We are offering 10,000,000 shares of our common
stock. Shares of our common stock trade on The NASDAQ Global Select Market under the symbol “SGMO.” On June 19, 2017, the last reported sale price of our common stock was $7.95 per share.
We estimate the total expenses of this offering, excluding the underwriting discounts and commissions, will be approximately
$230,000.
The underwriters may also purchase up to an additional 1,500,000 shares of our common stock within 30 days of the date of this prospectus supplement.
We anticipate that delivery of the shares of our common stock will be made through the facilities of the Depository Trust Company on or about June 26, 2017,
subject to customary closing conditions.
ABOUT THIS PROSPECTUS SUPPLEMENT
This prospectus supplement and the accompanying prospectus dated June 9, 2017 is part of a “shelf” registration statement on Form
S-3
we filed with the Securities and Exchange Commission which became effective on June 9, 2017. By using a “shelf” registration statement, we may sell shares of common stock, preferred stock, debt
securities, warrants to purchase common stock and/or warrants to purchase preferred stock, as described in the accompanying prospectus, from time to time in one or more offerings.
This document is in two parts. The first part is this prospectus supplement, which describes the specific terms of this common stock offering and also
adds to and updates information contained in the accompanying prospectus and the documents incorporated by reference herein. The second part, the accompanying prospectus, provides more general information. Generally, when we refer to this
prospectus, we are referring to both parts of this document combined. To the extent there is a conflict between the information contained in this prospectus supplement and the information contained in the accompanying prospectus or any document
incorporated by reference therein filed prior to the date of this prospectus supplement, you should rely on the information in this prospectus supplement; provided that if any statement in one of these documents is inconsistent with a statement in
another document having a later date—for example, a document incorporated by reference in the accompanying prospectus—the statement in the document having the later date modifies or supersedes the earlier statement.
We further note that the representations, warranties and covenants made by us in any agreement that is filed as an exhibit to any document that is
incorporated by reference herein were made solely for the benefit of the parties to such agreement, including, in some cases, for the purpose of allocating risk among the parties to such agreements, and should not be deemed to be a representation,
warranty or covenant to you. Moreover, such representations, warranties or covenants were accurate only as of the date when made. Accordingly, such representations, warranties and covenants should not be relied on as accurately representing the
current state of our affairs.
You should rely only on the information contained in this prospectus supplement or the accompanying prospectus, or
incorporated by reference herein. We have not authorized, and the underwriters have not authorized, anyone to provide you with information that is different. The information contained in this prospectus supplement or the accompanying prospectus, or
incorporated by reference herein, is accurate only as of the respective dates thereof, regardless of the time of delivery of this prospectus supplement and the accompanying prospectus or of any sale of our common stock. It is important for you to
read and consider all information contained in this prospectus supplement and the accompanying prospectus, including the documents incorporated by reference herein and therein, in making your investment decision. You should also read and consider
the information in the documents to which we have referred you in the sections entitled “Where You Can Find More Information” and “Incorporation of Certain Documents by Reference” in this prospectus supplement and in the
accompanying prospectus.
We are offering to sell, and seeking offers to buy, shares of our common stock only in jurisdictions where offers and
sales are permitted. The distribution of this prospectus supplement and the accompanying prospectus and the offering of the common stock in certain jurisdictions may be restricted by law. Persons outside the United States who come into possession of
this prospectus supplement and the accompanying prospectus must inform themselves about, and observe any restrictions relating to, the offering of the common stock and the distribution of this prospectus supplement and the accompanying prospectus
outside the United States. This prospectus supplement and the accompanying prospectus do not constitute, and may not be used in connection with, an offer
S-1
to sell, or a solicitation of an offer to buy, any securities offered by this prospectus supplement and the accompanying prospectus by any person in any jurisdiction in which it is unlawful for
such person to make such an offer or solicitation.
Unless otherwise stated, all references in this prospectus supplement and the accompanying
prospectus to “we,” “us,” “our,” “Sangamo,” the “Company” and similar designations refer to Sangamo Therapeutics, Inc. and its subsidiaries on a consolidated basis.
This prospectus supplement and the accompanying prospectus and information incorporated by reference into this prospectus supplement and the
accompanying prospectus also contain trademarks and trade names that are the property of their respective owners.
S-2
PROSPECTUS SUPPLEMENT SUMMARY
This summary highlights certain information about us, this offering and selected information contained elsewhere in or incorporated by reference in
this prospectus supplement. This summary is not complete and does not contain all of the information that you should consider before deciding whether to invest in our common stock. For a more complete understanding of our company and this offering,
we encourage you to read and consider carefully the more detailed information in this prospectus supplement and the accompanying prospectus, including the information included under the heading “Risk Factors” in this prospectus supplement
on page
S-8
and under the heading “Risk Factors” in the accompanying prospectus beginning on page 5, the information incorporated by reference in this prospectus supplement and the accompanying
prospectus, and the information included in any free writing prospectus that we have authorized for use in connection with this offering.
Our
Business
Overview
We are a clinical stage
biotechnology company focused on translating ground-breaking science into genomic therapies that transform patients’ lives using our industry-leading platform technologies in genome editing, gene therapy, gene regulation and cell therapy. Our
proprietary zinc finger
DNA-binding
proteins (ZFP) technology enables efficient and highly specific genome editing and gene regulation, and we are developing genome editing and gene therapies for the treatment
of genetically diverse diseases. We have several proprietary clinical and preclinical programs in development and have strategically partnered certain programs with biopharmaceutical companies to obtain funding for our own programs and to expedite
clinical and commercial development. Our long-term goal is to forward integrate into manufacturing, development and commercial operations to more fully capture the value of our proprietary genome editing and gene therapy products.
We, and our licensed partners, are the leaders in the research, development and commercialization of ZFPs, a naturally occurring class of proteins found
in humans. We have used our knowledge and expertise to develop a proprietary technology platform in both genome editing and gene regulation. ZFPs can be engineered to make ZFP nucleases (ZFNs), proteins that can be used to specifically modify DNA
sequences by adding or knocking out specific genes (genome editing), and ZFP transcription factors (ZFP TFs), proteins that can be used to turn genes on or off (gene regulation). Although we are focused on the development of human therapeutic
applications, ZFPs act at the DNA level and potentially have broad and fundamental applications in several other areas, such as plant agriculture and research reagents, including the production of transgenic animals and cell-line engineering. In the
process of developing this platform we have accrued significant scientific, manufacturing and regulatory capabilities and
know-how
that is generally applicable in the broader field of gene therapy.
The main focus for our company is the development of human therapeutics. We have initiated a Phase 1/2 clinical trials evaluating our proprietary
ZFN
in vivo
genome editing approach for the treatment of hemophilia B, a blood disorder, Mucopolysaccharidosis I (MPS I) and Mucopolysaccharidosis II (MPS II), rare lysosomal storage disorders (LSD). We also are planning to initiate
Phase 1/2 clinical trial evaluating a gene therapy for the treatment of hemophilia A, a blood disorder. In addition, we have proprietary preclinical programs in other LSDs and research stage programs in other monogenic diseases, including certain
central nervous system disorders and cancer immunotherapy.
S-3
We have established a collaborative partnership with Bioverativ, Inc., a
spin-out
company from Biogen, Inc., to research, develop and commercialize therapeutic genome editing products in hemoglobinopathies, including sickle cell disease (SCD) and beta-thalassemia. We also have a
collaborative partnership with Shire International GmbH, formerly Shire AG (Shire), to research, develop and commercialize our preclinical development program in Huntington’s disease. In May 2017, we entered into a collaboration agreement with
Pfizer, Inc. for the research, development and commercialization of
SB-525,
our gene therapy product candidate for Hemophilia A, and closely related products. See “Recent Development” below.
In fields outside human therapeutics, we have entered into strategic partnerships to facilitate the sale or licensing of our ZFP platform. We have a
license agreement with Sigma-Aldrich Corporation (Sigma). Under this agreement, Sigma has the exclusive rights to develop and market
ZFP-based
laboratory research reagents marketed under the trademark
CompoZr
®
as well as
ZFP-modified
cell lines for commercial production of protein pharmaceuticals and
ZFP-engineered
transgenic animals. We also have a license agreement with Dow AgroSciences, LLC (DAS), a wholly owned subsidiary of Dow Chemical Corporation. Under this agreement, DAS has the exclusive rights
to use our ZFP technology to modify the genomes or alter protein expression of plant cells, plants, or plant cell cultures and markets our ZFN technology under the trademark
EXZACT
TM
Precision Technology.
We have a substantial intellectual property position in
the genome editing field including the design, selection, composition and use of engineered ZFPs to support our commercial activities. As of June 7, 2017, we either owned outright or have exclusively licensed the commercial rights to
approximately 827 patents issued in the United States and foreign national jurisdictions, and we had 662 patent applications owned and licensed pending worldwide. We continue to license and file new patent applications that strengthen our core and
accessory patent portfolio. We believe that our intellectual property position is a critical element in our ability to research, develop and commercialize products and services based on Gene Therapy, Genome Editing, Cell Therapy and Gene Regulation
across our chosen applications.
In the development of our ZFP technology platform, we are focusing our resources on higher-value product
development for therapeutic use in humans and less on our
non-therapeutic
applications. Development of novel therapeutic products is costly and subject to a lengthy and uncertain regulatory process at the FDA.
Our future products will be gene-based therapeutics. Adverse events in both our own clinical program and other programs may have a negative impact on regulatory approval, the willingness of potential commercial partners to enter into agreements and
public perception for our therapeutic programs.
On January 5, 2017, we changed our corporate name from “Sangamo BioSciences, Inc.”
to “Sangamo Therapeutics, Inc.” The new corporate name underscores our focus on clinical development of genomic therapies using our industry-leading platform technologies across genome editing, gene therapy, gene regulation and cell
therapy.
Recent Development
On May 10, 2017, we
entered into a Collaboration and License Agreement (the “Pfizer Agreement”) with Pfizer, pursuant to which we and Pfizer established a collaboration for the research, development and commercialization of
SB-525,
our gene therapy product candidate for Hemophilia A, and closely related products.
Under the Pfizer
Agreement, we are responsible for conducting the Phase 1/2 clinical trial and certain manufacturing activities for
SB-525,
while Pfizer will be responsible for subsequent worldwide
S-4
development, manufacturing, marketing and commercialization of
SB-525.
We and Pfizer may also collaborate in the research and development of additional
AAV-based
gene therapy products for Hemophilia A. We and Pfizer agreed to form a joint steering committee and several subcommittees, each consisting of an equal number of representatives from us and Pfizer, to
oversee the collaboration.
Under the Pfizer Agreement, we have received an upfront payment of $70 million from Pfizer. Pfizer will reimburse
us for certain costs incurred in connection with the
SB-525
Phase 1/2 trial and certain manufacturing activities for
SB-525,
above a specified amount. In addition, we
are eligible to receive development milestone payments contingent on the achievement of specified clinical development, intellectual property, regulatory and first commercial sale milestones for
SB-525
and
potentially for other products. The total amount of potential clinical development, intellectual property, regulatory, and first commercial sale milestone payments, assuming the achievement of all specified milestones in the Pfizer Agreement, is up
to $475 million, which includes up to $300 million for
SB-525
and up to $175 million for other products that may be developed under the Pfizer Agreement, subject to reduction on account of
payments made under certain licenses for third party intellectual property. In addition, Pfizer agreed to pay us royalties for each potential licensed product developed under the Agreement that are an escalating, double-digit percentage of the
annual net sales of such product and are subject to reduction due to patent expiration, entry of biosimilar products to the market, and payments made under certain licenses for third party intellectual property.
Subject to the terms of the Pfizer Agreement, we granted Pfizer an exclusive, worldwide, royalty-bearing license, with the right to grant sublicenses,
to use certain technology controlled by us for the purpose of developing, manufacturing and commercializing
SB-525
and related products. In addition, we also granted Pfizer (i) a
non-exclusive,
worldwide, royalty free, fully paid license, with a limited right to grant sublicenses, under the licensed technology to conduct research on certain additional closely related Hemophilia A gene
therapy product candidates that could be added to the collaboration; and (ii) a
non-exclusive,
worldwide, royalty free, fully paid license, with the right to grant sublicenses, under certain diagnostic
technology controlled by us, to develop and commercialize companion diagnostics assays for the products. Under the Pfizer Agreement, Pfizer granted us a
non-exclusive,
worldwide, royalty free, fully paid
license, with the right to grant sublicenses, to use certain manufacturing technology developed under the collaboration and controlled by Pfizer to manufacture our products that utilize the AAV delivery system.
During a specified period, neither we nor Pfizer will be permitted to clinically develop or commercialize, outside of the collaboration, certain
AAV-based
gene therapy products for Hemophilia A.
The Pfizer Agreement may be terminated by (i) us or
Pfizer for the uncured material breach of the other party, (ii) us or Pfizer for the bankruptcy or other insolvency proceeding of the other party; and (iii) Pfizer, in its entirety or on a
product-by-product
or
country-by-country
basis upon advance written notice to us.
Risk Factors
An investment in our common stock is subject to
a number of risks and uncertainties
.
Before investing in our common stock, you should carefully consider the following, as well as the more detailed discussion of risk factors and other information included and incorporated by reference in
this prospectus supplement:
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∎
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Our success depends substantially on the results of clinical trials of our lead therapeutic programs, and we may not be able to demonstrate long-term safety and efficacy of product candidates in these programs;
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S-5
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∎
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Our potential therapeutic products are subject to a lengthy and uncertain regulatory process, and we may encounter unanticipated toxicity or adverse events or fail to demonstrate efficacy, causing us to delay, suspend
or terminate a development program which will prevent us from commercializing those products;
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∎
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While we have stated we intend to continue to advance additional early research programs through preclinical development and IND application filings and into clinical development, we may encounter difficulties that may
delay, suspend or scale back our efforts;
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∎
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We may not be able to find acceptable patients or may experience delays in enrolling patients for our clinical trials;
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∎
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As we cannot predict whether or when we will obtain regulatory approval to commercialize our product candidates, we cannot predict the timing of any future revenue from these product candidates;
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∎
|
|
We have limited experience in conducting clinical trials;
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∎
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If conflicts arise between us and our collaborators or strategic partners, these parties may act in their self-interest, which may limit our ability to implement our strategies; and
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∎
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Our collaborators and strategic partners may control aspects of our clinical trials, which could result in delays and other obstacles in the commercialization of our proposed products.
|
Company and Other Information
Our principal offices are
located at 501 Canal Boulevard, Richmond, California, 94804, and our telephone number there is (510)
970-6000
.
Our website address is www.sangamo.com
.
We do not incorporate the information on or
accessible through our website into this prospectus, and you should not consider any information on, or that can be accessed through, our website as part of this prospectus
.
For further information regarding us and our financial information,
you should refer to our recent filings with the Securities and Exchange Commission
.
See “Where You Can Find More Information” and “Incorporation of Certain Documents by Reference.”
S-6
THE OFFERING
|
Common stock offered by us in this offering
|
10,000,000 shares.
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Option to purchase additional shares
|
We have granted the underwriters an option for a period of up to 30 days from the date of this prospectus supplement to purchase up to 1,500,000 additional shares of common stock at the public offering price less the underwriting discounts and
commissions.
|
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Common stock to be outstanding after this offering
|
81,752,413 shares (or 83,252,413 shares if the underwriters immediately after this offering exercise in full their option to purchase additional shares).
|
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Use of proceeds
|
We intend to use the net proceeds from this offering for working capital and other general corporate purposes, including support for our continuing research and development of our genomic therapy product candidates and research programs,
clinical trials, commercialization activities, business development activities and, if opportunities arise, acquisitions of businesses, products, technologies or licenses that are complementary to our business. See “Use of Proceeds” on
page
S-10.
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Risk Factors
|
You should carefully read the information contained under the heading “Risk Factors” on page S-8 of this prospectus supplement and under the heading “Risk Factors” beginning on page 5 of the accompanying prospectus
for a discussion of factors that you should consider before deciding to invest in our common stock.
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NASDAQ Global Select Market symbol
|
“SGMO”
|
The number of shares of common stock to be outstanding after this offering is based on 71,752,413 shares
outstanding as of March 31, 2017. It excludes:
|
|
∎
|
|
10,379,522 shares of common stock issuable upon exercise of stock options outstanding as of March 31, 2017, of which 5,684,781 shares are exercisable under our 2013 Stock Incentive Plan (2013 Plan), at a weighted
average exercise price of $8.74 per share;
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|
∎
|
|
240,735 shares of common stock issuable upon settlement of outstanding restricted stock units;
|
|
|
∎
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|
2,473,272 shares available for grant as of March 31, 2017 under our 2013 Plan; and
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∎
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1,089,668 shares available for grant as of March 31, 2017 under our employee stock purchase plan.
|
Except as otherwise indicated, all information in this prospectus supplement assumes no exercise of the underwriter’s option to purchase additional
shares of common stock.
