Traws Pharma Inc (TRAW) 2025 Q2 法說會逐字稿

完整原文

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  • Operator

    Operator

  • Ladies and gentlemen, thank you for standing by. Welcome to the Traws Pharma, Inc. second quarter 2025 financial results and business update call. (Operator Instructions) As a reminder, this call is being recorded today, August 14, 2025.

    女士們、先生們,感謝你們的支持。歡迎參加 Traws Pharma, Inc. 2025 年第二季財務表現與業務更新電話會議。(操作員指示)提醒一下,本次通話於今天(2025 年 8 月 14 日)進行錄音。

  • At this time, I'd like to turn the call over to John Fraunces of Lifesci Advisors.

    現在,我想將電話轉給 Lifesci Advisors 的 John Fraunces。

  • John Franz - Investor Relations

    John Franz - Investor Relations

  • Thank you, operator, and welcome everyone to Traws Pharma's second-quarter 2025 financial results and business update conference call. This morning, Traws issued a press release reporting its second-quarter 2025 financial results and provided a business update. If you've not yet seen this press release, it is available in the investor relations section of the company's website.

    謝謝接線員,歡迎大家參加 Traws Pharma 2025 年第二季財務表現和業務更新電話會議。今天上午,Traws 發布了一份新聞稿,報告了其 2025 年第二季的財務表現並提供了業務更新。如果您尚未看到此新聞稿,可以在公司網站的投資者關係部分找到。

  • Following my introduction, we will hear from Traws Interim Chief Executive Officer Dr. Iain Dukes; Chief Science Officer, Dr. C. David Pauza; Chief Medical Officer, Dr. Robert R. Redfield, and Interim Chief Financial Officer Charles Parker.

    在我的介紹之後,我們將聽取 Traws 臨時首席執行官 Iain Dukes 博士、首席科學官 C. David Pauza 博士、首席醫療官 Robert R. Redfield 博士和臨時首席財務官 Charles Parker 的演講。

  • Before we begin, I'd like to remind everyone that statements made during this conference call will include forward-looking statements under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties that can cause actual results to differ materially.

    在我們開始之前,我想提醒大家,本次電話會議中所作的陳述將包括根據 1995 年《私人證券訴訟改革法案》安全港條款做出的前瞻性陳述,其中涉及可能導致實際結果大不相同的風險和不確定性。

  • Forward-looking statements speak only as of the date they are made, as the underlying facts and circumstances may change. Except as required by law, Traws disclaims any obligation to update these forward-looking statements to reflect future information, events, or circumstances. For more information on forward-looking statements, please review the disclaimer in this morning's press release and the risk factors in the company's SEC filings.

    前瞻性陳述僅代表其作出之日的觀點,因為基本事實和情況可能會改變。除法律要求外,Traws 不承擔更新這些前瞻性聲明以反映未來資訊、事件或情況的義務。有關前瞻性陳述的更多信息,請查看今天上午新聞稿中的免責聲明以及公司向美國證券交易委員會提交的文件中的風險因素。

  • With that, I will now turn the call over Traw's Interim CEO, Dr. Iain Dukes.

    現在,我將把電話轉給 Traw 的臨時執行長 Iain Dukes 博士。

  • Iain Dukes - Interim Chief Executive Officer

    Iain Dukes - Interim Chief Executive Officer

  • Thanks, John, and thanks to everyone for joining us today. Traws has made good progress this year towards our goal of bringing our antiviral candidates to patients as soon as possible. This morning, we announced that we have reprioritized our clinical trial plans to reflect potential short- and medium-term shareholder value with the following actions.

    謝謝,約翰,也謝謝大家今天加入我們。今年,Traws 在實現盡快為患者提供抗病毒藥物的目標方面取得了良好進展。今天上午,我們宣布已重新調整臨床試驗計劃的優先順序,以反映潛在的短期和中期股東價值,並採取以下行動。

  • In our COVID program, we have submitted to Human Research Ethics Committee, HREC, a Phase II study of ratutrelvir, a potential best-in-class ritonavir-free agent, in newly diagnosed COVID patients versus PAXLOVID to evaluate safety and efficacy as well as rates of disease rebound and instance of Long COVID development.

