Exhibit 99.2
管理層討論和分析財務狀況和經營業績
本管理層討論及分析旨在爲您提供我們的財務狀況和經營成果的敘述性解釋。我們建議您閱讀與本報告中附表99.1一起編制的截至2024年6月30日和2023年的六個月的未經審計的簡明合併中期財務報表，這些報表是根據國際會計準則（「IAS」）34準備的。 中間期財務報告（IAS 34）我們也建議您閱讀我們的管理層討論與分析以及我們的經審計的合併財務報表及其附註，這些內容出現在我們於2023年12月31日結束的年度報告（「年度報告」）中並已根據美國證券交易委員會（SEC）根據1934年修改版的美國證券交易法提出的。
除非另有說明或上下文另有要求，本報告中所有關於「Altamira」、「公司」、「我們」、「我們的」、「我們的」或類似術語的引用均指Altamira Therapeutics Ltd。出現在本報告中的商標、商號和服務標記爲其各自所有者的財產。
Altamira Therapeutics Ltd.是根據百慕大法律設立的豁免公司。 我們的註冊辦公室位於百慕大Hamilton的Church Street, 2 Clarendon House，郵編Hm 11。 於2023年12月13日，公司實施了一項1換20的逆向股份合併（「2023年逆向合併」），公司已發行並流通的普通股的每股金額和數量在本報告中均反映了2023年的逆向股份合併。
我們按照國際財務報告準則（"IFRS"）的規定，由國際會計準則委員會（"IASB"）和業績解讀發佈，編制和報告我們的合併基本報表和財務信息。我們的財務報表均未按照美國通用會計準則（"U.S. GAAP"）編制。我們以美元維護我們的賬簿和記錄。我們對本管理討論和分析中包含的某些數字進行了舍入調整。因此，某些表格中顯示的數字總和可能不是前述數字的算術總合。除非另有說明，本討論和分析中有關貨幣金額的所有參考均以美元表示。
本討論和分析截至2024年9月23日。
概述
我們是一家處於臨床前階段的生物製藥公司，開發並供應基於肽的納米顆粒技術，用於對體外組織進行有效的RNA傳遞（OligoPhore™ / SemaPhore™平台）。我們目前擁有兩個旗艦siRNA項目，使用我們專有的傳遞技術：KRAS驅動癌症的Am-401和類風溼性關節炎的Am-411，這兩者均處於臨床前開發階段，超出體內概念驗證階段。這種多功能傳遞平台也適用於mRNA和其他RNA形式，並通過外部許可提供給制藥公司或生物技術公司。在2023年，我們首次邁出了重塑公司圍繞RNA傳遞業務的第一步，通過將Altamira Medica AG的51%股權剝離出來，該公司生產並銷售Bentrio®，這是一種用於過敏性鼻炎的場外交易鼻噴霧劑。因此，我們繼續持有Bentrio®業務的49%股權（並獲得其他經濟權益）。此外，我們已宣佈出售/分拆我們的Am-125項目，這是一種用於眩暈的鼻噴霧（二期後），以及我們在耳鳴和聽力喪失方面的早期至後期臨床開發項目。
最近的發展
用於肝外RNA傳遞的OligoPhore™/SemaPhore™平台
2024年8月12日，我們宣佈在《自然免疫學》雜誌上發表了一篇經過同行評審的文章，展示了利用Altamira的SemaPhore™納米顆粒技術傳遞Zbtb46 mRNA治療動物癌症模型中腫瘤生長顯著減少的結果。華盛頓大學聖路易斯分校的一個研究組發表的這項研究顯示，在肉瘤和轉移性乳腺癌的小鼠模型中，利用SemaPhore™納米顆粒系統傳遞Zbtb46 mRNA導致Zbtb46的持續表達，恢復免疫刺激性的腫瘤微環境，以及腫瘤生長的顯著減少（p<0.0001）。當與免疫檢查點抑制劑（抗-PD1）治療結合時，結果變得更加顯著。根據作者的說法，「Zbtb46納米顆粒在抗-PD1敏感性【肉瘤】和抗-PD1耐藥性【乳腺癌】腫瘤模型中誘導出戲劇性的抗-PD1反應，在許多接受治療動物中產生了長期完全緩解的腫瘤。」延長使用Zbtb46納米顆粒的單藥療法甚至在對抗PD1耐藥的小鼠中也產生了完全緩解。通過治療消除肉瘤的小鼠在反覆挑戰後沒有發展新的癌症，表明發展了保護性免疫記憶。
2024年7月19日，我們宣佈了一項研究的預印本發表，展示了有效治療腹主動脈瘤（AAA）在動物模型中的方法。該研究由華盛頓大學聖路易斯分校和南佛羅里達大學坦帕分校的研究小組進行。研究表明，利用肽基納米顆粒（SemaPhore™）系統傳遞SOD2 mRNA治療AAA小鼠，導致主動脈擴張顯著減少（p<0.05），延遲破裂並顯著提高存活率（p<0.01），與未處理對照組相比。AAA是一種炎症性疾病，涉及由反應性氧氣化物（ROS）超出水平引起的氧化應激，導致腹主動脈異常增大（突出）。AAA的破裂可能危及生命；根據Shaw等人在2024年發表的StatPearls的文章，50%以上的患者在抵達急救室之前死亡，倖存者患有很高的發病率。
2024年5月1日，我們宣佈 我們已向美國專利局（USPTO）提交了一項臨時專利申請，描述了基於OligoPhore™的新型納米顆粒組合，這是Altamira基於肽的寡核苷酸遞送平台，或其衍生物，與siRNA序列結合，靶向NF-κb轉錄因子的p65蛋白。已觀察到p65的活化在多種癌症以及許多炎症性疾病中。例如，p65是類風溼關節炎（RA）炎症中衆所周知的重要檢查點，被認爲調節細胞增殖、細胞死亡，並刺激癌症的轉移。新的申請旨在擴展Altamira與其針對RA治療的Am-411開發計劃相關的知識產權。
2024年3月25日，我們宣佈已與Univercells集團（「Univercells」）達成合作協議，評估我們的SemaPhore™平台用於傳遞mRNA疫苗的應用。Univercells是一家全球生命科學公司，致力於以簡單、可擴展和成本效益高的方式創建用於開發和製造生物製品的平台，包括mRNA疫苗和治療藥物。根據協議條款，Univercells將使用Altamira的SemaPhore™納米顆粒平台測試體外和體內的專有mRNA疫苗傳遞。如果實驗證明成功，Univercells和Altamira打算討論並就使用Univercells生產平台進行基於納米顆粒的mRNA疫苗開發和製造的商業協議進行談判。
2024年2月7日，我們宣佈在《綜合醫學雜誌》發表了孟等人撰寫的文章，評估了使用各種肽來增強腺相關病毒（AAV）電芯轉導的效果。 重組AAV通常被用作攜帶體，引入細胞進行基因治療；一些基於AAV的基因治療藥物已獲得美國食品和藥物管理局（FDA）的批准。 這項研究旨在通過使用源自蜜蜂毒液中的肽，如背蜂毒素（melittin）衍生的肽，找到增加AAV基因治療製劑的溶體釋放的方法。 研究小組評估了76種melittin衍生物，包括p5RHH，這是Altamira的OligoPhore™ / SemaPhore™納米顆粒平台用於RNA傳遞的潛在肽。 科學家們發現將p5RHH插入AAV載體（p5RHH-rAAV）不僅增強了細胞轉導，而且成功地轉導了通常被認爲對AAV具有抵抗力的細胞系。 此外，在小鼠體內研究顯示，將p5RHH添加到幾種AAV血清型的AAV外殼中，與未經修改的AAV載體相比，顯著增強了肝轉導，在全身給藥後的最後時間點長達四周。
