as far as numerically goes, I think any separation from between the placebo group and the Enobosarm Treaty Group would be a success meaning we can show an observational difference between the power exerted going up the steps between the two groups. I think that would be a success. Remember, we're looking at change from baseline.

因此，在第二階段的研究中，我相信真正的成功在於能夠為第三階段的設計提供動力和資訊。這就是成功。就數字而言，我認為安慰劑組和 Enobosarm 條約組之間的任何分離都是成功的，這意味著我們可以顯示兩組之間所施加的力量之間的觀察差異。我認為那會是成功的。請記住，我們正在考慮相對於基線的變化。

So we've got a baseline value. And then we have a value 16 weeks, and then we'll have another value at the end of the extension. And I really think that the definition of success would be that we could observationally see a difference. As far as the Phase 3 trial, I think we're going to propose to the FDA and what we're going to try to do is we're going to power the Phase 3 study on, with the overall, remember, the FDA basically has told us that they believe that weight, or excuse me, the muscle loss or a drug to preserve muscle or preserve lean mass would be beneficial regardless to age, but they certainly recognize that the most at-risk patients are the aged population, which were study in the Phase 2.

這樣我們就有了一個基準值。然後我們有一個 16 週的值，然後在延期結束時我們將有另一個值。我真的認為成功的定義是我們可以透過觀察看到差異。至於 3 期試驗，我認為我們將向 FDA 提議，我們將嘗試做的是，我們將推動 3 期研究，總體而言，請記住，FDA基本上告訴我們，他們相信體重，或者對不起，肌肉損失或保留肌肉或保留瘦體重的藥物無論年齡如何都會有益，但他們當然認識到最危險的患者是老年人群，這是第二階段的研究。

So we do want us to include the younger patients in the Phase 3 study. So I would probably propose at this point that we would have a body weight endpoint, total body weight endpoint as the primary in the overall population. And then I would power the subgroup, meaning the patients over the age of 60 for airtime power because that is the at-risk population.

因此，我們確實希望將年輕患者納入第三階段研究。因此，我可能會建議在這一點上，我們將體重終點、總體重終點作為總體人群的主要終點。然後我會為亞組供電，即為 60 歲以上的患者提供通話時間供電，因為這是高風險族群。

So we intend obviously, if these patient populations have already lost lean as just due to their advancing age, and then we accelerate that with a grip 1 or a diet like this, then I think that that's where the value of enobosarm increasingly math, increasing physical function is going to be the most important from a patient outcome and quality of life.

因此，我們的意圖顯然是，如果這些患者群體已經因為年齡的增長而失去了瘦肉，然後我們通過握力1或這樣的飲食來加速這一過程，那麼我認為這就是enobosarm的價值越來越大的地方，增加從患者的治療結果和生活品質來看，身體功能將是最重要的。

And let me also add, Gary, that the Phase 3 program is going to be done like a typical Phase 3 program. As you know, we're looking at 16 weeks. And the reason we picked 16 weeks for Phase 2 is for two reasons. One is we know about half the total weight that's lost in a trial that goes on for 68 weeks happens in the first 16 weeks. And we also know from bariatric surgery data that in the first three months, the 55% of the muscle you lose in that whole year post surgery, it happens in the first three months.

加里，我還要補充一點，第三階段計劃將像典型的第三階段計劃一樣進行。如您所知，我們正在考慮 16 週。我們選擇 16 週作為第二階段的原因有兩個。其中之一是我們知道，在一項持續 68 週的試驗中，減掉的總體重量大約有一半發生在前 16 週。我們也從減重手術數據中得知，在手術後的頭三個月裡，您在手術後一整年中失去的肌肉的 55% 都發生在前三個月內。

So we know there's a lot of activity going on in muscle in that first 16 weeks. And we've got between the STEP-1 data and now the bariatric surgery data that gives you clarity on what's happening earlier. So the Phase 2 will help us understand what we want to do Phase 3. Time for the Phase 3 would be if we use semaglutide or tousepatide and probably use both. The first 16 weeks is what you need to titrate up and then you go on for another year. So it's about 68 weeks. So your Phase 3 program would be 68 weeks and your functional endpoint will be at the end of that 68 weeks. So you have a lot more time to maintain muscle and separate out the placebo group.

