Veru Inc. (VERU) 2026 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.

各位女士、各位先生，早安，歡迎參加 Veru Inc. 的投資人電話會議。(接線員指示) 請注意，本活動將被錄音。

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.

現在我想將會議交給 Veru Inc. 投資人關係與企業傳播執行董事 Sam Fisch 先生。請開始。

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。本次電話會議中所作之陳述可能包含前瞻性陳述。前瞻性陳述可能包括但不限於：公司就其業務、營運、監管互動、財務、研發及產品組合之計畫、目標、預期或意圖等陳述。此等前瞻性陳述受已知與未知之風險與不確定性影響，我們的實際結果可能與任何前瞻性陳述中所預測、暗示或包含者有重大差異。可能導致實際結果或發展出現重大差異之風險，載於我們向 SEC 提交的 10-Q 與 10-K 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, Vera Inc.'s Chairman, CEO, and President.

現在我想將電話會議交給 Vera Inc. 的董事長、執行長兼總裁 Mitchell Steiner 醫師。

Good morning. With me on this morning's call are Dr. Gary Barnette, the Chief Scientific Officer; Michele Greco, the Chief Financial Officer and Chief Administrative Officer; Phil Greenberg, General Counsel; and Sam Fisch, the Executive Director of Investor Relations and Corporate Communications. Thank you for joining our second quarter fiscal year 2026 and earnings call.

早安。今天早上的電話會議與我一同出席的有：首席科學長 Gary Barnette 醫師；首席財務長兼首席行政長 Michele Greco；總法律顧問 Phil Greenberg；以及投資人關係與企業傳播執行董事 Sam Fisch。感謝各位參加我們 2026 會計年度第二季與財報電話會議。

Veru is a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases. Our drug development program consists of two novel small molecules, enobosarm and sabizabulin. The first one on enobosarm is an oral selective androgen receptor modulator, SARM and is being developed as a next-generation drug that when combined with GLP-1 receptor agonist makes weight reduction more tissue selective for fat loss and preservation of lean mass and physical function, which is intended to lead to greater weight loss compared to a GLP-1 receptor agonist treatment alone with a focus on older patients with obesity.

Veru 是一家處於臨床後期階段的生物製藥公司，專注於開發用於治療心臟代謝與發炎性疾病的創新藥物。我們的藥物研發計畫包含兩個新型小分子：enobosarm 與 sabizabulin。其中第一個 enobosarm 是一種口服選擇性雄激素受體調節劑（SARM），正被開發為下一代藥物；當其與 GLP-1 受體致效劑合併使用時，可使減重在組織上更具選擇性，偏向脂肪減少並保留瘦體重與身體功能，旨在相較於單獨使用 GLP-1 受體致效劑治療達到更大的體重下降，並聚焦於肥胖的高齡患者。

Our second asset, sabizabulin, is a microtubule disruptor and it's being developed as a broad anti-inflammatory agent to reduce vascular plaque inflammation to slow the progression or promote the regression of atherosclerotic cardiovascular disease. This morning, we'll focus on an update of the clinical development progress of enobosarm in our obesity program. We will also provide financial highlights for fiscal 2026 second quarter ended March 31, 2026.

我們的第二項資產 sabizabulin 是一種微管破壞劑，正被開發為廣效抗發炎藥物，用以降低血管斑塊發炎，從而減緩動脈粥樣硬化性心血管疾病的進展或促進其逆轉。今天早上，我們將重點更新 enobosarm 在肥胖適應症計畫中的臨床開發進展。我們也將提供截至 2026 年 3 月 31 日止之 2026 會計年度第二季財務重點。

GLP-1 receptor agonist have been shown to produce significant weight loss in patients who have -- are overweight or have obesity. Unfortunately, this weight loss is tissue nonselective with the significant indiscriminate loss both lean mass and fat mass. Of the total weight loss up to 50% is attributable to lean mass.

GLP-1 受體致效劑已被證實可使過重或肥胖患者產生顯著的體重下降。不幸的是，這種減重在組織上並不具選擇性，會造成瘦體重與脂肪量皆出現顯著且不加區分的流失。在總體重下降中，最多可有 50% 可歸因於瘦體重的流失。

Although GLP-1 receptor agonist treatments have resulted in substantial weight loss for many patients. The strategy for the next generation of obesity drugs should be a combination therapy with a GLP-1 receptor agonist to cause patients who own and lose that while preserving lean mass and physical function and bone real density with the highest quality weight reduction. And Veru has focused the clinical development of enobosarm for weight loss on older patients who have obesity.

儘管 GLP-1 受體致效劑治療已為許多患者帶來可觀的體重下降。下一代肥胖藥物的策略應為與 GLP-1 受體致效劑的合併療法，使患者在減重的同時保留瘦體重、身體功能與骨礦物密度，以達到最高品質的體重下降。而 Veru 將 enobosarm 的減重臨床開發聚焦於肥胖的高齡患者。

More specifically, the focus has been on older patients who have sarcopenic obesity, which means they have both obesity and low muscle mass and are potentially at the greatest risk for reaching a critically low muscle mass, which may lead to physical function decline, taking the currently approved GLP-1 receptor agonist. According to the European Working Group on Sarcopenia and Older People 2, sarcopenia is defined by reduced muscle strength and function as the primary diagnostic criteria confirmed by low muscle quantity of quality, while the impaired physical performance reflects disease severity.