2024年1月24日，我們宣佈已向USPTO提交了第二份臨時專利申請，以使用包含公司的OligoPhore™平台和單一siRNA序列的納米粒子來廣泛覆蓋人類癌症治療中的不同KRAS突變。 聚平均值：3.6突變。納米粒子由Altamira開發，名爲Am-401。第二份臨時申請中包含體外數據，證實了其 聚平均值：3.6突變siRNA可用於敲降癌細胞系中廣泛範圍的KRAS突變。這些突變包括G12C、G12V、G12D、G12R、G12A和A146萬億，佔胰腺導管腺癌（PDAC）報告的KRAS突變的90.9％，結直腸癌（CRC）的65.3％，非小細胞肺癌（NSCLC）的80.0％。
Bentrio®可防止空氣傳播的過敏原
2024年8月23日和2024年9月16日，我們宣佈將Bentrio®的兩份獨家分銷協議延長。早期的延長協議與Pharma Nordic AS（「Pharma Nordic」）達成一致，將瑞典和丹麥納入許可領域，除了挪威。Pharma Nordic打算在2025年將Bentrio®引入這兩個額外的斯堪的納維亞國家。第二份延長協議與Nuance Pharma（「Nuance」）達成一致，將領地從中國、香港、澳門和韓國擴展到包括新加坡、馬來西亞、泰國、菲律賓、印度尼西亞、越南和臺灣。我們進一步宣佈，Nuance最近爲中國大陸的營銷批准提交了請求。
2024年4月24日，我們宣佈了來自澳洲的NASAR臨床試驗詳細結果的發佈，該試驗使用Bentrio®鼻噴霧治療季節性過敏性鼻炎（SAR），由Becker和同事在《Allergy》雜誌上發表。NASAR試驗在澳洲的兩個過敏季節中招募了100名患者，隨機分配到1:1的比例接受Bentrio®或鹽水鼻噴霧，這是目前無藥物管理SAR的標準護理。研究參與者自行每天三次連續兩週自行給藥。主要療效終點是反射性總鼻症狀評分（rTNSS）的平均每日減少量（ANCOVA模型）。
Bentrio®處理過的患者 的rTNSS明顯低於鹽水組（最小平方均值差異-1.1，p = 0.013），各個鼻部症狀均得到改善。通過過敏性鼻結膜炎生活質量問卷（RQLQ）測量，與鹽水對比，健康相關生活質量也顯著提高（p < 0.001）。患者和研究者均評價Bentrio®治療的有效性明顯優於鹽水對照（均p < 0.001）。兩種治療均表現出良好的安全性和耐受性。使用Bentrio®的患者使用緩解藥物較少，享受無症狀的日子較多，相對於鹽水治療。
急性前庭綜合徵中的Am-125
2024年6月20日，我們宣佈 由Özgirgin和他的同事在《神經病學前沿》雜誌上發表了一篇文章，描述了重力社相關的研究合理性以及β組胺在治療標準護理物理重定位手術後殘餘暈動病（BPPV）引起的頭暈的用途。 BPPV 的特點是由頭部位置相對於重力的變化產生的重複的眩暈發作，例如，在將頭向後傾斜時。 它通常由一個耳道內的脫落的內耳顆粒（耳石）引起，很多時候是後半規管。 碎片引發了不需要的前庭刺激，並且通常可以通過諸如Epley動作之類的物理重定位手術來清除，這已經被美國扁桃體耳鼻喉頭頸外科學會的臨床實踐指南強烈推薦。
即使在成功的身體重新定位手術的情況下，患者可能會出現殘留的頭暈。這種情況可能會持續幾天到幾周，並可能影響生活質量並具有使人無法動彈的性質。根據他們對可用治療期權的審查，該文章的作者建議使用前庭適應療法和前庭康復方案以促進前庭代償和通過Am-125的活性物質貝他組胺進行治療，改善內耳供血並促進前庭代償。良性陣發性位置性眩暈（BPPV）是最常見的眩暈類型，佔所有確診病例的17到42％；在美國，僅與BPPV的診斷相關的醫療費用每年接近20億美元。
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普通股公開發行
2024年9月17日，我們宣佈了一項公開發行的定價，發行總數爲5,555,556股普通股（或與之相應的可預付權證），配有A-1系列普通認股權證，可購買最多5,555,556股普通股，以及A-2系列普通認股權證，可購買最多5,555,556股普通股，每股的綜合公開發行價格爲0.72美元（或與之相應的可預付權證），並附帶A-1系列普通認股權證和A-2系列普通認股權證。A-1系列普通認股權證行使價格爲每股0.72美元，發行後立即行使，並將於首次發行日的十八個月紀念日或公司公開宣佈Am-401或Am-411納米粒子生物分佈數據呈正面的日期後60天之內到期。A-2系列普通認股權證行使價格爲每股0.72美元，發行後立即行使，並將於首次發行日的五週年紀念日或公司公開宣佈與Am-401或Am-411進一步開發和商業化相關協議的日期後六個月之內到期，前提是至少有一份協議涵蓋涵蓋歐洲聯盟或美國全部或部分領土的情況。該發行於2024年9月19日結束，須滿足一般的交割條件。公司從此次發行中獲得的總收益爲400萬美元，未經扣除放置代理商的費用和公司支付的其他發行費用，公司的淨收益爲330萬美元。
“At the market program”
On January 19, 2024, we entered into a sales agreement with H.C. Wainwright & Co., LLC (“HCW” and the “HCW Sales Agreement”). Pursuant to the terms of the HCW Sales Agreement we may offer and sell our common shares, from time to time through HCW by any method deemed to be an “at-the-market” offering as defined in Rule 415(a)(4) promulgated under the Securities Act. In the first six months of 2024, we sold 637,460 shares under the HCW Sales Agreement for aggregate gross proceeds of $1.66 million.
