Immunovant Reports Financial Results and Provides Corporate Updates for the Quarter Ended June 30, 2024
August 06, 2024 4:05 pm EDT Download as PDF
- Completed enrollment in batoclimab pivotal Myasthenia Gravis (MG) trial; top-line results and initiation of a potentially registrational program for IMVT-1402 on track for fiscal year end (March 31, 2025)
- Progressed development of lead asset IMVT-1402 with 3 Investigational New Drug (IND) applications expected to be active by calendar year end (December 31, 2024)
- Progressed Graves' disease (GD) program and on track to disclose additional results from the batoclimab study in GD as well as an overview of our development program for IMVT-1402 in GD in the fall of 2024
- As of June 30, 2024, Immunovant's cash and cash equivalents totaled approximately $560 million
NEW YORK, Aug. 06, 2024 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today reported corporate updates and financial results for its fiscal first quarter ended June 30, 2024.
"We are encouraged by the progress we made this quarter on the execution of our plans for both batoclimab and IMVT-1402. Not only did we complete enrollment in our pivotal trial of batoclimab for MG, but we also continued to make great progress towards initiating pivotal trials with IMVT-1402 across a range of indications. This is very exciting given the uniquely positive features of both the anti-FcRn class and the uniquely positive potential benefits of IMVT-1402," said Pete Salzmann, M.D., chief executive officer of Immunovant.
General Clinical Development Updates:
Immunovant continues to focus on unlocking the full potential of IMVT-1402 for the benefit of people with underserved autoantibody-driven diseases and remains on course to initiate four to five potentially registrational programs by March 31, 2025. In pursuit of this goal, Immunovant expects to have at least three IND applications active by December 31, 2024 to support clinical development of IMVT-1402 in multiple indications. As previously announced, Immunovant anticipates initiating clinical trials evaluating IMVT-1402 in a total of 10 indications by March 31, 2026.
Endocrinology Clinical Development Updates:
Immunovant previously announced initial results from the ongoing Phase 2 open-label, proof-of-concept study assessing the safety and efficacy of batoclimab in GD. The study represents the first evaluation of an anti-FcRn in GD. In the fall of this calendar year, Immunovant plans to provide a GD program update consisting of new epidemiologic data characterizing the potentially addressable market, additional results from the batoclimab study, and an overview of the IMVT-1402 development program in GD.
Top-line data from the current pivotal program evaluating batoclimab in thyroid eye disease (TED) continue to be expected in the first half of calendar year 2025. These data are expected to inform a decision regarding next steps for batoclimab in TED.
Neurology Clinical Development Updates:
Immunovant completed enrollment of the batoclimab pivotal trial in MG, with top-line results expected to be reported by March 31, 2025. Results from this trial are expected to inform a decision regarding next steps for batoclimab in MG. Immunovant also expects to initiate a potentially registrational program for IMVT-1402 in MG by March 31, 2025.
Immunovant continues to enroll patients in the batoclimab chronic inflammatory demyelinating polyneuropathy (CIDP) trial. The data from this trial, as well as learnings from other CIDP trials, will be used to optimize the trial design for a potentially registrational program for IMVT-1402 in CIDP. Initial data from period 1 of the batoclimab CIDP trial and the trial design for IMVT-1402 in CIDP are both expected to be disclosed by March 31, 2025.
Financial Highlights for Fiscal First Quarter Ended June 30, 2024:
Cash Position: As of June 30, 2024, Immunovant's cash and cash equivalents totaled approximately $560 million.
R&D Expenses: Research and development expenses were $75.5 million for the three months ended June 30, 2024, compared to $50.6 million for the three months ended June 30, 2023. The increase was primarily due to activities in preparation for potential future clinical trials of IMVT-1402, including contract manufacturing costs for drug substance, higher overall clinical trial costs related to our batoclimab pivotal clinical trials, and elevated personnel-related expenses. The increase was partially offset by lower overall costs related to our IMVT-1402 Phase 1 trial and nonclinical studies.
IPR&D Expenses: There were no acquired in-process research and development expenses for the three months ended June 30, 2024. During the three months ended June 30, 2023, acquired in-process research and development expenses were $12.5 million related to the achievement of development and regulatory milestones for batoclimab under the terms of the HanAll in-license agreement.
G&A Expenses: General and administrative expenses were $18.8 million for the three months ended June 30, 2024, compared to $15.4 million for the three months ended June 30, 2023. The increase was primarily due to higher personnel-related expenses, legal and other professional fees, information technology costs, and market research costs.