S-7
RISK FACTORS
An investment in our common stock involves a high degree of risk. Before deciding whether to invest in our common stock, you should consider
carefully the risks described below and the risk factors described under the heading “Risk Factors” beginning on page 5 of the accompanying prospectus, together with other information in this prospectus supplement, the accompanying
prospectus, the information and documents incorporated by reference, and in any free writing prospectus that we have authorized for use in connection with this offering. If any of these risks actually occurs, our business, financial condition,
results of operations or cash flow could be seriously harmed. This could cause the trading price of our common stock to decline, resulting in a loss of all or part of your investment. The risks and uncertainties described below and in the
accompanying prospectus are not the only ones facing us. Additional risks and uncertainties not presently known to us, or that we currently see as immaterial, may also harm our business.
Risks Related to This Offering
Management will have broad discretion
as to the use of the net proceeds from this offering, and we may not use the proceeds effectively.
Our management will have broad discretion
in the application of the net proceeds from this offering and could spend the proceeds in ways that do not improve our results of operations or enhance the value of our common stock
.
Our failure to apply these funds effectively could have a
material adverse effect on our business, delay the development of our product candidates and cause the price of our common stock to decline.
You will
experience immediate and substantial dilution in the net tangible book value per share of the common stock you purchase.
Since the price per
share of our common stock being offered is substantially higher than the net tangible book value per share of our common stock, you will suffer substantial dilution in the net tangible book value of the common stock you purchase in this
offering
.
Based on the sale of 10,000,000 shares at the public offering price of $7.25 per share in this offering, and after deducting underwriting discounts and commissions and estimated offering expenses payable by us, and based on a net
tangible book value of our common stock of $1.72 per share as of March 31, 2017, if you purchase shares of common stock in this offering, you will suffer immediate and substantial dilution of $4.91 per share in the net tangible book value of
common stock
.
See the section entitled “Dilution” below for a more detailed discussion of the dilution you will incur if you purchase common stock in this offering.
Future transactions where we raise capital may negatively affect our stock price.
We currently have the ability to offer and sell additional equity, debt securities and warrants to purchase such securities under an effective shelf
registration statement. Sales of substantial amounts of shares of our common stock or other securities under our shelf registration statement could lower the market price of our common stock and impair our ability to raise capital through the sale
of equity securities. In the future, we may issue additional options, warrants or other derivative securities convertible into our common stock.
S-8
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
Some statements contained in this prospectus supplement and the accompanying prospectus and the information incorporated by reference into this
prospectus supplement and the accompanying prospectus are forward-looking with respect to our operations, research, development and commercialization activities, clinical trials, operating results and financial condition
.
These statements
involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the
forward-looking statements
.
Forward-looking statements include, but are not limited to, statements about:
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∎
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product development and commercialization of our products;
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∎
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our intellectual property position;
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∎
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partnering, collaboration, acquisition and other strategic transactions;
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∎
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revenues from existing and new collaborations;
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∎
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our research and development and other expenses;
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∎
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sufficiency of our cash resources;
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∎
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our operational and legal risks; and
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∎
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our plans, objectives, expectations and intentions and any other statements that are not historical facts.
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In some cases, you can identify forward-looking statements by terms such as : “anticipates,” “believes,” “continues,”
“could,” “estimates,” “expects,” “intends,” “may,” “plans,” “seeks,” “should” and “will.” These statements reflect our current views with respect to future
events and are based on assumptions and subject to risks and uncertainties
.
Given these risks and uncertainties, you should not place undue reliance on these forward-looking statements
.
We discuss many of these risks in greater detail
under the headings “Risk Factors” in this prospectus supplement and in the accompanying prospectus
.
Also, these forward-looking statements represent our estimates and assumptions only as of the date of the document containing the
applicable statement
.
We undertake no obligation to publicly release any revisions or updates to forward-looking statements to reflect events or circumstances arising after the date of this prospectus supplement.
S-9
USE OF PROCEEDS
We estimate that the net proceeds to us from this offering will be approximately $67.9 million, or approximately $78.1 million if the underwriters
exercise in full their option to purchase additional shares of common stock, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.
We intend to use the net proceeds from this offering for working capital and other general corporate purposes, including support for our continuing
research and development of our genomic therapy product candidates and research programs, clinical trials, commercialization activities, business development activities and, if opportunities arise, acquisitions of businesses, products, technologies
or licenses that are complementary to our business.
The amounts and timing of the expenditures may vary significantly, depending upon numerous
factors, including our proprietary research and therapeutic programs and our clinical trials as well as the amount of cash used in our operations
.
Accordingly, our management will have broad discretion in the application of the net proceeds
and investors will be relying upon the judgment of our management regarding the application of these proceeds
.
We reserve the right to change the use of these proceeds.
Pending these uses, we intend to invest the proceeds of this offering in short-term, investment grade interest -bearing securities.
DIVIDEND POLICY
We have not paid dividends on our common stock, and currently do not plan to pay any cash dividends in the foreseeable future.
S-10
DILUTION
If you purchase our common stock in this offering, your interest will be diluted to the extent of the difference between the public offering price per
share and the net tangible book value per share of our common stock after this offering
.
Our net tangible book value as of March 31, 2017 was approximately $123.1 million, or $1.72 per share
.
Net tangible book value per share
is determined by dividing our total tangible assets, less total liabilities, by the number of shares of our common stock outstanding as of March 31, 2017
.
Dilution in net tangible book value per share represents the difference between
the amount per share paid by purchasers of shares of common stock in this offering and the net tangible book value per share of our common stock immediately after this offering.
After taking into account the sale by us of 10,000,000 shares of our common stock in this offering at the public offering price of $7.25 per share and
after deducting the underwriting discounts and commissions and estimated offering expenses payable by us, our as adjusted net tangible book value as of March 31, 2017 would have been approximately $191.1 million, or $2.34 per share
.
This
represents an immediate increase in net tangible book value of $0.62 per share to existing stockholders and immediate dilution of $4.91 per share to investors purchasing our common stock in this offering at the public offering price
.
The
following table illustrates this dilution on a per share basis:
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Public offering price per share
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$
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7.25
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Net tangible book value per share as of March 31, 2017
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$
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1.72
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Increase in net tangible book value per share after this offering
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$
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0.62
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Net tangible book value per share after this offering
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$
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2.34
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Dilution per share to new investors
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$
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4.91
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The number of shares of common stock to be outstanding immediately after this offering as shown above assumes that all
of the shares offered hereby are sold and is based on 71,752,413 shares of common stock outstanding as of March 31, 2017
.
This number of shares excludes:
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∎
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10,379,522 shares of common stock issuable upon exercise of options outstanding as of March 31, 2017, of which 5,684,781 shares are exercisable under our 2013 Stock Incentive Plan (2013 Plan), at a weighted average
exercise price of $8.74 per share;
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|
∎
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240,735 shares of common stock issuable upon settlement of outstanding restricted stock units;
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∎
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2,473,272 shares available for grant as of March 31, 2017 under our 2013 Plan; and
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∎
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1,089,668 shares available for grant as of March 31, 2017 under our employee stock purchase plan.
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This discussion of dilution, and the table quantifying it, assumes no exercise of any outstanding options to purchase shares of our common stock as of
March 31, 2017 and no exercise of the option by the underwriters to purchase 1,500,000 additional shares of common stock
.
The exercise of outstanding options to purchase shares of our common stock having an exercise price less than the
public offering price would increase the dilutive effect to new investors.
If the underwriters exercise in full their option to purchase 1,500,000
additional shares of common stock at the public offering price of $7.25 per share, and after deducting the underwriting discounts and commissions and estimated offering expenses payable by us, the as adjusted net tangible book value after this
offering would be approximately $2.42 per share, representing an increase in net tangible book value of approximately $0.70 per share to existing stockholders and immediate dilution in net tangible book value of approximately $4.83 per share to
investors purchasing our common stock in this offering at the public offering price.
S-11
UNDERWRITING
We and the underwriters for the offering named below have entered into an underwriting agreement with respect to the common stock being offered. Subject
to the terms and conditions of the underwriting agreement, each underwriter has severally agreed to purchase from us the number of shares of our common stock set forth opposite its name below. Cowen and Company, LLC and Wells Fargo Securities, LLC
are the representatives of the underwriters.
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Underwriter
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Number of Shares
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Cowen and Company, LLC
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6,000,000
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Wells Fargo Securities, LLC
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4,000,000
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Total
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10,000,000
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The underwriting agreement provides that the obligations of the underwriters are subject to certain conditions precedent
and that the underwriters have agreed, severally and not jointly, to purchase all of the shares sold under the underwriting agreement if any of these shares are purchased, other than those shares covered by the overallotment option described below.
If an underwriter defaults, the underwriting agreement provides that the purchase commitments of the
non-defaulting
underwriters may be increased or the underwriting agreement may be terminated.
We have agreed to indemnify the underwriters against specified liabilities, including liabilities under the Securities Act of 1933, as amended, and to
contribute to payments the underwriters may be required to make in respect thereof.
The underwriters are offering the shares, subject to prior
sale, when, as and if issued to and accepted by them, subject to approval of legal matters by their counsel and other conditions specified in the underwriting agreement. The underwriters reserve the right to withdraw, cancel or modify offers to the
public and to reject orders in whole or in part.
Option to Purchase Additional Shares.
We have granted to the
underwriters an option to purchase up to 1,500,000 additional shares of common stock at the public offering price, less the underwriting discount. This option is exercisable for a period of 30 days. To the extent that the underwriters exercise
this option, the underwriters will purchase additional shares from us in approximately the same proportion as shown in the table above.
Discounts and Commissions.
The following table shows the public offering price, underwriting discount and proceeds, before
expenses to us. These amounts are shown assuming both no exercise and full exercise of the underwriters’ option to purchase additional shares.
We estimate that the total expenses of the offering, excluding underwriting discount, will be approximately $230,000 and are payable by us.
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Total
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|
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Per Share
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|
Without
Underwriters’
Option
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|
With
Underwriters’
Option
|
|
|
Public offering price
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|
$
|
7.250
|
|
|
$
|
72,500,000
|
|
|
$
|
83,375,000
|
|
|
Underwriting discount
|
|
$
|
0.435
|
|
|
$
|
4,350,000
|
|
|
$
|
5,002,500
|
|
|
Proceeds, before expenses, to us
|
|
$
|
6.815
|
|
|
$
|
68,150,000
|
|
|
$
|
78,372,500
|
|
The underwriters propose to offer the shares of common stock to the public at the public offering price set forth on the
cover of this prospectus. The underwriters may offer the shares of common stock
S-12
to securities dealers at the public offering price less a concession not in excess of $0.261 per share. If all of the shares are not sold at the public offering price, the underwriters may change
the offering price and other selling terms.
Discretionary Accounts.
The underwriters do not intend to confirm sales
of the shares to any accounts over which they have discretionary authority.
Stabilization.
In connection with this
offering, the underwriters may engage in stabilizing transactions, overallotment transactions, syndicate covering transactions, penalty bids and purchases to cover positions created by short sales.
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|
∎
|
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Stabilizing transactions permit bids to purchase shares of common stock so long as the stabilizing bids do not exceed a specified maximum, and are engaged in for the purpose of preventing or retarding a decline in the
market price of the common stock while the offering is in progress.
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|
|
∎
|
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Overallotment transactions involve sales by the underwriters of shares of common stock in excess of the number of shares the underwriters are obligated to purchase. This creates a syndicate short position which may be
either a covered short position or a naked short position. In a covered short position, the number of shares over-allotted by the underwriters is not greater than the number of shares that they may purchase in the overallotment option. In a naked
short position, the number of shares involved is greater than the number of shares in the overallotment option. The underwriters may close out any short position by exercising their overallotment option and/or purchasing shares in the open market.
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|
|
∎
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Syndicate covering transactions involve purchases of common stock in the open market after the distribution has been completed in order to cover syndicate short positions. In determining the source of shares to close
out the short position, the underwriters will consider, among other things, the price of shares available for purchase in the open market as compared with the price at which they may purchase shares through exercise of the overallotment option. If
the underwriters sell more shares than could be covered by exercise of the overallotment option and, therefore, have a naked short position, the position can be closed out only by buying shares in the open market. A naked short position is more
likely to be created if the underwriters are concerned that after pricing there could be downward pressure on the price of the shares in the open market that could adversely affect investors who purchase in the offering.
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∎
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Penalty bids permit the representative to reclaim a selling concession from a syndicate member when the common stock originally sold by that syndicate member is purchased in stabilizing or syndicate covering
transactions to cover syndicate short positions.
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These stabilizing transactions, syndicate covering transactions and penalty bids may
have the effect of raising or maintaining the market price of our common stock or preventing or retarding a decline in the market price of our common stock. As a result, the price of our common stock in the open market may be higher than it would
otherwise be in the absence of these transactions. Neither we nor the underwriters make any representation or prediction as to the effect that the transactions described above may have on the price of our common stock. These transactions may be
effected on the NASDAQ Stock Market, in the
over-the-counter
market or otherwise and, if commenced, may be discontinued at any time.
Passive Market Making.
In connection with this offering, underwriters and selling group members may engage in passive
market making transactions in our common stock on the Nasdaq Stock Market in accordance with Rule 103 of Regulation M under the Securities Exchange Act of 1934, as amended, during a period before the commencement of offers or sales of common stock
and extending through
S-13
the completion of the distribution. A passive market maker must display its bid at a price not in excess of the highest independent bid of that security. However, if all independent bids are
lowered below the passive market maker’s bid, that bid must then be lowered when specified purchase limits are exceeded.
Lock-Up
Agreements.
Pursuant to certain
‘‘lock-up’’
agreements, we and our executive officers and directors, have agreed,
subject to certain exceptions, not to offer, sell, assign, transfer, pledge, contract to sell, or otherwise dispose of or announce the intention to otherwise dispose of, or enter into any swap, hedge or similar agreement or arrangement that
transfers, in whole or in part, the economic consequence of ownership of, directly or indirectly, or make any demand or request or exercise any right with respect to the registration of, or file with the SEC a registration statement under the
Securities Act relating to, any common stock or securities convertible into or exchangeable or exercisable for any common stock without the prior written consent of Cowen and Company, LLC, and Wells Fargo Securities, LLC for a period of 90 days
after the date of the pricing of the offering. The exceptions to the
lock-up
for executive officers and directors include, but are not limited to, (a) transfers of beneficially owned shares, common stock
or securities convertible into or exercisable or exchangeable for common stock (i) as a bona fide gift or gifts, (ii) to any trust for the direct or indirect benefit of the undersigned or the immediate family of the undersigned or
(iii) by will or intestacy to the executive officer’s or director’s, as applicable, legal representative, heir or legatee; (b) pursuant to any plan that complies with Rule
10b5-1
under the
Securities Exchange Act of 1934, as amended (the “Exchange Act”), entered into prior to the date of the
lock-up,
(c) the acquisition or exercise of any stock option issued under our existing
stock option plan; (d) any conversion of restricted stock units into shares of our common stock as provided in the applicable restricted stock issuance agreement, (e) any transfer of shares of our common stock in connection satisfying tax
withholding obligations upon issuance of such shares, and (f) the establishment of a trading plan pursuant to Rule
10b5-1
under the Exchange Act, provided that such plan does not provide for the transfer
and sale of common stock during the
lock-up
period; provided that in the case of any transfer or distribution pursuant to clause (a), each donee or distributee or transferee shall execute and deliver to Cowen
and Company, LLC and Wells Fargo Securities, LLC a
lock-up
letter for the balance of the
lock-up
period in the form required. The exceptions to the
lock-up
for us include: (x) our sale of shares in this offering; (y) the issuance of restricted common stock or options to acquire common stock pursuant to our benefit plans, qualified equity incentive
plans or other compensation plans; and (z) the issuance of up to 3,500,000 shares of common stock for strategic alliances occurring after this offering.
Canada
.
The common stock may be sold only to purchasers purchasing, or deemed to be purchasing, as principal that
are accredited investors, as defined in National Instrument
45-106
Prospectus Exemptions
or subsection 73.3(1) of the
Securities Act
(Ontario), and are permitted clients, as defined in National
Instrument
31-103
Registration Requirements, Exemptions and Ongoing Registrant Obligations
.
