附件99.3
Altamira生物提供業務更新和2024年上半年財務業績
| ● | 公司將於今日東部時間上午8點30分舉辦電話會議 |
| ● | RNA傳遞核心業務持續取得進展，得到新的研發設施支持 |
| ● | 獨立研究小組的出版物提供了新的證據，證明mRNA成功傳遞至肝外靶標 |
| ● | 與兩家分銷合作伙伴進行重要的領土擴張，爲Bentrio® |
| ● | 財務 結果首次以美元而非瑞士法郎呈現 |
百慕大，漢密爾頓 - 2024年9月24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遞送技術以應對肝臟之外目標的公司，今天提供了業務更新並報告了其2024年上半年財務業績。
「我們很興奮能夠繼續推動我們在RNA遞送方面的新核心活動，」Altamira Therapeutics的創始人、主席和首席執行官Thomas Meyer評論道。「最近在一家頂尖科學期刊上公佈的新鮮體內數據顯示，在治療中，肉瘤和乳腺癌的生長出現明顯減少」 Zbtb46 mRNA利用我們的SemaPhore納米粒子技術遞送。 當與抗PD1治療聯合使用時，這種抗腫瘤效果進一步增強。這些令人印象深刻的結果增加了支持RNA治療潛力的日益增長的證據，以及我們的平台有效且安全地將RNA分子遞送至肝臟以外的靶細胞，尤其是在癌症和炎症性疾病方面。”
邁耶先生說：「我們正在推進OligoPhore和SemaPhore平台的開發，以及我們在KRAS驅動的癌症和類風溼性關節炎中的Am-401和Am-411旗艦項目，受益於我們在瑞士巴塞爾地區瑞士創新園區獲得的新實驗室空間。與此同時，我們正在評估我們的平台是否可用於心臟再生和mRNA疫苗的聯合項目，與兩個合作伙伴合作，並尋求與其他製藥和生物科技公司的額外合作機會。此外，我們正繼續努力完成圍繞RNA輸送而進行的戰略重新定位，通過合作伙伴關係，在內耳治療方面的傳統資產。最後，由於最近進行了股票公開發行，我們已經能夠加強我們的財務狀況，以便過渡到基於合同開發和許可我們的RNA輸送技術的資本投入要少得多的商業模式。」
RNA 遞送 科技
Altamira核心業務的RNA傳遞公司的研發活動——基於其肽基OligoPhore™和SemaPhore™納米顆粒平台——不斷取得進展。關鍵重點放在納米顆粒配方和工藝開發上，圍繞這些平台進行納米顆粒的評估和開發，用於遞送特定siRNA或mRNA有效載荷的合作伙伴，並針對KRAS驅動的癌症和風溼性關節炎（RA）的兩個旗艦項目Am-401或Am-411的治療。2024年8月，公司不斷擴大的研發團隊中的一部分搬遷至瑞士奧爾施維爾的瑞士創新園區。在新的地點，公司可以利用現代化且設備齊全的實驗室設施來支持其不斷增長的活動。
Altamira的RNA輸送平台的有效性和多功能性的證據不斷增加，正如最近兩篇科學出版物所示：
| ● | 在 一篇經過同行評審的文章 自然免疫學，密蘇里州聖路易斯華盛頓大學的一個研究小組表明，系統性的 的交付 zbtb46 肉瘤和轉移性乳腺癌小鼠模型中含有 SemaPhore 納米顆粒的 mRNA 導致了持續的 zbtb46 表達，免疫刺激性腫瘤微環境得到恢復，腫瘤生長顯著減少（p<0.0001）。1 當與免疫檢查點抑制劑（抗PD1）治療聯合使用時，療效更加明顯。根據提交人的說法, 這個”zbtb46 納米顆粒在抗 PD1 反應 [肉瘤] 和抗 PD1 難治性中均可誘發顯著的抗 PD1 反應 [乳腺癌] 腫瘤模型，使許多接受治療的動物的腫瘤長期完全緩解。”延長單一療法 和 zbtb46 即使在對抗PD1萬億不耐藥的小鼠體內，納米顆粒也能完全緩解。肉瘤被消滅的小鼠 經過治療，在反覆挑戰後未出現其他腫瘤，這表明保護性免疫學的發展 記憶。 |
| 1 | Kabir AU等人（2024年），ZBTB46協調血管生成和免疫以控制腫瘤結果， Nat Immunol https://www.nature.com/articles/s41590-024-01936-4。 |
| ● | 另一個來自華盛頓大學的研究小組在一份預印本出版物中展示了一項研究的結果，該研究表明，治療 Sod2 mRNA通過SemaPhore納米顆粒系統性輸送給腹主動脈瘤（AAA）的小鼠，導致主動脈擴張顯著減少（p<0.05），延遲破裂並顯著改善生存率（p<0.01）。2 AAA是一種涉及氧化應激的炎症性疾病，由於過高水平的活性氧種類導致腹主動脈異常擴大（凸起）。 AAA破裂可能危及生命。 |
