Form 10-K
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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20-1450200
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(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification No.)
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2130 W. Holcombe Blvd., Ste. 800, Houston, TX
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77030
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(Address of principal executive offices)
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(Zip Code)
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Title of each class
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Name of each exchange on which registered
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Common Stock, par value $0.01 per share
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The NASDAQ Global Market
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Large accelerated filer
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Accelerated filer
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Non-accelerated filer
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(Do not check if a smaller reporting company)
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Smaller reporting company
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Item 1.
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Item 1A.
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Item 1B.
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Item 2.
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Item 3.
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Item 4.
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Item 5.
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Item 6.
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Item 7.
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Item 7A.
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Item 8.
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Item 9.
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Item 9A.
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Item 9B.
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Item 10.
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Item 11.
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Item 12.
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Item 13.
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Item 14.
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PART IV
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Item 15.
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Signatures
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the success, cost and timing of our product development activities and clinical trials;
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our ability to advance Chemical Induction of Dimerization (CID) CID-based technologies, including CaspaCIDe, CIDeCAR and GoCAR-T;
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our ability to obtain and maintain regulatory approval of BPX-501 and any other product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate;
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our ability to obtain funding for our operations, including funding necessary to complete further development and commercialization of our product candidates;
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the commercialization of our product candidates, if approved;
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our plans to research, develop and commercialize our product candidates;
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our ability to attract collaborators with development, regulatory and commercialization expertise;
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future agreements with third parties in connection with the commercialization of our product candidates and any other approved product;
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the size and growth potential of the markets for our product candidates, and our ability to serve those markets;
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the rate and degree of market acceptance of our product candidates;
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regulatory developments in the United States and foreign countries;
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our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately;
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the success of competing therapies that are or may become available;
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our ability to attract and retain key scientific or management personnel;
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our ability to grow our organization and increase the size of our facilities to meet our anticipated growth;
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the accuracy of our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
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our expectations regarding the period during which we qualify as an emerging growth company under the Jumpstart Our Business Startups Act of 2012, or the JOBS Act;
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our use of cash and other resources; and
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our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates.
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CaspaCIDe
is our safety switch, incorporated into our HSCT and T-cell receptor, or TCR, product candidates, where it is inactive unless the patient experiences a serious side effect. In that event, rimiducid is administered to fully or partially eliminate the cells, with the goal of terminating or attenuating the therapy and resolving the serious side effect.
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CIDeCAR
consists of CAR T cells modified to include our CaspaCIDe safety switch and in which the CAR T cell incorporates the signaling domains of two proteins, MyD88 and CD40. Together, these form our proprietary dual co-stimulatory domain, MC, which is designed to activate T cells more potently than co-stimulatory molecules CD28 and 4-1BB, which are used in most investigational CAR T cell therapies. Incorporation of CaspaCIDe in a CIDeCAR product candidate is intended to allow the potential enhanced potency of MC co-stimulation to be deployed safely in patients.
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GoCAR-T
consists of CAR T cells that are modified to include the proprietary dual co-stimulatory domain, MC. In contrast to CIDeCAR, MC is structured in GoCAR-T as a molecular switch, separate from the chimeric antigen receptor, which itself contains no co-stimulatory domains. GoCAR-T is designed to allow control of the activation and proliferation of the CAR T cells through the scheduled administration of a course of rimiducid infusions that may continue until the desired patient outcome is achieved. In the event of emergence of side effects, the level of activation of the GoCAR-T
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BPX-501.
Our lead product candidate, BPX-501, is an adjunct T cell therapy administered after allogeneic HSCT using genetically modified donor T cells incorporating the CaspaCIDe
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safety switch. BPX-501 is currently being evaluated in multiple Phase 1/2 clinical trials in adults and pediatric patients with leukemias, lymphomas, and genetic blood diseases in the U.S. and Europe. We believe that BPX-501 could enable physicians to maximize the benefits of T cell therapy for allogeneic HSCT, such as immune system reconstitution, prevention or treatment of relapse of underlying disease and improvement in stem cell engraftment, while mitigating some of the safety issues, such as high grade GvHD, associated with a stem cell transplant. BPX-501 is currently being evaluated in multiple Phase 1/2 clinical trials in the United States and Europe to assess whether BPX-501 T cells from haplo-identical donors administered following HCST are safe and can help speed immune reconstitution. In December 2015, interim data from the lead site in the ongoing BP-004 Phase 1/2 clinical trial was presented at the 57th Annual Meeting of the American Society of Hematology, or ASH. Pediatric patients in the study with a variety of genetic diseases achieved disease-free outcomes from a haploidentical T cell-depleted hematopoietic stem cell transplant, followed by an add-back of BPX-501 donor T cells. We are making preparations for dialogue with regulators in Europe and the U.S., expected to occur in the second quarter of 2016, with the goal of defining the path to regulatory approval initially for non-malignant pediatric diseases. Additionally, BPX-501 clinical trials in different transplant settings are ongoing, in which we are accumulating longer-term data to assess relevant clinical outcomes in malignant disease settings. The FDA has granted orphan drug designation for the combination of BPX-501 genetically modified T cells and activator agent rimiducid as "replacement T-cell therapy for the treatment of immunodeficiency and GvHD after allogenic hematopoietic stem cell transplant."
