Filed Pursuant to Rule 424(b)(5)
Registration Statement No. 333-251367
PROSPECTUS
26,668,685 Shares
Common Stock
Offered by the Selling Stockholders
This prospectus relates to the proposed resale or other disposition by the selling stockholders identified herein, or the Selling Stockholders, of (i) 72,131 shares, or the Merger Common Shares, of our common stock, par value $0.01, or Common Stock, (ii) 29,446 shares of Common Stock issuable upon the exercise of warrants to purchase Common Stock assumed by us in the Merger, par value $0.01 per share, (iii) 13,547,139 shares of Common Stock, or the Merger Conversion Shares, issuable upon the conversion of 203,197 shares, or the Merger Preferred Shares, of our Series A Non-Voting Convertible Preferred Stock, par value $0.01, or Series A Preferred Stock, and (iv) 13,019,969 shares of Common Stock, or the Private Placement Conversion Shares and together with the Merger Common Shares and the Merger Conversion Shares, the Shares, issuable upon the conversion of 195,290 shares of the Series A Preferred Stock, or the Private Placement Preferred Shares. Shares of the Series A Preferred Stock held by each Selling Stockholder will be converted to Common Stock at such Selling Stockholder’s election, pursuant to the terms of a certificate of designation of preferences, right and limitations of Series A Preferred Stock, or the Certificate of Designation.
The Merger Common Shares and Merger Preferred Shares were issued and sold to accredited investors in connection with the acquisition, or the Merger, of Viridian Therapeutics, Inc., a Delaware corporation, or Viridian, which closed on October 27, 2020. The Private Placement Preferred Shares were issued and sold to accredited investors in a private placement, or the 2020 Private Placement, which closed on October 30, 2020. We are not selling any Shares under this prospectus and will not receive any of the proceeds from the sale or other disposition of Shares by the Selling Stockholders.
The Selling Stockholders may sell the Shares on any national securities exchange or quotation service on which the securities may be listed or quoted at the time of sale, on the over-the-counter market, in one or more transactions otherwise than on these exchanges or systems, such as privately negotiated transactions, or using a combination of these methods, and at fixed prices, at prevailing market prices at the time of the sale, at varying prices determined at the time of sale, or at negotiated prices. See the disclosure under the heading “Plan of Distribution” elsewhere in this prospectus for more information about how the Selling Stockholders may sell or otherwise dispose of their Shares hereunder.
The Selling Stockholders may sell any, all or none of the securities offered by this prospectus and we do not know when or in what amount the Selling Stockholders may sell their Shares hereunder following the effective date of the registration statement of which this prospectus forms a part.
You should carefully read this prospectus and any applicable prospectus supplement, as well as any documents incorporated by reference, before you invest in any of the securities being offered.
Our Shares are listed on The Nasdaq Capital Market under the symbol “MGEN.” On December 22, 2020, the closing price for our Shares, as reported on The Nasdaq Capital Market, was $19.14 per share.
Investing in our securities involves a high degree of risk. You should review carefully the risks and uncertainties referenced under the heading “Risk Factors” contained in this prospectus beginning on page 5 and any applicable prospectus supplement, and under similar headings in the other documents that are incorporated by reference into this prospectus.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
The date of this prospectus is December 23, 2020.
TABLE OF CONTENTS
Page
1
ABOUT THIS PROSPECTUS
This prospectus is part of a registration statement on Form S-3 that we filed with the Securities and Exchange Commission, or the SEC, using a “shelf” registration process. Under this shelf registration process, the Selling Stockholders may, from time to time, sell the securities described in this prospectus in one or more offerings.
This prospectus contains and incorporates by reference information that you should consider when making your investment decision. Neither we, nor the Selling Stockholders, have authorized anyone to give any information or to make any representation other than those contained or incorporated by reference in this prospectus. The Selling Stockholders are offering to sell, and seeking offers to buy, our securities only in jurisdictions where it is lawful to do so. We have not authorized anyone to provide you with different information. This prospectus and any accompanying prospectus supplement do not constitute an offer to sell or the solicitation of an offer to buy any securities other than the securities described in any accompanying prospectus supplement or an offer to sell or the solicitation of an offer to buy such securities in any circumstances in which such offer or solicitation is unlawful. You should assume that the information appearing in this prospectus, any prospectus supplement, the documents incorporated by reference and any related free writing prospectus is accurate only as of their respective dates. Our business, financial condition, results of operations and prospects may have changed materially since those dates.