The HCW Sales Agreement effectively replaced the sales agreement that we had concluded with A.G.P./Alliance Global Partners (“A.G.P.” and the “A.G.P. Sales Agreement”) on November 20, 2018 and amended on April 5, 2019. Pursuant to the terms of the A.G.P. Sales Agreement, the Company could offer and sell its common shares, from time to time through A.G.P. by any method deemed to be an “at-the-market” offering as defined in Rule 415(a)(4) promulgated under the Securities Act. Prior to its termination, we sold an aggregate 123,512 of our common shares for an aggregate offering price of $13.1 million pursuant to the A.G.P. Sales Agreement.
2023 reverse share split
On December 13, 2023, we effected a reverse share split (the “2023 Reverse Share Split”) of our common shares at a ratio of one-for-twenty. When the reverse share split became effective, every 20 of our pre-split issued and outstanding common shares, par value $0.0001 per share, were combined into one common share, par value $0.002 per share. Effecting the 2023 Reverse Share Split reduced the number of our issued and outstanding common shares from 29,556,487 common shares to 1,477,785 common shares (after giving effect to rounding of fractional shares). It also simultaneously adjusted outstanding options issued under our equity incentive plan and outstanding warrants to purchase common shares. All per share amounts and numbers of common shares in this management’s discussion and analysis reflect the 2023 Reverse Share Split.
Collaboration and License Agreements
On December 11, 2020, we entered into an Exclusive License Agreement with Washington University located in St. Louis, Missouri (“WU”). Pursuant to the Agreement, WU granted us an exclusive, worldwide, royalty-bearing license (with the right to sublicense) during the term of the agreement under certain patent rights owned or controlled by WU to research, develop, make, have made, sell, offer for sale, use and import pharmaceutical products covered under such patent rights for all fields of use. Such licensed products may include “silencing RNA” (siRNAs) pharmaceutical preparations formulated in combination with our proprietary delivery technologies. In consideration for such worldwide, exclusive license, we will be obligated to pay WU: annual license maintenance fees in the low five figures through first commercial sale; pre-clinical and clinical regulatory milestones; sales milestones; and a low single digit royalty based on annual net sales of licensed products worldwide for at least the applicable patent term or period of marketing exclusivity, whichever is longer, but in no case less than a minimum royalty term of 12 years; and a percentage share (in the double digits) of sublicensing revenues received by the Company in connection with licensed products. Such regulatory and sales milestones may total up to an aggregate of $4,375,000. In the event the Company fails to meet certain regulatory diligence milestones, WU will have the right to terminate the license.
