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Altamira Therapeutics Provides Business Update

Altamira Therapeutics Provides Business Update

Altamira Therapeutics提供業務最新情況
Altamira Therapeutics ·  05/28 12:00

Hamilton, Bermuda, May 28, 2024 (GLOBE NEWSWIRE) --

百慕大漢密爾頓,2024年5月28日(環球新聞線)--

  • Achieved significant improvement in handling and transport stability of RNA nanoparticles
  • Pursuing partnering opportunities with AM-125 legacy asset in vertigo and / or potential other CNS indications
  • Streamlining corporate structure; switch in financial reporting from Swiss Francs to US Dollars
  • 取得了RNA納米顆粒處理運輸穩定性的顯著提高。
  • 追尋與AM-125的合作伙伴關係,在眩暈和/或其他潛在中樞神經系統適應症方面。
  • 簡化企業結構;從瑞士法郎轉換爲美元進行財務報告切換。

HAMILTON, BERMUDA / May 28, 2024 / Altamira Therapeutics Ltd. ("Altamira" or the "Company") (Nasdaq:CYTO), a company dedicated to developing and commercializing RNA delivery technology for targets beyond the liver, today provided a business update related to its RNA delivery platform, partnering of its legacy assets, corporate structuring and financial reporting.

百慕大漢密爾頓/2024年5月28日/Altamira Therapeutics Ltd.(“Altamira”或“公司”)(納斯達克:CYTO),一家致力於開發和商業化RNA遞送技術,瞄準肝臟以外目標的公司,今天提供了與其RNA遞送平台、合作伙伴的資產、企業結構和財務填報相關的業務更新。

Altamira's development work has resulted in significant enhancement of RNA nanoparticle stability, which has been one of the key challenges in the handling and transport of RNA formulations. Thanks to its new flow process production method, the Company obtained formulations of OligoPhore nanoparticles which are stable in liquid form when stored at 4°C for a period of at least three weeks. These formulations were, in addition, able to withstand shaking stress without significant changes in size, encapsulation or activity.

Altamira的開發工作已經取得了RNA納米顆粒的顯著穩定性增強,這一直是RNA製劑處理和運輸的主要挑戰之一。由於新的流程生產方法,公司得到了OligoPhore納米顆粒的製劑,在4℃的液態狀態下至少保存三週且具有穩定性。除此之外,這些製劑還能經受得住震盪應力而不會明顯改變尺寸、封裝或活性。

"The ability of nanoformulations to maintain their attributes during shaking stress is essential for transportation and one of the key limitations of lipid nanoparticles,1 the most common type of RNA delivery vehicles. These limitations became evident during the COVID-19 pandemic with significant resources being devoted towards transport logistics and storage capacity in frozen form," commented Covadonga Pañeda, Ph.D., Altamira Therapeutics' Chief Development Officer. "We are very excited about this major progress in making our formulations significantly more stable than the current state of the art, which requires freezing and other measures. The recently announced merger between two well-known privately-held RNA companies highlighted once again the high importance of RNA delivery technologies. Even the most potent RNA sequence will be useless if it cannot be delivered effectively and safely to its target. With our OligoPhore / SemaPhore platforms we can offer partners in pharma or biotech effective and safe solutions for delivering their siRNA, mRNA or other RNA modalities to extrahepatic targets and efficient endosomal release within those target cells and as the new results show, we may also be able to reduce the hurdles associated with transport."

