November 8, 2022.
November 8, 2022.
Delaware | | | 81-0710585 |
(State or other jurisdiction of incorporation or organization) | | | (I.R.S. Employer Identification |
One Kendall
Building 300, Suite 201
One Kendall
Building 300, Suite 201
Mitchell Bloom, Esq. James Xu, Esq. Goodwin Procter LLP 100 Northern Avenue Boston, Massachusetts 02210 (617)570-1000 | | | Erik Ostrowski AVROBIO, Inc.
100 Technology Square
Sixth Floor Cambridge, Massachusetts 02139 (617)914-8420 |
box.box: ☐
If this Form is a post-effective amendment to a registration statement filed pursuant to General Instruction I.D. filed to register additional securities or additional classes of securities pursuant to Rule 413(b) under the Securities Act, check the following box. ☐
Large accelerated filer | | | ☐ | | | Accelerated filer | | | ☐ |
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Smaller reporting company | | | ☒ | ||||||
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| | Emerging growth company | | | ☒ |
CALCULATION OF REGISTRATION FEE
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Title of Each Class of Securities to be Registered | Amount to be Registered(1) | Proposed Maximum Offering Price Per Unit(2) | Proposed Maximum Aggregate Offering Price(3) | Amount of Registration Fee(4) | ||||
Common Stock(5) | ||||||||
Preferred Stock(6) | ||||||||
Debt Securities(7) | ||||||||
Warrants(8) | ||||||||
Units(9) | ||||||||
Total Offering | $250,000,000 | N.A. | $250,000,000 | $32,450 | ||||
Total Registration Fee | $250,000,000 | $32,450 | ||||||
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December 20, 2019November 8, 2022December 19, 2019,November 3, 2022, the closing price for our common stock, as reported on The Nasdaq, Global Select Market, was $20.08$0.675 per share. Our principal executive offices are located at One Kendall100 Technology Square, Building 300, Suite 201,Sixth Floor, Cambridge, Massachusetts 02139.“Risk Factors”“Risk Factors” contained in this prospectus beginning on page 2 and any applicable prospectus supplement, and under similar headings in the other documents that are incorporated by reference into this prospectus.Prospectusprospectus is , 20192022
$250,000,000, subject to the Baby Shelf Limitation.$250,000,000.3128 of this prospectus.
2018,2021, which is on file with the SEC and is incorporated herein by reference, (ii) our Quarterly Reports on Form10-Q for the quarters ended March 31, 2019,2022, June 30, 20192022 and September 30, 2019,2022 which are on file with the SEC and are incorporated herein by reference and (iii) other documents we file with the SEC that are deemed incorporated by reference into this prospectus.
the impact of the ongoing COVID-19 pandemic on our clinical trial programs, clinical supply and business generally, as well as our plans and expectations with respect to the timing and resumption of any development activities that were or may be temporarily paused as a result of the COVID-19 pandemic; the existence or absence of side effects or other properties relating to our product candidates which could delay or prevent their regulatory approval, limit their commercial potential, or result in significant negative consequences following any potential marketing approval; the durability of effects from our product candidates; the anticipated regulatory pathway for our product candidates and planned interactions with regulatory agencies; our expectations regarding the size of the patient populations for our product candidates, if approved for commercial use; the implementation of our business model and our strategic plans for our business, product candidates, technology and plato our commercialization, marketing and manufacturing capabilities and strategy; the pricing and reimbursement of our product candidates, if approved; the scalability and commercial viability of our manufacturing methods and processes, including our the rate and degree of market acceptance and clinical utility of our product candidates, in particular, and gene therapy, in general; our ability to establish or maintain collaborations or strategic relationships or obtain additional funding;“may,” “will,” “could,” “should,” “expects,” “intends,” “plans,“aims,” “anticipates,” “believes,” “continue,” “could,” “designed to,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “predicts,” “projects,” “potential,“seeks,” “continue,“strives,” “should,” “will,” and similar expressions or the negative of these terms, or similar expressions.terms. Accordingly, these statements involve estimates, assumptions, risks and uncertainties which could cause actual results to differ materially from those expressed in them. Any forward-looking statements are qualified in their entirety by reference to the factors discussed throughout this prospectus and the documents incorporated by reference herein, and in particular those factors referenced in the section “Risk Factors.”platform, including our transition to a proprietary four-plasmid-produced lentiviral vector, or LV2, and our use of busulfan as a conditioning regimen administered through therapeutic drug monitoring, or TDM;use of cryopreservation and implementation ofmove to a closed, automated manufacturing system;
the scope of protection we and/or our licensors are able to establish and maintain for intellectual property rights covering our current and future product candidates;
our financial performance;
our ability to retain the continued service of our key professionals and to identify, hire and retain additional qualified professionals;
developments and projections relating to our competitors and our industry;
our expectations related to the use of our cash reserves;
our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
our ability to remediatecomply with the material weaknesses that weterms of our Loan and Security Agreement, dated as of November 2, 2021, with Silicon Valley Bank;
our ability to satisfy the continued listing requirements of Nasdaq, including a minimum bid price, and to maintain our common stock listing on Nasdaq or any stock exchange;
our expectations regarding the time during which we are an emerging growth company under the Jumpstart Our Business Startups Act of 2012, as amended, or the JOBS Act; and
other risks and uncertainties, including those listed under the caption “Risk Factors”
