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As filed with the Securities and Exchange Commission on July 16, 2015
Registration No. 333-205124
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Amendment No. 4
The Securities Act of 1933
(Exact name of Registrant as specified in its charter)
|(State or other jurisdiction of|
incorporation or organization)
| ||(Primary Standard Industrial|
Classification Code Number)
| ||(I.R.S. Employer|
2533 South Coast Highway 101, Suite 210
Cardiff-by-the-Sea, California 92007
(Address, including zip code, and telephone number, including area code, of Registrants principal executive offices)
Patrick Soon-Shiong, M.D., FRCS (C), FACS
Chairman and Chief Executive Officer
2533 South Coast Highway 101, Suite 210
Cardiff-by-the-Sea, California 92007
(Name, address, including zip code, and telephone number, including area code, of agent for service)
Martin J. Waters
Daniel R. Koeppen
Wilson Sonsini Goodrich & Rosati, P.C.
12235 El Camino Real, Suite 200
San Diego, California 92130
Barry J. Simon, M.D.
President and Chief Operating Officer
2533 South Coast Highway 101, Suite 210
Cardiff-by-the-Sea, California 92007
Sean M. Clayton
Charles S. Kim
Kristin E. VanderPas
1333 2nd Street, Suite 400
Santa Monica, California 90401
Approximate date of commencement of proposed sale to the public: As soon as practicable after this registration statement becomes effective.
If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933 check the following box:
If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.
If this Form is a post effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.
If this Form is a post effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act. (Check one):
|Large accelerated filer|| || ||Accelerated filer|| |
|Non-accelerated filer|| || (do not check if a smaller reporting company)|| ||Smaller reporting company|| |
CALCULATION OF REGISTRATION FEE
Title of Each Class of
Securities to be Registered
Common Stock, $0.0001 par value per share
| ||8,050,000|| ||$23.00|| ||$185,150,000|| ||$21,515|
|(1) ||Includes the additional shares that the underwriters have the right to purchase from the Registrant, if any. |
|(2) ||Estimated solely for the purpose of computing the amount of the registration fee pursuant to Rule 457(a) under the Securities Act of 1933, as amended. |
|(3) ||The Registrant previously paid $20,045 of the registration fee in connection with the initial filing of this registration statement. |
The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.
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This is an initial public offering of shares of common stock by NantKwest, Inc. The initial public offering price is expected to be between $20.00 and $23.00 per share. Prior to this offering, there has been no public market for our common stock. We are offering 7,000,000 shares to be sold in the offering.
We have applied to list our common stock on The NASDAQ Global Select Market under the symbol NK.
Following this offering, our Chairman and Chief Executive Officer, and entities affiliated with him, will control more than a majority of the voting power of our common stock. As a result of their ownership, they will be able to control any action requiring the general approval of our stockholders, including the election of our board of directors, the adoption of amendments to our certificate of incorporation and bylaws and the approval of any merger or sale of substantially all of our assets. We will be a controlled company within the meaning of the NASDAQ corporate governance rules. See ManagementControlled Company.
We are an emerging growth company as defined under the federal securities laws and, as such, have elected to comply with certain reduced public company reporting requirements.
Investing in our common stock involves risks that are described in the Risk Factors beginning on page 17 of this prospectus.
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Public offering price
| ||$|| ||$|
Underwriting discounts and commissions(1)
| ||$|| ||$|
Proceeds to us before expenses
| ||$|| ||$|
| ||(1)||See Underwriting for a description of the compensation payable to the underwriters. |
We have granted the underwriters an option for a period of 30 days to purchase up to an additional 1,050,000 shares from us at the initial public offering price, less the underwriting discounts and commissions.
Funds managed by Franklin Templeton, existing stockholders of our company, have indicated an interest in purchasing approximately $45.0 million of shares of our common stock in this offering at the initial public offering price. In addition, entities affiliated with Dr. Patrick Soon-Shiong, our Chairman and Chief Executive Officer, have indicated an interest in purchasing up to $10.0 million of shares of our common stock in this offering at the initial public offering price. However, because indications of interest are not binding agreements or commitments to purchase, the underwriters may determine to sell more, fewer or no shares in this offering to any of these parties, or any of these parties may determine to purchase more, fewer or no shares in this offering.
