Cidara Therapeutics Provides Corporate Update and Reports Second Quarter 2024 Financial Results
Cidara Therapeutics Provides Corporate Update and Reports Second Quarter 2024 Financial Results
SAN DIEGO, Aug. 13, 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 second quarter ended June 30, 2024, and provided an update on its corporate activities and product pipeline.
聖地亞哥,2024年8月13日——Cidara Therapeutics, Inc.(納斯達克股票代碼:CDTX)(以下簡稱 「公司」)(以下簡稱 「公司」)是一家生物技術公司,利用其專有的Cloudbreak平台開發藥物-FC偶聯物(DFC)免疫療法,今天公佈了截至2024年6月30日的第二季度財務業績,並提供了其公司活動和產品線的最新情況。
"We continue to focus on our Cloudbreak DFC platform with the advancement of CD388 and other programs," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "Our Phase 2b study to evaluate the efficacy and safety of CD388, a long-acting drug candidate that provides season-long, universal protection from influenza, is on track to start in the fall of 2024 during the Northern Hemisphere influenza season with 4,000 subjects to be enrolled in the United States and 1,000 subjects to be enrolled in the United Kingdom. We believe that CD388 has important advantages over vaccines to provide long-term protection against both seasonal and pandemic strains of influenza with a single dose per flu season."
Cidara總裁兼首席執行官傑弗裏·斯坦博士表示:「隨着 CD388 和其他計劃的推進,我們將繼續專注於我們的Cloudbreak DFC平台。」「我們旨在評估 CD388 的療效和安全性的20期研究有望在2024年秋季的北半球流感季節開始,將有4,000名受試者在美國入組,在英國招募1,000名受試者,1,000名受試者將在英國入組,1,000名受試者將在英國入組。我們認爲,與疫苗相比,CD388 具有重要的優勢,可以在每個流感季節使用一劑疫苗爲季節性和大流行性流感提供長期保護。」
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 J&J Innovative Medicine, previously Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (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 (Janssen License Agreement). Cidara is finalizing the protocol for a Phase 2b clinical trial, which the Company intends to initiate in the fall of 2024 during the 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 (Private Placement) led by RA Capital Management, with significant participation from Bain Capital Life Sciences, Biotech Value Fund 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 (Napp), a member of the international network of Mundipharma independent associated companies (Mundipharma), for the divestiture of rezafungin (Purchase Agreement). Cidara estimates that it will achieve approximately $128.0 million in cost savings over the patent life of rezafungin. On July 18, 2024, Cidara received a notice of satisfaction from Mundipharma that it had completed the required performance obligations under a transition services agreement and, accordingly, the $11.1 million development milestone advance previously made to Cidara, and reimbursable to Mundipharma, was forgiven by Mundipharma.
- IND Clearance for CBO421: Cidara received investigational new drug application (IND) clearance for CBO421 in July 2024.
- 重新獲得了 CD388 的全球獨家開發和商業權:2024 年 4 月,Cidara 與強生創新醫學(前身爲強生製藥公司(詹森)之一的詹森製藥公司(Janssen Pharmicals, Inc.)簽訂了最終協議,以重新收購爲預防所有甲型和乙型流感菌株而開發的 CD388 的全球獨家開發和商業權(詹森許可協議)。Cidara正在敲定一項20期臨床試驗的協議,該公司打算在2024年秋季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,Cidara以2.4億美元的私募配售(私募配售)達成了出售優先股的最終協議,貝恩資本生命科學、生物技術價值基金和迦南合夥人參與了該協議。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 計劃中的第20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(Mundipharma)成員納普製藥集團有限公司(Napp)簽訂了資產購買協議,以剝離雷扎芬金(收購協議)。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。2024年7月18日,西達拉收到了Mundipharma的滿意通知,稱其已完成了過渡服務協議規定的績效義務,因此,Mundipharma原諒了先前向Cidara支付並可報銷給Mundipharma的1,110萬美元發展里程碑預付款。
- CBO421 的 IND 許可:西達拉於 2024 年 7 月獲得了 CBO421 的研究性新藥申請 (IND) 許可。
Second Quarter 2024 Financial Results
2024 年第二季度財務業績
- Revenue totaled $0.3 million and $1.3 million for the three and six months ended June 30, 2024, respectively, compared to $5.1 million and $11.3 million for the same periods in 2023, respectively. Revenue for the three and six months ended June 30, 2024 and 2023 related to research and development and clinical supply services provided to Janssen under the preexisting Janssen Collaboration Agreement. The Janssen Collaboration Agreement was terminated upon the effectiveness of the Janssen License Agreement on April 24, 2024.