Any resale of the common stock must be made in accordance with an exemption from, or in a transaction
not subject to, the prospectus requirements of applicable securities laws.
Securities legislation in certain provinces or territories of Canada may
provide a purchaser with remedies for rescission or damages if this prospectus supplement (including any amendment thereto) contains a misrepresentation, provided that the remedies for rescission or damages are exercised by the purchaser within the
time limit prescribed by the securities legislation of the purchaser’s province or territory. The purchaser should refer to any applicable provisions of the securities legislation of the purchaser’s province or territory for particulars of
these rights or consult with a legal advisor.
Pursuant to section 3A.3 of National Instrument
33-105
Underwriting Conflicts
(NI
33-105),
the underwriters are not required to comply with the disclosure requirements of NI
33-105
regarding underwriter conflicts of
interest in connection with this offering.
S-14
United Kingdom.
Each of the underwriters has represented and agreed that:
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∎
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it has not made or will not make an offer of the securities to the public in the United Kingdom within the meaning of section 102B of the Financial Services and Markets Act 2000 (as amended) (FSMA) except to legal
entities which are authorized or regulated to operate in the financial markets or, if not so authorized or regulated, whose corporate purpose is solely to invest in securities or otherwise in circumstances which do not require the publication by us
of a prospectus pursuant to the Prospectus Rules of the Financial Services Authority (FSA);
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∎
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it has only communicated or caused to be communicated and will only communicate or cause to be communicated an invitation or inducement to engage in investment activity (within the meaning of section 21 of FSMA) to
persons who have professional experience in matters relating to investments falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 or in circumstances in which section 21 of FSMA does not apply
to us; and
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∎
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it has complied with and will comply with all applicable provisions of FSMA with respect to anything done by it in relation to the securities in, from or otherwise involving the United Kingdom.
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Switzerland.
The securities will not be offered, directly or indirectly, to the public in Switzerland and this prospectus
does not constitute a public offering prospectus as that term is understood pursuant to article 652a or 1156 of the Swiss Federal Code of Obligations.
European Economic Area.
In relation to each Member State of the European Economic Area (the “EEA”) which has
implemented the European Prospectus Directive (each, a “Relevant Member State”), an offer of our shares may not be made to the public in a Relevant Member State other than:
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∎
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to any legal entity which is a qualified investor, as defined in the European Prospectus Directive;
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∎
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to fewer than 100 or, if the Relevant Member State has implemented the relevant provision of the 2010 PD Amending Directive, 150 natural or legal persons (other than qualified investors as defined in the European
Prospectus Directive), subject to obtaining the prior consent of the relevant dealer or dealers nominated by us for any such offer, or;
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∎
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in any other circumstances falling within Article 3(2) of the European Prospectus Directive,
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provided that no such
offer of our shares shall require us or any underwriter to publish a prospectus pursuant to Article 3 of the European Prospectus Directive or supplement prospectus pursuant to Article 16 of the European Prospectus Directive.
For the purposes of this description, the expression an “offer to the public” in relation to the securities in any Relevant Member State means
the communication in any form and by any means of sufficient information on the terms of the offer and the securities to be offered so as to enable an investor to decide to purchase or subscribe for the securities, as the expression may be varied in
that Relevant Member State by any measure implementing the European Prospectus Directive in that member state, and the expression “European Prospectus Directive’’ means Directive 2003/71/EC (and amendments hereto, including the 2010
PD Amending Directive, to the extent implemented in the Relevant Member State) and includes any relevant implementing measure in each Relevant Member State. The expression 2010 PD Amending Directive means Directive 2010/73/EU.
We have not authorized and do not authorize the making of any offer of securities through any financial intermediary on our behalf, other than offers
made by the underwriters and their respective affiliates, with a view to the final placement of the securities as contemplated in this document. Accordingly, no purchaser of the shares, other than the underwriters, is authorized to make any further
offer of shares on our behalf or on behalf of the underwriters.
S-15
Electronic Offer, Sale and Distribution of Shares.
A prospectus in electronic
format may be made available on the websites maintained by one or more of the underwriters or selling group members, if any, participating in this offering and one or more of the underwriters participating in this offering may distribute
prospectuses electronically. The representatives may agree to allocate a number of shares to underwriters and selling group members for sale to their online brokerage account holders. Internet distributions will be allocated by the underwriters and
selling group members that will make internet distributions on the same basis as other allocations. Other than the prospectus in electronic format, the information on these websites is not part of this prospectus or the registration statement of
which this prospectus forms a part, has not been approved or endorsed by us or any underwriter in its capacity as underwriter, and should not be relied upon by investors.
Other Relationships.
Certain of the underwriters and their affiliates have provided, and may in the future provide,
various investment banking, commercial banking and other financial services for us and our affiliates for which they have received, and may in the future receive, customary fees.
Listing on The NASDAQ Global Select Market
Our shares of
common stock are traded on The NASDAQ Global Select Market under the symbol “SGMO.” The transfer agent for our shares of common stock to be issued in this offering is Computershare.
S-16
LEGAL MATTERS
The legality of the common stock offered by this prospectus supplement has been passed upon for us by Morgan, Lewis & Bockius LLP, San
Francisco, California. The underwriters are being represented in connection with this offering by Proskauer Rose LLP, New York, New York.
EXPERTS
Ernst & Young LLP, independent registered public accounting firm, has audited our consolidated financial statements
included in our Annual Report on Form
10-K
for the year ended December 31, 2016, and the effectiveness of our internal control over financial reporting as of December 31, 2016, as set forth in their
reports, which are incorporated by reference in this prospectus supplement and elsewhere in the registration statement. Our financial statements are incorporated by reference in reliance on Ernst & Young LLP’s reports, given on their
authority as experts in accounting and auditing.
WHERE YOU CAN FIND MORE INFORMATION
We have filed a “shelf” registration statement with the Securities and Exchange Commission, or the Commission, covering the shares of common
stock we are offering under this prospectus supplement. This prospectus supplement and the accompanying prospectus do not contain all of the information set forth in the registration statement and the exhibits to the registration statement. For
further information with respect to us and the securities we are offering under this prospectus supplement, we refer you to the registration statement and the exhibits and schedules filed as part of the registration statement.
We file annual, quarterly and current reports, proxy statements and other information with the Commission. You may read and copy any document we file at
the Commission’s Public Reference Room at 100 F Street, N.E., Washington, D.C. 20549. Please call the Commission at
1-800-SEC-0330
for further information on the Public Reference Room. Our public filings, including reports, proxy and information
statements, are also available on the Commission’s web site at
http://www.sec.gov
. We maintain a website at
www.sangamo.com
. The information contained on our website is not incorporated by reference in this prospectus supplement
or the accompanying prospectus, and you should not consider it a part of this prospectus supplement or the accompanying prospectus.
S-17
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The Commission allows us to “incorporate by reference” information from other documents that we file with them, which means that we can
disclose important information by referring to those documents. The information incorporated by reference is considered to be part of this prospectus supplement and the accompanying prospectus, and information that we file later with the Commission
will automatically update and supersede this information. We incorporate by reference into this prospectus supplement and the accompanying prospectus the documents listed below, and any future filings (other than the portions thereof deemed to be
“furnished” to the Commission pursuant to Item 2.02 or Item 7.01 of Current Report on Form
8-K)
we make with the Commission under Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act, prior to the
termination of this offering:
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∎
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our annual report on Form
10-K
for the year ended December 31, 2016, filed with the Commission on February 28, 2017;
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∎
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our quarterly report on Form
10-Q
for the quarters ended March 31, 2017; filed with the Commission on May 10, 2017;
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∎
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our current reports on Form
8-K
filed with the SEC on January 6, 2017, February 24, 2017; February 28, 2017; March 20, 2017; May 10, 2017 (except Item
2.02); May 26, 2017; and June 6, 2017;
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∎
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our definitive proxy statement filed in connection with our 2017 Annual Meeting of Stockholders filed with the Commission on April 25, 2017; and
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∎
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the description of our common stock contained in our registration statement on Form
8-A
filed under Section 12(g) of the Exchange Act, with the Commission on March 31, 2000,
including any amendment or reports filed for the purpose of updating such description.
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To the extent that any statement in this
prospectus supplement or the accompanying prospectus is inconsistent with any statement that is incorporated by reference and that was made on or before the date of this prospectus supplement or the accompanying prospectus, the statement in this
prospectus supplement or the accompanying prospectus shall supersede such incorporated statement. The incorporated statement shall not be deemed, except as modified or superseded, to constitute a part of this prospectus supplement, the accompanying
prospectus or the registration statement. Statements contained in this prospectus supplement and the accompanying prospectus as to the contents of any contract or other document are not necessarily complete and, in each instance, we refer you to the
copy of each contract or document filed as an exhibit to the registration statement.
We will furnish without charge to each person, including any
beneficial owner of our securities, to whom a copy of this prospectus supplement and the accompanying prospectus is delivered, upon written or oral request, a copy of the information that has been incorporated into this prospectus supplement and the
accompanying prospectus by reference (except exhibits, unless they are specifically incorporated into this prospectus supplement and the accompanying prospectus by reference). You should direct any requests for copies to:
Sangamo Therapeutics, Inc.
501 Canal Boulevard,
Richmond, CA 94804
Attention: Investor Relations
(510)
970-6000
S-18
PROSPECTUS
SANGAMO THERAPEUTICS, INC.
$200,000,000
Common
Stock
Preferred Stock
Debt Securities
Warrants
to Purchase Common Stock
Warrants to Purchase Preferred Stock
We may offer and sell from time to time shares of common stock, shares of preferred stock, debt securities or warrants to purchase shares of
common stock or shares of preferred stock. We may sell any combination of the above described securities, in one or more offerings in amounts, at prices and on terms determined at the time of the offering. We refer to the shares of common stock,
shares of preferred stock, debt securities and warrants to purchase shares of common stock or shares of preferred stock collectively as the “securities.”
This prospectus provides you with a general description of the securities that we may offer. Each time we sell securities, we will provide a
prospectus supplement that will contain specific information about the terms of that offering. The prospectus supplement may also add information or update information contained in this prospectus. You should read both this prospectus and any
prospectus supplement together with the documents incorporated by reference and described under the heading “Where You Can Find More Information” before you make your investment decision.
We may sell the securities to underwriters or dealers, through agents, or directly to investors.
An investment in the securities offered under this prospectus involves a high degree of risk. You should carefully consider the risk
factors described in the applicable prospectus supplement and certain of our filings with the Securities and Exchange Commission, as described under “
Risk Factors
” on page 5.
Our common stock trades on The NASDAQ Global Select Market under the symbol SGMO. On June 6, 2017 the last reported sale price of our
common stock on The NASDAQ Global Select Market was $7.20 per share.
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
The date of this prospectus is June 9, 2017.
TABLE OF CONTENTS
i
ABOUT THIS PROSPECTUS
This prospectus is part of a “shelf” registration statement we filed with the Securities and Exchange Commission, or the SEC. By
using a shelf registration statement, we may sell any combination of securities described in this prospectus from time to time for an aggregate offering price of up to $200,000,000.
You should rely only on the information contained in or specifically incorporated by reference into this prospectus or a prospectus
supplement. No dealer, sales person, agent or other individual has been authorized to give any information or to make any representations not contained in this prospectus. If given or made, such information or representations must not be relied upon
as having been authorized by us.
This prospectus does not constitute an offer to sell, or a solicitation of an offer to buy, the
securities offered hereby in any jurisdiction where, or to any person to whom, it is unlawful to make such offer or solicitation.
The
information contained in this prospectus is accurate only as of the date of this prospectus, regardless of the time of delivery of this prospectus or of any sale of securities. Neither the delivery of this prospectus nor any sale made hereunder
shall, under any circumstances, create an implication that there has not been any change in the facts set forth in this prospectus or in our affairs since the date of this prospectus.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
Some statements contained in this prospectus and the information incorporated by reference into this prospectus are forward-looking with
respect to our operations, research, development and commercialization activities and financial condition. Such forward-looking statements are based on our current views and assumptions regarding future events, future business conditions and the
outlook for the company based on currently available information. Statements that are forward-looking in nature should be read with caution because they involve risks and uncertainties, which are included, for example, in specific and general
discussions about:
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•
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product development and commercialization of our products;
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•
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partnering, collaboration, acquisition and other strategic transactions;
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•
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revenues from existing and new collaborations;
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•
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our research and development and other expenses;
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•
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sufficiency of our cash resources;
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•
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our operational and legal risks; and
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•
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our plans, objectives, expectations and intentions and any other statements that are not historical facts
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Various terms and expressions similar to them are intended to identify these cautionary statements. These terms include:
“anticipates,” “believes,” “continues,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “seeks,” “should” and “will.”
Actual results may differ materially from those expressed or implied in those statements. Factors that could cause these differences include, but are not limited to, those discussed under “Risk Factors.” Sangamo undertakes no obligation to
publicly release any revisions to forward-looking statements to reflect events or circumstances arising after the date of this prospectus. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of
the date of this prospectus.
1
ABOUT SANGAMO THERAPEUTICS, INC.
We are a clinical stage biotechnology company focused on translating ground-breaking science into genomic therapies that transform
patients’ lives using our industry-leading platform technologies in genome editing, gene therapy, gene regulation and cell therapy. Our proprietary zinc finger
DNA-binding
protein (ZFP) technology enables
efficient and highly specific genome editing and gene regulation, and we are developing genome editing and cell and gene therapies for the treatment of diverse genetic diseases. We have several proprietary clinical and preclinical programs in
development and have strategically partnered certain programs with biopharmaceutical companies to obtain funding for our own programs and to expedite clinical and commercial development. Our long-term goal is to forward integrate into manufacturing,
development and commercial operations to more fully capture the value of our proprietary genome editing and gene therapy products.
We,
and our licensed partners, are the leaders in the research, development and commercialization of ZFPs, a naturally occurring class of proteins found in humans. We have used our knowledge and expertise to develop a proprietary technology platform in
both genome editing and gene regulation. ZFPs can be engineered to make zinc finger nucleases (ZFNs), proteins that can be used to specifically modify DNA sequences by adding or knocking out specific genes (genome editing), and ZFP transcription
factors (ZFP TFs), proteins that can be used to turn genes on or off (gene regulation). Although we are focused on the development of human therapeutic applications, ZFPs act at the DNA level and potentially have broad applications in several other
areas, such as plant agriculture and research reagents, including the production of transgenic animals and cell-line engineering. In the process of developing this platform we have accrued significant scientific, manufacturing and regulatory
capabilities and
know-how
that is generally applicable in the broader field of gene therapy.
The
main focus for our company is the development of human therapeutics. We have initiated Phase 1/2 clinical trials evaluating our proprietary
ZFN-mediated
in vivo
genome editing approach for the
treatment of hemophilia B, a blood clotting disorder, Mucopolysaccharidosis I (MPS I) and Mucopolysaccharidosis II (MPS II), rare lysosomal storage disorders (LSD). We are also initiating a Phase 1/2 clinical trial evaluating a gene therapy for the
treatment of hemophilia A, a blood clotting disorder. In addition, we have proprietary preclinical programs in other LSDs and research stage programs in other monogenic diseases, including certain central nervous system disorders and cancer
immunotherapy.
We have established a collaborative partnership with Bioverativ Inc., a
spin-out
company from Biogen Inc., to research, develop and commercialize therapeutic genome editing products in hemoglobinopathies, including sickle cell disease (SCD) and beta-thalassemia. We also have a collaborative partnership with Shire International
GmbH, formerly Shire AG (Shire), to research, develop and commercialize our preclinical development program in Huntington’s disease. Recently we also established a collaborative agreement with Pfizer Inc. (Pfizer) for the development and
commercialization of
SB-525,
our gene therapy product candidate for Hemophilia A, and closely related products. See “Recent Development” below for a more detailed description of the collaboration.
In fields outside human therapeutics, we have entered into strategic partnerships to facilitate the sale or licensing of our ZFP
platform. We have a license agreement with Sigma-Aldrich Corporation (Sigma). Under this agreement, Sigma has the exclusive rights to develop and market
ZFP-based
laboratory research reagents marketed under
the trademark CompoZr
®
as well as
ZFP-modified
cell lines for commercial production of protein pharmaceuticals and
ZFP-engineered
transgenic animals. We also have a license agreement with Dow AgroSciences, LLC (DAS), a wholly owned subsidiary of Dow Chemical Corporation. Under this agreement, DAS has the exclusive rights
to use our ZFP technology to modify the genomes or alter protein expression of plant cells, plants, or plant cell cultures and markets our ZFN technology under the trademark EXZACT
™
Precision
Technology.
