SEC Form S-3 filed by Sangamo Therapeutics Inc.
Delaware (State or other jurisdiction of incorporation or organization) | 68-0359556 (I.R.S. Employer Identification Number) | ||
Scott Willoughby Senior Vice President and General Counsel Sangamo Therapeutics, Inc. 501 Canal Blvd. Richmond, California 94804 (510) 970-6000 | Chadwick L. Mills Courtney M.W. Tygesson Cooley LLP 3 Embarcadero Center, 20th Floor San Francisco, CA 94111 (415) 693-2000 | ||
Large accelerated filer | ☐ | Accelerated filer | ☒ | ||||||
Non-accelerated filer | ☐ | Smaller reporting company | ☒ | ||||||
Emerging growth company | ☐ | ||||||||
• | a base prospectus, which covers the offering, issuance and sale by the registrant of up to a maximum aggregate offering price of $500,000,000 of the registrant’s common stock, preferred stock, debt securities and/or warrants from time to time in one or more offerings; and |
• | a sales agreement prospectus, which covers the offering, issuance and sale by the registrant of up to a maximum aggregate offering price of $194,473,577.60 of the registrant’s common stock that may be issued and sold from time to time under a sales agreement with Jefferies LLC. |
• | designation or classification; |
• | aggregate principal amount or aggregate offering price; |
• | maturity date, if applicable; |
• | original issue discount, if any; |
• | rates and times of payment of interest or dividends, if any; |
• | redemption, conversion, exercise, exchange or sinking fund terms, if any; |
• | ranking; |
• | restrictive covenants, if any; |
• | voting or other rights, if any; |
• | conversion or exchange prices or rates, if any, and, if applicable, any provisions for changes to or adjustments in the conversion or exchange prices or rates and in the securities or other property receivable upon conversion or exchange; and |
• | material or special U.S. federal income tax considerations, if any. |
• | the names of those agents or underwriters; |
• | applicable fees, discounts and commissions to be paid to them; |
• | details regarding over-allotment or other options, if any; and |
• | the net proceeds to us. |
• | our estimates regarding the sufficiency of our cash resources and our expenses, capital requirements and need for substantial additional financing, and our ability to obtain additional financing, including the impact of business development and clinical advancements on our cash runway; |
• | our ability to continue to operate as a going concern; |
• | our projected operating and financial performance; |
• | our plans for advancing our development programs and the plans of our collaboration partners for advancing our partnered programs, and the expected charges and cost savings associated with our restructurings and facility closures; |
• | anticipated research and development of product candidates and potential commercialization of any resulting approved products; |
• | the initiation, scope, rate of progress, enrollment, dosing, anticipated results and timing of our preclinical studies and clinical trials and those of our collaborators or strategic partners; |
• | the therapeutic and commercial potential of our product candidates, including the durability of therapeutic effects; |
• | the therapeutic and commercial potential of technologies used by us in our product candidates, including our gene therapy and gene editing technologies, ZF technology platform and ZF transcriptional regulators, which include ZF repressors; |
• | our ability to realize the expected benefits of the global epigenetic regulation and capsid delivery license agreement with Genentech, a member of the Roche group, the potential for Genentech to complete clinical development, regulatory interactions, manufacturing and global commercialization of any resulting products, and the potential for us to receive milestone payments and royalties from Genentech; |
• | anticipated investigational new drug and clinical trial application submissions and potential acceptance thereof by the U.S. Food and Drug Administration, or FDA, and regulatory authorities outside the United States; |
• | the potential for isaralgagene civaparvovec to qualify for the FDA’s Accelerated Approval program, including the adequacy of data generated in the Phase 1/2 STAAR study to support any such approval; expectations concerning the availability of additional data to support a potential Biologics License Application submission for isaralgagene civaparvovec and the timing of such submission; |
• | our ability to establish and maintain collaborations and strategic partnerships and realize the expected benefits of such arrangements, including our ability to find a collaboration partner for our Fabry disease program and to engage in additional transactions with respect to our STAC-BBB capsid delivery program and epigenetic regulation capabilities, and Pfizer’s continued advancements of the giroctocogene fitelparvovec program, including the potential for Pfizer to complete clinical development, regulatory interactions, manufacturing and global commercialization of any resulting products; |
• | anticipated revenues from existing and new collaborations and the timing thereof; |
• | our and our collaborators’ anticipated plans and timelines in conducting our ongoing and potential future clinical trials and presenting clinical data from such clinical trials, and the anticipated advancement of our product candidates to late-stage development; |
• | our estimates regarding the impact of the macroeconomic environment on our business and operations and the business and operations of our collaborators, including preclinical studies, clinical trials and manufacturing, and our ability to manage such impacts; |
• | our research and development and other expenses; |
• | our ability to obtain adequate preclinical and clinical supplies of our product candidates from current and potential new suppliers and manufacturers; |
• | our ability, and the ability of our collaborators and strategic partners, to obtain and maintain regulatory approvals for product candidates and the timing and costs associated with obtaining regulatory approvals; |
