Athersys Inc (ATHX) 2022 Q3 法說會逐字稿

Good morning. My name is Devon, and I will be your conference operator today. At this time, I would like to welcome everyone to the Athersys Third Quarter 2022 Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. (Operator Instructions) Corporate Communication and Investor Relations, Ellen Greeley, you may begin your conference.

早安.我叫 Devon，今天將擔任您的電話會議主持人。現在，我歡迎大家參加 Athersys 2022 年第三季業績電話會議。所有線路已靜音，以防止任何背景噪音。演講者發言結束後，將進行問答環節。 （接線生指示）企業傳播與投資者關係部 Ellen Greeley，您可以開始您的電話會議了。

Good morning, and welcome to Athersys' Third Quarter 2022 Financial Results and Business Update Conference Call. Please note that any remarks management may make about future expectations, plans and prospects constitute forward-looking statements for purposes of the safe harbor provision under the Private Securities Litigation Reform Act of 1995.

早安，歡迎參加 Athersys 2022 年第三季財務表現及業務更新電話會議。請注意，管理層對未來預期、計劃和前景的任何評論均構成《1995 年私人證券訴訟改革法》安全港條款所指的前瞻性陳述。

Actual results may differ materially from those indicated by the forward-looking statements as a result of various factors, including those discussed in our Forms 10-Q, 10-K and other filings with the SEC. Also, this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, November 15, 2022.

由於各種因素，包括我們向美國證券交易委員會 (SEC) 提交的 10-Q 表、10-K 表和其他文件中討論的因素，實際結果可能與前瞻性陳述中所述的結果有重大差異。此外，本次電話會議所包含的時間敏感資訊僅在直播日期（2022 年 11 月 15 日）有效。

Athersys undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except as required by law.

除非法律要求，Athersys 不承擔修改或更新任何前瞻性陳述以反映本次電話會議日期之後的事件或情況的義務。

With that, I would like to turn the call over to Dan Camardo, Chief Executive Officer of Athersys. Dan, please go ahead.

接下來，我想把電話轉給 Athersys 執行長 Dan Camardo。請 Dan 繼續。

Thank you, Ellen, and welcome, everyone, to Athersys' Third Quarter 2022 Earnings Call. Joining me on the call today are Maia Hansen, our Chief Operating Officer; Kasey Rosado, our Interim Chief Financial Officer; and Dr. Robert Willie Mays, our Executive Vice President and Head of Regenerative Medicine and Neuroscience programs.

謝謝艾倫，歡迎大家參加Athersys 2022年第三季財報電話會議。今天與我一起參加電話會議的還有我們的營運長Maia Hansen、我們的臨時財務長Kasey Rosado，以及我們的執行副總裁兼再生醫學和神經科學計畫負責人Robert Willie Mays博士。

Since our second quarter earnings call, we've been hard at work executing on a plan to transform Athersys and put the company on a path to success. I'd like to start out by affirming our confidence in the potential and opportunity we have in MultiStem for treating ischemic stroke, acute respiratory distressed syndrome, trauma and several other serious diseases.

自從第二季財報電話會議以來，我們一直在努力執行一項旨在轉型Athersys、引領公司走向成功的計畫。首先，我想重申我們對MultiStem在治療缺血性中風、急性呼吸窘迫症候群、創傷和其他幾種嚴重疾病方面的潛力和機會的信心。

During the third quarter, we made good progress across several areas, including addressing our balance sheet and operating expenses, growing enrollment of patients in our MASTERS-2 ischemic stroke trial and pursuing discussions with potential business partners.

在第三季度，我們在多個領域取得了良好進展，包括解決資產負債表和營運費用、增加 MASTERS-2 缺血性中風試驗的患者招募以及與潛在商業夥伴進行討論。

Since we held a business update call last month, I'd like to focus our call today on our financial performance and highlight expectations for the fourth quarter. Since our second quarter earnings call announcement in August, we've taken significant actions to improve our financial situation by reducing our operating expenses, raising capital in the near term and managing our liabilities.

由於我們上個月舉行了業務更新電話會議，今天的電話會議我想重點討論我們的財務業績，並強調對第四季度的預期。自8月宣布第二季財報以來，我們已採取重大措施改善財務狀況，包括降低營運支出、短期內籌集資金以及管理負債。

In mid-August, we raised approximately $12 million in gross proceeds. Given other financing options and current market dynamics, that initial agreement provided immediate liquidity under attractive terms.