Net Loss: Net loss was $87.2 million ($0.60 per common share) for the three months ended June 30, 2024, compared to $73.9 million ($0.57 per common share) for the three months ended June 30, 2023. Net loss for the three months ended June 30, 2024 and June 30, 2023 included $13.5 million and $10.7 million, respectively, related to non-cash stock-based compensation expense.
Common Stock: As of June 30, 2024, there were 146,195,673 shares of common stock issued and outstanding.
About Immunovant, Inc.
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. For additional information on the Company, please visit immunovant.com.
Forward-Looking Statements
This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as "can," "may," "might," "will," "would," "should," "expect," "believe," "estimate," "design," "plan," "anticipate," "intend," and other similar expressions are intended to identify forward-looking statements. Such forward looking statements include statements regarding Immunovant's expectations regarding the timing, design, and results of clinical trials of IMVT-1402 and batoclimab, including the number and timing of (a) FDA clearance with respect to IND applications, and (b) potential registrational programs and clinical trials of IMVT-1402; Immunovant's plan to develop IMVT-1402 and batoclimab across a broad range of indications; and potential benefits of IMVT-1402's unique product attributes and potential best-in-class profile. All forward-looking statements are based on estimates and assumptions by Immunovant's management that, although Immunovant believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Immunovant expected. Such risks and uncertainties include, among others: Immunovant may not be able to protect or enforce its intellectual property rights; initial results or other preliminary analyses or results of early clinical trials may not be predictive of final trial results or of the results of later clinical trials; the timing and availability of data from clinical trials; the timing of discussions with regulatory agencies, as well as regulatory submissions and potential approvals; the continued development of Immunovant's product candidates, including the number and timing of the commencement of additional clinical trials; Immunovant's scientific approach, clinical trial design, indication selection, and general development progress; future clinical trials may not confirm any safety, potency, or other product characteristics described or assumed in this press release; any product candidate that Immunovant develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; Immunovant's product candidates may not be beneficial to patients, or even if approved by regulatory authorities, successfully commercialized; the potential impact of macroeconomic and geopolitical factors on Immunovant's business operations and supply chain, including its clinical development plans and timelines; Immunovant's business is heavily dependent on the