SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 9, 2021
(Exact name of Registrant as specified in its Charter)
(State or other jurisdiction of incorporation or organization)
|(Commission File Number)||(IRS Employer Identification No.)|
|320 West 37th Street|
|(Address of principal executive offices)||(Zip Code)|
Registrant’s telephone number, including area code: (917) 580-3099
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
|Title of each class|
Name of each exchange on which registered
|Common Stock, $0.0001 par value per share||IMVT||The Nasdaq Stock Market LLC|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On August 9, 2021, Immunovant, Inc., or the Company, issued a press release announcing its financial results for its first quarter ended June 30, 2021. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information contained in this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information in this Current Report shall not be incorporated by reference in any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item 9.01 Financial Statements and Exhibits.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|By:|| ||/s/ Pamela Yanchik Connealy|
| ||Pamela Yanchik Connealy|
| ||Chief Financial Officer|
|Date: August 9, 2021|
Immunovant Reports Financial Results for the Quarter Ended June 30, 2021
Company Ended the Quarter With Cash of Approximately $379 Million
and Subsequently Received a Direct Investment of $200 Million from Roivant
NEW YORK, Aug. 09, 2021 (GLOBE NEWSWIRE) – Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage biopharmaceutical company focused on enabling normal lives for people with autoimmune diseases, today reported financial results for its fiscal first quarter ended June 30, 2021. Immunovant ended the quarter with approximately $379 million in cash.
“We are excited to announce that in July 2021, the FDA granted Orphan Drug Designation to IMVT-1401 for treatment of Myasthenia Gravis,” said Pete Salzmann, M.D., Chief Executive Officer of Immunovant. “We have also initiated engagement with the FDA’s Division of Neurology to discuss protocol modifications for a pivotal study in Myasthenia Gravis and our team is excited to reach alignment with the FDA prior to the end of the year” continued Dr. Salzmann.
Immunovant plans to initiate a pivotal study in Myasthenia Gravis (“MG”) in early 2022. Immunovant also plans to resume development in Warm Autoimmune Hemolytic Anemia (“WAIHA”) and in Thyroid Eye Disease (“TED”) and initiate clinical studies in at least two other indications in the next 12 months. Immunovant expects at least one of these indications (beyond MG) to be a pivotal study.
On August 2nd, Immunovant announced that it had received a $200 million strategic investment from Roivant Sciences. Immunovant intends to use the proceeds from this investment to expedite development of IMVT-1401 in multiple indications.
Immunovant will host a conference call and audio webcast on Monday, August 9, 2021 at 8 a.m. ET. 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
An archived webcast recording will be available on Immunovant’s website for a limited time.
Financial Highlights for Fiscal First Quarter Ended June 30, 2021:
R&D Expenses: Research and development expenses were $18.7 million for the three months ended June 30, 2021, compared to $16.9 million for the three months ended June 30, 2020. The year-over-year increase primarily reflected higher personnel-related expenses and increases related to clinical activities for analyzing data and the program-wide data review, partially offset by lower contract manufacturing costs.
G&A Expenses: General and administrative expenses were $11.2 million for the three months ended June 30, 2021, compared to $9.7 million for the three months ended June 30, 2020. The year-over-year increase was primarily due to higher personnel-related expenses (including stock-based compensation), due to higher headcount.
Net Loss: Net loss was $30.5 million ($0.31 per common share) for the three months ended June 30, 2021, compared to $26.7 million ($0.38 per common share) for the three months ended June 30, 2020. Net loss for the three months ended June 30, 2021 and 2020 included $3.9 million and $4.0 million, respectively, related to non-cash stock-based compensation expense.
Common Stock: As of June 30, 2021, there were 97,977,595 shares of common stock issued and outstanding.
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.
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. Such forward looking statements include Immunovant’s plan to develop IMVT-1401 across a broad range of autoimmune indications; Immunovant’s plan to return to the clinic and initiate a pivotal MG trial in early 2022, and resume development of WAIHA and TED; Immunovant’s plans to initiate additional clinical studies in at least two other indications in the next 12 months; Immunovant’s expectation to initiate at least one other pivotal trial (in addition to MG) in 2022, after discussions with regulators; Immunovant’s ability to manage increases in LDL and reductions in albumin within its development program via monitoring and management criteria, adjustments to dosing, and individualized anti-lipid therapy as appropriate; and the potential for a phase two trial in TED. 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 timing of the commencement of additional clinical trials and resumption of current 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 candidates 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 the ongoing COVID-19 pandemic on Immunovant’s clinical development plans and timelines; Immunovant’s business is heavily dependent on the successful development, regulatory approval and commercialization of its sole product candidate, IMVT-1401; Immunovant is at an early stage in development of IMVT-1401; and Immunovant will require additional capital to fund its operations and advance IMVT-1401 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 most recent Annual Report on Form 10-K, its Form 10-Q to be filed with the SEC on August 9, 2021, 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.
Condensed Consolidated Statements of Operations
(Unaudited, in thousands, except share and per share data)
| ||Three Months Ended June 30,|
|Research and development||$||18,705||$||16,922|
|General and administrative||11,181||9,664|
|Total operating expenses||29,886||26,586|
|Other expense, net||626||74|
|Loss before (benefit) provision for income taxes||(30,512)||(26,660)|
|(Benefit) provision for income taxes||(41)||48|
|Net loss per common share — basic and diluted||$||(0.31)||$||(0.38)|
|Weighted average shares outstanding — basic and diluted||97,976,982||70,818,867|
Condensed Consolidated Balance Sheets
(Unaudited, in thousands, except share and per share data)
|June 30,||March 31,|
|Prepaid expenses and other current assets||5,821||8,860|
|Total current assets||384,826||409,006|
|Operating lease right-of-use assets||3,008||3,282|
|Property and equipment, net||193||201|
|Liabilities and Stockholders’ Equity|
|Current portion of operating lease liabilities||1,085||1,179|
|Total current liabilities||20,523||18,771|
|Operating lease liabilities, net of current portion||1,972||2,238|
|Commitments and contingencies|
|Series A preferred stock, par value $0.0001 per share, 10,000 shares authorized, issued and outstanding at June 30, 2021 and March 31, 2021||— ||— |
|Preferred stock, par value $0.0001 per share, 10,000,000 shares authorized, no shares issued and outstanding at June 30, 2021 and March 31, 2021||— ||— |
|Common stock, par value $0.0001 per share, 500,000,000 shares authorized, 97,977,595 shares issued and outstanding at June 30, 2021 and 500,000,000 shares authorized, 97,971,243 shares issued and outstanding at March 31, 2021||10 ||10|
|Additional paid-in capital||594,377||590,425|
|Accumulated other comprehensive income (loss)||273||(298)|
|Total stockholders’ equity||365,532||391,480|
|Total liabilities and stockholders’ equity||$||388,027||$||412,489|