    在我們的 COVID 計劃中,我們已向人類研究倫理委員會 (HREC) 提交了一項 II 期研究,該研究針對新診斷的 COVID 患者,對 ratutrelvir(一種潛在的最佳無利托那韋藥物)與 PAXLOVID 進行比較,以評估安全性和有效性以及疾病反彈率和長期 COVID 發展的情況。

  • Separately, we proposed to evaluate in a single-arm study, the effects of ratutrelvir in PAXLOVID-ineligible patients who represent a significant vulnerable population with few treatment options. Our expectation is to be able to report results from these Phase II studies by year-end 2025. Importantly, in second quarter of 2025, Pfizer reported $427 million in sales of PAXLOVID, representing a 70% increase compared to the same period in the prior year.

    另外,我們建議在單臂研究中評估 ratutrelvir 對不適合使用 PAXLOVID 的患者的影響,這些患者代表了相當脆弱的人群,治療選擇很少。我們期望能夠在 2025 年底前報告這些第二階段研究的結果。重要的是,2025年第二季度,輝瑞報告PAXLOVID的銷售額為4.27億美元,比去年同期成長了70%。

  • For the influenza program, we'll continue our constructive discussions with the Biomedical Advanced Research and Development Authority, or BARDA, regarding the inclusion of tivoxavir marboxil, or TXM, in the drug stockpiling initiative for influenza, including bird flu. We believe that this represents a major short- and medium-term commercial potential for this program. While H5N1 influenza is widespread in poultry and dairy herds, with several recent human cases in farm workers, it has not progressed to date in the US at rates feared for a near-term potential pandemic.

    對於流感項目,我們將繼續與生物醫學高級研究與發展局(BARDA)進行建設性討論,將替沃沙韋瑪波西酯(TXM)納入流感(包括禽流感)藥物儲備計畫。我們相信這代表了該計劃巨大的短期和中期商業潛力。儘管 H5N1 流感病毒在禽類和乳牛群中廣泛傳播,並且最近在農場工人中出現了幾例人類感染病例,但迄今為止,該病毒在美國的傳播速度尚未達到人們所擔心的近期潛在大流行的程度。

  • The current health risk has been determined to be low by the CDC, which continues to monitor for bird flu transmission in humans. Accordingly, the immediate likelihood of successfully recruiting a Phase II study incorporating bird flu-infected subjects would be low and initiation of this study has been deferred.

    美國疾病管制與預防中心已確定目前的健康風險較低,並將繼續監測人禽流感的傳播情況。因此,成功招募涉及禽流感感染者的 II 期研究受試者的可能性很低,並且該研究的啟動已被推遲。

  • During a Type D meeting, the FDA reaffirmed its position that clinical trial data, rather than reliance on the Animal Rule, is the registrational path for bird flu therapeutics. Recent approval of our Phase II bird flu/seasonal flu protocol by both Australian and South Korean regulatory authorities will allow us to quickly initiate a clinical study in either the Southern or Northern Hemispheres, respectively, should the incidence rates of bird flu increase.

    在 D 級會議期間,FDA 重申了其立場,即臨床試驗數據(而不是依賴動物規則)是禽流感治療藥物的註冊途徑。澳洲和韓國監管機構最近批准了我們的第二階段禽流感/季節性流感方案,這將使我們能夠在禽流感發病率上升時分別在南半球或北半球迅速啟動臨床研究。

  • I'll now hand over the call to our Chief Scientific Officer, Dr. David Pauza Porter; and our Chief Medical Officer, Dr. Robert Redfield, for more detailed comments on our COVID program.

    現在,我將把電話交給我們的首席科學官 David Pauza Porter 博士和我們的首席醫療官 Robert Redfield 博士,請他們對我們的 COVID 計劃發表更詳細的評論。

  • David?

    戴維?