We have a substantial intellectual property position in the genome editing field including the design, selection, composition
and use of engineered ZFPs to support our commercial activities. As of February 7, 2017,
2
we either owned outright or have exclusively licensed the commercial rights to approximately 791 patents issued in the United States and foreign national jurisdictions, and we had 650 patent
applications owned and licensed pending worldwide. We continue to license and file new patent applications that strengthen our core and accessory patent portfolio. We believe that our intellectual property position is a critical element in our
ability to research, develop and commercialize products and services based on Gene Therapy, Genome Editing, Cell Therapy and Gene Regulation across our chosen applications.
In the development of our ZFP technology platform, we are focusing our resources on higher-value product development for therapeutic use in
humans and less on our
non-therapeutic
applications. Development of novel therapeutic products is costly and subject to a lengthy and uncertain regulatory process at the U.S. FDA. Our future products will be
genomic therapies. Adverse events in both our own clinical program and other programs may have a negative impact on regulatory approval, the willingness of potential commercial partners to enter into agreements and public perception for our
therapeutic programs.
On January 5, 2017, we changed our corporate name from “Sangamo BioSciences, Inc.” to “Sangamo
Therapeutics, Inc.” The new corporate name underscores our focus on clinical development of genomic therapies using our industry-leading platform technologies across genome editing, gene therapy, gene regulation and cell therapy.
Recent Development
On May 10, 2017,
we entered into an Exclusive Global Collaboration and License Agreement (Pfizer Agreement) with Pfizer, pursuant to which we and Pfizer established a collaboration for the research, development and commercialization of
SB-525,
our gene therapy product candidate for Hemophilia A, and closely related products.
Under
the Pfizer Agreement, we will be responsible for conducting the Phase 1/2 clinical trial and certain manufacturing activities for
SB-525,
while Pfizer will be responsible for subsequent worldwide development,
manufacturing, marketing and commercialization of
SB-525.
We and Pfizer may also collaborate in the research and development of additional
AAV-based
gene therapy
products for Hemophilia A. We and Pfizer agreed to form a joint steering committee and several subcommittees, each consisting of an equal number of representatives from us and Pfizer, to oversee the collaboration.
Under the Pfizer Agreement, we will receive an upfront payment of $70.0 million from Pfizer. Pfizer will reimburse us for certain costs
incurred in connection with the
SB-525
Phase 1/2 trial and certain manufacturing activities for
SB-525,
above a specified amount. In addition, we are eligible to receive
development milestone payments contingent on the achievement of specified clinical development, intellectual property, regulatory and first commercial sale milestones for
SB-525
and potentially for other
products. The total amount of potential clinical development, intellectual property, regulatory, and first commercial sale milestone payments, assuming the achievement of all specified milestones in the Pfizer Agreement, is up to
$475.0 million, which includes up to $300.0 million for
SB-525
and up to $175.0 million for other products that may be developed under the Pfizer Agreement, subject to reduction on account of
payments made under certain licenses for third party intellectual property. In addition, Pfizer agrees to pay us royalties for each potential licensed product developed under the Agreement that are an escalating, double-digit percentage of the
annual net sales of such product and are subject to reduction due to patent expiration, entry of biosimilar products to the market, and payments made under certain licenses for third party intellectual property.
Subject to the terms of the Pfizer Agreement, we will grant Pfizer an exclusive, worldwide, royalty-bearing license, with the right to grant
sublicenses, to use certain technology controlled by us for the purpose of developing, manufacturing and commercializing
SB-525
and related products. In addition, we will also grant Pfizer (i) a
non-exclusive,
worldwide, royalty free, fully paid license, with a limited right to grant sublicenses, under the licensed technology to conduct research on certain additional closely related Hemophilia A gene
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therapy product candidates that could be added to the collaboration; and (ii) a
non-exclusive,
worldwide, royalty free, fully paid license, with the
right to grant sublicenses, under certain diagnostic technology controlled by us, to develop and commercialize companion diagnostics assays for the products. Under the Pfizer Agreement, Pfizer will grant us a
non-exclusive,
worldwide, royalty free, fully paid license, with the right to grant sublicenses, to use certain manufacturing technology developed under the collaboration and controlled by Pfizer to
manufacture our products that utilize the AAV delivery system.
During a specified period, neither we nor Pfizer will be permitted to
clinically develop or commercialize, outside of the collaboration, certain
AAV-based
gene therapy products for Hemophilia A.
The Pfizer Agreement may be terminated by (i) us or Pfizer for the uncured material breach of the other party, (ii) us or Pfizer for
the bankruptcy or other insolvency proceeding of the other party; and (iii) Pfizer, in its entirety or on a
product-by-product
or
country-by-country
basis upon advance written notice to us.
Our principal offices are located at
501 Canal Boulevard, Richmond, California 94804, and our telephone number there is
(510) 970-6000.
4
RISK FACTORS
An investment in the securities offered through this prospectus involves certain risks. You should carefully consider the risk factors
below and specific risks set forth under the caption “Risk Factors” in the applicable prospectus supplement, and under the caption “Risk Factors” in our filings with the Securities and Exchange Commission pursuant to Sections
13(a), 13(c), 14 or 15(d) of the Securities Exchange Act of 1934, as amended, incorporated by reference herein, before making an investment decision. The risks and uncertainties we have described are not the only ones facing our company. Additional
risks and uncertainties not presently known to us or that we currently consider immaterial may also affect our business operations. To the extent that a particular offering implicates additional significant risks, we will include a discussion of
those risks in the applicable prospectus supplement.
Risks Relating to Development, Commercialization and Regulatory Approval of our Products and
Technology
Our success depends substantially on the results of clinical trials of our lead therapeutic programs, and we may not
be able to demonstrate long-term safety and efficacy of product candidates in these programs.
We are currently conducting Phase
1/2 clinical trials evaluating product candidates for the treatment of hemophilia A, hemophilia B, MPS I (Hurler syndrome) and MPS II (Hunter syndrome), and plan on initiating a Phase 1/2 clinical trial evaluating product candidate for the treatment
of hemophilia A. We have previously announced that we expect to release data on these programs by the end of 2017 or early 2018. Our success and prospect depend substantially on the progress of these highly visible lead programs. Our failure to
demonstrate safety or obtain positive clinical trial results, or our inability to meet the expected timeline of clinical trials or release of data, for these programs would have a material adverse effect on our business operations and financial
conditions, which may cause a significant decline in our stock price.
While we have achieved positive results in preclinical studies of
these product candidates, they have not been tested in humans, and there is no guarantee that we can duplicate such positive safety and efficacy results in clinical trials. Furthermore, all four programs are novel
in-vivo
gene therapy or genome editing therapies that utilize adeno-associated virus (AAV) approach to deliver therapeutic level of ZFN into the patient’s blood stream. The AAV delivery system has not
been validated in human clinical trials previously, and if such delivery system does not meet the safety criteria or cannot produce the desirable efficacy results as we expected, we may be forced to suspend or terminate all four programs.
Our ability to advance clinical trials successfully and on a timely basis for these programs is subject to a number of additional risks,
including but are not limited to the following:
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the ability to identify and recruit sufficient number of acceptable patients to complete enrollment of trials;
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the occurrence of unexpected adverse events or toxicity;
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disagreement with the FDA on the interpretation of our clinical trial results;
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defects in the preparation and manufacturing of our product candidates;
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failure by third parties, including vendors, manufacturers and clinical trial organizations, to provide timely and adequate supplies and services;
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development of similar gene therapies by our competitors;
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unexpected costs and expenses and lack of sufficient funding for these programs; and
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loss of licenses to critical intellectual properties,
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Even if we are able to complete phase 1/2 trials for these programs successfully, we will likely
be required to conduct additional clinical trials, with larger patient populations, before obtaining the necessary regulatory approval to commercialize our products. However, there is no guarantee that the positive results achieved in earlier trials
are indicative of long-term efficacy in late stage clinical trials. A number of companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in late stage clinical trials even after achieving promising results in
earlier stage clinical trials. If a larger population of patients does not experience positive results, or if these results are not reproducible, our products may not receive approval from the FDA, which could have a material adverse effect on our
business that would cause our stock price to decline significantly.
Our potential therapeutic products are subject to a lengthy and
uncertain regulatory process, and we may encounter unanticipated toxicity or adverse events or fail to demonstrate efficacy, causing us to delay, suspend or terminate a development program which will prevent us from commercializing those products.
The FDA must approve any human therapeutic product before it can be marketed in the United States. The process for receiving
regulatory approval is long and uncertain, and a potential product may not withstand the rigors of testing under the regulatory approval processes.
Before commencing clinical trials in humans, we must submit an IND application to the FDA. The FDA has 30 days to comment on the application,
and if the agency has no comments, we or our commercial partner may begin clinical trials. While we have stated our intention to file additional IND applications in the future, this is only a statement of intent, and we may not be able to do so
because the associated product candidates may not meet the necessary preclinical requirements. In addition, there can be no assurance that, once filed, an IND application will result in the actual initiation of clinical trials or that we will be
able to meet our targeted timeline for the initiation of clinical trials. Clinical trials are subject to oversight by institutional review boards and the FDA. In addition, our proposed clinical studies may require review from the Recombinant DNA
Advisory Committee (RAC), which is the advisory board to the National Institutes of Health (NIH), focusing on clinical trials involving gene transfer.
Clinical trials:
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must be conducted in conformance with the FDA’s good clinical practices, within the guidelines of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for
Human Use (ICH) and other applicable regulations;
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must meet requirements for Institutional Review Board (IRB) oversight;
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must follow Institutional Biosafety Committee (IBC) and NIH RAC guidelines where applicable;
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must meet requirements for informed consent;
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are subject to continuing FDA oversight;
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may require oversight by a Data Safety Monitoring Board (DSMB);
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may require large numbers of test subjects; and
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may be suspended by a commercial partner, the FDA, or us at any time if it is believed that the subjects participating in these trials are being exposed to unacceptable health risks or if the FDA finds deficiencies in
the IND application or the conduct of these trials.
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If we are not able to obtain the necessary regulatory approval to
commercialize our products of if such approval is delayed or suspended, it would have an adverse effect on our business operations and trading price of our common stock
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While we have stated we intend to continue to advance additional early research programs
through preclinical development and IND application filings and into clinical development, we may encounter difficulties that may delay, suspend or scale back our efforts.
In the future we intend to advance early research programs through preclinical development and to file new IND applications for human clinical
trials evaluating these candidates. The preparation and submission of IND applications requires us to conduct rigorous and time-consuming preclinical testing, studies, and documentation relating to, among other things, the toxicity, safety,
manufacturing, chemistry and clinical protocol of our product candidates. We may experience unforeseen difficulties that could delay or otherwise prevent us from executing this strategy successfully. For example, we may encounter problems in the
manufacturing of our products and fail to demonstrate consistency in the formulation of the drug. Our preclinical tests may produce negative or inconclusive results, which may lead us to decide, or regulators may require us, to conduct additional
preclinical testing. If we cannot obtain positive results in preclinical testing, we may decide to abandon the projects altogether. In addition, our ability to complete and file certain IND applications depends on the support of our partners and the
timely performance of their obligations under relevant collaboration agreements. If our partners are not able to perform such obligations or if they choose to slow down or delay the progress, we may not be able to prepare and file the intended IND
applications on a timely basis or at all. Furthermore, the filing of several IND applications involves significant cost and labor, and we may not have sufficient resources and personnel to complete the filing of all intended IND applications, which
may force us to scale back the number of IND applications or forego potential IND applications that we believe are promising. Any delay, suspension or reduction of our efforts to pursue our preclinical and IND strategy could have a material adverse
effect on our business and cause our stock price to decline.
We may not be able to find acceptable patients or may experience
delays in enrolling patients for our clinical trials.
We may experience difficulties or delays in recruiting and enrolling a
sufficient number of patients to participate in our clinical trials due to a variety of reasons, including competition from other clinical trial programs for the same indication, failure of patients to meet our enrollment criteria and premature
withdrawals of patients prior to the completion of clinical trials. The FDA and institutional review boards may also require large numbers of patients, and the FDA may require that we repeat a clinical trial. Any delay resulting from our failure to
enroll a sufficient number of patients on a timely basis may have a material adverse effect on our business.
As we cannot predict
whether or when we will obtain regulatory approval to commercialize our product candidates, we cannot predict the timing of any future revenue from these product candidates.
We cannot commercialize any of our products to generate revenue until the appropriate regulatory authorities have reviewed and approved the
applications for the product candidates. We cannot ensure that the regulatory agencies will complete their review processes in a timely manner or that we will obtain regulatory approval for any product candidate that we or our collaborators develop.
Satisfaction of regulatory requirements typically takes many years, is dependent upon the type, complexity and novelty of the product and requires the expenditure of substantial resources. Regulatory approval processes outside the United States
include all of the risks associated with the FDA approval process. In addition, we may experience delays or rejections based upon additional government regulation from future legislation or administrative action or changes in FDA policy during the
period of product development, clinical trials and FDA regulatory review.
We have limited experience in conducting advanced
clinical trials.
We have either initiated or are planning to conduct Phase 1/2 clinical trials evaluating product candidates for
hemophilia A, hemophilia B, and two LSDs, MPS I (Hurler syndrome) and MPS II (Hunter syndrome). We also have
on-going
Phase 2 trials to evaluate the safety and efficacy of
SB-728
for HIV/AIDS. For potential marketing application approval, additional clinical testing will be required, which involves significantly greater
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resources, commitments and expertise. Therefore, we may be required to scale up our operations and enter into collaborative relationships with pharmaceutical companies that could assume
responsibility for late-stage development and commercialization.
We have limited experience in conducting advanced clinical trials and
may not possess the necessary resources and expertise to complete such trials, and we may need to seek partnerships or collaboration with third parties to advance these trials. We have entered into a collaborative agreement with Bioverativ to
provide funding and assistance in the development of certain product candidates through the clinical trial process. Under the agreement with Bioverativ, we are responsible for all research and development through the first human clinical trial for
the treatment of beta-thalassemia and both parties are responsible for research and development through the submission of IND for product candidates to treat sickle cell disease (SCD). On May 10, 2017, we entered into an agreement with Pfizer
to establish a collaboration for the research, development and commercialization of
SB-525
for Hemophilia A, and closely related products. However, there is no guarantee that we will be able to enter into
future collaborative relationships with third parties that can provide us with the funding and expertise for later stage trials.
Regulatory approval, if granted, will be limited to specific uses or geographic areas, which could limit our ability to generate
revenues.
Regulatory approval will be limited to the indicated use for which we can market a product. Further, once regulatory
approval for a product is obtained, the product and its manufacturer are subject to continual review. Discovery of previously unknown problems with a product or manufacturer may result in restrictions on the product, manufacturer, and manufacturing
facility, including withdrawal of the product from the market. In Japan and Europe, regulatory agencies also set or approve prices.
Even
if regulatory clearance of a product is granted, this clearance is limited to those specific states and conditions for which the product is useful, as demonstrated through clinical trials. We cannot ensure that any product developed by us, alone or
with others, will prove to be safe and effective in clinical trials and will meet all of the applicable regulatory requirements needed to receive marketing clearance in a given country.
Outside the United States, our ability to market a product is contingent upon receiving a marketing authorization from appropriate regulatory
authorities; therefore we cannot predict whether or when we would be permitted to commercialize our product outside the United States. These foreign regulatory approval processes include all of the risks associated with FDA clearance described
above.
Commercialization of our technologies will depend, in part, on strategic partnering with other companies. If we are not able
to find partners in the future or if our partners do not diligently pursue product development efforts, we may not be able to develop our technologies or products, which could slow our growth and decrease the value of our stock.
We expect to rely, to some extent, on our strategic partners to provide funding in support of our research and to perform independent research
and preclinical and clinical testing. Our technology is broad-based, and we do not currently possess the resources necessary to fully develop and commercialize potential products that may result from our technologies or the resources or capabilities
to complete the lengthy marketing approval processes that may be required for the products. Therefore, we plan to rely on strategic partnerships to help us develop and commercialize our products. For example, we intend to seek partnership for our
clinical programs for the treatment of HIV/AIDs. If we are unable to find partners or if the partners we find, such as Bioverativ, Pfizer and Shire, are unable or unwilling to advance our programs, or if they do not diligently pursue product
approval, this may slow our progress and adversely affect our ability to generate revenues. In addition, our partners may sublicense or abandon development programs or we may have disagreements or disputes with our partners, which would cause
associated product development to slow or cease. In addition, the business or operations of our partners may change significantly through restructuring, acquisition or other strategic
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transactions or decisions that may negatively impact their ability to advance our programs. There can be no assurance that we will be able to establish further strategic collaborations for our
products. We may require significant time to secure collaborations or partners because we need to effectively market the benefits of our technology to these future collaborators and partners, which may direct the attention and resources of our
research and development personnel and management away from our primary business operations. Further, each collaboration or partnering arrangement will involve the negotiation of terms that may be unique to each collaborator or partner. These
business development efforts may not result in a collaboration or partnership.
