Achieve Life Sciences Inc (ACHV) 2025 Q2 法說會逐字稿

Greetings, and welcome to the Achieve Life Sciences second quarter 2025 earnings conference call and Webcast. As a reminder, this conference is being recorded.

您好，歡迎參加 Achieve Life Sciences 2025 年第二季財報電話會議和網路廣播。提醒一下，本次會議正在錄製中。

I would now like to turn the call over to Nicole Jones, Achieve Investor Relations. Thank you. You may begin.

現在我想將電話轉給 Achieve 投資者關係部的 Nicole Jones。謝謝。你可以開始了。

Thank you, operator. Good morning, everyone, and thank you for joining us today. From Achieve Life Sciences, we are joined by Rick Stewart, Chief Executive Officer; Dr. Cindy Jacobs, President and Chief Medical Officer; Jaime Xinos, Chief Commercial Officer; and Mark Oki, Chief Financial Officer. The management team will be available for Q&A following the prepared remarks. A replay will be available later today using the information in the earnings press release or by visiting the Achieve website.

謝謝您，接線生。大家早安，感謝大家今天加入我們。來自 Achieve Life Sciences 的嘉賓包括執行長 Rick Stewart、總裁兼首席醫療官 Cindy Jacobs 博士、首席商務官 Jaime Xinos 和財務長 Mark Oki。管理團隊將在準備好的發言後回答提問。今天晚些時候，您可以使用收益新聞稿中的信息或訪問 Achieve 網站來觀看重播。

Today's conference call will contain certain forward-looking statements, including statements regarding the goals, strategies, beliefs, expectations and future potential operating results of Achieve. Although management believes these statements are reasonable based on estimates, assumptions and projections as of today, these statements are not guarantees of future performance. Time-sensitive information may no longer be accurate at the time of any telephonic or webcast replay.

今天的電話會議將包含某些前瞻性陳述，包括有關 Achieve 的目標、策略、信念、期望和未來潛在營運績效的陳述。儘管管理層認為這些聲明根據目前的估計、假設和預測是合理的，但這些聲明並不能保證未來的表現。任何電話或網路廣播重播時，時間敏感資訊可能不再準確。

Actual results may differ materially as a result of risks, uncertainties and other factors, including, but not limited to, the factors set forth in the company's filings with the SEC. Achieve undertakes no obligation to update or revise any of these forward-looking statements. Please refer to Achieve documents available on our website and filed with the SEC concerning factors that could affect the company.

由於風險、不確定性和其他因素（包括但不限於公司向美國證券交易委員會提交的文件中列出的因素），實際結果可能存在重大差異。Achieve 不承擔更新或修改任何這些前瞻性聲明的義務。請參閱我們網站上提供的 Achieve 文件以及向美國證券交易委員會提交的有關可能影響公司的因素的文件。

I'll now turn the call over to Rick.

我現在將電話轉給里克。

Thank you, Nicole, and good morning, everyone. We appreciate your time and participation in today's call. This quarter marks a defining moment in Achieve's progress toward the first new treatment for nicotine dependence in nearly 20 years. We achieved three transformative milestones. Firstly, the successful submission of our new drug application for cytisinicline as a treatment for nicotine dependence for smoking cessation to the FDA; secondly, a strategic commercial partnership with the exceptional team at Omnicom; and thirdly, a $49 million capital raise that positions us to reach critical value inflection points in 2026, including potential product approval.

謝謝你，妮可，大家早安。我們感謝您參加今天的電話會議並付出時間。本季是 Achieve 公司近 20 年來在首個治療尼古丁依賴症的新療法方面取得進展的決定性時刻。我們實現了三個變革里程碑。首先，我們成功向 FDA 提交了用於治療戒菸尼古丁依賴症的新藥申請；其次，我們與 Omnicom 的優秀團隊建立了戰略商業合作夥伴關係；第三，我們籌集了 4900 萬美元的資金，這將使我們能夠在 2026 年達到關鍵的價值轉折點，包括潛在的產品批准。

The NDA submission starts the regulatory clock and the PDUFA date will be defined on NDA acceptance, which we expect in mid-September. This is an exciting moment for Achieve after years of dedication to bring cytisinicline to FDA review and for patients and physicians who currently lack adequate tools to successfully quit. The opportunity to collaborate with Omnicom, a world-recognized leader in health care marketing, advertising and technology, positions Achieve to quickly scale and leverage external expertise and infrastructure to execute our commercial launch strategy.

NDA 提交啟動了監管時鐘，PDUFA 日期將在 NDA 接受時確定，我們預計在 9 月中旬。對於 Achieve 公司來說，經過多年的努力，將西替尼克蘭提交給 FDA 審查，這是一個激動人心的時刻，對於目前缺乏足夠工具成功戒菸的患者和醫生來說，也是一個激動人心的時刻。有機會與醫療保健行銷、廣告和技術領域的全球公認領導者 Omnicom 合作，使 Achieve 能夠快速擴展規模並利用外部專業知識和基礎設施來執行我們的商業發布策略。

Omnicom's deep experience and proven success with pharma and biotech clients includes successfully executing more than 100 product launches and new indications over the last three years. Finally, we're profoundly grateful to our stockholders whose continued investment support reflects an unwavering belief in our potential to create meaningful change in public health.

Omnicom 在與製藥和生物技術客戶合作方面擁有豐富的經驗和成功經驗，包括在過去三年中成功執行了 100 多項產品發布和新適應症。最後，我們衷心感謝我們的股東，他們持續的投資支持反映了他們堅定不移地相信我們在公共衛生領域創造有意義變革的潛力。

The market opportunity is huge. 29 million Americans smoke. Every year, more than 15 million try to quit with poor success rates. The narrative needs to change to recognize nicotine dependence as a medical condition, much like how the GLP-1s did for obesity. Patients and physicians currently lack adequate tools to be successful. For nearly a generation, innovation has stood still in nicotine dependence for smoking cessation, leaving patients frustrated, providers powerless and public health carrying the burden of over $600 billion in annual costs in the US.