更具體而言，我們聚焦於患有肌少性肥胖的高齡患者，亦即同時具有肥胖與低肌肉量者；在使用目前已核准的 GLP-1 受體致效劑時，他們可能面臨達到臨界低肌肉量的最高風險，進而導致身體功能下降。根據「歐洲肌少症與高齡者工作小組 2（European Working Group on Sarcopenia and Older People 2）」的定義，肌少症以肌力與功能下降作為主要診斷標準，並以肌肉量或肌肉品質偏低加以確認；而身體表現受損則反映疾病嚴重程度。

As you can see, the working group emphasis is on physical strength and function. Thus, muscle loss alone does not define sarcopenia. As a consequence, we have chosen to also objectively evaluate and measure physical function by stair climb test in the Phase 2 QUALITY clinical study. And Veru's completed the Phase 2b QUALITY clinical trial was a multicenter, double-blind, placebo-controlled randomized, dose-finding clinical trial designed to evaluate safety and efficacy of enobosarm 3 milligrams, enobosarm 6 milligrams or placebo as a treatment to augment fat loss and prevent muscle loss in 168 older patients that's greater than equal to 60 years of age, receiving semaglutide [Wegovy] for weight reduction.

如各位所見，該工作小組強調的是體力與功能。因此，僅有肌肉流失並不足以定義肌少症。因此，我們在第 2 期 QUALITY 臨床研究中，也選擇以爬樓梯測試客觀評估並量測身體功能。Veru 已完成的第 2b 期 QUALITY 臨床試驗為多中心、雙盲、安慰劑對照、隨機、劑量探索試驗，旨在評估 enobosarm 3 毫克、enobosarm 6 毫克或安慰劑之安全性與療效；受試者為 168 名年齡大於等於 60 歲、使用 semaglutide [Wegovy] 進行減重的高齡患者，以評估其作為增強脂肪流失並預防肌肉流失之治療。

After the efficacy dose-finding active weight loss portion of the Phase 2b clinical trial was completed at 16 weeks, participants continued into a Phase 2b maintenance extension study where all patients discontinue semaglutide treatment, but continue to receiving either placebo, enobosarm 3 milligrams and enobosarm 6 milligram, as monotherapy in a double-blind fashion for 12 weeks.

在第 2b 期臨床試驗的療效劑量探索之主動減重階段於 16 週完成後，受試者進入第 2b 期維持期延伸研究；在該延伸研究中，所有患者停止 semaglutide 治療，但仍以雙盲方式持續接受安慰劑、enobosarm 3 毫克或 enobosarm 6 毫克作為單一療法，為期 12 週。

Phase 2b QUALITY clinical trial was a positive study that demonstrated that preserving lean mass and physical function with enobosarm plus semaglutide led to greater fat loss. As I mentioned, Veru focused on the impact of weight loss on physical function, not just lean mass and older patients with obesity in the Phase 2b QUALITY clinical study.

第 2b 期 QUALITY 臨床試驗為一項正向研究，顯示 enobosarm 與 semaglutide 併用可保留瘦體重與身體功能，並帶來更大的脂肪流失。如我所提，Veru 在第 2b 期 QUALITY 臨床研究中，聚焦於減重對身體功能的影響，而不僅僅是瘦體重，且研究對象為肥胖的高齡患者。

Physical function was measured by the stair climb test, which is a common activity of daily living, declines in physical function, as measured by the stair climb test we predict in older patients at high risk of mobility disabilities, gate difficulties, falls and bone factors, hospitalizations and mortality. It has been reported that stair climb power declined by 1.38% annually with aging.

身體功能以爬樓梯測試衡量；爬樓梯是常見的日常生活活動。以爬樓梯測試衡量的身體功能下降，我們預期會使高齡且具有高度風險的患者更可能出現行動障礙、步態困難、跌倒與骨折、住院以及死亡。據報導，隨著老化，爬樓梯功率每年下降 1.38%。

Now it should be noted that the Phase 2b QUALITY clinical study is the first human study to demonstrate that the weight reduction in older patients who have obesity receiving a GLP-1 receptor agonist puts them at a higher risk for accelerated loss of lean mass with physical function decline. A prespecified responder analysis was conducted using a greater than 10% decline in stair climb power as a cutoff at 16 weeks, which is a significant loss as it represents loss of stair climb power that would naturally occur with aging over a seven- to eight-year period in older patients.

需要指出的是，第 2b 期 QUALITY 臨床研究是首個人體研究，證明肥胖高齡患者在接受 GLP-1 受體致效劑減重時，會面臨更高的瘦體重加速流失與身體功能下降風險。我們進行了一項預先指定的反應者分析，以 16 週時爬樓梯功率下降超過 10% 作為切點；此為顯著的流失，因其相當於高齡患者在自然老化過程中約 7 至 8 年才會出現的爬樓梯功率下降幅度。

In a Phase 2b QUALITY study, the loss in lean mass matter, as 44.3% of patients on placebo for semaglutide group had at least a 10% decline in stair climb power physical function at 16 weeks. And what happened to the study group that received enobosarm combination with the GLP-1 receptor agonist. In the Phase 2b QUALITY clinical study, enobosarm treatment preserved lean mass, which translated into a reduction in the proportion of patients that had a clinically significant stair climb physical function decline when compared to patients receiving a GLP-1 receptor alone.

