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Cidara Therapeutics Provides Corporate Update and Reports First Quarter 2024 Financial Results

Cidara Therapeutics Provides Corporate Update and Reports First Quarter 2024 Financial Results

Cidara Therapeutics提供公司最新情況並報告2024年第一季度財務業績
Cidara Therapeutics ·  05/15 12:00

SAN DIEGO, May 15, 2024 — Cidara Therapeutics, Inc. (Nasdaq: CDTX) (the Company), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today reported financial results for the first quarter ended March 31, 2024, and provided an update on its corporate activities and product pipeline.

聖地亞哥,2024年5月15日——Cidara Therapeutics, Inc.(納斯達克股票代碼:CDTX)(以下簡稱 “公司”),一家使用其專有Cloudbreak的生物技術公司 開發藥物-FC偶聯物(DFC)免疫療法的平台,旨在挽救生命並提高面臨嚴重疾病的患者的護理標準。該平台今天公佈了截至2024年3月31日的第一季度財務業績,並提供了其公司活動和產品線的最新情況。

"Our reacquisition of our CD388 program, which we have developed to date in collaboration with Janssen Pharmaceuticals, Inc., a Johnson & Johnson Company, (Janssen) as a once-per-flu season universal preventative of influenza A and B, along with the divestiture of the rezafungin program to our former partner Mundipharma, enables us to focus all of our development efforts on our Cloudbreak DFC platform," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "Our priority now is to evaluate the efficacy and safety of CD388 in providing season-long, universal protection from influenza in a Phase 2b study, which we intend to initiate during the upcoming Northern Hemisphere influenza season."

傑弗裏·斯坦說:“我們重新收購了迄今爲止與強生公司詹森製藥公司(詹森)合作開發的 CD388 計劃,該計劃是流感季節一次的甲型和乙型流感通用預防劑,並將rezafungin計劃剝離給了我們的前合作伙伴Mundipharma,這使我們能夠將所有開發工作集中在Cloudbreak DFC平台上。”,博士,Cidara總裁兼首席執行官。“我們現在的首要任務是在一項2b期研究中評估 CD388 在提供爲期一個季節的普遍流感保護方面的有效性和安全性,我們打算在即將到來的北半球流感季節啓動該研究。”

Dr. Stein continued, "Concurrent with the reacquisition of CD388, we closed a $240.0 million private placement led by RA Capital Management, with significant participation from Bain Capital Life Sciences, Biotech Value Fund (BVF), and Canaan Partners. We are thrilled with the substantial investment by this top-tier syndicate of new and existing investors and believe it is indicative of the significant potential of CD388 as a universal preventative of seasonal and pandemic influenza. We believe that CD388 may have significant advantages beyond and in addition to flu vaccines, with the potential for universal protection even in the absence of a robust immune system, and without the requirement for seasonal influenza strain prediction."

斯坦因博士繼續說:“在重新收購 CD388 的同時,我們完成了由RA Capital Management牽頭的2.4億美元私募配售,貝恩資本生命科學、生物技術價值基金(BVF)和迦南合夥人大量參與。我們對這個由新老投資者組成的頂級集團的大量投資感到非常興奮,並認爲這表明 CD388 作爲季節性和大流行性流感的通用預防劑具有巨大潛力。我們認爲,除了流感疫苗外,CD388 還可能具有顯著的優勢,即使沒有強大的免疫系統,也不需要季節性流感菌株預測,也有可能實現全民保護。”