  • C. David Pauza - Chief Scientific Officer, Virology

    C. David Pauza - Chief Scientific Officer, Virology

  • Thank you, Iain. COVID-19 continues to be a major public health threat due to the evolution and rapid spread of new viral variants. Today, six major variants are spreading in the United States and the NB.1.8.1 variant, first appearing in April of this year, is already responsible for more than 40% of infections nationwide.

    謝謝你,伊恩。由於新病毒變種的進化和快速傳播,COVID-19 仍然是一個重大的公共衛生威脅。目前,美國有六種主要變種病毒正在傳播,今年4月首次出現的NB.1.8.1變種已造成全國40%以上的感染。

  • The speed at which new variants arise and increase within the population tells us that the virus is spreading at a high rate and retains potential for causing severe disease. As vaccine immunity declines overall, increases in the rate of virus spread are increasingly likely. Effective antiviral drugs may now be the best option for managing COVID-19.

    新變種出現和在人群中增長的速度告訴我們,病毒正在高速傳播,並具有引發嚴重疾病的潛力。隨著疫苗免疫力整體下降,病毒傳播速度增加的可能性越來越大。有效的抗病毒藥物現在可能是控制 COVID-19 的最佳選擇。

  • Ratutrelvir is an investigational main protease inhibitor, developed and tested by Traws Pharma, has proven to be effective against all viral variants tested so far in preclinical studies and is expected to retain potency against existing and anticipated viral variants. We are now advancing ratutrelvir into Phase II clinical studies to accelerate its entry into the marketplace.

    Ratutrelvir 是一種研究性的主要蛋白酶抑制劑,由 Traws Pharma 開發和測試,已被證明對迄今為止在臨床前研究中測試的所有病毒變體有效,並且預計對現有和預期的病毒變體保持效力。我們目前正在推進拉圖瑞韋的 II 期臨床研究,以加速其進入市場。

  • Ratutrelvir is designed for use without ritonavir, a booster compound used to increase the effectiveness of PAXLOVID because ritonavir interferes with a number of commonly prescribed medications. Consequently, many patients seeking treatment for COVID-19 are ineligible to take PAXLOVID and need a safe alternative.

    Ratutrelvir 的設計使用無需與利托那韋一起使用,利托那韋是一種增強化合物,用於提高 PAXLOVID 的有效性,因為利托那韋會幹擾許多常用處方藥。因此,許多尋求 COVID-19 治療的患者沒有資格服用 PAXLOVID,需要安全的替代品。

  • Ratutrelvir was well tolerated in Phase I clinical studies, where we evaluated a once-daily oral dose for 10 consecutive days. The longer treatment interval is intended to eliminate the virus and prevent rebound, which is experienced by many individuals with or without treatment for COVID-19.

    拉圖瑞韋在 I 期臨床研究中耐受性良好,我們評估了連續 10 天每天一次的口服劑量。延長治療間隔是為了消除病毒並防止反彈,許多接受或未接受 COVID-19 治療的人都會經歷反彈。

  • We've applied for permission to conduct a Phase II clinical trial in patients with COVID-19, including those people eligible for PAXLOVID and people who are ineligible for PAXLOVID. By demonstrating ratutrelvir's benefit in COVID-19 patients, we expect to address the estimated $1.5 billion annual market opportunity of individuals who are seeking treatment but are ineligible for PAXLOVID and to demonstrate the multiple benefits of ratutrelvir therapy.

    我們已申請許可對 COVID-19 患者進行 II 期臨床試驗,其中包括符合 PAXLOVID 治療資格的患者和不符合 PAXLOVID 治療資格的患者。透過證明 ratutrelvir 對 COVID-19 患者的益處,我們期望解決那些正在尋求治療但不符合 PAXLOVID 資格的個人每年約 15 億美元的市場機會,並證明 ratutrelvir 療法的多重益處。

  • Dr. Redfield, would you like to add comments?

    雷德菲爾德博士,您想補充評論嗎?