• | our ability to comply with, and the impact of, regulatory requirements, obligations and restrictions on our business and operations; |
• | our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others, including our ability to obtain and maintain rights to the technologies required to develop and commercialize our product candidates; |
• | competitive developments, including the impact on our competitive position of rival products and product candidates and our ability to meet such competition; |
• | our operational and legal risks; |
• | our plans, objectives, expectations and intentions and any other statements that are not historical facts; and |
• | our intended use of the net proceeds from offerings of our securities under this prospectus. |
• | the title and stated value; |
• | the number of shares we are offering; |
• | the liquidation preference per share; |
• | the purchase price per share; |
• | the dividend rate per share, dividend period and payment dates and method of calculation for dividends; |
• | whether dividends will be cumulative or non-cumulative and, if cumulative, the date from which dividends will accumulate; |
• | our right, if any, to defer payment of dividends and the maximum length of any such deferral period; |
• | the procedures for any auction and remarketing, if any; |
• | the provisions for a sinking fund, if any; |
• | the provisions for redemption or repurchase, if applicable, and any restrictions on our ability to exercise those redemption and repurchase rights; |
• | any listing of the preferred stock on any securities exchange or market; |
• | whether the preferred stock will be convertible into our common stock or other securities of ours, including warrants, and, if applicable, the conversion period, the conversion price, or how it will be calculated, and under what circumstances it may be adjusted; |
• | whether the preferred stock will be exchangeable for debt securities, and, if applicable, the exchange period, the exchange price, or how it will be calculated, and under what circumstances it may be adjusted; |
• | voting rights, if any, of the preferred stock; |
• | preemption rights, if any; |
• | restrictions on transfer, sale or other assignment, if any; |
• | a discussion of any material or special United States federal income tax considerations applicable to the preferred stock; |
• | the relative ranking and preferences of the preferred stock as to dividend rights and rights if we liquidate, dissolve or wind up our affairs; |
• | any limitations on issuances of any class or series of preferred stock ranking senior to or on a parity with the series of preferred stock being issued as to dividend rights and rights if we liquidate, dissolve or wind up our affairs; and |
• | any other specific terms, rights, preferences, privileges, qualifications or restrictions of the preferred stock. |
• | senior to all classes or series of our common stock and to all of our equity securities ranking junior to the preferred stock; |
• | on a parity with all of our equity securities the terms of which specifically provide that the equity securities rank on a parity with the preferred stock; and |
• | junior to all of our equity securities the terms of which specifically provide that the equity securities rank senior to the preferred stock. |
• | prior to the time the stockholder became an interested stockholder, the board of directors of the corporation 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 number of shares outstanding (but not the outstanding voting stock owned by the interested stockholder) those shares owned by (a) persons who are directors and also officers and (b) employee stock plans in which employee participants do not have the right to determine confidentially whether shares held subject to the plan will be tendered in a tender or exchange offer; or |
• | at or subsequent to the time the stockholder became an interested stockholder, the business combination is approved by the board of directors and authorized at an annual or special meeting of stockholders, and not by written consent, by the affirmative vote of at least 66 2⁄3% 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, lease, exchange, mortgage, transfer, pledge or other disposition involving the interested stockholder (in one transaction or a series of transactions) of assets of the corporation having an aggregate market value equal to 10% or more of the aggregate market value of either all of the assets of the corporation or its outstanding stock; |
• | 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, directly or indirectly, of increasing the proportionate share of the stock or any class or series of the corporation beneficially owned by the interested stockholder; and |
• | the receipt by the interested stockholder of the benefit, directly or indirectly (except proportionately as a stockholder of such corporation), of any loans, advances, guarantees, pledges or other financial benefits, other than certain benefits set forth in Section 203, provided by or through the corporation. |
• | the title of the series of debt securities; |
• | any limit upon the aggregate principal amount that may be issued; |
• | the maturity date or dates; |
• | the form of the debt securities of the series; |
• | the applicability of any guarantees; |
• | whether or not the debt securities will be secured or unsecured, and the terms of any secured debt; |
• | whether the debt securities rank as senior debt, senior subordinated debt, subordinated debt or any combination thereof, and the terms of any subordination; |
• | if the price (expressed as a percentage of the aggregate principal amount thereof) at which such debt securities will be issued is a price other than the principal amount thereof, the portion of the principal amount thereof payable upon declaration of acceleration of the maturity thereof, or if applicable, the portion of the principal amount of such debt securities that is convertible into another security or the method by which any such portion shall be determined; |
• | the interest rate or rates, which may be fixed or variable, or the method for determining the rate and the date interest will begin to accrue, the dates interest will be payable and the regular record dates for interest payment dates or the method for determining such dates; |