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Research and Development Expense
Our research and development expense is highly dependent on the development phases of our research projects and therefore may fluctuate substantially from period to period. Our research and development expense mainly relates to the following key programs:
| ● | OligoPhore™ / SemaPhore™ delivery platforms. Through the acquisition of Trasir Therapeutics Inc. (“Trasir”) in 2021 we entered the field of RNA delivery technology. OligoPhore™ and SemaPhore™ are based on a propriety peptide which allows for efficient delivery of nucleic acid payloads such as siRNA (small interfering ribonucleic acid) or mRNA (messenger ribonucleic acid) into target cells, notably into non-liver tissues, using systemic or local administration. We are developing the OligoPhore™ / SemaPhore™ delivery technology to make it available through out-licensing to partners in the pharma / biotech industry for use with their proprietary RNA molecules. |
| ● | AM-401 for KRAS Driven Cancer. In July 2021 we initiated the development of AM-401 as the first lead program to demonstrate the potential of our OligoPhore™ oligonucleotide delivery platform. The therapeutic objective for AM-401 is to slow down KRAS driven tumor cell proliferation or to stop it altogether by delivering siRNA specifically inside tumor cells for gene knock down. We are employing siRNA which is targeting different KRAS mutations (polyKRASmut) and have shown that it knocks down a broad range of KRAS mutations in cancer cell lines. We aim to advance the AM-401 program through preclinical studies with the objective of filing for an IND in 2026. In this context, we initiated various development work relating to the peptide and siRNA components of AM-401. |
| ● | AM-411 for Rheumatoid Arthritis. In July 2022 we announced the initiation of AM-411, our second lead program for an RNA therapeutic based on the OligoPhore™ delivery platform. AM-411 seeks to treat rheumatoid arthritis (RA) by targeting siRNA at p65, one of the main transcriptional regulators of the NF-kB pathway and a key checkpoint in RA inflammation. We aim to advance the AM-411 program through preclinical studies with the objective of filing for an IND in 2026. |
| ● | AM-125 for Vertigo. We have been developing AM-125 as a reformulation of betahistine for intranasal delivery. In 2019 we initiated the “TRAVERS” Phase 2 trial to evaluate the safety and efficacy of AM-125 in 124 patients suffering from acute vestibular syndrome following surgery. In June 2022 we reported top-line results from the trial showing good tolerability and a dose- and time-dependent improvement in balance and signs and symptoms of vestibular dysfunction. In parallel to the clinical development, we have been conducting various preclinical studies with AM-125 and working on the analytical and process development for the manufacturing of the drug product. The FDA cleared our IND application in June 2023 which will allow for the conduct of clinical trials in the U.S. In the context of our strategic transition to become a company focused on RNA delivery technology, we intend to out-license or sell the AM-125 program. |
| ● | Bentrio® for Allergy and Viral Infection: In September 2020 we initiated the development of AM-301, a drug-free nasal spray for protection against airborne viruses and allergens, through our new subsidiary Altamira Medica AG. Following formulation development, we tested AM-301 first in vitro in a series of experiments using reconstituted human nasal epithelia. Our clinical development in allergic rhinitis comprised four trials: one study each with controlled exposure to grass pollen for 4 hours and to house dust mites for 3 hours (both with 36 patients), one study on the distribution and residence time of AM-301 within the nasal cavity (8 healthy volunteers), and one study with environmental exposure to seasonal allergens for two weeks (NASAR trial; 100 patients). The two challenge studies were completed in 2021 and 2022 and showed good tolerability and protective effects of AM-301 for 3-4 hours; the extended nasal residence time of the formulation within the nasal cavity was confirmed in the trial with human volunteers. The NASAR trial demonstrated a statistically significant and clinically relevant improvement in nasal symptoms and health related quality of life in seasonal allergic rhinitis (SAR) and was also superior in efficacy outcomes to saline nasal spray, the current standard of care in drug free treatments for SAR. In viral infection, we conducted a trial in patients suffering from acute COVID-19 in 2022; top-line results were presented as inconclusive in early 2023. In the context of our decision to reposition our company around the RNA delivery business, we sold in November 2023 51% of the share capital of Altamira Medica to a Swiss private equity investor. We retained 49% of the company’s share capital and will be entitled to receive 25% of Altamira Medica’s future gross licensing income. |
Other research and development expenses mainly relate to the maintenance of our late-stage projects Sonsuvi® (AM-111) and Keyzilen® (AM-101) and pre-clinical studies of AM-102 (second generation tinnitus treatment).
For a discussion of our other key financial statement line items, please see “Item 5—Operating and Financial Review and Prospects–Operating results — Financial Operations Overview” in the Annual Report.
4
Results of Operations
The numbers below have been derived from our unaudited condensed consolidated interim financial statements as of and for the six months ended June 30, 2024 and 2023. The discussion below should be read along with this financial information, and it is qualified in its entirety by reference to them.
