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.
圣地亚哥,2024年8月13日——Cidara Therapeutics, Inc.(纳斯达克股票代码:CDTX)(以下简称 “公司”)(以下简称 “公司”)是一家生物技术公司,利用其专有的Cloudbreak平台开发药物-FC偶联物(DFC)免疫疗法,今天公布了截至2024年6月30日的第二季度财务业绩,并提供了其公司活动和产品线的最新情况。
"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总裁兼首席执行官杰弗里·斯坦博士表示:“随着 CD388 和其他计划的推进,我们将继续专注于我们的Cloudbreak DFC平台。”“我们旨在评估 CD388 的疗效和安全性的20期研究有望在2024年秋季的北半球流感季节开始,将有4,000名受试者在美国入组,在英国招募1,000名受试者,1,000名受试者将在英国入组,1,000名受试者将在英国入组。我们认为,与疫苗相比,CD388 具有重要的优势,可以在每个流感季节使用一剂疫苗为季节性和大流行性流感提供长期保护。”
Recent Corporate Highlights
近期企业要闻
- 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.
- 重新获得了 CD388 的全球独家开发和商业权:2024 年 4 月,Cidara 与强生创新医学(前身为强生制药公司(詹森)之一的詹森制药公司(Janssen Pharmicals, Inc.)签订了最终协议,以重新收购为预防所有甲型和乙型流感菌株而开发的 CD388 的全球独家开发和商业权(詹森许可协议)。Cidara正在敲定一项20期临床试验的协议,该公司打算在2024年秋季的北半球流感季节启动该试验。
- 完成了2.4亿美元的私募配售:2024年4月,在重新收购 CD388 的同时,Cidara以2.4亿美元的私募配售(私募配售)达成了出售优先股的最终协议,贝恩资本生命科学、生物技术价值基金和迦南合伙人参与了该协议。根据与詹森达成的协议,私募的收益用于为8,500万美元的预付款提供资金,1.55亿美元总收益的其余部分预计将用于提供 CD388 计划中的第20阶段试验的收入数据以外的跑道。
- 将rezafungin剥离给其前被许可人Mundipharma:2024年4月,西达拉与Mundipharma独立关联公司国际网络(Mundipharma)成员纳普制药集团有限公司(Napp)签订了资产购买协议,以剥离雷扎芬金(收购协议)。Cidara估计,在rezafungin的专利有效期内,它将节省约1.28亿美元的成本。2024年7月18日,西达拉收到了Mundipharma的满意通知,称其已完成了过渡服务协议规定的绩效义务,因此,Mundipharma原谅了先前向Cidara支付并可报销给Mundipharma的1,110万美元发展里程碑预付款。
- CBO421 的 IND 许可:西达拉于 2024 年 7 月获得了 CBO421 的研究性新药申请 (IND) 许可。
Second Quarter 2024 Financial Results
2024 年第二季度财务业绩
- 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日的三个月和六个月,总收入分别为30万美元和130万美元,而2023年同期分别为510万美元和1,130万美元。截至2024年6月30日和2023年6月30日的三个月和六个月的收入与根据先前存在的詹森合作协议向詹森提供的研发和临床供应服务有关。詹森合作协议于 2024 年 4 月 24 日在 Janssen 许可协议生效后终止。
- 截至2024年6月30日,现金及现金等价物总额为1.644亿美元,而截至2023年12月31日为3580万美元。
- 在截至2024年6月30日的三个月和六个月中,收购的在编研发费用为8,490万美元,涉及根据詹森许可协议于2024年4月24日向詹森支付的8,500万美元的预付款,外加40万美元的直接交易成本,由用于结算先前存在的詹森合作协议关系的50万美元和解收益所抵消。
- 截至2024年6月30日的三个月和六个月中,研发费用分别为670万美元和1,260万美元,而2023年同期分别为870万美元和1,840万美元。与截至2023年6月30日的三个月和六个月相比,截至2024年6月30日的三个月和六个月的研发费用有所减少,这主要是由于与我们的Cloudbreak平台相关的非临床支出减少,但支持我们的Cloudbreak平台的人事成本增加所抵消。
- 截至2024年6月30日的三个月和六个月中,销售、一般和管理(SG&A)支出分别为470万美元和830万美元,而2023年同期分别为320万美元和680万美元。所有时期的销售和收购费用主要与咨询、人事和法律费用有关。
- 2024年4月24日,西达拉与纳普签订了收购协议,根据该协议,我们向纳普出售了其所有rezafungin资产和相关合同。我们在2024年4月24日完成了所有销售条件。我们确定,出售rezafungin代表了战略转变,将对我们的运营和财务业绩产生重大影响。因此,出售rezafungin被归类为已终止业务。截至2024年6月30日的三个月,已终止业务的净收入为300万美元,截至2024年6月30日的六个月中已终止业务的净收入为90万美元,而2023年同期已终止业务的净亏损为750万美元,已终止业务的净收益为250万美元。
- 截至2024年6月30日的三个月和六个月的净亏损分别为9,120万美元和1.015亿美元,而2023年同期的净亏损分别为1,360万美元和1,060万美元。
- 在截至2024年6月30日的三个月和六个月中,西达拉没有根据其市场销售协议出售普通股。
- 截至2024年6月30日,Cidara有4568,991股已发行普通股,24万股A系列可转换投票优先股,可转换为16,800,000股普通股,以及2,104,472股X系列可转换优先股,可转换为1,052,236股普通股。
- 2024年7月18日,公司股东批准在2024年4月完成的私募中发行的24万股A系列可转换投票优先股的转换后,最多发行16,800,000股普通股。2024年7月19日,公司在自动转换35,275股A系列可转换投票优先股后,发行了2469,250股普通股。在这次自动转换之后,Cidara立即发行和流通了7,038,241股普通股。
About Cidara Therapeutics
关于 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正在使用其专有的Cloudbreak平台开发新的药物-FC偶联物(DFC)。这些靶向免疫疗法为创建 “单分子混合物” 提供了独特的机会,该混合物由靶向小分子和与人类抗体片段(Fc)耦合的肽组成。DFC旨在通过抑制特定疾病靶标的同时激活免疫系统来挽救生命并提高面临癌症和其他严重疾病的患者的护理标准。Cidara 总部位于加利福尼亚州圣地亚哥。欲了解更多信息,请访问。
Forward-Looking Statements
前瞻性陈述
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.