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BPX-601
is a GoCAR-T™ product candidate containing Bellicum’s proprietary iMC, or inducible MyD88/CD40, activation switch, designed to treat solid tumors expressing prostate stem cell antigen, or PSCA, such as some prostate, pancreatic, bladder, esophageal and gastric cancers. We have obtained positive proof-of-principle preclinical data showing enhanced T-cell proliferation, persistence and in vivo anti-tumor activity compared to standard CAR T therapies. The initial planned indication for BPX-601 development is non-resectable pancreatic cancer. We expect to begin enrolling patients in a Phase 1 trial of BPX-601 in mid-2016.
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BPX-701
is a CaspaCIDe®-enabled natural high affinity T cell receptor, or TCR, product candidate designed to target malignant cells expressing the preferentially-expressed antigen in melanoma, or PRAME.
Based on
in vitro
studies, BPX-701 has demonstrated strong affinity to panels of cancer cells presenting PRAME peptides and low affinity to non-tumor cells. In other
in vitro
studies, rimiducid administration has shown the ability to eliminate BPX-701 cells.
We are developing BPX-701 in collaboration with Leiden University Medical Center. Initial planned indications for BPX-701 development are Refractory or Relapsed Acute Myeloid Leukemia, or AML, and Myelodysplastic Syndromes, or MDS, with an additional study planned for metastatic uveal melanoma. Each of these are orphan indications where PRAME is highly expressed and for which current treatment options are limited. We expect to begin enrolling patients in a Phase 1 trial of BPX-701 in mid-2016.
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BPX-401
is a CIDeCAR™ product candidate incorporating Bellicum’s proprietary MC co-stimulatory domain and the CaspaCIDe safety switch, and is designed as a next-generation CAR T cell therapy for hematological cancers expressing the CD19 antigen. CD19 is expressed in many hematological cancers, including acute lymphocytic leukemia, or ALL, chronic lymphocytic leukemia, or CLL, and certain non-Hodgkin’s lymphomas. While there are several competitive programs where the activity of CD19 CAR T cell therapy has been established, we believe that safety issues, such as cytokine release syndrome and neurological toxicity remain a concern which may be addressed by BPX-401. We expect to begin enrolling patients in a Phase 1 trial of BPX-401 in the second half of 2016.
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Cellular Immunotherapy Approach
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Safety Challenges
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Efficacy Challenges
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Allogeneic HSCT
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GvHD and viral infections are frequent and potentially fatal side effects
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Attempts to control GvHD (steroids, T-Cell depletion, etc.) increase likelihood of non-engraftment, relapse of underlying disease and viral infection
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CAR-T
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Serious immune toxicity (cytokine release syndrome) or neurotoxicity)
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CARs have not demonstrated the same high response rates to solid tumor antigens as have been seen against CD19-targeted leukemias
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Standard-of-care (steroids) and/or cytokine receptor antagonists, such as tocilizumab, can be ineffective; long ICU stay, relapse of underlying disease, infections and death
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Small number of validated tumor antigens that can be targeted
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Other safety approaches* have slow onset of action or have safety issues of their own
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For certain antigen targets, severe toxicity from treatment prevents sufficient therapeutic window for clinical benefit
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TCR
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High risk of off-target or off-organ toxicities
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Human clinical data still early
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Caspase-9: Signaling Molecule for Apoptosis.
Caspase-9 is the initiating enzyme in the apoptosis pathway. When activated, caspase-9 starts a signaling cascade, including the activation of caspase-3, which ultimately leads to apoptosis, a non-inflammatory process of cell elimination.
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MyD88/CD40: Signaling Molecules for Activation and Proliferation.
Myeloid differentiation primary response gene, or MyD88, is a protein that has functions in cellular responses to stimuli such as stress, cytokines and bacteria or viruses. CD40 is a co-stimulatory protein found on antigen-presenting cells, such as dendritic cells and B cells and is required for their activation. Although the effects of MyD88 and CD40 have been studied previously in dendritic cell therapies, our novel approach applies them to T cell based immunotherapies.