Comparison of the six months ended June 30, 2024 and 2023
| JUNE 30 | ||||||||||||
| 2024 | 2023 | Change | ||||||||||
| (in thousands of US$) | % | |||||||||||
| Other operating income | 34 | 77 | (56 | )% | ||||||||
| Research and development | (1,963 | ) | (1,481 | ) | 33 | % | ||||||
| Sales and marketing | - | - | n/a | |||||||||
| General and administrative | (1,988 | ) | (2,252 | ) | (12 | )% | ||||||
| Operating loss | (3,917 | ) | (3,656 | ) | 7 | % | ||||||
| Finance expense | (186 | ) | (938 | ) | (80 | )% | ||||||
| Finance income | 1 | 70 | (99 | )% | ||||||||
| Share of loss of an associate | (237 | ) | - | n/a | ||||||||
| Loss before tax | (4,339 | ) | (4,524 | ) | (4 | )% | ||||||
| Income tax gain/(loss) | - | - | n/a | |||||||||
| Net loss from continuing operations | (4,339 | ) | (4,524 | ) | (4 | )% | ||||||
| Discontinued operations: | ||||||||||||
| Loss after tax from discontinued operations | - | (1,421 | ) | (100 | )% | |||||||
| Net loss attributable to owners of the Company | (4,339 | ) | (5,945 | ) | (27 | )% | ||||||
| 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 | (31 | ) | (739 | )% | |||||||
| Items that are or may be reclassified to profit or loss | ||||||||||||
| Foreign currency translation differences, net of taxes of $ 0 | 15 | (80 | ) | (119 | )% | |||||||
| Share of other comprehensive income of an associate | (44 | ) | - | n/a | ||||||||
| Other comprehensive income/(loss), net of taxes of $ 0 | 169 | (111 | ) | (252 | )% | |||||||
| Total comprehensive loss attributable to owners of the Company | (4,170 | ) | (6,056 | ) | (31 | )% | ||||||
5
Research and development expense
| SIX MONTHS ENDED | ||||||||||||
| JUNE 30, 2024 | JUNE 30, 2023 | Change % | ||||||||||
| (in thousands of US$) | ||||||||||||
| Clinical projects | 27 | 110 | (75 | )% | ||||||||
| Pre-clinical projects | 276 | 115 | 140 | % | ||||||||
| Drug manufacturing and substance | 567 | 150 | 278 | % | ||||||||
| Employee benefits | 845 | 924 | (9 | )% | ||||||||
| Other research and development expenses | 248 | 182 | 36 | % | ||||||||
| Total | 1,963 | 1,481 | 33 | % | ||||||||
Research and development expenses amounted to $2.0 million in the six months ended June 30, 2024. This represents an increase of 33% compared to the six months ended June 30, 2023. Research and development expenses reflected the following:
| ● | Clinical projects. In the six months ended June 30, 2024 clinical expenses were $27 thousand, which was 75% lower than in the six months ended June 30, 2023 as clinical trials had essentially been completed in 2023. |
| ● | Pre-clinical projects. In the six months ended June 30, 2024, pre-clinical expenses were $276 thousand and thus more than double the amount in the six months ended June 30, 2023 due to increased activities in RNA delivery projects. |
| ● | Drug manufacture and substance. In the six months ended June 30, 2024, expenses related to drug manufacture and substance rose by $417 thousand or 278% over the level in the first half of 2023 as the Company’s RNA delivery projects progressed (analytical development, formulation development, peptide and RNA synthesis). |
| ● | Employee benefits. Employee expenses decreased by 9% in the six months ended June 30, 2024 to reach $845 thousand primarily due to a reduction in headcount as there were no longer any clinical trials ongoing compared to the same period in 2023. |
| ● | Other research and development expenses. Other research and development expenses increased by $66 thousand in the six months ended June 30, 2024 compared to the same period in 2023 which was primarily due to higher expenditures for intellectual property filings and prosecution. |
General and administrative expense
| SIX MONTHS ENDED | ||||||||||||
| JUNE 30, 2024 | JUNE 30, 2023 | Change % | ||||||||||
| (in thousands of US$) | ||||||||||||
| Employee benefits | 574 | 342 | 68 | % | ||||||||
| Lease expenses | 15 | 10 | 50 | % | ||||||||
| Business development | - | 7 | (100 | )% | ||||||||
| Travel and representation | 24 | 19 | 26 | % | ||||||||
| Administration costs | 1,312 | 1,809 | (27 | )% | ||||||||
| Depreciation Right-of-use assets | 63 | 65 | (3 | )% | ||||||||
| Total | 1,988 | 2,252 | (12 | )% | ||||||||
6
General and administrative expense decreased to CHF 2.0 million in the six months ended June 30, 2024, compared to CHF 2.3 million in the same period in the previous year, primarily due to lower general and administration costs, whereas employee benefits increased primarily due to the reinforcement of headcount in finance and administration.
Finance income and finance expense
| SIX MONTHS ENDED | ||||||||||||
| JUNE 30, 2024 | JUNE 30, 2023 | |||||||||||
| (in thousands of US$) | ||||||||||||
| Interest income | 1 | 29 | (97 | )% | ||||||||
| Gain on modification of financial instruments | - | 41 | (100 | )% | ||||||||
| Total finance income | 1 | 70 | (99 | )% | ||||||||
| Interest expense (incl. Bank charges) | 6 | 575 | (99 | )% | ||||||||
| Net foreign exchange loss | 180 | 131 | 37 | % | ||||||||
| Revaluation loss from derivative financial instrument | - | 224 | (100 | )% | ||||||||
| Loss on derecognition of financial instruments | - | 8 | (100 | )% | ||||||||
| Total finance expense | 186 | 938 | (80 | )% | ||||||||
| Finance income/(expense), net | (185 | ) | (868 | ) | (79 | )% | ||||||
Interest expense
Interest expense in the six months ended June 30, 2024 decreased 99% to $6 thousand and included interest related to lease liabilities and bank charges. In the first half of 2023, interest expense included interest on the FiveT convertible loans.
Foreign currency exchange gain / (loss), net
For the six months ended June 30, 2024, fluctuations in foreign currency exchange rates resulted in a loss of $180 thousand, compared to a loss of $131 thousand during the same period in the previous year.
