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Operator
Operator
Good morning, and welcome to the Altamira Therapeutics first half 2024 and business update conference call. On today's call are Thomas Meyer, Altamira's, Founder, Chairman and Chief Executive Officer; and Covadonga Paneda, Altamira's Chief Operating Officer.
早安,歡迎參加 Altamira Therapeutics 2024 年上半年業務更新電話會議。參加今天電話會議的有 Altamira 的創辦人、董事長兼執行長 Thomas Meyer,以及 Altamira 的營運長 Covadonga Paneda。
Earlier today, Altamira issued a news release with the first half 2024 financial results as well as comprehensive business update. The release is available on the company's website at www. altamiratherapeutics.com and has been filed with the SEC.
今天早些時候,Altamira 發布了一份新聞稿,公佈了 2024 年上半年的財務業績以及全面的業務更新。新聞稿可在本公司網站 www.altamiratherapeutics.com 上查閱,並已提交給美國證券交易委員會。
During today's call, the company will be making forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These include statements that address future operating financial or business performance or its strategies or expectations.
在今天的電話會議中,公司將根據 1995 年《私人證券訴訟改革法案》的規定,做出前瞻性聲明。這些聲明包括有關未來經營財務或業務績效、策略或預期等方面的聲明。
Forward-looking statements are based on management's current expectations and beliefs and involves significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements.
前瞻性陳述是基於管理階層目前的預期和信念,並涉及重大風險和不確定性,可能導致實際結果、發展和業務決策與這些陳述所設想的內容有重大差異。
These risks and uncertainties include but are not limited to the timing and conduct of our clinical trials, the clinical unity of our product candidates, the timing or likelihood of regulatory filings in approvals our intellectual property position and our financial position as well as those described in the risk factors section in our annual report on Form 20-F and future filings with the Securities and Exchange Commission.
這些風險和不確定性包括但不限於臨床試驗的時間安排和進行情況、候選產品的臨床有效性、監管審批文件提交的時間或可能性、我們的智慧財產權狀況和財務狀況,以及我們在 20-F 表格年度報告的風險因素部分和未來向美國證券交易委員會提交的文件中所描述的風險和不確定性。
In addition, any forward-looking statements represent the company's views only as of today and should not be relied upon as representing its views as of any subsequent date. While it may elect to update these forward-looking statements at some point in the future. It specifically disclaims any obligation to do so even if its views change.
此外,任何前瞻性陳述僅代表本公司截至今日的觀點,不應被視為代表本公司在任何後續日期的觀點。雖然未來某個時候公司可能會選擇更新這些前瞻性聲明。它明確聲明,即使其觀點改變,也沒有義務這麼做。
With that, I'll hand the call over to Altamira therapeutics, CEO, Thomas Meyer. Please begin.
接下來,我將把電話交給 Altamira Therapeutics 的執行長 Thomas Meyer。請開始。
Thomas Meyer - Chairman of the Board, Chief Executive Officer
Thomas Meyer - Chairman of the Board, Chief Executive Officer
Thank you, operator. Hello, everyone, and thank you for joining our first half 2024 financial results and business update call. I will kick off the call by providing an overview of recent corporate developments, our Chief Operating Officer Covadonga Paneda, will then discuss the progress in our new core business of RNA delivery.
謝謝接線生。大家好,感謝各位參加我們2024年上半年財務表現及業務更新電話會議。我將首先概述公司近期的發展情況,然後我們的首席營運長科瓦東加·帕內達將討論我們在RNA遞送這一新核心業務方面取得的進展。
Finally, I will discuss our financials and outlook for 2024 before opening the call for any questions.
最後,我將討論我們的財務狀況和 2024 年的展望,之後將開放提問環節。
In 2021, we entered the field of RNA delivery through the acquisition of Tracer Therapeutics and initiated our strategic repositioning around Tracer's exciting peptide-based nanoparticle technology for extra hepatic RNA delivery.
2021 年,我們透過收購 Tracer Therapeutics 進入了 RNA 遞送領域,並圍繞 Tracer 令人興奮的基於勝肽的奈米顆粒技術(用於肝外 RNA 遞送)開始了我們的策略重新定位。
Looking back, this was definitely the right decision to take. Also it has taken us longer than expected to harness the potential of the Trace technology which we now call our OligoPhore and SemaPhore platforms. I'm pleased to say that we have made great progress and continue to gain momentum with our RNA delivery programs.
現在回想起來,這絕對是正確的決定。此外,我們花了比預期更長的時間發揮 Trace 技術的潛力,我們現在稱之為 OligoPhore 和 SemaPhore 平台。我很高興地告訴大家,我們的 RNA 遞送計畫取得了巨大進展,並且持續發展壯大。
This shows in various forms. Fresh in vivo data recently published in Nature Immunology, a top-ranking scientific journal showed dramatic reductions in cancer growth following treatment with CBT 46 mRNA delivered with our SemaPhore nanoparticle technology.
這以多種形式表現出來。最近發表在頂級科學期刊《自然免疫學》上的最新體內數據顯示,使用我們採用 SemaPhore 奈米顆粒技術遞送的 CBT 46 mRNA 進行治療後,癌症生長顯著減少。
Development of both the OligoPhore and the SemaPhore platforms as well as of our AM401 and AM411 flagship programs in KRAS-driven cancers and in rheumatoid arthritis is progressing, benefiting from our new access to lab space at the Switzerland innovation part in the Basel area.