In addition, an affiliate of Celgene Corporation, an existing stockholder of our company, has agreed to purchase $17.0 million of our common stock in a separate private placement concurrent with the completion of this offering at a price per share equal to the initial public offering price. The sale of such shares will not be registered under the Securities Act of 1933, as amended. The closing of this offering is not conditioned upon the closing of such concurrent private placement.
Neither the Securities and Exchange Commission nor any other regulatory body has approved or disapproved of these securities or passed upon the accuracy or adequacy of this prospectus. Any representation to the contrary is a criminal offense.
The shares will be ready for delivery on or about , 2015.
Joint Book-Running Managers
| || || || || || |
|BofA Merrill Lynch|| || ||Citigroup|| || ||Jefferies|| || ||Piper Jaffray|
MLV & Co.
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Neither we nor the underwriters have authorized anyone to provide any information or to make any representations other than those contained in this prospectus or in any free writing prospectuses we have prepared. We take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. This prospectus is an offer to sell only the shares offered hereby, but only under circumstances and in jurisdictions where it is lawful to do so. The information contained in this prospectus is current only as of its date.
For investors outside the United States: Neither we nor any of the underwriters have done anything that would permit this offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United States. You are required to inform yourselves about, and to observe any restrictions relating to, this offering and the distribution of this prospectus.
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The following summary highlights selected information contained elsewhere in this prospectus and is qualified in its entirety by the more detailed information and financial statements included elsewhere in this prospectus. It does not contain all the information that may be important to you and your investment decision. You should carefully read this entire prospectus, including the matters set forth under Risk Factors, Managements Discussion and Analysis of Financial of Financial Conditions and Results of Operations, and our financial statements and related notes included elsewhere in this prospectus. In this prospectus, unless context requires otherwise, references to we, us, our, NantKwest, or the Company refer to NantKwest, Inc.
We are a pioneering clinical-stage immunotherapy company focused on harnessing the power of the innate immune system by using the natural killer cell to treat cancer, infectious diseases and inflammatory diseases. Natural killer, or NK, cells are the bodys first line of defense due to their innate ability to rapidly seek and destroy abnormal cells, such as cancer or virally-infected cells, without prior exposure or activation by other support molecules required to activate adaptive immune cells such as T-cells.
We believe that our proprietary NK cell line, coupled with our planned integrated discovery ecosystem, uniquely positions us to implement precision cancer medicine and potentially change the current paradigm of cancer care by leveraging the advances that have evolved during the past decade and addressing newly discovered challenges of cancer. We believe that many recent advances in cancer treatments have not adequately addressed the heterogeneity of tumor cells, the large mutation load per tumor cell identified by advanced genomics sequencing technologies, and the resistance of the cancer stem cell to chemotherapy. Cancer is only recently understood to be a complex of rare diseases, with hundreds of patient-specific, cancer-promoting mutated proteins, some known and many more unknown. Identifying and targeting these mutated proteins is our strategy to overcome the challenges of cancer in the era of genomics, transcriptomics and immuno-oncology. We believe neoepitopes, which are newly discovered antigens selectively expressed on the cancer cells and not on the essential normal tissue, represent large untapped targeting opportunities for immune effector cells such as our activated NK cells.