2021. plato: Our clinical stageleading clinical-stage gene therapy company with a shared purpose to free people from a lifetime of genetic disease. Our company is focused on developing potentially curativeex vivo lentiviral-based HSC gene therapies (which we sometimes refer to as ex vivo lentiviral gene therapies) to treat patients with rare diseases following a single dose treatment regimen. Our gene therapies employ hematopoietic stem cellsHSCs that are harvested from the patient and then modified with a lentiviral vectorsvector to insert the equivalent of a functional copy of the gene that is defectivemutated in the target disease. We believe that our approach, which is designed to transform stem cells from patients into therapeutic products, has the potential to provide curative benefit for a range of diseases. Our initial focus is on a group of rare genetic diseases referred to as lysosomal storage diseases,disorders, some of which today are primarily managed with enzyme replacement therapies, or ERTs. These lysosomal storage diseasesdisorders have well-understood biologies, identified patient populations, established standards of care yet with significant unmet needs, and represent large market opportunities with approximately $4.0$3.4 billion in worldwide net sales in 2018.lentiviral-basedlentiviral gene therapy has been observed to be well-toleratedstudied in several third parties’ clinical trials for rare diseases such as transfusion-dependent beta thalassemia, cerebral adrenoleukodystrophy, or ALD,CALD, metachromatic leukodystrophy, or MLD, andADA-SCID. The use of ex vivo lentiviral-based gene therapies was initially restricted primarily to the most acutely adenosine deaminase severe diseases where the risks of the typical requirement for ablating the patients’ bone marrow, which significantly impairs those patients’ immune systems, had a clinically justifiable risk/benefit profile due to the novelty of the approach and the severity of the diseases.combined immunodeficiency, or ADA-SCID. To date, over 200hundreds of patients have been treated with lentiviral-basedlentiviral gene therapies in third parties’ and our rare disease clinical trials, and we believe the technology can be developed for other serious conditions based on a rigorous risk/benefit assessment. The ablation procedure, also known as the conditioning regimen, is typically an inherent part ofessential step in theex vivo gene therapy treatment procedure and is administered prior to the gene therapy. We have worked to optimize the conditioning regimen through utilization of a precision busulfan dosing program, which we refer to as Target Concentration Intervention, or TCI. TCI is designed to enable careful titrating of exposure to the conditioning drug to a specific area under the curve, or AuC. The conditioning regimen createsutilized as part of our plato platform includes TCI to assess how rapidly the individual patient metabolizes the conditioning agent so physicians can adjust the dose as needed, with a riskgoal of toxicity, which weminimizing side effects from conditioning while maximizing the potential of durable engraftment. We believe can be managed through utilization of therapeutic drug monitoring, or TDM. We are refining our approach to conditioning to use a single-agent, myeloablative conditioning regimen administered in conjunction with TDM, which is designed to permit patients to receive appropriate levels of conditioning to promote long-term engraftment while seeking to lessen toxicity. Such an approach could potentially allow the conditioning regimen to be performed during a limited hospital stay or potentially through an outpatient procedure, on acase-by-case basis as may be directed by the patient’s physician. We believe our approach, utilizing a single myeloablative conditioning agent, coupled with TDM, has the potential to extend the reach of our gene therapies to a broad range of diseases as first-line therapies. Our goal is to broaden the applicability of lentiviral-based gene therapy by initially targeting diseases with tractable gene mutations, well-understood biology and that benefit from the sustained systemic delivery of an active protein.diseaseslysosomal disorders in which the current standard of care provides the mechanistic proof that the enzymes or proteins produced endogenously following treatment with our gene therapies can offer benefit to patients. Typically, in lysosomal storage diseases,disorders, a gene mutation results in the deficiency or malfunctioning of an enzyme or other protein. This results in the inability of lysosomes to properly process cellular byproducts.materials such as damaged organelles. As a result, these byproductssubstrates and their metabolites accumulate to toxic levels in the body’s cells and, in turn, disrupt the function of multiple tissues and organs. FabryGaucher disease Gaucher disease(types 1 and 3), Hunter syndrome and Pompe disease are currently primarily managed bybi-weekly (or weekly in the case of Hunter syndrome), multi-hour infusions with ERTs that seek to exogenously replace the missing functional enzyme. However, given their characteristics,pharmacokinetics, most ERTs typically remain in the plasma only for a short period of time and thus are not ideal because they are only dosed weekly or every two weeks. Cystinosis is currently treated with two oral formulations of cysteamine that must be taken orally every 12 or six hours, leading to significant pill burden and compliance challenges. Further, oral cysteamine treatment has no effect on ocular cystine crystal deposits, thus requiring patients to be treated with topical cysteamine eye drops which must be applied as frequently as each hour the patient is awake. These existing therapies manage, rather than cure, the underlying diseases and, as a result, patients continue to have disease progression. Further, the frequent, periodic and life-long dosing schedule required for ERTs and cysteamine results in significant costs for the healthcare system and is burdensome for the patient.Commercial-ScaleCommercially-Scalable PlatformSince forming our company, we have centered our efforts onbased on preceding academic approaches. While we believe these approaches have been adequate for our development programs to date,an important key to our strategy is to continuously improve our technology and production processes and to leverage these improvements across our gene therapies, if approved. Plato is designed to provide the foundation for the potential worldwide commercialization of our gene
“AVRO.”