successful development, regulatory approval, and commercialization of batoclimab and/or IMVT-1402; Immunovant is at various stages of clinical development for batoclimab and IMVT-1402; and Immunovant will require additional capital to fund its operations and advance batoclimab and IMVT-1402 through clinical development. These and other risks and uncertainties are more fully described in Immunovant's periodic and other reports filed with the Securities and Exchange Commission (SEC), including in the section titled "Risk Factors" in Immunovant's Form 10-Q to be filed with the SEC on August 6, 2024, and Immunovant's subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Immunovant undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
IMMUNOVANT, INC. Consolidated Statements of Operations (Unaudited, in thousands, except share and per share data) |
|
| Three Months Ended June 30, |
| | 2024 | | | | 2023 | |
Operating expenses: | | | |
Research and development | $ | 75,473 | | | $ | 50,575 | |
Acquired in-process research and development | | — | | | | 12,500 | |
General and administrative | | 18,808 | | | | 15,402 | |
Total operating expenses | | 94,281 | | | | 78,477 | |
Interest income | | (7,180) | | | | (4,065) | |
Other income, net | | (28) | | | | (464) | |
Loss before provision (benefit) for income taxes | | (87,073) | | | | (73,948) | |
Provision (benefit) for income taxes | | 77 | | | | (11) | |
Net loss | $ | (87,150) | | | $ | (73,937) | |
Net loss per common share – basic and diluted | $ | (0.60) | | | $ | (0.57) | |
Weighted-average common shares outstanding – basic and diluted | | 146,085,729 | | | | 130,503,264 | |
IMMUNOVANT, INC. Consolidated Balance Sheets (Unaudited, in thousands, except share and per share data) |
|
| June 30, 2024 | | March 31, 2024 |
Assets | | | |
Current assets: | | | |
Cash and cash equivalents | $ | 560,005 | | | $ | 635,365 | |
Accounts receivable | | 2,417 | | | | 5,337 | |
Prepaid expenses and other current assets | | 26,625 | | | | 25,068 | |
Total current assets | | 589,047 | | | | 665,770 | |
Operating lease right-of-use assets | | 66 | | | | 133 | |
Property and equipment, net | | 565 | | | | 462 | |
Total assets | $ | 589,678 | | | $ | 666,365 | |
Liabilities and Stockholders' Equity | | | |
Current liabilities: | | | |
Accounts payable | $ | 11,035 | | | $ | 7,155 | |
Accrued expenses | | 33,914 | | | | 41,315 | |
Current portion of operating lease liabilities | | 69 | | | | 138 | |
Total current liabilities | | 45,018 | | | | 48,608 | |
Total liabilities | | 45,018 | | | | 48,608 | |
Commitments and contingencies | | | |
Stockholders' equity: | | | |
Series A preferred stock, par value $0.0001 per share, 10,000 shares authorized, issued and outstanding at June 30, 2024 and March 31, 2024 | | — | | | | — | |
Preferred stock, par value $0.0001 per share, 10,000,000 shares authorized, no shares issued and outstanding at June 30, 2024 and March 31, 2024 | | — | | | | — | |
