IMVT Immunovant Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
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IMVT-1401 (ASCEND-WAIHA)
Warm autoimmune hemolytic anemia
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Phase 2a
Phase 2a
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Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
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IMVT-1401 (ASCEND GO-2)
Graves Ophthalmopathy / Thyroid Eye Disease (TED)
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Phase 2b
Phase 2b
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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IMVT-1401
Myasthenia Gravis (MG)
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Phase 2
Phase 2
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Phase 2 data released August 25, 2020. Phase 3 trial to be initiated 1H 2021.
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IMVT-1401
Graves Ophthalmopathy
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Phase 2a
Phase 2a
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Phase 2a initial data March 30, 2020 noted 65% mean reduction in total IgG.
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Latest News
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NEW YORK, Feb. 16, 2021 (GLOBE NEWSWIRE) -- Immunovant, Inc. (NASDAQ:IMVT), a clinical-stage biopharmaceutical company focused on enabling normal lives for patients with autoimmune diseases, today reported financial results for its fiscal third quarter and nine months ended December 31, 2020. Immunovant ended the quarter with approximately $422 million in cash.
In February 2021, we voluntarily paused dosing in our clinical trials for IMVT-1401 due to elevated total cholesterol and LDL levels observed in patients treated with IMVT-1401. We have informed our regulators and investigators of this voluntary pause of dosing in ASCEND GO-2, a Phase 2b trial in Thyroid Eye Disease and ASCEND-WAIHA, a Phase 2 trial in Warm Autoimmune Hemolytic Anemia.
In order to better characterize the observed lipid findings, we have begun to conduct a program-wide data review with input from external scientific experts. Our unblinded analysis of the data from ASCEND GO-2 trial remains ongoing. The full set of data is now being collected, quality-controlled and consolidated. In the open label ASCEND-WAIHA trial, we also plan to conduct an interim data review from participants in Cohort 1 (680 mg weekly) after similarly consolidating and quality-controlling the data. We expect to continue development of IMVT-1401 and plan to progress discussions with regulatory authorities to align on the next steps in its continued development. We expect to provide a further update on our current and future indications and timelines in the second quarter of calendar year 2021.
Financial Highlights for Fiscal Third Quarter Ended December 31, 2020
R&D Expenses: Research and development expenses increased by $16.1 million, from $5.0 million for the three months ended December 31, 2019 to $21.1 million for the three months ended December 31, 2020. This year-over-year increase was primarily due to an $8.9 million increase in contract manufacturing costs driven by the expansion of our clinical trial programs for the treatment of autoimmune disease, and $1.4 million and $0.9 million increases in costs related to clinical studies and clinical research, respectively, due to expansion of clinical trials.
G&A Expenses: General and administrative expenses increased by $4.4 million, from $6.1 million for the three months ended December 31, 2019 to $10.5 million for the three months ended December 31, 2020. The year-over-year increase was primarily due to personnel-related costs (including stock-based compensation expense) resulting from higher headcount.
Net Loss: Net loss was $31.8 million ($0.32 per common share) for the three months ended December 31, 2020, compared to $11.3 million ($0.28 per common share) for the three months ended December 31, 2019. Net loss for the three months ended December 31, 2020 and 2019 included $6.0 million and $1.4 million, respectively, related to non-cash stock-based compensation expense.
Common Stock: As of December 31, 2020, there were 97,971,243 shares of common stock issued and outstanding.
Financial Highlights for Fiscal Nine Months Ended December 31, 2020
R&D Expenses: Research and development expenses were $50.0 million for the nine months ended December 31, 2020, compared to $33.8 million for the nine months ended December 31, 2019. The year-over-year increase was primarily due to increases in contract manufacturing costs of $15.5 million driven by the expansion of clinical trial programs for the treatment of autoimmune diseases and costs related to non-clinical and clinical studies of $2.6 million. Other increases include higher personnel-related expenses (including stock-based compensation expense) due to higher headcount to support clinical operations and increased professional services.
G&A Expenses: General and administrative expenses were $29.2 million for the nine months ended December 31, 2020, compared to $11.8 million for the nine months ended December 31, 2019. The year-over-year increase was primarily due to higher stock-based compensation expense and higher personnel-related costs, both of which were due to higher headcount. Other increases include higher legal and professional fees to support our growth and operations as a public company.