所以我們知道，在最初的 16 週內，肌肉會進行大量的活動。我們已經獲得了 STEP-1 數據和目前的減重手術數據，可以讓您清楚地了解之前發生的情況。因此，第二階段將幫助我們了解第三階段想要做什麼。第三階段的時間是我們使用索馬魯肽或 tousepatide，並且可能同時使用兩者。前 16 週是您需要逐步增加的時間，然後再繼續一年。所以大約是68週。因此，您的第 3 階段計劃將持續 68 週，您的功能終點將在 68 週結束時。所以你有更多的時間來維持肌肉並區分安慰劑組。

And so the way to look at it is the Phase 2 is just the beginning. And the one-year study will allow you to see the additional fat burning benefits of having a drug that directly reduces fat we're having a glucagon receptor agonist that it's not going to have a competing signal we clinched stop eating and the competing signal is going to be the muscle deprivation deficit tolling to bring to eat because that's self-preservation you get rid of that noise than the GLP-1 can work better.

因此，第二階段只是一個開始。這項為期一年的研究將讓您看到直接減少脂肪的藥物對燃燒脂肪的額外好處，我們有胰高血糖素受體激動劑，它不會產生競爭信號，我們堅持停止進食，競爭信號是這將是肌肉剝奪缺陷帶來的痛苦，因為這是自我保護，你擺脫這種噪音比GLP-1 可以更好地發揮作用。

And finally, with more muscle, you lose more fat. So that's why we think weight losses and endpoint and particularly is a good endpoint. And particularly now the FDA is thinking about clinical benefit is not just weight loss. It's wage laws in our case, function. And so I think it puts us in a good position. Also, the label will reflect that because again, the FDA doesn't really see muscle loss for cosmetic reasons, they see muscle preservation for functional reasons. Long answer, but hopefully, I gave you some clarity.

最後，隨著肌肉的增加，你會減掉更多的脂肪。這就是為什麼我們認為減肥和終點，尤其是一個很好的終點。特別是現在 FDA 正在考慮的臨床益處不僅僅是減肥。在我們的例子中，這是工資法，功能。所以我認為這讓我們處於有利的位置。此外，標籤將反映這一點，因為 FDA 並沒有真正看到肌肉損失是出於美容原因，他們認為肌肉保存是出於功能性原因。答案很長，但希望我能給你一些清晰的答案。

Yes, that was helpful. Thank you.

是的，這很有幫助。謝謝。

Okay.

好的。

Thank you. Ladies and gentlemen, this concludes the question-and-answer session. I would like to turn the conference back over to Dr. Michel Steiner for any closing remarks.

謝謝。女士們、先生們，問答環節到此結束。我想將會議轉回給米歇爾·施泰納博士做總結發言。

Thank you, operator. I appreciate everyone who joined us on today's call. I look forward to updating all of you on our progress at our next investors call. Thank you again. Bye now.

謝謝你，接線生。我感謝參加今天電話會議的所有人。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。再次感謝您。再見了。

Thank you. The digital replay of the conference call will be available beginning approximately noon Eastern Time today, August 8 by dialing 1 (877) 344-7529 in the US and 1 (412) 317-0088 internationally. You will be prompted to enter the replay access code, which will be (256-1276). Please record your name and company when joining. Conference call has now concluded. Thank you for attending today's discussion.

謝謝。電話會議的數位重播將於東部時間今天（8 月 8 日）中午左右開始，美國境內請撥打 1 (877) 344-7529，國際地區請撥打 1 (412) 317-0088。系統將提示您輸入重播存取代碼，該代碼將（256-1276）。加盟時請備註您的姓名和公司。電話會議現已結束。感謝您參加今天的討論。