Only two years of audited financial statements in addition to any required unaudited interim financial statements with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure;
Reduced disclosure about our executive compensation arrangements;
No advisory votes on executive compensation or golden parachute arrangements;
Exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting; and
An exemption from new or revised financial accounting standards until they would apply to private companies and from compliance with any new requirements adopted by the Public Company Accounting Oversight Board requiring mandatory audit firm rotation.
of (i) the last day of the fiscal year in which we have total annual gross revenues of $1.07$1.235 billion or more; (ii) the last day of our fiscal year following the fifth anniversary of our initial public offering in June 2018; (iii) the date on which we have issued more than $1.0 billion in nonconvertible debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the Securities and Exchange Commission, or SEC. We may choose to take advantage of some but not all of these exemptions. We have taken advantage of reduced reporting requirements in this prospectus. Accordingly, the information contained herein may be different from the information you receive from other public companies in which you hold stock. We have elected to avail ourselves of the exemption for the delayed adoption of certain accounting standards and, therefore, are not subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.
outstanding. The existence of authorized but unissued shares of preferred stock may enable our board of directors to discourage an attempt to obtain control of us by means of a merger, tender offer, proxy contest or otherwise. For example, if in the due exercise of its fiduciary obligations, our board of directors were to determine that a takeover proposal is not in the best interests of our stockholders, our board of directors could cause shares of preferred stock to be issued without stockholder approval in one or more private offerings or other transactions that might dilute the voting or other rights of the proposed acquirer or insurgent stockholder or stockholder group. In this regard, our certificate of incorporation grants our board of directors broad power to establish the rights and preferences of authorized and unissued shares of preferred stock. The issuance of shares of preferred stock could decrease the amount of earnings and assets available for distribution to holders of shares of common stock. The issuance may also adversely affect the rights and powers, including voting rights, of these holders and may have the effect of delaying, deterring or preventing a change in control of us.September 30, 2019, 31,667,661November 3, 2022, 43,774,088 shares of our common stock were outstanding and held by 12 stockholders of record.
Indemnification
meetings of our stockholders. These procedures provide that notice of stockholder proposals must be timely given in writing to our corporate secretary prior to the meeting at which the action is to be taken. Generally, to be timely, notice must be received at our principal executive offices not less than 90 days nor more than 120 days prior to the first anniversary date of the annual meeting for the preceding year. Our bylaws specify the requirements as to form and content of all stockholders’ notices. These requirements may preclude stockholders from bringing matters before the stockholders at an annual or special meeting.
There are no restrictions on our repurchase or redemption of shares of preferred stock while there is any arrearage in the payment of dividends or sinking fund installments.