“納米制劑在震盪應力下維持其屬性的能力對於運輸而言至關重要,這也是脂質納米顆粒的主要限制因素,是RNA遞送載體的最常見類型。這些限制在COVID-19流行期間變得尤爲明顯,導致大量資源被投入到冷鏈物流和存儲容量方面。” Altamira Therapeutics首席研究官Covadonga Pañeda博士評論道:“我們對這一重大進展感到非常興奮,因爲能夠使我們的製劑比現有技術更穩定,這需要冰凍和其他措施。最近宣佈的兩家著名私人RNA公司的合併再次凸顯了RNA遞送技術的重要性。即使是最強大的RNA序列,如果不能有效且安全地傳遞到其目標,也是無用的。使用我們的OligoPhore / SemaPhore平台,我們可以爲製藥或生物技術的合作伙伴提供傳遞其siRNA,mRNA或其他RNA模式到肝臟以外靶點以及內向體液囊泡釋放的有效且安全解決方案,正如新的結果所顯示的那樣,我們也許能夠降低運輸方面面臨的障礙。” 1“納米制劑在震盪應力下維持其屬性的能力對於運輸而言至關重要,這也是脂質納米顆粒的主要限制因素,是RNA遞送載體的最常見類型。這些限制在COVID-19流行期間變得尤爲明顯,導致大量資源被投入到冷鏈物流和存儲容量方面。” Altamira Therapeutics首席研究官Covadonga Pañeda博士評論道:“我們對這一重大進展感到非常興奮,因爲能夠使我們的製劑比現有技術更穩定,這需要冰凍和其他措施。最近宣佈的兩家著名私人RNA公司的合併再次凸顯了RNA遞送技術的重要性。即使是最強大的RNA序列,如果不能有效且安全地傳遞到其目標,也是無用的。使用我們的OligoPhore / SemaPhore平台,我們可以爲製藥或生物技術的合作伙伴提供傳遞其siRNA,mRNA或其他RNA模式到肝臟以外靶點以及內向體液囊泡釋放的有效且安全解決方案,正如新的結果所顯示的那樣,我們也許能夠降低運輸方面面臨的障礙。”

Pursuing partnering opportunities with the AM-125 program in vertigo and / or other CNS indications

在眩暈和/或其他中樞神經系統適應症方面,追尋與AM-125方案的合作伙伴關係。

Altamira continues to make progress with the planned partnering of its legacy asset AM-125, a patented nasal spray formulation of the histamine analog betahistine. AM-125 has been developed for the treatment of acute vestibular syndrome (AVS) to provide an alternative to current standard of care treatment with oral betahistine, which is hampered by poor bioavailability. A phase 2 clinical trial in Europe demonstrated that a four-week treatment course with AM-125 in AVS patients was well tolerated and helped to accelerate vestibular compensation enabling patients to regain balance and recover faster. To date, Altamira invested about 18 million US dollars in the program.

Altamira繼續在計劃中的與其受保護的鼻噴霧製劑AM-125的合作伙伴關係方面取得進展。AM-125已經開發用於治療急性前庭綜合徵(AVS),以提供一種替代口服苯扎氨基丁酸的標準治療方式,該治療方式受到生物可用性低的影響。歐洲的II期臨床試驗表明,在AVS患者中接受爲期四周的AM-125治療具有良好的耐受性,並幫助加速前庭補償,使患者恢復平衡,恢復更快。迄今爲止,Altamira已在該項目上投資約1800萬美元。

Apart from its potential in AVS treatment, AM-125 is expected to have clinical utility in other central nervous system disorders known for the involvement of histamine. Studies by independent research groups have shown clinical benefits of betahistine in the treatment of Attention-deficit / hyperactivity disorder (ADHD), cognitive function in dementia, memory loss and weight gain, among others. Altamira's own research with intranasal betahistine demonstrated a statistically significant decrease in weight gain under antipsychotic treatment. Histamine is also a known pharmacologic target in narcolepsy, Prader-Willi Syndrome, for which Altamira has an Orphan Drug designation, or Tourette syndrome. From discussions with potential partners, Altamira is seeing interest in AM-125's potential in such other potential indications in particular for the US market, where there is currently no oral betahistine marketed.

除了在AVS治療方面的潛力外,預計AM-125還具有在已知有組織胺參與的其他中樞神經系統疾病方面的臨床功效。獨立研究小組的研究表明,苯扎氨基丁酸在治療注意缺陷/多動障礙(ADHD)、老年癡呆症的認知功能、記憶喪失和體重增加方面具有臨床效益,以及其他方面。Altamira用鼻內苯扎氨基丁酸的研究表明,在抗精神病藥物治療下,體重增加顯著減少。已知組織胺在小睡病、普拉德綜合症(對此Altamira獲得了孤兒藥指定),或者抽動症中是一種已知藥理靶點。Altamira正在與潛在合作伙伴進行討論,看到AM-125在其他潛在適應症方面的潛力,特別是在當前美國市場上沒有口服苯扎氨基丁酸的情況下。