Multiple Modes of Tumor Cell Killing. Our immuno-oncology NK platform has multiple modes to potentially induce cell death against the tumor or infected cell by: (1) direct killing by binding to stress ligands expressed by the diseased cell with the release of toxic granules directly into the tumor cell, (2) antibody mediated killing by binding to antibodies administered in combination and enhancing the cancer killing effect of the administered antibody, enabling targeted cell killing through antibody dependent cellular cytotoxicity, or ADCC, and (3) target activated killing by binding to known or newly discovered tumor-specific antigens expressed on the surface of tumor cells and inducing cell death by the release of toxic granules directly into the tumor cell, by the release of cytokines and chemokines which recruit additional innate and adaptive immune responses and by the recruitment of cytotoxic
By implementing an integrated discovery ecosystem and targeting these multiple modes of NK killing of abnormal cells, we believe we are uniquely positioned to potentially address a broad range of known and unknown cancer-promoting mutated proteins and to transform clinical cancer care. Our targeted therapeutic areas include: (1) cancer, focusing on bulky hematological cancers and solid tumors as well as cancer stem cells, (2) infectious diseases, including viral, fungal and bacterial infections, and (3) inflammatory diseases, ranging from rare inherited diseases to more prevalent autoimmune disorders.
Our Integrated Discovery Ecosystem for Precision Medicine. In order to effectively target newly discovered neoepitopes, we plan to integrate the following ecosystem to help drive the development of
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genetically modified NK cells anticipated to be directed against these cancer-promoting mutated proteins: (1) a high-speed supercomputing infrastructure to help identify both known antigens on the surface of tumor cells and neoepitopes in clinical patients suffering from cancer, in a timely manner and at large scale; (2) a next-generation genomic and transcriptomic sequencing infrastructure to identify the expression of the neoepitopes on the surface of the tumor cell; (3) a diverse library of human antibodies from which to interrogate and extract an antibody matching the neoepitope; and (4) an NK cell potentially capable of being produced as a scalable, cell-based off-the-shelf therapy without the need for patient compatibility matching.
We have assembled a team of proven, experienced and visionary leaders in biotechnology. Our team is led by Patrick Soon-Shiong, M.D., FRCS (C), FACS, our Chairman and Chief Executive Officer. Dr. Soon-Shiong was first introduced to us in 2006 when our technology was at a very early stage of development and, although we did not enter into any investment or employment agreement with him at that time or provide him with any compensation, he provided us with advice and scientific development strategies, including demonstration of activity in the clinical setting following radiation of the cells and demonstration of safety and activity following multiple infusions in patients with both solid and liquid tumors at the end stage of disease. Dr. Soon-Shiong later made an equity investment in our company in December 2014 and joined as our Chief Medical Officer in January 2015 and became our Chairman and Chief Executive Officer in March 2015. Dr. Soon-Shiong, a renowned surgeon and scientist, has pioneered novel therapies for both diabetes and cancer, published over 100 scientific papers in the United States, and issued over 95 patents on groundbreaking advancements spanning myriad fields. He performed the first encapsulated islet stem cell transplant in a diabetic patient in the United States. He invented, developed and launched the first nanoparticle delivery system of human albumin, Abraxane, now approved for metastatic breast, lung and pancreatic cancer and is expected to achieve sales of greater than $1.0 billion in 2015. Dr. Soon-Shiong was founder, Chairman and CEO of American Pharmaceutical Partners (sold to Fresenius SE for $5.7 billion in 2008), Abraxis BioScience (sold to Celgene Corporation for $3.7 billion in 2010) and NantWorks, an ecosystem of companies to create a transformative global health information and next generation pharmaceutical development network. Barry Simon, M.D., our President and Chief Operating Officer, who was our Chief Executive Officer from 2007 until March 2015, brings decades of drug development and executive leadership experience from Hoffmann-La Roche, Connetics Corp. and Immunomedics.
Prior to Dr. Soon-Shiong joining our company at the end of 2014, we focused on developing our aNK cell line, including entering into license agreements with respect to our cell line, conducting pre-clinical studies and clinical trials to evaluate the safety of our aNK cell line as a monotherapy, and filing an IND for our first product candidate. We also genetically modified our aNK cell line to develop our haNK and taNK platforms. The aNK, haNK and taNK platforms are at the center of our business strategy, and Dr. Simon oversaw the development of this technology during his time as our Chief Executive Officer. Subsequent to Dr. Soon-Shiongs arrival, he has focused on developing our strategic plan, including the development of our planned integrated discovery ecosystem and discovery, research and development of neoepitopes. Additionally, we believe that Dr. Soon-Shiongs experience and expertise will be valuable to us through all of the phases of commercializing our product candidates.