OligoPhore 和 SemaPhore 平台以及我們在 KRAS 驅動的癌症和類風濕性關節炎方面的旗艦項目 AM401 和 AM411 的開發都在取得進展,這得益於我們在巴塞爾地區的瑞士創新中心獲得了新的實驗室空間。
At the same time, we are evaluating our platforms for using cardiac regeneration and for mRNA vaccines in joint projects with two partners.
同時,我們正在與兩個合作夥伴開展聯合項目,評估我們的平台在心臟再生和 mRNA 疫苗方面的應用。
Through our business development activities, we're exploring and discussing additional exciting collaboration opportunities with other pharma and biotech companies. While we progress with our RNA delivery activities, we keep working towards completion of our strategic repositioning by divesting or licensing out our legacy assets.
透過我們的業務拓展活動,我們正在探索和討論與其他製藥和生物技術公司進行更多令人興奮的合作機會。在我們推進 RNA 遞送活動的同時,我們也在透過剝離或授權我們的傳統資產,不斷努力完成我們的策略重組。
We already divested part of our venture and nasal spray business by retaining a 49% stake and additional economics from share of licensing revenues and in case of a sale, we will still participate significantly in the upside of this business.
我們已經剝離了部分風險投資和鼻噴劑業務,保留了 49% 的股份,並從授權收入中獲得額外收益。如果出售,我們仍將大幅分享該業務的成長收益。
The main focus of our current partnering activities is on AM-125, our betahistine nasal spray for the treatment of vertigo. In connection with the repositioning, we have also been optimizing our cost structure, significantly reducing the cash burn rate, and contributing to this further simplifying the group structure. Ultimately, the goal will be to have a much different business model.
我們目前合作活動的主要重點是 AM-125,這是我們用於治療眩暈的倍他司汀鼻噴劑。為了配合業務重新定位,我們也一直在優化成本結構,大幅降低現金消耗率,並進一步簡化集團結構。最終目標是建立一個截然不同的商業模式。
Compared to the development of drug products, we expect to operate a much less capital-intense business based on revenues from contract development and revenue streams from licensing rights to our RNA delivery technology. Last week, we raised in a public offering of common shares gross proceeds of $4 million to strengthen our financial position and support the ongoing transition to the new business model.
與藥物產品開發相比,我們預計這項業務的資本密集度要低得多,其收入主要來自合約開發以及我們 RNA 遞送技術的許可權收入。上週,我們透過公開發行普通股籌集了 400 萬美元的總收益,以增強我們的財務狀況並支持向新商業模式的持續過渡。
The shares were issued together with warrants, which could provide us with up to $8 million in additional cash upon reaching certain development and business milestones. Following the summary, I'm handing the call over to Covadonga Paneda, our COO, who will provide you with a more detailed update on our RNA delivery business. Cova?
這些股票與認股權證一起發行,一旦達到某些發展和業務里程碑,我們可以獲得高達 800 萬美元的額外現金。總結完畢後,我將把電話交給我們的營運長科瓦東加·帕內達,他將為大家提供關於我們 RNA 遞送業務的更詳細的最新資訊。科瓦?
Covadonga Paneda - Chief Operating Officer
Covadonga Paneda - Chief Operating Officer
Thanks, Thomas, and good morning, everyone. These are exciting times to work in the R&D space. research and development activities in Altamira's core business RNA delivery built on our peptide-based OligoPhore and SemaPhore nanoparticle platforms continue to progress.
謝謝你,托馬斯,大家早安。對於研發領域而言,這是一個令人興奮的時代。 Altamira 的核心業務——基於肽基 OligoPhore 和 SemaPhore 奈米顆粒平台的 RNA 遞送——的研發活動正在不斷取得進展。
The key focus during the first half of the year has been a nanoparticle formulation and process development around the platform. As well, as on the evaluation and development of nanoparticles, the delivery of specific RNA and mRNA payloads for our partners and for our two flagship programs, AM-401 and AM-411 the treatment of KRAS driven cancers and rheumatoid arthritis, respectively.
今年上半年,研究重點是圍繞該平台進行奈米顆粒配方和製程開發。此外,我們還對奈米顆粒進行評估和開發,為我們的合作夥伴以及我們的兩個旗艦項目 AM-401 和 AM-411 提供特定的 RNA 和 mRNA 有效載荷,分別用於治療 KRAS 驅動的癌症和類風濕性關節炎。
Evidence for the effectiveness and versatility of Altamira's RNA delivery platform keeps growing, as shown by two recent scientific publications.
最近發表的兩篇科學論文表明,Altamira 的 RNA 遞送平台的有效性和多功能性的證據不斷增加。
A research group from Washington University presented in a preprint publication, the results of a study showing that administration of SOD 2 mRNA delivered systemically with SemaPhore nanoparticles to mice with abdominal aortic aneurysm or AAA, resulted in a significant reduction in aorta dilation, delayed structure, and promoted a significant improvement in survival way.
華盛頓大學的研究小組在預印本出版物中展示了一項研究結果,該研究表明,透過 SemaPhore 奈米顆粒向患有腹主動脈瘤 (AAA) 的小鼠全身遞送 SOD 2 mRNA,可顯著減少主動脈擴張,延緩結構改變,並顯著提高生存率。
AAA is an inflammatory disease involving oxidative stress caused by excessive levels of reactive oxygen species, which results in abnormal enlargement of the abdominal aorta and rupture may be life threatening. In the second study published in Nature Immunology, SemaPhore was evaluated as a delivery vehicle for mRNA in the context of cancer.