• | our right, if any, to defer payment of interest and the maximum length of any such deferral period; |
• | if applicable, the date or dates after which, or the period or periods during which, and the price or prices at which, we may, at our option, redeem the series of debt securities pursuant to any optional or provisional redemption provisions and the terms of those redemption provisions; |
• | the date or dates, if any, on which, and the price or prices at which we are obligated, pursuant to any mandatory sinking fund or analogous fund provisions or otherwise, to redeem, or at the holder’s option to purchase, the series of debt securities and the currency or currency unit in which the debt securities are payable; |
• | the denominations in which we will issue the series of debt securities, if other than denominations of $1,000 and any integral multiple thereof; |
• | any and all terms, if applicable, relating to any auction or remarketing of the debt securities of that series and any security for our obligations with respect to such debt securities and any other terms which may be advisable in connection with the marketing of debt securities of that series; |
• | whether the debt securities of the series shall be issued in whole or in part in the form of a global security or securities; the terms and conditions, if any, upon which such global security or securities may be exchanged in whole or in part for other individual securities; and the depositary for such global security or securities; |
• | if applicable, the provisions relating to conversion or exchange of any debt securities of the series and the terms and conditions upon which such debt securities will be so convertible or exchangeable, including the conversion or exchange price, as applicable, or how it will be calculated and may be adjusted, any mandatory or optional (at our option or the holders’ option) conversion or exchange features, the applicable conversion or exchange period and the manner of settlement for any conversion or exchange; |
• | if other than the full principal amount thereof, the portion of the principal amount of debt securities of the series which shall be payable upon declaration of acceleration of the maturity thereof; |
• | additions to or changes in the covenants applicable to the particular debt securities being issued, including, among others, the consolidation, merger or sale covenant; |
• | additions to or changes in the events of default with respect to the securities and any change in the right of the trustee or the holders to declare the principal, premium, if any, and interest, if any, with respect to such securities to be due and payable; |
• | additions to or changes in or deletions of the provisions relating to covenant defeasance and legal defeasance; |
• | additions to or changes in the provisions relating to satisfaction and discharge of the indenture; |
• | additions to or changes in the provisions relating to the modification of the indenture both with and without the consent of holders of debt securities issued under the indenture; |
• | the currency of payment of debt securities if other than U.S. dollars and the manner of determining the equivalent amount in U.S. dollars; |
• | whether interest will be payable in cash or additional debt securities at our or the holders’ option and the terms and conditions upon which the election may be made; |
• | the terms and conditions, if any, upon which we will pay amounts in addition to the stated interest, premium, if any and principal amounts of the debt securities of the series to any holder that is not a “United States person” for federal tax purposes; |
• | any restrictions on transfer, sale or assignment of the debt securities of the series; and |
• | any other specific terms, preferences, rights or limitations of, or restrictions on, the debt securities, any other additions or changes in the provisions of the indenture, and any terms that may be required by us or advisable under applicable laws or regulations. |
• | if we fail to pay any installment of interest on any series of debt securities, as and when the same shall become due and payable, and such default continues for a period of 90 days; provided, however, that a valid extension of an interest payment period by us in accordance with the terms of any indenture supplemental thereto shall not constitute a default in the payment of interest for this purpose; |
• | if we fail to pay the principal of, or premium, if any, on any series of debt securities as and when the same shall become due and payable whether at maturity, upon redemption, by declaration or otherwise, or in any payment required by any sinking or analogous fund established with respect to such series; provided, however, that a valid extension of the maturity of such debt securities in accordance with the terms of any indenture supplemental thereto shall not constitute a default in the payment of principal or premium, if any; |
• | if we fail to observe or perform any other covenant or agreement contained in the debt securities or the indenture, other than a covenant specifically relating to another series of debt securities, and our failure continues for 90 days after we receive written notice of such failure, requiring the same to be remedied and stating that such is a notice of default thereunder, from the trustee or holders of at least 25% in aggregate principal amount of the outstanding debt securities of the applicable series; and |
• | if specified events of bankruptcy, insolvency or reorganization occur. |
• | the direction so given by the holder is not in conflict with any law or the applicable indenture; and |
• | subject to its duties under the Trust Indenture Act, the trustee need not take any action that might involve it in personal liability or might be unduly prejudicial to the holders not involved in the proceeding. |
• | the holder has given written notice to the trustee of a continuing event of default with respect to that series; |