8月中旬，我們籌集了約1200萬美元的總收益。考慮到其他融資選擇和當前的市場動態，最初的協議以極具吸引力的條款提供了即時的流動性。

We also just completed a follow-on equity financing, raising $5.5 million in gross proceeds. The equity raise we completed last week provides us with additional liquidity as we planned for the first quarter of 2023 and work towards achieving several near-term milestones.

我們也剛完成了後續股權融資，總收益達550萬美元。上週完成的股權融資為我們規劃2023年第一季並努力實現幾個近期里程碑提供了額外的流動性。

We fully realize that additional funds are required to bring MultiStem to market, and we remain focused on our primary goal of completing the MASTERS-2 trial and achieve our other value-creating business and strategic objectives.

我們充分認識到，將 MultiStem 推向市場需要額外的資金，我們仍然專注於完成 MASTERS-2 試驗的主要目標，並實現我們的其他創造價值的業務和策略目標。

Actions we've taken to address our operating expenses and liabilities have yielded meaningful savings and moved us toward a more managed and disciplined approach to supporting our priorities. To date, we've reduced expenses from approximately $7 million a month and growing down to approximately $3 million per month and decreasing with a clear path to $2.5 million per month by the end of this year. This has been achieved by thoughtfully managing outstanding account payables and relationship with key vendors.

我們為解決營運費用和負債問題而採取的措施已帶來顯著的節支，並促使我們採取更具管理性和紀律性的方式，以支持我們的優先事項。迄今為止，我們已將支出從每月約700萬美元降至每月約300萬美元，並預計在今年年底前降至每月250萬美元。這得益於我們精心管理未償付的應付帳款以及與主要供應商的關係。

Our largest liability remains with our CDMO and represents over 80% of our account payable balance. We continue to actively engage with this important vendor with the goal of reaching a settlement on our outstanding obligations and preserving our relationship for the long term.

我們最大的債務仍來自CDMO，占我們應付帳款餘額的80%以上。我們將繼續與這家重要的供應商積極溝通，以期就未償債務達成和解，並維護我們的長期合作關係。

As a reminder, our contract manufacturer has completed production of investigational product necessary for us to complete MASTERS-2 under the current clinical protocol. They have also completed production of clinical product using a more efficient bioreactor process with sufficient inventory available to complete our Phase II trauma trial. We also have a few hundred doses of clinical bioreactor product that was approved for use in our ARDS MACOVIA trial which we suspended.

提醒一下，我們的合約製造商已完成根據現行臨床方案完成 MASTERS-2 所需的試驗性產品的生產。他們還使用更有效率的生物反應器製程完成了臨床產品的生產，並擁有足夠的庫存來完成我們的 II 期創傷試驗。我們還有數百劑臨床生物反應器產品，已獲準用於我們暫停的 ARDS MACOVIA 試驗。

We intend to hold on to that product as we explore various business development options. Another action we've taken to reduce our operating expenses is the wind down of ReGenesys, which is our Animal Health research unit in Belgium. We have notified staff of our intention to close this facility by the end of the year. We're exploring potential business partners for this program, which has demonstrated the benefit of MultiStem in a preclinical animal setting, targeting progressive diseases like [cane] osteoarthritis.

我們打算繼續保留產品，同時探索各種業務發展方案。為了降低營運成本，我們採取的另一項措施是逐步關閉位於比利時的動物健康研究部門ReGenesys。我們已通知員工，計劃在年底前關閉該機構。我們正在為該計畫尋找潛在的業務合作夥伴，該計畫已在臨床前動物實驗中證明了MultiStem的益處，尤其針對[甘蔗]骨關節炎等漸進性疾病。

As part of stabilizing our financial position, we are grateful to have received shareholder support to implement a reverse stock split to satisfy NASDAQ continued listing requirements. After discussing our options with NASDAQ on August 29, we implemented a 1 for 25 reverse split. Among other benefits, this action was intended to bring our share price into a more attractive range.

為了穩定財務狀況，我們非常感激股東的支持，得以實施反向股票分割，以滿足納斯達克的持續上市要求。在8月29日與納斯達克討論計畫後，我們實施了1比25的反向股票分割。此舉除其他益處外，還旨在將我們的股價提升至更具吸引力的區間。

We've subsequently received a notice of noncompliance from NASDAQ on October 14 that our market valuation of common stock had fallen below $35 million for 30 consecutive days, and we have until April 12, 2023, to regain compliance and avoid the possibility of delisting.