- Cash and cash equivalents totaled $164.4 million as of June 30, 2024, compared with $35.8 million as of December 31, 2023.
- Acquired in-process research and development expenses were $84.9 million for the three and six months ended June 30, 2024 and related to an upfront payment of $85.0 million paid to Janssen under the Janssen License Agreement, on April 24, 2024, plus $0.4 million in direct transaction costs, offset by a settlement gain of $0.5 million to settle the preexisting Janssen Collaboration Agreement relationship.
- Research and development expenses were $6.7 million and $12.6 million for the three and six months ended June 30, 2024, respectively, compared to $8.7 million and $18.4 million for the same periods in 2023, respectively. The decrease in research and development expenses for the three and six months ended June 30, 2024, compared to the three and six months ended June 30, 2023 is primarily due to lower nonclinical expenses associated with our Cloudbreak platform, offset by higher personnel costs supporting our Cloudbreak platform.
- Selling, general and administrative (SG&A) expenses were $4.7 million and $8.3 million for the three and six months ended June 30, 2024, respectively, compared to $3.2 million and $6.8 million for the same period in 2023, respectively. The SG&A expenses for all periods primarily relate to consulting, personnel and legal costs.
- On April 24, 2024, Cidara entered into the Purchase Agreement with Napp, pursuant to which we sold to Napp all of its rezafungin assets and related contracts. We completed all conditions of the sale on April 24, 2024. We determined that the sale of rezafungin represented a strategic shift that will have a major effect on our operations and financial results. Accordingly, the sale of rezafungin is classified as discontinued operations. Net income from discontinued operations for the three months ended June 30, 2024, was $3.0 million and net income from discontinued operations for the six months ended June 30, 2024 was $0.9 million, compared to net loss from discontinued operations of $7.5 million and net income from discontinued operations of $2.5 million for the same periods in 2023, respectively.
- Net loss for the three and six months ended June 30, 2024 was $91.2 million and $101.5 million, respectively, compared to a net loss of $13.6 million and $10.6 million for the same periods in 2023, respectively.
- During the three and six months ended June 30, 2024, Cidara did not sell shares of common stock pursuant to its at-the-market sales agreement.
- As of June 30, 2024, Cidara had 4,568,991 shares of common stock outstanding, 240,000 shares of Series A Convertible Voting Preferred Stock outstanding, which are convertible into 16,800,000 shares of common stock, and 2,104,472 shares of Series X Convertible Preferred Stock outstanding, which are convertible into 1,052,236 shares of common stock.
- On July 18, 2024, the Company's stockholders approved the issuance of up to 16,800,000 shares of common stock upon conversion of 240,000 shares of Series A Convertible Voting Preferred Stock issued in the Private Placement completed in April 2024. On July 19, 2024, the Company issued 2,469,250 shares of common stock upon automatic conversion of 35,275 shares of Series A Convertible Voting Preferred Stock. Cidara had 7,038,241 shares of common stock issued and outstanding immediately following this automatic conversion.