• | the holders of at least 25% in aggregate principal amount of the outstanding debt securities of that series have made written request, such holders have offered to the trustee indemnity satisfactory to it against the costs, expenses and liabilities to be incurred by the trustee in compliance with the request; and |
• | the trustee does not institute the proceeding, and does not receive from the holders of a majority in aggregate principal amount of the outstanding debt securities of that series other conflicting directions within 90 days after the notice, request and offer. |
• | to cure any ambiguity, defect or inconsistency in the indenture or in the debt securities of any series; |
• | to comply with the provisions described under the section titled “—Consolidation, Merger or Sale;” |
• | to provide for uncertificated debt securities in addition to or in place of certificated debt securities; |
• | to add to our covenants, restrictions, conditions or provisions such new covenants, restrictions, conditions or provisions for the benefit of the holders of all or any series of debt securities, to make the occurrence, or the occurrence and the continuance, of a default in any such additional covenants, restrictions, conditions or provisions an event of default or to surrender any right or power conferred upon us in the 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, as set forth in the indenture; |
• | to make any change that does not adversely affect the interests of any holder of debt securities of any series in any material respect; |
• | to provide for the issuance of and establish the form and terms and conditions of the debt securities of any series as provided under the section titled “—General” to establish the form of any certifications required to be furnished pursuant to the terms of the indenture or any series of debt securities, or to add to the rights of the holders of any series of debt securities; |
• | to evidence and provide for the acceptance of appointment under any indenture by a successor trustee; or |
• | to comply with any requirements of the SEC in connection with the qualification of any indenture under the Trust Indenture Act. |
• | extending the fixed maturity of any debt securities of any series; |
• | reducing the principal amount, reducing the rate of or extending the time of payment of interest, or reducing any premium payable upon the redemption of any series of any debt securities; or |
• | reducing the percentage of debt securities, the holders of which are required to consent to any amendment, supplement, modification or waiver. |
• | provide for payment; |
• | register the transfer or exchange of debt securities of the series; |
• | replace stolen, lost or mutilated debt securities of the series; |
• | pay principal of and premium and interest on any debt securities of the series; |
• | maintain paying agencies; |
• | hold monies for payment in trust; |
• | recover excess money held by the trustee; |
• | compensate and indemnify the trustee; and |
• | appoint any successor trustee. |
• | issue, register the transfer of, or exchange any debt securities of that series during a period beginning at the opening of business 15 days before the day of mailing of a notice of redemption of any debt securities that may be selected for redemption and ending at the close of business on the day of the mailing; or |
• | register the transfer of or exchange any debt securities so selected for redemption, in whole or in part, except the unredeemed portion of any debt securities we are redeeming in part. |
• | 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; |
• | 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; |
• | in the case of warrants to purchase common stock or preferred stock, the number of shares of common stock or preferred stock, as the case may be, purchasable upon the exercise of one warrant and the price at which these shares may be purchased upon such exercise; |
• | the effect of any merger, consolidation, sale or other disposition of our business on the warrant agreements and the warrants; |
• | the terms of any rights to redeem or call the warrants; |
• | any provisions for changes to or adjustments in the exercise price or number of securities issuable upon exercise of the warrants; |
• | the dates on which the right to exercise the warrants will commence and expire; |
• | the manner in which the warrant agreements and warrants may be modified; |
• | a discussion of material or special U.S. federal income tax considerations, if any, of holding or exercising the warrants; |
• | the terms of the securities issuable upon exercise of the warrants; and |
• | any other specific terms, preferences, rights or limitations of or restrictions on the warrants. |
• | in the case of warrants to purchase debt securities, the right to receive payments of principal of, or premium, if any, or interest on, the debt securities purchasable upon exercise or to enforce covenants in the applicable indenture; or |
• | in the case of warrants to purchase common stock or preferred stock, the right to receive dividends, if any, or payments upon our liquidation, dissolution or winding up or to exercise voting rights, if any. |
• | the performance of third-party service providers; |
• | how it handles securities payments and notices; |
• | whether it imposes fees or charges; |
• | how it would handle a request for the holders’ consent, if ever required; |
• | whether and how you can instruct it to send you securities registered in your own name so you can be a holder, if that is permitted in the future; |
• | how it would exercise rights under the securities if there were a default or other event triggering the need for holders to act to protect their interests; and |
• | if the securities are in book-entry form, how the depositary’s rules and procedures will affect these matters. |
• | an investor cannot cause the securities to be registered in his or her name, and cannot obtain non-global certificates for his or her interest in the securities, except in the special situations we describe below; |