Net Loss: Net loss was $79.3 million ($0.94 per common share) for the nine months ended December 31, 2020, compared to $45.8 million ($1.16 per common share) for the nine months ended December 31, 2019. Net loss for the nine months ended December 31, 2020 and 2019 included $13.3 million and $5.1 million, respectively, related to non-cash stock-based compensation expense.
About Immunovant, Inc.
Immunovant is a clinical-stage biopharmaceutical company focused on enabling normal lives for patients with autoimmune diseases. Immunovant is developing IMVT-1401, a novel, fully human anti-FcRn monoclonal antibody, as a subcutaneous injection for the treatment of autoimmune diseases mediated by pathogenic IgG antibodies.
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 "may," "might," "will," "would," "should," "expect," "believe," "estimate," and other similar expressions are intended to identify forward-looking statements. For example, all statements Immunovant makes concerning Immunovant's clinical programs and its product candidate, IMVT-1401; Immunovant's current program-wide data review with input from external scientific experts; Immunovant's expectation to continue development of IMVT-1401 and plan to progress discussions with regulatory authorities to align on the next steps in its continued development; Immunovant's expectation to provide a further update on its current and future indications and timelines in the second quarter of calendar year 2021; and the potential efficacy of Immunovant's current product candidate and any future product candidates for patients with autoimmune disease are forward-looking. 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 availability of data from clinical trials; the expectations for regulatory submissions and approvals; the continued development of Immunovant's product candidates; Immunovant's scientific approach and general development progress; the availability and commercial potential of Immunovant's product candidates including the size of potentially addressable markets and degree of market acceptance; the potential impact of the recent COVID-19 pandemic on Immunovant's clinical development plans and timelines; and actions by regulatory authorities with respect to Immunovant's product candidates. These statements are also subject to a number of material risks and uncertainties that are described under the section titled "Risk Factors" in Immunovant's most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q in each case filed with the Securities and Exchange Commission. 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, except as required by law.
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 31,2020 2019 2020 2019 Operating expenses: Research and development (includes $2,549 and $4,025 of stock-based compensation expense for the three and nine months ended December 31, 2020, respectively, and $311 and $2,683 of stock-based compensation expense for the three and nine months ended December 31, 2019, respectively)(1) $ 21,091 $ 4,953 $ 49,989 $ 33,759 General and administrative (includes $3,443 and $9,309 of stock-based compensation expense for the three and nine months ended December 31, 2020, respectively, and $1,103 and $2,440 of stock-based compensation expense for the three and nine months ended December 31, 2019, respectively)(2) 10,549 6,088 29,211 11,836 Total operating expenses 31,640 11,041 79,200 45,595 Interest expense — 376 — 625 Other expense (income), net 503 (221 ) 352 (539 ) Loss before (benefit) provision for income taxes (32,143 ) (11,196 ) (79,552 ) (45,681 ) (Benefit) provision for income taxes (367 ) 100 (279 ) 156 Net loss $ (31,776 ) $ (11,296 ) $ (79,273 ) $ (45,837 ) Net loss per common share – basic and diluted(3) $ (0.32 ) $ (0.28 ) $ (0.94 ) $ (1.16 ) Weighted-average common shares outstanding – basic and diluted(3) 97,920,460 41,035,055 84,413,511 39,408,236 (1) Includes $0 and $176 of costs allocated from Roivant Sciences Ltd. for the three and nine months ended December 31, 2020, respectively, and $0 and $152 of costs allocated from Roivant Sciences Ltd. for the three and nine months ended December 31, 2019, respectively.
(2) Includes $185 and $522 of costs allocated from Roivant Sciences Ltd. for the three and nine months ended December 31, 2020, respectively, and $487 and $1,001 of costs allocated from Roivant Sciences Ltd. for the three and nine months ended December 31, 2019, respectively.
(3) Retroactively restated for the reverse recapitalization.IMMUNOVANT, INC.