In addition,selection clauses in our amended and restated bylaws containsmay limit our stockholders’ ability to bring a provision by virtueclaim in a judicial forum that they find favorable for disputes with us or our directors, officers or employees, which may discourage such lawsuits against us and our directors, officers and employees even though an action, if successful, might benefit our stockholders. Section 22 of which unless we consent in writing to the selection of an alternative forum, the United States District Court for the District of Massachusetts
will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act. If any actionAct creates a concurrent jurisdiction for state and federal courts over all suits brought concerning a duty or liability created by the subject mattersecurities laws, rules and regulations thereunder. While the Delaware Supreme Court and other state courts have upheld the validity of which is within the scope of the preceding sentence is filed in a court other than the United States District Court for the District of Massachusetts, the plaintiff or plaintiffs shall be deemed by this provision of our amended and restated bylaws (i) to have consented to removal of the action by us to the United States District Court for the District of Massachusetts, in the case of an action filed in a state court, and (ii) to have consented to transfer of the action to the United States District Court for the District of Massachusetts. We have chosen the United States Court for the District of Massachusetts as the exclusive forum for such causes of action because our principal executive offices are located in Cambridge, Massachusetts. Some companies that have adopted similar federal district court forum selection provisions are currently subject to a suit in the Court of Chancery of the State of Delaware by stockholders who assert that the federal district court forum selection provision is not enforceable. On December 19, 2018, the Court of Chancery of the State of Delaware issued a decision declaring that such federal forum selection provisions purporting to require claims under the Securities Act be brought in federal court, are ineffective and invalid under Delaware law. In August 2019, the decision was appealedthere is uncertainty as to the Delaware Supreme Court, and the appeal remains pending before the Delaware Supreme Court. Unless and until the Court of Chancery’s decision is reversed by the Delaware Supreme Court or otherwise abrogated, we do not intend towhether other courts will enforce our federal forum selectionFederal Forum Provision. The Federal Forum Provision may also impose additional litigation costs on stockholders who assert the provision designatingis unenforceable, and if the District of Massachusetts as the exclusive forum for Securities Act claims. In the event that the Delaware Supreme Court affirms the Court of Chancery’s decision or otherwise determines that federal forum selection provisions are invalid, the Company’s Board of Directors intendsFederal Forum Provision is found to amend promptly our amended and restated bylaws to remove our federal forum selection bylaw provision. As a result of the Court of Chancery’s decision or a decision by the Supreme Court of Delaware affirming the Court of Chancery’s decision,be unenforceable, we may incur additional costs associated with resolving such matters. The Court of Chancery of the State of Delaware and the United States District Court for the District of Massachusetts may also reach different judgments or results than would other courts, including courts where a stockholder considering an action may be located or would otherwise choose to bring the action, and such judgments may be more or less favorable to us than our federal forum selection bylaw provision, which could have an adverse effect on our business, financial condition and results of operations.stockholders.
before the stockholder became interested, our board of directors approved either the business combination or the transaction which resulted in the stockholder becoming an interested stockholder;
upon consummation of the transaction which resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced, excluding for purposes of determining the voting stock outstanding, shares owned by persons who are directors and also officers, and employee stock plans, in some instances, but not the outstanding voting stock owned by the interested stockholder; or
at or after the time the stockholder became interested, the business combination was approved by our board of directors and authorized at an annual or special meeting of the stockholders by the affirmative vote of at leasttwo-thirds of the outstanding voting stock which is not owned by the interested stockholder.
any merger or consolidation involving the corporation and the interested stockholder;
any sale, transfer, lease, pledge or other disposition involving the interested stockholder of 10% or more of the assets of the corporation;
subject to exceptions, any transaction that results in the issuance or transfer by the corporation of any stock of the corporation to the interested stockholder;
subject to exceptions, any transaction involving the corporation that has the effect of increasing the proportionate share of the stock of any class or series of the corporation beneficially owned by the interested stockholder; and
the receipt by the interested stockholder of the benefit of any loans, advances, guarantees, pledges or other financial benefits provided by or through the corporation.
do not limit the amount of debt securities that we may issue; allow us to issue debt securities in one or more series; do not require us to issue all of the debt securities of a series at the same time; and allow us to reopen a series to issue additional debt securities without the consent of the holders of the debt securities of such series. the title of the debt securities and whether they are senior or subordinated;
the aggregate principal amount of the debt securities being offered, the aggregate principal amount of the debt securities outstanding as of the most recent practicable date and any limit on their aggregate principal amount, including the aggregate principal amount of debt securities authorized;
if convertible, the terms on which such debt securities are convertible, including the initial conversion price or rate and the conversion period and any applicable limitations on the ownership or transferability of common stock or other securities of ours received on conversion;
the date or dates, or the method for determining the date or dates, on which the principal of the debt securities will be payable;
the dates on which interest will be payable;
the record dates for interest payment dates, or the method by which such dates will be determined;
the persons to whom interest will be payable;
the place or places where the principal of, and any premium or make-whole amount, and interest on, the debt securities will be payable;
where the debt securities may be surrendered for registration of transfer or conversion or exchange;
the times, prices and other terms and conditions upon which we may redeem the debt securities;
any obligation we have to redeem, repay or repurchase the debt securities pursuant to any sinking fund or analogous provision or at the option of holders of the debt securities, and the times and prices at which we must redeem, repay or repurchase the debt securities as a result of such obligation;
the currency or currencies in which the debt securities are denominated and payable if other than United States dollars, which may be a foreign currency or units of two or more foreign currencies or a composite currency or currencies and the terms and conditions relating thereto, and the manner of determining the equivalent of such foreign currency in United States dollars;
whether the debt securities will be in registered form, bearer form, or both, and (i) if in registered form, the person to whom any interest shall be payable, if other than the person in whose name the security is registered at the close of business on the regular record date for such interest, or (ii) if in bearer form, the manner in which, or the person to whom, any interest on the security shall be payable if otherwise than upon presentation and surrender upon maturity;
any restrictions applicable to the offer, sale or delivery of securities in bearer form and the terms upon which securities in bearer form of the series may be exchanged for securities in registered form of the series and vice versa, if permitted by applicable laws and regulations;
whether any debt securities of the series are to be issuable initially in temporary global form and whether any debt securities of the series are to be issuable in permanent global form with or without coupons and, if so, whether beneficial owners of interests in any such permanent global security may, or shall be required to, exchange their interests for other debt securities of the series, and the manner in which interest shall be paid;
the identity of the depositary for securities in registered form, if such series are to be issuable as a global security;
whether and under what circumstances we will pay any additional amounts on the debt securities in respect of any tax, assessment or governmental charge;
whether and under what circumstances the debt securities being offered are convertible into common stock or other securities of ours, as the case may be, including the conversion price or rate and the manner or calculation thereof;
the name of the applicable trustee and the nature of any material relationship with us or any of our affiliates, and the percentage of debt securities of the class necessary to require the trustee to take action; and
any other terms of such debt securities not inconsistent with the provisions of the applicable indenture.