• | an investor will be an indirect holder and must look to his or her own bank or broker for payments on the securities and protection of his or her legal rights relating to the securities, as we describe above; |
• | an investor may not be able to sell interests in the securities to some insurance companies and to other institutions that are required by law to own their securities in non-book-entry form; |
• | an investor may not be able to pledge his or her interest in a global security in circumstances where certificates representing the securities must be delivered to the lender or other beneficiary of the pledge in order for the pledge to be effective; |
• | the depositary’s policies, which may change from time to time, will govern payments, transfers, exchanges and other matters relating to an investor’s interest in a global security; |
• | we and any applicable trustee have no responsibility for any aspect of the depositary’s actions or for its records of ownership interests in a global security, nor do we or any applicable trustee supervise the depositary in any way; |
• | the depositary may, and we understand that DTC will, require that those who purchase and sell interests in a global security within its book-entry system use immediately available funds, and your broker or bank may require you to do so as well; and |
• | financial institutions that participate in the depositary’s book-entry system, and through which an investor holds its interest in a global security, may also have their own policies affecting payments, notices and other matters relating to the securities. |
• | if the depositary notifies us that it is unwilling, unable or no longer qualified to continue as depositary for that global security and we do not appoint another institution to act as depositary within 90 days; |
• | if we notify any applicable trustee that we wish to terminate that global security; or |
• | if an event of default has occurred with regard to securities represented by that global security and has not been cured or waived. |
• | at a fixed price or prices, which may be changed; |
• | at market prices prevailing at the time of sale; |
• | at prices related to such prevailing market prices; or |
• | at negotiated prices. |
• | the name or names of the underwriters, dealers or agents, if any; |
• | the purchase price of the securities or other consideration therefor, and the proceeds, if any, we will receive from the sale; |
• | any over-allotment or other options under which underwriters may purchase additional securities from us; |
• | any agency fees or underwriting discounts and other items constituting agents’ or underwriters’ compensation; |
• | any public offering price; |
• | any discounts or concessions allowed or reallowed or paid to dealers; and |
• | any securities exchange or market on which the securities may be listed. |
• | our annual report on Form 10-K for the year ended December 31, 2023, which was filed with the SEC on March 13, 2024; |
• | the information specifically incorporated by reference into our annual report on Form 10-K for the year ended December 31, 2023 from our definitive proxy statement on Schedule 14A, which was filed with the SEC on April 19, 2024; |
• | our quarterly reports on Form 10-Q for the quarters ended March 31, 2024, June 30, 2024 and September 30, 2024, which were filed with the SEC on May 9, 2024, August 6, 2024 and November 12, 2024, respectively; |
• | our current reports on Form 8-K (other than information furnished rather than filed), which were filed with the SEC on January 19, 2024, February 6, 2024, March 25, 2024, April 30, 2024, June 5, 2024 and July 24, 2024; and |
• | the description of our common stock in our registration statement on Form 8-A, which was filed with the SEC on March 31, 2000, including all amendments and reports filed for the purpose of updating such description, including Exhibit 4.1 of our annual report on Form 10-K for the year ended December 31, 2023. |
• | There is substantial doubt about our ability to continue to operate as a going concern. We need substantial additional funding to execute our operating plan and to continue to operate as a going concern. If adequate funds are not available to us on a timely basis, or at all, we will be required to take additional actions to address our liquidity needs, including additional cost reduction measures such as further reducing operating expenses and delaying, reducing the scope of, discontinuing or altering our research and development activities, which would have a material adverse effect on our business and prospects, or we may be required to cease operations entirely, liquidate all or a portion of our assets, and/or seek protection under the U.S. Bankruptcy Code, and you may lose all or part of your investment. Future sales and issuances of equity securities would also result in substantial dilution to our stockholders. |
• | We are a biotechnology company with no approved products or product revenues. Our success depends substantially on results of preclinical studies and clinical trials demonstrating safety and efficacy of our product candidates to the satisfaction of applicable regulatory authorities. Obtaining positive clinical trial results and regulatory approvals is expensive, lengthy, challenging and unpredictable and may never occur for any product candidates. |
• | We are early in our research and development efforts for our core preclinical neurology programs that are the current focus of our business. We may encounter difficulties in advancing product candidates from research programs to preclinical and clinical development. |
• | Success in research and preclinical studies or early clinical trial results may not be indicative of results obtained in later trials. Likewise, preliminary, initial or interim data from clinical trials may be materially different from final data. |
• | Many of our product candidates are based on novel ZF technologies that have yet to yield any approved commercially viable therapeutic products. |
• | We have historically incurred significant operating losses since inception and anticipate continued losses for the foreseeable future. We may never become profitable. |