  • Robert Redfield - Chief Medical Officer

    Robert Redfield - Chief Medical Officer

  • Thanks, Dave. COVID-19 has become a nearly year-round public health problem with multiple peaks of infection throughout the year. Current treatments have significant limitations. For example, PAXLOVID includes the addition of ritonavir, a pharmacokinetic enhancer that can result in significant drug-drug interactions, limiting its use in many elderly patients on certain anticoagulants. Treatment is also complicated by the high rate of COVID rebound and the development of a prolonged post-infection symptoms known as Long COVID.

    謝謝,戴夫。新冠肺炎疫情已成為幾乎全年性的公共衛生問題,全年出現多個感染高峰。目前的治療方法有很大的限制。例如,PAXLOVID 中添加了利托那韋,這是一種藥物動力學增強劑,可能導致顯著的藥物交互作用,限制了其在許多服用某些抗凝血劑的老年患者中的使用。由於 COVID 反彈率高,以及感染後出現長期症狀(即長期 COVID),治療也變得複雜。

  • Unfortunately, COVID vaccines do not effectively prevent infection. As a consequence, viral transmission continues unchecked in the community, whether or not vaccines are used. Many infected individuals do not seek treatment because they've heard of the unpleasant or only partially effective PAXLOVID and they're not able to take PAXLOVID due to drug-drug interactions caused by ritonavir.

    不幸的是,COVID 疫苗不能有效預防感染。因此,無論是否使用疫苗,病毒在社區的傳播仍不受控制。許多感染者沒有尋求治療,因為他們聽說過令人不快或僅部分有效的 PAXLOVID,並且由於利托那韋引起的藥物相互作用,他們無法服用 PAXLOVID。

  • Traws Pharma's answer is ratutrelvir, a new investigational drug that does not require ritonavir to reach its therapeutic levels and can be taken for 10 days instead of the 5 days recommend for PAXLOVID. Ratutrelvir treatment may expand access for all patients to receive COVID-19 therapy. We are hopeful that the longer duration will result in more complete elimination of the virus and will prevent viral rebounds and hopefully reduce the incidence of Long COVID.

    Traws Pharma 的答案是 ratutrelvir,這是一種新型研究藥物,不需要利托那韋即可達到治療水平,並且可以服用 10 天,而不是 PAXLOVID 建議的 5 天。Ratutrelvir 治療可能會擴大所有患者接受 COVID-19 治療的機會。我們希望更長的持續時間能夠更徹底地消滅病毒,並防止病毒反彈,並希望減少長期 COVID 的發生率。

  • Traws Pharma is committed to providing broader access to COVID therapeutics that include the treatment and the prevention of Long COVID. Long COVID currently affects more than 15 million people in the United States. It can cause or reduce significant disability and reduce the quality of life. Ratutrelvir was designed specifically to address these factors that may contribute to Long COVID. Therefore, including the possibility for the virus to linger in the body after current treatments are completed.

    Traws Pharma 致力於提供更廣泛的 COVID 療法,包括治療和預防長期 COVID。目前,長期新冠疫情影響著美國超過 1500 萬人。它會導致或減輕嚴重的殘疾並降低生活品質。Ratutrelvir 的設計專門針對可能導致長期 COVID 的這些因素。因此,包括目前治療完成後病毒仍有可能殘留在體內。

  • Our overall goal is to provide the best COVID-19 therapy for the greatest number of people while reducing the threat of Long COVID.

    我們的總體目標是為最多的人提供最佳的 COVID-19 治療方法,同時減少長期 COVID 的威脅。

  • Iain?

    伊恩?

  • Iain Dukes - Interim Chief Executive Officer

    Iain Dukes - Interim Chief Executive Officer

  • Thank you, Bob. Turning to our influenza program. Dr. Pauza and Dr. Redfield have the following observations. David?

    謝謝你,鮑伯。談談我們的流感計劃。Pauza 博士和 Redfield 博士有以下觀察結果。戴維?