Our vision is to be the premier immunotherapy company harnessing the power of the innate immune system and the NK cell to pioneer precision medicine in the treatment of cancer, infectious diseases and inflammatory diseases. Our mission is to leverage an integrated and extensive genomics and transcriptomics discovery engine to identify antibodies targeted to newly discovered neoepitopes and to mobilize the human immune system of cancer patients to kill tumor cells and facilitate long-term remission. We expect to regularly add newly discovered neoepitopes from our discovery engine, and we believe the thousands of newly discovered antigens selectively expressed on the cancer cells and not on the essential normal tissue, will provide us with the ability to continue to create new and targeted libraries of antibodies to potentially be delivered as living drugs for metastatic cancer cells and cancer stem cells.
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Direct Killing: aNK Platform. We have developed a unique NK cell which we believe is capable of being produced as a cell-based off-the-shelf therapy, with killing potential for cancer and virally-infected cells. Unlike normal NK cells, our NK cells do not express inhibitory receptors, which diseased cells often utilize to turn off the killing function of NK cells. We have developed a unique activated NK, or aNK cell which lacks these inhibitory receptors but retains activation receptors that enable selective targeting and killing of diseased cells. The killing mechanism of our aNK cells is increased compared to normal NK cells by virtue of delivering a larger payload of compounds responsible for the direct killing of diseased cells. We believe our aNK cells can be grown at commercial scale as an on demand, living drug using our proprietary manufacturing and distribution processes.
Safety studies of aNK cells have been conducted in multiple Phase I clinical trials for a variety of bulky hematological cancers and solid tumors enrolling over 40 patients to date, with encouraging evidence of activity and durable remissions. Based on these clinical trials, we plan to develop the therapeutic applications of this aNK platform through molecular engineering of our aNK cells designed to leverage the multiple modes of killing available to aNKs, including antibody-mediated killing, our haNK platform, and antigen targeted killing, our taNK platform, described below.
Antibody-Mediated Killing: haNK Platform. We have genetically modified our aNK cells to incorporate high-affinity CD16 receptors, which bind to antibodies. These high-affinity NK, or haNK, cells are designed to directly bind to externally administered monoclonal antibodies, or mAbs, such as Herceptin, Erbitux and Rituxan and may be able to enhance the cancer killing effect of the externally administered mAbs, enabling targeted cell killing through ADCC. mAbs are prevalently used to treat cancer and generate over $50.0 billion in reported annual sales. We believe, based on currently available information, that only approximately 10% to 20% of the addressable patient population for mAb therapies carry high-affinity CD16 receptors. This implies that our haNK product candidates may have significant market potential as combination therapies to potentially address a large number of patients who have poor responses to mAbs.
Target Activated Killing: taNK Platform. We have genetically modified our aNKs to incorporate chimeric antigen receptors, or CARs, to target specific antigens on the surface of abnormal cells. These target activated Natural Killer, or taNK, cells are designed to directly bind to tumor-specific antigens in multiple bulky hematological cancers and solid tumors and induce cell death by the release of toxic granules directly into the tumor cell, by the release of cytokines and chemokines which recruit additional innate and adaptive immune responses and by the recruitment of cytotoxic T-cells. These tumor-specific antigens can be divided into the following four classes, which can be targeted by our taNK platform: (1) checkpoint inhibitors expressed on the surface of tumor cells such as PDL1; (2) well-established tumor surface antigens such as HER-2, CD33 and ROR1; (3) newly discovered neoepitopes; and (4) novel surface receptors associated with cancer stem cells.