Unless the context otherwise requires, we use the terms “miRagen,” “company,” “we,” “us,” and “our” in this prospectus to refer to miRagen Therapeutics Inc. and our consolidated subsidiaries.
This prospectus contains trade names, trademarks and service marks of others, which are the property of their respective owners. Solely for convenience, trademarks and trade names referred to in this prospectus may appear without the ® or TM symbols.
1
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This prospectus, including the documents that we incorporate by reference herein, contains, and any applicable prospectus supplement or free writing prospectus including the documents we incorporate by reference therein may contain, forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements contained in this prospectus and the documents referenced above, other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “plan,” “expect,” “predict,” “potential,” “opportunity,” “goals,” or “should,” and similar expressions are intended to identify forward-looking statements.
Such statements are based on management’s current expectations and involve risks and uncertainties.
Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, statements relating to:
| • | our integration efforts following the acquisition of Viridian; | ||||||||||
| • | our future research and development activities, including clinical testing and the costs and timing thereof; | ||||||||||
| • | our strategy, including clinical development of VRDN-001 and other product candidates, and the clinical and commercial potential of our product candidates, if approved; | ||||||||||
| • | sufficiency of our cash resources; | ||||||||||
| • | our ability to raise additional funding when needed; | ||||||||||
| • | any statements concerning anticipated regulatory activities or licensing or collaborative arrangements; | ||||||||||
| • | business interruptions resulting from the coronavirus disease, or COVID-19, outbreak or similar public health crises, which could cause a disruption of the development of our product candidates and adversely impact our business; | ||||||||||
| • | our research and development and other expenses; | ||||||||||
| • | our operations and legal risks; | ||||||||||
| • | our ability to maintain listing on a national securities exchange; and | ||||||||||
| • | any statement of assumptions underlying any of the foregoing. | ||||||||||
We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described above and under the heading “Risk Factors.” Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the future events and trends discussed in this prospectus may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.
We undertake no obligation to revise or publicly release the results of any revision to these forward-looking statements, except as required by law. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement.
2
PROSPECTUS SUMMARY
Overview
We are a biotechnology company advancing new treatments for patients with diseases that are underserved by current therapies. Our most advanced program, VRDN-001, is a clinical-stage anti-IGF-1R monoclonal antibody in development for thyroid eye disease, or TED, a debilitating condition that can cause bulging eyes, or proptosis, as well as double vision and potential blindness. In association with the merger described below, our business strategy transitioned to prioritizing VRDN-001 in development of thyroid eye disease and away from legacy programs developing product candidates that modulate microRNAs.
Pending feedback from regulatory authorities, we expect to initiate a Phase 2 clinical trial of VRDN-001 in TED in 2021. This planned clinical trial will be informed by data from previous U.S. and European Union, or EU, studies in which more than 100 oncology patients were administered the antibody under the name AVE-1642. The pharmacokinetic, pharmacodynamic, and safety and tolerability data from these previous studies will inform our trial designs in TED. We hold exclusive worldwide rights to develop and commercialize VRDN-001 for all non-oncology indications that do not use radiopharmaceuticals, including the treatment of TED. Our product candidate VRDN-001 was previously licensed from ImmunoGen, Inc.
In parallel with the development of VRDN-001, we are advancing VRDN-002 with the goal of developing a convenient, at-home subcutaneous injection product. VRDN-002 seeks to improve on first-generation IGF-1R-targeted antibodies by incorporating half-life extension technology to reduce the dose required to provide efficacy in TED. We expect to file an investigational new drug application for VRDN-002 by the end of 2021.