本新闻稿包含经修订的1933年《证券法》第27A条和经修订的1934年《证券交易法》第21E条所指的 “前瞻性陈述”,此类前瞻性陈述是根据1995年《私人证券诉讼改革法》的安全港条款作出的。“前瞻性陈述” 描述未来的预期、计划、结果或策略,前面通常以 “预期”、“期望”、“打算”、“可能”、“计划” 或 “意愿” 等词语开头。本新闻稿中的前瞻性陈述包括但不限于以下方面的陈述:我们是否会在 2024 年秋季启动 CD388 的 20期临床试验;在 IND 批准后我们是否及何时可以启动 CBO421 的临床试验;以及 CD388 或 CBO421 最终是否会被美国或任何国家的监管机构批准商业销售或将产生任何收入。此类陈述存在多种风险和不确定性,可能导致未来的情况、事件或结果与前瞻性陈述中的预测存在重大差异,例如Cidara临床前或临床试验的意外延迟或负面结果,监管机构延迟采取行动,以及其他阻碍患者入组或 CD388 或其他DFC开发的其他方面。在Cidara最新的10-Q表季度报告以及随后向美国证券交易委员会提交的其他文件中,在 “风险因素” 标题下确定了这些风险和其他风险。本新闻稿中包含的所有前瞻性陈述仅代表截至发表之日,并基于管理层截至该日的假设和估计。Cidara不承担任何义务公开更新任何前瞻性陈述,无论是收到新信息、未来事件发生还是其他原因。
INVESTOR CONTACT:
Brian Ritchie
LifeSci Advisors
(212) 915-2578
britchie@lifesciadvisors.com
投资者联系人:
布莱恩·里奇
生命科学顾问
(212) 915-2578
britchie@lifesciadvisors.com
MEDIA CONTACT:
Veronica Eames
LifeSci Communications
(646) 970-4682
veames@lifescicomms.com
媒体联系人:
维罗妮卡·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.简明合并运营报表(未经审计) | |||||||||||||||
三个月已结束 6月30日 |
六个月已结束 6月30日 |
||||||||||||||
(以千计,股票和每股数据除外) | 2024 | 2023 | 2024 | 2023 | |||||||||||
收入: | |||||||||||||||
协作收入 | 302 美元 | 5,090 美元 | 1,275 美元 | 11,310 美元 | |||||||||||
总收入 | 302 | 5,090 | 1,275 | 11,310 | |||||||||||
运营费用: | |||||||||||||||
收购了正在进行的研发 | 84,883 | — | 84,883 | — | |||||||||||
研究和开发 | 6,657 | 8,657 | 12,576 | 18,367 | |||||||||||
销售、一般和管理 | 4,746 | 3,181 | 8,342 | 6,834 | |||||||||||
运营费用总额 | 96,286 | 11,838 | 105,801 | 25,201 | |||||||||||
运营损失 | (95,984) | ) | (6,748) | ) | (104,526) | ) | (13,891) | ) | |||||||
其他收入,净额: | |||||||||||||||
净利息收入 | 1,774 | 623 | 2,139 | 855 | |||||||||||
其他收入总额,净额 | 1,774 | 623 | 2,139 | 855 | |||||||||||
扣除所得税支出的持续经营净亏损 | (94,210) | ) | (6,125) | ) | (102,387) | ) | (13,036) | ) | |||||||
所得税支出 | — | (40 | ) | — | (40 | ) | |||||||||
持续经营业务的净亏损 | (94,210) | ) | (6,165 | ) | (102,387) | ) | (13,076) | ) | |||||||
已终止业务的收益(亏损)(包括截至2024年6月30日的三个月和六个月内处置已终止业务的亏损1,799美元),扣除所得税 | 3,001 | (7,459) | ) | 852 | 2,465 | ||||||||||
净亏损和综合亏损 | $ (91,209 | ) | 美元 (13,624 | ) | $ (101,535) | ) | 美元 (10,611) | ) | |||||||
来自持续经营业务的每股普通股基本亏损和摊薄净亏损 | 美元 (20.65) | ) | 美元 (1.37 | ) | 美元 (22.50) | ) | 美元 (3.10 | ) | |||||||
已终止业务的普通股基本和摊薄后每股净收益(亏损) | 0.66 | (1.65) | ) | 0.19 | 0.59 | ||||||||||
普通股每股基本亏损和摊薄后净亏损 | 美元 (19.99 美元) | ) | 美元 (3.02 | ) | 美元 (22.31) | ) | 美元 (2.51 | ) | |||||||
用于计算每股普通股基本和摊薄后净收益(亏损)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 | ) |
简明的合并资产负债表数据 | |||||||
2024年6月30日 | 2023 年 12 月 31 日 | ||||||
(以千计) | (未经审计) | ||||||
现金和现金等价物 | 164,369 美元 | 35,778 美元 | |||||
总资产 | 173,357 | 67,030 | |||||
负债总额 | 42,421 | 75,240 | |||||
股东权益总额(赤字) | 130,936 | (8,210) | ) |