Condensed Consolidated Balance Sheets
(Unaudited, in thousands, except share and per share data)December 31, 2020 March 31, 2020 Assets Current assets: Cash $ 421,974 $ 100,571 Prepaid expenses 6,973 5,460 Income tax receivable 481 36 Value-added tax receivable — 3,009 Total current assets 429,428 109,076 Operating lease right-of-use assets 3,469 — Property and equipment, net 132 65 Deferred offering costs — 246 Total assets $ 433,029 $ 109,387 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $ 2,100 $ 1,190 Accrued expenses 13,281 10,938 Current portion of operating lease liabilities 1,104 — Due to Roivant Sciences Ltd. — 3,190 Total current liabilities 16,485 15,318 Operating lease liabilities, net of current portion 2,392 — Total liabilities 18,877 15,318 Commitments and contingencies Stockholders' equity:(1) Series A preferred stock, par value $0.0001 per share, 10,000 shares authorized, issued and outstanding at December 31, 2020 and March 31, 2020 — — Preferred stock, par value $0.0001 per share, 10,000,000 shares authorized, no shares issued and outstanding at December 31, 2020 and March 31, 2020 — — Common stock, par value $0.0001 per share, 500,000,000 shares authorized, 97,971,243 shares issued and outstanding at December 31, 2020 and 500,000,000 shares authorized, 56,455,376 shares issued and 54,655,376 shares outstanding at March 31, 2020 10 5 Additional paid-in capital 584,174 185,306 Accumulated other comprehensive income (loss) 467 (16 ) Accumulated deficit (170,499 ) (91,226 ) Total stockholders' equity 414,152 94,069 Total liabilities and stockholders' equity $ 433,029 $ 109,387 (1) Retroactively restated for the reverse recapitalization.
Contact:
John Strumbos, Ph.D., MBA
Vice President, Finance & Strategy
Immunovant, Inc.
[email protected]
-
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NEW YORK, Feb. 02, 2021 (GLOBE NEWSWIRE) -- Immunovant (NASDAQ:IMVT), a clinical-stage biopharmaceutical company focused on enabling normal lives for patients with autoimmune diseases, today announced a voluntary pause of dosing in its ongoing clinical trials for IMVT-1401.
The Company has become aware of a physiological signal consisting of elevated total cholesterol and LDL levels in IMVT-1401-treated patients in ASCEND GO-2, a Phase 2b trial in Thyroid Eye Disease (TED). Cholesterol levels were not measured in prior clinical trials of IMVT-1401 in Myasthenia Gravis (MG) and in healthy subjects. Out of an abundance of caution, the Company has decided to voluntarily pause dosing in ongoing clinical studies in both TED and in Warm Autoimmune Hemolytic Anemia, in order to inform patients, investigators, and regulators as well as to modify the monitoring program.
ASCEND GO-2 is a randomized, placebo-controlled trial in TED evaluating different doses, each given weekly for 12 weeks. In this study, cholesterol parameters are assessed at baseline, at twelve weeks, and at week 20 following eight weeks off drug. Based on preliminary, unblinded data from about 40 patients through week 12, mean LDL cholesterol at week 12 was increased by approximately 65% in the 680mg dose group, by approximately 40% in the 340mg dose group, and did not increase in the control group. Average HDL and triglyceride levels increased to a much lesser degree. For context, commercially available statins report a reduction in LDL cholesterol between 27-60%. At the twenty-week timepoint, average LDL levels had declined to baseline or lower in the 680mg dose group, in the 340mg dose group, and in the control group. No serious cardiovascular events have been reported to date in IMVT-1401 clinical trials.
Harbour BioMed, the license holder for 1401 in Greater China, has informed Immunovant that based on their preliminary review of blinded data in their ongoing clinical studies in Chinese patients with MG and Idiopathic Thrombocytopenic Purpura, similar increases in cholesterol have not been observed. The Company is not aware whether trials involving other anti-FcRn agents in development have performed detailed assessments of lipid parameters.
The Company will work closely with regulators and scientific experts to characterize the detailed profile of these lipid changes and to understand the mechanism of these changes across indications. After discussion and agreement with regulators regarding protocol modifications, the Company intends to continue to pursue development of IMVT-1401.
Immunovant will host a conference call on Tuesday, February 2 at 8:00am EST. Following prepared remarks, the call will include a live question-and-answer session for the investment community. To access the webcast, please visit Immunovant's website at www.immunovant.com. Participants may also dial in using the numbers provided below:
Toll Free: 1-877-407-9039
Toll/International: 1-201-689-8470An archived webcast recording will be available on the Immunovant's website for a limited period of time.