市場機會巨大。 2900萬美國人吸煙。每年有超過 1500 萬人嘗試戒菸，但成功率很低。敘述需要改變，將尼古丁依賴視為一種醫療狀況，就像 GLP-1 對肥胖症的作用一樣。目前，患者和醫生缺乏足夠的工具來獲得成功。近一代人以來，戒菸創新一直停滯在對尼古丁的依賴上，這讓患者感到沮喪，服務提供者無能為力，而美國公共衛生每年要承擔超過 6000 億美元的負擔。

Historically, individuals seeking to quit smoking have faced limited options, and we aim to change this. As we move forward, we will work with the FDA through the review process and should we receive approval, be prepared to launch cytisinicline in late 2026.

從歷史上看，尋求戒菸的人面臨的選擇有限，我們的目標是改變這種狀況。在我們推進的過程中，我們將與 FDA 合作完成審查程序，如果獲得批准，我們將準備在 2026 年底推出 cytisinicline。

Before the team dives into the details, I want to express our gratitude to those who have been instrumental in supporting our progress. Firstly, the patients and physicians who participated in our clinical program, their engagement and commitment has been invaluable. Secondly, our entire Achieve team for their dedication in delivering the NDA submission on time through a significant company-wide effort. And thirdly, our investors for their continued support, guidance and belief in our mission.

在團隊深入討論細節之前，我想向那些為我們的進步提供重要支持的人表示感謝。首先，參與我們臨床計畫的患者和醫生的參與和承諾非常寶貴。其次，我們整個 Achieve 團隊透過全公司範圍的共同努力，按時提交了 NDA 申請。第三，感謝我們的投資者對我們使命的持續支持、指導和信任。

On today's call, Cindy will update you on regulatory time lines and progress on the ORCA-OL study. Jaime will provide an update on our commercial planning, and Mark will conclude the details on the recent financing and current cash runway.

在今天的電話會議上，Cindy 將向您通報 ORCA-OL 研究的監管時間表和進度。Jaime 將提供我們商業規劃的最新情況，Mark 將總結最近的融資和當前現金流的細節。

In short, our three announcements this quarter demonstrate that we are advancing confidently on three fronts: regulatory, commercial and financial. Our path is clear, and we are committed to executing it to the fullest.

簡而言之，我們本季的三項公告顯示我們在監管、商業和金融三個方面充滿信心地前進。我們的道路很明確，我們致力於全力以赴地執行它。

With that, I'll turn it over to Cindy.

說完這些，我就把話題交給辛蒂 (Cindy)。

Thank you, Rick. Our regulatory accomplishment with the NDA submission during the second quarter was the result of years of focused development work. As Rick just mentioned, in June, we officially submitted our NDA for cytisinicline as a treatment for nicotine dependence to achieve smoking cessation as our first indication. This is a comprehensive and well-supported application incorporating nonclinical data and manufacturing information as well as the clinical trial results from two well-controlled Phase III studies, ORCA-2 and ORCA-3, along with the long-term safety exposure data from our ORCA-OL clinical trial.

謝謝你，里克。我們在第二季提交 NDA 的監管成果是多年專注開發工作的成果。正如 Rick 剛才提到的，6 月份，我們正式提交了西替尼林的 NDA，將其作為治療尼古丁依賴症的藥物，以達到戒菸的目的，這是我們的第一個適應症。這是一個全面且得到良好支持的應用程序，結合了非臨床數據和製造資訊以及兩項控制良好的 III 期研究 ORCA-2 和 ORCA-3 的臨床試驗結果，以及來自我們的 ORCA-OL 臨床試驗的長期安全暴露數據。

The NDA submission is supported by data from over 2,000 clinical trial participants providing a comprehensive foundation and characterizing cytisinicline's efficacy, safety and tolerability. Regarding tolerability and as requested by FDA, we included long-term exposure safety results in over 300 participants who had completed at least six months of cumulative cytisinicline treatment. Also important to highlight this last quarter was reaching the second major milestone of FDA's request for having over 100 participants completing one year of cumulative cytisinicline treatment before approval. This safety data will be submitted in the standard 120-day safety update during the NDA review period. Meeting both critical thresholds for safety exposure data on schedule was essential in completing the NDA submission and for FDA's review toward market approval.

NDA 提交得到了超過 2,000 名臨床試驗參與者的數據的支持，這些數據提供了全面的基礎並描述了 cytisinicline 的功效、安全性和耐受性。關於耐受性，根據 FDA 的要求，我們納入了已完成至少六個月累積西替尼治療的 300 多名參與者的長期暴露安全結果。值得強調的是，上個季度我們達到了 FDA 要求的第二個重要里程碑，即在獲得批准之前，有超過 100 名參與者完成了一年的累積 cytisinicline 治療。此安全資料將在 NDA 審查期間的標準 120 天安全更新中提交。按時滿足安全暴露資料的兩個關鍵閾值對於完成 NDA 提交和 FDA 的市場批准審查至關重要。

As of the end of July, 290 participants have completed one year of cytisinicline treatment in the OL study, and the last participant is projected to complete treatment by early October. We are also in the process of collecting exit survey responses from participants when they complete the OL study. And so far, we have survey responses from 40% of the 290. These responses and their comments have been encouraging as to the impact cytisinicline has had on them and potentially could have on the lives of other people battling nicotine dependence.

截至 7 月底，OL 研究中已有 290 名參與者完成了一年的西替尼治療，最後一名參與者預計將於 10 月初完成治療。當參與者完成 OL 研究時，我們也正在收集他們的退出調查回應。到目前為止，我們已經收到了 290 人中的 40% 的調查回應。這些回應和評論令人鼓舞，因為它們表明西替尼對他們產生了影響，並且可能對其他與尼古丁依賴作鬥爭的人的生活產生影響。

For example, 98% of the survey respondents stated they believe cytisinicline contributed to their ability to either stop or reduce their nicotine dependence, citing fewer cravings and less intense withdrawal symptoms compared to their previous quit attempts and with very few or manageable side effects. Impressively, 99% stated they would recommend cytisinicline to a friend or family member. Many also expressed their gratitude with specific comments, highlighting their extensive battle with nicotine for decades and that they finally feel that they have won.