On October 27, 2020, we completed our acquisition of Viridian in accordance with the terms of the Agreement and Plan of Merger, signed and closed on October 27, 2020, or the Merger Agreement. Under the terms of the Merger Agreement, at the closing of the Merger, we issued the securityholders of Viridian 72,131 shares of Common Stock and 203,202 shares of Series A Preferred Stock. The Series A Preferred Stock is non-voting and is contingently convertible to common stock subject to stockholder approval. On November 12, 2020, we effected a reverse stock split of our issued and outstanding common stock and options for common stock at a ratio of 1-for-15, which resulted in the Series A Preferred Stock being convertible into 66.67 shares of Common Stock, subject to certain conditions. The estimated consideration for the transaction was approximately $97.4 million. As the transaction does not qualify as a business combination, it will be accounted for as an asset acquisition. We concluded to account for this acquisition as an asset acquisition as substantially all of the fair value of the non-monetary assets acquired was concentrated in a single identifiable asset, the license rights.
In connection with the Merger, a non-transferrable contingent value right, or CVR, was distributed to our stockholders of record as of the close of business on November 6, 2020. Holders of the CVR will be entitled to receive certain stock and/or cash payments from proceeds received by us, if any, related to the disposition of our legacy assets for a period of five years following the closing of the Merger.
Additionally, in connection with the Merger, on October 27, 2020, we entered into a Securities Purchase Agreement, or the Purchase Agreement, with the purchasers named therein. Pursuant to the Purchase Agreement, we sold an aggregate of approximately 195,290 shares of Series A Preferred Stock for an aggregate purchase price of approximately $91.0 million. Each share of Series A Preferred Stock is convertible into 66.67 shares of our Common Stock, as described below. The powers, preferences, rights, qualifications, limitations and restrictions applicable to the Series A Preferred Stock are set forth in the Certificate of Designation filed in connection with the Merger. We plan to use the proceeds from the 2020 Private Placement to potentially advance multiple compounds through Phase 2 proof of concept studies in TED and expand our orphan disease pipeline.
Corporate Information
We were incorporated under the laws of the State of Delaware in June 2014. Our principal executive office is located at 6200 Lookout Road, Boulder, Colorado, 80301, and our telephone number is (720) 643-5200. Our website
3
address is www.miragen.com. We do not incorporate the information on or accessible through our website into this prospectus, and you should not consider any information on, or that can be accessed through, our website as part of this prospectus.
In addition, unless we specifically state otherwise, historical information in this prospectus has been retrospectively adjusted to reflect a 1-for-15 reverse stock split of our common stock, effected on November 12, 2020.
4
RISK FACTORS
Investing in our securities involves a high degree of risk. Before deciding whether to invest in our securities, you should consider carefully the risks and uncertainties described under the heading “Risk Factors” included below and discussed under the heading “Risk Factors” contained in our most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, as may be amended or updated by subsequent reports that are incorporated by reference into this prospectus in their entirety. The risks described in these documents are not the only ones we face, but those that we consider to be material. There may be other unknown or unpredictable economic, business, competitive, regulatory or other factors that could have material adverse effects on our future results. Past financial performance may not be a reliable indicator of future performance, and historical trends should not be used to anticipate results or trends in future periods. If any of these risks actually occur, our business, financial condition, results of operations or cash flow could be adversely affected, which could cause the trading price of our common stock to decline, resulting in a loss of all or part of your investment. Please also read carefully the discussion below under the heading “Special Note Regarding Forward-Looking Statements.”
Summary Risk Factors
Investing in our Common Stock involves a high degree of risk because our business is subject to numerous risks and uncertainties, as fully described below. The principal factors and uncertainties that make investing in our Common Stock risky include, among others:
•There is no guarantee that our acquisition of Viridian will increase stockholder value.
•We will need to raise additional capital, and if we are unable to do so when needed, we will not be able to continue as a going concern.
•We have historically incurred losses, have a limited operating history on which to assess our business, and anticipate that we will continue to incur significant losses for the foreseeable future.
•We may not be entitled to forgiveness of our recently received Paycheck Protection Program loan, and our application for the Paycheck Protection Program loan could in the future be determined to have been impermissible or could result in damage to our reputation.
•We have never generated any revenue from product sales and may never be profitable.
•Raising additional capital may cause dilution to our stockholders, restrict our operations, or require us to relinquish rights.
•Clinical trials are costly, time consuming, and inherently risky, and we may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities.
•Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial viability of an approved label, or result in significant negative consequences following marketing approval, if any.
