Immunovant Reports Financial Results and Provides Corporate Updates for the Quarter Ended December 31, 2023
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Insights
Immunovant's strategic move to initiate multiple potentially registrational programs for IMVT-1402 indicates a robust pipeline with a focus on diversification across various autoimmune indications. The mention of 'potentially registrational' suggests these studies could lead directly to applications for regulatory approval, which is a significant step forward from earlier phase trials. The reported reduction in immunoglobulin G (IgG) levels by a mean of 74% in the Phase 1 trial for IMVT-1402 without notable changes in serum albumin and LDL cholesterol is promising, as it indicates efficacy alongside a potentially favorable safety profile.
Moreover, the ongoing Phase 2 and Phase 3 trials for batoclimab in different indications, such as Graves' disease, CIDP, MG and TED, suggest that Immunovant is progressing towards addressing a range of autoimmune disorders. The response rates in Graves’ disease being meaningfully higher than 50 percent could position batoclimab favorably in the market if these results translate into later-stage trials. The anticipation of initial data from the Phase 2b CIDP trial and top-line data from MG and TED trials by 2025 positions the company at a critical juncture for potential market entry and revenue generation.
Immunovant's financial health is an essential factor for stakeholders, with a cash position of approximately $691 million as of December 31, 2023. This reserve appears to be sufficient to fund their ambitious clinical development plans without immediate additional capital raise, which is a positive sign for investors. However, the reported net loss of $51.4 million for the fiscal third quarter, although less than the previous year's $63.2 million, still underscores the high costs associated with drug development.
The increase in R&D expenses, particularly due to the development of IMVT-1402 and batoclimab, is reflective of the company's investment in its pipeline. While increased spending is typical for clinical-stage companies, the value of these investments hinges on the successful progression of clinical trials and eventual product approvals. The non-cash stock-based compensation expense included in the net loss is also noteworthy, as it represents a significant part of the company's compensation strategy and can impact earnings per share.
The autoimmune disease market is highly competitive, with numerous established and emerging therapies. Immunovant's focus on developing therapies with a potentially 'best-in-class' profile for IMVT-1402 could provide a competitive edge if the safety and efficacy data hold up in later-stage trials. The specificity of targeting the neonatal Fc receptor (FcRn) is a novel approach and could meet unmet needs within the autoimmune space, which is a market with significant patient populations and potential revenue.
The company's plan to initiate trials in 10 indications over the next two fiscal years reflects an aggressive growth strategy, which could significantly expand its market presence if successful. The progress of global Phase 3 clinical trials and the expected data readouts will be closely monitored by the market, as these milestones are critical for evaluating the company's potential for future revenue streams and its positioning within the biopharmaceutical sector.
- Immunovant plans to initiate 4-5 potentially registrational programs for IMVT-1402 over the next fiscal year
- Immunovant plans to initiate trials in 10 indications for IMVT-1402 over the next two fiscal years
- Initial period 1 data from Phase 2b clinical trial of batoclimab in chronic inflammatory demyelinating polyneuropathy (CIDP) expected in the second or third quarter of calendar year 2024
- Global Phase 3 clinical trials of batoclimab in myasthenia gravis (MG) and thyroid eye disease (TED) progressing and on track for expected top-line data in the second half of calendar year 2024 (MG) and the first half of calendar year 2025 (TED)
NEW YORK, Feb. 12, 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 third quarter ended December 31, 2023.
“We have laid a strong and exciting foundation for Immunovant,” said Pete Salzmann, M.D., chief executive officer at Immunovant. “We believe our initial Phase 1 data for IMVT-1402 in healthy adults supports its potential best-in-class profile, and we are actively designing potential registrational programs across a range of different indications. We look forward to sharing more details of the development plan for IMVT-1402, as well as key data readouts from batoclimab trials in neurology over the course of 2024.”
Clinical Development Updates:
IMVT-1402:
Immunovant’s second-generation antibody targeting the neonatal fragment crystallizable receptor (FcRn) continued to show potentially best-in-class profile in a Phase 1 clinical trial in healthy adults. Initial data from the 600 mg MAD cohort showed that four subcutaneously administered doses of 600 mg IMVT-1402 reduced total immunoglobulin G (IgG) levels by a mean of
Batoclimab:
In an open-label Phase 2 proof-of-concept clinical trial of batoclimab in Graves’ disease, response rates from an initial cohort of patients who were hyperthyroid despite treatment with an anti-thyroid medication for more than 12 weeks were meaningfully higher than 50 percent, after receiving once-weekly subcutaneous injections of 680 mg batoclimab for 12 weeks. This trial is ongoing. Initial results from period 1 of the Phase 2b clinical trial in CIDP are expected in the second or third quarter of calendar year 2024, while top-line data from the Phase 3 clinical trials in MG and TED are on track and expected in the second half of calendar year 2024 and the first half of calendar year 2025, respectively.
Financial Highlights for Fiscal Third Quarter Ended December 31, 2023:
Cash Position: As of December 31, 2023, Immunovant’s cash and cash equivalents totaled approximately
R&D Expenses: Research and development expenses were
IPR&D Expenses: There were no acquired in-process research and development expenses for the three months ended December 31, 2023. Acquired in-process research and development expenses were
G&A Expenses: General and administrative expenses were
Net Loss: Net loss was
Common Stock: As of December 31, 2023, there were 145,094,052 shares of common stock issued and outstanding.