Continued simplification of group structure

繼續簡化公司結構

In the first half of 2024, the Company has continued its efforts to simplify its corporate structure and align it with the strategic repositioning around its RNA delivery platform. In a first step, it partially divested its Bentrio activities by selling 51% of Altamira Medica AG (including the Australian subsidiary Auris Medical Pty Ltd) in November 2023. In a second step, the Company transferred its Irish subsidiary Auris Medical Ltd. to Altamira Medica AG (which renamed it Altamira Medica Ltd.). Further, the Company is about to merge two of its subsidiaries in Basel (Switzerland), Auris Medical AG and Altamira Therapeutics AG. The merged entity will be called Altamira Therapeutics AG and continue to serve as the core operating subsidiary of the Company. Following completion of the merger, the Altamira Group will comprise the parent company Altamira Therapeutics Ltd. (Hamilton, Bermuda), and its subsidiaries Altamira Therapeutics AG (Basel, Switzerland), Altamira Therapeutics Inc. (Newark DE, USA), Otolanum AG (Basel, Switzerland) as well as the associated company Altamira Medica AG (Basel, Switzerland).

在2024年上半年,公司繼續努力簡化其企業結構,並將其調整到其RNA遞送平台的戰略重新定位之上。在第一步中,它通過出售其Altamira Medica AG的51%(包括澳大利亞子公司Auris Medical Pty Ltd)於2023年11月部分剝離其Bentrio活動。在第二步中,公司將其愛爾蘭子公司Auris Medical Ltd.轉讓給了Altamira Medica AG(並將其更名爲Altamira Medica Ltd.)。此外,公司即將合併其在巴塞爾(瑞士)的兩家子公司Auris Medical AG和Altamira Therapeutics AG。合併後的實體將被稱爲Altamira Therapeutics AG,並繼續作爲公司的核心運營子公司。合併完成後,Altamira Group將包括母公司Altamira Therapeutics Ltd.(百慕大漢密爾頓),其子公司Altamira Therapeutics AG(瑞士巴塞爾),Altamira Therapeutics Inc.(美國紐瓦克DE),Otolanum AG(瑞士巴塞爾)以及相關公司Altamira Medica AG(瑞士巴塞爾)。

Switch to financial reporting in US Dollars

切換到美元財務報告

Altamira plans to release its half-year 2024 financial results and business update report by the end of August 2024. The financial results will be presented for the first time in US Dollars, which the Company adopted as its new reporting currency, replacing the Swiss Franc. The Special General Meeting of Altamira held on October 31, 2023 had already approved to change the currency denomination of the authorized share capital from Swiss Francs to US Dollars. Since the Company's common shares are publicly listed only in the US and a majority of the Company's shareholders are domiciled in the US, Altamira expects the switch in reporting currency to facilitate the communication with investors and the financial community.

Altamira計劃於2024年8月底發佈其上半年2024財務業績和業務更新報告。該財務業績將首次以美元呈現,公司已經將其採用爲新的報告貨幣,取代了瑞士法郎。Altamira於2023年10月31日舉行的特別股東大會已經批准以美元更改授權股本的貨幣記賬方式。由於公司的普通股僅在美國上市,而公司的大多數股東都居住在美國,因此,Altamira預計切換財務報告貨幣將有助於與投資者和金融界進行溝通。

About Altamira Therapeutics

關於Altamira Therapeutics

Altamira Therapeutics (Nasdaq: CYTO) is developing and supplying peptide-based nanoparticle technologies for efficient RNA delivery to extrahepatic tissues (OligoPhore / SemaPhore platforms). The Company currently has two flagship siRNA programs using its proprietary delivery technology: AM-401 for KRAS driven cancer and AM-411 for rheumatoid arthritis, both in preclinical development beyond in vivo proof of concept. The versatile delivery platform is also suited for mRNA and other RNA modalities and made available to pharma or biotech companies through out-licensing. In addition, Altamira holds a 49% stake (with additional economic rights) in Altamira Medica AG, its commercial-stage legacy asset Bentrio, an OTC nasal spray for allergic rhinitis. Further, the Company is in the process of partnering / divesting its inner ear legacy assets. Founded in 2003, Altamira is headquartered in Hamilton, Bermuda, with its main operations in Basel, Switzerland. For more information, visit: https://altamiratherapeutics.com/

Altamira Therapeutics(Nasdaq:CYTO)正在開發和提供基於肽的納米顆粒技術,以有效遞送RNA到肝臟外組織(OligoPhore / SemaPhore平台)。公司目前擁有兩個旗艦siRNA項目,均使用其專有的遞送技術:AM-401​​用於KRAS驅動的癌症和AM-411用於類風溼性關節炎,均爲體內概念證明之外的臨床前開發。多功能遞送平台也適用於mRNA和其他RNA模式,並通過出許可證向製藥或生物技術公司提供。此外,Altamira持有Altamira Medica AG的49%股份(附加經濟權益),其商業化階段的遺產資產Bentrio是一種OTC鼻噴霧劑,用於過敏性鼻炎。此外,公司正在進行內耳遺產資產的合作/剝離過程。Altamira成立於2003年,總部位於百慕大哈密爾頓,主要運營地點位於瑞士巴塞爾。有關更多信息,請訪問:https://altamiratherapeutics.com/