•We are heavily dependent on the success of our product candidates, which are in the early stages of clinical development. Some of our product candidates have produced results only in non-clinical settings, or for other indications than those for which we contemplate conducting development and seeking U.S. Food and Drug Administration, or FDA, approval, and we cannot give any assurance that we will generate data for any of our product candidates sufficiently supportive to receive regulatory approval in our planned indications, which will be required before they can be commercialized.
•Product development involves a lengthy and expensive process with an uncertain outcome, and results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results.
5
Risks Related to Ownership of our Common Stock
Our failure to meet the continued listing requirements of The Nasdaq Capital Market could result in a delisting of our Common Stock.
Our Common Stock is currently listed on The Nasdaq Capital Market. To maintain the listing of our Common Stock on The Nasdaq Capital Market, we are required to meet certain listing requirements, including, among others, a minimum bid price of $1.00 per share.
If we fail to satisfy the continued listing requirements of The Nasdaq Capital Market, such as the corporate governance requirements or the minimum closing bid price requirement, The Nasdaq Capital Market may take steps to delist our Common Stock, which could have a materially adverse effect on our ability to raise additional funds as well as the price and liquidity of our Common Stock. Such a delisting would likely have a negative effect on the price of our Common Stock and would impair our stockholders’ ability to sell or purchase our Common Stock when they wish to do so. In the event of a delisting, we can provide no assurance that any action taken by us to restore compliance with listing requirements would allow our Common Stock to become listed again, stabilize the market price or improve the liquidity of our Common Stock, prevent our Common Stock from dropping below the Nasdaq minimum bid price requirement, or prevent future non-compliance with The Nasdaq Capital Market’s listing requirements.
On October 8, 2020, we received a deficiency letter from the Listing Qualifications Department of the Nasdaq Stock Market notifying us that, for the last 30 consecutive business days, the bid price for our Common Stock had closed below the minimum $1.00 per share requirement for continued inclusion on the Nasdaq Capital Market, or the Minimum Bid Price Requirement. In accordance with Nasdaq Listing Rules, we have an initial period of 180 calendar days to regain compliance with the minimum bid price rule. If we do not regain compliance with the Minimum Bid Price Requirement by April 6, 2021, then we may be eligible for an additional 180 calendar day compliance period.
We are actively monitoring our stock price and will consider any and all options available to regain compliance. Our stockholders approved a reverse stock split of our Common Stock at our 2020 annual meeting of stockholders and we effected a 1-for-15 reverse stock split on November 12, 2020. The alternatives to trading on the Nasdaq Stock Market or another national securities exchange are generally considered to be less efficient and less broad-based than the national securities exchanges and the liquidity of our Common Stock will likely be reduced if it fails to regain compliance with the Minimum Bid Price Requirement.
There can be no assurance that we will be successful in maintaining the listing of our Common Stock on The Nasdaq Capital Market. This could impair the liquidity and market price of our Common Stock. In addition, the delisting of our Common Stock from a national exchange could have a material adverse effect on our access to capital markets, and any limitation on market liquidity or reduction in the price of our Common Stock as a result of that delisting could adversely affect our ability to raise capital on terms acceptable to us, or at all.
Anti-takeover provisions in our charter documents and under Delaware law and the terms of some of our contracts could make an acquisition of us more difficult and may prevent attempts by our stockholders to replace or remove our management.
Provisions in our certificate of incorporation and bylaws may delay or prevent an acquisition or a change in management. These provisions include a prohibition on actions by written consent of our stockholders and the ability of our board of directors to issue preferred stock without stockholder approval. In addition, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporate Law, which prohibits stockholders owning in excess of 15% of our outstanding voting stock from merging or combining with us. Although we believe these provisions collectively will provide for an opportunity to receive higher bids by requiring potential acquirers to negotiate with our board of directors, they would apply even if the offer may be considered beneficial by some stockholders. In addition, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove then current management by making it more difficult for
6
stockholders to replace members of the board of directors, which is responsible for appointing the members of management.
Get the next $MGEN alert in real time by email
Crush Q1 2026 with the Best AI Superconnector
Stay ahead of the competition with Standout.work - your AI-powered talent-to-startup matching platform.