例如，98% 的調查受訪者表示，他們相信西替尼鹼有助於他們戒除或減少對尼古丁的依賴，與先前的戒菸嘗試相比，他們的菸癮減少了，戒斷症狀減輕了，而且副作用很少或可以控制。令人印象深刻的是，99％的人表示他們會向朋友或家人推薦西替尼克蘭。許多人也透過具體的評論表達了他們的感激之情，強調他們幾十年來與尼古丁進行了廣泛的鬥爭，並最終感到自己取得了勝利。

Although the final study results from this ORCA-OL study is not required by FDA for market approval of cytisinicline, we plan on completing all trial activities to lock the final study database by the end of this year. And we will look for future opportunities to publish and present the completed trial results in 2026.

儘管 FDA 並未要求 ORCA-OL 研究的最終研究結果來批准金雀花鹼的上市，但我們計劃在今年年底前完成所有試驗活動以鎖定最終的研究資料庫。而我們將尋找未來的機會，在2026年發布並展示已完成的試驗結果。

As we look ahead in the next few months, we expect to receive the 74-day letter from FDA in September, and we will be submitting our 120-day safety update documents and data sets in October. The 74-day letter will also indicate that the NDA submission has been accepted for review and give targeted completion review dates, which will begin the official countdown to a potential approval decision.

展望未來幾個月，我們預計將在 9 月收到 FDA 的 74 天信函，並將在 10 月提交 120 天安全更新文件和資料集。這封為期 74 天的信函還將表明 NDA 提交已被接受審查，並給出目標完成審查日期，這將開始對潛在批准決定的正式倒數計時。

Now I'll turn the call over to Jaime to share more about our commercial launch preparations.

現在我將把電話轉給 Jaime，讓他分享更多有關我們的商業發布準備工作的資訊。

Thank you, Cindy, and good morning, everyone. This quarter, we made meaningful progress toward executing our core commercial objective, delivering cytisinicline to patients who are ready to quit using the most advanced tools and strategies available. Over the next several months, we will be building our brand, driving stakeholder engagement and finalizing our go-to-market activities in preparation for potential launch in 2026.

謝謝你，辛迪，大家早安。本季度，我們在執行核心商業目標方面取得了有意義的進展，即使用最先進的工具和策略向準備戒菸的患者提供西替尼克蘭。在接下來的幾個月裡，我們將打造我們的品牌，推動利害關係人的參與，並完成我們的上市活動，為 2026 年的潛在上市做準備。

Our path to launch is on track and full of momentum as evidenced by the selection of Omnicom to provide a diverse range of critical launch capabilities. Our partnership brings together seven specialized Omnicom agencies operating as a single unified team across brand development, provider and patient initiatives, market access, public relations, media and marketing technology.

我們的發布之路進展順利，並且充滿動力，選擇 Omnicom 提供各種關鍵發布功能證明了這一點。我們的合作夥伴關係將使七家專業的 Omnicom 代理商組成一個統一的團隊，負責品牌開發、供應商和患者計劃、市場准入、公共關係、媒體和行銷技術。

This partnership gives us access to the scale, speed and capabilities of a much larger organization and allows us to maintain a lean internal team who will lead key functional areas. This collaboration also supports our commitment to a modern data-driven approach to launch. We are building and will leverage a proprietary AI-enabled commercial platform and tools that will enable precision, agility and measurable outcomes to support smarter decision-making across the entire organization.

透過此次合作，我們可以獲得更大組織的規模、速度和能力，並讓我們能夠維持一支精幹的內部團隊來領導關鍵職能領域。此次合作也支持了我們致力於採用現代數據驅動方法開展工作的承諾。我們正在建構並將利用專有的人工智慧商業平台和工具，以實現精確性、靈活性和可衡量的成果，從而支援整個組織做出更明智的決策。

From targeting and engagement to performance optimization, our tech-focused strategy will help us to reduce costs, mitigate risk and remain highly adaptive to real-world signals. Our strategy is intentional, insight-led and focused on driving both commercial value and improved patient outcomes.

從定位和參與到效能優化，我們以技術為中心的策略將幫助我們降低成本、減輕風險並維持對現實世界訊號的高度適應性。我們的策略是有目的的、以洞察力為主導的，並專注於推動商業價值和改善患者治療效果。

As we look ahead to a potential launch in '26, we are confident in our ability to execute efficiently, scale effectively and deliver long-term value for patients, providers and shareholders alike. Our launch readiness efforts are anchored in three strategic imperatives: availability, access and awareness, all underpinned by a commitment to measurable impact to ensure the efficiency and effectiveness of our investments. I'll provide a brief update on our recent progress and near-term priorities across each of these pillars.

展望 26 年可能推出的產品，我們對自己高效執行、有效擴展以及為患者、供應商和股東創造長期價值的能力充滿信心。我們的發布準備工作以三個策略要點為基礎：可用性、可近性和意識，所有這些都以對可衡量影響的承諾為基礎，以確保我們投資的效率和效果。我將簡要介紹我們在各個支柱方面的最新進展和近期優先事項。

Starting with availability. This work stream encompasses trade and distribution activities to ensure product readiness at launch. We've made meaningful progress in this area, supported by external expert consultants and now guided by an internal achieve lead. We have contracted with a leading third-party logistics provider or 3PL, named in our NDA and plan to begin implementation in the fourth quarter. Our home state licensing application has been submitted and once accepted, will trigger the sequential submission of additional state applications.

從可用性開始。此工作流程涵蓋貿易和分銷活動，以確保產品在發佈時做好準備。在外部專家顧問的支持下，我們在這一領域取得了有意義的進展，現在由內部領導指導。我們已與保密協議中提到的一家領先的第三方物流供應商或 3PL 簽訂了合同，併計劃在第四季度開始實施。我們的本州許可申請已提交，一旦被接受，將觸發其他州申請的順序提交。

Following a comprehensive evaluation, we have shortlisted potential partners for specialty like distribution services. We believe this capability will be especially important in the early phase of launch to help ensure that prescriptions written are prescriptions filled. On the access front, we've built a strong foundation and are now accelerating our efforts.

經過全面評估，我們已篩選出分銷服務等專業領域的潛在合作夥伴。我們相信，這種能力在發布的早期階段尤其重要，有助於確保開出的處方能夠得到配藥。在訪問方面，我們已經建立了堅實的基礎，現在正在加快努力。

Our new Vice President of Market Access has joined the team, and we've engaged a best-in-class access agency to expand upon the foundational work we've already completed, including extensive payer research and market assessment to ensure the value of cytisinicline is clearly reflected in our pricing, contracting and coverage strategies.