The loss of partnering agreements may delay or terminate
the potential development or commercialization of products we may derive from our technologies, but it may also delay or terminate our ability to test our product candidates. If any partner fails to conduct the collaborative activities successfully
or in a timely manner, the preclinical or clinical development or commercialization of the affected product candidates or research programs could be delayed or terminated.
Under typical partnering agreements, we would expect to receive revenue for the research and development of our product candidates based on
achievement of specific milestones, as well as royalties based on a percentage of sales of the commercialized products. Achieving these milestones will depend, in part, on the efforts of our partner as well as our own. If we, or any partner, fail to
meet specific milestones, then the partnership may be terminated, which could reduce our revenues. For more information on risks relating to our third party collaborative agreements, see “Risks Relating to our Collaborative Relationships.”
We may be unable to license gene transfer technologies that we may need to commercialize our ZFP technology.
In order to regulate or modify a gene in a cell, the ZFP must be efficiently delivered to the cell. We have licensed certain gene transfer
technologies for our ZFP in research including AAV and mRNA technology. We are evaluating these systems and other technologies that may need to be used in the delivery of ZFP into cells for in vitro and in vivo applications. However, we may not be
able to license the gene transfer technologies required to develop and commercialize our product candidates. We have not developed our own gene transfer technologies, and we rely on our ability to enter into license agreements to provide us with
rights to the necessary gene transfer technology. Our approach has been to license appropriate technology as required. The inability to obtain a license to use gene transfer technologies with entities which own such technology on reasonable
commercial terms, if at all, could delay or prevent the preclinical evaluation, drug development collaborations, clinical testing, and/or commercialization of our therapeutic product candidates.
Our gene regulation and genome editing technology is relatively new, and if we are unable to use this technology in all our intended
applications, it would limit our revenue opportunities.
Our technology involves a relatively new approach to gene regulation and
genome editing. Although we have generated ZFPs for thousands of gene sequences, we have not created ZFPs for all gene sequences and may not be able do so, which could limit the usefulness of our technology. In addition, while we have demonstrated
the function of engineered ZFNs and ZFP TFs in mammalian cells, yeast, insects, plants and animals, we have not yet demonstrated clinical efficacy of this technology in a controlled clinical trial in humans, and the failure to do so could restrict
our ability to develop commercially viable products. If we, and our collaborators or strategic partners, are unable to extend our results to new commercially important genes, experimental animal models, and human clinical studies, we may be unable
to use our technology in all its intended applications.
The expected value and utility of our ZFNs and ZFP TFs is in part based on our
belief that the targeted editing of genes or specific regulation of gene expression may enable us to develop a new therapeutic approach as well as to help scientists better understand the role of genes in disease, and to aid their efforts in drug
discovery and development. We also believe that
ZFP-mediated
targeted genome editing and gene regulation will have utility in agricultural applications. There is only a limited understanding of the role of
specific genes in all
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these fields. Life sciences companies have developed or commercialized only a few products in any of these fields based on results from genomic research or the ability to regulate gene
expression. We, our collaborators or our strategic partners, may not be able to use our technology to identify and validate drug targets or to develop commercial products in the intended markets.
Effective delivery of ZFNs and ZFP TFs into the appropriate target cells and tissues is critical to the success of the therapeutic
applications of our ZFP technology. In order to have a meaningful therapeutic effect, these products must be delivered to sufficient numbers of cells in the targeted tissue. The ZFN or ZFP TF must be present in that tissue for sufficient time to
effect either modification of a therapeutically relevant gene or regulation of its expression. In our current clinical and preclinical programs, we administer these product candidates as a nucleic acid that encodes the ZFN or ZFP TF. We use
different formulations to deliver the ZFN or ZFP TF depending on the required duration of expression, the targeted tissue and the indication that we intend to treat, including our proprietary AAV delivery system. However, there can be no assurances
that we will be able to effectively deliver our ZFNs and ZFP TFs to produce a beneficial therapeutic effect.
We are conducting
proprietary research to discover new product candidates. These programs increase our financial risk of product failure, may significantly increase our research expenditures, and may involve conflicts with future collaborators and strategic partners.
Our proprietary research programs consist of research that is funded solely by us or by grant funding and in which we retain
exclusive rights to therapeutic products generated by such research. This is in contrast to certain of our research programs that may be funded by corporate partners in which we may share rights to any resulting products. Conducting proprietary
research programs may not generate corresponding revenue and may create conflicts with our collaborators or strategic partners over rights to our intellectual property with respect to our proprietary research activities. Any conflict with our
collaborators or strategic partners could reduce our ability to enter into future collaborations or partnering agreements and negatively impact our relationship with existing collaborators and partners that could reduce our revenue and delay or
terminate our product development. As we continue to focus our strategy on proprietary research and therapeutic development, we expect to experience greater business risks, expend significantly greater funds and require substantial commitments of
time from our management and staff.
Even if our technology proves to be effective, it still may not lead to commercially viable
products.
Even if our collaborators or strategic partners are successful in using our ZFP technology in drug discovery, protein
production, therapeutic development or plant agriculture, they may not be able to commercialize the resulting products or may decide to use other methods competitive with our technology. To date, no company has received marketing approval or has
developed or commercialized any therapeutic or agricultural products based on our technology. Should our technology fail to provide safe, effective, useful or commercially viable approaches to the discovery and development of these products, this
would significantly limit our business and future growth and would adversely affect our value.
Even if our product development
efforts are successful and even if the requisite regulatory approvals are obtained, our products may not gain market acceptance among physicians, patients, healthcare payers and the medical community.
A number of additional factors may limit the market acceptance of our products including the following:
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rate of adoption by healthcare practitioners;
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rate of a product’s acceptance by the target population;
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timing of market entry relative to competitive products;
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availability of alternative therapies;
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price of our product relative to alternative therapies;
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availability of third-party reimbursement;
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extent of marketing efforts by us and third-party distributors or agents retained by us; and
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side-effects or unfavorable publicity concerning our products or similar products.
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Therefore,
even after we have obtained the required regulatory approval for our products, we may not be able to commercialize these products successfully if we cannot achieve an adequate level of market acceptance.
We currently rely on third parties to conduct some or all aspects of manufacturing of our product candidates for preclinical and
clinical development. If one of our third-party manufacturers fails to perform adequately or fulfill our needs, we may be required to incur significant costs and devote significant efforts, to find new suppliers or manufacturers.
We currently have limited experience in, and we do not own facilities for, clinical-scale manufacturing of our product candidates and we rely
upon third-party contract manufacturing organizations to manufacture and supply drug product for our preclinical and clinical studies. The manufacture of pharmaceutical products in compliance with the FDA’s current good manufacturing practices
(cGMP), requires significant expertise and capital investment, including the development of advanced manufacturing techniques and process controls. Manufacturers of pharmaceutical products often encounter difficulties in production, including
difficulties with production costs and yields, quality control, including stability of the product candidate and quality assurance testing, shortages of qualified personnel, as well as compliance with strictly enforced cGMP requirements, other
federal and state regulatory requirements and foreign regulations. If our manufacturers were to encounter any of these difficulties or otherwise fail to comply with their obligations to us or under applicable regulations, our ability to provide
study drugs in our clinical studies would be jeopardized. Any delay or interruption in the supply of clinical study materials could delay the completion of our clinical studies, increase the costs associated with maintaining our clinical study
programs and, depending upon the period of delay, require us to commence new studies at significant additional expense or terminate the studies completely.
All manufacturers of our product candidates must comply with cGMP requirements enforced by the FDA through its facilities inspection program.
These requirements include, among other things, quality control, quality assurance and the maintenance of records and documentation. Manufacturers of our product candidates may be unable to comply with these cGMP requirements and with other FDA,
state and foreign regulatory requirements. The FDA or similar foreign regulatory agencies may also implement new standards at any time, or change their interpretation and enforcement of existing standards for manufacture, packaging or testing of
products. We have little control over our manufacturers’ compliance with these regulations and standards. A failure to comply with these requirements may result in fines and civil penalties, suspension of production, suspension or delay in
product approval, product seizure or recall or withdrawal of product approval. If the safety of any product supplied is compromised due to our manufacturers’ failure to adhere to applicable laws or for other reasons, we may not be able to
obtain regulatory approval for or successfully commercialize our products and we may be held liable for any injuries sustained as a result. Any of these factors could cause a delay of clinical studies, regulatory submissions, approvals or
commercialization of our product candidates, entail higher costs or impair our reputation.
Our current agreements with our suppliers do
not provide for the entire supply of the drug product necessary for all anticipated clinical studies or for full scale commercialization. If we and our suppliers cannot agree to the terms and conditions for them to provide the drug product necessary
for our clinical and commercial supply needs, we may not be able to manufacture the product candidate until a qualified alternative supplier is identified, which could also delay the development of, and impair our ability to commercialize, our
product candidates.
The number of third-party suppliers with the necessary manufacturing and regulatory expertise and facilities is
limited, and it could be expensive and take a significant amount of time to arrange for alternative suppliers,
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which could have a material adverse effect on our business. New suppliers of any product candidate would be required to qualify under applicable regulatory requirements and would need to have
sufficient rights under applicable intellectual property laws to the method of manufacturing the product candidate. Obtaining the necessary FDA approvals or other qualifications under applicable regulatory requirements and ensuring
non-infringement
of third-party intellectual property rights could result in a significant interruption of supply and could require the new manufacturer to bear significant additional costs which may be passed on to
us.
We do not currently have the infrastructure or capability to manufacture, market and sell therapeutic products on a commercial
scale.
In order for us to commercialize our therapeutic products directly, we would need to develop, or obtain through outsourcing
arrangements, the capability to manufacture, market and sell our products on a commercial scale. Currently, we do not have the ability nor the financial resources to establish the infrastructure and organizations needed to execute these functions,
including such infrastructure needed for the commercialization of any product from our therapeutic program, which can be complex and costly. If we are unable to establish adequate manufacturing, sales, marketing and distribution capabilities, we
will not be able to directly commercialize our therapeutics products, which would limit our future growth.
Risks Relating to our Industry
If our competitors develop, acquire, or market technologies or products that are more effective than ours, this would reduce or eliminate
our commercial opportunity.
Any products that we or our collaborators or strategic partners develop by using our ZFP technology
platform will enter into highly competitive markets. Even if we are able to generate products that are safe and effective for their intended use, competing technologies may prove to be more effective or less expensive, which, to the extent these
competing technologies achieve market acceptance, will limit our revenue opportunities. In some cases, competing technologies have proven to be effective and less expensive. Competing technologies may include other methods of regulating gene
expression or modifying genes. ZFNs and ZFP TFs have broad application in the life sciences industry and compete with a broad array of new technologies and approaches being applied to genetic research by many companies. Competing proprietary
technologies with our product development focus include but are not limited to:
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For genome editing and gene therapy products:
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other gene therapy/cDNAs;
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siRNA and microRNA approaches, exon skipping;
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CRISPR/Cas technology; and
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TALE proteins, meganucleases, and MegaTALs.
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For our
Non-Therapeutic
Applications:
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For protein production
: gene amplification, CRISPR/Cas technology, TALE technology, insulator technology, and mini-chromosomes;
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For target validation
: antisense, siRNA, TALE technology and CRISPR/Cas technology;
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For plant agriculture
: recombination approaches, mutagenesis approaches, TALE technology, CRISPR/Cas technology, mini-chromosomes; and
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For transgenic animals
: somatic nuclear transfer, embryonic stem cell, TALE, CRISPR/Cas technology and transposase technologies.
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In addition to possessing competing technologies, our competitors include pharmaceutical and biotechnology companies with:
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substantially greater capital resources than ours;
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larger research and development staffs and facilities than ours; and
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greater experience in product development and in obtaining regulatory approvals and patent protection.
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These organizations also compete with us to:
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attract qualified personnel;
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attract parties for acquisitions, joint ventures or other collaborations; and
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license the proprietary technologies of academic and research institutions that are competitive with our technology, which may preclude us from pursuing similar opportunities.
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Accordingly, our competitors may succeed in obtaining patent protection or commercializing products before us. In addition, any products that
we develop may compete with existing products or services that are well established in the marketplace.
Adverse public perception
in the field of gene therapy and genome editing may negatively impact regulatory approval of, or demand for, our potential products.
Our potential therapeutic products are delivered to patients as gene-based drugs, or gene therapy. The clinical and commercial success of our
potential products will depend in part on public acceptance of the use of gene therapy and genome editing for the prevention or treatment of human diseases. Public attitudes may be influenced by claims that gene therapy or genome editing is unsafe,
and, consequently, our products may not gain the acceptance of the public or the medical community. Negative public reaction to gene therapy or genome editing in general could result in greater government regulation and stricter labeling
requirements of gene based products, including any of our products, and could cause a decrease in the demand for any products we may develop.
Laws or public sentiment may limit the production of genetically modified agricultural products, and these laws could reduce our
partner’s ability to sell such products.
Genetically modified products are currently subject to public debate and heightened
regulatory scrutiny, either of which could prevent or delay production of agricultural products. We have a research license and commercial option agreement with DAS through which we provide DAS with access to our proprietary ZFP technology and the
exclusive right to use our ZFP technology to modify the genomes or alter the nucleic acid or protein expression of plant cells, plants or plant cell cultures. The field-testing, production and marketing of genetically modified plants and plant
products are subject to federal, state, local and foreign governmental regulation. Regulatory agencies administering existing or future regulations or legislation may not allow production and marketing of our genetically modified products in a
timely manner or under technically or commercially feasible conditions. In addition, regulatory action or private litigation could result in expenses, delays or other impediments to our product development programs or the commercialization of
resulting products.
The FDA currently applies the same regulatory standards to foods developed through genetic engineering as those
applied to foods developed through traditional plant breeding. Genetically engineered food products, however, will be subject to
pre-market
review if these products raise safety questions or are deemed to be
food additives. Governmental authorities could also, for social or other purposes, limit the use of genetically modified products created with our gene regulation technology.
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Even if the regulatory approval for genetically modified products developed under our agreement
with DAS was obtained, our success will also depend on public acceptance of the use of genetically modified products including drugs, plants, and plant products. Claims that genetically modified products are unsafe for consumption or pose a danger
to the environment may influence public attitudes. Our genetically modified products may not gain public acceptance. The subject of genetically modified organisms has received negative publicity in the United States and particularly in Europe, and
such publicity has aroused public debate. The adverse publicity in Europe could lead to greater regulation and trade restrictions on imports of genetically altered products. Similar adverse public reaction or sentiment in the United States to
genetic research and its resulting products could result in greater domestic regulation and could decrease the demand for our technology and products.
Risks Relating to our Finances
We
have incurred significant operating losses since inception and anticipate that we will incur continued losses for the foreseeable future.
We have generated operating losses since we began operations in 1995. Our net losses for the years ended December 31, 2016, 2015 and 2014
were $71.7 million, $40.7 million and $26.4 million, respectively. The extent of our future losses and the timing of profitability are uncertain, and we expect to incur losses for the foreseeable future. We have been engaged in
developing our ZFP technology since inception, which has and will continue to require significant research and development expenditures. To date, we have generated our funding from issuance of equity securities, revenues derived from collaboration
agreements, other strategic partnerships in
non-therapeutic
applications of our technology, federal government research grants and grants awarded by research foundations. As of March 31, 2017, we had an
accumulated deficit of $457.5 million. Since our IPO in 2000, we have generated an aggregate of approximately $331.4 million in gross proceeds from the sale of our equity securities. We expect to continue to incur additional operating
losses for the next several years as we continue to advance our product candidates. If the time required to generate significant product revenues and achieve profitability is longer than we currently anticipate or if we are unable to generate
liquidity through equity financing or other sources of funding, we may be forced to curtail or suspend our operations.
We may be
unable to raise additional capital, which would harm our ability to develop our technology and products.