我們隨後於 10 月 14 日收到納斯達克的不合規通知，表示我們的普通股市場估值已連續 30 天跌破 3500 萬美元，我們必須在 2023 年 4 月 12 日之前重新達到合規要求，避免被摘牌的可能性。

As we presented our preclinical and clinical work during a research webinar and at industry conferences, such as Meeting on the Mesa, we are pursuing discussions with potential partners. Much of our preclinical research has been highlighted in various scientific publications, but was never offered or pursued from a business development perspective.

我們在研究網路研討會和Meeting on the Mesa等產業會議上展示了我們的臨床前和臨床研究成果，並正在與潛在合作夥伴進行洽談。我們的許多臨床前研究成果已在各種科學出版物中被重點介紹，但從未從業務發展的角度提出或開展。

Now in addition to licensing opportunities for ischemic stroke, we're also looking at co-commercialization opportunities in ways to advance our pipeline. We've made significant investments over time to understand how MultiStem cells work, why they are unique and how they can optimally be manufactured at scale and we intend to work with partners to build on our experience. Although our efforts are resulting in conversations with new potential partners, it's too early to predict outcomes.

現在，除了缺血性中風的授權機會外，我們還在尋求共同商業化的機會，以推進我們的產品線。長期以來，我們投入了大量資金，以了解多幹細胞的工作原理、它們的獨特之處以及如何以最佳方式實現規模化生產。我們計劃與合作夥伴攜手，鞏固我們的經驗。雖然我們的努力正在促成與新的潛在合作夥伴的對話，但現在預測結果還為時過早。

In Japan, we continue to work with Healios as they hold meetings with PMDA and determine their next steps related to achieving commercial approval for MultiStem in both ARDS and ischemic stroke. As part of our restructuring efforts and ongoing negotiations with our CDMO, we agreed to a license and tech transfer for certain manufacturing rights to Healios for producing product in Japan. This is a lengthy process that we've initiated with Healios while we continue to evaluate a path forward for MultiStem approval in Japan.

在日本，我們繼續與 Healios 合作，他們正在與 PMDA 舉行會議，並確定 MultiStem 在 ARDS 和缺血性中風治療中獲得商業批准的後續步驟。作為我們重組工作以及與 CDMO 持續談判的一部分，我們同意將部分生產權許可和技術轉移給 Healios，以便其在日本生產產品。這是一個漫長的過程，我們與 Healios 共同啟動，同時我們仍在繼續評估 MultiStem 在日本獲批的途徑。

Turning now to our clinical work. Our top priority remains achieving a successful outcome for MASTERS-2, and we are currently in a critical window of time to review potential protocol changes with FDA and EMA.

現在談談我們的臨床工作。我們的首要任務仍然是確保MASTERS-2試驗成功，目前我們正處於與FDA和EMA共同審查潛在方案變更的關鍵時期。

We analyze results from the MASTERS-1 and TREASURE trial to generate statistical models and align insights to reevaluate the MASTERS-2 trial design with the goal of enhancing the prospect of a timely outcome focused on the most appropriate targets.

我們分析了 MASTERS-1 和 TREASURE 試驗的結果，以產生統計模型並調整見解來重新評估 MASTERS-2 試驗設計，目的是提高針對最合適目標的及時結果的前景。

This month, we will be meeting with key opinion leaders, regulatory experts and statisticians to review the data and determine what, if any protocol changes should be made. Once we receive input from these experts, we will then consult with the FDA and the EMA on any potential recommendations to modify the MASTERS-2 trial design and be in a better position to communicate in an expected enrollment completion date.

本月，我們將與關鍵意見領袖、監管專家和統計學家會面，審查數據並確定是否需要對方案進行修改。一旦收到這些專家的意見，我們將與FDA和EMA協商，探討修改MASTERS-2試驗設計的任何潛在建議，以便更好地溝通預計的入組完成日期。

In the meantime, we continue to actively engage clinical trial sites and work towards growing patient enrollment. As we look ahead for the remainder of Q4, we are clear on our priorities. Number one, we continue to enroll patients in our MASTERS-2 trial. Number two, we engaged with the key opinion leaders and other industry experts on the totality of data we now have available to us with the recent TREASURE trial results and evaluate our options to then discuss with regulatory agencies. Number three, is to advance our business development discussions with the intention of seeking strategic partnerships that will work with us to advance MultiStem on a regional or a global level. And number four, we will continue to manage our balance sheet actively and responsibly for long-term success.

