Vyome Holdings Inc (HIND) 2025 Q4 法說會逐字稿

Ladies and gentlemen, thank you for standing by. Good afternoon and welcome to the Vyome Holdings, Inc., fourth-quarter and year-end 2025 financial results and corporate update conference call. (Operator Instructions) Please note this event is being recorded.

各位女士、先生，感謝您稍候。下午好，歡迎參加 Vyome Holdings, Inc. 2025 年第四季及全年財務業績與公司最新進展電話會議。（接線員指示）請注意，本活動將被錄音。

I'd now like to turn the conference over to Jules Abraham from the company's investor relations firm. Please go ahead.

現在我想將會議交給公司投資人關係顧問公司 Jules Abraham。請開始。

Thank you, operator. Good morning, and thank you all for participating in today's conference call.

謝謝，接線員。各位早安，感謝各位參與今天的電話會議。

Earlier, the company released its financial results for the quarter ended December 31, 2025. A copy of that press release can be found on the company's website under the Investors tab. Joining me on today's earnings call from Vyome Holdings' management team are Venkat Nelabhotla, Chief Executive Officer; and Robert Dickey, Chief Financial Officer.

稍早，公司已公布截至 2025 年 12 月 31 日止季度的財務結果。該新聞稿副本可於公司網站「投資人」頁籤下查閱。今天與我一同出席 Vyome Holdings 法說電話會議的管理團隊成員包括：執行長 Venkat Nelabhotla，以及財務長 Robert Dickey。

During this call, management will be making forward-looking statements, including statements that address Vyome Holdings' expectations for future performance or operational results. Forward-looking statements involve risks and other factors that may cause actual results to differ materially from those statements. For more information about these risks, please refer to the risk factors described in the company's most recently filed annual report on Form 10-K and subsequent periodic reports filed with the SEC and Vyome Holdings' press release that accompanies this call, particularly the cautionary statements within.

在本次電話會議中，管理層將作出前瞻性陳述，包括涉及 Vyome Holdings 對未來表現或營運結果之預期的陳述。前瞻性陳述涉及風險及其他因素，可能導致實際結果與該等陳述存在重大差異。如需了解更多相關風險資訊，請參閱公司最近提交的 Form 10-K 年度報告及其後向美國證券交易委員會（SEC）提交的定期報告中所述之風險因素，以及隨本次電話會議發布之 Vyome Holdings 新聞稿，特別是其中的警示性聲明。

The contents of this call contains time-sensitive information that is accurate only as of today, March 30, 2026. And except as required by law, Vyome Holdings disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call.

本次電話會議內容包含具時效性的資訊，僅在今日（2026 年 3 月 30 日）為準確。除法律要求外，Vyome Holdings 不承擔公開更新或修訂任何資訊以反映本次電話會議後發生之事件或情況的義務。

It's now my pleasure to turn the call over to CEO, Venkat Nelabhotla. Venkat?

現在我很高興將電話會議交給執行長 Venkat Nelabhotla。Venkat？

Thank you, Jules, and thank you, everyone, for joining us.

謝謝你，Jules，也謝謝各位加入我們。

2025 has been a transformational year for Vyome as we sharpened our focus and positioned the company as a disciplined clinical-stage biopharmaceutical company centered on heightened immuno-inflammatory medical need indications. Vyome is in a breakout phase now with strong Phase 2 data of VT-1953 and a strong cash position.

2025 年對 Vyome 而言是具有轉型意義的一年；我們進一步聚焦，並將公司定位為一家紀律嚴謹的臨床階段生物製藥公司，專注於免疫發炎領域中高度未被滿足的醫療需求適應症。Vyome 目前正處於突破階段，VT-1953 擁有強勁的第二期臨床數據，且現金部位充裕。

Our strategy is simple: focus on high-impact assets, execute with discipline, and build value through clearly defined clinical and regulatory milestones. We are currently focused on our primary asset, VT-1953, which we believe will provide significant value in the market.

我們的策略很簡單：聚焦高影響力資產、以紀律執行，並透過明確界定的臨床與法規里程碑來創造價值。我們目前聚焦於主要資產 VT-1953，我們相信其將在市場上帶來顯著價值。

VT-1953 targets malignant fungating wounds, a severely debilitating, emotionally distressing, and rare condition characterized by mal-order, pain, and loss of dignity that affects an estimated 1 million cancer patients each year. There are currently no FDA-approved therapies for this condition, and it represents an important opportunity for patients should it meet the FDA approval.

VT-1953 針對惡性蕈狀潰瘍傷口（malignant fungating wounds），這是一種嚴重致殘、在情緒上令人痛苦且罕見的病況，其特徵包括惡臭、疼痛與尊嚴喪失；據估計每年影響約 100 萬名癌症患者。目前此病況尚無 FDA 核准的治療方式；若能獲得 FDA 核准，將為患者帶來重要機會。

In our Phase 2 investigator-initiated study, VT-1953 demonstrated statistically significant improvement in mal-order, improvement in quality of life, reduction in pain, with a very good safety profile. We believe these results provide a strong foundation for pivotal development.

在我們的第二期研究者發起試驗中，VT-1953 在惡臭方面呈現具統計顯著性的改善，並改善生活品質、降低疼痛，同時具備非常良好的安全性概況。我們相信這些結果為關鍵性試驗（pivotal）開發奠定了堅實基礎。

In addition, we made significant progress on the regulatory development of VT-1953. This includes our January 2026 application for orphan drug designation with the FDA, and we anticipate productive discussions with the agency on pivotal study design in the second quarter of 2026. We expect to provide updates on both topics in the near term.