Potential Advantages of Our aNK Platform over T-Cell and Other Immunotherapies
The immune system has two components: innate immune cells, such as NK cells, which are always switched on to attack diseased cells, and adaptive immune cells, such as T-cells, which are mobilized to mount a delayed response. Our proprietary aNK platform is specifically designed to potentially address many of the limitations associated with current adaptive autologous cellular immunotherapies, including the benefits highlighted below. We believe key limitations of adaptive autologous immunotherapy include the need to retrieve non-compromised immune cells from a cancer patient and the requirement for a complex and costly manufacturing process to develop the therapy. As a consequence of this need to harvest active T-cells, current Phase I clinical trials for autologous CAR-T cell therapies in large part enroll patients from highly selected, advanced stage disease in hematological cancers. In contrast, our allogeneic, off-the-shelf NK cells do not rely on the patients own immune system, which is often compromised, to achieve their therapeutic effect.
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Some of the key potential advantages of our aNK platform are highlighted below.
| |||| ||Innate immune response. aNK cells are always activated and can naturally detect and rapidly destroy a wide variety of diseased cells without prior exposure to pathogens, antigens or activation by stimulatory molecules. In contrast, the adaptive immune system requires co-stimulation for activation, resulting in delayed killing. |
| |||| ||Promotion of adaptive immune response. aNK cells stimulate the adaptive component of the immune system by producing chemokines and other molecules that activate and recruit adaptive immune cells, including T-cells, to attack the diseased cells. |
| |||| ||Capability of activating both innate and adaptive immune system with a single agent. By combining a PDL1 antibody as a CAR in our NK cells, our PDL1.taNK product candidate, we believe that we have the ability to both activate T-cells and induce direct killing by NK cells simultaneously with the administration of a single therapy. |
| |||| ||Wide therapeutic potential across multiple tumor types and even late-stage disease. In preclinical studies and Phase I safety clinical trials to date, aNK cells have demonstrated activity in a spectrum of cancers, including bulky hematological cancers and solid tumors, even in late-stage cancer patients who have failed multiple rounds of chemotherapy, radiation and stem cell transplantation. |
| |||| ||Ability to attack cancer stem cells. aNK cells have been shown in preclinical studies to attack cancer stem cells, which are resistant to conventional chemotherapy. |
| |||| ||Application in diseases beyond cancer. We believe aNK cells have the potential to treat diseases beyond cancer such as infectious diseases and inflammation because of the inherent ability of NK cells to kill virally infected and abnormal cells. Preclinical studies in Ebola virus demonstrate this capability. |
| |||| ||Well tolerated. aNK cells are hypo-immunogenic and have shown no dose limiting toxicities in over 40 patients who have received therapy to date, even when some patients received as many as 18 infusions of aNK cells over six cycles. In contrast, Phase I clinical trials of CAR-T cell therapy report severe adverse toxicities of cytokine release syndrome and neurotoxicity in a number of patients. |
| |||| ||Ease of administration. aNK cells may be administrable in outpatient facilities, offering physicians the flexibility to titrate and re-dose therapy based on patient tolerability and need. In contrast, CAR-T cell therapy is a complex and costly procedure, at times requiring hospitalization, pre-conditioning and intensive care unit admission following severe adverse toxicities associated with cytokine release syndrome. |
| |||| ||Virtually universal patient compatibility. aNK cells do not require patient-donor matching or a minimum level of patient immuno-competence. |
| |||| ||Low-cost, efficient and scalable manufacturing. aNK cells can be cryopreserved, stockpiled and readily accessed on demand from what we believe is the worlds only current good manufacturing practices, or cGMP, compliant NK cell bank, a proprietary asset of our company. |
Our Product Candidate Pipeline
We plan to use the data from the Phase I clinical trials of aNK cells conducted to date to serve as the foundation of the development strategy for our three distinct modes of tumor cell killing, each with its own attributes, targeted therapeutic areas and pipeline.
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Direct Killing. Our aNK cells have activation receptors that naturally bind to stress-induced proteins. They possess a unique property of resistance to viral counterattack. We are developing our aNK product candidates as monotherapies for the treatment of virally-induced cancers such as polyomavirus induced Merkel cell carcinoma, human Papillomavirus, or HPV, induced cervical cancer and head and neck cancer as well as infectious diseases such as Ebola and other viral, fungal and bacterial infections. We are currently initiating a Phase II clinical trial for our aNK product candidate for Merkel cell carcinoma. Additionally, we intend to pursue combination therapies with low-dose cytotoxic agents and radiation therapy that may augment the ability of our aNK cells to attack cancer cells through these multiple combined points of attack.
