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Cyclo Therapeutics Reports Full Year 2023 Financial Results and Provides Business Update

Cyclo Therapeutics Reports Full Year 2023 Financial Results and Provides Business Update

Cyclo Therapeutics公佈2023年全年財務業績並提供業務最新情況
Cyclo Therapeutics ·  03/18 00:00

GAINESVILLE, Fla. – Cyclo Therapeutics, Inc. (Nasdaq: CYTH) ("Cyclo Therapeutics" or the "Company"), a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families living with diseases, today reported its financial results for the full year 2023 and provided a business update.

佛羅里達州蓋恩斯維爾— Cyclo Therapeutics, Inc 納斯達克股票代碼:CYTH)(“Cyclo Therapeutics” 或 “公司”)是一家臨床階段的生物技術公司,致力於通過科學和創新爲患病患者和家庭開發改變生活的藥物,今天公佈了其2023年全年財務業績並提供了業務最新情況。

"We made significant progress over the course of the past year. We continue to be extremely active with the NPC patient and scientific communities and believe these valuable interactions underscore the progress we have seen with the advancement of our TransportNPC study," commented N. Scott Fine, Chief Executive Officer of Cyclo Therapeutics. "Following the completion of the merger with Applied Molecular Transport, we are poised to continue building momentum and achieving the value-driving milestones ahead. Importantly, supported with the positive feedback from FDA and alignment on our strategy moving forward, we remain focused on generating the appropriate data required to successfully drive our TransportNPC study across the finish line and the potential to provide a much-needed treatment option for the NPC community. We are grateful for the continued support of our investors, including Rafael Holdings and other longtime shareholders, who have bolstered our cash runway and helped position us to achieve our mission and continue our work to advance the clinical development of TrappsolCyclo."

“在過去的一年中,我們取得了重大進展。Cyclo Therapeutics首席執行官N. Scott Fine評論說,我們繼續與NPC患者和科學界保持非常活躍,並相信這些寶貴的互動凸顯了我們在TransportNPC研究進展中取得的進展。“與應用分子運輸的合併完成後,我們有望繼續保持勢頭,實現未來的價值驅動里程碑。重要的是,在FDA的積極反饋以及我們對未來戰略的調整的支持下,我們將繼續專注於生成成功推動我們的TransportNPC研究走向終點線所需的適當數據,並探討爲NPC社區提供急需的治療選擇的潛力。我們感謝包括Rafael Holdings和其他長期股東在內的投資者的持續支持,他們擴大了我們的現金流,幫助我們實現了使命並繼續努力推進Trappsol的臨床開發Cyclo。”

William Conkling, Chief Executive Officer of Rafael Holdings, Inc., added, "We are pleased with the continued clinical progress and operational execution and look forward to the continued advancement of those efforts in 2024."

拉斐爾控股公司首席執行官威廉·康克林補充說:“我們對持續的臨床進展和運營執行感到滿意,並期待這些工作在2024年繼續取得進展。”

Recent Highlights

近期亮點

  • Granted U.S. patent covering use of TrappsolCyclo for treatment of Alzheimer's Disease from the U.S. Patent and Trademark Office;
  • Completed merger with Applied Molecular Transport Inc to focus on advancing Cyclo Therapeutics' pivotal Phase 3 global study, TransportNPC, evaluating Trappsol Cyclo for NPC;
  • Dr. Caroline Hastings, Chair of the Company's Phase 3 TrappsolCyclo program steering committee and Global Principal Investigator for the Company's ongoing TransportNPC study presented at the 20th Annual WORLDSymposium; and
  • Announced positive outcome from Type C Meeting with the U.S. FDA discussing TrappsolCyclo clinical program for the treatment of Niemann-Pick Disease Type C1.
  • Strengthened Balance Sheet with early exercise of warrants by board members, management and a significant shareholder resulting in bolstered cash proceeds of $2.4 million. The Investors include Rafael Holdings, Inc., a significant shareholder of the Company, several directors of the Company, Company management, and their affiliates.
  • 獲得涵蓋Trappsol用途的美國專利來自美國專利商標局的用於治療阿爾茨海默氏病的Cyclo;
  • 完成了與應用分子運輸公司的合併,專注於推進Cyclo Therapeutics的關鍵性3期全球研究TransportNPC,該研究對特拉普索爾進行了評估 NPC 的 Cyclo;
  • 卡羅琳·黑斯廷斯博士,公司第三階段 Trappsol 董事長Cyclo項目指導委員會和該公司正在進行的TransportNPC研究的全球首席研究員,該研究在20年會上發表第四 年度世界研討會;以及
  • 宣佈與美國食品藥品管理局討論Trappsol的C型會議取得積極成果Cyclo C1 型尼曼-匹克氏病治療臨床計劃。
  • 董事會成員、管理層和大股東提前行使認股權證,從而加強資產負債表,從而增加240萬澳元的現金收益。投資者包括該公司的重要股東拉斐爾控股公司、公司的幾位董事、公司管理層及其附屬公司。

Summary of Financial Results for the Full Year 2023

2023 年全年財務業績摘要

Net loss for the year ended December 31, 2023 was approximately $20.1 million. Research and development expenses increased 58% to $14.2 million for the year ended December 31, 2023, from $9.0 million for the year ended December 31, 2022. The changes in research and development expenses resulted from the increased activity in the Company's Phase 3 study of TrappsolCyclo for the treatment of NPC.