我們新的市場准入副總裁已加入團隊，並且我們已聘請了一家一流的准入機構來擴展我們已經完成的基礎工作，包括廣泛的付款人研究和市場評估，以確保西替尼的價值在我們的定價、承包和覆蓋策略中得到清晰的反映。

Our key priorities in the coming quarter include finalizing our pricing strategy, refining our value message and completing payer segmentation and communication plans. We anticipate beginning the pre-approval information exchange with payers in Q4 with outsourced account managers beginning field work in Q1 of next year. We are laser-focused on clearly defining and communicating the differentiated value of cytisinicline backed by rigorous clinical evidence to support favorable coverage decisions. Early engagement with payers is critical to building the relationships and understanding required to enable rapid access following approval. Securing access and insurance coverage for our patients is a top priority.

我們下一季的重點包括確定定價策略、完善價值資訊以及完成付款人細分和溝通計劃。我們預計將於第四季開始與付款人進行預先批准資訊交換，外包客戶經理將於明年第一季開始現場工作。我們專注於清晰地定義和傳達西替尼林的差異化價值，並以嚴格的臨床證據為後盾，支持有利的覆蓋決策。與付款人的早期接觸對於建立批准後快速獲得治療所需的關係和理解至關重要。確保患者能夠獲得醫療服務和保險覆蓋是我們的首要任務。

Turning to awareness. Our efforts are focused on building product-specific awareness and establishing Achieve's reputation as a trusted science-driven partner. Unlike therapeutic categories that require broad disease education, the need in smoking cessation is well understood. Our strategy centers on reframing nicotine dependence as a medical condition, not a lifestyle choice and one that warrants the use of effective and well-tolerated treatments like cytisinicline.

轉向意識。我們的努力重點是建立產品特定的意識並建立 Achieve 作為值得信賴的科學驅動型合作夥伴的聲譽。與需要廣泛疾病教育的治療類別不同，戒菸的必要性是眾所周知的。我們的策略重點是將尼古丁依賴重新定義為一種醫療狀況，而不是一種生活方式的選擇，並且需要使用有效且耐受性良好的治療方法，例如西替尼林。

We are taking a focused data-driven approach, engaging two high-impact audiences, motivated patients who are ready to quit and most likely to succeed with cytisinicline and health care providers who are already prescribing high volumes of smoking cessation therapies. Our goal is to activate these patients to initiate conversations with their providers and ensure those providers are informed, equipped and ready to prescribe. To support this strategy, we are now triangulating multiple data sources, including prescribing patterns, patient behavioral signals and public health data sets to identify and prioritize the highest impact targets.

我們採取以數據為重點的方法，吸引兩大具有高影響力的受眾，即準備戒菸且最有可能透過西替尼林獲得成功的積極患者，以及已經開出大量戒菸療法處方的醫療保健提供者。我們的目標是鼓勵這些患者主動與醫療服務提供者對話，並確保這些醫療服務提供者了解情況、具備相應能力並準備好開藥。為了支持這項策略，我們現在正在對多個資料來源進行三角測量，包括處方模式、患者行為訊號和公共衛生資料集，以確定和優先考慮影響最大的目標。

In parallel, we're developing advanced analytics and machine learning capabilities that will continuously evaluate and optimize how we reach and convert these targets. This includes building dynamic audience models and segmentation strategies that allow us to personalize messaging based on where both patients and providers are in their decision-making journey. Whether it's raising initial awareness, addressing clinical questions or prompting action, our content and channels will be designed to meet each stakeholder with the right message at the right time. This precision targeted approach not only enhances effectiveness, it also improves efficiency and return on investment, ensuring that every dollar spent contributes to measurable outcomes and long-term value creation.

同時，我們正在開發高級分析和機器學習功能，以不斷評估和優化我們實現和轉換這些目標的方式。這包括建立動態受眾模型和細分策略，使我們能夠根據患者和提供者在決策過程中的位置來個性化訊息傳遞。無論是提高初步意識、解決臨床問題或促使採取行動，我們的內容和管道都將旨在在正確的時間向每個利害關係人傳達正確的訊息。這種精準的目標方法不僅提高了有效性，還提高了效率和投資報酬率，確保每一美元的支出都能帶來可衡量的成果和長期價值創造。

As we look ahead, we are energized by the opportunity in front of us. We know that launching a drug, especially as a small company and for the first time, is often seen as a high-risk endeavor, but we are not doing this alone. We have built deep strategic relationships with experienced partners, including Omnicom and others who are not just vendors, but believers in our mission and co-architects of our path forward. These partners bring a wealth of experience across every critical function, and they are fully aligned with our vision for cytisinicline to become a powerful life-changing option for the millions of people still struggling with nicotine dependence. Their investment in our success, both operationally and philosophically adds strength, stability and confidence as we move towards launch.

展望未來，我們為眼前的機會充滿活力。我們知道，推出一種藥物，特別是對於一家小公司來說，首次推出這種藥物，通常被視為一項高風險的舉措，但我們並不是孤軍奮戰。我們與經驗豐富的合作夥伴建立了深厚的策略關係，其中包括宏盟集團和其他不僅僅是供應商、而且相信我們的使命並共同規劃我們前進道路的公司。這些合作夥伴在各個關鍵職能領域都擁有豐富的經驗，他們完全認同我們的願景，即讓西替尼成為數百萬仍在與尼古丁依賴作鬥爭的人們改變生活的強大選擇。他們對我們在營運和理念上的成功的投資為我們走向成功增添了力量、穩定性和信心。

We are guided by data, driven by purpose and supported by a team, both internal and external, that is all in on delivering something truly transformative. The work ahead is substantial, but our focus is clear. We believe cytisinicline can change the way the world approaches smoking cessation, and we are ready to lead that change.

我們以數據為指導，以目標為驅動，並得到內部和外部團隊的支持，全力以赴實現真正變革的目標。未來的工作很艱鉅，但我們的重點很明確。我們相信，西替尼林可以改變世界戒菸的方式，我們已準備好引領這項改變。

I'll now turn the call over to Mark to review the financials.