在第 2b 期 QUALITY 研究中，瘦體重的流失確實重要：在 semaglutide 的安慰劑組中，有 44.3% 的患者於 16 週時爬樓梯功率（身體功能）至少下降 10%。那麼，接受 enobosarm 與 GLP-1 受體致效劑合併治療的研究組又如何呢？在第 2b 期 QUALITY 臨床研究中，enobosarm 治療可保留瘦體重，並轉化為：相較於僅接受 GLP-1 受體致效劑的患者，出現具臨床意義之爬樓梯身體功能下降的患者比例降低。

More specifically, the enobosarm 3-milligram plus semaglutide group had a statistically significant, clinically meaningful 59.8% relative reduction in proportion of patients that lost at least 10% stair climb power compared to the placebo plus semaglutide group, and that p-value is 0.0006. In the enobosarm 6 milligram group plus semaglutide, there was a 44.1% relative reduction in the proportion of patients with at least a 10% decline in stair climb power from baseline first placebo plus semaglutide group, and that p-value was 0.051.

更具體而言，enobosarm 3 毫克加 semaglutide 組，相較於安慰劑加 semaglutide 組，在爬樓梯功率至少下降 10% 的患者比例上，呈現具統計顯著且具臨床意義的 59.8% 相對降低，p 值為 0.0006。於 enobosarm 6 毫克加 semaglutide 組，相較於安慰劑加 semaglutide 組，基線至 16 週爬樓梯功率至少下降 10% 的患者比例相對降低 44.1%，p 值為 0.051。

Based on the results of this short-term study, we believe there is an urgent unmet need for a drug that prevents a loss of muscle and physical function as well as augment a loss of fat for greater weight loss and at risk older patients with sarcopenic obesity receiving a GLP-1 receptor agonist for weight reduction. The next important question is can you potentially have greater weight loss by adding enobosarm to a GLP-1 receptor agonist treatment.?

根據這項短期研究的結果，我們認為，對於因減重而接受 GLP-1 受體致效劑治療、且屬於肌少性肥胖的高風險老年患者，迫切存在一項尚未被滿足的需求：需要一種藥物能夠預防肌肉與身體功能的流失，同時增加脂肪流失，以達到更大的減重效果。下一個重要問題是：在 GLP-1 受體致效劑治療中加入 enobosarm，是否有可能帶來更大的減重？

First of all, as the Phase 2B QUALITY clinical studies demonstrated, patients receiving enobosarm had greater fat loss. Plus, if you're able to preserve muscle and physical function with enobosarm, while taking a GLP-1 receptor agonist, we would expect that more calories will be burned, which is expected to result of greater weight loss compared to GLP-1 receptor agonist alone, especially in the long study.

首先，正如第 2b 期 QUALITY 臨床研究所顯示，接受 enobosarm 的患者有更大的脂肪流失。此外，如果在使用 GLP-1 受體致效劑的同時，能透過 enobosarm 保留肌肉與身體功能，我們預期將燃燒更多熱量，進而帶來比單用 GLP-1 受體致效劑更大的減重效果，尤其是在較長期的研究中。

Now let's turn to the current progress of our Phase 2b PLATEAU clinical study. A common clinical and therapeutic challenge with GLP-1 receptor agonist treatments is that 88% of patients after one year on a GLP-1 receptor agonist hit a weight-loss plateau where they stop losing additional weight. Based on the SURMOUNT-1 study conducted by Eli (technical difficulty).

現在讓我們談談第 2b 期 PLATEAU 臨床研究的最新進展。GLP-1 受體致效劑治療在臨床與治療上常見的一項挑戰是：在使用 GLP-1 受體致效劑滿一年後，有 88% 的患者會達到減重平台期，也就是停止進一步減重。根據禮來（Eli）所進行的 SURMOUNT-1 研究（技術問題）。

One explanation might be that the loss of muscle caused by nonselective tissue weight loss may reach a point that now stimulates the appetite in patients receiving a GLP-1 receptor agonist, so they consume more calories, which in term cause patients to stop losing weight to hit that wind loss plateau. Again, enobosarm shown clinical studies to directly burn fat and to preserve muscle to increase physical function and burn more calories. Thus by preserving muscle, appetite stay suppressed while more calls of burn, which can help to break through the weight loss plateau leading to incremental reduction.

其中一種解釋可能是：由於非選擇性的組織性體重下降所造成的肌肉流失，可能達到某個程度後，會刺激接受 GLP-1 受體致效劑治療的患者食慾，使其攝取更多熱量，進而導致患者停止減重並進入減重平台期。同樣地，enobosarm 在臨床研究中顯示可直接燃燒脂肪，並保留肌肉、提升身體功能，從而燃燒更多熱量。因此，透過保留肌肉，食慾可維持被抑制，同時燃燒更多熱量，這有助於突破減重平台期，帶來額外的減重幅度。

Now let's turn to the design of the Phase 2b PLATEAU clinical study. Which is a double-blind, placebo-controlled study to evaluate the effect of enobosarm 3 milligrams of total body mass -- excuse me, total body weight, fat mass, lean mass and physical function, bond metal density and safety in approximately 200 older patients, age greater than or equal to 65, we have obesity BMI greater or equal to 35% and are initiating semaglutide GOVI GLP-1 receptor agonist treatment for weight reduction.