- 截至2024年6月30日的三個月和六個月,總收入分別爲30萬美元和130萬美元,而2023年同期分別爲510萬美元和1,130萬美元。截至2024年6月30日和2023年6月30日的三個月和六個月的收入與根據先前存在的詹森合作協議向詹森提供的研發和臨床供應服務有關。詹森合作協議於 2024 年 4 月 24 日在 Janssen 許可協議生效後終止。
- 截至2024年6月30日,現金及現金等價物總額爲1.644億美元,而截至2023年12月31日爲3580萬美元。
- 在截至2024年6月30日的三個月和六個月中,收購的在編研發費用爲8,490萬美元,涉及根據詹森許可協議於2024年4月24日向詹森支付的8,500萬美元的預付款,外加40萬美元的直接交易成本,由用於結算先前存在的詹森合作協議關係的50萬美元和解收益所抵消。
- 截至2024年6月30日的三個月和六個月中,研發費用分別爲670萬美元和1,260萬美元,而2023年同期分別爲870萬美元和1,840萬美元。與截至2023年6月30日的三個月和六個月相比,截至2024年6月30日的三個月和六個月的研發費用有所減少,這主要是由於與我們的Cloudbreak平台相關的非臨床支出減少,但支持我們的Cloudbreak平台的人事成本增加所抵消。
- 截至2024年6月30日的三個月和六個月中,銷售、一般和管理(SG&A)支出分別爲470萬美元和830萬美元,而2023年同期分別爲320萬美元和680萬美元。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。
- 2024年4月24日,西達拉與納普簽訂了收購協議,根據該協議,我們向納普出售了其所有rezafungin資產和相關合同。我們在2024年4月24日完成了所有銷售條件。我們確定,出售rezafungin代表了戰略轉變,將對我們的運營和財務業績產生重大影響。因此,出售rezafungin被歸類爲已終止業務。截至2024年6月30日的三個月,已終止業務的淨收入爲300萬美元,截至2024年6月30日的六個月中已終止業務的淨收入爲90萬美元,而2023年同期已終止業務的淨虧損爲750萬美元,已終止業務的淨收益爲250萬美元。
- 截至2024年6月30日的三個月和六個月的淨虧損分別爲9,120萬美元和1.015億美元,而2023年同期的淨虧損分別爲1,360萬美元和1,060萬美元。
- 在截至2024年6月30日的三個月和六個月中,西達拉沒有根據其市場銷售協議出售普通股。
- 截至2024年6月30日,Cidara有4568,991股已發行普通股,24萬股A系列可轉換投票優先股,可轉換爲16,800,000股普通股,以及2,104,472股X系列可轉換優先股,可轉換爲1,052,236股普通股。
- 2024年7月18日,公司股東批准在2024年4月完成的私募中發行的24萬股A系列可轉換投票優先股的轉換後,最多發行16,800,000股普通股。2024年7月19日,公司在自動轉換35,275股A系列可轉換投票優先股後,發行了2469,250股普通股。在這次自動轉換之後,Cidara立即發行和流通了7,038,241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 cancers and other 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 .
Cidara Therapeutics正在使用其專有的Cloudbreak平台開發新的藥物-FC偶聯物(DFC)。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癌症和其他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。
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," "intends," "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 the fall of 2024, whether and when we may initiate a clinical trial for CBO421 following IND clearance, and whether CD388 or CBO421 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」、「打算」、「可能」、「計劃」 或 「意願」 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:我們是否會在 2024 年秋季啓動 CD388 的 20期臨床試驗;在 IND 批准後我們是否及何時可以啓動 CBO421 的臨床試驗;以及 CD388 或 CBO421 最終是否會被美國或任何國家的監管機構批准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:
Veronica Eames
LifeSci Communications
(646) 970-4682
veames@lifescicomms.com
媒體聯繫人:
維羅妮卡·埃姆斯
LifeSci
(646) 970-4682
veames@lifescicomms.com
CIDARA THERAPEUTICS, INC.Condensed Consolidated Statements of Operations (unaudited) | |||||||||||||||
Three Months Ended June 30, |
Six Months Ended June 30, |
||||||||||||||
(In thousands, except share and per share data) | 2024 | 2023 | 2024 | 2023 | |||||||||||
Revenues: | |||||||||||||||
Collaboration revenue | $302 | $5,090 | $1,275 | $11,310 | |||||||||||
Total revenues | 302 | 5,090 | 1,275 | 11,310 | |||||||||||
Operating expenses: | |||||||||||||||
Acquired in-process research and development | 84,883 | – | 84,883 | – | |||||||||||
Research and development | 6,657 | 8,657 | 12,576 | 18,367 | |||||||||||
Selling, general and administrative | 4,746 | 3,181 | 8,342 | 6,834 | |||||||||||
Total operating expenses | 96,286 | 11,838 | 105,801 | 25,201 | |||||||||||
Loss from operations | (95,984 | ) | (6,748 | ) | (104,526 | ) | (13,891 | ) | |||||||
Other income, net: | |||||||||||||||