Denomination, Interest, Registration and Transfer
surrender them for registration of transfer or exchange at the corporate trust office of the applicable trustee or at the office of any transfer agent that we designate for such purpose.
issue, register the transfer of or exchange debt securities of any series during a period beginning at the opening of business 15 days before the day that the notice of redemption of any debt securities selected for redemption is mailed and ending at the close of business on the day of such mailing;
register the transfer of or exchange any debt security, or portion thereof, so selected for redemption, in whole or in part, except the unredeemed portion of any debt security being redeemed in part; and
issue, register the transfer of or exchange any debt security that has been surrendered for repayment at the option of the holder, except the portion, if any, of such debt security not to be so repaid.
either we are the continuing entity, or the successor entity, if other than us, assumes the obligations (a) to pay the principal of, and any premium or make-whole amount, and interest on, all of the debt securities and (b) to duly perform and observe all of the covenants and conditions contained in the applicable indenture;
after giving effect to the transaction, there is no event of default under the applicable indentures and no event which, after notice or the lapse of time, or both, would become such an event of default, occurs and continues; and
an officers’ certificate and legal opinion covering such conditions are delivered to each applicable trustee.
Events of Default, Notice and Waiver
default in the payment of any installment of interest on any debt security of such series continuing for 90 days unless such date has been extended or deferred;
default in the payment of principal of, or any premium or make-whole amount on, any debt security of such series when due and payable unless such date has been extended or deferred;
default in the performance or breach of any covenant or warranty in the debt securities or in the indenture by us continuing for 90 days after written notice described below;
bankruptcy, insolvency or reorganization, or court appointment of a receiver, liquidator or trustee of us; and
any other event of default provided with respect to a particular series of debt securities.
we have deposited with the applicable trustee all required payments of the principal, any premium or make-whole amount, interest and, to the extent permitted by law, interest on overdue installment of interest, plus applicable fees, expenses, disbursements and advances of the applicable trustee; and
all events of default, other than thenon-payment of accelerated principal, or a specified portion thereof, and any premium or make-whole amount, have been cured or waived.
the time, method and place of conducting any proceeding for any remedy available to the applicable trustee, or of exercising any trust or power conferred upon such trustee. However, a trustee may refuse to follow any direction which:
is in conflict with any law or the applicable indenture;
may involve the trustee in personal liability; or
may be unduly prejudicial to the holders of debt securities of the series not joining the proceeding.
to evidence the succession of another person to us as obligor under such indenture;
to provide for uncertificated debt securities in addition to or in place of certificated debt securities;
to add to our covenants for the benefit of the holders of all or any series of debt securities or to surrender any right or power conferred upon us in such indenture;
to add to, delete from, or revise the conditions, limitations, and restrictions on the authorized amount, terms, or purposes of issue, authentication, and delivery of debt securities;
to make any change that does not adversely affect the rights of any securityholder in any material respect;
to establish the form or terms of debt securities of any series;
to provide for the acceptance of appointment by a successor trustee or facilitate the administration of the trusts under an indenture by more than one trustee; or
to cure any ambiguity, defect or inconsistency in an indenture, provided that such action shall not adversely affect the interests of holders of debt securities of any series issued under such indenture.