Revaluation gain / (loss) from derivative financial instruments
For the six months ended June 30, 2024, there was no revaluation gain or loss recorded through profit or loss. In the six months ended June 30, 2023, the revaluation loss of $224 thousand from derivative financial instruments included the revaluation of the financial derivatives embedded in the 2022 FiveT Loan.
On January 30, 2018 we issued 1,875 warrants in connection with a direct offering of 3,125 common shares, each warrant entitling its holder to purchase one common share at an exercise price of $2,000.00 per common share. As of June 30, 2024, the fair value of the warrants amounted to $0. There was no revaluation gain or loss of the derivative for the six months ended June 30, 2024 and 2023.
Cash flow
Comparison of the six months ended June 30, 2024 and 2023
The table below summarizes our cash flows for the six months ended June 30, 2024 and 2023:
| SIX MONTHS ENDED | ||||||||
| JUNE 30, 2024 | JUNE 30, 2023 | |||||||
| (in thousands of US$) | ||||||||
| Net cash used in operating activities | (3,204 | ) | (8,431 | ) | ||||
| Net cash from investing activities | 1 | - | ||||||
| Net cash from financing activities | 2,514 | 8,412 | ||||||
| Net effect of currency translation on cash | 20 | 57 | ||||||
| Cash and cash equivalents at beginning of the period | 734 | 17 | ||||||
| Cash and cash equivalents at end of the period | 65 | 55 | ||||||
7
Cash and funding sources
On January 19, 2024, we entered into a sales agreement with H.C. Wainwright & Co., LLC (“HCW” and the “HCW Sales Agreement”). Pursuant to the terms of the HCW Sales Agreement we may offer and sell our common shares, from time to time through HCW by any method deemed to be an “at-the-market” offering as defined in Rule 415(a)(4) promulgated under the Securities Act. Pursuant to the HCW Sales Agreement. In the first six months of 2024, we sold 637,460 shares under the HCW Sales Agreement for aggregate gross proceeds of $1.66 million.
The HCW Sales Agreement effectively replaced the sales agreement that we had concluded with A.G.P./Alliance Global Partners (“A.G.P.” and the “A.G.P. Sales Agreement”) on November 20, 2018 and amended on April 5, 2019. Pursuant to the terms of the A.G.P. Sales Agreement, the Company could offer and sell its common shares, from time to time through A.G.P. by any method deemed to be an “at-the-market” offering as defined in Rule 415(a)(4) promulgated under the Securities Act. In 2023, we sold 104,147 shares under the ATM for aggregate proceeds of $5.1 million. We terminated the A.G.P. Sales Agreement effective January 1, 2024. Prior to its termination, we sold an aggregate 123,512 of our common shares for an aggregate offering price of $13.1 million pursuant to the A.G.P. Sales Agreement.
On November 21, 2023, we closed the transaction for the partial divestiture of our Bentrio® business, by selling a 51% stake in our subsidiary Altamira Medica AG to a Swiss private equity investor. The transaction also included the sale of Auris Medical Pty Ltd, Melbourne (Australia), a wholly owned subsidiary of Altamira Medica AG, which was subsequently renamed Altamira Medica Pty Ltd. The cash consideration for the 51% stake was CHF 2,040,000. The transaction further included a cash contribution of CHF 1,000,000 in total to Altamira Medica’s capital by its two shareholders pro rata of their shareholdings following the closing. Accordingly, we contributed CHF 490,000 in cash to our investment in Altamira Medica.
On July 10, 2023, the Company closed a public offering of 43,750 common shares and 511,806 pre-funded warrants and accompanying common warrants to purchase up to 555,556 common shares, at a combined public offering price of $9.00 per share, pre-funded warrant and accompanying common warrant. The common warrants have an exercise price of CHF 8.00 per share, are exercisable immediately and expire five years from the date of issuance. The Company additionally granted 36,113 warrants to the Placement Agent with a strike price of CHF 10.00 and an exercise period of 5 years. As of December 31, 2023, all pre-funded warrants were exercised for a total amount of $112,597. The total gross proceeds from the offering amounted to $5,000,000.
On May 1, 2023, the Company entered into a convertible loan agreement with FiveT IM ( see Note 4, Loans). Under the 2023 FiveT Loan we sold an aggregate 443,294 common shares at an average price of CHF 5.07 to FiveT IM in 2023. In connection with the 2023 FiveT Loan, FiveT IM received warrants to purchase an aggregate of 81,274 common shares at an exercise price of CHF 30.76 per common share, which could be exercised up to five years. On December 7, 2023, we entered into a letter agreement (the “Warrant Inducement Agreement”) under which FiveT IM was granted the option to exercise the warrants by or before December 14, 2023 at a reduced exercise price which was defined as 90% of the daily trading volume weighted average price for our common shares on the NASDAQ stock exchange on the trading day following the date of each such exercise and receive additional warrants upon any such exercise. FiveT IM exercised all existing warrants at the weighted average exercise price of CHF 6.656 per common share, yielding proceeds of CHF 541,034 to the Company. On December 15, 2023, we issued to FiveT IM new warrants to purchase 81,274 common shares at CHF 6.656 each for six months from their date of issuance and to purchase 81,274 common shares at CHF 6.656 each for two years from their date of issuance. The 6-month warrants expired unexercised on June 15, 2024.