• | Biotechnology and genomic medicine are highly competitive businesses. Our competitors may develop rival technologies and products that are superior to or are commercialized more quickly than our technologies and product candidates. |
• | Manufacturing genomic medicines is complex, expensive, highly regulated and risky. We are currently substantially reliant on third-party manufacturers. Manufacturing challenges may result in unexpected costs, supply interruptions and harm and delay to our product development efforts. |
• | Even if we obtain regulatory approvals for our product candidates, our approved products may not gain market acceptance among physicians and patients and adequate coverage and reimbursement from third-party payors and may not demonstrate commercial viability. |
• | We may not be able to obtain, maintain and enforce necessary and desirable intellectual property protections for our technologies and product candidates in all desired jurisdictions, which could adversely affect the value of our technologies and our product development efforts and could increase the risks of costly, lengthy and distracting litigation with unpredictable results. |
• | Third parties, who may or may not be competitors, may allege that we are infringing, misappropriating, or otherwise practicing in an unauthorized manner their patents or other proprietary rights. Such allegations may result in infringement actions, other misappropriation actions or threats of such actions, all of which could increase the risks of costly, lengthy and distracting litigation with unpredictable results. |
• | Our recent restructurings may not result in anticipated savings or operational efficiencies and could result in total costs and expenses that are greater than expected. |
• | Our success depends on hiring, integrating and retaining additional highly qualified skilled employees and retaining current key executives and employees, which may be challenging given the uncertainty regarding our ability to obtain sufficient additional funding and to continue to operate as a going concern as well as the competition among numerous biopharmaceutical companies and academic institutions for individuals with these skills. |
• | Unfavorable global economic conditions could have a negative impact on our operations, which could materially and adversely affect our ability to continue to operate as a going concern and otherwise have a material adverse effect on our business, financial condition, results of operations, prospects and market price of our common stock. |
• | The market price of our common stock has been and will likely continue to be volatile, and you could lose all or part of any investment in our common stock. |
• | We have fully impaired our goodwill and indefinite-lived intangible assets, have recorded significant impairment of our right-of-use and other long-lived assets, and may be required to record significant additional charges if our long-lived assets become further impaired in the future. |
• | our estimates regarding the sufficiency of our cash resources and our expenses, capital requirements and need for substantial additional financing, and our ability to obtain additional financing, including the impact of business development and clinical advancements on our cash runway; |
• | our ability to continue to operate as a going concern; |
• | our projected operating and financial performance; |
• | our plans for advancing our development programs and the plans of our collaboration partners for advancing our partnered programs, and the expected charges and cost savings associated with our restructurings and facility closures; |
• | anticipated research and development of product candidates and potential commercialization of any resulting approved products; |
• | the initiation, scope, rate of progress, enrollment, dosing, anticipated results and timing of our preclinical studies and clinical trials and those of our collaborators or strategic partners; |
• | the therapeutic and commercial potential of our product candidates, including the durability of therapeutic effects; |
• | the therapeutic and commercial potential of technologies used by us in our product candidates, including our gene therapy and gene editing technologies, ZF technology platform and ZF transcriptional regulators, which include ZF repressors; |
• | our ability to realize the expected benefits of the global epigenetic regulation and capsid delivery license agreement with Genentech, a member of the Roche group, the potential for Genentech to complete clinical development, regulatory interactions, manufacturing and global commercialization of any resulting products, and the potential for us to receive milestone payments and royalties from Genentech; |
• | anticipated investigational new drug and clinical trial application submissions and potential acceptance thereof by the U.S. Food and Drug Administration, or FDA, and regulatory authorities outside the United States; |
• | the potential for isaralgagene civaparvovec to qualify for the FDA’s Accelerated Approval program, including the adequacy of data generated in the Phase 1/2 STAAR study to support any such approval; expectations concerning the availability of additional data to support a potential Biologics License Application submission for isaralgagene civaparvovec and the timing of such submission; |
• | our ability to establish and maintain collaborations and strategic partnerships and realize the expected benefits of such arrangements, including our ability to find a collaboration partner for our Fabry disease program and to engage in additional transactions with respect to our STAC-BBB capsid delivery program and epigenetic regulation capabilities, and Pfizer’s continued advancements of the giroctocogene fitelparvovec program, including the potential for Pfizer to complete clinical development, regulatory interactions, manufacturing and global commercialization of any resulting products; |
• | anticipated revenues from existing and new collaborations and the timing thereof; |
• | our and our collaborators’ anticipated plans and timelines in conducting our ongoing and potential future clinical trials and presenting clinical data from such clinical trials, and the anticipated advancement of our product candidates to late-stage development; |