接下來我們談談第 2b 期 PLATEAU 臨床研究的設計。這是一項雙盲、安慰劑對照研究，用以評估 enobosarm 3 毫克對總體重——抱歉，是總體重、脂肪量、瘦體重與身體功能、骨礦物質密度以及安全性的影響；研究對象約 200 名老年患者，年齡大於或等於 65 歲，患有肥胖（BMI 大於或等於 35%），並正開始使用 semaglutide GOVI GLP-1 受體致效劑進行減重治療。

The primary efficacy endpoint of the study is the percent change for baseline in total by way at 68 weeks. Interim analysis will be conducted 36 weeks to as sess the percent change from baseline in lean body mass and total fat mass as measured by DXA scan.

本研究的主要療效終點為第 68 週時總體重相較基線的百分比變化。將於第 36 週進行期中分析，以評估以 DXA 掃描測量之瘦體重與總脂肪量相較基線的百分比變化。

The key secondary endpoints to the overall study, a total fat, total lean mass, physical function again measured by sterilants, mobility, disability assessment, bone marrow density, and patient-reported outcome questionnaires for physical function, HbA1c and insulin resistance. The objective of the Phase IIb plateau clinical trial is to focus on the effect of longer-term GLP-1 receptor agonist treatment in older patients who have obesity. The Phase 2b PLATEAU clinical study will also assess the ability of enobosarm to break through the white loss plateau.

本整體研究的關鍵次要終點包括：總脂肪量、總瘦體重、身體功能（同樣以量表衡量）、行動能力、失能評估、骨髓密度，以及以病人回報結果（PRO）問卷評估的身體功能、HbA1c 與胰島素阻抗。第 2b 期 PLATEAU 臨床試驗的目標，是聚焦於在患有肥胖的老年患者中，較長期 GLP-1 受體致效劑治療的影響。第 2b 期 PLATEAU 臨床研究也將評估 enobosarm 突破減重平台期的能力。

Observed in patients receiving a GLP-1 receptor agonist treatment to achieve clinically meaningful incremental weight reduction as well as to preserve muscle mass and physical function by 68 weeks. The interim analysis of the clinical study will occur when all patients have been treated for 36 weeks.

亦即在接受 GLP-1 受體致效劑治療的患者中，達成具臨床意義的額外減重，同時在第 68 週前保留肌肉量與身體功能。當所有患者皆已接受治療滿 36 週時，將進行本臨床研究的期中分析。

Now semaglutide was selected as a GLP-1 receptor agonist for the Phase 2 study to build on Veru's previous clinical experience using enobosarm in combination with semaglutide in the positive Phase 2 QUALITY clinical study. Further, the clinical data from the Phase 2b PLATEAU clinical study using injectable semaglutide may support the use of oral semaglutide and oral enobosarm fixed-dose combination in future Phase 3 clinical studies. In contrast, there are no approved oral formulations which is apatite.

本第 2 期研究選擇 semaglutide 作為 GLP-1 受體致效劑，是為了延續 Veru 先前在正向的第 2 期 QUALITY 臨床研究中，將 enobosarm 與 semaglutide 併用的臨床經驗。此外，第 2b 期 PLATEAU 臨床研究使用注射型 semaglutide 所取得的臨床數據，可能支持在未來第 3 期臨床研究中採用口服 semaglutide 與口服 enobosarm 的固定劑量複方。相較之下，目前尚無已核准的口服劑型，這是一項限制。

On March 9, 2026, we announced the enrollment the first patient in the Phase 2b PLATEAU clinical study. I'm very pleased with the current enrollment rate, and we're on track for results of the 36 interim analysis, which is expected in Q1 calendar year 2027.

2026 年 3 月 9 日，我們宣布第 2b 期 PLATEAU 臨床研究已完成首位患者入組。我對目前的入組速度非常滿意，我們也正按計畫推進第 36 週期中分析的結果，預計於 2027 年曆年第一季公布。

Now Veru is targeting the at-risk older patients with sarcopenic obesity. So how large is that market? How about the total market for obesity?

目前 Veru 鎖定的是具風險的肌少性肥胖老年患者。那麼這個市場有多大？那整體肥胖市場又有多大？

The Wall Street Journal reported last week that there are more than 1 billion people in the world with obesity. The World Health Organization estimates that there are 2.5 billion adults globally, either overweight or obese, with the rate of adult obesity more than doubling since 1990. And right now, we're only two companies, Lilly and Novo Nordisk that together are treating less than 2% of them. Hope of the total market for sarcopenic obesity. The overall prevalence of obesity and low muscle mass is almost 30 million adults in the US.

《華爾街日報》上週報導，全球有超過 10 億人患有肥胖。世界衛生組織估計，全球有 25 億名成年人屬於過重或肥胖，自 1990 年以來成人肥胖率已增加一倍以上。而目前只有兩家公司——禮來與諾和諾德——合計治療的人數仍不到其中的 2%。再看肌少性肥胖的整體市場。在美國，肥胖合併低肌肉量的整體盛行人數接近 3,000 萬名成年人。

How about the total market of the patients who are 65 years and older with obesity? The prevalence of obesity in patients who are 65 years and older is 41.5% among the 47.4 million patients enrolled in Medicare Part D plans, and that's about $20 million potential patients. As you can see, taken together, the market opportunity for enobosarm in combination with GLP-1 receptor agonist in older patients with sarcopenic obesity is very large.