Recent Corporate Highlights

近期企業要聞

  • Reacquired exclusive global development and commercial rights to CD388: In April 2024, Cidara entered into a definitive agreement with Janssen, to reacquire the exclusive global development and commercial rights to CD388, which is in development for the prevention of all strains of influenza A and B. Cidara is finalizing the protocol for a Phase 2b clinical trial, which the Company intends to initiate during the upcoming Northern Hemisphere influenza season.
  • Closed $240.0 million private placement: In April 2024 and in conjunction with the reacquisition of CD388, Cidara closed a definitive agreement for the sale of preferred stock in a $240.0 million private placement led by RA Capital Management, with significant participation from Bain Capital Life Sciences, BVF, and Canaan Partners. The proceeds from the private placement were used to fund the upfront payment of $85.0 million under the agreement with Janssen and the remainder of the gross proceeds of $155.0 million are expected to provide runway beyond topline data from CD388's planned Phase 2b trial.
  • Divested rezafungin to its former licensee, Mundipharma: In April 2024, Cidara entered into an asset purchase agreement with Napp Pharmaceutical Group Limited, a member of the international network of Mundipharma independent associated companies, for the divestiture of rezafungin. Cidara estimates that it will achieve approximately $128.0 million in cost savings over the patent life of rezafungin.
  • Appointed Laura Tadvalkar, Ph.D., Ryan Spencer, and James Merson, Ph.D., to Board of Directors: In April 2024 and in connection with the private placement, appointed Dr. Tadvalkar, Managing Director at RA Capital Management, Mr. Spencer, Chief Executive Officer and a director of Dynavax Technologies, and Dr. Merson, former Global Therapeutic Area Head for Infectious Diseases at Janssen Research & Development, LLC, to the Company's Board of Directors, while David Gollaher, Ph.D. and Timothy Franson, M.D., stepped down from the Board.
  • Announced a Reverse Stock Split: On April 12, 2024, Cidara's Board of Directors approved a 1-for-20 reverse stock split. On April 22, 2024 the Company filed an amendment to its Amended and Restated Certificate of Incorporation to effect a reverse stock split of its issued and outstanding common stock, at a ratio of 1-for-20, and a reduction in the number of authorized shares of common stock, at a ratio that is equal to half of the reverse stock split ratio. The Company's common stock began trading on a split-adjusted basis commencing upon market open on April 24, 2024 under a new CUSIP number, 171757206, and remain listed on the Nasdaq Capital Market under the symbol "CDTX".
  • Presented at 34th European Society of Clinical Microbiology and Infectious Diseases (ESCMID) conference: In April 2024, Cidara presented data from the Phase 2a study of CD388, showing the DFC was well tolerated and demonstrated statistically significant antiviral effects when administered as a single subcutaneous dose in healthy volunteers challenged with influenza at the 34th ESCMID conference. The Company also presented data from a Phase 1 single ascending dose study of CD388 which showed the drug has an extended half-life of 6-8 weeks.
  • Presented at AACR Annual Meeting 2024: In April 2024, Cidara presented new data on novel Cloudbreak DFC candidates at the AACR Annual Meeting. The Company delivered four poster presentations highlighting the data on the Company's multispecific CD73/PD-1 DFC, its CCR5-targeting DFC, and CBO421, its lead oncology DFC candidate targeting CD73.
  • 重新獲得了 CD388 的全球獨家開發和商業權:2024 年 4 月,Cidara 與 Janssen 簽訂了最終協議,以重新收購 CD388 的全球獨家開發和商業權,該公司正在開發用於預防所有甲型和乙型流感菌株。西達拉正在敲定一項2b期臨床試驗的協議,該公司打算在即將到來的北半球流感季節啓動該試驗。
  • 完成了2.4億美元的私募配售:2024年4月,在重新收購 CD388 的同時,西達拉完成了出售優先股的最終協議,該協議由RA Capital Management牽頭,貝恩資本生命科學、BVF和Canaan Partners進行了大量參與。根據與詹森達成的協議,私募的收益用於爲8,500萬美元的預付款提供資金,1.55億美元總收益的其餘部分預計將用於提供 CD388 計劃中的2b階段試驗的收入數據以外的跑道。
  • 將rezafungin剝離給其前被許可人Mundipharma:2024年4月,西達拉與Mundipharma獨立關聯公司國際網絡成員納普製藥集團有限公司簽訂了資產購買協議,以剝離雷扎芬金。Cidara估計,在rezafungin的專利有效期內,它將節省約1.28億美元的成本。
  • 任命勞拉·塔德瓦爾卡博士、瑞安·斯賓塞和詹姆斯·默森博士爲董事會成員:2024 年 4 月,在私募中,任命了 RA Capital Management 董事總經理塔德瓦爾卡博士、戴納瓦克斯科技首席執行官兼董事斯賓塞先生和詹森研發有限責任公司前全球傳染病治療領域負責人默森博士爲公司董事會,而大衛·格拉赫博士和醫學博士蒂莫西·弗蘭森則辭去了董事會的職務。
  • 宣佈反向股票拆分:2024 年 4 月 12 日,西達拉董事會批准了 1 比 20 的反向股票拆分。2024年4月22日,公司提交了對經修訂和重述的公司註冊證書的修正案,以1比20的比例對其已發行和流通的普通股進行反向分割,並減少普通股的授權數量,比例等於反向股票拆分比率的一半。該公司的普通股從2024年4月24日開市開始按拆分調整後的基礎上交易,股票編號爲171757206,並繼續在納斯達克資本市場上市,股票代碼爲 “CDTX”。
  • 在第 34 屆歐洲臨床微生物學和傳染病學會 (ESCMID) 會議上發表:2024 年 4 月,Cidara 提供了 CD388 2a 期研究的數據,顯示在第 34 屆ESCMID會議上,DFC具有良好的耐受性,並且在第34屆ESCMID會議上以單一皮下劑量給藥時表現出具有統計學意義的抗病毒作用。該公司還提供了 CD388 的 1 期單一遞增劑量研究的數據,該研究顯示該藥物的半衰期延長了 6-8 周。
  • 在2024年AACR年會上發表:2024年4月,西達拉在AACR年會上公佈了有關Cloudbreak DFC新候選人的新數據。該公司發表了四場海報演講,重點介紹了該公司的多特異性CD73/PD-1 DFC、其靶向CCR5的DFC和靶向CD73的主要腫瘤學DFC候選藥物 CBO421 的數據。