Financial Highlights for Fiscal Nine Months Ended December 31, 2023:
R&D Expenses: Research and development expenses were
IPR&D Expenses: Acquired in-process research and development expenses were
G&A Expenses: General and administrative expenses were
Net Loss: Net loss was
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 www.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,” "intend," and other similar expressions are intended to identify forward-looking statements. Such forward looking statements include Immunovant’s expectations regarding the timing, design, and results of clinical trials of batoclimab and IMVT-1402; Immunovant's plan to develop batoclimab and IMVT-1402 across a broad range of autoimmune indications; the number and timing of potentially registrational programs and clinical trials Immunovant plans to initiate for IMVT-1402; and potential benefits of batoclimab’s and 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: initial results or other preliminary analyses or results of early clinical trials may not be predictive 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 global factors, such as the post-COVID-19 environment, geopolitical tensions, and adverse macroeconomic conditions 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 IMVT-1402; Immunovant is at an early stage of development for IMVT-1402 and in various stages of clinical development for batoclimab; 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 February 12, 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. Condensed Consolidated Statements of Operations (Unaudited, in thousands, except share and per share data) | |||||||||||||||
| Three Months Ended December 31, | Nine Months Ended December 31, | ||||||||||||||
| 2023 | 2022 | 2023 | 2022 | ||||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | $ | 48,338 | $ | 42,252 | $ | 146,872 | $ | 108,420 | |||||||
| Acquired in-process research and development | — | 10,000 | 12,500 | 10,000 | |||||||||||
| General and administrative | 13,215 | 11,775 | 42,458 | 35,597 | |||||||||||
| Total operating expenses | 61,553 | 64,027 | 201,830 | 154,017 | |||||||||||
| Interest income | (8,933 | ) | (2,944 | ) | (16,569 | ) | (4,098 | ) | |||||||
| Other (income) expense, net | (1,094 | ) | 1,757 | (1,579 | ) | 609 | |||||||||
| Loss before provision (benefit) for income taxes | (51,526 | ) | (62,840 | ) | (183,682 | ) | (150,528 | ) | |||||||
| Provision (benefit) for income taxes | (108 | ) | 387 | 335 | 1,000 | ||||||||||
| Net loss | $ | (51,418 | ) | $ | (63,227 | ) | $ | (184,017 | ) | $ | (151,528 | ) | |||
| Net loss per common share – basic and diluted | $ | (0.36 | ) | $ | (0.49 | ) | $ | (1.36 | ) | $ | (1.26 | ) | |||
| Weighted-average common shares outstanding – basic and diluted | 144,523,034 | 128,574,190 | 135,577,267 | 120,665,299 | |||||||||||
| IMMUNOVANT, INC. Condensed Consolidated Balance Sheets (Unaudited, in thousands, except share and per share data) | |||||||
| December 31, 2023 | March 31, 2023 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 690,937 | $ | 376,532 | |||
| Accounts receivable | 1,029 | 700 | |||||
| Prepaid expenses and other current assets | 18,810 | 27,101 | |||||
| Total current assets | 710,776 | 404,333 | |||||
| Operating lease right-of-use assets | 294 | 1,172 | |||||
| Property and equipment, net | 376 | 333 | |||||
| Total assets | $ | 711,446 | $ | 405,838 | |||
| Liabilities and Stockholders’ Equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 3,910 | $ | 1,353 | |||
| Accrued expenses | 27,886 | 40,771 | |||||
| Current portion of operating lease liabilities | 306 | 1,173 | |||||
| Total current liabilities | 32,102 | 43,297 | |||||
| Operating lease liabilities, net of current portion | — | 47 | |||||
| Total liabilities | 32,102 | 43,344 | |||||
| Commitments and contingencies | |||||||
| Stockholders’ equity: | |||||||
| Series A preferred stock, par value | — | — | |||||
| Preferred stock, par value | — | — | |||||
| Common stock, par value | 14 | 13 | |||||
| Additional paid-in capital | 1,430,294 | 927,976 | |||||
| Accumulated other comprehensive (loss) income | (600 | ) | 852 | ||||
| Accumulated deficit | (750,364 | ) | (566,347 | ) | |||
| Total stockholders’ equity | 679,344 | 362,494 | |||||
| Total liabilities and stockholders’ equity | $ | 711,446 | $ | 405,838 | |||
Contact:
Chau Cheng, PhD, MBA
Vice President, Investor Relations
Immunovant, Inc.
info@immunovant.com
FAQ
How many potentially registrational programs does Immunovant plan to initiate for IMVT-1402 in the next fiscal year?
In how many indications does Immunovant plan to initiate trials for IMVT-1402 over the next two fiscal years?
What was the total cash and cash equivalents for Immunovant as of December 31, 2023?
What were the research and development expenses for Immunovant for the three months ended December 31, 2023?
How many shares of common stock were issued and outstanding for Immunovant as of December 31, 2023?