那麼 65 歲及以上肥胖患者的整體市場呢？在參加 Medicare Part D 計畫的 4,740 萬名患者中，65 歲及以上患者的肥胖盛行率為 41.5%，約相當於 2,000 萬名潛在患者。如您所見，綜合而言，enobosarm 與 GLP-1 受體致效劑併用、用於肌少性肥胖老年患者的市場機會非常龐大。

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

接下來我將把電話會議交給財務長兼執行長 Michele Greco，請她說明財務重點。Michele？

Thank you, Dr. Steiner. Let's review the results for the three months ended March 31, 2026. Research and development costs decreased to $3.1 million from $3.9 million in the prior quarter. The decrease is primarily due to wind down of the Phase 2b QUALITY clinical study for enobosarm as a treatment to augment fat loss and prevent muscle loss, which was completed during fiscal 2025. Personnel costs also decreased primarily due to the reduced share-based compensation expense.

謝謝您，Steiner 醫師。讓我們回顧截至 2026 年 3 月 31 日止三個月的業績。研發費用由上一季的 390 萬美元降至 310 萬美元。下降主要是因為 enobosarm 用於增加脂肪流失並預防肌肉流失的第 2b 期 QUALITY 臨床研究已於 2025 財年完成並進入收尾階段。人事成本也下降，主要由於以股份為基礎的薪酬費用減少。

Selling, general and administrative expenses were $4.1 million compared to $5.2 million in the prior quarter. The decrease is primarily due to a decrease in the share-based compensation expense. We recognized a gain on the sale of ENTADFI assets of $974,000 in the prior year's quarter, which is based on nonrefundable consideration received related to promissory notes previously due to Bureau. As the promissory notes are now settled, no additional gain is expected in future periods.

銷售、一般及行政費用為 410 萬美元，較上一季的 520 萬美元下降。下降主要是因為以股份為基礎的薪酬費用減少。我們在去年同期確認出售 ENTADFI 資產的收益 97.4 萬美元，該收益係基於先前應付予 Veru 的本票相關、已收取之不可退還對價。由於該等本票現已結清，預期未來期間不會再有額外收益。

During the prior fiscal year, the company entered into a settlement agreement with Onconetix, which included payment of Series D preferred stock and warrants. During the current period, the increase in fair value of the equity securities received was $3.9 million as a result of the realized gain from the conversion of the preferred stock and then sale of the underlying common stock and change in the fair value of the remaining preferred stock and warrants.

在上一個財政年度，公司與 Onconetix 達成和解協議，其中包含支付 D 系列優先股及認股權證。在本期內，所收到之權益證券公允價值增加 390 萬美元，主要來自優先股轉換後出售其所對應普通股所實現的收益，以及剩餘優先股與認股權證公允價值的變動。

Favorable antidilution provisions triggered by the Onconetix reverse stock split during the period contributed to the increase in the fair value. The bottom line result for continuing operations was a net loss of $3.1 million or $0.13 per diluted common share compared to a net loss of $7.9 million or $0.54 per diluted common share in the prior year's quarter.

本期間內，Onconetix 反向股票分割所觸發的有利反稀釋條款，促使公允價值上升。持續營運的最終結果為淨損失310萬美元（每股稀釋普通股0.13美元），相較於去年同期季度淨損失790萬美元（每股稀釋普通股0.54美元）。

During the quarter, the company recognized an additional gain on sale of the FC2 business of $351,000 for the net proceeds received from Clear Future in the settlement of the dispute related to a pre-closing tax receivable and liability, which is included as income from discontinued operations. In the prior year period, Veru sold the FC2 Female Condom business to Clear Future.

本季度，公司就與 Clear Future 針對交割前稅務應收款及負債相關爭議之和解所收取的淨款項，確認 FC2 業務出售的額外收益35.1萬美元，並列入停業部門收益。在前一年度期間，Veru 已將 FC2 女性保險套業務出售予 Clear Future。

In our financial statements, all direct revenues, costs and expenses related to the FC2 Female Condom business are classified within loss from discontinued operations, net of tax, in the statement of operations. Net loss was $2.7 million or $0.12 per diluted common share compared to a net loss of $7.9 million or $0.54 per diluted common share in the prior quarter.

在我們的財務報表中，與 FC2 女性保險套業務相關的所有直接收入、成本及費用，均於營運報表中分類為停業部門損失（扣除所得稅後）。淨損失為270萬美元（每股稀釋普通股0.12美元），相較於前一季度淨損失790萬美元（每股稀釋普通股0.54美元）。

Now turning to the results for the six months ended March 31, 2026. The Research and development costs decreased to $4.5 million from $9.6 million in the prior period. The decrease is primarily due to a wind down of the Phase 2b QUALITY clinical study for enobosarm as a treatment to augment fat loss and prevent muscle loss, which was completed during fiscal 2025. Personnel costs also decreased primarily due to the reduced share-based compensation expense.

接下來說明截至2026年3月31日止六個月的業績。研發費用由前期的960萬美元降至450萬美元。下降主要係因 enobosarm 用於增強減脂並防止肌肉流失之第2b期 QUALITY 臨床研究進入收尾階段，且已於2025財政年度完成。人員成本亦主要因股份基礎給付費用降低而下降。

Selling, general and administrative expenses were $8.2 million compared to $10.4 million in the prior period. The decrease is primarily due to a decrease in the share-based compensation expense. We recognized a gain on the sale of the ENTADFI assets of $1.7 million in the prior period. In conjunction with the sale of the FC2 Female Condom business during the prior fiscal year, we recorded a gain on extinguishment of debt of $8.6 million related to the termination of the SWK Holdings residual royalty agreement.