Antibody-Mediated Killing. Our haNK cells are genetically engineered to express high-affinity CD16 receptors, designed to enhance the therapeutic efficacy of antibodies through ADCC. We intend to develop our haNK product candidates as combination therapies with widely-used FDA-approved mAbs such as Herceptin, Erbitux and Rituxan. We plan to initiate a Phase I/II clinical trial for our product candidate Herceptin-haNK in 2016. We believe that our haNK product candidates may allow us to potentially address larger markets and earlier lines of treatment. Some biopharmaceutical companies have used our haNK cells as a lot release quality control test for their therapeutic antibodies. If these companies develop and launch these antibodies, we intend to leverage the development performed by these biopharmaceutical companies who have licensed our haNK cells for non-therapeutic use by initiating studies of our haNK product candidates in combination with these antibodies, with the goal of the combination potentially enhancing the activity of these antibodies in patients with low affinity CD16 receptors. We believe this enhanced efficacy provides a rationale for studying haNK cell combinations with these new antibodies, whether during the development phase or after commercial launch by the biopharmaceutical company. We plan to accelerate clinical development of our aNK and haNK product candidates by entering into Phase II and Phase II/III clinical trials with our product candidates in combination with marketed drugs.
Target Activated Killing. Our taNK cells are genetically engineered to directly bind to tumor surface antigens by incorporating CARs to target specific antigens on the surface of abnormal cells. We believe our taNK product candidates may be able to treat patients with bulky hematological cancers and solid tumors, areas in which CAR-T cell therapies have been challenged. We plan to initiate Phase I/II clinical trials for our CD33.taNK product candidate for acute myeloid leukemia, or AML, and our PDL1.taNK product candidate for bulky hematological cancers and solid tumors, in 2016.
We are planning to advance a broad pipeline of aNK, haNK and taNK product candidates with the goal of addressing a wide spectrum of diseases ranging from orphan diseases to more prevalent indications. The following chart highlights some of our near-term opportunities.
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Accelerated Clinical Development Plan
We plan to advance our aNK and haNK programs by entering into Phase II and Phase II/III clinical trials with our product candidates in combination with commercially marketed drugs and select product candidates in late-stage development, both mAbs and chemotherapy agents.
mAb combinations. We plan to pursue opportunities for our aNK and haNK programs with pharmaceutical companies for commercially approved mAbs and select late-stage mAbs in development. Over 40 biopharmaceutical companies have licensed our haNK cells for non-therapeutic use in order to select and validate their monoclonal antibodies for development. Certain biopharmaceutical companies have also used our haNK cells as a lot release quality control test for their therapeutic mAbs. Our accelerated strategy is to leverage the development performed by these biopharmaceutical companies by initiating investigator-initiated and company-sponsored Phase II and Phase II/III clinical trials of our haNK product candidates in combination with commercially approved mAbs and select late-stage mAbs in development, with the combination potentially enhancing the activity of these antibodies in patients with low affinity CD16 receptors.
Chemotherapy combinations. A large number of monoclonal antibodies and chemotherapy drugs are being marketed for multiple indications. Published data shows that chemotherapy agents such as 5FU, cyclophosphamide and paclitaxel, when administered in low doses, generally enhance the immune system. We plan to accelerate clinical development of our aNK product candidates by entering into investigator-initiated and company-sponsored Phase II and Phase II/III trials of these product candidates administered in combination with approved chemotherapy agents. The table below describes our accelerated clinical development plan for aNK and haNK product candidates in combination with commercially marketed drugs and select late-stage product candidates in development.