AAA 是一種發炎性疾病,涉及活性氧過量引起的氧化應激,導致腹主動脈異常擴張,破裂可能危及生命。在發表於《自然免疫學》的第二項研究中,SemaPhore 被評估為癌症背景下 mRNA 的遞送載體。
Here, another research group from Washingtom University showed that systemic administration of ZBTB46 mRNE with SemaPhore nanoparticles to mouse models of sarcoma and metastatic breast cancer, resulted in sustained ZBTB46 expression, restored immunostimulatory tumor macro environment and highly significant reduction in tumor growth.
華盛頓大學的另一個研究小組表明,將 ZBTB46 mRNE 與 SemaPhore 奈米顆粒一起系統性地應用於肉瘤和轉移性乳癌的小鼠模型,可導致 ZBTB46 持續表達,恢復免疫刺激性腫瘤宏觀環境,並顯著減少腫瘤生長。
When ZBTB46 mRNA nanoparticles were combined with an immune checkpoint inhibitor treatment, such as anti-PD-1, outcomes were even more pronounced, showing that an anti-PD-1 response in both the anti-PD responsive sarcoma model and in the anti-PD-1 refractory breast cancer model, generating long-term complete remission of tumor in many of the treated animals.
當 ZBTB46 mRNA 奈米顆粒與免疫檢查點抑制劑治療(如抗 PD-1)結合使用時,結果更加顯著,表明在抗 PD 反應性肉瘤模型和抗 PD-1 抗藥性乳癌模型中均產生了抗 PD-1 反應,並在許多接受治療的動物中產生了腫瘤的長期完全緩解。
Extended monotherapy with ZBTB46 nanoparticles produce complete remission, even in the mine reflectory to anti-PD-1 treatment. Mytisarcoma eliminated to treatment did not about additional tumors following repeated challenges indicating the development of a protective immunological memory.
即使在對PD-1抗體治療有抵抗力的患者中,ZBTB46奈米顆粒的長期單藥治療也能產生完全緩解。經治療消除的肉瘤在反覆感染後沒有出現其他腫瘤,這表明產生了保護性的免疫記憶。
Meanwhile, Altamira's own development work has resulted in significant enhancement of a nanoparticle stability, which has been one of the key challenges in handling and transport of RNA formulation. Thanks to its new flow process production method, the company obtained formulations of OligoPhore nanoparticles that are stable in liquid form when stored at four degrees for a period of at least one month.
同時,Altamira 自身的研發工作顯著提高了奈米顆粒的穩定性,而奈米顆粒的穩定性一直是 RNA 製劑處理和運輸的關鍵挑戰之一。由於其新的流動製程生產方法,該公司獲得了 OligoPhore 奈米顆粒的配方,該配方在 4 攝氏度下儲存至少一個月後仍能保持液態。
These formulations were in addition, able to withstand shaking stress without significant physical chemical changes. The ability of the nana formulations to maintain their attributes during shaking stress is essential for transportation and one of the key limitations of lipid nanoparticles.
此外,這些配方還能承受搖晃應力而不發生明顯的物理化學變化。奈米顆粒製劑在搖晃應力下保持其特性的能力對於運輸至關重要,也是脂質奈米顆粒的關鍵限制。
The most common type of RNA delivery vehicle, focusing on our proprietary development programs, AM-401 and AM-41, Altamira filed during the first half of 2024, several patent applications with the US Patent and Trademark Office. This aim to complete the existing intellectual property and extend direction of protection. For AM-401, coverage of different KRAS mutations in cancer treatment with nanoparticles comprising the OligoPhore platform and a single siRNA sequence, polyKRASmut.
Altamira 在 2024 年上半年向美國專利商標局提交了多項專利申請,重點是我們專有的開發項目 AM-401 和 AM-41,這是最常見的 RNA 遞送載體類型。此舉旨在完善現有的智慧財產權保護,並擴大保護方向。AM-401 是一種利用包含 OligoPhore 平台和單一 siRNA 序列 polyKRASmut 的奈米顆粒來治療癌症的不同 KRAS 突變的奈米顆粒。
In vitro data confirms the ability of polyKRASmut siRNA to knock down KRAS carrying the following mutation G12C, G12V, G12D, G12R,G12A, and A146T which account for the majority of the KRAS mutations in pancreatic, colorectal, and non-small cell lung cancer.
體外數據證實,polyKRASmut siRNA 能夠敲低攜帶下列突變的 KRAS:G12C、G12V、G12D、G12R、G12A 和 A146T,這些突變佔胰臟癌、結直腸癌和非小細胞肺癌中 KRAS 突變的大多數。
For AM-411 coverage of nanoparticles comprising siRNA sequences targeting the P65 protein, a component of the NF-κB beta transcription factor, and OligoPhore is sought. Activation of P65 has been observed in multiple types of cancer as well as in many inflammatory diseases.
針對含有靶向 P65 蛋白(NF-κB β 轉錄因子的一個組成部分)的 siRNA 序列的奈米顆粒的 AM-411 覆蓋率和 OligoPhore 正在尋求。在多種癌症以及許多發炎性疾病中都觀察到了 P65 的活化。
For instance, P65 is a well-known key checkpoint in rheumatoid arthritis inflammation and sold to regulate key biological prothesis that become disregulated in rheumatoid arthritis. The company aims to advance both AM-401 and AM-411 towards an investigation of new drug application filing in the with the FDA in 2026 and to out-license them either following the IND or after Phase I clinical trial at the latest.