與此同時，Altamira自己的開發工作導致了納米粒子穩定性的顯著提高，這一直是RNA配方的處理和 運輸 中的關鍵挑戰之一。由於公司採用了新的流程生產方法，獲得了在4°C條件下儲存至少一個月的液體形式下穩定的OligoPhore納米顆粒配方。這些配方此外還能夠在經受搖動應力的情況下保持穩定，而不發生重大的理化變化。納米配方在搖動應力下保持其特性的能力對於運輸至關重要，也是脂質納米顆粒這種最常見的RNA遞送載體的一個關鍵限制。
對於其專有開發項目Am-401和Am-411，Altamira在2024年上半年向美國專利及商標局提交了專利申請。這些旨在補充現有的知識產權並延長保護期限。對於Am-401，覆蓋不同的KRAS突變體在癌症治療中使用包含OligoPhore平台和單一siRNA序列的納米顆粒， 聚平均值：3.6突變的尋求。體外數據證實了 聚平均值：3.6突變 siRNA可以用來沉默攜帶以下變異的KRAS基因：G12C、G12V、G12D、G12R、G12A和A146億，這些變異在胰腺癌、結直腸癌和非小細胞肺癌中佔據了大多數。對於Am-411，正在尋求覆蓋靶向NF-κB 轉錄因子p65蛋白的siRNA序列的納米粒子，以及OligoPhore。已觀察到p65在多種癌症類型以及許多炎症性疾病中的激活。例如，在類風溼關節炎炎症中，p65是一個著名的重要檢查點，並被認爲在調節細胞增殖、細胞死亡和刺激癌症轉移中發揮作用。該公司計劃將Am-401和Am-411均推進至2026年向美國食品藥品監督管理局（FDA）提交新藥審批（IND），並在此之後或在最遲進行第1期臨床試驗後將它們進行外包授權。
Altamira正在追求RNA輸送業務的「拿着鎬頭挑選」策略，該策略基於授權其平台科技給生物科技和製藥行業的合作伙伴，供其用於自身的RNA藥品開發項目。第一批此類合作已經建立：
| ● | 與Heqet Therapeutics s.r.l.合作，Altamira正在研究基於OligoPhore平台的納米顆粒，其中包括某些非編碼RNA（ncRNA），用於在動物模型中實現心肌梗死後的心臟組織再生。 |
| 2 | Yan等（2024），將小鼠SOD2 mRNA系統傳遞至實驗性腹主動脈瘤，減輕擴張和破裂，bioRxiv：2024.06.17.599454。https://www.biorxiv.org/content/10.1101/2024.06.17.599454v1。 |
2
| ● | 藉助基於比利時的Univercells Group Altamira公司評估使用SemaPhore平台進行mRNA疫苗傳遞。由於電芯進入過程中mRNA損失較低，納米顆粒可能允許使用更低劑量，從而可能導致更有效和更高效的疫苗。 |
在這些評估取得積極成果後，Altamira及其合作伙伴打算討論並談判許可協議。通過其業務發展活動，公司正在尋求與其他製藥和生物技術公司的合作機會。
Bentrio® 鼻噴霧
Altamira Medica AG（「Medica」）的關聯公司在實施其增長策略時取得了進展，與Bentrio公司合作良好®一款無藥物、無防腐劑的鼻噴劑用於治療過敏性鼻炎。與其國際分銷商中的兩家公司最近同意擴大其專屬分銷領域：
| ● | 與Nuance Pharma（「Nuance」）合作，擴大在東南亞和東亞的領土。 根據修訂後的協議，Nuance的領土將從中國、香港、澳門和韓國擴展到新加坡、馬來西亞、泰國、菲律賓、印度尼西亞、越南和臺灣，總人口超過63000萬。Nuance自2022年底以來一直在香港營銷Bentrio，並最近提交了在中國大陸獲得營銷批准的申請。 |
| ● | 與Pharma Nordic合作，將領域從挪威擴展到瑞典和丹麥，這兩個國家的人口總共達到1650萬。Pharma Nordic於2024年成功在挪威推出Bentrio，並計劃於2025年將該產品引入瑞典和丹麥。 |
此外，針對在美國、歐洲和其他主要市場的分銷，討論和談判正在進行中。