Our goal is to become the leader in the field of immunotherapy by changing the paradigm of care to precision medicine through harnessing the power of the innate immune system, the natural killer cell, to treat cancer, infectious diseases and inflammatory diseases. The key elements of our strategy include:
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Utilize the multiple modes of killing by innate immune therapy. We plan to pursue a comprehensive clinical development plan designed to maximize the commercial potential and clinical knowledge of aNK cells and the role of innate and adaptive immunotherapy as the backbone in the treatment of cancer, as monotherapy and in combination with chemotherapy,
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radiation and surgical therapies. We intend to pursue accelerated regulatory approval pathways and attempt to obtain orphan drug status and breakthrough therapy designation, where appropriate, as well as pursue large market opportunities in many solid tumors.
| |||| ||Leverage our integrated discovery engine to discover neoepitopes. Through our strategic collaborations with affiliates of NantWorks and with Sorrento, we plan to identify both known antigens on the surface of tumor cells and neoepitopes in clinical patients, identify the expression of the neoepitopes on the surface of the tumor cell and interrogate a large diverse library of human antibodies and extract an antibody matching the neoepitope. Through this cohesive and expansive discovery engine, we plan to identify antibodies to target newly discovered neoepitopes, thereby driving the development of our product candidate pipeline and establishing just in time precision medicine. |
| |||| ||Pursue opportunities with pharmaceutical companies for commercially approved mAbs and select late-stage mAbs in development. Over 40 biopharmaceutical companies have licensed our haNK cells for non-therapeutic use, including as a lot release quality control test for therapeutic antibodies, for them to select and validate their mAbs for development. As a result of these prior non-clinical collaborations for assay testing, we plan to leverage the development performed by these biopharmaceutical companies for therapeutic purposes by initiating studies of our haNK product candidates in combination with these antibodies, with the combination potentially enhancing the activity of these antibodies in patients with low affinity CD16 receptors. |
| |||| ||Accelerate clinical development of aNK and haNK by entering into Phase II and Phase II/III clinical trials with our product candidates in combination with marketed drugs and select late-stage product candidates. Published data show that therapeutic mAbs generally have enhanced activity in patients with high-affinity NK cells and that chemotherapy agents such as 5FU, cyclophosphamide and paclitaxel, when administered in low doses, generally enhance the immune system. We plan to accelerate clinical development of our haNK product candidates by entering into investigator-initiated and company-sponsored Phase II and Phase II/III clinical trials of our aNK product candidates administered in combination with commercially approved mAbs and select late-stage mAbs in development or our aNKs in combination with approved chemotherapy agents. |
| |||| ||Establish low-cost, scalable manufacturing capabilities to support late-stage clinical trials and global commercialization. We believe our aNK cells offer a unique advantage of a simplified, on-demand manufacturing process that is relatively easy to scale. We are building a state-of-the-art, cell-based manufacturing facility with the capacity to support large-scale clinical trials and commercialization. We are developing novel manufacturing methods, both in equipment utilizing state-of-the-art optics and proprietary media designed to maximize the attributes of our NK platform. |
| |||| ||Extend our NK platform to address diseases beyond cancer. We believe our aNK cells have the potential to treat diseases beyond cancer such as infectious and inflammatory diseases because of the inherent role of NK cells to kill virally infected and abnormal cells. Preclinical studies in Ebola virus demonstrate this capability. In addition to Ebola, we plan to investigate and develop our aNK cells for the treatment of HIV, tuberculosis and influenza, among others. |
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Risks Associated with Our Business
Our business is subject to numerous risks, as more fully described in the section entitled Risk Factors immediately following this prospectus summary. You should read these risks before you invest in our common stock. We may be unable, for many reasons, including those that are beyond our control, to implement our business strategy. In particular, risks associated with our business include:
| |||| ||We are a clinical-stage biopharmaceutical company with a limited operating history and have incurred significant losses since our inception, and we anticipate that we will continue to incur losses for the foreseeable future; |
| |||| ||The foundation of our business is based upon the success of our aNK cells as a technology platform. Our aNK platform and other product candidate families, including genetically modified taNK and haNK product candidates, will require significant additional clinical testing before we can potentially seek regulatory approval and launch commercial sales; |