銷售、一般及行政費用為820萬美元，較前期的1,040萬美元下降。下降主要係因股份基礎給付費用減少。我們在前期確認出售 ENTADFI 資產的收益170萬美元。配合前一財政年度出售 FC2 女性保險套業務，我們就終止 SWK Holdings 殘餘權利金協議所相關之債務消滅，認列860萬美元收益。

During the current period, the company recorded a gain of $3.8 million from the increase in the fair value of equity securities compared to a loss from the decrease in fair value of equity securities of $0.3 million in the prior period. The increase in fair value of the equity securities during the current year period is the result of a realized gain from the conversion of the Onconetix preferred stock and sale of the underlying common stock and change in fair value of the remaining preferred stock and warrants. Favorable antidilution provisions triggered by the Onconetix reverse stock split during the period contributed to the increase in fair value.

本期公司因權益證券公允價值上升而認列380萬美元收益，相較於前期因權益證券公允價值下降而認列30萬美元損失。本年度期間權益證券公允價值上升，係源於 Onconetix 優先股轉換並出售其所對應普通股所產生的已實現收益，以及剩餘優先股與認股權證的公允價值變動。本期間 Onconetix 反向股票分割所觸發的有利反稀釋條款亦促使公允價值上升。

The bottom line results for continuing operations was a net loss of $8.4 million or $0.39 per diluted common share compared to a net loss of $9.6 million or $0.66 per diluted common share in the prior period. The net loss was $8.1 million or $0.38 per diluted common share compared to a net loss of $16.8 million or $1.15 per diluted common share in the prior period.

持續營運的最終結果為淨損失840萬美元（每股稀釋普通股0.39美元），相較於前期淨損失960萬美元（每股稀釋普通股0.66美元）。淨損失為810萬美元（每股稀釋普通股0.38美元），相較於前期淨損失1,680萬美元（每股稀釋普通股1.15美元）。

Looking at the balance sheet. As of March 31, 2026, our cash, cash equivalents, and restricted cash balance was $27.6 million compared to $15.8 million as of September 30, 2025. On both March 31, 2026 and September 30, 2025, there was $0.1 million of restricted cash related to the sale of the FC2 Female Condom business. Our net working capital was $28 million on March 31, 2026 compared to $11.1 million on September 30, 2025.

接著看資產負債表。截至2026年3月31日，我們的現金、約當現金及受限制現金餘額為2,760萬美元，較2025年9月30日的1,580萬美元增加。於2026年3月31日及2025年9月30日，均有10萬美元受限制現金與 FC2 女性保險套業務出售相關。截至2026年3月31日，我們的淨營運資金為2,800萬美元，較2025年9月30日的1,110萬美元增加。

On October 31, 2025, Veru completed an underwritten public offering of 1.4 million shares of our common stock, prefunded warrants to purchase up to 7 million shares of our common stock. Accompanying Series A warrants to purchase up to 8.4 million shares of our common stock and accompanying Series B warrants to purchase up to 8.4 million shares of our common stock at a public offering price of $3 per share of common stock and the accompanying Series A and Series B warrants. Net proceeds to the company from this offering were approximately $23.4 million after deducting underwriting discounts and commissions and costs paid by the company.

2025年10月31日，Veru 完成承銷公開發行：發行140萬股普通股，以及可購買最多700萬股普通股的預付認股權證。並同時附帶可購買最多840萬股普通股的A系列認股權證，以及同時附帶可購買最多840萬股普通股的B系列認股權證；普通股及所附A系列與B系列認股權證之公開發行價格為每股3美元。扣除承銷折讓與佣金及公司支付之費用後，本次發行為公司帶來的淨募資約為2,340萬美元。

The company is not profitable and has had negative cash flows from operations. Based on the company's current operating plan, our cash as of the issuance date of these financial statements, is expected to be sufficient for the company to fund operations beyond the Interim analysis in the Phase 2b clinical study that would be performed to assess percent change from baseline in lean body mass and fat mass as measured by DXA scans.

公司目前尚未獲利，且營運活動現金流為負。依公司目前的營運計畫，截至本財務報表出具日之現金，預期足以支應公司營運至第2b期臨床研究之期中分析之後；該期中分析將用以評估以 DXA 掃描量測之瘦體重與脂肪量相較基準值的百分比變化。

During the six months ended March 31, 2026, we used cash of $15.1 million for operating activities compared with $19.1 million used for operating activities in the prior period. We generated cash from investing activities of $2.5 million for the six months ended March 31, 2026, compared to $18.4 million in the prior year period. The cash generated during the current period represents proceeds from the sale of the on kinetics equity securities of $3.2 million and $0.3 million for the settlement of a dispute related to pre-closing tax matters related to the sale of the FC2 business.

截至2026年3月31日止六個月，我們於營運活動使用現金1,510萬美元，較前期營運活動使用的1,910萬美元減少。截至2026年3月31日止六個月，我們自投資活動產生現金250萬美元，相較於前一年度同期的1,840萬美元。本期所產生的現金主要來自出售 Onconetix 權益證券所得320萬美元，以及就與出售 FC2 業務相關之交割前稅務事項爭議和解所得30萬美元。

The cash generated in the prior period relates to proceeds from the sale of the FC2 Female Condom business of $16.3 million, proceeds of $1.7 million from the sale of entity assets and proceeds of $393,000 from the sale of equity securities. Net proceeds provided by financing activities for the six months ended March 31, 2026, was $23.4 million, which were the proceeds from the sale of common stock and warrants in an underwritten public offering net of commissions and costs. We used cash and financing activities for the six months ended March 31, 2025, of $4.2 million related to the change of control payment to SWK pursuant to the residual royalty agreement, which terminated in conjunction with the sale of the FC2 Female Condom business.