Upon any distribution to our creditors in a liquidation, dissolution or reorganization, the payment of the principal of and interest on any subordinated debt securities will be subordinated to the extent provided in the applicable indenture in right of payment to the prior payment in full of all senior debt. However, our obligation to make payments of the principal of and interest on such subordinated debt securities otherwise will not be affected. No payment of principal or interest will be permitted to be made on subordinated debt securities at any time if a default on senior debt exists that permits the holders of such senior debt to accelerate its maturity and the default is the subject of judicial proceedings or we receive notice of the default. After all senior debt is paid in full and until the subordinated debt securities are paid in full, holders of subordinated debt securities will be subrogated to the rights of holders of senior debt to the extent that distributions otherwise payable to holders of subordinated debt securities have been applied to the payment of senior debt. The subordinated indenture will not restrict the amount of senior debt or other indebtedness of ours. As a result of these subordination provisions, in the event of a distribution of assets upon insolvency, holders of subordinated debt securities may recover less, ratably, than our general creditors.
either (i) all securities of such series have already been delivered to the applicable trustee for cancellation; or (ii) all securities of such series have not already been delivered to the applicable trustee for cancellation but (a) have become due and payable, (b) will become due and payable within one year, or (c) if redeemable at our option, are to be redeemed within one year, and we have irrevocably deposited with the applicable trustee, in trust, funds in such currency or currencies, currency unit or units or composite currency or currencies in which such debt securities are payable, an amount
we have paid or caused to be paid all other sums payable; and
an officers’ certificate and an opinion of counsel stating the conditions to discharging the debt securities have been satisfied has been delivered to the trustee.
respect to payments on such debt securities and the obligations to register the transfer or exchange of such debt securities, to replace temporary or mutilated, destroyed, lost or stolen debt securities, to maintain an office or agency in respect of such debt securities, or to hold monies for payment in trust.
the offering price and aggregate number of warrants offered; the currency for which the warrants may be purchased; if applicable, the designation and terms of the securities with which the warrants are issued and the number of warrants issued with each such security or each principal amount of such security; if applicable, the date on and after which the warrants and the related securities will be separately transferable; in the case of warrants to purchase debt securities, the principal amount of debt securities purchasable upon exercise of one warrant and the price at, and currency in which, this principal amount of debt securities may be purchased upon such exercise; the effect of any merger, consolidation, sale or other disposition of our business on the warrant agreement and the warrants; any provisions for changes to or adjustments in the exercise price or number of securities issuable upon exercise of the warrants; the manner of exercise; the dates on which the right to exercise the warrants will commence and expire; the manner in which the warrant agreement and warrants may be modified; the terms of the securities issuable upon exercise of the warrants; and
the designation and terms of the units and of the securities comprising the units, including whether and under what circumstances those securities may be held or transferred separately; any provisions of the governing unit agreement; the price or prices at which such units will be issued; the applicable United States federal income tax considerations relating to the units; any provisions for the issuance, payment, settlement, transfer or exchange of the units or of the securities comprising the units; and any other terms of the units and of the securities comprising the units. The following provisions will generally apply to all unit agreements unless otherwise stated in the applicable prospectus supplement: to cure any ambiguity, including modifying any provisions of the governing unit agreement that differ from those described below; to correct or supplement any defective or inconsistent provision; or
impair any right of the holder to exercise or enforce any right under a security included in the unit if the terms of that security require the consent of the holder to any changes that would impair the exercise or enforcement of that right; or
reduce the percentage of outstanding units or any series or class the consent of whose holders is required to amend that series or class, or the applicable unit agreement with respect to that series or class, as described below.
If the change affects only the units of a particular series issued under that agreement, the change must be approved by the holders of a majority of the outstanding units of that series; or
If the change affects the units of more than one series issued under that agreement, it must be approved by the holders of a majority of all outstanding units of all series affected by the change, with the units of all the affected series voting together as one class for this purpose.
sell our assets substantially as an entirety to, another corporation or other entity, the successor entity will succeed to and assume our obligations under the unit agreements. We will then be relieved of any further obligation under these agreements.
Holders may exchange or transfer their units at the office of the unit agent. Holders may also replace lost, stolen, destroyed or mutilated units at that office. We may appoint another entity to perform these functions or perform them ourselves.
Holders will not be required to pay a service charge to transfer or exchange their units, but they may be required to pay for any tax or other governmental charge associated with the transfer or exchange. The transfer or exchange, and any replacement, will be made only if our transfer agent is satisfied with the holder’s proof of legal ownership. The transfer agent may also require an indemnity before replacing any units.