First Quarter 2024 Financial Results

2024 年第一季度財務業績

  • Revenue totaled $8.5 million for the three months ended March 31, 2024, compared to $26.1 million for the same period in 2023. Revenue for the three months ended March 31, 2024 related to the achievement of a milestone, ongoing research and development and clinical supply services provided to Mundipharma, Janssen and Melinta, royalty revenue, as well as product revenue related to shipments of REZZAYO naked vials to Mundipharma. Revenue for the three months ended March 31, 2023 related to the achievement of a milestone and ongoing research and development and clinical supply services provided to Mundipharma, Janssen and Melinta.
  • Cash and cash equivalents totaled $29.0 million as of March 31, 2024, compared with $35.8 million as of December 31, 2023.
  • Cost of product revenue was $1.6 million for the three months ended March 31, 2024, and primarily consisted of direct material costs, third-party manufacturing costs and indirect overhead costs associated with the manufacture, quality assessment and delivery of REZZAYO naked vials shipped to Mundipharma. Prior to regulatory approval, all direct and indirect manufacturing costs were charged to research and development expense in the period incurred.
  • Research and development expenses were $11.6 million for the three months ended March 31, 2024, compared to $18.9 million for the same period in 2023. The decrease in research and development expenses for the three months ended March 31, 2024, compared to the three months ended March 31, 2023 is primarily due to lower clinical expenses associated with the rezafungin clinical trials, lower clinical expenses associated with our Cloudbreak platform and lower personnel costs.
  • Selling, general and administrative (SG&A) expenses were $6.0 million for the three months ended March 31, 2024, compared to $4.5 million for the same period in 2023. The SG&A expenses for all periods primarily relate to consulting, personnel and legal costs.
  • Net loss for the three months ended March 31, 2024 was $10.3 million, compared to a net income of $3.0 million for the same period in 2023.
  • During the three months ended March 31, 2024, Cidara did not sell shares of common stock pursuant to its at-the-market sales agreement.
  • As of March 31, 2024, Cidara had 4,561,696 shares of common stock outstanding and 2,104,472 shares of Series X Convertible Preferred Stock outstanding, which are convertible into 1,052,236 shares of common stock.
  • 截至2024年3月31日的三個月,總收入爲850萬美元,而2023年同期爲2610萬美元。截至2024年3月31日的三個月的收入與里程碑的實現、向Mundipharma、Janssen和Melinta提供的持續研發和臨床供應服務、特許權使用費收入以及與向Mundipharma運送REZZAYO裸瓶相關的產品收入有關。截至2023年3月31日的三個月收入與實現里程碑以及向Mundipharma、Janssen和Melinta提供的持續研發和臨床供應服務有關。
  • 截至2024年3月31日,現金及現金等價物總額爲2900萬美元,而截至2023年12月31日爲3580萬美元。
  • 截至2024年3月31日的三個月,產品收入成本爲160萬美元,主要包括直接材料成本、第三方製造成本以及與運往Mundipharma的REZZAYO裸瓶的製造、質量評估和交付相關的間接管理費用。在監管部門批准之前,所有直接和間接的製造成本均計入所發生期間的研發費用。
  • 截至2024年3月31日的三個月,研發費用爲1160萬美元,而2023年同期爲1,890萬美元。與截至2023年3月31日的三個月相比,截至2024年3月31日的三個月的研發費用有所減少,這主要是由於與rezafungin臨床試驗相關的臨床費用減少,與我們的Cloudbreak平台相關的臨床費用減少以及人員成本降低。
  • 截至2024年3月31日的三個月,銷售、一般和管理(SG&A)支出爲600萬美元,而2023年同期爲450萬美元。所有時期的銷售和收購費用主要與諮詢、人事和法律費用有關。
  • 截至2024年3月31日的三個月,淨虧損爲1,030萬美元,而2023年同期的淨收入爲300萬美元。
  • 在截至2024年3月31日的三個月中,西達拉沒有根據其市場銷售協議出售普通股。
  • 截至2024年3月31日,西達拉已發行4,561,696股普通股和2,104,472股X系列可轉換優先股,可轉換爲1,052,236股普通股。