例如,P65 是類風濕性關節炎發炎中一個眾所周知的關鍵檢查點,用於調節類風濕性關節炎中失調的關鍵生物假體。該公司計劃推進 AM-401 和 AM-411 的研發,爭取在 2026 年向 FDA 提交新藥申請,並在 IND 提交後或最遲在 I 期臨床試驗後進行對外授權。
Altamira is pursuing a 'picks and shovels' strategy with the RNA delivery business. This strategy is based on the licensing of its platform technology to partners in the biotech and pharma industry for the use with their own RNA payload. The first of such celebrations have been set up.
Altamira 在 RNA 遞送業務方面採取的是「用鎬和鏟子」的策略。該策略是將其平台技術授權給生物技術和製藥行業的合作夥伴,供其與自己的 RNA 有效載荷一起使用。首批此類慶祝活動已經籌備完畢。
With Heqet Therapeutics, a spin-off from King's College London, Altamira is working on nanoparticles based on the OligoPhore platform and comprising certain non-coding RNAs for the regeneration of damaged heart tissue following myocardial infraction in animal model.
Altamira 與倫敦國王學院的衍生公司 Heqet Therapeutics 合作,正在研究基於 OligoPhore 平台的奈米顆粒,該平台包含某些非編碼 RNA,用於在動物模型中心肌梗塞後再生受損的心臟組織。
With Belgium-based univercells group, Altamira is evaluating the use of the SemaPhore platform for delivery of mRNA vaccine. Thanks to lower mRNA loss during cell entrants, the nanoparticle may allow for using lower doses and thus result in potentially more effective and efficient vaccines. Upon positive outcomes of this evaluation, Altamira and its partners intend to discuss and negotiate licensing agreement.
Altamira 與總部位於比利時的 univercells 集團合作,正在評估使用 SemaPhore 平台遞送 mRNA 疫苗的效果。由於奈米顆粒在進入細胞過程中造成的 mRNA 損失較少,因此可以使用較低的劑量,可能產生更有效、更有效率的疫苗。如果評估結果積極,Altamira及其合作夥伴打算討論和協商許可協議。
Through this business development activities, the company is pursuing additional collaboration opportunities with other pharma and biotech companies. In August 2024 part of companies expanding research and development team moved to Switzerland Innovation Park in Allschwil near Basel.
透過這些業務拓展活動,該公司正在尋求與其他製藥和生技公司進行更多合作的機會。2024 年 8 月,部分公司擴大研發團隊遷至巴塞爾附近的阿爾施維爾瑞士創新園區。
At the new location, the company has access to modern and well-equipped lab facilities to support its growing activities. I will now turn the call back to Tom.
在新址,公司可以使用現代化且設備齊全的實驗室設施,以支援其不斷成長的業務活動。現在我將把電話轉回給湯姆。
I will now turn the call back to Tom.
現在我將把電話轉回給湯姆。
Thomas Meyer - Chairman of the Board, Chief Executive Officer
Thomas Meyer - Chairman of the Board, Chief Executive Officer
Thanks, Cova. I will discuss now our 2 main legacy assets, the Bentrio drug-free nasal spray for allergy and our AM-125 Bentrio nasal spray for vertigo and other disorders of the central nervous system. Our associate Altamira Medical AG made further progress in implementing its growth strategy with Bentrio, a drug-free, preservative free nasal spray for the treatment of allergic rhinitis.
謝謝,Cova。現在我將討論我們的兩個主要傳統資產,即用於治療過敏的 Bentrio 無藥鼻噴霧劑和用於治療眩暈和其他中樞神經系統疾病的 AM-125 Bentrio 鼻噴劑。我們的合作夥伴 Altamira Medical AG 在實施其成長策略方面取得了進一步進展,推出了 Bentrio,這是一款用於治療過敏性鼻炎的無藥物、無防腐劑的鼻噴霧劑。
We are very pleased that Medica agreed with two of its international distributors to expand their exclusive distribution territories.
我們非常高興 Medica 與其兩家國際經銷商達成協議,擴大其獨家經銷區域。
With Nuance pharma to extend the territory across South East and East Asia. Under the amended agreement, Nuance's territory will expand from China, Hong Kong, Macau, and South Korea, to also include Singapore, Malaysia, Thailand, Philippines, Indonesia, Vietnam, and Taiwan, with a combined population of greater than 630 million people.
與 Nuance Pharma 合作,將業務拓展至東南亞和東亞地區。根據修訂後的協議,Nuance 的業務範圍將從中國大陸、香港、澳門和韓國擴展到新加坡、馬來西亞、泰國、菲律賓、印尼、越南和台灣,這些地區的總人口將超過 6.3 億。
Nuance has been marketing Bentrio since late 2022 in Hong Kong, and recently submitted the request for marketing approval for Mainland China. We expect Nuance to launch Bentrio in Mainland China in 2025, and this huge market to become a key growth driver in the years ahead.
Nuance 自 2022 年底以來一直在香港銷售 Bentrio,最近提交了在中國大陸銷售的批准申請。我們預計 Nuance 將於 2025 年在中國大陸推出 Bentrio,而這個龐大的市場將成為未來幾年關鍵的成長驅動力。
Medica will be entitled to a milestone payment of $1 million upon Chinese marketing approval. With Pharma Nordic to extend the territory from Norway to also include Sweden and Denmark, which together have a population of 16.5 million people.
Medica公司獲得中國市場准入許可後,將有權獲得100萬美元的里程碑付款。Pharma Nordic 將業務範圍從挪威擴展到瑞典和丹麥,這兩個國家加起來的人口為 1,650 萬人。
Pharma Nordic launched Bentrio successfully in Norway in 2024, and it tends to introduce product Sweden and Denmark in 2025. Scandinavia is a very interesting market for nasal sprays in general. The two licensed territory expansions are strong mutual vote of confidence by the partners and we look forward to further growing the venture franchise with them. Meanwhile, discussions and negotiations for the marketing and distribution of venture in the US, Europe, and other key markets are ongoing.