If we have the right to redeem, accelerate or settle any units before their maturity, and we exercise our right as to less than all those units or other securities, we may block the exchange or transfer of those units during the period beginning 15 days before the day we mail the notice of exercise and ending on the day of that mailing, in order to freeze the list of holders to prepare the mailing. We may also refuse to register transfers of or exchange any unit selected for early settlement, except that we will continue to permit transfers and exchanges of the unsettled portion of any unit being partially settled. We may also block the transfer or exchange of any unit in this manner if the unit includes securities that are or may be selected for early settlement.
on or through the facilities of to or through a market maker otherwise than on the type and amount of securities we are offering; the name of the agent or any underwriters; the public offering or purchase price; any discounts and commissions to be allowed or paid to the agent or underwriters; any discounts and commissions to be allowed or paid to dealers; and any exchanges on which the securities will be listed. defined in the Securities Act, may then resell such securities to the public at varying prices to be determined by such dealer at the time of resale.The Nasdaq Global Select Market or any other securities exchange or quotation or trading service on which such securities may be listed, quoted or traded at the time of sale; and/orThe Nasdaq Global Select Market or such other securities exchanges or quotation or trading services.
the purchase by an institution of the securities covered under that contract shall not at the time of delivery be prohibited under the laws of the jurisdiction to which that institution is subject; and
if the securities are also being sold to underwriters acting as principals for their own account, the underwriters shall have purchased such securities not sold for delayed delivery. The underwriters and other persons acting as our agents will not have any responsibility in respect of the validity or performance of delayed delivery contracts.
We may engage in at the market offerings into an existing trading market in accordance with Rule 415(a)(4) under the Securities Act. In addition, we may enter into derivative transactions with third parties, or sell securities not covered by this prospectus to third parties in privately negotiated transactions. If the applicable prospectus supplement so indicates, in connection with those derivatives, the third parties may sell securities covered by this prospectus and the applicable prospectus supplement, including in short sale transactions. If so, the third party may use securities pledged by us or borrowed from us or others to settle those sales or to close out any related open borrowings of stock, and may use securities received from us in settlement of those derivatives to close out any related open borrowings of stock. The third party in such sale transactions will be an underwriter and, if not identified in this prospectus, will be named in the applicable prospectus supplement (or a post-effective amendment). In addition, we may otherwise loan or pledge securities to a financial institution or other third party that in turn may sell the securities short using this prospectus and an applicable prospectus supplement. Such financial institution or other third party may transfer its economic short position to investors in our securities or in connection with a concurrent offering of other securities.
2018,2021, have been audited by Ernst & Young LLP, independent registered public accounting firm, as set forth in their report thereon included therein, and incorporated herein by reference. Such financial statements are, and audited financial statements to be included in subsequently filed documents will be, incorporated herein in reliance upon the reportsreport of Ernst & Young LLP pertaining to such financial statements (to the extent covered by consents filed with the Securities and Exchange Commission) given on the authority of such firm as experts in accounting and auditing.(www.sec.gov)(www.sec.gov).One Kendall100 Technology Square, Building 300, Suite 201,Sixth Floor, Cambridge, Massachusetts 02139, and our website is located atwww.avrobio.com. Information contained on our website is not incorporated by reference into this prospectus and, therefore, is not part of this prospectus or any accompanying prospectus supplement.
• 2018,2021, filed with the SEC on March 25, 2019;17, 2022;• 20182021 from our definitive proxy statement onSchedule 14A (other than information furnished rather than filed), which was filed with the SEC on April 26, 2019;27, 2022;• ReportReports on Form10-Q for the quarterquarters ended March 31, 2019,2022, filed with the SEC onMay 13, 201910, 2022; our Quarterly Report on Form10-Q for the quarter ended, June 30, 2019,2022, filed with the SEC onAugust, 8, 20199, 2022; our Quarterly Report on Form10-Q for the quarter ended, and September 30, 2019,2022, filed with the SEC onNovember 7, 20198, 2022;• 20192022, our Current Report on Form8-K/A 8-K filed with the SEC onJanuary 11, 2019June 10, 2022 and, our Current ReportsReport on Form8-K filed with the SEC onJanuary 22, 2019,February 6, 2019,AprilJune 29, 2019,June 12, 2019,July 15, 20192022 andJuly 17, 2019, (in each case, except(except for information contained therein which is furnished rather than filed) and our Current Report on Form 8-K filed with the SEC on October 7, 2022; and• description.description, including Exhibit 4.3 to our Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on March 16, 2020.One Kendall100 Technology Square, Building 300, Suite 201,Sixth Floor, Cambridge, Massachusetts 02139, or via telephone at (617)914-8420.