此外，我們在 VT-1953 的法規開發方面也取得重大進展。包括我們於 2026 年 1 月向 FDA 申請孤兒藥資格認定，並預期於 2026 年第二季就關鍵性試驗設計與主管機關進行具建設性的討論。我們預計在近期就這兩項主題提供最新進展。

Over the last several months, we have strengthened our team and execution capabilities, including leadership depth across clinical, regulatory, and oncology domains. Based on independent third-party analysis, the estimated US addressable market is approximately $2.2 billion, with a potential valuation of approximately $1 billion following successful pivotal study final readouts, which are anticipated at the end of 2027. These are external estimates and subject to uncertainty. Looking ahead, we expect FDA interaction and VT-1953 pivotal study design alignment in the first half of 2026, followed by initiation of pivotal development and progression toward interim data analysis in the mid-2027 timeframe.

在過去幾個月，我們強化了團隊與執行能力，包括在臨床、法規與腫瘤領域的領導深度。根據獨立第三方分析，美國可觸及市場規模估計約為 22 億美元；若關鍵性試驗最終讀出成功（預計於 2027 年底），潛在估值約為 10 億美元。上述為外部估計，且存在不確定性。展望未來，我們預期於 2026 年上半年與 FDA 互動並就 VT-1953 關鍵性試驗設計達成一致，之後啟動關鍵性開發，並朝 2027 年年中左右的期中數據分析推進。

In parallel, VT-1908, our proprietary eye drops being developed in uveitis preclinical models, continues to advance toward further development. This is also an important advancement as it may help maintain vision in patients by reducing problems caused by steroid use, the standard treatment for the condition. This represents a significant value in the market, and we look forward to providing updates as it develops.

同時，我們的專有眼藥水 VT-1908（於葡萄膜炎臨床前模型中開發）也持續推進至下一階段開發。這同樣是一項重要進展，因其可能透過降低類固醇使用（該病況的標準治療）所造成的問題，協助患者維持視力。這在市場上代表顯著價值，我們也期待在其開發進展時提供更新。

Finally, we have maintained a clean capital structure with only common equity, no debt, no preferred stock, and strong discipline on dilution. Our current resources are expected to support operations through mid-2027, enabling us to reach key value inflection milestones. If I summarize in one line, we are a focused company with strong clinical signals, disciplined capital strategy, and a clear path to value creation.

最後，我們維持了乾淨的資本結構：僅有普通股權、無負債、無特別股，並在稀釋方面保持高度紀律。我們目前資源預期可支持營運至 2027 年年中，使我們能達成關鍵的價值拐點里程碑。若用一句話總結：我們是一家聚焦的公司，具備強勁的臨床訊號、紀律嚴謹的資本策略，以及清晰的價值創造路徑。

I will now turn the call over to Rob.

接下來我將把電話會議交給 Rob。

Thank you, Venkat.

謝謝你，Venkat。

For the year ended December 31, 2025, operating expenses were approximately $3 million. The net loss of approximately $10.45 million primarily reflects one-time merger and financing-related expenses of approximately $7.7 million, including non-cash charges associated with merger and financing transactions.

截至 2025 年 12 月 31 日止年度，營運費用約為 300 萬美元。淨損約 1,045 萬美元，主要反映一次性併購與融資相關費用約 770 萬美元，其中包括與併購及融資交易相關的非現金費用。

As of December 31, 2025, cash and cash equivalents were approximately $5 million, together with additional financing of approximately $5.3 million in 2026 from our ATM agreement, which is expected to cover our anticipated runway, including potential VT-1953 pivotal study interim analysis around mid-2027.

截至 2025 年 12 月 31 日，現金及約當現金約為 500 萬美元；另加上我們依 ATM 協議於 2026 年取得的額外融資約 530 萬美元，預期可涵蓋我們預估的資金使用期（runway），包括 VT-1953 關鍵性試驗於 2027 年年中左右可能進行的期中分析。

Total assets were approximately $6.5 million, and total liabilities were approximately $2.7 million, with stockholders' equity of approximately $3.8 million.

總資產約為 650 萬美元，總負債約為 270 萬美元，股東權益約為 380 萬美元。

We have no debt and maintain a clean, simple capital structure, and our financing strategy remains focused on disciplined cost management and efficient capital allocation and alignment with clinical milestones. We believe our current financial position supports execution of our strategy through key inflection points.

我們沒有任何負債，並維持乾淨、簡單的資本結構；我們的融資策略仍聚焦於具紀律的成本管理、有效率的資本配置，以及與臨床里程碑的一致性。我們相信目前的財務狀況可支持我們的策略執行，直至關鍵拐點。

I will now turn the call back to Venkat.

接下來我將把電話會議交還給 Venkat。

Thank you, Rob.

謝謝你，Rob。

As we move into 2026, our priorities remain clear: execution, focus on VT-1,953 and disciplined value creation. We appreciate the continued support of our shareholders and look forward to updating you on our progress.

邁入 2026 年，我們的優先事項依然明確：執行、聚焦 VT-1,953，並以紀律創造價值。我們感謝股東持續的支持，並期待向各位更新我們的進展。

Operator, we can now open the line for questions.

接線員，我們現在可以開放提問。

(Operator Instructions) At this time, this concludes our question-and-answer session. I would like to turn the conference back over to Venkat Nelabhotla for any closing remarks.

（接線員指示）此刻，我們的問答環節到此結束。我想將會議交回 Venkat Nelabhotla，請他做任何結語。

Thank you, operator. Thank you all for participating in this conference call.

謝謝你，接線員。感謝各位參與本次電話會議。

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

本次會議現已結束。感謝您出席今天的簡報。您現在可以掛線。