Pharma Nordic 於 2024 年在挪威成功推出了 Bentrio,並計劃於 2025 年將此產品引入瑞典和丹麥。總的來說,斯堪的納維亞半島是鼻噴劑市場一個非常有趣的地區。這兩項特許經營權的擴張體現了合作夥伴之間強烈的相互信任,我們期待與他們進一步發展合資企業。同時,雙方正在就合資企業在美國、歐洲和其他主要市場的營銷和分銷進行討論和談判。
With our second nasal spray program, AM-125 for the treatment of acute vestabular syndrome, ABS and potentially other disorders of the central nervous system. We continue to work towards partnering of the asset.
我們的第二款鼻噴劑產品 AM-125 用於治療急性前庭症候群、ABS 以及其他中樞神經系統疾病。我們將繼續努力尋求該資產的合作機會。
AM-125 has been developed to help acutely dizzy patients get back on their feet more quickly. The drug product is a reformulation of betahistine, a histamine analog, which in the traditional oral formulation is the standard-of-care treatment for vertigo in many countries around the world.
AM-125 的研發目的是幫助急性眩暈患者更快恢復正常活動。該藥物是倍他司汀(一種組織胺類似物)的改良配方,其傳統口服製劑是世界許多國家治療眩暈的標準療法。
A Phase II clinical trial in Europe demonstrated that a four week treatment course with AM-125 and ABS patients was well tolerated and helped to accelerate vestibular compensation enabling patients to regain balance and recover faster.
歐洲的一項 II 期臨床試驗表明,使用 AM-125 治療 ABS 患者四周的療程耐受性良好,有助於加速前庭代償,使患者能夠恢復平衡並更快地康復。
In the US the oral betahistine exceptionally has not been marketed for decades and no comparable product exists. Altamira received in summer 2023, IND clearance from the FDA for a Phase clinical trial in benign proximal positional vertigo, BPPV, which is the most frequent type of ABS.
在美國,口服倍他司汀已經幾十年沒有上市銷售了,目前還沒有類似的類似產品。Altamira 於 2023 年夏季獲得 FDA 的 IND 批准,可進行良性近端位置性眩暈 (BPPV) 的臨床試驗,BPPV 是最常見的 ABS 類型。
BPPV accounts for 17% to 42% of all diagnosed vertical cases. US health care costs associated with the diagnosis of BPPV alone approach $2 billion per year. Now a few words about the simplification of our corporate structure. Since the partial divestiture of the venture business in late 2023, we have continued our efforts to streamline our group structure and align it with our strategic positioning around the RNA delivery platforms.
良性陣發性姿勢性眩暈(BPPV)佔所有已確診垂直性眩暈病例的 17% 至 42%。僅與良性陣發性位置性眩暈 (BPPV) 診斷相關的美國醫療保健費用每年就接近 20 億美元。現在簡單談談我們公司架構的簡化問題。自 2023 年底部分剝離創投業務以來,我們一直在努力精簡集團結構,並使其與我們圍繞 RNA 遞送平台的策略定位保持一致。
In the first half of 2024, we transferred our Irish subsidiary to Altamira Medica AG, merged 2 of our subsidiaries in Basel to the combined entity, which is called Altamira Therapeutics AG and which continues to serve as the core operating subsidiary.
2024 年上半年,我們將愛爾蘭子公司轉讓給了 Altamira Medica AG,並將我們在巴塞爾的 2 家子公司合併為一家名為 Altamira Therapeutics AG 的合併實體,該實體繼續作為核心營運子公司。
Following this restructuring, the Altamira Group comprises the parent company of Altamira Therapeutics Limited in Hamilton, Bermuda, and its subsidiaries, Altamira Therapeutics AG in Basel, Altamira Therapeutics Inc. Newark, Delaware, Otalanum in Basel as well as the associated company, Altamira America AG.
重組後,Altamira 集團包括位於百慕達漢密爾頓的 Altamira Therapeutics Limited 母公司及其子公司,位於巴塞爾的 Altamira Therapeutics AG、位於特拉華州紐瓦克的 Altamira Therapeutics Inc.、位於巴塞爾的 Otalanum 以及關聯公司 Altamira America AG。
This means that we are no longer using the name of Auris Medical. Upon the partnering or licensing out of AM-125, which is currently concentrated in our Otalanum AG subsidiary, we expect to do one more final step of simplification.
這意味著我們將不再使用 Auris Medical 這個名稱。在將目前集中在我們子公司 Otalanum AG 的 AM-125 進行合作或授權後,我們希望再進行最後一步簡化。
Now turning to our financials. Before reviewing our financial results for the first half of 2024, I would like to note that the financial statements are presented for the first time in US dollars rather than Swiss franc. Further, I need to highlight that the income statement for the first half of 2023 has been revised retrospectively due to the partial divestiture of the venture business.
現在來看我們的財務狀況。在回顧我們 2024 年上半年的財務表現之前,我想指出,財務報表首次以美元而不是瑞士法郎列示。此外,我需要強調的是,由於部分剝離了創投業務,2023 年上半年的損益表已追溯修訂。
The venture activities are reported now as discontinued operations. Continuing operations thus comprise the RNA delivery development programs as well as those related to AM-125. Overall, we were pretty much on track with expenses in the first half of 2024.