2022
PROSPECTUS (Subject to Completion) | | | Dated November 8, 2022 |
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Assumed offering price per share | | | $0.675 | | | |
Net tangible book value per share as of September 30, 2022 | | | $2.24 | | | |
Decrease in net tangible book value per share attributable to new investors attributable to this offering | | | 1.00 | | | |
As adjusted net tangible book value per share as of September 30, 2022, after giving effect to this offering | | | | | 1.24 | |
Dilution in net tangible book value per share to new investors participating in this offering | | | | | $0.57 |
• | our Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC on March 17, 2022; |
• | the information specifically incorporated by reference into our Annual Report on Form 10-K for the year ended December 31, 2021 from our definitive proxy statement on Schedule 14A (other than information furnished rather than filed), which was filed with the SEC on April 27, 2022; |
• | our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2022, filed with the SEC on May 10, 2022, June 30, 2022, filed with the SEC on August, 9, 2022, and September 30, 2022, filed with the SEC on November 8, 2022; |
• | our Current Report on Form 8-K filed with the SEC on January 7, 2022, our Current Report on Form 8-K filed with the SEC on June 10, 2022, our Current Report on Form 8-K filed with the SEC on June 29, 2022 (except for information contained therein which is furnished rather than filed) and our Current Report on Form 8-K filed with the SEC on October 7, 2022; and |
• | the description of our common stock contained in our registration statement on Form 8-A filed with the SEC on June 18, 2018, including any amendments or reports filed for the purposes of updating this description, including Exhibit 4.3 to our Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on March 16, 2020. |
SEC registration fee | $ | 32,450 | ||
FINRA filing fee | 38,000 | |||
Legal fees and expenses | * | |||
Accounting fees and expenses | * | |||
Printing fees and expenses | * | |||
Transfer agent and trustee fees | * | |||
Miscellaneous | * | |||
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Total | $ | * |
SEC registration fee | | | $19,291 |
FINRA filing fee | | | 26,758 |
Legal fees and expenses | | | * |
Accounting fees and expenses | | | * |
Printing fees and expenses | | | * |
Transfer agent and trustee fees | | | * |
Miscellaneous | | | * |
Total | | | $* |
* | Estimated expenses not presently known |
any breach of the director’s duty of loyalty to us or our stockholders;
any act or omission not in good faith or that involves intentional misconduct or a knowing violation of law;
any unlawful payments related to dividends or unlawful stock purchases, redemptions or other distributions; or
any transaction from which the director derived an improper personal benefit.
II-1
In addition, our bylaws provide that:
we will indemnify our directors, officers and, in the discretion of our board of directors, certain employees to the fullest extent permitted by the DGCL, as it now exists or may in the future be amended; and
we will advance reasonable expenses, including attorneys’ fees, to our directors and, in the discretion of our board of directors, to our officers and certain employees, in connection with legal proceedings relating to their service for or on behalf of us, subject to limited exceptions.
Item 16. Exhibits
EXHIBIT INDEX
Exhibit No. | | | Description |
1.1* | |
| |
| |||
Form of Underwriting Agreement | |||
| | Sales Agreement dated November 8, 2022 by and among the Registrant and Cowen and Company, LLC | |
| | Fourth Amended and Restated Certificate of Incorporation of the Registrant, filed as Exhibit | |
| Amended and RestatedBy-laws, filed as Exhibit | ||
| Form of Specimen Common Stock | ||
| Second Amended and Restated Investors’ Rights Agreement among the Registrant and certain of its | ||
| | Description of Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934, as amended, filed as Exhibit 4.3 to the to the Registrant’s Annual Report on Form 10-K filed on March 16, 2020 (File No. 001-38537) and incorporated herein by reference | |
| | Form of Senior Indenture between the Registrant and one or more trustees to be named | |
| Form of Subordinated Indenture between the Registrant and one or more trustees to be named | ||
4.6* | |||
| Form of Certificate of Designations | ||
4.7* | |||
| Form of Warrant Agreements | ||
4.8* | |||
| Form of Unit Agreement and Unit Certificate | ||
4.9* | |||
| Form of Preferred Stock Certificate | ||
4.10 | |||
| |||
| Opinion of Goodwin Procter LLP | ||
| | Opinion of Goodwin Procter LLP relating to the sales agreement prospectus | |
| | Consent of Ernst & Young LLP | |
| Consent of Goodwin Procter LLP (included in Exhibit 5.1) | ||
| | Consent of Goodwin Procter LLP (included in Exhibit 5.2) | |
| | Power of Attorney (included on the signature page to this registration statement) | |
25.1** | |||
| FormT-1 Statement of Eligibility of Trustee for Senior Indenture under the Trust Indenture Act of 1939 | ||
25.2** | |||
| FormT-1 Statement of Eligibility of Trustee for Subordinated Indenture under the Trust Indenture Act of 1939 | ||
| | Filing Fee Table |
* | To be filed, if necessary, by amendment or as an exhibit to a document to be incorporated or deemed to be incorporated by reference in this registration statement, including a Current Report on Form8-K. |
** | To be filed by amendment pursuant to Section 305(b)(2) of the Trust Indenture Act of 1939. |
+ | Filed herewith. |
20th8th day of December, 2019. AVROBIO, INC. By: NAMETITLEDATEGeoff MacKay December 20, 2019 Erik Ostrowski December 20, 2019 Bruce Booth, D.Phil December 20, 2019 DirectorDecember 20, 2019 DirectorDecember 20, 2019 DirectorDecember 20, 2019