Bentrio的療效和安全性已在總共四項臨床試驗中得到證實。 其中規模最大的一項（「NASAR」研究）在澳洲招募了100名患有季節性過敏性鼻炎的患者，最近在過敏症學領域的一本主要科學期刊上發表了一篇同行評議的文章。3 在NASAR研究中，參與者自行每天三次使用Bentrio或鹽水鼻噴霧兩週。 該研究顯示，與鹽水相比，Bentrio的每日反思性總鼻症狀評分（rTNSS）有統計學上顯著的減少（p = 0.013），並且在與健康相關的生活質量（Rhinoconjunctivitis Live Questionnaire）上有統計學上極其顯著的改善（p < 0.001）以及患者和調查員對Bentrio療效的全球評級均更高（p < 0.001）。此外，Bentrio表現出良好的安全性和耐受性，與鹽水對照組類似，使用緩解藥物的患者較少，並且其中更多的患者享受無症狀的日子與鹽水治療相比。
在其戰略轉向RNA遞送的背景下，Altamira於2023年11月將Medica的51%股權出售給一家瑞士私募股權投資者，以大約$230萬的現金考慮。在未來Medica的許可收入中，Altamira將有權獲得25%，並且在出售時Medica的價值增值中也同樣如此，這捕捉了業務上漲潛力的另一份份額。
| 3 | 貝克爾等人（2024年）在季節性過敏性鼻炎中，Am-301，一種形成屏障的鼻噴劑，與鹽水噴霧進行對照的隨機臨床試驗，過敏 79(7):1858-67。https://onlinelibrary.wiley.com/doi/10.1111/all.16116 |
3
內耳治療
Altamira 繼續努力尋求其內耳治療資產的合作伙伴關係，特別是 Am-125，一種專利的鼻噴霧，用於治療急性前庭綜合徵（AVS），該藥物也可能用於其他多種中樞神經系統疾病。Am-125 是 β組胺劑的重製劑，β組胺劑是世界許多國家中治療眩暈的標準治療方法。歐洲的一項2期臨床試驗表明，AVS 患者經過爲期四周的 Am-125 治療後耐受性良好，並有助於加速前庭代償，使患者恢復平衡和康復更快。在美國，口服 β組胺劑在數十年來極少有市場，2023 年夏天，Altamira 獲得 FDA 批准通過 IND 進行 2期臨床試驗治療良性陣發性位置性眩暈（BPPV），這是 AVS 中最常見的類型。BPPV 佔所有診斷病例的 17% 至 42%；僅與 BPPV 的診斷相關的美國醫療保健成本每年達 20 億美元。4
進一步簡化團隊結構
2023年底部分剝離Bentrio活動後，Altamira繼續努力簡化其公司結構，並使其與圍繞其RNA傳遞平台的戰略再定位相一致。公司將其愛爾蘭子公司Auris Medical Ltd.轉讓給Altamira Medica AG，並將其位於瑞士巴塞爾的兩家子公司Auris Medical AG和Altamira Therapeutics AG合併。合併實體稱爲Altamira Therapeutics AG，並繼續作爲公司的核心運營子公司。在這次重組之後，Altamira集團包括母公司Altamira Therapeutics Ltd.（百慕大漢密爾頓），以及其子公司Altamira Therapeutics AG（瑞士巴塞爾）、Altamira Therapeutics Inc.（美國特拉華州紐瓦克）、Otolanum AG（瑞士巴塞爾），以及關聯公司Altamira Medica AG（瑞士巴塞爾）。
First Half 2024 Financial Results and Outlook
Following the partial divestiture of the Bentrio business, related activities have been reclassified and are reported as discontinued operations. Continuing operations thus comprise the RNA delivery development programs as well as those related to AM-125. The financial results are reported for the first time in US dollars, which the Company adopted as its new presentation currency, replacing the Swiss franc.