我現在將電話轉給馬克來審查財務狀況。

Thanks, Jaime. We are excited to have closed the second quarter with a strengthened balance sheet following the successful completion of a $45 million underwritten public offering in June. And just last week, the underwriters partially exercised their overallotment option, generating additional gross proceeds of $4.3 million to the company. The offering included common stock and warrants and was met with strong support from current shareholders as well as new institutional and retail investors.

謝謝，傑米。我們很高興在 6 月成功完成 4,500 萬美元承銷公開發行後，以增強的資產負債表結束了第二季。就在上週，承銷商部分行使了超額配售選擇權，為該公司帶來了 430 萬美元的額外總收益。此次發行包括普通股和認股權證，並得到了現有股東以及新的機構和散戶投資者的大力支持。

As of June 30, 2025, we had cash, cash equivalents and marketable securities totaling $55.4 million. These funds are expected to support operations into the second half of 2026. Total operating expenses for the three and six months ended June 30, 2025, were $12.6 million and $25.5 million, respectively, consistent with our expectations as we increased investment in regulatory, quality and pre-commercial planning. With respect to net loss for the 3 and 6 months ended June 30, 2025, it was $12.7 million and $25.5 million, respectively. Our funding strategy has always been designed to support our highest priorities. And with this recent capital raise, we believe we are well positioned to execute our regulatory and early commercial initiatives while remaining committed to financial discipline.

截至 2025 年 6 月 30 日，我們的現金、現金等價物及有價證券總額為 5,540 萬美元。預計這些資金將支持到2026年下半年的營運。截至 2025 年 6 月 30 日的三個月和六個月的總營運費用分別為 1,260 萬美元和 2,550 萬美元，這與我們的預期一致，因為我們增加了對監管、品質和商業化前規劃的投資。截至 2025 年 6 月 30 日的三個月和六個月的淨虧損分別為 1,270 萬美元和 2,550 萬美元。我們的融資策略始終旨在支持我們的最高優先事項。透過最近的融資，我們相信我們已做好準備，在繼續遵守財務紀律的同時，執行我們的監管和早期商業計劃。

With that, I'll turn the call to Rick for closing remarks.

說完這些，我將把電話轉給 Rick 來做最後發言。

Thank you, Mark. This past quarter has been a defining one for Achieve. We delivered three separate milestones with more to come in the next 12 months as we anticipate products approval and launch. In the near term, we expect to receive the FDA's day 74 NDA acceptance letter in mid-September. We'll add the 100-plus paid subjects with one year's exposure from the ORCA-OL open-label safety study at the 120-day safety update, and we'll accelerate our commercial launch preparation.

謝謝你，馬克。過去一個季度對 Achieve 來說具有決定性意義。我們實現了三個獨立的里程碑，隨著產品獲得批准和推出，未來 12 個月內還將實現更多里程碑。短期內，我們預計將於 9 月中旬收到 FDA 第 74 天的 NDA 接受函。我們將在120天的安全更新中添加來自ORCA-OL開放標籤安全性研究中的100多名經過一年暴露的付費受試者，並加快我們的商業發布準備。

Achieve is disciplined in executing its strategy with a clear focus on financial prudency, on executing a clear regulatory strategy with the FDA and also optimizing its product launch capabilities by collaborating with Omnicom and other external partners who are recognized leaders in the space. These accomplishments are the result of extraordinary determination by Achieve's dedicated team who've worked tirelessly to bring this vision to life and by the over 2,000 patients who enrolled in our trials committing to quit smoking and vaping in pursuit of a better health and lifestyle.

Achieve 在執行其策略時非常嚴謹，明確注重財務審慎，與 FDA 一起執行明確的監管策略，同時透過與 Omnicom 和其他在該領域公認的領導者外部合作夥伴合作來優化其產品發布能力。這些成就是 Achieve 敬業團隊非凡決心的結果，他們孜孜不倦地努力將這一願景變為現實，也是超過 2,000 名參加我們試驗的患者承諾戒菸和戒電子煙以追求更好的健康和生活方式的結果。

We are confident that our focused efforts will have a meaningful impact on patients and create long-term value for all stockholders. Again, thank you for your time, and we look forward to updating you on our continued progress in the coming quarters.

我們相信，我們的專注努力將對患者產生有意義的影響，並為所有股東創造長期價值。再次感謝您的時間，我們期待在未來幾季向您通報我們的持續進展。

With that, operator, we are now ready for Q&A.

接線員，現在我們可以進行問答了。

(Operator Instructions)

（操作員指示）

Thomas Flaten, Lake Street Capital.

托馬斯‧弗拉頓（Thomas Flaten），湖街資本公司。

Good morning, everyone. Thanks for taking the questions. Cindy, just a quick one for you just to confirm, in the 120-day safety update, will you submit only 100 patients or the full 290 that you now have access to?

大家早安。感謝您回答這些問題。Cindy，我只想快速確認一下，在 120 天的安全更新中，您只提交 100 名患者還是提交您現在可以訪問的全部 290 名患者？

We'll be submitting all of the subjects at the time of the database cut that occurred in June. So it will be more than 100, but not exactly the 290 over the 200 that we have right now.

我們將在六月資料庫削減時提交所有主題。因此，數量將超過 100，但不會正好是我們現在擁有的 290/200。

Got it. And Rick, you mentioned launch in late '26. And if we assume an approval in late June, how should we think about your ramp in commercial spending ahead of launch? Is it going to be completely approval dependent? Or will you begin ramping that spend, let's say, first half of next year?

知道了。里克，你提到了 26 年底的發射。如果我們假設在六月底獲得批准，我們應該如何看待你們在推出之前增加商業支出？這是否完全取決於批准？或者說，你會從明年上半年開始增加支出嗎？

Yeah, it will be incremental. I mean we have to invest in the pre-commercial activities prior to the approval. So I think you'll see an increase over the coming quarters. But as soon as we reach approval, then you'll see an increase. But I think the key message here is that we keep a very disciplined approach to that commercial investment. But again, I think you'll look at this once we've got the NDA acceptance, you'll start to see a ramp-up, but not excessive.