On February 4, 2022, the Company entered into a convertible loan agreement, as amended, with FiveT IM (the “Lender”), pursuant to which the Lender agreed to loan to the Company CHF 5,000,000 (the “2022 FiveT Loan”), which bore interest at the rate of 10% per annum and matured 12 months from the disbursement date of February 8, 2022.
On April 13, 2023, the Company and FiveT IM entered into an amendment to the 2022 FiveT Loan, which amended the conversion price of the 2022 FiveT Loan to a fixed price equal to the lower of (a) the mean daily trading volume weighted average price (“VWAP”) of the Company’s common shares on the Nasdaq Stock Market on the 20 trading days preceding the effective date of the FiveT Loan Amendment or (b) 90% of the VWAP on the effective date of the FiveT Loan Amendment. From April 13, 2023 to April 17, 2023, FiveT IM converted the entire 2022 FiveT Loan into an aggregate of 217,051 common shares at an average conversion price of $28.95 per share. As a result, the 2022 FiveT Loan is no longer outstanding and has been terminated.
8
On December 28, 2022, the Company entered into two separate loan agreements with two private investors (the “Private Lenders”), pursuant to which Private Lenders agreed to loan to the Company an aggregate of CHF 350,000, which loans bear interest at the rate of 5% per annum and were to mature as of May 30, 2023. The Company agreed to grant to the Private Lenders warrants to purchase an aggregate 2,359 common shares. The warrants are exercisable at an exercise price of CHF 89.02 per share for up to five years from the date of issuance. On May 12, 2023, the Company and the Private Lenders entered into an amendment to the loan agreement, which extended the maturity date of the loan from May 31, 2023 to July 31, 2023 and lowered the strike price for the Warrants attached to the loan to CHF 17.62 per common share, which is the Swiss Franc equivalent of the trading volume weighted average price for common shares on the NASDAQ stock exchange on the trading day preceding the date of the amendment. The loans were repaid on July 15, 2023.
On September 9, 2022, the Company entered into a loan agreement with FiveT IM, Dominik Lysek and Thomas Meyer, the Company’s CEO (the “Lenders”), pursuant to which the Lenders agreed to loan to the Company an aggregate of CHF 600,000 (the “September 2022 Loan Agreement”), which loan bears interest at the rate of 5% per annum and was to mature as of March 31, 2023. The Company agreed to issue to the Lenders warrants to purchase an aggregate 2,085 common shares. Such warrants are exercisable at an exercise price of CHF 144 per share for up to five years form October 1, 2022. On May 12, 2023, the Company and the Lenders entered into an amendment to the loan agreement, which extended the maturity date of the loan from May 31, 2023 to July 31, 2023, introduced a right for Lenders to convert the loan into common shares of the Company at CHF 22.40 per common share, which is the Swiss Franc equivalent of 120% of the mean daily trading volume weighted average price for common shares on the NASDAQ stock exchange on the 20 trading days preceding the date of the amendment, and a right for the Company to repay the loan in common shares of the Company priced at the lower of (i) the mean daily trading volume weighted average price for the common shares on the 20 trading days preceding the repayment date or (ii) 90% of the daily trading volume weighted average price for common shares on the repayment date, and lowered the strike price for the Warrants attached to the loan to CHF 17.62 per common share, which is the Swiss Franc equivalent of the trading volume weighted average price for common shares on the NASDAQ stock exchange on trading day preceding the date of the amendment. The loan was repaid on July 15, 2023.
On December 5, 2022, we entered into a purchase agreement with Lincoln Park Capital Fund, LLC (“LPC” and the “2022 Commitment Purchase Agreement”). Pursuant to the purchase agreement, LPC agreed to subscribe for up to $10.0 million of our common shares over the 24-month term of the purchase agreement. As consideration for LPC’s irrevocable commitment to purchase common shares upon the terms of and subject to satisfaction of the conditions set forth in the 2022 Commitment Purchase Agreement, the Company agreed to issue 2,500 common shares immediately to LPC as commitment shares. In 2023, we issued an aggregate 17,500 common shares for aggregate proceeds of $854,475 and in the first six months of 2024 we issued an aggregate of 555,279 common shares for aggregate proceeds of $984,087 to LPC under the 2022 Commitment Purchase Agreement.
The 2022 Commitment Purchase Agreement effectively replaced the 2020 Commitment Purchase Agreement. Under the 2020 Commitment Purchase Agreement LPC agreed to purchase common shares for up to $10,000,000 over the 30-month term of the Purchase Agreement. Prior to its termination we had issued 325,000 common shares for aggregate proceeds of $4.0 million to LPC under the 2020 Commitment Purchase Agreement.
We have no other ongoing material financial commitments, such as lines of credit or guarantees that are expected to affect our liquidity over the next five years, other than leases.
9
Funding requirements
We expect that we will need additional funding. We have incurred recurring losses and negative cash flows from operations since inception and we expect to generate losses from operations for the foreseeable future primarily due to research and development costs for our RNA delivery platforms and our product candidates AM-401 and AM-411. We also expect to continue to incur additional costs associated with operating as a public company.
We expect our total cash need in 2024 to be in the range of $5.8 to 7.0 million. We believe that our cash position of $65 thousand at June 30, 2024, proceeds from the public offering of common shares with warrants in September 2024, the exercise of warrants and the planned divestiture or partnering of our AM-125 development program and revenues from our 49% stake in our associated company Altamira Medica AG, the receipt of grants, licensing and service fees from collaborations in the field of RNA delivery as well as further issuances of common shares under the HCW Sales Agreement or an equity line will fund our projected operations through August 2025.