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CaspaCIDe
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CIDeCAR
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GoCAR-T
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Cell Type
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Donor T cells (HSCT) or patient T cells (CAR-T or TCRs)
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Patient T cells
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Patient T cells
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Proprietary Components
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caspase-9 safety switch
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caspase-9 safety switch + MC co-stimulation
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MC co-stimulation switch
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Applications
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HSCT and TCR therapy
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CAR-T therapy
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CAR-T therapy
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Potential Safety Benefit
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Modulation of effect with rimiducid triggers T-cell apoptosis
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Modulation of effect with rimiducid triggers T-cell apoptosis
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Modulation of effect with rimiducid triggers T-cell activation & proliferation
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Potential Efficacy Benefit
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Widens therapeutic window for maximum benefit from treatment
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Widens therapeutic window; MC may enhance T-cell activity
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Widens therapeutic window; MC may enhance T-cell activity
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Product Candidates
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BPX-501,BPX-701
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BPX-401
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BPX-601
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Viral Vectors.
We use a retrovirus to transduce our T cell based product candidates. We believe that the retrovirus is optimal for T cell transduction given that it is an integrating vector that induces long-term gene expression, exhibits high transduction efficiency, has sufficient capacity for DNA content, and has been safely used in clinical trials.
As an alternative approach, we are investigating in parallel the use of lentivirus for several of our product candidates. In certain embodiments, lentiviral vectors may provide advantages over retroviral vectors. The vector production is performed at multiple third-party supplier facilities under GMP procedures and requirements. These suppliers have significant experience and expertise in vector manufacturing and have dedicated capacity to satisfy demand for large clinical trials and product commercialization.
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Genetically Modified T Cells.
We have agreements with reputable contract manufacturing organizations, or CMOs, with facilities in both the United States and Europe for processing and manufacturing our genetically modified T cells. We have designed and refined a proprietary process for cell engineering that has been improved from lab-based open procedures used in academic and research settings to a functionally closed system that is more appropriate for large-scale clinical trials and commercialization. Our system is compliant with current guidelines and regulations for cell-based manufacturing in the United States and Europe and has been successfully transferred and implemented by our CMOs.
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Rimiducid.
Rimiducid is a synthetic small molecule which has been rationally designed to trigger the proprietary switch proteins in our CID platform. We have separate third-party manufacturers for the active pharmaceutical ingredient, or API, and the finished drug product. Manufacturers of both the API and finished drug product are licensed to manufacture a
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We have internally developed technology disclosed in three pending U.S. utility patent applications and nine pending foreign patent applications which relate to our CIDeCAR technology. If U.S. patents issue therefrom, the estimated expiration date of the last to expire patent is in 2035. If patents are issued in foreign jurisdictions, the anticipated expiration date of the last to expire patent will be in 2035.
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We have internally developed technology disclosed in two pending utility patent applications in the United States and eight pending foreign patent applications which relates to our GoCAR-T technology. If U.S. patents issue from the U.S. applications, the estimated expiration date of the last to expire patent is in 2035. If patents are issued in foreign jurisdictions, the anticipated expiration dates will be in 2035.
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We have internally developed technology disclosed in pending U.S. utility patent applications, and a pending foreign patent application, which relates to a “non-inducible” CAR and “non-inducible” co-stimulatory polypeptide, which may also be used in combination with our CIDeCAR technology. If a U.S. patent issues, the estimated expiration date of the patent is 2035. If patents are issued in foreign jurisdictions, the anticipated expiration dates will be in 2035.
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Pursuant to our licenses from Baylor, we have exclusive commercial rights to five issued U.S. patents expiring in 2024 or later, eight pending U.S. utility patent applications, six issued foreign patents expiring in 2024 or later and 18 pending patent applications in foreign jurisdictions that relate to our GoCAR-T, BPX-501 and certain of our other technologies. If U.S. patents issue from the currently pending U.S. patent applications, the estimated expiration date of the last to expire patent is 2031. If patents from the currently pending patent applications are issued in foreign jurisdictions, the estimated expiration dates range from 2024 to 2031.
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Pursuant to our license agreement with ARIAD Pharmaceuticals, Inc., or ARIAD, as amended, we have exclusive commercial rights within our field of use to 31 patents, eight in the United States and 23 in foreign jurisdictions, which relate to dimerizer technology. The estimated expiration date of the last to expire U.S. patent is 2032. The estimated expiration date of the last to expire foreign patent is 2032.
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completion of nonclinical laboratory tests and animal studies according to good laboratory practices, or GLPs, and applicable requirements for the humane use of laboratory animals or other applicable regulations;
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submission to the FDA of an IND, which must become effective before human clinical trials may begin;
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performance of adequate and well-controlled human clinical trials according to the FDA’s regulations commonly referred to as good clinical practices, or GCPs, and any additional requirements for the protection of human research patients and their health information, to establish the safety and efficacy of the proposed biological product for its intended use;
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submission to the FDA of a BLA for marketing approval that includes substantial evidence of safety, purity, and potency from results of nonclinical testing and clinical trials;
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satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the biological product is produced to assess compliance with cGMP, to assure that the facilities, methods and controls are adequate to preserve the biological product’s identity, strength, quality and purity and, if applicable, the FDA’s current good tissue practices, or GTPs, for the use of HCT/Ps;
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potential FDA audit of the nonclinical study and clinical trial sites that generated the data in support of the BLA; and
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FDA review and approval, or licensure, of the BLA.