About Immunovant
Immunovant is a clinical-stage biopharmaceutical company focused on enabling normal lives for patients with autoimmune diseases. Immunovant is developing IMVT-1401, a novel, fully human anti-FcRn monoclonal antibody, as a subcutaneous injection for the treatment of autoimmune diseases mediated by pathogenic IgG antibodies.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 "may," "might," "will," "would," "should," "expect," "believe," "estimate," and other similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning Immunovant's intent to continue the development of IMVT-1401 after discussion and agreement with regulators, the ability of Immunovant to identify new opportunities, the potential efficacy and success of IMVT-1401 and the potential of IMVT-1401 to become a best-in-class treatment for multiple autoimmune diseases and to improve the quality of life for patients suffering from these conditions. 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 availability of data from clinical trials; the expectations for regulatory submissions and approvals; the continued development of Immunovant's product candidates; Immunovant's scientific approach and general development progress; the availability and commercial potential of Immunovant's product candidates including the size of potentially addressable markets and degree of market acceptance; the potential impact of the recent COVID-19 pandemic on Immunovant's clinical development plans and timelines; and actions by regulatory authorities with respect to Immunovant's product candidates. 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 most recent Quarterly Report on Form 10-Q filed with the SEC on November 12, 2020. 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.Contact:
John Strumbos, Ph.D., MBA
Vice President, Finance & Strategy
Immunovant, Inc.
[email protected] -
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- Dr. Jain brings deep expertise in the design and execution of complex clinical trials, having overseen the development of more than 15 new chemical entities and marketed products
- Dr. Jain's broad and diverse clinical experience makes her uniquely well-suited to lead the initiation of multiple Phase 3 programs for IMVT-1401 across different therapeutic areas
NEW YORK, Jan. 12, 2021 (GLOBE NEWSWIRE) -- Immunovant (NASDAQ:IMVT), a clinical-stage biopharmaceutical company focused on enabling normal lives for patients with autoimmune diseases, today announced the appointment of Rita Jain, M.D. as Chief Medical Officer. Dr. Jain brings over 20 years of drug development and biopharmaceutical leadership experience to Immunovant, including industry-leading experience in both early and late phase development.
"We are thrilled to announce Rita's addition to the Immunovant management team," said Pete Salzmann, M.D., Chief Executive Officer of Immunovant. "Her impressive breadth of experience leading regulatory strategy and clinical development in numerous therapeutic areas will help us unlock the broad potential of IMVT-1401 across multiple indications. I'm particularly excited about her success in late stage development as we begin phase 3 programs."
Dr. Jain is a board-certified rheumatologist who previously served as Senior Vice President and Chief Medical Officer of Akebia Therapeutics. She has led all aspects of clinical development across a diverse set of therapeutic areas including immunology, inflammation, and nephrology, among others. Prior to joining Akebia, Dr. Jain was Vice President of Men's and Women's Health and Metabolic Development at AbbVie and served as a Vice President in Pharmaceutical Development at Abbott Laboratories. Dr. Jain led the design and execution of multiple late stage programs for high impact products, including Orlissa® and Oriahnn®. Earlier in her career, Dr. Jain was a faculty member at North Shore University Hospital, with an academic appointment as Assistant Professor of Medicine at New York University School of Medicine. She retains a passion for helping patients, aligning with Immunovant's vision of enabling normal lives for patients with autoimmune diseases
"I am incredibly excited to be joining this dynamic and entrepreneurial company," said Dr. Jain. "The transformational promise of the anti-FcRn mechanism, coupled with the best-in-class potential of IMVT-1401, creates a truly unique opportunity to make a major impact for patients."
In addition to Dr. Jain's appointment, Immunovant announced today that, due to temporary site closures for new enrollment related to the recent surge in COVID-19 cases, results from Cohort 1 of ASCEND-WAIHA, a Phase 2a trial of IMVT-1401 in Warm Autoimmune Hemolytic Anemia (WAIHA), are now anticipated in the second quarter of 2021. For the same reason, results from ASCEND GO-2, a Phase 2b trial of IMVT-1401 in Thyroid Eye Disease (TED), are now anticipated in the third quarter of 2021.