Common stock, par value $0.0001 per share, 500,000,000 shares authorized, 146,195,673 shares issued and outstanding at June 30, 2024 and 500,000,000 shares authorized, 145,582,999 shares issued and outstanding at March 31, 2024 | | 14 | | | | 14 | |
Additional paid-in capital | | 1,455,659 | | | | 1,441,518 | |
Accumulated other comprehensive income | | 1,820 | | | | 1,908 | |
Accumulated deficit | | (912,833) | | | | (825,683) | |
Total stockholders' equity | | 544,660 | | | | 617,757 | |
Total liabilities and stockholders' equity | $ | 589,678 | | | $ | 666,365 | |
Contact:
Renee Barnett, MBA
Chief Financial Officer
Immunovant, Inc.
info@immunovant.com
Source: Immunovant Inc.
Released August 6, 2024
Immunovant公布截至2024年6月30日的季度财务业绩并提供公司最新情况
2024 年 8 月 6 日美国东部时间下午 4:05 以 PDF 格式下载
- 已完成巴托克利单抗关键性重症肌无力(MG)试验的入组;一线结果和IMVT-1402可能注册计划的启动有望在财政年度末(2025年3月31日)完成
- 主导资产IMVT-1402的开发取得进展,预计将在日历年度末(2024年12月31日)之前激活3项在研新药(IND)申请
- 格雷夫斯病(GD)项目取得进展,并有望披露巴托克利单抗在GD的更多研究结果,以及我们在2024年秋季在GD中开发imvt-1402的开发计划的概述
- 截至2024年6月30日,Immunovant的现金及现金等价物总额约为5.6亿美元
纽约,2024年8月6日(GLOBE NEWSWIRE)——致力于让自身免疫性疾病患者过上正常生活的临床阶段免疫学公司Immunovant, Inc.(纳斯达克股票代码:IMVT)今天公布了截至2024年6月30日的第一财季公司最新情况和财务业绩。
“本季度我们在执行batoclimab和IMVT-1402计划方面取得的进展令我们感到鼓舞。我们不仅完成了用于MG的巴托克利单抗的关键试验的入组,而且在启动针对各种适应症的IMVT-1402的关键试验方面,我们也继续取得长足的进展。鉴于抗FCRN类别的独特积极特征和IMVT-1402独特的积极潜在益处,这非常令人兴奋。” Immunovant首席执行官皮特·萨尔兹曼万德说。
一般临床开发更新:
Immunovant继续专注于释放IMVT-1402的全部潜力,使自身抗体驱动性疾病得不到充分治疗的患者受益,并有望在2025年3月31日之前启动四到五个可能的注册计划。为了实现这一目标,Immunovant预计,到2024年12月31日,至少有三项IND申请处于活跃状态,以支持IMVT-1402在多种适应症中的临床开发。正如先前宣布的那样,Immunovant预计将在2026年3月31日之前启动评估IMVT-1402总共10种适应症的临床试验。
内分泌学临床开发更新:
Immunovant此前公布了正在进行的2期开放标签概念验证研究的初步结果,该研究评估了巴托克利单抗在GD中的安全性和有效性。该研究是对GD中抗FCRN的首次评估。在本日历年秋季,Immunovant计划提供GD项目更新,包括描述潜在市场的新流行病学数据、batoclimab研究的其他结果以及GD中imvt-1402开发计划的概述。
目前评估巴托克利单抗治疗甲状腺眼病(TED)的关键项目的主要数据预计将在2025年上半年公布。预计这些数据将为有关Batoclimab在TED中的下一步措施的决定提供信息。
神经病学临床开发更新:
Immunovant完成了MG中巴托克利单抗关键试验的入组,预计将在2025年3月31日之前公布主要结果。该试验的结果预计将为有关巴托克利单抗在MG中的下一步措施的决定提供依据。Immunovant还预计将在2025年3月31日之前启动一项可能在MG中启动IMVT-1402的注册计划。
Immunovant继续招募患者参加巴托克利单抗慢性炎性脱髓鞘性多发性神经病(CIDP)试验。该试验的数据以及其他CIDP试验的经验将用于优化CIDP中IMVT-1402可能注册计划的试验设计。batoclimab CIDP试验第一阶段的初始数据和CIDP中imvt-1402的试验设计预计都将在2025年3月31日之前披露。
截至2024年6月30日的第一财季财务摘要:
现金状况:截至2024年6月30日,Immunovant的现金和现金等价物总额约为5.6亿美元。
研发费用:截至2024年6月30日的三个月,研发费用为7,550万美元,而截至2023年6月30日的三个月,研发费用为5,060万美元。增长主要是由于为未来可能的IMVT-1402临床试验做准备的活动,包括药物的合同制造成本、与我们的batoclimab关键临床试验相关的总体临床试验成本增加以及人员相关费用增加。与我们的IMVT-1402 1期试验和非临床研究相关的总体成本降低部分抵消了这一增长。
知识产权与研发费用:截至2024年6月30日的三个月中,没有收购的在建研发费用。在截至2023年6月30日的三个月中,收购的在制研发费用为1,250万美元,这与根据Hanall许可协议条款实现batoclimab的开发和监管里程碑有关。
并购费用:截至2024年6月30日的三个月,一般和管理费用为1,880万美元,而截至2023年6月30日的三个月为1,540万美元。增长主要是由于人事相关费用、法律和其他专业费用、信息技术成本和市场研究成本的增加。
净亏损:截至2024年6月30日的三个月,净亏损为8,720万美元(每股普通股亏损0.60美元),而截至2023年6月30日的三个月,净亏损为7,390万美元(每股普通股亏损0.57美元)。截至2024年6月30日和2023年6月30日的三个月,净亏损分别包括与非现金股票薪酬支出相关的1,350万美元和1,070万美元。
普通股:截至2024年6月30日,共有146,195,673股普通股已发行和流通。
关于 Immunovant, Inc.
Immunovant, Inc. 是一家临床阶段的免疫学公司,致力于让自身免疫性疾病患者过上正常生活。作为抗FCRN技术的开拓者,该公司正在开发创新的靶向疗法,以满足自身免疫性疾病患者的复杂和多变需求。有关该公司的更多信息,请访问immunovant.com。