We have incurred
significant operating losses and negative operating cash flows since inception and have not achieved profitability. We expect capital outlays and operating expenditures to increase over the next several years as we expand our infrastructure and
research and product development activities. While we believe our financial resources will be adequate to sustain our current operations for at least the next twelve months, we may need to seek additional sources of capital through equity or debt
financing. In addition, as we focus our efforts on proprietary human therapeutics, we will need to seek FDA approval of potential products, a process that could cost in excess of hundreds of millions of dollars per product. Furthermore, we may
experience difficulties in accessing the capital market due to external factors beyond our control such as volatility in the equity markets for emerging biotechnology companies and general economic and market conditions both in the United States and
abroad. We cannot be certain that we will be able to obtain financing on terms acceptable to us, or at all. Our failure to obtain adequate and timely funding will materially adversely affect our business and our ability to develop our technology and
products candidates. Furthermore, any sales of additional equity securities may result in dilutions to our stockholders and any debt financing may include business and financial covenants that restricts our operations.
We are at the development phase of operations and may not succeed or become profitable.
We began operations in 1995 and are in the early phases of product development, and we have incurred significant losses since inception. To
date, our revenues have been generated from collaboration agreements, other collaborations in
non-therapeutic
applications of our technology, federal government research grants and
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grants awarded by research foundations. Our focus on higher-value therapeutic product development and related collaboration requires us to incur substantial expenses associated with product
development. In addition, the preclinical or clinical failure of any single product may have a significant effect on the actual or perceived value of our stock. Our business is subject to all of the risks inherent in the development of a new
technology, which includes the need to:
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attract and retain qualified scientific and technical staff and management, particularly scientific staff with expertise to develop our early-stage technology into therapeutic products;
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obtain sufficient capital to support the expense of developing our technology platform and developing, testing and commercializing products;
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develop a market for our products; and
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successfully transition from a company with a research focus to a company capable of supporting commercial activities.
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Risks Relating to our Relationships with Collaborators and Strategic Partners
If conflicts arise between us and our collaborators or strategic partners, these parties may act in their self-interest, which may limit
our ability to implement our strategies.
If conflicts arise between our corporate or academic collaborators or strategic partners
and us, the other party may act in its self-interest, which may limit our ability to implement our strategies. Some of our academic collaborators and strategic partners are conducting multiple product development efforts within each area that is the
subject of the collaboration with us. Our collaborators or strategic partners, however, may develop, either alone or with others, products in related fields that are competitive with the products or potential products that are the subject of these
collaborations. Competing products, either developed by the collaborators or strategic partners or to which the collaborators or strategic partners have rights, may result in the withdrawal of partner support for our product candidates.
Some of our collaborators or strategic partners could also become our competitors in the future. Our collaborators or strategic partners could
develop competing products, preclude us from entering into collaborations with their competitors, fail to obtain timely regulatory approvals, terminate their agreements with us prematurely, or fail to devote sufficient resources to the development
and commercialization of products. Any of these developments could harm our product development efforts.
Our collaborators and
strategic partners may control aspects of our clinical trials, which could result in delays and other obstacles in the commercialization of our proposed products.
We depend on third party collaborators and strategic partners to design and conduct our clinical trials for some of our therapeutic programs.
As a result, we may not be able to conduct these programs in the manner or on the time schedule we currently contemplate, which may negatively impact our business operations. In addition, if any of these collaborators or strategic partners withdraws
support for our programs or proposed products or otherwise impair their development; our business could be negatively affected.
We have a
collaborative agreement with Shire, pursuant to which we are engaging in a joint program with Shire to research, develop and commercialize human therapeutics and diagnostics for Huntington’s disease and other monogenic diseases based on our ZFP
technology. Under this agreement, we will provide certain target feasibility activities and upon Shire’s request, certain research activities under a research plan, agreed upon by both companies. Shire is responsible for clinical development
and commercialization of products generated from the research program from and after the acceptance of an IND or CTA for the product.
We
also have a collaborative agreement with Bioverativ for the clinical development and commercialization of therapeutics based on our ZFP technology for hemoglobinopathies, including beta-thalassemia and SCD.
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Under the agreement, we are responsible for all discovery, research and development activities through the first human clinical trial for the first product candidate developed for the treatment
of beta-thalassemia. In the SCD program, both parties are responsible for research and development activities through the submission of an IND.
In addition, under our agreement with Pfizer, we will be responsible for conducting the Phase 1/2 clinical trial and certain manufacturing
activities for
SB-525,
while Pfizer will be responsible for subsequent worldwide clinical development, manufacturing, marketing and commercialization of
SB-525.
We may
also collaborate in the research and development of
AAV-based
gene therapy products for Hemophilia.
Under our agreement with Bioverativ and Pfizer, they have control and broad discretion over all or certain aspects of the clinical development
and commercialization of any product developed under the agreement, and we will have little, if any, influence on how these programs will be conducted. Our lack of control over the clinical development in our agreement with Bioverativ and Pfizer
could cause delays or other difficulties in the development and commercialization of our product candidates, which may prevent us from completing the intended IND filings in a timely fashion and receiving any milestone, royalty payments and other
benefits under the agreement. In addition, under their respective agreement(s), Bioverativ, Pfizer and Shire have certain rights to terminate the agreements by providing us with advance notices, therefore, the actual milestone payments that we may
receive under these agreements may be lower than the full amounts stated above.
Our collaborators or strategic partners may decide
to adopt alternative technologies or may be unable to develop commercially viable products with our technology, which would negatively impact our revenues and our strategy to develop these products.
Our collaborators or strategic partners may adopt alternative technologies, which could decrease the marketability of ZFP technology.
Additionally, because many of our collaborators or strategic partners are likely to be working on more than one development project, they could choose to shift their resources to projects other than those they are working on with us. If they do so,
this would delay our ability to test our technology and would delay or terminate the development of potential products based on our ZFP technology. Further, our collaborators and strategic partners may elect not to develop products arising out of
our collaborative and strategic partnering arrangements or to devote sufficient resources to the development, manufacturing, marketing or sale of these products. If they terminate the collaborative relationship with us, we will be required to seek
the support of other partners or collaborators. We may not have sufficient resources and expertise to develop these programs by ourselves, and we may not be able to identify a suitable partner or negotiate a favorable collaboration agreement to
allow us to continue the development of these programs. If any of these events occur, we may not be able to develop our technologies or commercialize our products.
If we do not successfully commercialize
ZFP-based
research reagents,
ZFP-modified
cell lines for commercial protein production, or
ZFP-engineered
transgenic animals under our license agreement with Sigma-Aldrich Corporation or
ZFP-based
agricultural products with Dow AgroSciences, or if Sigma-Aldrich Corporation or Dow AgroSciences terminates our agreements, our ability to generate revenue under these license agreements may be limited.
In July 2007 we entered into a license agreement with Sigma to collaborate on the application and development of
ZFP-based
products for use in the laboratory research reagents markets. The agreement provides Sigma with access to our ZFP technology and the exclusive right to use our ZFP technology to develop and commercialize
products for use as research reagents and to offer services in related research fields. Under the agreement, Sigma has exclusive rights to develop and distribute
ZFP-modified
cell lines for commercial
production of protein pharmaceuticals and, certain
ZFP-engineered
transgenic animals for commercial applications. In addition, under our license agreement with DAS relating to plant agriculture, DAS has the
exclusive right to develop agricultural products using our ZFP technology in plant cells, plants or plant cell cultures. Both Sigma and DAS have the right to sublicense our technology in their respective areas. In addition to upfront payments, we
may also receive additional license fees, shared sublicensing revenues, royalty payments
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and milestone payments depending on the success of the development and commercialization of the licensed products and services covered under both agreements. The commercial milestones and
royalties are typically based upon net sales of licensed products.
We cannot be certain that we or our collaboration partners will
succeed in the development of commercially viable products in these fields of use, and there is no guarantee that we or our collaboration partners will achieve the milestones set forth in the respective license agreements. To the extent we or our
collaboration partners do not succeed in developing and commercializing products or if we or our collaboration partners fail to achieve such milestones, our revenues and benefits under the license agreements will be limited. In addition, the
respective license agreements may be terminated by Sigma and DAS at any time by providing us with a
90-day
notice. In the event Sigma or DAS decides to terminate the license agreements, our ability to generate
revenue under such license agreements will cease.
Our collaborations with outside scientists may be subject to change, which could limit
our access to their expertise.
We work with scientific advisors and collaborators at academic research institutions. These scientists are
not our employees and may have other commitments that would limit their availability to us. Although our scientific advisors generally agree not to do competing work, if a conflict of interest between their work for us and their work for another
entity arises, we may lose their services. Although our scientific advisors and academic collaborators sign agreements not to disclose our confidential information, it is possible that some of our valuable proprietary knowledge may become publicly
known through them, which may cause competitive harm to our business.
Risks Relating to our Intellectual Property and Business Operation
Because it is difficult and costly to protect our proprietary rights, and third parties may have filed patent applications that are
similar to ours, we cannot guarantee the proprietary protection of our technologies and products.
Our commercial success will
depend in part on obtaining patent protection of our technology and successfully defending any of our patents that may be challenged. The patent positions of pharmaceutical and biotechnology companies can be highly uncertain and can involve complex
legal and factual questions. No consistent policy regarding the breadth of claims allowed in biotechnology patents has emerged to date. Accordingly, we cannot predict the breadth of claims allowed in patents we own or license that a third party may
receive.
We are a party to various license agreements that give us rights under specified patents and patent applications. Our current
licenses, as our future licenses frequently will, contain performance obligations. If we fail to meet those obligations, the licenses could be terminated. If we are unable to continue to license these technologies on commercially reasonable terms,
or at all, we may be forced to delay or terminate aspects of our product development and research activities.
With respect to our present
and any future sublicenses, since our rights derive from those granted to our sublicensor, we are subject to the risk that our sublicensor may fail to perform its obligations under the master license or fail to inform us of useful improvements in,
or additions to, the underlying intellectual property owned by the original licensor.
We are unable to exercise the same degree of
control over intellectual property that we license from third parties as we exercise over our internally developed intellectual property. We do not control the prosecution of certain of the patent applications that we license from third parties;
therefore, the patent applications may not be prosecuted as we desire or in a timely manner.
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The degree of future protection for our proprietary rights is uncertain, and we cannot ensure
that:
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we or our licensors were the first to make the inventions covered by each of our pending patent applications;
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we or our licensors were the first to file patent applications for these inventions;
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the patents of others will not have an adverse effect on our ability to do business;
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others will not independently develop similar or alternative technologies or reverse engineer any of our products, processes or technologies;
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any of our pending patent applications will result in issued patents;
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any patents issued or licensed to us or our collaborators or strategic partners will provide a basis for commercially viable products or will provide us with any competitive advantages;
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any patents issued or licensed to us will not be challenged and invalidated by third parties; or
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we will develop additional products, processes or technologies that are patentable.
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have filed and in the future are likely to file patent applications that are similar to ours. We are aware that there are academic groups and other companies that are attempting to develop technology that is based on the use of zinc finger, TALE,
CRISPR/Cas and other
DNA-binding
proteins, and that these groups and companies have filed patent applications. Several patents have been issued, although we have no current plans to use the associated
inventions. If these or other patents issue, it is possible that the holder of any patent or patents granted on these applications may bring an infringement action against our collaborators, strategic partners, or us claiming damages and seeking to
enjoin commercial activities relating to the affected products and processes. The costs of litigating the claim could be substantial. Moreover, we cannot predict whether we, our collaborators, or strategic partners would prevail in any actions. In
addition, if the relevant patent claims were upheld as valid and enforceable and our products or processes were found to infringe the patent or patents, we or our collaborators could be prevented from making, using, or selling the relevant product
or process unless we or our collaborators could obtain a license or were able to design around the patent claims. We can give no assurance that such a license would be available to us and our collaborators on commercially reasonable terms, or at
all, or that we would be able to successfully design around the relevant patent claims. There may be significant litigation in the genomics industry regarding patent and other intellectual property rights, which could subject us to litigation. If we
become involved in litigation, it could consume a substantial portion of our managerial and financial resources.
We rely on trade secrets
to protect technology where we believe patent protection is not appropriate or obtainable. Trade secrets, however, are difficult to protect. While we require employees, academic collaborators and consultants to enter into confidentiality agreements,
we may not be able to adequately protect our trade secrets or other proprietary information or enforce these confidentiality agreements.
Our collaborators, strategic partners, and scientific advisors have rights to publish data and information in which we may have rights. If we
cannot maintain the confidentiality of our technology and other confidential information in connection with our collaborations and strategic partnerships, then we may not be able to receive patent protection or protect our proprietary information.
If we use biological and hazardous materials in a manner that causes injury or violates laws, we may be liable for damages.
Our research and development activities involve the controlled use of potentially harmful biological materials as well as
hazardous materials, chemicals, and various radioactive compounds typically employed in molecular and cellular biology. We routinely use cells in culture and gene delivery vectors, and we employ small amounts of radioisotopes in trace experiments.
Although we maintain
up-to-date
licensing and training programs,
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we cannot completely eliminate the risk of accidental contamination or injury from the use, storage, handling, or disposal of these materials. In the event of contamination or injury, we could be
held liable for damages that result, and any liability could exceed our resources. We currently carry insurance covering certain claims arising from our use of these materials. However, if we are unable to maintain our insurance coverage at a
reasonable cost and with adequate coverage, our insurance may not cover any liability that may arise. We are subject to federal, state, and local laws and regulations governing the use, storage, handling, and disposal of these materials and
specified waste products. To date, we have not experienced significant costs in complying with regulations regarding the use of these materials.
Failure to attract, retain, and motivate skilled personnel and cultivate key academic collaborations will delay our product development
programs and our research and development efforts.
Our success depends on our continued ability to attract, retain, and motivate
highly qualified management and scientific personnel and our ability to develop and maintain important relationships with leading research and academic institutions and scientists. Competition for skilled and qualified personnel and academic and
other research collaborations is intense. If we lose the services of personnel with the necessary skills, including the members of our senior management team, it could significantly impede the achievement of our research and development objectives.
If we fail to negotiate additional acceptable collaborations with academic and other research institutions and scientists, or if our existing collaborations are unsuccessful, our development programs may be delayed or may not succeed.
Risks Relating to our Common Stock and Corporate Organization
Our stock price has been volatile and may continue to be volatile, which could result in substantial losses for investors.
During the three months ended March 31, 2017, the closing price of our common stock, as reported by the NASDAQ Global Select Market,
ranged from a low of $3.10 to high of $5.20. During the fiscal year ended December 31, 2016, our common stock price fluctuated, ranging from a low of $2.70 to a high of $4.74. Volatility in our common stock could cause stockholders to incur
substantial losses. An active public market for our common stock may not be sustained, and the market price of our common stock may continue to be highly volatile. The market price of our common stock has fluctuated significantly in response to
various factors, some of which are beyond our control, including but not limited to the following:
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announcements by us or collaborators providing updates on the progress or development status of product candidates;
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data from clinical trials;
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initiation or termination of clinical trials;
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changes in market valuations of similar companies;
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overall market and economic conditions, including the equity markets for emerging biotechnology companies;
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deviations in our results of operations from the guidance given by us;
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announcements by us or our competitors of new or enhanced products, technologies or services or significant contracts, acquisitions, strategic relationships, joint ventures or capital commitments;
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announcement of changes in business and operations by our collaborators and partners, or changes in our existing collaboration agreements;
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regulatory developments;
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changes, by one or more of Sangamo’s security analysts, in recommendations, ratings or coverage of our stock.
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additions or departures of key personnel;
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future sales of our common stock or other securities by us, management or directors, liquidation of institutional funds that comprised large holdings of our stock; and
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decreases in our cash balances.
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Our stock price is also influenced by public perception
of gene therapy and government regulation of potential products.
Reports of serious adverse events in a retroviral gene transfer
trial for infants with
X-linked
severe combined immunodeficiency
(X-linked
SCID) in France and subsequent FDA actions putting related trials on hold in the United States
had a significant negative impact on the public perception and stock price of certain companies involved in gene therapy. Stock prices of these companies declined whether or not the specific company was involved with retroviral gene transfer for the
treatment of infants with
X-linked
SCID, or whether the specific company’s clinical trials were placed on hold in connection with these events. Other potential adverse events in the field of gene therapy
may occur in the future that could result in greater governmental regulation of our potential products and potential regulatory delays relating to the testing or approval of our potential products. These external events may have a negative impact on
public perception of our business, which could cause our stock price to decline.
We may be subject to rescission rights and other
penalties for shares sold under the ATM Agreement.