同時，我們將繼續積極參與臨床試驗，並努力擴大患者入組規模。展望第四季度剩餘時間，我們明確了我們的優先事項。首先，我們將繼續招募MASTERS-2試驗的患者。其次，我們與關鍵意見領袖和其他行業專家就我們目前掌握的近期TREASURE試驗結果的全部數據進行了溝通，並評估了我們的方案，以便與監管機構進行討論。第三，我們將推動業務發展的討論，尋求能夠與我們攜手在區域或全球層面推動MultiStem的策略合作夥伴關係。第四，我們將繼續積極負責管理資產負債表，以取得長期成功。

Coming off of our recent financing, we will continue to raise our presence with institutional investors, and we look forward to participating in an Alliance Global Partner Biotech Conference at the end of this month. We will also be meeting with investors in person during the JPMorgan Healthcare Conference in San Francisco in early January.

憑藉近期的融資，我們將繼續加強與機構投資者的合作，並期待參加本月底舉行的 Alliance Global Partner 生物技術大會。我們也將在1月初於舊金山舉行的摩根大通醫療保健大會上與投資人進行面對面交流。

I'd now like to turn the call over to Kasey Rosado to discuss the quarter's financial results.

現在我想將電話轉給 Kasey Rosado 討論本季的財務表現。

Thank you, Dan. As a final topic, I'd like to summarize our financial results for the third quarter. Revenues for the quarter were $6,500 compared to $4.8 million for the third quarter of 2021. Collaboration revenues fluctuate from period to period based on the delivery of services under the arrangements with Healios.

謝謝，丹。最後，我想總結一下我們第三季的財務表現。本季營收為 6,500 美元，而 2021 年第三季為 480 萬美元。根據與 Healios 的協議，協作收入會根據服務交付情況而波動。

As of September 30, 2022, and during the third quarter of 2022, the services under that arrangement are largely complete and are limited to closeout activities. Research and development expenses were $12.4 million for the third quarter of 2022 compared with $17.2 million for the comparable period in 2021.

截至2022年9月30日及2022年第三季度，該協議項下的服務已基本完成，且僅限於收尾工作。 2022年第三季研發費用為1,240萬美元，而2021年同期為1,720萬美元。

The $4.8 million decrease is due to our restructuring efforts, which have reduced salaries and benefits of $2 million in internal research supplies of $1.8 million, manufacturing costs of $200,000, outstanding services of $600,000 and decreases in other research and development costs of $400,000.

480 萬美元的減少是由於我們的重組努力，重組使工資和福利減少了 200 萬美元，內部研究用品減少了 180 萬美元，製造成本減少了 20 萬美元，未償服務減少了 60 萬美元，其他研發成本減少了 40 萬美元。

General and administrative expenses were $3.7 million for the third quarter of 2022 compared with $3.6 million for the comparable period in 2021. The slight increase is primarily related to restructuring costs. We expect our general and administrative expenses to decrease in connection with our restructuring plan.

2022年第三季的一般及行政費用為370萬美元，而2021年同期為360萬美元。小幅成長主要與重組成本有關。我們預計，由於重組計劃的實施，我們的一般及行政費用將有所下降。

Net loss for the third quarter of 2022 was $13.7 million or $1.15 per share. compared to a net loss of $16.2 million or $1.76 per share for the third quarter of 2021. Our cash balance at the end of September was $13.8 million. We have made substantial progress in reducing our operating burn rate while working with suppliers on payables and other obligations. But as Dan mentioned, we will need additional capital to support ongoing operations.

2022年第三季淨虧損為1,370萬美元，合每股1.15美元，2021年第三季淨虧損為1,620萬美元，合每股1.76美元。截至9月底，我們的現金餘額為1,380萬美元。在與供應商就應付款項和其他債務進行合作的同時，我們在降低營運消耗率方面取得了顯著進展。但正如Dan所提到的，我們需要額外的資金來支持持續營運。

Thank you, Kasey. So with that overview, I'd like to thank everyone for their attention. And I'd like to answer a few questions we received in advance before opening the lines for additional questions.

謝謝，凱西。以上是概述，感謝大家的關注。在開放更多提問之前，我想先回答幾個我們之前收到的問題。

There are no further questions at this time. With that said, concludes today's conference. Thank you for attending today's presentation. You may now disconnect.

目前沒有其他問題。今天的會議到此結束。感謝您參加今天的演講。現在您可以斷開連線了。