前期所產生的現金主要與出售 FC2 女性保險套業務所得1,630萬美元、出售實體資產所得170萬美元，以及出售權益證券所得39.3萬美元相關。截至2026年3月31日止六個月，融資活動提供的淨現金流入為2,340萬美元，係承銷公開發行出售普通股及認股權證之所得款項（扣除佣金及費用後）。截至2025年3月31日止六個月，我們於融資活動使用現金420萬美元，係依據殘餘權利金協議向 SWK 支付控制權變更款項；該協議已於出售 FC2 女性保險套業務時一併終止。

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

接下來我想把電話交回給 Steiner 醫師。Steiner 醫師？

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

謝謝你，Michele。接下來我將開放提問。接線員？

Ladies and gentlemen, at this time, we will begin the question-and-answer session. (Operator Instructions)

各位女士、先生，現在我們將開始問答環節。(接線員指示)

Leland Gershell, Oppenheimer.

Oppenheimer 的 Leland Gershell。

A couple of questions from us. Assuming success in the PLATEAU study, would you expect to need two Phase 3s or could you perhaps get by with one pivotal and perhaps use PLATEAU as supportives? And I also wanted to ask, in further studies with enobosarm given the development of evolving agents for obesity, some orals are coming through. Others want to know if the design would capture those agents as well.

我們這邊有幾個問題。假設 PLATEAU 研究成功，您預期需要兩項第3期試驗，還是可能只需要一項關鍵性試驗，並將 PLATEAU 作為支持性資料即可？另外我也想問，鑑於肥胖症領域正在發展中的新型藥物不斷出現，其中一些口服藥也正在推進；也有人想了解，後續針對 enobosarm 的研究設計是否也會把那些藥物納入考量。

Would the ultimate label be agnostic to the primary weight loss agent? Would you need to study the specific weight loss agents to have those reflected in the indication label for an enobosarm? Thank you.

最終的標示是否會對主要減重藥物保持中立（不特定）？您是否需要研究特定的減重藥物，才能讓這些內容反映在恩博沙姆（enobosarm）的適應症標示上？謝謝。

So thank you, Leland. So the first question is basically, if we're successful, what's the next step? And you go to a Phase 3. So let's be very clear what that means.

好的，謝謝你，Leland。第一個問題基本上是，如果我們成功了，下一步是什麼？那就是進入第三期試驗（Phase 3）。所以我們要非常清楚這代表什麼。

As you know, the FDA has come back and told us that incremental weight loss of greater than 5% for the efficacy portion of the study is sort of the anchor, okay? So you have greater than 5% that stands on its own. If you want to add the function benefits and the bone benefits, then you have to show those separately, but you -- at least you're moving forward with incremental weight loss.

如各位所知，FDA 已回覆並告訴我們，就研究的療效部分而言，超過 5% 的增量減重（incremental weight loss）是某種「錨點」，好嗎？所以，超過 5% 這件事本身就站得住腳。如果你想加入功能性效益與骨骼效益，那就必須分別證明，但你——至少在增量減重方面是往前推進的。

If you have -- if your incremental weight loss is less than 5% then you have two ways to move forward. One is physical function as a primary endpoint. And the reason the Phase 2b is so important is because we're doing a lot of work on physical function to make sure that we have a very clear understanding of the Phase 3 endpoint for physical function as a claim. And furthermore, we're collecting bone mineral density information.

如果——如果你的增量減重低於 5%，那你有兩種方式可以往前走。其一是把身體功能（physical function）作為主要終點。而第二期 2b 試驗之所以如此重要，是因為我們在身體功能上做了大量工作，以確保我們對第三期試驗中、可作為主張（claim）的身體功能終點有非常清楚的理解。此外，我們也在收集骨密度（BMD）資訊。

As you know, the FDA has recently reported back in December of 2025 that BMD alone can be a surrogate endpoint in place of fractures. And so that could be very interesting as we know GLP-1s can cause bone loss in this patient population undergoing this accelerated weight loss. So if the incremental weight loss is greater than 5%, then that will be the primary endpoint with function and BMD secondary endpoints. If incremental weight loss was less than 5%, (technical difficulty).

如各位所知，FDA 最近在 2025 年 12 月回報指出，單靠 BMD 就可以作為骨折的替代性終點（surrogate endpoint）。因此這可能非常有意思，因為我們知道在這個接受加速減重的病人族群中，GLP-1 可能造成骨質流失。所以如果增量減重大於 5%，那它將是主要終點，而功能與 BMD 為次要終點。如果增量減重小於 5%，（技術問題）。

That's why this trial is so critical. It's a perfect trial because it's measuring all these things and body composition that can inform us on what the Phase (technical difficulty) working out which direction they're going to take. So this is not just for enobosarm. Myostatin inhibitors, if you want to have incremental weight loss and function in BMD, you have to measure those all separately, and they have to be separate claims, and you have to make sure you have the data to do that. And we're the only company that really is focused on function with the very objective measurement.