前瞻性陈述
本新闻稿包含前瞻性陈述,以1995年《私人证券诉讼改革法》和其他联邦证券法中的安全港条款为目的。使用 “可以”、“可能”、“可能”、“将”、“应该”、“期望”、“相信”、“估计”、“设计”、“计划”、“预测”、“打算” 等词语以及其他类似的表述旨在识别前瞻性陈述。此类前瞻性陈述包括有关Immunovant对IMVT-1402和batoclimab临床试验的时机、设计和结果的预期的陈述,包括(a)美国食品药品管理局批准IND申请的数量和时间,以及(b)IMVT-1402的潜在注册计划和临床试验;Immunovant计划开发各种适应症的IMVT-1402和batoclimab;以及 IMVT-1402 独特的产品属性和潜在的同类最佳配置所带来的潜在优势。所有前瞻性陈述均基于Immunovant管理层的估计和假设,尽管Immunovant认为这些估计和假设是合理的,但本质上是不确定的。所有前瞻性陈述都受到风险和不确定性的影响,这些风险和不确定性可能导致实际结果与Immunovant的预期存在重大差异。此类风险和不确定性包括:Immunovant可能无法保护或执行其知识产权;早期临床试验的初步结果或其他初步分析或结果可能无法预测最终试验结果或后续临床试验的结果;临床试验数据的时机和可用性;与监管机构讨论的时机以及监管机构提交的文件和潜在的批准;Immunovant候选产品的持续开发,包括数量和时间其他临床试验的开始;Immunovant的科学方法、临床试验设计、适应症选择和总体开发进展;未来的临床试验可能无法证实本新闻稿中描述或假设的任何安全性、效力或其他产品特性;Immunovant开发的任何候选产品可能无法在预期的时间表内或根本无法通过临床开发取得进展或获得所需的监管部门批准;Immunovant的候选产品可能不会对患者有益,或者即使批准者监管机构成功商业化;宏观经济和地缘政治因素对Immunovant业务运营和供应链的潜在影响,包括其临床开发计划和时间表;Immunovant的业务在很大程度上依赖于巴托利单抗和/或IMVT-1402的成功开发、监管批准和商业化;Immunovant的巴托利单抗和IMVT-1402的临床开发处于不同的阶段;Immunovant 将需要额外的资金来为其运营提供资金并推进batoclimab和IMVT-1402的发展通过临床开发。Immunovant向美国证券交易委员会(SEC)提交的定期报告和其他报告对这些以及其他风险和不确定性进行了更全面的描述,包括Immunovant将于2024年8月6日向美国证券交易委员会提交的10-Q表格中标题为 “风险因素” 的部分,以及Immunovant随后向美国证券交易委员会提交的文件。任何前瞻性陈述仅代表其发表之日。Immunovant没有义务公开更新或修改任何前瞻性陈述,无论是由于新信息、未来事件还是其他原因。
IMMUNOVANT, INC. 合并运营报表 (未经审计,以千计,股票和每股数据除外) |
|
| 三个月已结束 6月30日 |
| | 2024 | | | | 2023 | |
运营费用: | | | |
研究和开发 | $ | 75,473 | | | $ | 50,575 | |
收购了正在进行的研发 | | — | | | | 12,500 | |
一般和行政 | | 18,808 | | | | 15,402 | |
运营费用总额 | | 94,281 | | | | 78,477 | |
利息收入 | | (7,180) | | | | (4,065) | |
其他收入,净额 | | (28) | | | | (464) | |
所得税准备金(收益)前的亏损 | | (87,073) | | | | (73,948) | |
所得税准备金(福利) | | 77 | | | | (11) | |
净亏损 | $ | (87,150) | | | $ | (73,937) | |
每股普通股净亏损——基本亏损和摊薄后 | $ | (0.60) | | | $ | (0.57) | |
加权平均已发行普通股——基本股和摊薄后普通股 | | 146,085,729 | | | | 130,503,264 | |
IMMUNOVANT, INC. 合并资产负债表 (未经审计,以千计,股票和每股数据除外) |
|
| 2024年6月30日 | | 2024 年 3 月 31 日 |
资产 | | | |
流动资产: | | | |
现金和现金等价物 | $ | 560,005 | | | $ | 635,365 | |
应收账款 | | 2,417 | | | | 5,337 | |
预付费用和其他流动资产 | | 26,625 | | | | 25,068 | |
流动资产总额 | | 589,047 | | | | 665,770 | |
经营租赁使用权资产 | | 66 | | | | 133 | |
财产和设备,净额 | | 565 | | | | 462 | |
总资产 | $ | 589,678 | | | $ | 666,365 | |
负债和股东权益 | | | |
流动负债: | | | |
应付账款 | $ | 11,035 | | | $ | 7,155 | |
应计费用 | | 33,914 | | | | 41,315 | |
经营租赁负债的流动部分 | | 69 | | | | 138 | |
流动负债总额 | | 45,018 | | | | 48,608 | |
负债总额 | | 45,018 | | | | 48,608 | |
承付款和意外开支 | | | |
股东权益: | | | |
A系列优先股,面值每股0.0001美元,截至2024年6月30日和2024年3月31日已授权、已发行和流通的1万股 | | — | | | | — | |
优先股,面值每股0.0001美元,已授权1,000万股,截至2024年6月30日和2024年3月31日未发行和流通股票 | | — | | | | — | |
普通股,面值每股0.0001美元,已授权5亿股,截至2024年6月30日已发行和流通146,195,673股股票,授权5亿股,截至2024年3月31日已发行和流通145,582,999股 | | 14 | | | | 14 | |
额外的实收资本 | | 1,455,659 | | | | 1,441,518 | |
累计其他综合收益 | | 1,820 | | | | 1,908 | |
累计赤字 | | (912,833) | | | | (825,683) | |
股东权益总额 | | 544,660 | | | | 617,757 | |
负债和股东权益总额 | $ | 589,678 | | | $ | 666,365 | |
联系人:
蕾妮·巴内特,工商管理硕士
首席财务官
Immunovant, Inc.
info@immunovant.com
资料来源:Immunovant Inc.
2024 年 8 月 6 日发布