"We're extremely excited about the potential for IMVT-1401 in multiple therapeutic areas and have made good progress toward the initiation of our Phase 3 trial of IMVT-1401 in Myasthenia Gravis (MG), which remains on track for the first half of 2021," said Dr. Salzmann. "I'm also pleased with the team's progress developing INDs for new indications. We remain on track to announce three new indications by August of 2021," he added.
About Immunovant
Immunovant is a clinical-stage biopharmaceutical company focused on enabling normal lives for patients with autoimmune diseases. Immunovant is developing IMVT-1401, a novel, fully human anti-FcRn monoclonal antibody, as a subcutaneous injection for the treatment of autoimmune diseases mediated by pathogenic IgG antibodies.
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 "may," "might," "will," "would," "should," "expect," "believe," "estimate," and other similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning the ability of Immunovant to identify new opportunities, the potential efficacy and success of IMVT-1401, the potential of IMVT-1401 to become a best-in-class treatment for multiple autoimmune diseases and to improve the quality of life for patients suffering from these conditions, and the anticipated timing of clinical trial data. 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 availability of data from clinical trials; the expectations for regulatory submissions and approvals; the continued development of Immunovant's product candidates; Immunovant's scientific approach and general development progress; the availability and commercial potential of Immunovant's product candidates including the size of potentially addressable markets and degree of market acceptance; and the potential impact of the recent COVID-19 pandemic on Immunovant's clinical development plans and timelines. 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 most recent Quarterly Report on Form 10-Q filed with the SEC on November 12, 2020. 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.
Contact:
John Strumbos, Ph.D., MBA
Vice President, Finance & Strategy
Immunovant, Inc.
[email protected] - Dr. Jain brings deep expertise in the design and execution of complex clinical trials, having overseen the development of more than 15 new chemical entities and marketed products
-
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NEW YORK, Nov. 12, 2020 (GLOBE NEWSWIRE) -- Immunovant, Inc. (NASDAQ:IMVT), a clinical-stage biopharmaceutical company focused on enabling normal lives for patients with autoimmune diseases, today reported financial results for its fiscal second quarter and six months ended September 30, 2020. Immunovant ended the quarter with approximately $444 million in cash.
"Our team made outstanding operational and strategic progress during the fiscal second quarter," said Pete Salzmann, M.D., Chief Executive Officer of Immunovant. "First, we reported positive topline results from our randomized, placebo-controlled trial of IMVT-1401 in patients with moderate-to-severe Myasthenia Gravis (MG). Second, we announced the appointment of Michael Elliott, MBBS, Ph.D., an accomplished industry leader in immunology, as Chief Scientific Officer. And third, we further strengthened our balance sheet with approximately $188 million of net proceeds from a public equity offering," he continued.
"We plan to report results from the high-dose cohort of ASCEND WAIHA, an open-label Phase 2a clinical trial of IMVT-1401 in Warm Autoimmune Hemolytic Anemia (WAIHA), in the first quarter of calendar year 2021. We plan to report results from ASCEND GO-2, a Phase 2b clinical trial of IMVT-1401 in patients with Thyroid Eye Disease (TED), in the first half of calendar year 2021. We also plan to announce three new indications for IMVT-1401 by August 2021," he added.
Financial Highlights for Fiscal Second Quarter Ended September 30, 2020
R&D Expenses: Research and development expenses increased by $1.7 million, from $10.3 million for the three months ended September 30, 2019 to $12.0 million for the three months ended September 30, 2020. The year-over-year increase was primarily driven by higher costs related to expansion of ongoing clinical trials, initiation of a non-clinical study and additional professional services.
G&A Expenses: General and administrative expenses increased by $4.8 million, from $4.2 million for the three months ended September 30, 2019 to $9.0 million for the three months ended September 30, 2020. The year-over-year increase was primarily due to higher headcount, resulting in additional personnel costs and stock-based compensation expense.
Net Loss: Net loss was $20.8 million ($0.25 per common share) for the three months ended September 30, 2020, compared to $14.5 million ($0.38 per common share) for the three months ended September 30, 2019. Net loss for the three months ended September 30, 2020 and 2019 included $3.4 million and $3.1 million, respectively, related to non-cash stock-based compensation expense.
Common Stock: As of September 30, 2020, there were 97,890,705 shares of the common stock issued and outstanding.