是的，它將是漸進的。我的意思是我們必須在獲得批准之前投資前期商業活動。所以我認為你會看到未來幾季的成長。但一旦我們獲得批准，你就會看到成長。但我認為這裡的關鍵訊息是我們對商業投資採取非常嚴謹的態度。但是，我認為，一旦我們獲得了保密協議的批准，你就會看到這一點，你就會開始看到成長，但不會過度。

And then one final one, if I may, for Jaime. I might be getting ahead of the pricing work you're already doing, but are you assuming that a premium price relative to the generic CHANTIX will be available to you? Or should we be thinking about something closer to the generic pricing that we see today?

如果可以的話，我還有最後一個問題想問 Jaime。我可能比您已經在做的定價工作領先一步，但您是否認為您可以獲得相對於通用 CHANTIX 的溢價？或者我們應該考慮更接近我們今天看到的通用定價？

I think. Thanks for the question. We would view this as a branded product at a premium price. And also, I think that resonates based on the profile and what we are able to differentiate versus the current options. And that's what we've been going in and having discussions with payers about. They aren't in disagreement with that.

我認為。謝謝你的提問。我們認為這是一款高價的品牌產品。而且，我認為這是根據個人資料以及我們能夠區分當前選項的內容而產生的共鳴。這就是我們一直在與付款人討論的內容。他們對此並不反對。

John Vandermosten, Zacks.

約翰·范德莫斯滕，Zacks。

Great, thank you guys for taking my question. also had a question for Jaime on just the initial contact method for reaching out to providers. I think in the presentation you mentioned e-mail and social. And perhaps you can walk us through all those initial contact methods. And then I guess, the flow chart based on the response, how you move to different levels and communicating with everyone.

太好了，謝謝你們回答我的問題。我還想問 Jaime 一個關於聯絡供應商的初始聯絡資訊的問題。我認為您在演示中提到了電子郵件和社交。也許您可以向我們介紹所有這些初始聯繫。然後我猜，根據回應的流程圖，你如何移動到不同的層次並與每個人溝通。

Yeah. Thanks for the question. So I think that's still yet to be determined because as we've noted in a lot of our conversations, we really want to identify the individual needs of the physicians that we are targeting and meet them where they are. And so I think there are obviously opportunities for engagement across all of those channels that you mentioned, such as social and e-mail, putting reps where it is appropriate, where they can get strong access and where they need to have those conversations in person. Virtual reps as well will be another option that we'll be looking at. But again, it's really going to depend on what we define further through our targeting exercise as where they want to have those engagements with pharma.

是的。謝謝你的提問。所以我認為這還有待確定，因為正如我們在許多對話中提到的那樣，我們真正想要確定我們所針對的醫生的個人需求，並滿足他們的需求。因此，我認為，您提到的所有管道（例如社交媒體和電子郵件）顯然都存在參與的機會，可以將銷售代表安排在適當的位置，讓他們能夠獲得強大的訪問權限，並讓他們能夠親自進行對話。虛擬代表也將是我們正在考慮的另一個選項。但同樣，這實際上取決於我們透過目標定位進一步確定他們希望在何處與製藥公司合作。

Okay, thank you. You bet.

好的，謝謝。當然。

Thank you.

謝謝。

Gary Nachman, Raymond James.

蓋瑞納赫曼、雷蒙詹姆斯。

Hi, good morning and congrats on all the progress. Congrats on all the progress. So back to the full safety data for the 290 patients at 12 months. Any commentary just on the overall safety profile, if it was consistent with the six-month data? And how will you be releasing that, assuming after you provide the updated safety data to FDA at 120 days? And then are there any communications with the FDA prior to the day 74 letter? Or is that the first time that you hear back from them? And then I have a follow-up.

嗨，早上好，恭喜你取得的所有進展。祝賀你取得的所有進展。因此，回到 12 個月時 290 名患者的完整安全數據。如果與六個月的數據一致，那麼對整體安全狀況有什麼評論嗎？假設您在 120 天後向 FDA 提供更新的安全數據，您將如何發布這些數據？那麼在第 74 天的信函之前是否與 FDA 進行過任何溝通？還是這是您第一次收到他們的回覆？然後我有一個後續問題。

Sure. For the 120 safety day update, we will be submitting it in October. And the data currently right now, and we've obviously made this public, has been reviewed by the Data Safety Monitoring Committee throughout this process, and there's been no different or unique safety signals that have been seen. So it is consistent with what we would expect at six months in one year. The next, I think, question was -- sorry, what was the second question?

當然。對於 120 個安全日的更新，我們將在 10 月提交。目前的數據（我們顯然已經將其公開）已經在整個過程中經過數據安全監控委員會的審查，並且沒有發現任何不同或獨特的安全信號。因此，這與我們對一年內六個月的預期是一致的。我認為下一個問題是——抱歉，第二個問題是什麼？

Yeah. Just how you well, in terms of your communications with the FDA at the day 74 letter, is that the next time you hear from them? Or is there any back and forth prior to that?

是的。就您與 FDA 在第 74 天的溝通情況而言，您下次還會收到他們的回覆嗎？或在此之前有任何來回嗎？

Normally, at this time, there's back and forth with FDA, and that's what we're experiencing, and that's what's happening. So it's all normal procedures in that regard. They're contacting us, asking where various things are. We're very responsive, letting them know where they are in the NDA. And so it is a back-and-forth process that's been and it's normal.

通常，此時，我們會與 FDA 進行反覆溝通，這就是我們所經歷的，也是正在發生的事情。因此，就此而言，這都是正常程序。他們聯絡我們，詢問各種東西在哪裡。我們反應非常積極，讓他們知道保密協議的進展。所以這是一個反覆的過程，這是正常的。

Okay. And any chance for a priority review or I guess you're anticipating a standard review, that's the most likely scenario?

好的。是否有可能進行優先審查，或者我猜您期待進行標準審查，這是最有可能的情況？

Well, at this point, we are. However, we're always hopeful for a priority review. We have requested it. And also there is the new Commissioners National Priority Voucher that they just published a couple of weeks ago, how to kind of request it, and we have requested it. We don't view that, that is a likely possibility. But in all of our interactions, we are trying as best as we can to highlight this submission and NDA review process for priority as best as we can.