• | our estimates regarding the impact of the macroeconomic environment on our business and operations and the business and operations of our collaborators, including preclinical studies, clinical trials and manufacturing, and our ability to manage such impacts; |
• | our research and development and other expenses; |
• | our ability to obtain adequate preclinical and clinical supplies of our product candidates from current and potential new suppliers and manufacturers; |
• | our ability, and the ability of our collaborators and strategic partners, to obtain and maintain regulatory approvals for product candidates and the timing and costs associated with obtaining regulatory approvals; |
• | our ability to comply with, and the impact of, regulatory requirements, obligations and restrictions on our business and operations; |
• | our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others, including our ability to obtain and maintain rights to the technologies required to develop and commercialize our product candidates; |
• | competitive developments, including the impact on our competitive position of rival products and product candidates and our ability to meet such competition; |
• | our operational and legal risks; |
• | our plans, objectives, expectations and intentions and any other statements that are not historical facts; and |
• | the anticipated use of any net proceeds from this offering. |
Assumed public offering price per share | $2.70 | |||||
Net tangible book value per share of September 30, 2024 | $0.19 | |||||
Increase in net tangible book value per share attributable to this offering | $0.62 | |||||
As adjusted net tangible book value per share as of September 30, 2024, after giving effect to this offering | $0.81 | |||||
Dilution per share to new investors purchasing our common stock in this offering | $1.89 | |||||
• | 11,039,435 shares of common stock issuable upon the exercise of options outstanding as of September 30, 2024, having a weighted-average exercise price of $6.77 per share; |
• | 11,654,833 shares of common stock issuable upon the vesting of restricted stock units outstanding as of September 30, 2024; |
• | 18,083,835 shares of common stock reserved for future issuance under our Amended and Restated 2018 Equity Incentive Plan, as of September 30, 2024; and |
• | 2,479,167 shares of common stock reserved for future issuance under our 2020 Employee Stock Purchase Plan as of September 30, 2024. |
• | prior to the time the stockholder became an interested stockholder, the board of directors of the corporation 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 number of shares outstanding (but not the outstanding voting stock owned by the interested stockholder) those shares owned by (a) persons who are directors and also officers and (b) employee stock plans in which employee participants do not have the right to determine confidentially whether shares held subject to the plan will be tendered in a tender or exchange offer; or |
• | at or subsequent to the time the stockholder became an interested stockholder, the business combination is approved by the board of directors and authorized at an annual or special meeting of stockholders, and not by written consent, by the affirmative vote of at least 66 2⁄3% 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, lease, exchange, mortgage, transfer, pledge or other disposition involving the interested stockholder (in one transaction or a series of transactions) of assets of the corporation having an aggregate market value equal to 10% or more of the aggregate market value of either all of the assets of the corporation or its outstanding stock; |
• | 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, directly or indirectly, of increasing the proportionate share of the stock or any class or series of the corporation beneficially owned by the interested stockholder; and |
• | the receipt by the interested stockholder of the benefit, directly or indirectly (except proportionately as a stockholder of such corporation), of any loans, advances, guarantees, pledges or other financial benefits, other than certain benefits set forth in Section 203, provided by or through the corporation. |
• | our annual report on Form 10-K for the year ended December 31, 2023, which was filed with the SEC on March 13, 2024; |
• | the information specifically incorporated by reference into our annual report on Form 10-K for the year ended December 31, 2023 from our definitive proxy statement on Schedule 14A, which was filed with the SEC on April 19, 2024; |
• | our quarterly reports on Form 10-Q for the quarters ended March 31, 2024, June 30, 2024 and September 30, 2024, which were filed with the SEC on May 9, 2024, August 6, 2024 and November 12, 2024, respectively; |
• | our current reports on Form 8-K (other than information furnished rather than filed), which were filed with the SEC on January 19, 2024, February 6, 2024, March 25, 2024, April 30, 2024, June 5, 2024 and July 24, 2024; and |
• | the description of our common stock in our registration statement on Form 8-A, which was filed with the SEC on March 31, 2000, including all amendments and reports filed for the purpose of updating such description, including Exhibit 4.1 of our annual report on Form 10-K for the year ended December 31, 2023. |
Item 14. | Other Expenses of Issuance and Distribution |
Amount | |||
SEC registration fee | $76,550 | ||
The Nasdaq Capital Market listing fee | (1) | ||
Accounting fees and expenses | (1) | ||
Legal fees and expenses | (1) | ||
Transfer agent and registrar fees and expenses | (1) | ||
Trustee fees and expenses | (1) | ||
Blue sky fees and expenses (including legal fees) | (1) | ||
Printing and miscellaneous fees and expenses | (1) | ||
Total | $(1) | ||
(1) | The amount of securities and number of offerings are indeterminable and the expenses cannot be estimated at this time. An estimate of the aggregate expenses in connection with the sale and distribution of securities being offered will be included in the applicable prospectus supplement. |