  • C. David Pauza - Chief Scientific Officer, Virology

    C. David Pauza - Chief Scientific Officer, Virology

  • Well, thank you, Iain. Seasonal influenza has a severe public health impact in the US. However, lurking behind the risk for seasonal disease is a larger problem of influenza spreading in wild birds and mammals where the virus is evolving rapidly and in unpredictable ways. The current global outbreak of avian influenza or bird flu caused massive die-offs of birds and marine mammals throughout the world, impacted milk production in dairies, and wiped out many poultry operations.

    好吧,謝謝你,伊恩。季節性流感對美國的公共衛生造成了嚴重影響。然而,在季節性疾病風險背後隱藏著一個更大的問題,即流感在野生鳥類和哺乳動物中傳播,病毒正在以難以預測的方式迅速進化。目前全球爆發的禽流感疫情導致世界各地大量鳥類和海洋哺乳動物死亡,影響了乳牛場的牛奶產量,並摧毀了許多家禽養殖場。

  • Bird flu also poses an extreme risk to human beings. The history of human bird flu dating back three decades or more showed more than 50% of reported infections were fatal. Thus, bird flu is a very high-risk agent and only a few changes in the virus already present in animals are needed to allow for more efficient spread within the human population.

    禽流感也對人類構成極大威脅。人類禽流感的歷史可以追溯到三十多年前,報告的感染病例中超過 50% 是致命的。因此,禽流感是一種高風險的病原體,只需要對動物體內現有的病毒進行少量改變,就可以在人類中更有效地傳播。

  • In response to this threat, Traws Pharma developed and tested tivoxavir marboxil, an investigational oral drug intended to be taken once after infection for treatment and prevention of bird flu. The bird flu virus circulating currently in wild and domestic animals, is rewriting the books on lethal influenza. This virus grows faster than seasonal influenzas and has extraordinary capacity to kill all animal species where it has been tested.

    為了應對這一威脅,Traws Pharma 開發並測試了替沃沙韋瑪波西酯,這是一種試驗性口服藥物,旨在感染後服用一次,用於治療和預防禽流感。目前在野生和家養動物中傳播的禽流感病毒正在改寫致命流感的記錄。這種病毒的生長速度比季節性流感病毒更快,並且具有殺死所有經測試的動物物種的超強能力。

  • The high viral growth rate renders it less susceptible to common influenza therapies and requires the specific development of treatments targeting this bird flu threat. Tivoxavir marboxil was evaluated in human clinical studies using dose levels that are predicted based on our animal studies to be effective for treating bird flu. Tivoxavir marboxil is safe and produce blood drug levels that might control virus for 21 days or longer after a single dose.

    病毒生長速度快,因此不太容易受到常見流感療法的影響,需要專門開發針對這種禽流感威脅的治療方法。在人體臨床研究中,我們根據動物研究預測了替沃沙韋瑪波西酯對治療禽流感有效的劑量水平,並對其進行了評估。替沃沙韋瑪波西酯是安全的,單次服用後可產生控制病毒 21 天或更長時間的血液藥物水平。

  • Traws Pharma believes that tivoxavir marboxil is the first influenza therapy developed specifically for bird flu and it was designed to overcome the extraordinary challenges of a highly virulent influenza virus.

    Traws Pharma 認為,替沃沙韋瑪波西酯是第一個專門針對禽流感開發的流感療法,旨在克服高毒性流感病毒的巨大挑戰。

  • Dr. Redfield?

    雷德菲爾德博士?

  • Robert Redfield - Chief Medical Officer

    Robert Redfield - Chief Medical Officer

  • As the former Director for the United States Center for Disease Control and Prevention and a lifelong infectious disease physician, I understand the need to promote health measures for the current threats and to be prepared for high-risk emerging diseases. We believe that avian H5N1 virus is one of the great threats to public health and must be addressed with serious preparedness measures, including stockpiling effective treatments.

    身為美國疾病管制與預防中心前主任和終身傳染病醫生,我了解需要針對當前威脅採取衛生措施,並為高風險新興疾病做好準備。我們認為,禽流感H5N1病毒是對公共衛生的重大威脅之一,必須採取嚴肅的防範措施,包括儲備有效的治療方法。

  • A highly infectious influenza that cannot be effectively treated with current medications poses an extreme risk to the US population. We strongly believe that new measures are required to prepare for an H5N1 outbreak and that Traws Pharma is advancing tivoxavir marboxil as a valuable option.