嗯，目前為止，我們確實如此。然而，我們始終希望獲得優先審查。我們已經提出請求。此外，他們幾週前剛發布了新的專員國家優先券，如何申請，我們已經申請了。我們不這麼認為，這是一種很有可能的情況。但在我們所有的互動中，我們都在盡力優先強調這項提交和 NDA 審查流程。

Okay. Great. And then, Jaime, regarding the Omnicom partnership, any specific work that you're doing together right now in the early days while you wait for the approval or certainly until you have better visibility on time lines. Does it make sense to do any unbranded marketing to physicians to get them comfortable? Obviously, they know the unmet need in nicotine dependence, but you want to reframe the message. So what are you doing on that front to position you better for the launch?

好的。偉大的。然後，Jaime，關於與 Omnicom 的合作關係，在等待批准的初期，或直到您對時間表有更好的了解之前，您現在正在一起做哪些具體工作。向醫生進行非品牌行銷以讓他們感到安心是否有意義？顯然，他們知道尼古丁依賴中未滿足的需求，但你想重新建構資訊。那麼，您在這方面做了哪些工作來為產品發布做好更好的準備？

Yeah. I'll start with the first part of that question. We have engaged all seven of our agencies and are fully operational with various work streams that we view as high-priority activities that need to be conducted now to better inform what we need to do at launch and how we will deploy resources going forward. So across all of the functional areas that I mentioned on the call as well as, I think, in the press release, we have teams who are activated.

是的。我先從這個問題的第一部分開始。我們已經與所有七個機構進行了接觸，並全面開展了各種工作流程，我們認為這些工作流程是需要立即進行的高優先級活動，以便更好地告知我們在啟動時需要做什麼以及我們將如何部署未來的資源。因此，在我電話會議中以及新聞稿中提到的所有職能領域中，我們都有活躍的團隊。

And we are also working very aggressively towards building our launch road map and our AI-driven our AI-enabled platform, which will allow each of those functional areas to work as one team seamlessly in one ecosystem where all of the data are coming in, being analyzed and then helping us to inform decision-making and then eventually performance metrics down the road. So all of that is underway, and we are obviously working very hard as a lean team within Achieve. We have leadership across all the work streams and then we've got leadership within the Omnicom organizations moving this launch forward. So we are well underway.

我們也積極地建立我們的發布路線圖和人工智慧驅動的平台，這將使每個功能領域能夠在一個生態系統中無縫地作為一個團隊工作，所有數據都會進入這個生態系統，進行分析，然後幫助我們為決策提供信息，並最終為未來的績效指標提供信息。所以所有這一切都在進行中，而且我們作為 Achieve 內部的精益團隊顯然正在非常努力地工作。我們在所有工作流程中都有領導，我們在宏盟集團內部也有領導推動這項發布。所以我們進展順利。

Regarding awareness activities, our early focus is going to be driving that message that the conversation needs to get started again because it's been so long, 20 years since something new has come to the market. So we think it's important that they know that there will be a new treatment, and we also need to elevate the seriousness of those conversations.

關於宣傳活動，我們早期的重點是傳達這樣的訊息：需要重新開始對話，因為距離新產品進入市場已經過了 20 年。因此，我們認為讓他們知道將會有新的治療方法很重要，我們也需要提高這些對話的嚴肅性。

So that's the work that we'll be doing early on. The more product-specific work will come closer to launch because we want whatever efforts and whatever resources we dedicate towards that awareness to go directly to prescribing, so we can track and monitor the effectiveness of those communications. So the early work will be more around elevating the conversation, making sure we have the right patient identified for physicians who should be -- this product should be prescribed for and changing that medical conversation that this is not a moral or a lifestyle choice. This is actually a medical -- this is a medical condition that needs to be treated with a medical solution.

這就是我們早期要做的工作。更針對產品的工作將更接近推出，因為我們希望為提高知名度而投入的所有努力和資源都能直接用於處方，這樣我們就可以追蹤和監控這些溝通的有效性。因此，早期的工作將更多地圍繞著提升對話，確保我們為應該開立這種產品的醫生找到合適的患者，並改變醫療對話，使之成為道德或生活方式的選擇。這其實是一種醫療問題——這是一種需要用醫療方法治療的醫療狀況。

Okay. Great. And then just last one quickly for Rick. Just any update on the synthetic version of cytisinicline, timing of that potentially? And also if there are any partnership discussions that have progressed, specifically with some comorbid conditions like COPD?

好的。偉大的。然後，最後再快速向 Rick 說一句。有關於合成的金雀花鹼的任何更新信息，可能的時間是什麼時候？是否有任何合作討論取得了進展，特別是針對某些合併症，如 COPD？

Yeah. Thanks, Gary. Yes, we're continuing to work on the potential for the synthetic. But frankly, our focus really has been on the NDA submission and ensuring that, that's been a success. So yes, we continue to work on it. In terms of partnering, I'd say exactly the same thing. Our focus has remained on a successful NDA submission. And I would suggest that once the NDA has now been submitted that we can start to have further discussions around that.

是的。謝謝，加里。是的，我們正在繼續研究合成材料的潛力。但坦白說，我們的重點確實放在 NDA 提交上，並確保它成功。是的，我們會繼續努力。就合作而言，我也會說同樣的話。我們的重點仍然是成功提交 NDA。我建議，一旦提交了保密協議，我們就可以開始就此進行進一步的討論。

Okay, great.

好的，太好了。

Justin Walsh, Jones Trading.

賈斯汀·沃爾什，瓊斯貿易公司。

Hi, thanks for taking the question. Congrats on all the progress. I'm wondering if you expect your partnership with Omnicom to impact potential discussions with more traditional pharma partners.

你好，謝謝你回答這個問題。祝賀你取得的所有進展。我想知道您是否希望與 Omnicom 的合作能夠影響與更多傳統製藥合作夥伴的潛在討論。

Do you want me to take that, Rick?

你想讓我拿著它嗎，瑞克？

Yeah. I think it's all complementary, right? As you build this out, at the center of all of this, we've got the Omnicom partnership, but there are going to be other opportunities to build out more traditional routes. But for now, again, we're focused very much on ensuring that the Omnicom platform is fully functional, and we'll bring in additional resources as required. I think the market right now is pretty dynamic, and we need to maintain our flexibility to ensure that we've got the right resources at the right time and ultimately targeting the right patients and physicians.