該合資企業的經營活動目前已宣布終止。因此,持續運作包括 RNA 遞送開發計劃以及與 AM-125 相關的計劃。整體而言,我們在 2024 年上半年的支出基本上符合預期。
Total operating loss from continuing operations was $3.9 million in the period compared against $3.6 million in the first half of 2023. The increase was primarily related to higher expenditures on research and development which increased 32.6% to $2 million. This was partially compensated by lower general and administrative expenses, which decreased 11.7% to $2 million.
本期持續經營業務的總營業虧損為 390 萬美元,而 2023 年上半年為 360 萬美元。成長主要與研發支出增加有關,研發支出成長了 32.6%,達到 200 萬美元。一般及行政費用下降了 11.7%,至 200 萬美元,部分彌補了這一損失。
Net loss from continuing operations reached $4.3 million in the first half of 2024, which was 4% lower than in the corresponding reporting period in 2023. Finance expense decreased markedly from $0.9 million to $0.2 million. On the other hand, the company recorded pro rate loss of its associate company, Altamira Medica of $0.2 million.
2024 年上半年持續經營業務淨虧損達 430 萬美元,比 2023 年同期報告虧損減少了 4%。財務費用從 90 萬美元大幅下降至 20 萬美元。另一方面,該公司記錄了其關聯公司 Altamira Medica 按比例虧損 0.20 萬美元。
In the first half of 2023, there was no such impact as Altamira Medica was deconsolidated and classified as associates only upon its partial devestiture in November 2023. The company's net loss for the first half of 2024 amounted to $4.3 million, which was 27% lower than the $5.9 million recorded in the first half of 2023.
2023 年上半年,由於 Altamira Medica 在 2023 年 11 月部分解散後被取消合併,並被歸類為聯營公司,因此沒有產生此類影響。該公司 2024 年上半年的淨虧損為 430 萬美元,比 2023 年上半年記錄的 590 萬美元減少了 27%。
During the first 6 months of 2023, the company had recorded an after-tax loss of $1.4 million from discontinued operations. There was no such loss recorded in the first half of 2024. Turning to the balance sheet. Here, we are not seeing major changes compared to December 31, 2023. Shareholders' equity amounted to $6.3 million as of June 30, 2024, compared with $7.7 million at year-end 2023.
2023 年上半年,該公司因終止經營業務而錄得稅後虧損 140 萬美元。2024年上半年沒有出現此類損失。接下來看一下資產負債表。與 2023 年 12 月 31 日相比,這裡並沒有發生重大變化。截至 2024 年 6 月 30 日,股東權益為 630 萬美元,而 2023 年底為 770 萬美元。
There was no financial debt outstanding at either time point. Cash used in operations decreased from $8.4 million in the first half of 2023 to $3.2 million in the first half of 2024. Financing activities provided $8.4 million in the first 6 months of 2023 versus $2.5 million in the first six months of 2024.
這兩個時間點均無未償債務。2023 年上半年經營活動所用現金為 840 萬美元,2024 年上半年經營活動所用現金為 320 萬美元。2023 年上半年融資活動收入為 840 萬美元,而 2024 年上半年為 250 萬美元。
Cash and cash equivalents on June 30, 2024, totaled $65,000 compared with $55,000 at June 30, 2023. Altamira expects total cash needs in 2024 to be in the range of $5.8 million to $7 million, which is slightly lower than initially budgeted. During the third quarter of 2024, the company raised $0.7 million from share issuances under the 2022 Commitment Purchase Agreement with Lincoln Park Capital Fund.
截至 2024 年 6 月 30 日,現金及現金等價物總額為 65,000 美元,截至 2023 年 6 月 30 日為 55,000 美元。Altamira 預計 2024 年的總現金需求將在 580 萬美元至 700 萬美元之間,略低於最初的預算。2024 年第三季度,該公司根據與林肯公園資本基金簽訂的 2022 年承諾購買協議,透過發行股票籌集了 70 萬美元。
In addition, last week, we received gross proceeds of $4 million, net $3.3 million upfront from a public offering of common shares and prefunded warrants in lieu of common shares, which have two types of milestone linked common share warrants attached.
此外,上週我們透過公開發行普通股和預付認股權證(代替普通股)獲得了 400 萬美元的總收益,其中預付淨額為 330 萬美元,這些認股權證附帶兩種與里程碑掛鉤的普通股認股權證。
These milestones are defined as positive bio-distribution data for our AM-401 and AM-411 nanoparticles which we seek to obtain in the course of 2025. The entry into one or more agreements relating further development commercialization for AM-401 or AM411 which we seek to obtain as mentioned on opening of an IND by the FDA in 2026 or completion of a Phase I clinical trial at the latest. Both milestones will be very significant for the company and could provide additional funding of up to $8 million.
這些里程碑被定義為我們的 AM-401 和 AM-411 奈米粒子的積極生物分佈數據,我們希望在 2025 年獲得這些數據。如前所述,我們將尋求在 2026 年 FDA 開啟 IND 或最遲完成 I 期臨床試驗後,就 AM-401 或 AM411 的進一步開發商業化達成一項或多項協議。這兩個里程碑對公司來說都意義重大,並可能帶來高達 800 萬美元的額外資金。
It is, however, to be noted that there can be no guarantee that the warrants will be exercised by the holders. With the current cash as well as expected proceeds from RNA delivery project revenues, our associate Altamira Medica, the partnering of AM-125 as well as from other sources, we consider our cash needs to be covered for the next 12 months. With this, let me conclude with a brief summary and some perspectives.