截至2023年12月31日止年度的淨虧損約爲2,010萬美元。截至2023年12月31日止年度的研發費用從截至2022年12月31日的900萬美元增長了58%,至1,420萬美元。研發費用的變化是該公司對Trappsol的第三階段研究活動增加所致Cyclo 用於治療 NPC。

The Company ended the year with approximately $9.2 million of cash.

該公司在年底擁有約920萬澳元的現金。

About Cyclo Therapeutics

關於 Cyclo 療法

Cyclo Therapeutics, Inc. is a clinical-stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families living with disease. The Company's TrappsolCyclo, an orphan drug designated product in the United States and Europe, is the subject of four formal clinical trials for Niemann-Pick Disease Type C1, a rare and fatal genetic disease, (www.ClinicalTrials.gov NCT02939547, NCT02912793, NCT03893071 and NCT04860960). The Company is conducting a Phase 2b clinical trial using TrappsolCyclo intravenously in early Alzheimer's disease (NCT05607615) based on encouraging data from an Expanded Access program for Alzheimer's disease (NCT03624842). Additional indications for the active ingredient in TrappsolCyclo are in development. For additional information, visit the Company's website: www.cyclotherapeutics.com.

Cyclo Therapeutics, Inc. 是一家臨床階段的生物技術公司,致力於通過科學和創新爲患病患者和家庭開發改變生活的藥物。該公司的 TrappsolCyclo是美國和歐洲的孤兒藥指定產品,是尼曼-匹克病C1型的四項正式臨床試驗的主題,尼曼-匹克病是一種罕見的致命遺傳病,(www.clinicalTrials.gov NCT02939547NCT02912793NCT03893071NCT04860960)。該公司正在使用Trappsol進行2b期臨床試驗在早期的阿爾茨海默氏病中靜脈注射 Cyclo (NCT05607615)基於阿爾茨海默氏病擴大准入計劃的令人鼓舞的數據(NCT03624842)。Trappsol 中活性成分的其他適應症Cyclo 正在開發中。欲了解更多信息,請訪問公司的網站: www.cyclotherap

Safe Harbor Statement

安全港聲明

This press release contains "forward-looking statements" about the company's current expectations about future results, performance, prospects and opportunities, including, without limitation, statements regarding the satisfaction of closing conditions relating to the offering and the anticipated use of proceeds from the offering. Statements that are not historical facts, such as "anticipates," "believes" and "expects" or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual results in future periods to differ materially from what is expressed in, or implied by, these statements. The factors which may influence the company's future performance include the company's ability to obtain additional capital to expand operations as planned, success in achieving regulatory approval for clinical protocols, enrollment of adequate numbers of patients in clinical trials, unforeseen difficulties in showing efficacy of the company's biopharmaceutical products, success in attracting additional customers and profitable contracts, and regulatory risks associated with producing pharmaceutical grade and food products. These and other risk factors are described from time to time in the company's filings with the Securities and Exchange Commission, including, but not limited to, the company's reports on Forms 10-K and 10-Q. Unless required by law, the company assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

本新聞稿包含有關公司當前對未來業績、業績、前景和機會的預期的 “前瞻性陳述”,包括但不限於有關本次發行成交條件的滿足情況以及發行所得收益的預期用途的陳述。非歷史事實的陳述,例如 “預期”、“相信” 和 “期望” 或類似的表述,均爲前瞻性陳述。這些陳述受許多風險、不確定性和其他因素的影響,這些因素可能導致未來時期的實際結果與這些陳述中所表達或暗示的結果存在重大差異。可能影響公司未來業績的因素包括公司獲得額外資金以按計劃擴大業務的能力、成功獲得監管部門對臨床方案的批准、註冊足夠數量的患者參與臨床試驗、在顯示公司生物製藥產品功效方面出現不可預見的困難、成功吸引更多客戶和盈利合同以及與生產醫藥級和食品相關的監管風險。公司向美國證券交易委員會提交的文件中不時描述這些和其他風險因素,包括但不限於公司關於10-K和10-Q表的報告。除非法律要求,否則公司沒有義務因新信息或未來事件而更新或修改任何前瞻性陳述。

View source version on businesswire.com: https://www.businesswire.com/news/home/20240318041375/en/

在 businesswire.com 上查看源版本: https://www.businesswire.com/news/home/20240318041375/en/

Investor Contact:

JTC Team, LLC
Jenene Thomas
(833) 475-8247
CYTH@jtcir.com

投資者聯繫人:

JTC Team, LLC
珍妮·托馬斯
(833) 475-8247
CYTH@jtcir.com

声明:本內容僅用作提供資訊及教育之目的,不構成對任何特定投資或投資策略的推薦或認可。 更多信息
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