是的。我認為這一切都是互補的，對嗎？在建立這一切的過程中，在所有這一切的核心中，我們與 Omnicom 建立了合作夥伴關係，但還會有其他機會來建立更傳統的路線。但就目前而言，我們再次高度重視確保 Omnicom 平台全面發揮作用，並根據需要引入額外資源。我認為現在的市場非常活躍，我們需要保持靈活性，以確保我們在正確的時間獲得正確的資源，並最終瞄準正確的患者和醫生。

And if I can just add to that sorry, if I could just add one quick note to that. I think, as Rick mentioned in the prepared remarks, Omnicom is a well-known health care entity. In fact, they've launched over 100 products and new indications over the last three years with the likes of Merck, J&J, Novartis, AZ, BMS. So they're not an unknown company to many of these large pharma players. So if anything, I think our relationship and the work that we're doing with them adds credibility that we will have a complete launch package and be able to drive value in the market.

抱歉，如果我可以補充一點，如果我可以補充一點的話。我認為，正如 Rick 在準備好的演講中提到的那樣，Omnicom 是一家知名的醫療保健實體。事實上，過去三年來，他們與默克、強生、諾華、AZ、BMS 等公司合作推出了 100 多種產品和新適應症。因此，對於許多大型製藥公司來說，他們並不是一家陌生的公司。因此，無論怎樣，我認為我們之間的關係以及我們與他們所做的工作增加了可信度，即我們將擁有完整的發布套件並能夠在市場上創造價值。

One final thing, Justin. I think as you look at our kind of launch platform and go-forward platform, we are primarily focused on primary care physicians and addressing that market highly efficiently and in a very precise targeted manner. But as I've said in the past, the comorbidities associated with smoking, be that cardiovascular, hypertension, respiratory disease, it does offer the platform does offer opportunities to target what we internally called if, whether that's an oncologist, cardiologist, pulmonologists, et cetera. So I think the platform itself has got great value driving forward.

最後一件事，賈斯汀。我認為，當您看到我們的發布平台和前進平台時，我們主要專注於初級保健醫生，並以非常有效率和非常精確的目標方式滿足該市場的需求。但正如我過去所說的那樣，與吸煙相關的併發症，無論是心血管疾病、高血壓還是呼吸系統疾病，它確實提供了一個平台，提供了針對我們內部所稱的疾病的機會，無論是腫瘤學家、心臟病專家、肺病專家等等。所以我認為該平臺本身俱有巨大的推動價值。

(Operator Instructions)

（操作員指示）

Boris Tolkachev, Freedom.

鮑里斯‧托爾卡切夫，《自由》。

It might be too early to ask. However, I was wondering if we could expect any updates on future clinical development road map before the end of the year? And also, do you plan to share any interim results from the ORCA-OL trial ahead of full publication?

現在問這個問題可能還為時過早。但是，我想知道我們是否可以在年底之前期待有關未來臨床開發路線圖的任何更新？此外，您是否計劃在全面發布之前分享 ORCA-OL 試驗的任何中期結果？

I'm not sure I heard the first question. This is Cindy. But we are planning on completing the entire database for the ORCA-OL study, and that's going to happen quickly actually by the end of this year. And we will be looking at conferences as well as getting publications ready early next year for hopefully a conference maybe by quarter two or during the 2026 year, a number of times that we can present the data because there will be a lot of safety as well as efficacy data for us to present. That is the only ongoing trial we have right now. So obviously, our focus on that trial will allow us to hopefully proceed quickly with getting results in 2026 out to everyone.

我不確定我是否聽到了第一個問題。這是辛迪。但我們計劃完成 ORCA-OL 研究的整個資料庫，實際上這將在今年年底前迅速完成。我們將關注會議並準備在明年初發表的出版物，希望能夠在第二季或 2026 年召開一次會議，屆時我們可以多次展示數據，因為將會有大量的安全性和有效性數據供我們展示。這是我們目前唯一正在進行的審判。因此，顯然，我們對該試驗的關注將使我們能夠快速推進並在 2026 年向所有人公佈結果。

Boris, we see great value in the data from an open-label safety study. I think with one year's exposure to the drug, so far, we've seen an important element, which is the tolerability of the drug to patients during that period. And we think that's going to stand us in good stead in the future. So as Cindy said in her prepared remarks, the safety profile looks pretty much in line with what we've seen in the Phase III trials. And of course, the secondary endpoint is efficacy. And we're really, really interested to see what that long-term efficacy data will look like.

鮑里斯，我們看到開放標籤安全性研究的資料具有巨大的價值。我認為，透過一年對該藥物的接觸，到目前為止，我們已經看到了一個重要因素，即該藥物在此期間對患者的耐受性。我們認為這將為我們的未來帶來好處。因此，正如辛蒂在準備好的發言中所說，安全性概況與我們在第三階段試驗中看到的非常一致。當然，次要終點是療效。我們真的非常有興趣看看長期療效數據是什麼樣的。

And we have reached the end of the question-and-answer session. I'll hand it back to Rick Stewart for closing remarks.

問答環節現已結束。我將把它交還給里克·斯圖爾特 (Rick Stewart) 作結束語。

Great. So thank you, everyone, for joining us today and for your questions, and thank you to the patients and the health care professionals who have participated in our clinical program to date, enabling us to submit the new drug application for cytisinicline. We're very excited about the potential for cytisinicline, and we look forward to providing you with future updates.

偉大的。所以，感謝大家今天的參與和提問，也感謝迄今為止參與我們臨床計劃的患者和醫療保健專業人員，這使我們能夠提交 cytisinicline 的新藥申請。我們對金雀花鹼的潛力感到非常興奮，並期待為您提供未來的更新。

And finally, I'd like to thank our shareholders for their continued support and the dedicated and talented team at Achieve for their commitment. Operator, that concludes today's call.

最後，我要感謝股東們的持續支持以及 Achieve 敬業且才華橫溢的團隊的奉獻。接線員，今天的通話到此結束。

That concludes today's call. All parties may disconnect. Have a good day.

今天的電話會議到此結束。各方均可斷開連線。祝你有美好的一天。