但要注意的是,不能保證認股權證持有人一定會行使這些認股權證。憑藉目前的現金以及 RNA 遞送專案收入的預期收益、我們的關聯公司 Altamira Medica、與 AM-125 的合作以及其他來源,我們認為我們未來 12 個月的現金需求將得到滿足。最後,讓我做一個簡要總結並提出一些看法。
At the beginning of today's presentation, I mentioned the growing momentum in our new core business of RNA delivery. It is very exciting to see the significant progress that we have been making over the past few months and quarters in our R&D.
在今天的演講開始時,我提到了我們新的核心業務——RNA遞送——日益增長的發展勢頭。看到我們在過去幾個月和幾季在研發方面取得的重大進展,我感到非常興奮。
I'm really proud of the great achievements of our strong and highly motivated RNA team. both with sRNA and mRNA applications. Progress in the latter is particularly noteworthy since mRNA formulation and delivery are generally considered to be challenging.
我為我們實力雄厚、積極進取的RNA團隊所取得的巨大成就感到非常自豪,無論是在sRNA或mRNA應用方面。後者的進展尤其值得關注,因為 mRNA 的製備和遞送通常被認為是具有挑戰性的。
Not the least due to such challenges, the use of mRNA for therapeutics has barely begun. We have just scratched the surface of something that will become a very powerful approach in human medicine. From our business development context, we are seeing a very significant potential for our OligoPhore and SemaPhore platforms.
正是由於這些挑戰,mRNA在治療領域的應用才剛起步。我們僅僅觸及了皮毛,而這將會成為人類醫學中非常強大的方法。從我們的業務發展角度來看,我們看到了 OligoPhore 和 SemaPhore 平台的巨大潛力。
We certainly still have some way to go with our R&D. There will soon be much more in vivo work with bio-distribution being a key focus for our activities. I'm glad that going forward, we can benefit for our work from the well-equipped lab facilities at the Switzerland innovation part as well as from our growing network of specialized external service providers.
我們的研發工作顯然還有很長的路要走。不久之後,我們將進行更多體內研究,生物分佈將成為我們研究工作的重點。我很高興,展望未來,我們可以利用瑞士創新中心設備齊全的實驗室設施以及我們不斷壯大的專業外部服務提供者網路來開展工作。
As for our legacy assets, our associate, Altamira Medica keeps executing on its growth strategy. We expect to see a significant increase in revenues in 2025 from distributors driven by the anticipated launches in Mainland China, Southeast Asia, Sweden, and Denmark, as well as certain other countries. Given the strongest efficacy good tolerability of [venturing] allergy, we see a good partnering potential in other key markets.
至於我們的傳統資產,我們的關聯公司 Altamira Medica 將繼續執行其成長策略。我們預計,在中國大陸、東南亞、瑞典、丹麥以及其他一些國家的預期產品上市推動下,2025 年分銷商的收入將大幅成長。鑑於其在抗過敏方面具有極強的療效和良好的耐受性,我們認為在其他重點市場具有良好的合作潛力。
Meanwhile, we are positioning AM-125 for partnering as an innovative, reformulated drug product with significant sales potential vertical, but also in other disorders of the central nervous system. In short, we look forward to advancing our projects towards important new milestones and to updating you with further reports about our progress. With that, I would now like to turn the call back to the operator to open the lines for questions.
同時,我們將 AM-125 定位為具有巨大銷售潛力的創新改良藥物產品,可用於垂直領域以及其他中樞神經系統疾病的治療。簡而言之,我們期待著推進我們的項目,邁向重要的新里程碑,並向您報告我們的進度。接下來,我想把電話轉回給接線生,以便接聽提問電話。
Operator
Operator
(Operator Instructions)
(操作說明)
Hunter Diamond of Diamond Equity.
鑽石股權公司的獵人鑽石。
Hunter Diamond - Analyst
Hunter Diamond - Analyst
Yes. congratulations on the results. Most of my questions are answered but my question relates to bench of distribution in Sweden and in Denmark. Now it's been launched in Norway, can you discuss the marketing approach in Norway or partnerships to replicate the success you've had in Norway within the new markets?
是的,恭喜你取得這樣的成績。我的大部分問題都得到了解答,但我的問題與瑞典和丹麥的分銷管道有關。現在產品已在挪威上市,您能否談談在挪威的行銷策略或合作夥伴關係,以便將您在挪威的成功複製到新市場?
Thomas Meyer - Chairman of the Board, Chief Executive Officer
Thomas Meyer - Chairman of the Board, Chief Executive Officer
Hi Hunter, yeah. Pharma Nordic is pursuing here a very good strategy. They are actually working with a network of physicians. So this is allergologists and ENT physicians, so to familiarize them with the product. At the same time, they have a sales force calling on the pharmacies.
嗨,Hunter,是的。北歐製藥公司正在推行一項非常好的策略。他們實際上是在與一個醫生網絡合作。所以,這是針對過敏科醫生和耳鼻喉科醫生的,目的是讓他們熟悉產品。同時,他們也派出了銷售團隊拜訪藥局。
They have also been using social media quite extensively. And just one example was that the tick tock event, which was just three minutes, something like that, which generated within three or four days, about 700,000 views and 500 or 600 comments.
他們也一直在廣泛使用社群媒體。舉個例子,例如「滴答滴答」活動,時長只有三分鐘左右,在三到四天內就產生了大約 70 萬次觀看和 500 或 600 條評論。
So it's an approach that plays on various levels. Now Pharma Nordic has pretty detailed plans here also for Sweden and Denmark. I mean, each country, of course, is a little bit different. However, they're all Scandinavian and so therefore, there also benefits here from applying, let's say, marketing materials and experiences to the other countries.