這就是為什麼這項試驗如此關鍵。這是一個完美的試驗，因為它測量了所有這些項目以及身體組成（body composition），能夠提供資訊，幫助我們在第三期（技術問題）釐清他們將採取哪個方向。所以這不只是針對恩博沙姆。對於肌生成抑制素（myostatin）抑制劑而言，如果你想同時主張增量減重、功能與 BMD，你必須把這些都分別測量，而且必須是分開的主張，並且要確保你有足夠的數據來支持。而我們是唯一一家真正聚焦在功能、並採用非常客觀量測方式的公司。

So that's why this trial will be interesting. As you know, we've derisked a lot of it with the Phase 2 QUALITY study that we've done. But the palm of the QUALITY study is 16 weeks, and even more than that time to see weight loss, incremental weight loss. And so we're doing the definitive study to answer that question.

所以這就是為什麼這項試驗會很有意思。如各位所知，我們已透過已完成的第二期 QUALITY 研究，降低了很多風險（derisked）。但 QUALITY 研究的治療期是 16 週，而要看到減重、增量減重，可能需要更長時間。因此我們正在做一項決定性（definitive）的研究來回答這個問題。

To answer your second question, yes, the field is -- just to refresh everybody's memory, the second question is if we do move forward and we've got all these companies coming out with weight loss agents, orals, and non-orals, is the claim going to be enobosarm with any GLP-1 receptor agonist? Or the studies have to be specific to the GLP-1 receptor agonist in the form of the formulation of that agonist?

回答你的第二個問題：是的，這個領域——我先幫大家回顧一下，第二個問題是：如果我們確實往前推進，而市場上有這麼多公司推出減重藥物（口服與非口服），那麼主張會不會是「恩博沙姆可搭配任何 GLP-1 受體促效劑」？還是說研究必須針對特定的 GLP-1 受體促效劑，以及該促效劑的製劑形式？

And the answer is, my understanding is that certainly initially, it's going to be based on the specific GLP-1 receptor agonist. So that's why it was important for us to focus on semaglutide initially. But I think since each of these have different -- each of these GLP-1 receptor agonists have different effects on weight loss that you're probably going to have to do -- whether it's us or anybody else is probably have to combine it with the specific weight loss agent initially.

我的理解是，答案是：至少在一開始，肯定會以特定的 GLP-1 受體促效劑為基礎。所以我們一開始聚焦在司美格魯肽（semaglutide）是很重要的。但我認為，由於每一種——每一種 GLP-1 受體促效劑對減重的效果不同，你很可能必須——不論是我們或其他任何人——一開始都得與特定的減重藥物做合併研究。

And then we'll see what happens in the field later. It may get to a point that GLP-1 alone or GLP-1 GIP alone. But initially, it's -- in my opinion, it's going to be specific to the GLP-1 receptor agonist.

然後我們再看看之後這個領域會如何發展。可能會發展到某個程度，只要 GLP-1 單獨使用，或 GLP-1/GIP 單獨使用即可。但一開始——以我看來——會是針對特定的 GLP-1 受體促效劑。

Now Gary Barnett is on the call. He's our Chief Scientific Officer. What do you think about that question, Gary?

現在 Gary Barnett 也在線上。他是我們的首席科學官（Chief Scientific Officer）。Gary，你怎麼看這個問題？

Yeah, it's a great question. I think that at some point, I can envision -- remember, the consequence that we're treating with enobosarm is weight loss and weight loss occurs with all of the GLPs and all of the incretins, and all of them will have a similar issue with the loss of lean mass and the plateau that we're addressing in the PLATEAU study.

是的，這是個很好的問題。我認為在某個時間點，我可以想像——請記得，我們用恩博沙姆要處理的後果是減重，而所有 GLP 類與所有腸泌素（incretins）都會造成減重；而它們都會有類似的問題：瘦體重（lean mass）流失，以及我們在 PLATEAU 研究中要處理的停滯期（plateau）。

I think that not to see a world where we include multiple different incretins as in our Phase 3. But Mitch is exactly correct. The FDA's long-time mantra is you get in your label once you study in your Phase 3. So right now, our plan is to really focus on one or two increases in the Phase 3 program.

我認為未來的世界裡，我們在第三期試驗納入多種不同的腸泌素並非不可想像。但 Mitch 說得完全正確。FDA 長期以來的口號是：你在第三期研究中研究了什麼，你才能把什麼寫進標示（label）。所以目前，我們的計畫是在第三期計畫中真正聚焦於一到兩種腸泌素。

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

各位女士先生，我們的問答環節到此結束。我想把會議交回 Mitchell Steiner 醫師，請他做結語。

Thank you, operator. I appreciate everyone who joined us on today's call, and I look forward to updating all of you on our progress in our next investors call. Have a great day.

謝謝你，接線員。感謝今天加入我們電話會議的每一位，我也期待在下一次投資人電話會議中向各位更新我們的進展。祝各位有美好的一天。

The digital replay of the conference call will be available beginning approximately 12 PM Eastern Time today, May 13, by dialing 1 855 669 9658 in the US and 1 412 317 0088 internationally. You will be prompted to enter the replay access code, which will be 8826 955. Please record your name and company when joining.

本次電話會議的數位重播將於今日（5 月 13 日）美東時間約中午 12 點起提供；美國境內請撥 1 855 669 9658，國際請撥 1 412 317 0088。系統將提示您輸入重播存取碼：8826 955。加入時請留下您的姓名與公司。

The conference call has now concluded. Thank you for attending today's discussion.

本次電話會議現已結束。感謝您參與今天的討論。