Forward-Looking Statements

前瞻性聲明

This press release may contain statements that constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are statements other than historical facts and may include statements that address future operating, financial or business performance or Altamira's strategies or expectations. In some cases, you can identify these statements by forward-looking words such as "may", "might", "will", "should", "expects", "plans", "anticipates", "believes", "estimates", "predicts", "projects", "potential", "outlook" or "continue", or the negative of these terms or other comparable terminology. Forward-looking statements are based on management's current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include, but are not limited to, the success of strategic transactions, including licensing or partnering, with respect to Altamira's legacy assets, Altamira's need for and ability to raise substantial additional funding to continue the development of its product candidates, the clinical utility of Altamira's product candidates, the timing or likelihood of regulatory filings and approvals, Altamira's intellectual property position and Altamira's financial position, including the impact of any future acquisitions, dispositions, partnerships, license transactions or changes to Altamira's capital structure, including future securities offerings. These risks and uncertainties also include, but are not limited to, those described under the caption "Risk Factors" in Altamira's Annual Report on Form 20-F for the year ended December 31, 2023, and in Altamira's other filings with the Securities Exchange Commission ("SEC"), which are available free of charge on the SEC's website at: www.sec.gov. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated. All forward-looking statements and all subsequent written and oral forward-looking statements attributable to Altamira or to persons acting on behalf of Altamira are expressly qualified in their entirety by reference to these risks and uncertainties. You should not place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and Altamira does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law.

本新聞稿可能包含構成《1933年證券法》第27A條修正案和《1934年證券交易法》第21E條修正案所述“前瞻性聲明”的陳述。前瞻性聲明是指除歷史事實以外的其他陳述,可能包括涉及未來營運、財務或業務績效或Altamira的策略或期望的陳述。在某些情況下,您可以通過前瞻性詞語,例如“可能”、“可能會”、“將要”、“應該”、“預期”、“計劃”、“預計”、“相信”、“估計”、“預測”、“項目”、“潛在”、“前景”或“繼續”,或這些術語的否定形式或其他可比較的術語來識別這些陳述。前瞻性聲明基於管理層的當前期望和信念,並涉及重大的風險和不確定性,可能導致實際結果、發展和業務決策與這些聲明所考慮的差異顯著。這些風險和不確定性包括但不限於戰略交易的成功,包括針對Altamira的舊資產進行許可或合作交易,Altamira需要並有能力籌集大量額外資金以繼續開發其產品候選方案,Altamira產品候選方案的臨床實用性,法規申報和批准的時間或可能性,Altamira的知識產權地位和Altamira的財務狀況,包括任何未來的收購、出售、合作伙伴關係、許可交易或Altamira資本結構的變化,包括未來的證券發行。這些風險和不確定性還包括但不限於在Altamira的2023年20-F年度報告的“風險因素”標題下所述,並在Altamira的其他提交給證券交易委員會(“SEC”)的備案文件中所述,這些文件可免費在SEC的網站www.sec.gov上獲取。如果這些風險或不確定性中的一個或多個變成現實,或者基礎假設被證明不正確,則實際結果可能與所示指標有所不同。所有前瞻性聲明以及所有隨後的書面和口頭前瞻性聲明,均歸屬於Altamira或代表Altamira行事的人員,並在其整體上明確地參照了這些風險和不確定性。您不應過度依賴前瞻性聲明。前瞻性聲明僅在其發表之日起生效,Altamira無義務因新信息、未來發展或其他原因更新前瞻性聲明,除非依據適用法律所要求。


1 Ruppl et al., 2024, Don't shake it! Mechanical stress testing of mRNA-lipid nanoparticles, Eur J Pharm Biopharm 198:114265. https://pubmed.ncbi.nlm.nih.gov/38492867

1Ruppl等人,2024年,《歐洲藥學與生物製劑學雜誌》,《不要搖晃!mRNA-脂質納米粒子機械應力測試》,198:114265。https://pubmed.ncbi.nlm.nih.gov/38492867

譯文內容由第三人軟體翻譯。


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