    一種傳染性極強的流感無法用現有藥物有效治療,對美國民眾構成極大風險。我們堅信,需要採取新的措施來應對 H5N1 疫情,而 Traws Pharma 正在推廣替沃沙韋瑪波西酯作為一種有價值的選擇。

  • Imagine how much suffering could have been prevented if we had had a national drug stockpile that could contain the right kind of COVID-19 drugs and enough of it to prevent the spread in death within the United States. While COVID-19 was unexpected, the global spread of H5N1 virus among animals presents a clear risk for viral adaptation and efficient human-to-human transmission.

    想像一下,如果我們擁有一個國家藥品儲備庫,其中可以包含正確的 COVID-19 藥物,並且有足夠的藥物來防止死亡在美國境內蔓延,那麼可以避免多少痛苦。雖然 COVID-19 是出乎意料的,但 H5N1 病毒在動物中的全球傳播顯然存在病毒適應和人際傳播的風險。

  • With the known potential -- lethal potential of H5N1 in humans, a human-adapted H5N1 outbreak could be catastrophic. Traws Pharma is advancing tivoxavir marboxil to support a national strategy for preparing to confront an outbreak of H5N1 influenza. Importantly, the target of tivoxavir marboxil, a viral protein called cap-dependent endonuclease is an essential component of the influenza virus replication and is highly conserved among all influenza virus types.

    由於 H5N1 對人類具有已知的致命潛力,因此,人類感染 H5N1 病毒的爆發可能會造成災難性的後果。Traws Pharma 正在推進替沃沙韋瑪波西酯的研發,以支持應對 H5N1 流感爆發的國家戰略。重要的是,替沃沙韋瑪波西酯的靶點是一種稱為帽子依賴性核酸內切酶的病毒蛋白,它是流感病毒複製的重要組成部分,並且在所有流感病毒類型中高度保守。

  • Whether pandemic threats arise from H5N1 or almost any other type of influenza virus, it is likely that tivoxavir marboxil will retain activity and be effective in treating and possibly preventing the threat of pandemic influenza.

    無論大流行威脅是由 H5N1 或幾乎任何其他類型的流感病毒引起的,替沃沙韋瑪波西酯都可能保持活性並有效治療甚至預防大流行性流感的威脅。

  • Traws Pharma is engaged with the US Food and Drug Administration, or the FDA, and the Biomedical Advanced Research and Development Authority, or BARDA, regarding the development of tivoxavir marboxil for the national stockpile. The FDA has commented on the design of the clinical trials for proceeding with tivoxavir marboxil development and BARDA has provided advice regarding drug development for pandemic preparedness.

    Traws Pharma 正與美國食品藥物管理局 (FDA) 和生物醫學高級研究與發展局 (BARDA) 合作,開發用於國家儲備的替沃沙韋瑪波西酯。FDA 已對繼續進行替沃沙韋瑪波西酯開發的臨床試驗設計發表了評論,BARDA 也已就大流行防範藥物開發提供了建議。

  • We continue our interactions with these agencies as part of our overall effort to provide an effective countermeasure to the risk of pandemic influenza.

    我們繼續與這些機構互動,這是我們為應對流感大流行風險提供有效對策的整體努力的一部分。

  • Iain?

    伊恩?

  • Iain Dukes - Interim Chief Executive Officer

    Iain Dukes - Interim Chief Executive Officer

  • Thank you, Bob. Before we review our financial results, I will make a few remarks on our legacy on quality assets comprised of two unique kinase inhibitors, rigosertib and narazaciclib. Traws' strategic objectives for these programs is to establish value-creating partnerships. In the second quarter, we published compelling efficacy data for rigosertib in a rare disease called recessive dystrophic epidermolysis bullosa associated local advanced or metastatic squamous cell carcinoma, or RDEB.