所以這是一種多層次的方法。現在,Pharma Nordic 也針對瑞典和丹麥制定了相當詳細的計畫。我的意思是,當然,每個國家的情況都略有不同。然而,它們都是斯堪的納維亞國家,因此,將行銷材料和經驗應用到其他國家也會有好處。
So the whole team there is pretty motivated to get going next year. And of course, at the same time, continue the ramp-up in Norway. I mean, we all know from experience that this is a process that takes several years here before you can have a really significant share of the market.
所以整個團隊都很有動力在明年大展身手。當然,同時,也要繼續在挪威加大生產力。我的意思是,我們都從經驗中得知,在這裡,你需要幾年的時間才能真正佔據相當大的市場份額。
But the start has been very promising, and I think it's also a good sign that Pharma Nordic was very positive and very keen actually on expanding the territory.
但開局非常順利,而且我認為 Pharma Nordic 非常積極,並且非常熱衷於拓展業務版圖,這也是一個好兆頭。
Hunter Diamond - Analyst
Hunter Diamond - Analyst
Great, thank you. And the second question, I don't know how much it relates to, but Moderna, and I'm sure you know some of these large mRNA companies have cut their R&D budgets. Is there any effect on your business or any thoughts on that? Like how it affects smaller enterprises related to larger companies, maybe it's a benefit to smaller businesses that there's less R&D at larger corporations?
太好了,謝謝。第二個問題,我不知道它與 Moderna 有多大關係,但我相信你也知道,一些大型 mRNA 公司已經削減了研發預算。這會對您的業務造成什麼影響?或者您對此有什麼看法?就像它對隸屬於大公司的小型企業的影響一樣,也許大公司研發投入較少對小型企業來說反而是一種優勢?
Thomas Meyer - Chairman of the Board, Chief Executive Officer
Thomas Meyer - Chairman of the Board, Chief Executive Officer
Yeah. Well, I think there is still a lot's of work and activity at companies like Moderna I mean, I'm certainly not the right person here to comment on Moderna's R&D plans whatsoever. I mean what I can say is simply that the use of mRNA here for therapeutics, and of course, other vaccines still holds tremendous potential I would rather see this a little bit here as focusing strategy.
是的。嗯,我認為像 Moderna 這樣的公司仍然有很多工作和活動要做。我的意思是,我當然不是評論 Moderna 研發計劃的合適人選。我的意思是,我只能說,mRNA 在治療領域,當然還有其他疫苗領域,仍然具有巨大的潛力。我更願意看到它在這裡作為一種重點策略。
Of course, you can pursue many different projects at the same time. But it requires, obviously, certain resources. Now what we see here is clearly the upside with mRNA. I mean you can really boost here certain biological activities.
當然,你可以同時進行許多不同的專案。但顯然,這需要一定的資源。現在我們顯然看到了mRNA的優勢。我的意思是,在這裡確實可以促進某些生物活動。
And when you think of small molecules, I mean, the majority vast majority of small molecules, they inhibit or block things and for that, you can use siRNA and sRNA has a very good potential. Now for small molecules to actually enhance or boost certain activity that has been always a very, very big challenge. And now with mRNA, you can do this in a very targeted and specific fashion and that's going to really revolutionize medicine.
說到小分子,我的意思是,絕大多數小分子,它們都能抑製或阻斷某些東西,而對於這一點,你可以使用 siRNA,sRNA 具有非常好的潛力。要讓小分子真正增強或提高某些活性,一直以來都是非常非常大的挑戰。現在有了mRNA,就可以以非常有針對性和特異性的方式進行治療,這將真正革新醫學。
It's not just me saying this, I'm definitely not the most, let's say, knowledgeable person to comment on this, but I mean this is clearly what we feel, what we hear at conferences mRNA that's going to be bright future. And I think what we have read or heard here about some program adjustments that is not deviating at all from the long-term trend that is going on.
這並非我個人的觀點,我當然不是這方面最了解的人,但我的意思很明顯,這是我們在會議上聽到的,也是我們感受到的,mRNA 的未來一片光明。我認為我們在這裡讀到或聽到的一些關於專案調整的消息,與正在進行的長期趨勢完全一致。
Hunter Diamond - Analyst
Hunter Diamond - Analyst
Okay. Great, no. Exactly. I just was curious because you are more immersed in the area from conferences. So i was just wondering your take on it. Okay thank you for taking my questions.
好的。太好了,不。確切地。我只是好奇,因為你透過參加會議對這個領域更加了解。所以我想知道你對此有何看法。好的,謝謝您回答我的問題。
Operator
Operator
(Operator Instructions)
(操作說明)
I'm showing no further questions. We will now turn the call back over to management for any concluding remarks.
我不再提問。現在我們將把電話交還給管理階層,請他們作總結性發言。
Thomas Meyer - Chairman of the Board, Chief Executive Officer
Thomas Meyer - Chairman of the Board, Chief Executive Officer
Yeah, Thank you, Antonia. I believe we have covered all major topics today. So, I will simply thank everyone for attending this morning's call and for the questions. And I will wish you a terrific day ahead. Thank you, bye.
是的,謝謝你,安東妮亞。我相信我們今天已經涵蓋了所有主要議題。所以,我只想感謝大家今天早上參加電話會議並提出問題。祝您今天過得愉快。謝謝,再見。
Operator
Operator
And this concludes today's conference call. Thank you for participating. You may now disconnect.
今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線了。