Financial Highlights for Fiscal Six Months Ended September 30, 2020
R&D Expenses: Research and development expenses were $28.9 million for the six months ended September 30, 2020, compared to $28.8 million for the six months ended September 30, 2019. Expenses in 2019 included $10.0 million related to the achievement of the first development and regulatory milestone under Immunovant's license agreement with HanAll Biopharma Co., Ltd. Excluding the effects of this one-time milestone, research and development expenses increased by $10.1 million for the six months ended September 30, 2020 compared to the same period in the prior year. The year-over-year increase was primarily due to increases in contract manufacturing costs and non-clinical and clinical studies, driven by the expansion of clinical trial programs for the treatment of autoimmune diseases. Other increases include higher personnel-related expenses (including stock-based compensation expense) due to higher headcount to support clinical operations and increased professional services.
G&A Expenses: General and administrative expenses were $18.7 million for the six months ended September 30, 2020, compared to $5.8 million for the six months ended September 30, 2019. The year-over-year increase was primarily due to higher stock-based compensation expense and higher personnel-related costs, both of which were due to higher headcount. Other increases include higher legal and professional fees to support our growth and operations as a public company.
Net Loss: Net loss was $47.5 million ($0.61 per common share) for the six months ended September 30, 2020, compared to $34.5 million ($0.90 per common share) for the six months ended September 30, 2019. Net loss for the six months ended September 30, 2020 and 2019 included $7.4 million and $3.7 million, respectively, related to non-cash stock-based compensation expense.
About Immunovant, Inc.
Immunovant, Inc. is a clinical-stage biopharmaceutical company focused on enabling normal lives for patients with autoimmune diseases. Immunovant is developing IMVT-1401, a novel, fully human anti-FcRn monoclonal antibody, as a subcutaneous injection for the treatment of autoimmune diseases mediated by pathogenic IgG antibodies.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 "may," "might," "will," "would," "should," "expect," "believe," "estimate," and other similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning Immunovant's clinical programs, including the number and timing of clinical programs, development initiatives and new indications for IMVT-1401; the potential efficacy of Immunovant's product candidates for patients with autoimmune diseases; Immunovant's expectations with respect to clinical development opportunities; and Immunovant's statements and expectations regarding its balance sheet. 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 availability of data from clinical trials; the expectations for regulatory submissions and approvals; the continued development of Immunovant's product candidates; Immunovant's scientific approach and general development progress; the availability and commercial potential of Immunovant's product candidates including the size of potentially addressable markets and degree of market acceptance; and the potential impact of the recent COVID-19 pandemic on Immunovant's clinical development plans and timelines. These statements are also subject to a number of material risks and uncertainties that are described under the section titled "Risk Factors" in Immunovant's most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q in each case filed with the Securities and Exchange Commission. 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, except as required by law.IMMUNOVANT, INC.
Condensed Consolidated Statements of Operations
(Unaudited, in thousands, except share and per share data)
Three Months Ended
September 30,Six Months Ended
September 30,2020 2019 2020 2019 Operating expenses: Research and development (includes $999 and $1,476 of stock-based compensation expense for the three and six months ended September 30, 2020, respectively, and $2,307 and $2,372 of stock-based compensation expense for the three and six months ended September 30, 2019, respectively)(1) $ 11,976 $ 10,331 $ 28,898 $ 28,807 General and administrative (includes $2,362 and $5,866 of stock-based compensation expense for the three and six months ended September 30, 2020, respectively, and $830 and $1,337 of stock-based compensation expense for the three and six months ended September 30, 2019, respectively)(2) 8,998 4,163 18,662 5,748 Total operating expenses 20,974 14,494 47,560 34,555 Interest expense — 249 — 249 Other income, net (225 ) (294 ) (151 ) (319 ) Loss before provision for income taxes (20,749 ) (14,449 ) (47,409 ) (34,485 ) Provision for income taxes 40 33 88 56 Net loss $ (20,789 ) $ (14,482 ) $ (47,497 ) $ (34,541 ) Net loss per common share – basic and diluted(3) $ (0.25 ) $ (0.38 ) $ (0.61 ) $ (0.90 ) Weighted-average common shares outstanding – basic and diluted(3) 84,353,438 38,590,381 77,623,132 38,590,381 (1) Includes $68 and $176 of costs allocated from Roivant Sciences Ltd. for the three and six months ended September 30, 2020, respectively, and $1 and $152 of costs allocated from Roivant Sciences Ltd. for the three and six months ended September 30, 2019, respectively.