    謝謝你,鮑伯。在回顧我們的財務表現之前,我將對我們的優質資產遺產發表一些評論,這些資產包括兩種獨特的激酶抑制劑 rigosertib 和 narazaciclib。Traws 這些專案的策略目標是建立創造價值的合作關係。在第二季度,我們公佈了 rigosertib 在治療一種罕見疾病(隱性營養不良性大皰性表皮鬆解症相關局部晚期或轉移性鱗狀細胞癌,或 RDEB)方面的令人信服的療效數據。

  • In the study, rigosertib demonstrated a compelling overall response rate of 80% with complete responses in 50% of evaluable patients and good overall tolerability. These data suggest rigosertib as a potential treatment for RDEB SCC where there's substantial unmet need and no approved therapies.

    在研究中,rigosertib 顯示出令人信服的 80% 的整體反應率,其中 50% 的可評估患者獲得完全反應,並且整體耐受性良好。這些數據表明,rigosertib 是 RDEB SCC 的潛在治療方法,該疾病存在大量未滿足的需求,且尚未獲得批准的療法。

  • We're excited by the compelling efficacy and tolerability of rigosertib in this rare disease, and we're committed to finding an appropriate partner to advance this important potential medicine to approval.

    我們對 rigosertib 在這種罕見疾病中表現出的顯著療效和耐受性感到非常興奮,我們致力於尋找合適的合作夥伴來推動這種重要的潛在藥物獲得批准。

  • I will now ask our Interim CFO, Charles Parker, to review our financial results. Charles?

    我現在將要求我們的臨時財務長查爾斯·帕克 (Charles Parker) 審查我們的財務結果。查爾斯?

  • Charles Parker - Interim Chief Financial Officer

    Charles Parker - Interim Chief Financial Officer

  • Thanks, Iain. This morning, Traws issued a press release for the quarter ended June 30, 2025. I'll refer you to our recent 10-Q filing for a review of the full financial statements. You can also access the press release and the 10-Q on our website.

    謝謝,伊恩。今天上午,Traws 發布了截至 2025 年 6 月 30 日的季度新聞稿。我將請您參閱我們最近的 10-Q 文件,以審查完整的財務報表。您也可以在我們的網站上存取新聞稿和 10-Q。

  • Turning to our financials. As of June 30, 2025, Traws had cash, cash equivalents, and short-term investments of approximately $13.1 million compared to $21.3 million as of December 31, 2024.

    談到我們的財務狀況。截至 2025 年 6 月 30 日,Traws 的現金、現金等價物和短期投資約為 1,310 萬美元,而截至 2024 年 12 月 31 日為 2,130 萬美元。

  • Moving through our second-quarter 2025 financial results. Revenue for the quarter ended June 30, 2025, was $2.7 million compared to $57,000 for the same period in 2024. The increase is attributable to $2.7 million in deferred revenue, recognized as revenue in the second quarter, related to mutual termination of a licensing agreement associated with our legacy oncology program in April of this year.

    回顧我們 2025 年第二季的財務表現。截至 2025 年 6 月 30 日的季度營收為 270 萬美元,而 2024 年同期的營收為 57,000 美元。這一增長歸因於 270 萬美元的遞延收入,該收入在第二季度確認為收入,與今年 4 月我們共同終止與我們傳統腫瘤學項目相關的許可協議有關。

  • Research and development expense for the second quarter in 2025 totaled $2.3 million, compared to $4 million for the comparable period in 2024. The decrease of $1.7 million primarily relates to a decrease in expenses of our oncology program and a decrease in personnel expenses. This was partially offset by an increase in expenses related to our virology programs.

    2025 年第二季的研發費用總計 230 萬美元,而 2024 年同期為 400 萬美元。170 萬美元的減少主要與我們的腫瘤學課程費用減少和人員費用減少有關。這部分被我們病毒學課程相關費用的增加所抵銷。

  • General and administrative expense for the second quarter in 2025 totaled $1.7 million compared to $2 million for the comparable period in 2024. This decrease of $0.3 million is primarily attributable to a decrease in personnel-related expenses and stock-based compensation, partially offset by an increase in professional and consulting fees.