| ● | Total operating loss from continuing operations was $3.9 million in the first half of 2024, compared against $3.6 million in the first half of 2023. The increase was primarily related to higher expenditures on research and development (+32.6% to $2.0 million), which was partially compensated by lower general and administrative expenses (-11.7% to $2.0 million). |
| ● | Net loss from continuing operations reached $4.3 million in the first half of 2024, which was 4.0% lower than in the corresponding reporting period in 2023. Finance expense decreased markedly ($0.2 million vs. $0.9 million); on the other hand, the Company recorded a pro rata loss of its associate company Altamira Medica of $0.2 million (first half of 2023: none)5. |
| ● | The Company’s net loss for the first half of 2024 amounted to $4.3 million, which was 27.0% lower than in the first half of 2023 ($5.9 million). During the first six months of 2023 the Company had recorded an after-tax loss of $1.4 million from discontinued operations (first half of 2024: none)5. |
| ● | 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 six months of 2023 vs. $2.5 million in the first six months of 2024. Cash and cash equivalents on June 30, 2024 totaled $65 thousand compared with $55 thousand at June 30, 2023. |
| ● | Shareholders’ equity amounted to $6.3 million as of June 30, 2024 compared with $7.7 million at year-end 2023. There was no financial debt outstanding at either timepoint. |
Altamira expects total cash needs in 2024 to be in the range of $5.8 million to $7.0 million. 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 and gross proceeds of $4.0 million upfront from a public offering of common shares with milestone-linked warrants.
| 4 | Özgirgin et al. (2024), Residual dizziness after BPPV management: exploring pathophysiology and treatment beyond canalith repositioning maneuvers, Front Neurol 15:1382196. https://www.frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1382196/full |
| 5 | Altamira Medica was deconsolidated and classified as associate upon its partial divestiture in November 2023. |
4
First Half 2024 and Business Update Conference Call & Webcast Details
Altamira’s Senior Management will hold an investor call today, Tuesday, September 24, 2024, at 8:30 a.m. EDT its business update and first half 2024 results. Founder, Chairman, and CEO Thomas Meyer and COO Covadonga Pañeda will deliver prepared remarks followed by a Q&A session where they will address questions from investors and analysts.
| ● | Event: Altamira Therapeutics First Half 2024 Financial Results and Business Update Call |
| ● | Date: Tuesday, September 24, 2024 |
| ● | Time: 8:30 am EDT |
| ● | Webcast URL: https://edge.media-server.com/mmc/p/4wp8659n |
Registration for Call
| ● | https://register.vevent.com/register/BI039aac00f0eb4f228e9662f9b90a1ea4 |
| ● | Click on the call link and complete the online registration form. |
| ● | Upon registering you will receive the dial-in info and a unique PIN to join the call as well as an email confirmation with the details. |
| ● | Select a method for joining the call: |
| o | Dial-In: A dial in number and unique PIN are displayed to connect directly from your phone. |
| o | Call Me: Enter your phone number and click “Call Me” for an immediate callback from the system. The call will come from a US number. |
Conference Call Replay
A replay of the call will be available after the live event and accessible through the webcast link:
https://edge.media-server.com/mmc/p/4wp8659n
5
Consolidated
Statement of Profit or Loss and Other Comprehensive Income/(Loss)
For the six months ended June 30, 2024 and 2023 (in US$)
| Six
months ended June 30 | ||||||||
| 2024 | 20231) 2) | |||||||
| Other operating income | 34,298 | 77,474 | ||||||
| Research and development | (1,963,664 | ) | (1,480,708 | ) | ||||
| General and administrative | (1,987,972 | ) | (2,252,587 | ) | ||||
| Operating loss | (3,917,338 | ) | (3,655,821 | ) | ||||
| Finance expense | (186,000 | ) | (937,585 | ) | ||||