| |||| ||Utilizing aNK cells represents a novel approach to immunotherapy, including cancer treatment, and we must overcome significant challenges in order to successfully develop, commercialize and manufacture our aNK and other product candidates; |
| |||| ||Even if we successfully develop and commercialize our aNK product candidate for Merkel cell carcinoma, we may not be successful in developing and commercializing our other product candidates and our commercial opportunities may be limited; |
| |||| ||We may not be able to file investigational new drug applications, or INDs, to commence additional clinical trials on the timelines we expect, and even if we are able to, the FDA may not permit us to proceed in a timely manner, or at all; |
| |||| ||We face significant competition in the biopharmaceutical industry, and many of our competitors have substantially greater experience and resources than we have; |
| |||| ||Our business plan involves the creation of a complex integrated ecosystem capable of addressing a wide range of indications. As a result, our future success depends on our ability to prioritize among many different opportunities; |
| |||| ||Our planned ecosystem is to be comprised of multiple novel technologies that have never been tested in combination with our product candidates, and we do not know whether our attempts to use them in combination will be effective; |
| |||| ||Clinical drug development involves a lengthy and expensive process with an uncertain outcome, results of earlier studies and clinical trials may not be predictive of future clinical trial results, we may not be able to rely on the aNK Phase I clinical trial data for our other product candidates, and our clinical trials may fail to adequately demonstrate substantial evidence of safety and efficacy of our product candidates; |
| |||| ||We do not have any therapeutic products that are approved for commercial sale. Our ability to generate revenue from product sales and become profitable depends significantly on our success in a number of factors; |
| |||| ||We will need to obtain substantial additional financing to complete the development and any commercialization of our product candidates; |
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| |||| ||Dr. Soon-Shiong, our Chairman and Chief Executive and our principal stockholder, has significant interests in other companies which may conflict with our interests; |
| |||| ||Our Chairman and Chief Executive Officer and entities affiliated with him collectively own and will own after this offering a significant majority of our common stock and will exercise significant influence over matters requiring stockholder approval, regardless of the wishes of other stockholders; and |
| |||| ||We have identified certain material weaknesses in our internal control over financial reporting. Failure to maintain effective internal controls could cause our investors to lose confidence in us and adversely affect the market price of our common stock. If our internal controls are not effective, we may not be able to accurately report our financial results or prevent fraud. |
Concurrent Private Placement
An affiliate of Celgene Corporation, an existing stockholder of our company, has agreed to purchase $17.0 million of our common stock in a separate private placement concurrent with the completion of this offering at a price per share equal to the initial public offering price. The sale of such shares will not be registered under the Securities Act of 1933, as amended, or the Securities Act. The closing of this offering is not conditioned upon the closing of such concurrent private placement. The underwriters will not receive any discount, commission, or other compensation in connection with the concurrent private placement.
We were incorporated on October 7, 2002 in the state of Illinois under the name ZelleRx Corporation. On January 22, 2010, we changed our name to Conkwest, Inc. In March 2014, we formed Conkwest, Inc., our wholly owned subsidiary in the state of Delaware, or Conkwest Delaware, for the purposes of changing the state of our incorporation to the state of Delaware. In March 2014, we merged with and into Conkwest Delaware, with Conkwest Delaware surviving the merger. On July 10, 2015, we changed our name to NantKwest, Inc. Our principal executive offices are located at The Plastino Building, 2533 South Coast Highway 101, Suite 210, Cardiff-by-the-Sea, California 92007 and our telephone number is Our corporate website address is www.nantkwest.com. Information contained on or accessible through our website is not a part of this prospectus, and the inclusion of our website address in this prospectus is an inactive textual reference only.
This prospectus contains references to our trademarks and to trademarks belonging to other entities. Solely for convenience, trademarks and trade names referred to in this prospectus, including logos, artwork and other visual displays, may appear without the ® or TM symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensor to these trademarks and trade names. We do not intend our use or display of other companies trade names or trademarks to imply a relationship with, or endorsement or sponsorship of us by, any other companies.
Implications of Being an Emerging Growth Company