SEC Form 4 filed by L Joseph Turner
4 - Viridian Therapeutics, Inc.\DE (0001590750) (Issuer)
Medical Specialities
Health Care
SEC Form 4 filed by Evan Peter Harwin
4 - Viridian Therapeutics, Inc.\DE (0001590750) (Issuer)
Medical Specialities
Health Care
SEC Form 4 filed by S. Jeffrey Hatfield
4 - Viridian Therapeutics, Inc.\DE (0001590750) (Issuer)
Medical Specialities
Health Care
SEC Form 8-K filed
8-K - Viridian Therapeutics, Inc.\DE (0001590750) (Filer)
Medical Specialities
Health Care
SEC Form SC 13G filed
SC 13G - Viridian Therapeutics, Inc.\DE (0001590750) (Subject)
Medical Specialities
Health Care
SEC Form 4 filed by Stuart William Marshall
4 - MIRAGEN THERAPEUTICS, INC. (0001590750) (Issuer)
Medical Specialities
Health Care
miRagen Therapeutics Announces Company Name Change to Viridian Therapeutics and New Executive Appointments, Including Expansion of Leadership Team
Jonathan Violin, Ph.D., M.B.A. appointed President, CEO and director Barrett Katz, M.D., M.B.A. joins Viridian as Chief Medical OfficerViridian is developing VRDN-001 and VRDN-002 for the treatment of thyroid eye diseaseCompany recently licensed exclusive rights from Xencor, Inc. to develop and commercialize therapeutic antibodies targeting IGF-1R incorporating Xtend™ Fc half-life extension technology BOULDER, Colo., Jan. 19, 2021 (GLOBE NEWSWIRE) -- miRagen Therapeutics, Inc. (NASDAQ: MGEN), a development-stage biotechnology company, today announced its name change to Viridian Therapeutics, Inc. (“Viridian”). Beginning tomorrow, Viridian will trade on NASDAQ under the ticker symbol "VR
Medical Specialities
Health Care
miRagen Enters into License Agreement with Xencor for use of Xtend™ Antibody Technology for Investigational Antibodies to Treat Thyroid Eye Disease
Company obtains exclusive rights to develop and commercialize antibody therapeutics targeting insulin-like growth factor-1 receptor (IGF-1R) using Xencor’s Xtend™ half-life extension technology miRagen expects to file an Investigational New Drug (IND) application for VRDN-002, including half-life extension, by the end of 2021 BOULDER, Colo., Dec. 17, 2020 (GLOBE NEWSWIRE) -- miRagen Therapeutics, Inc. (NASDAQ: MGEN), a development-stage biotechnology company, today announced an agreement under which miRagen gains exclusive rights to develop and commercialize therapeutic antibodies targeting IGF-1R incorporating Xtend™ Fc technology from Xencor, Inc. This clinically validated technology p
Medical Specialities
Health Care
miRagen Therapeutics Announces Company Name Change to Viridian Therapeutics and New Executive Appointments, Including Expansion of Leadership Team
Jonathan Violin, Ph.D., M.B.A. appointed President, CEO and director Barrett Katz, M.D., M.B.A. joins Viridian as Chief Medical OfficerViridian is developing VRDN-001 and VRDN-002 for the treatment of thyroid eye diseaseCompany recently licensed exclusive rights from Xencor, Inc. to develop and commercialize therapeutic antibodies targeting IGF-1R incorporating Xtend™ Fc half-life extension technology BOULDER, Colo., Jan. 19, 2021 (GLOBE NEWSWIRE) -- miRagen Therapeutics, Inc. (NASDAQ: MGEN), a development-stage biotechnology company, today announced its name change to Viridian Therapeutics, Inc. (“Viridian”). Beginning tomorrow, Viridian will trade on NASDAQ under the ticker symbol "VR
Medical Specialities
Health Care
SEC Form SC 13G/A filed by Miragen Therapeutics, Inc.
SC 13G/A - Viridian Therapeutics, Inc.\DE (0001590750) (Subject)
Medical Specialities
Health Care
SEC Form SC 13G filed
SC 13G - Viridian Therapeutics, Inc.\DE (0001590750) (Subject)
Medical Specialities
Health Care
SEC Form SC 13G filed
SC 13G - Viridian Therapeutics, Inc.\DE (0001590750) (Subject)
Medical Specialities
Health Care