About Cidara Therapeutics

關於 Cidara Therapeu

Cidara Therapeutics is using its proprietary Cloudbreak platform to develop novel drug-Fc conjugates (DFCs). These targeted immunotherapies offer the unique opportunity to create "single molecule cocktails" comprised of targeted small molecules and peptides coupled to a human antibody fragment (Fc). DFCs are designed to save lives and improve the standard of care for patients facing serious diseases by inhibiting specific disease targets while simultaneously engaging the immune system. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.

Cidara Therapeutics 正在使用其專有的 Cloudb 開發新型藥物-FC偶聯物(DFC)的平台。這些靶向免疫療法爲創建 “單分子混合物” 提供了獨特的機會,該混合物由靶向小分子和與人類抗體片段(Fc)耦合的肽組成。DFC旨在通過抑制特定疾病靶標的同時激活免疫系統來挽救生命並提高面臨嚴重疾病的患者的護理標準。Cidara 總部位於加利福尼亞州聖地亞哥。欲了解更多信息,請訪問 www.cidara.com。

Forward-Looking Statements

前瞻性陳述

This release contains "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, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "anticipates," "expect," "may," "plan" or "will". Forward-looking statements in this release include, but are not limited to, statements related to whether we will start a Phase 2b clinical trial for CD388 in 2024, whether CD388 will be shown to have advantages beyond and in addition to flu vaccines, and whether CD388 will ultimately be approved for commercial sale by regulators in the U.S. or any country or will generate any revenue. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, such as unanticipated delays in or negative results from Cidara's preclinical or clinical trials, delays in action by regulatory authorities, and other obstacles on the enrollment of patients or other aspects of CD388, or other DFC development. These and other risks are identified under the caption "Risk Factors" in Cidara's most recent Quarterly Report on Form 10-Q and other filings subsequently made with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