    2025 年第二季的一般及行政費用總計 170 萬美元,而 2024 年同期為 200 萬美元。這項減少 30 萬美元主要是由於人員相關費用和股票薪酬的減少,但專業和諮詢費用的增加部分抵消了這一減少。

  • The net loss for the second quarter of 2025 was $0.9 million. This was driven by the recognition of the licensing revenue of $2.7 million. As a result, the net loss for the second quarter in 2025 was $0.11 per basic and diluted common share. This compares to a net loss of $123.1 million or a net loss of $20.52 per basic and diluted common share for the comparable period in 2024. Traws' second-quarter 2024 net loss reflects a noncash charge of $117.5 million related to in-process R&D from Onconova's April 2024 acquisition of Trawsfynydd.

    2025年第二季淨虧損為90萬美元。這是由於 270 萬美元的許可收入確認所致。因此,2025 年第二季的淨虧損為每股基本普通股和稀釋普通股 0.11 美元。相比之下,2024 年同期的淨虧損為 1.231 億美元,或每股基本和稀釋普通股淨虧損 20.52 美元。Traws 2024 年第二季的淨虧損反映了 Onconova 於 2024 年 4 月收購 Trawsfynydd 所產生的與在研發相關的 1.175 億美元的非現金費用。

  • Now I'd like to turn the call back to Iain.

    現在我想把電話轉回給伊恩。

  • Iain Dukes - Interim Chief Executive Officer

    Iain Dukes - Interim Chief Executive Officer

  • Thanks, Charles. Before we open the line for questions, I will briefly summarize the topics we've covered on today's call. We're excited about our two potential best-in-class antiviral product candidates for two multibillion-dollar markets. Ratutrelvir in development as a potential ritonavir-free treatment for COVID and tivoxavir marboxil in development as a single-dose treatment for influenza, including bird flu.

    謝謝,查爾斯。在我們開始提問之前,我將簡要總結我們在今天電話會議上討論的主題。我們對我們的兩種針對兩個價值數十億美元的市場的潛在最佳抗病毒產品候選藥物感到非常興奮。Ratutrelvir 正在開發中,作為 COVID 的潛在無利托那韋治療方法,而 tivoxavir marboxil 正在開發中,作為流感(包括禽流感)的單劑量治療藥物。

  • We reprioritized our programs to maximize the opportunity to provide investors with the short- and medium-term value with acceleration of ratutrelvir, our potential treatment for COVID. In regard to our influenza program, with the waning cases of birth flu in the United States, we intend to focus our efforts on inclusion of tivoxavir marboxil in the drug stockpiling initiative to help ensure pandemic readiness and continue our constructive discussions with BARDA.

    我們重新調整了專案的優先順序,以最大限度地為投資者提供短期和中期價值,並加速我們的潛在 COVID 治療方法 ratutrelvir 的研發。關於我們的流感項目,隨著美國出生流感病例的減少,我們打算集中精力將替沃沙韋瑪波西酯納入藥物儲備計劃,以幫助確保大流行的準備,並繼續與生物醫學高級研究與發展局進行建設性的討論。

  • And lastly, we remain committed to finding an appropriate partner to assist in developing and commercializing our legacy oncology assets.

    最後,我們仍然致力於尋找合適的合作夥伴來協助開發和商業化我們遺留的腫瘤資產。

  • As we begin the Q&A session, I want to thank everyone for joining us today. Now we will open up the call for questions. Operator, please go ahead.

    在我們開始問答環節之際,我要感謝大家今天的參與。現在我們將開始提問。接線員,請繼續。

  • Operator

    Operator

  • (Operator Instructions) Thank you. Ladies and gentlemen, thank you for your participation on today's conference call. This concludes today's event. You may now disconnect.

    (操作員指示)謝謝。女士們、先生們,感謝你們參加今天的電話會議。今天的活動到此結束。您現在可以斷開連線。