In December 2016, we entered into an “at-the-market” sales agreement,
or the ATM Agreement, pursuant which we may sell, from time to time, an aggregate of $75 million of our common stock. The shares under the ATM Agreement were to be sold pursuant to a shelf registration statement on Form S-3 that initially became
effective in February 2014. In March 2017, we sold an aggregate of $3.8 million of our common stock under the ATM Agreement at an average price per share of $4.39, and at the times of those sales, we believed that our registration statement was then
effective. However, subsequent to those sales, we were advised that our registration statement had in fact expired prior to the time of the March 2017 ATM sales. Because our registration statement had in fact expired prior to the time of such
sales, we may be deemed to have violated Section 5 of the Securities Act, which requires registration of public offerings of securities. Consequently, purchasers who purchased shares of our common stock under the ATM Agreement in March 2017 may have
a rescission right, for a period of one year from the date of their purchase of such shares, to obtain recovery of the consideration paid in connection with their purchase or, if they had already sold the shares, file a claim against us for damages
resulting from their purchase. Any liability would depend, in part, upon the number of shares purchased and the purchaser’s ability to establish that their shares were acquired directly from us. While we believe it is unlikely that a
successful claim will be asserted against us by any purchasers, we cannot guarantee that no such legal claims will be asserted against us by any purchasers. In addition, we could become subject to enforcement actions and/or penalties and fines
by federal authorities, and we are unable to predict the likelihood of any such enforcement actions being brought against us, or the amount of any such potential penalties or fines.
Anti-takeover provisions in our certificate of incorporation and Delaware law could make an acquisition of the Company more difficult
and could prevent attempts by our stockholders to remove or replace current management.
Anti-takeover provisions of Delaware law
and in our certificate of incorporation and our bylaws may discourage, delay or prevent a change in control of our company, even if a change in control would be beneficial to our stockholders. In addition, these provisions may frustrate or prevent
any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors. In particular, under our certificate of incorporation our board of directors may
issue up to 5,000,000 shares of preferred stock with rights and privileges that might be senior to our common stock, without
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the consent of the holders of the common stock. Moreover, without any further vote or action on the part of the stockholders, the board of directors would have the authority to determine the
price, rights, preferences, privileges, and restrictions of the preferred stock. This preferred stock, if it is ever issued, may have preference over, and harm the rights of, the holders of common stock. Although the issuance of this preferred stock
would provide us with flexibility in connection with possible acquisitions and other corporate purposes, this issuance may make it more difficult for a third party to acquire a majority of our outstanding voting stock.
Similarly, our authorized but unissued common stock is available for future issuance without stockholder approval.
In addition, our bylaws:
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state that stockholders may not act by written consent but only at a stockholders’ meeting;
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establish advance notice requirements for nominations for election to the board of directors or proposing matters that can be acted upon at stockholders’ meetings; and
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prohibit stockholders from calling a special meeting of stockholders.
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We are also subject to
Section 203 of the Delaware General Corporation Law, which provides, subject to certain exceptions, that if a person acquires 15% of our voting stock, the person is an “interested stockholder” and may not engage in “business
combinations” with us for a period of three years from the time the person acquired 15% or more or our voting stock. The application of Section 203 may, in some circumstances, deter or prevent a change in control of our company even when
such change may be beneficial to our stockholders.
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USE OF PROCEEDS
Except as may be otherwise set forth in the prospectus supplement accompanying this prospectus, we will use the net proceeds we receive from
sales of the securities offered hereby for general corporate purposes, including support for our continuing research and development, preclinical and clinical trial activities, commercialization activities, business development activities, and, if
opportunities arise, acquisitions of businesses, products, technologies or licenses that are complementary to our business, although we have no current plans, commitments or agreements with respect to any acquisitions as of the date of this
prospectus.
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RATIO OF EARNINGS TO FIXED CHARGES
The following summary is qualified by the more detailed information appearing in the computation table found in Exhibit 12.1 to the
registration statement of which this prospectus is part and the historical financial statements, including the notes to those financial statements, incorporated by reference in this prospectus. The following table sets forth our ratio of earnings to
fixed charges for each of the periods indicated:
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Year Ended December 31
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2016
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2015
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2014
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2013
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2012
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Ratio of earnings to fixed charges (1)
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N/A (2)
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N/A (2)
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N/A (2)
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N/A (2)
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N/A (2)
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(1)
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The ratio of earnings to fixed charges was computed by dividing earnings by fixed charges. For this purpose, earnings consist of net loss before fixed charges. Fixed charges consist of interest expense on outstanding
lease liabilities, interest expense, amortization of debt expense and discount or premium related to indebtedness, whether expensed or capitalized.
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(2)
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Earnings were insufficient to cover fixed charges for these periods. We have not included a ratio of earnings to combined fixed charges and preferred stock dividends because we do not have any preferred stock
outstanding as of the date of this prospectus. The amount of the coverage deficiency was $71.7 million, $46.4 million, $26.4 million, $26.6 million and $22.3 million for the years ended December 31, 2016, 2015, 2014,
2013 and 2012, respectively.
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PLAN OF DISTRIBUTION
We may sell the securities being offered by us in this prospectus:
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directly to purchasers or investors;
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through underwriters; or
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through a combination of any of these methods of sale.
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We and our agents and underwriters may
sell the securities being offered by us in this prospectus from time to time in one or more transactions:
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at a fixed price or prices which may be changed;
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at market prices prevailing at the time of sale;
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at prices related to such prevailing market prices; or
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Offers to purchase securities may be solicited directly by us, or by
agents designated by us, from time to time. Any such agent, which may be deemed to be an underwriter as that term is defined in the Securities Act of 1933, as amended (the “Securities Act”), involved in the offer or sale of the securities
in respect of which this prospectus is delivered will be named, and any commissions payable by us to such agent will be set forth, in the applicable prospectus supplement.
If an underwriter is, or underwriters are, utilized in the offer and sale of securities in respect of which this prospectus and the
accompanying prospectus supplement are delivered, we will execute an underwriting agreement with such underwriter(s) for the sale to it or them and the name(s) of such underwriter(s) and the terms of the transaction, including any underwriting
discounts, commissions and other items constituting compensation of the underwriters and dealers, if any, will be set forth in such prospectus supplement, which will be used by the underwriter(s) to make resales of the securities in respect of which
this prospectus and such prospectus supplement are delivered to the public. The securities will be acquired by the underwriters for their own accounts and may be sold by the underwriters from time to time in one or more transactions, including
negotiated transactions, at a fixed public offering price or at varying prices determined at the time of sale. Any public offering price and any discounts, commissions or concessions allowed or reallowed or paid to dealers may be changed from time
to time. We may grant underwriters who participate in the distribution of securities an option to purchase additional securities to cover over-allotments, if any, in connection with the distribution.
We may sell directly to, and solicit offers from institutional investors, individuals, or the public. We will describe the terms of any such
sales in the applicable prospectus supplement relating to the offering.
If a dealer is utilized in the sale of the securities in respect
of which this prospectus is delivered, we will sell such securities to the dealer, as principal. The dealer may then resell such securities to the public at varying prices to be determined by such dealer at the time of resale. The name of the dealer
and the terms of the transaction will be identified in the applicable prospectus supplement relating to the offering.
If an agent is used
in an offering of securities being offered by this prospectus, the agent will be named, and the terms of the agency will be described, in the applicable prospectus supplement relating to the offering. Unless otherwise indicated in the prospectus
supplement, an agent will act on a best efforts basis for the period of its appointment.
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If indicated in the applicable prospectus supplement, we will authorize underwriters or their
agents to solicit offers by certain institutional investors to purchase our securities pursuant to contracts providing for payment and delivery at a future date. Institutional investors with which these contracts may be made include commercial and
savings banks, insurance companies, pension funds, investment companies, educational and charitable institutions and others. In all cases, these purchasers must be approved by us. The obligations of any purchaser under any of these contracts will
not be subject to any conditions except that (a) the purchase of the securities must not at the time of delivery be prohibited under the laws of any jurisdiction to which that purchaser is subject and (b) if the securities are also being
sold to underwriters, we must have sold to these underwriters the securities not subject to delayed delivery. Underwriters and other agents will not have any responsibility in respect of the validity or performance of these 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.
Certain of the underwriters, dealers or agents utilized by us in any offering may be
customers of, including borrowers from, engage in transactions with, and perform services for us or one or more of our affiliates in the ordinary course of business. Underwriters, dealers, agents and other persons may be entitled, under agreements
which may be entered into with us, to indemnification against and contribution toward certain civil liabilities, including liabilities under the Securities Act. The terms of any indemnification provisions will be set forth in a prospectus
supplement.
Until the distribution of the securities is completed, rules of the Securities and Exchange Commission may limit the ability
of the underwriters and certain selling group members, if any, to bid for and purchase the securities. As an exception to these rules, the representatives of the underwriters, if any, are permitted to engage in certain transactions that stabilize
the price of the securities in accordance with Regulation M, but only in the case of a fixed-price offering. Such transactions may consist of bids or purchases for the purpose of pegging, fixing or maintaining the price of the securities.
If underwriters create a short position in the securities in connection with the offering thereof (i.e., if they sell more securities than are
set forth on the cover page of the applicable prospectus supplement), the representatives of such underwriters may reduce that short position by purchasing securities in the open market. Any such representatives also may elect to reduce any short
position by exercising all or part of any over-allotment option described in the applicable prospectus supplement.
Any such
representatives also may impose a penalty bid on certain underwriters and selling group members. This means that if the representatives purchase securities in the open market to reduce the underwriters’ short position or to stabilize the price
of the securities, they may reclaim the amount of the selling concession from the underwriters and selling group members who sold those shares as part of the offering thereof.
In general, purchases of a security for the purpose of stabilization or to reduce a syndicate short position could cause the price of the
security to be higher than it might otherwise be in the absence of such purchases. The
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imposition of a penalty bid might have an effect on the price of a security to the extent that it were to discourage resales of the security by purchasers in the offering.
Neither we nor any of the underwriters, if any, makes any representation or prediction as to the direction or magnitude of any effect that the
transactions described above may have on the price of the securities. In addition, neither we nor any of the underwriters, if any, makes any representation that the representatives of the underwriters, if any, will engage in such transactions or
that such transactions, once commenced, will not be discontinued without notice.
Each series of securities covered by this prospectus
would be a new issue with no established trading market, other than our common stock which is listed on the NASDAQ Global Select Market. Any shares of common stock sold pursuant to a prospectus supplement will be listed on the NASDAQ Global Select
Market or a stock exchange on which the common stock offered is then listed, subject (if applicable) to an official notice of issuance. Any underwriters for whom securities are sold by us for public offering and sale may make a market in the
securities, but the underwriters will not be obligated to do so and may discontinue any market making at any time without notice. The securities other than the common stock may or may not be listed on a national securities exchange or eligible for
quotation or trading on the NASDAQ Global Select Market. Therefore, we cannot provide any assurance to you concerning the liquidity of any of the securities covered by this prospectus.
Under the securities laws of some states, the securities registered by the registration statement that includes this prospectus may be sold in
those states only through licensed brokers or dealers.
The anticipated date of delivery of the securities offered by this prospectus will
be described in the applicable prospectus supplement relating to the offering. The securities offered by this prospectus may or may not be listed on a national securities exchange or a foreign securities exchange. We cannot give any assurances that
there will be a market for any of the securities offered by this prospectus and any prospectus supplement.
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THE SECURITIES WE MAY OFFER
The descriptions of the securities contained in this prospectus, together with the applicable prospectus supplement, summarize the material
terms and provisions of the various types of securities that we may offer. We will describe in the applicable prospectus supplement relating to any securities the particular terms of the securities offered by that prospectus supplement. If we so
indicate in a prospectus supplement, the terms of the securities may revise, amend, modify or supersede the terms we have summarized below. We will also include in the prospectus supplement information, where applicable, about material United States
federal income tax considerations relating to the securities, and the securities exchange or market, if any, on which the securities will be listed or quoted.
We may sell from time to time, in one or more offerings, one or more of the following securities:
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warrants to purchase common stock; and
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warrants to purchase preferred stock.
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These securities may be offered and sold from time to
time for an aggregate offering price not to exceed $200,000,000.
This prospectus may not be used to consummate a sale of securities
unless it is accompanied by a prospectus supplement.
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DESCRIPTION OF COMMON STOCK
For a description of the material terms and provisions of our common stock and each other class of our securities which qualifies or limits
our common stock, please see the applicable prospectus supplement, as well as the description of our capital stock in our Registration Statement on Form
8-A
dated March 31, 2000 which is incorporated by
reference in this prospectus.
DESCRIPTION OF PREFERRED STOCK
Under Delaware law and our certificate of incorporation, our board of directors is authorized, without stockholder approval, to issue shares
of preferred stock from time to time in one or more series. Our board of directors may fix the rights, preferences, privileges and restrictions of this stock. Some of the rights, preferences and privileges that our board of directors may designate
include dividend rights, conversion rights, voting rights, terms of redemption, liquidation preferences and sinking fund terms. Our board of directors may determine the number of shares constituting any series or the designation of such series. Any
or all of the rights, preferences and privileges selected by the board of directors may be greater than the rights of the common stock.
If we offer a specific series of preferred stock under this prospectus, we will describe the terms of the preferred stock in the applicable
prospectus supplement and will file a copy of the certificate of designation establishing the terms of the preferred stock with the SEC. To the extent required or applicable, this description will include:
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the title and stated value;
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the number of shares offered, the liquidation preference per share and the offering price;
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the dividend rate(s), period(s) and/or payment date(s), or method(s) of calculation for such dividends;
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whether dividends will be cumulative or
non-cumulative
and, if cumulative, the date from which dividends accumulate;
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the provisions for any sinking fund, if any;
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the provisions for redemption, if any;
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any listing of the preferred stock on any securities exchange or market;
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whether preferred stock will be convertible into or exchangeable for our common stock or other of our securities, and, if applicable, the conversion or exchange price (or how it will be calculated) and conversion or
exchange period;
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if appropriate, a discussion of any applicable U.S. federal income tax considerations;
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the relative ranking and preference of the preferred stock as to dividend rights and rights upon liquidation, dissolution or winding up of the affairs of Sangamo; and
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any other specific terms, preferences, rights, limitations or restrictions.
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The transfer
agent and registrar for any class or series of preferred stock will be set forth in the applicable prospectus supplement.
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DESCRIPTION OF DEBT SECURITIES
The following description, together with the additional information we include in any applicable prospectus supplements, summarizes the
material terms and provisions of the debt securities that we may offer under this prospectus, but is not complete. We may issue debt securities, in one or more series, as either senior or subordinated debt or as senior or subordinated convertible
debt. While the terms we have summarized below will apply generally to any future debt securities we may offer under this prospectus, we will describe the particular terms of any debt securities that we may offer in more detail in the applicable
prospectus supplement. The terms of any debt securities we offer under a prospectus supplement may revise, amend, modify or supersede the terms we describe below. As of the date of this prospectus, we have no outstanding registered debt securities.
Unless the context requires otherwise, whenever we refer to the “indentures,” we also are referring to any supplemental indentures that specify the terms of a particular series of debt securities.
We will issue any senior debt securities under the senior indenture that we will enter into with the trustee named in the senior indenture. We
will issue any subordinated debt securities under the subordinated indenture that we will enter into with the trustee named in the subordinated indenture. We have filed forms of these documents as exhibits to the registration statement, of which
this prospectus is a part, and supplemental indentures. Forms of debt securities containing the terms of the debt securities being offered, and other related documents will be filed as exhibits to the registration statement of which this prospectus
is a part or will be incorporated by reference from reports that we file with the SEC.
The indentures and the trustee will be qualified
under the Trust Indenture Act of 1939, as amended, or the Trust Indenture Act. We use the term “trustee” to refer to either the trustee under the senior indenture or the trustee under the subordinated indenture, as applicable.
The following summaries of material provisions of the senior debt securities, the subordinated debt securities and the indentures are subject
to, and qualified in their entirety by reference to, all of the provisions of the indenture applicable to a particular series of debt securities. We urge you to read the applicable prospectus supplements related to the debt securities that we may
offer under this prospectus, as well as the complete indentures that contains the terms of the debt securities. Except as we may otherwise indicate, the terms of the senior indenture and the subordinated indenture are identical.