| Finance income | 513 | 69,540 | ||||||
| Share of loss of an associate | (237,007 | ) | - | |||||
| Net loss from continuing operations | (4,339,832 | ) | (4,523,866 | ) | ||||
| Discontinued operations: | ||||||||
| Loss after tax from discontinued operations | - | (1,420,862 | ) | |||||
| Net loss attributable to owners of the Company | (4,339,832 | ) | (5,944,728 | ) | ||||
| Other comprehensive income/(loss): | ||||||||
| Items that will never be reclassified to profit or loss | ||||||||
| Remeasurements of defined benefit liability, net of taxes of $0 | 198,277 | (31,634 | ) | |||||
| Items that are or may be reclassified to profit or loss | ||||||||
| Foreign currency translation differences, net of taxes of $0 | 14,662 | (80,121 | ) | |||||
| Share of other comprehensive income of an associate | (43,712 | ) | - | |||||
| Other comprehensive income/(loss), net of taxes of $0 | 169,227 | (111,755 | ) | |||||
| Total comprehensive loss attributable to owners of the Company | (4,170,605 | ) | (6,056,483 | ) | ||||
| Basic and diluted loss per share3) | (2.11 | ) | (28.31 | ) | ||||
| Basic and diluted loss per share from continuing operations3) | (2.11 | ) | (21.55 | ) | ||||
| 1) | Amounts have been re-presented from those previously published to reflect the change in the Company’s presentation currency from Swiss francs to US dollars |
| 2) | Revised for the reclassification of certain activities as discontinued operations. |
| 3) | Weighted average number of shares outstanding: first half 2024: 2,060,714; first half 2023: 209,955. |
6
Consolidated
Statement of Financial Position
As of June 30, 2024 and December 31, 2023 (in US$)
| June 30, | June 30, | |||||||
| 2024 | 2023 1) | |||||||
| ASSETS | ||||||||
| Non-current assets | ||||||||
| Property and equipment | 1 | 1 | ||||||
| Right-of-use assets | 417,619 | 95,198 | ||||||
| Intangible assets | 4,627,072 | 4,627,072 | ||||||
| Other non-current financial assets | 88,999 | 95,070 | ||||||
| Investment in an associate | 2,411,469 | 2,872,623 | ||||||
| Total non-current assets | 7,545,160 | 7,689,964 | ||||||
| Current assets | ||||||||
| Other receivables | 121,310 | 88,916 | ||||||
| Prepayments | 75,213 | 337,293 | ||||||
| Derivative financial instruments | 262,035 | 293,630 | ||||||
| Cash and cash equivalents | 65,455 | 733,701 | ||||||
| Total current assets | 524,013 | 1,453,540 | ||||||
| Total assets | 8,069,173 | 9,143,504 | ||||||
| EQUITY AND LIABILITIES | ||||||||
| Equity | ||||||||
| Share capital | 5,341 | 2,956 | ||||||
| Share premium | - | 23,889,332 | ||||||
| Other reserves | 5,054,761 | 5,129,585 | ||||||
| Retained earnings/(Accumulated deficit) | 1,258,213 | (21,346,630 | ) | |||||
| Total shareholders’ equity/(deficit) attributable to owners of the Company | 6,318,315 | 7,675,243 | ||||||
| Non-current liabilities | ||||||||
| Non-current lease liabilities | 304,053 | - | ||||||
| Employee benefit liability | 218,940 | 411,917 | ||||||
| Total non-current liabilities | 522,993 | 411,917 | ||||||
| Current liabilities | ||||||||
| Current lease liabilities | 123,384 | 118,430 | ||||||
| Trade and other payables | 526,571 | 523,367 | ||||||
| Accrued expenses | 577,910 | 414,547 | ||||||
| Total current liabilities | 1,227,865 | 1,056,344 | ||||||
| Total liabilities | 1,750,858 | 1,468,261 | ||||||
| Total equity and liabilities | 8,069,173 | 9,143,504 | ||||||
| 1) | Amounts have been re-presented from those previously published to reflect the change in the Company’s presentation currency from Swiss francs to US dollars |
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About 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, which holds 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/
Forward-Looking Statements
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 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. 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.
Investor Contact:
Hear@altamiratherapeutics.com
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