(2) Includes $173 and $337 of costs allocated from Roivant Sciences Ltd. for the three and six months ended September 30, 2020, respectively, and $270 and $514 of costs allocated from Roivant Sciences Ltd. for the three and six months ended September 30, 2019, respectively.
(3) Retroactively restated for the reverse recapitalization.IMMUNOVANT, INC.
Condensed Consolidated Balance Sheets
(Unaudited, in thousands, except share and per share data)
September 30, 2020 March 31, 2020 Assets Current assets: Cash $ 444,372 $ 100,571 Prepaid expenses 5,854 5,460 Income tax receivable 40 36 Value-added tax receivable — 3,009 Total current assets 450,266 109,076 Operating lease right-of-use assets 3,493 — Property and equipment, net 136 65 Deferred offering costs — 246 Total assets $ 453,895 $ 109,387 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $ 5,787 $ 1,190 Accrued expenses 5,787 10,938 Current portion of operating lease liabilities 1,102 — Due to Roivant Sciences Ltd. 134 3,190 Total current liabilities 12,810 15,318 Operating lease liabilities, net of current portion 2,679 — Total liabilities 15,489 15,318 Commitments and contingencies Stockholders' equity:(1) Series A preferred stock, par value $0.0001 per share, 10,000 shares authorized, issued and outstanding at September 30, 2020 and March 31, 2020 — — Preferred stock, par value $0.0001 per share, 10,000,000 shares authorized, no shares issued and outstanding at September 30, 2020 and March 31, 2020 — — Common stock, par value $0.0001 per share, 500,000,000 shares authorized, 97,890,705 shares issued and outstanding at September 30, 2020 and 500,000,000 shares authorized, 56,455,376 shares issued and 54,655,376 shares outstanding at March 31, 2020 10 5 Additional paid-in capital 577,341 185,306 Accumulated other comprehensive loss (222 ) (16 ) Accumulated deficit (138,723 ) (91,226 ) Total stockholders' equity 438,406 94,069 Total liabilities and stockholders' equity $ 453,895 $ 109,387 (1) Retroactively restated for the reverse recapitalization.
Contact:
John Strumbos, Ph.D., MBA
Vice President, Finance and Strategy
Immunovant, Inc.
[email protected] -
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NEW YORK, Sept. 04, 2020 (GLOBE NEWSWIRE) -- Immunovant, Inc. (NASDAQ:IMVT), a clinical-stage biopharmaceutical company focused on enabling normal lives for patients with autoimmune diseases, today announced the closing of its previously announced underwritten public offering of 6,060,606 shares of its common stock, which includes the full exercise of the underwriters' option to purchase 790,513 additional shares of common stock, at a price to the public of $33.00 per share. The aggregate gross proceeds to Immunovant from the offering were approximately $200.0 million, before deducting underwriting discounts and commissions and offering expenses. All of the shares of common stock were sold by Immunovant.
SVB Leerink, Guggenheim Securities and Chardan acted as joint bookrunning managers for the offering. LifeSci Capital LLC and Baird acted as the co-lead managers for the offering.
Registration statements relating to these securities have been filed with the U.S. Securities and Exchange Commission, and became effective on September 1, 2020. A copy of the final prospectus may be obtained from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6218, or by email at [email protected]; Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, by telephone at (212) 518-5548 or by email at [email protected]; or Chardan Capital Markets LLC, 17 State Street, 21st floor, New York, NY 10004.
This announcement is neither an offer to sell nor a solicitation of an offer to buy any of these securities, and shall not constitute an offer, solicitation, or sale in any jurisdiction in which such offer, solicitation, or sale is unlawful.
About Immunovant
Immunovant, Inc. is a clinical-stage biopharmaceutical company focused on enabling normal lives for patients with autoimmune diseases. Immunovant is developing IMVT-1401, a novel, fully human anti-FcRn monoclonal antibody, as a subcutaneous injection for the treatment of autoimmune diseases mediated by pathogenic IgG antibodies.
Contact:
John Strumbos, Ph.D., MBA
Vice President, Finance and Strategy
Immunovant, Inc.
[email protected]