We have based the above estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect.
Our future funding requirements will depend on many factors, including but not limited to:
| ● | the scope, rate of progress, results and cost of our nonclinical testing and other related activities; |
| ● | the cost of sourcing key ingredients for our RNA delivery programs and of manufacturing our product candidates and any products that we may develop; |
| ● | the scope of the further development of our RNA delivery platforms and the number and characteristics of product candidates that we pursue; and |
| ● | the terms and timing of any collaborative, licensing, and other arrangements that we may establish, including any required milestone and royalty payments thereunder. |
As of the date of this Interim Report we have warrants outstanding, which are exercisable for an aggregate of 12,150,116 common shares at a weighted average exercise price of $1.20 per share, which comprise an aggregate 11,111,112 warrants linked to the Company reaching certain development and business milestones, options which are exercisable for an aggregate of 404,608 common shares at a weighted average exercise price of $2.56 per share, and sold an aggregate of $1.66 million of common shares under the HCW Sales Agreement, and we may seek to register additional common shares for sale under such agreement, subject to the volume limitations under Instruction I.B.5 of Form F-3.
Additional funds may not be available on a timely basis, on favorable terms, or at all, and such funds, if raised, may not be sufficient to enable us to continue to implement its long-term business strategy. If additional capital is not available when required, we may need to delay or curtail our operations until such funding is received. The length of time and cost of developing our product candidates and/or failure of them at any stage of the approval process will materially affect our financial condition and future operations. Such matters are not within our control and thus all associated outcomes are uncertain. If we are not able to raise capital when needed, we could be forced to delay, reduce or eliminate our product development programs, which could materially harm our business, prospects, financial condition and operating results. This could then result in bankruptcy, or the liquidation of the Company. These factors raise substantial doubt about the Company’s ability to continue as a going concern. These financial statements have been prepared on a going concern basis, which contemplates the continuity of normal activities and realization of assets and settlement of liabilities in the normal course of business.
For more information as to the risks associated with our future funding needs, see “Item 3—Key Information-D. Risk factors” in the Annual Report.
Contractual obligations and commitments
Under the terms of our collaboration and license agreement with Xigen related to AM-111, we are obliged to make development milestone payments on an indication-by-indication basis of up to CHF 1.5 million upon the successful completion of a Phase 2 clinical trial and regulatory milestone payments on a product-by-product basis of up to CHF 2.5 million, subject to a mid-twenties percentage reduction for smaller indications, e.g., those qualifying for orphan drug status, upon receiving marketing approval for a product. The milestones are not included in the table above as they have not met the recognition criteria for provisions and the timing of these is not yet determinable as it is dependent upon the achievement of earlier mentioned milestones.
10
Significant Accounting Policies and Use of Estimates and Judgment
There have been no material changes to the significant accounting policies and estimates described in “Item 5—Operating and Financial Review and Prospects–A. Operating results—Significant accounting policies and use of estimates and judgment” in the Annual Report.
Recent Accounting Pronouncements
See Note 4 to our audited financial statements included in our most recent Annual Report on Form 20-F for a full description of recent accounting pronouncements, including the expected dates of adoption and effects on the Company’s financial condition, results of operations and cash flows.
Cautionary Statement Regarding Forward Looking Statements
Forward-looking statements appear in a number of places in this discussion and analysis and include, but are not limited to, statements regarding our intent, belief or current expectations. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to:
| ● | our operation as a drug development-stage company with limited operating history and a history of operating losses; |
| ● | our need for substantial additional funding to continue the development of our RNA delivery platforms and product candidates before we can expect to become profitable from sales of our platform technology and products and the possibility that we may be unable to raise additional capital when needed; |
| ● | the timing, scope, terms and conditions of a potential divestiture or partnering of the Company’s AM-125 development program in vertigo as well as the cash such transaction(s) may generate; |
| ● | our dependence on the success of OligoPhore™, SemaPhore™, AM-401 and AM-411, which are still in preclinical development, and may eventually prove to be unsuccessful; |
| ● | the chance that we may become exposed to costly and damaging liability claims resulting from the testing of our product candidates in the clinic; |
| ● | the chance our clinical trials may not be completed on schedule, or at all, as a result of factors such as delayed enrollment or the identification of adverse effects; |
| ● | our reliance on our current strategic relationship with Washington University and the potential success or failure of strategic relationships, joint ventures or mergers and acquisitions transactions; |
| ● | our reliance on third parties to conduct certain of our nonclinical studies and on third-party, single-source suppliers to supply certain key ingredients for RNA delivery platforms or to produce our product candidates; |
| ● | our ability to obtain, maintain and protect our intellectual property rights and operate our business without infringing or otherwise violating the intellectual property rights of others; |
| ● | our ability to meet the continuing listing requirements of Nasdaq and remain listed on The Nasdaq Capital Market; |
| ● | the chance that certain intangible assets related to our product candidates will be impaired; and |
| ● | other risk factors set forth in our most recent Annual Report on Form 20-F. |
Our actual results or performance could differ materially from those expressed in, or implied by, any forward-looking statements relating to those matters. Accordingly, no assurances can be given that any of the events anticipated by the forward-looking statements will transpire or occur, or if any of them do so, what impact they will have on our results of operations, cash flows or financial condition. Except as required by law, we are under no obligation, and expressly disclaim any obligation, to update, alter or otherwise revise any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise.
11