General
The terms of each series of debt
securities will be established by or pursuant to a resolution of our board of directors and set forth or determined in the manner provided in an officers’ certificate or by a supplement indenture. Debt securities may be issued in separate
series without limitation as to aggregate principal amount. We may specify a maximum aggregate principal amount for the debt securities of any series. We will describe in the applicable prospectus supplement the terms of the series of debt
securities being offered, including:
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the principal amount being offered, and if a series, the total amount authorized and the total amount outstanding;
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any limit on the amount that may be issued;
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whether or not we will issue the series of debt securities in global form, and, if so, the terms and who the depositary will be;
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whether and under what circumstances, if any, we will pay additional amounts on any debt securities held by a person who is not a United States person for tax purposes, and whether we can redeem the debt securities if
we have to pay such additional amounts;
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the annual interest rate, 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;
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whether or not the debt securities will be secured or unsecured, and the terms of any secured debt;
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the terms of the subordination of any series of subordinated debt;
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the place where payments will be payable;
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restrictions on transfer, sale or other assignment, if any;
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our right, if any, to defer payment of interest and the maximum length of any such deferral period;
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the date, if any, after which, and the price 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;
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the date, if any, on which, and the price 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;
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whether the indenture will restrict our ability or the ability of our subsidiaries to:
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incur additional indebtedness;
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issue additional securities;
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pay dividends or make distributions in respect of our capital stock or the capital stock of our subsidiaries;
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place restrictions on our subsidiaries’ ability to pay dividends, make distributions or transfer assets;
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make investments or other restricted payments;
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sell or otherwise dispose of assets;
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enter into sale-leaseback transactions;
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engage in transactions with stockholders or affiliates;
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issue or sell stock of our subsidiaries; or
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effect a consolidation or merger;
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whether the indenture will require us to maintain any interest coverage, fixed charge, cash flow-based, asset-based or other financial ratios;
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a discussion of certain material or special United States federal income tax considerations applicable to the debt securities;
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information describing any book-entry features;
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provisions for a sinking fund purchase or other analogous fund, if any;
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the applicability of the provisions in the indenture on discharge;
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whether the debt securities are to be offered at a price such that they will be deemed to be offered at an “original issue discount” as defined in paragraph (a) of Section 1273 of the Internal
Revenue Code of 1986, as amended;
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the denominations in which we will issue the series of debt securities, if other than denominations of $1,000 and any integral multiple thereof;
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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; and
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any other specific terms, preferences, rights or limitations of, or restrictions on, the debt securities, including any additional events of default or covenants provided with respect to the debt securities, and any
terms that may be required by us or advisable under applicable laws or regulations.
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Conversion or Exchange Rights
We will set forth in the applicable prospectus supplement the terms on which a series of debt securities may be convertible into or
exchangeable for our common stock, our preferred stock or other securities (including securities of a third-party). We will include provisions as to whether conversion or exchange is mandatory, at the option of the holder or at our option. We may
include provisions pursuant to which the number of shares of our common stock, our preferred stock or other securities (including securities of a third-party) that the holders of the series of debt securities receive would be subject to adjustment.
Consolidation, Merger or Sale
Unless we provide otherwise in the prospectus supplement applicable to a particular series of debt securities, the indentures will not contain
any covenant that restricts our ability to merge or consolidate, or sell, convey, transfer or otherwise dispose of all or substantially all of our assets.
Events of Default under the Indenture
Unless we provide otherwise in the prospectus supplement applicable to a particular series of debt securities, the following are events of
default under the indentures with respect to any series of debt securities that we may issue:
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if we fail to pay interest when due and payable and our failure continues for 90 days and the time for payment has not been extended;
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if we fail to pay the principal, premium or sinking fund payment, if any, when due and payable at maturity, upon redemption or repurchase or otherwise, and the time for payment has not been extended;
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if we fail to observe or perform any other covenant contained in the debt securities or the indentures, other than a covenant specifically relating to another series of debt securities, and our failure continues for 90
days after we receive notice from the trustee or we and the trustee receive notice from the holders of at least 51% in aggregate principal amount of the outstanding debt securities of the applicable series; and
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if specified events of bankruptcy, insolvency or reorganization occur.
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We will describe in each applicable
prospectus supplement any additional events of default relating to the relevant series of debt securities.
If an event of default with
respect to debt securities of any series occurs and is continuing, other than an event of default specified in the last bullet point above, the trustee or the holders of at least 51% in aggregate principal amount of the outstanding debt securities
of that series, by notice to us in writing, and to the trustee if notice is given by such holders, may declare the unpaid principal, premium, if any, and accrued interest, if any, due and payable immediately. If an event of default specified in the
last bullet point above occurs with respect to us, the unpaid principal, premium, if any, and accrued interest, if any, of each issue of debt securities then outstanding shall be due and payable without any notice or other action on the part of the
trustee or any holder.
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Subject to the terms of the indentures, the holders of a majority in principal amount of the
outstanding debt securities of an affected series may waive any default or event of default with respect to the series and its consequences, except defaults or events of default regarding payment of principal, premium, if any, or interest, unless we
have cured the default or event of default in accordance with the indenture. Any waiver shall cure the default or event of default.
Subject to the terms of the indentures, if an event of default under an indenture shall occur and be continuing, the trustee will be under no
obligation to exercise any of its rights or powers under such indenture at the request or direction of any of the holders of the applicable series of debt securities, unless such holders have offered the trustee reasonable indemnity or security
satisfactory to it against any loss, liability or expense. The holders of a majority in principal amount of the outstanding debt securities of any series will have the right to direct the time, method and place of conducting any proceeding for any
remedy available to the trustee, or exercising any trust or power conferred on the trustee, with respect to the debt securities of that series, provided that:
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the direction so given by the holder is not in conflict with any law or the applicable indenture; and
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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.
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The indentures provide that if an event of default has occurred and is continuing, the trustee will be required in the
exercise of its powers to use the degree of care that a prudent person would use in the conduct of its own affairs. The trustee, however, may refuse to follow any direction that conflicts with law or the indenture, or that the trustee determines is
unduly prejudicial to the rights of any other holder of the relevant series of debt securities, or that would involve the trustee in personal liability. Prior to taking any action under the indentures, the trustee will be entitled to indemnification
against all costs, expenses and liabilities that would be incurred by taking or not taking such action.
Modification of Indenture; Waiver
Subject to the terms of the indenture for any series of debt securities that we may issue, we and the trustee may change an indenture without
the consent of any holders with respect to the following specific matters:
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to fix any ambiguity, defect or inconsistency in the indenture;
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to comply with the provisions described above under “Description of Debt Securities—Consolidation, Merger or Sale”;
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to comply with any requirements of the SEC in connection with the qualification of any indenture under the Trust Indenture Act;
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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;
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to provide for the issuance of and establish the form and terms and conditions of the debt securities of any series as provided under “Description of Debt Securities—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;
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to evidence and provide for the acceptance of appointment hereunder by a successor trustee;
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to provide for uncertificated debt securities and to make all appropriate changes for such purpose;
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to add to our covenants such new covenants, restrictions, conditions or provisions for the benefit of the holders, 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 to us in the indenture; or
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to change anything that does not adversely affect the interests of any holder of debt securities of any series in any material respect.
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In addition, under the indentures, the rights of holders of a series of debt securities may be changed by us and the trustee with the written
consent of the holders of at least a majority in aggregate principal amount of the outstanding debt securities of each series that is affected. However, subject to the terms of the indenture for any series of debt securities that we may issue or
otherwise provided in the prospectus supplement applicable to a particular series of debt securities, we and the trustee may only make the following changes with the consent of each holder of any outstanding debt securities affected:
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extending the stated maturity of the series of debt securities;
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reducing the principal amount, reducing the rate of or extending the time of payment of interest, or reducing any premium payable upon the redemption or repurchase of any debt securities; or
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reducing the percentage of debt securities, the holders of which are required to consent to any amendment, supplement, modification or waiver.
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Discharge
Each indenture provides that,
subject to the terms of the indenture and any limitation otherwise provided in the prospectus supplement applicable to a particular series of debt securities, we can elect to be discharged from our obligations with respect to one or more series of
debt securities, except for specified obligations, including obligations to:
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register the transfer or exchange of debt securities of the series;
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replace stolen, lost or mutilated debt securities of the series;
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maintain paying agencies;
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recover excess money held by the trustee;
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compensate and indemnify the trustee; and
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appoint any successor trustee.
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In order to exercise our rights to be discharged, we must
deposit with the trustee money or government obligations sufficient to pay all the principal of, any premium and interest on, the debt securities of the series on the dates payments are due.
Form, Exchange and Transfer
We will
issue the debt securities of each series only in fully registered form without coupons and, unless we otherwise specify in the applicable prospectus supplement, in denominations of $1,000 and any integral multiple thereof. The indentures provide
that we may issue debt securities of a series in temporary or permanent global form and as book-entry securities that will be deposited with, or on behalf of, The Depository Trust Company or another depositary named by us and identified in a
prospectus supplement with respect to that series. See “Legal Ownership of Securities” below for a further description of the terms relating to any book-entry securities.
At the option of the holder, subject to the terms of the indentures and the limitations applicable to global securities described in the
applicable prospectus supplement, the holder of the debt securities of any series can exchange the debt securities for other debt securities of the same series, in any authorized denomination and of like tenor and aggregate principal amount.
Subject to the terms of the indentures and the limitations applicable to global securities set forth in the applicable prospectus supplement,
holders of the debt securities may present the debt securities for exchange or
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for registration of transfer, duly endorsed or with the form of transfer endorsed thereon duly executed if so required by us or the security registrar, at the office of the security registrar or
at the office of any transfer agent designated by us for this purpose. Unless otherwise provided in the debt securities that the holder presents for transfer or exchange, we will make no service charge for any registration of transfer or exchange,
but we may require payment of any taxes or other governmental charges.
We will name in the applicable prospectus supplement the security
registrar, and any transfer agent in addition to the security registrar, that we initially designate for any debt securities. We may at any time designate additional transfer agents or rescind the designation of any transfer agent or approve a
change in the office through which any transfer agent acts, except that we will be required to maintain a transfer agent in each place of payment for the debt securities of each series.
If we elect to redeem the debt securities of any series, we will not be required to:
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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
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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.
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Information Concerning the Trustee
The
trustee, other than during the occurrence and continuance of an event of default under an indenture, undertakes to perform only those duties as are specifically set forth in the applicable indenture and is under no obligation to exercise any of the
powers given it by the indentures at the request of any holder of debt securities unless it is offered reasonable security and indemnity against the costs, expenses and liabilities that it might incur. However, upon an event of default under an
indenture, the trustee must use the same degree of care as a prudent person would exercise or use in the conduct of his or her own affairs.
Payment
and Paying Agents
Unless we otherwise indicate in the applicable prospectus supplement, we will make payment of the interest on any
debt securities on any interest payment date to the person in whose name the debt securities, or one or more predecessor securities, are registered at the close of business on the regular record date for the interest.
We will pay principal of and any premium and interest on the debt securities of a particular series at the office of the paying agents
designated by us, except that unless we otherwise indicate in the applicable prospectus supplement, we will make interest payments by check that we will mail to the holder or by wire transfer to certain holders. Unless we otherwise indicate in the
applicable prospectus supplement, we will designate the corporate trust office of the trustee as our sole paying agent for payments with respect to debt securities of each series. We will name in the applicable prospectus supplement any other paying
agents that we initially designate for the debt securities of a particular series. We will maintain a paying agent in each place of payment for the debt securities of a particular series.
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DESCRIPTION OF WARRANTS
We may issue warrants to purchase shares of common stock or shares of preferred stock. The warrants may be issued independently or together
with any other securities and may be attached to or separate from the other securities. Each series of warrants may be issued under a separate warrant agreement to be entered into between us and a bank or trust company, as warrant agent. The
warrants will be evidenced by warrant certificates. Unless otherwise specified in the prospectus supplement, the warrant certificates may be traded separately from the securities with which the warrant certificates were issued. Warrant certificates
may be exchanged for new warrant certificates of different denominations at the office of an agent that we will appoint. Until a warrant is exercised, the holder of a warrant does not have any of the rights of a holder of our securities and is not
entitled to any payments on any securities issuable upon exercise of the warrants.
The prospectus supplement relating to a series of
warrants will describe the specific terms of the warrants including the following:
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the title of the warrants;
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the aggregate number of the warrants;
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the price or prices at which the warrants will be issued and the currency in which the price for the warrants may be paid;
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the price at which and the currency in which the securities purchasable upon exercise of the warrants may be purchased and the various factors considered in determining that price;
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the dates on which the right to exercise the warrants will commence and expire and whether the exercise of warrants will be at the option of holders, at our option, or automatic;
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whether the warrants are exercisable by payment of cash, surrender of other securities, or both;
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provisions for changes to or adjustments in the exercise price of the warrants;
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if applicable, the minimum or maximum amount of the warrants that may be exercised at any one time;
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if applicable, the designation and terms of the series of preferred stock with which the warrants are issued;
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if applicable, the designation and terms of the other securities with which the warrants are issued and the number of the warrants issued with each such other security;
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if applicable, the date on and after which the warrants and other related securities will be separately transferable;
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if applicable, any anti-dilution protection against future issuances;
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whether the warrants will be issued in registered form or bearer form;
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information with respect to book-entry procedures, if any;
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if applicable, a discussion of material U.S. federal income tax considerations; and
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any other terms of the warrants, including terms, procedures, and limitations relating to the exchange or exercise of the warrants.
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35
LEGAL MATTERS
The legality of the securities offered by this prospectus has been passed upon for us by Morgan, Lewis & Bockius LLP, San Francisco,
California.
EXPERTS
Ernst & Young LLP, independent registered public accounting firm, has audited our consolidated financial statements included in our
Annual Report on Form
10-K
for the year ended December 31, 2016, and the effectiveness of our internal control over financial reporting as of December 31, 2016, as set forth in their reports, which
are incorporated by reference in this prospectus and elsewhere in the registration statement. Our financial statements are incorporated by reference in reliance on Ernst & Young LLP’s reports, given on their authority as experts in
accounting and auditing.
WHERE YOU CAN FIND MORE INFORMATION
This prospectus is part of a registration statement that we filed with the SEC. The registration statement that contains this prospectus,
including the exhibits to the registration statement, contains additional information about us and the securities offered by this prospectus.
We file annual, quarterly and current reports, proxy statements and other information with the SEC. You may read and copy any document we file
at the SEC’s Public Reference Room at 100 F. Street, N.E., Washington, D.C. 20549. Please call the SEC at
1-800-SEC-0330
for
further information on the Public Reference Room. Our public filings, including reports, proxy and information statements, are also available on the SEC’s web site at http://www.sec.gov. We maintain a website at www.sangamo.com. The information
contained on our website is not incorporated by reference in this prospectus and any accompanying prospectus supplement, and you should not consider it a part of this prospectus and any accompanying prospectus supplement.
36
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The SEC allows us to “incorporate by reference” information from other documents that we file with them, which means that we can
disclose important information by referring to those documents. The information incorporated by reference is considered to be part of this prospectus, and information that we file later with the SEC will automatically update and supersede this
information. We incorporate by reference into this prospectus the documents listed below, and any future filings (other than the portions thereof deemed to be “furnished” to the SEC pursuant to Item 2.02 or Item 7.01 of Current
Report on Form
8-K)
we make with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), until we have sold all of the securities to
which this prospectus relates or the offering is otherwise terminated, including any such filing prior to the effectiveness of this registration statement:
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our annual report on Form
10-K
for the year ended December 31, 2016, filed with the Commission on February 28, 2017;
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our quarterly report on Form
10-Q
for the quarter ended March 31, 2017;
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our current reports on Form
8-K
filed with the SEC on January 6, February 24, February 28, March 20, May 10, 2017 (except Item 2.02), May 26, 2017
and June 6, 2017;
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our definitive proxy statement filed in connection with our 2017 Annual Meeting of Stockholders filed with the Commission on April 25, 2017; and
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the description of our common stock contained in our registration statement on Form
8-A
filed under Section 12(g) of the Exchange Act with the SEC on March 31, 2000,
including any amendment or reports filed for the purpose of updating such description.
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To the extent that any statement in
this prospectus is inconsistent with any statement that is incorporated by reference and that was made on or before the date of this prospectus, the statement in this prospectus shall supersede such incorporated statement. The incorporated statement
shall not be deemed, except as modified or superseded, to constitute a part of this prospectus or the registration statement. Statements contained in this prospectus as to the contents of any contract or other document are not necessarily complete
and, in each instance, we refer you to the copy of each contract or document filed as an exhibit to the registration statement.
We will
furnish without charge to each person, including any beneficial owner, to whom a copy of this prospectus is delivered, upon written or oral request, a copy of any or all of the information that has been incorporated into this prospectus by reference
(except exhibits, unless they are specifically incorporated into this prospectus by reference) but not delivered with this prospectus. You should direct any requests for copies to:
Sangamo Therapeutics, Inc.
501
Canal Boulevard
Richmond, CA 94804
(510) 970-6000
37
10,000,000 shares
Sangamo Therapeutics, Inc.
Common Stock
Joint book-running
managers
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Cowen
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Wells Fargo Securities
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June 21, 2017
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