Item 15. | Indemnification of Directors and Officers |
• | any breach of duty of loyalty to the Registrant or to its stockholders; |
• | acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law; |
• | unlawful payment of dividends or unlawful stock repurchases or redemptions under Section 174 of the DGCL; or |
• | any transaction from which the director derived an improper personal benefit. |
• | any breach of duty of loyalty to the Registrant or to its stockholders; |
• | acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law; |
• | any transaction from which the officer derived an improper personal benefit; or |
• | any action by or in the right of the corporation. |
Item 16. | Exhibits |
Exhibit Number | |||
1.1* | Form of Underwriting Agreement. | ||
Amendment No. 4 to Open Market Sale Agreement, between Sangamo Therapeutics, Inc. and Jefferies LLC, dated November 12, 2024. | |||
Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.3 to the Registrant’s Current Report on Form 8-K filed June 2, 2023). | |||
Certificate of Amendment of the Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed June 5, 2024). | |||
Fifth Amended and Restated Bylaws (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed December 19, 2022). | |||
Form of Specimen Common Stock Certificate (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed January 6, 2017). | |||
4.2* | Specimen Preferred Stock Certificate and Form of Certificate of Designation of Preferred Stock. | ||
Form of Indenture, between Registrant and one or more trustees to be named. | |||
4.4* | Form of Debt Securities. | ||
Form of Common Stock Warrant Agreement and Warrant Certificate. | |||
Form of Preferred Stock Warrant Agreement and Warrant Certificate. | |||
Form of Debt Securities Warrant Agreement and Warrant Certificate. | |||
Opinion of Cooley LLP. | |||
Consent of independent registered public accounting firm. | |||
Consent of Cooley LLP is contained in Exhibit 5.1 to this Registration Statement. | |||
Power of Attorney is contained on the signature page hereto. | |||
25.1* | Statement of Eligibility of Trustee under the Indenture (to be filed separately under the electronic form type 305B2, if applicable). | ||
Filing fee table. | |||
* | To be filed by amendment or as an exhibit to a Current Report on Form 8-K and incorporated herein by reference, if applicable. |
Item 17. | Undertakings |
(a) | The undersigned registrant hereby undertakes: |
(1) | To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement: |
(i) | to include any prospectus required by Section 10(a)(3) of the Securities Act of 1933; |
(ii) | to reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20% change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement; and |
(iii) | To include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement; |
(2) | That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. |
(3) | To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering. |
(4) | That, for the purpose of determining liability under the Securities Act of 1933 to any purchaser: |
(i) | Each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and |
(ii) | Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the purpose of providing the information required by section 10(a) of the Securities Act of 1933 shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date. |
(5) | That, for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial distribution of the securities, the undersigned registrant undertakes that in a primary offering of securities of the undersigned registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser: |
(i) | Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424; |
(ii) | Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned registrant; |
(iii) | The portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant or its securities provided by or on behalf of the undersigned registrant; and |
(iv) | Any other communication that is an offer in the offering made by the undersigned registrant to the purchaser. |
(b) | The undersigned registrant hereby undertakes that, for the purpose of determining liability of the registrant under the Securities Act of 1933, each filing of the registrant’s annual report pursuant to section 13(a) or section 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee |
(c) | Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act of 1933 and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act of 1933 and will be governed by the final adjudication of such issue. |
(d) | The undersigned registrant hereby undertakes to file an application for the purpose of determining the eligibility of the trustee to act under subsection (a) of section 310 of the Trust Indenture Act (“Act”) in accordance with the rules and regulations prescribed by the Commission under section 305(b)(2) of the Act. |
SANGAMO THERAPEUTICS, INC. | ||||||
By: | /s/ Alexander D. Macrae | |||||
Alexander D. Macrae, M.B., Ch.B., Ph.D. President and Chief Executive Officer | ||||||
Signature | Title | Date | ||||
/s/ Alexander D. Macrae | President, Chief Executive Officer and Director (Principal Executive Officer) | November 12, 2024 | ||||
Alexander D. Macrae, M.B., Ch.B., Ph.D. | ||||||
/s/ Prathyusha Duraibabu | Senior Vice President and Chief Financial Officer (Principal Financial and Accounting Officer) | November 12, 2024 | ||||
Prathyusha Duraibabu | ||||||
/s/ H. Stewart Parker | Director and Chairman of the Board | November 12, 2024 | ||||
H. Stewart Parker | ||||||
/s/ Courtney Beers | Director | November 12, 2024 | ||||
Courtney Beers, Ph.D. | ||||||
/s/ Robert F. Carey | Director | November 12, 2024 | ||||
Robert F. Carey | ||||||
/s/ Kenneth J. Hillan | Director | November 12, 2024 | ||||
Kenneth J. Hillan, M.B., Ch.B. | ||||||
Signature | Title | Date | ||||
/s/ Margaret A. Horn | Director | November 12, 2024 | ||||
Margaret A. Horn | ||||||
/s/ John H. Markels | Director | November 12, 2024 | ||||
John H. Markels, Ph.D. | ||||||
/s/ James R. Meyers | Director | November 12, 2024 | ||||
James R. Meyers | ||||||
/s/ Karen L. Smith | Director | November 12, 2024 | ||||
Karen L. Smith, M.D., Ph.D., M.B.A., L.L.M. | ||||||