本新聞稿包含經修訂的1933年《證券法》第27A條和經修訂的1934年《證券交易法》第21E條所指的 “前瞻性陳述”,此類前瞻性陳述是根據1995年《私人證券訴訟改革法》的安全港條款作出的。“前瞻性陳述” 描述未來的預期、計劃、結果或策略,前面通常以 “預期”、“期望”、“可能”、“計劃” 或 “將” 等詞語開頭。本新聞稿中的前瞻性陳述包括但不限於以下方面的陳述:我們是否將在2024年開始針對 CD388 進行2b期臨床試驗,CD388 是否會被證明在流感疫苗之外具有其他優勢,以及美國或任何國家的監管機構是否會批准CD388 進行商業銷售或將產生任何收入。此類陳述存在多種風險和不確定性,可能導致未來的情況、事件或結果與前瞻性陳述中的預測存在重大差異,例如Cidara臨床前或臨床試驗的意外延遲或負面結果,監管機構延遲採取行動,以及其他阻礙患者入組或 CD388 或其他DFC開發的其他方面。在Cidara最新的10-Q表季度報告以及隨後向美國證券交易委員會提交的其他文件中,在 “風險因素” 標題下確定了這些風險和其他風險。本新聞稿中包含的所有前瞻性陳述僅代表截至發表之日,並基於管理層截至該日的假設和估計。Cidara不承擔任何義務公開更新任何前瞻性陳述,無論是收到新信息、未來事件發生還是其他原因。

INVESTOR CONTACT:
Brian Ritchie
LifeSci Advisors
(212) 915-2578
britchie@lifesciadvisors.com

投資者聯繫人:
布萊恩·裏奇
生命科學顧問
(212) 915-2578
britchie@lifesciadvisors.com

MEDIA CONTACT:
Michael Fitzhugh
LifeSci Communications
mfitzhugh@lifescicomms.com

媒體聯繫人:
邁克爾·菲茨休
LifeSci
mfitzhugh@lifescicomms.com

CIDARA THERAPEUTICS, INC.

Condensed Consolidated Statements of Operations (unaudited)

Three Months Ended
March 31,
(In thousands, except share and per share data) 2024 2023
Revenues:
Collaboration revenue $5,637 $26,107
Product revenue 2,826
Total revenues 8,463 26,107
Operating expenses:
Cost of product revenue 1,563
Research and development 11,593 18,869
Selling, general and administrative 5,998 4,457
Total operating expenses 19,154 23,326
Income (loss) from operations (10,691 ) 2,781
Other income, net:
Interest income, net 365 232
Total other income, net 365 232
Net income (loss) and comprehensive income (loss) (10,326 ) 3,013
Allocation of earnings to participating securities (636 )
Net income (loss) attributable to common stockholders $(10,326 ) $2,377
Basic net earnings (loss) per common share $(2.28 ) $0.60
Diluted net earnings (loss) per common share $(2.28 ) $0.60
Shares used to compute basic net earnings (loss) per common share 4,537,782 3,932,050
Shares used to compute diluted net earnings (loss) per common share 4,537,782 5,059,514
CIDARA THERAPEUTICS, INC.

簡明合併運營報表(未經審計)

三個月已結束
3月31日
(以千計,股票和每股數據除外) 2024 2023
收入:
協作收入 5,637 美元 26,107 美元
產品收入 2,826
總收入 8,463 26,107
運營費用:
產品收入成本 1,563
研究和開發 11,593 18,869
銷售、一般和管理 5,998 4,457
運營費用總額 19,154 23,326
運營收入(虧損) (10,691) ) 2,781
其他收入,淨額:
淨利息收入 365 232
其他收入總額,淨額 365 232
淨收益(虧損)和綜合收益(虧損) (10,326) ) 3,013
將收益分配給參與證券 (636) )
歸屬於普通股股東的淨收益(虧損) 美元 (10,326) ) 2,377 美元
普通股每股基本淨收益(虧損) $ (2.28 ) 0.60 美元
普通股攤薄後的每股淨收益(虧損) $ (2.28 ) 0.60 美元
用於計算每股普通股基本淨收益(虧損)的股票 4,537,782 3,932,050
用於計算每股普通股攤薄後淨收益(虧損)的股票 4,537,782 5,059,514
Condensed Consolidated Balance Sheet Data
March 31,
2024
December 31,
2023
(In thousands) (unaudited)
Cash and cash equivalents $29,018 $35,778
Total assets 52,716 67,030
Total liabilities 70,496 75,240
Total stockholders' equity (deficit) (17,780 ) (8,210 )
簡明的合併資產負債表數據
3月31日
2024
十二月三十一日
2023
(以千計) (未經審計)
現金和現金等價物 29,018 美元 35,778 美元
總資產 52,716 67,030
負債總額 70,496 75,240
股東權益總額(赤字) (17,780) ) (8,210) )

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