Interest income, net | 1,774 | 623 | 2,139 | 855 | |||||||||||
Total other income, net | 1,774 | 623 | 2,139 | 855 | |||||||||||
Net loss from continuing operations before income tax expense | (94,210 | ) | (6,125 | ) | (102,387 | ) | (13,036 | ) | |||||||
Income tax expense | – | (40 | ) | – | (40 | ) | |||||||||
Net loss from continuing operations | (94,210 | ) | (6,165 | ) | (102,387 | ) | (13,076 | ) | |||||||
Income (loss) from discontinued operations (including loss on disposal of discontinued operations of $1,799 during the three and six months ended June 30, 2024), net of income taxes | 3,001 | (7,459 | ) | 852 | 2,465 | ||||||||||
Net loss and comprehensive loss | $(91,209 | ) | $(13,624 | ) | $(101,535 | ) | $(10,611 | ) | |||||||
Basic and diluted net loss per common share from continuing operations | $(20.65 | ) | $(1.37 | ) | $(22.50 | ) | $(3.10 | ) | |||||||
Basic and diluted net earnings (loss) per common share from discontinued operations | 0.66 | (1.65 | ) | 0.19 | 0.59 | ||||||||||
Basic and diluted net loss per common share | $(19.99 | ) | $(3.02 | ) | $(22.31 | ) | $(2.51 | ) | |||||||
Shares used to compute basic and diluted net earnings (loss) per common share | 4,563,772 | 4,505,813 | 4,550,774 | 4,220,511 |
CIDARA THERAPEUTICS, Inc.簡明合併運營報表(未經審計) | |||||||||||||||
三個月已結束 6月30日 |
六個月已結束 6月30日 |
||||||||||||||
(以千計,股票和每股數據除外) | 2024 | 2023 | 2024 | 2023 | |||||||||||
收入: | |||||||||||||||
協作收入 | 302 美元 | 5,090 美元 | 1,275 美元 | 11,310 美元 | |||||||||||
總收入 | 302 | 5,090 | 1,275 | 11,310 | |||||||||||
運營費用: | |||||||||||||||
收購了正在進行的研發 | 84,883 | — | 84,883 | — | |||||||||||
研究和開發 | 6,657 | 8,657 | 12,576 | 18,367 | |||||||||||
銷售、一般和管理 | 4,746 | 3,181 | 8,342 | 6,834 | |||||||||||
運營費用總額 | 96,286 | 11,838 | 105,801 | 25,201 | |||||||||||
運營損失 | (95,984) | ) | (6,748) | ) | (104,526) | ) | (13,891) | ) | |||||||
其他收入,淨額: | |||||||||||||||
淨利息收入 | 1,774 | 623 | 2,139 | 855 | |||||||||||
其他收入總額,淨額 | 1,774 | 623 | 2,139 | 855 | |||||||||||
扣除所得稅支出的持續經營淨虧損 | (94,210) | ) | (6,125) | ) | (102,387) | ) | (13,036) | ) | |||||||
所得稅支出 | — | (40 | ) | — | (40 | ) | |||||||||
持續經營業務的淨虧損 | (94,210) | ) | (6,165 | ) | (102,387) | ) | (13,076) | ) | |||||||
已終止業務的收益(虧損)(包括截至2024年6月30日的三個月和六個月內處置已終止業務的虧損1,799美元),扣除所得稅 | 3,001 | (7,459) | ) | 852 | 2,465 | ||||||||||
淨虧損和綜合虧損 | $ (91,209 | ) | 美元 (13,624 | ) | $ (101,535) | ) | 美元 (10,611) | ) | |||||||
來自持續經營業務的每股普通股基本虧損和攤薄淨虧損 | 美元 (20.65) | ) | 美元 (1.37 | ) | 美元 (22.50) | ) | 美元 (3.10 | ) | |||||||
已終止業務的普通股基本和攤薄後每股淨收益(虧損) | 0.66 | (1.65) | ) | 0.19 | 0.59 | ||||||||||
普通股每股基本虧損和攤薄後淨虧損 | 美元 (19.99 美元) | ) | 美元 (3.02 | ) | 美元 (22.31) | ) | 美元 (2.51 | ) | |||||||
用於計算每股普通股基本和攤薄後淨收益(虧損)的股票 | 4,563,772 | 4,505,813 | 4,550,774 | 4,220,511 |
Condensed Consolidated Balance Sheet Data | |||||||
June 30, 2024 | December 31, 2023 | ||||||
(In thousands) | (unaudited) | ||||||
Cash and cash equivalents | $164,369 | $35,778 | |||||
Total assets | 173,357 | 67,030 | |||||
Total liabilities | 42,421 | 75,240 | |||||
Total stockholders' equity (deficit) | 130,936 | (8,210 | ) |
簡明的合併資產負債表數據 | |||||||
2024年6月30日 | 2023 年 12 月 31 日 | ||||||
(以千計) | (未經審計) | ||||||
現金和現金等價物 | 164,369 美元 | 35,778 美元 | |||||
總資產 | 173,357 | 67,030 | |||||
負債總額 | 42,421 | 75,240 | |||||
股東權益總額(赤字) | 130,936 | (8,210) | ) |