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Phase 1.
The biological product is initially introduced into healthy human subjects and tested for safety. In the case of some products for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients.
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Phase 2
. The biological product is evaluated in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance, optimal dosage and dosing schedule.
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Phase 3
. Clinical trials are undertaken to further evaluate dosage, clinical efficacy, potency, and safety in an expanded patient population at geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall risk to benefit ratio of the product and provide an adequate basis for product labeling.
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an annual, nondeductible fee on any entity that manufactures or imports certain specified branded prescription drugs and biologic agents apportioned among these entities according to their market share in some government healthcare programs;
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an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program, retroactive to January 1, 2010, to 23.1% and 13% of the average manufacturer price for most branded and generic drugs, respectively and capped the total rebate amount for innovator drugs at 100% of the Average Manufacturer Price, or AMP;
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a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturers’ outpatient drugs to be covered under Medicare Part D;
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extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;
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expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals with income at or below 133% of the federal poverty level, thereby potentially increasing manufacturers’ Medicaid rebate liability;
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expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program; and
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a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.
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completing clinical trials through all phases of clinical development of our current product candidates, as well as the product candidates that are being developed by our partners and licensees;
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seeking and obtaining marketing approvals for product candidates that successfully complete clinical trials;
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launching and commercializing product candidates for which we obtain marketing approval, with a partner or, if launched independently, successfully establishing a sales force, marketing and distribution infrastructure;
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identifying and developing new product candidates;
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progressing our pre-clinical programs into human clinical trials;
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establishing and maintaining supply and manufacturing relationships with third parties;
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developing new molecular switches based on our proprietary CID technology platform;
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maintaining, protecting, expanding and enforcing our intellectual property; and
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attracting, hiring and retaining qualified personnel.
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obtaining regulatory approval, as the FDA and other regulatory authorities have limited experience with commercial development of T-cell therapies for cancer;
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sourcing clinical and, if approved, commercial supplies for the materials used to manufacture and process our product candidates;
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developing a consistent and reliable process, while limiting contamination risks, for engineering and manufacturing T cells
ex vivo
and infusing the engineered T cells into the patient;
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educating medical personnel regarding the potential safety benefits, as well as the challenges, of incorporating our product candidates into their treatment regimens; and
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establishing sales and marketing capabilities upon obtaining any regulatory approval to gain market acceptance of a novel therapy.
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the patient eligibility criteria defined in the protocol;
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the size of the patient population required for analysis of the trial’s primary endpoints;
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the proximity of patients to study sites;
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the design of the clinical trial;
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our ability to recruit clinical trial investigators with the appropriate competencies and experience;
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our ability to obtain and maintain patient consents; and
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the risk that patients enrolled in clinical trials will drop out of the clinical trials before completion.
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identifying, recruiting, integrating, maintaining and motivating additional employees;
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managing our internal development efforts effectively, including the clinical and FDA review process for our product candidates, while complying with our contractual obligations to contractors and other third parties; and improving our operational, financial and management controls, reporting systems and procedures.
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We may be unable to identify manufacturers on acceptable terms or at all because the number of potential manufacturers is limited and the FDA or an equivalent foreign regulatory agency must approve any replacement contractor. This approval would require new testing and compliance inspections. In addition, a new manufacturer would have to be educated in, or develop substantially equivalent processes for, production of our products after receipt of FDA approval, if any.
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Our third-party manufacturers might be unable to timely formulate and manufacture our product or produce the quantity and quality required to meet our clinical and commercial needs, if any.
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Contract manufacturers may not be able to execute our manufacturing procedures appropriately.
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Our future contract manufacturers may not perform as agreed or may not remain in the contract manufacturing business for the time required to supply our clinical trials or to successfully produce, store and distribute our products.
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Manufacturers are subject to ongoing periodic unannounced inspection by the FDA, the Drug Enforcement Administration, or corresponding agencies in other geographic locations, to ensure strict compliance with cGMP and other government regulations and corresponding foreign standards. We do not have control over third-party manufacturers’ compliance with these regulations and standards.
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We may not own, or may have to share, the intellectual property rights to any improvements made by our third-party manufacturers in the manufacturing process for our products.
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Our third-party manufacturers could breach or terminate their agreement with us.
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differing regulatory requirements in foreign countries;
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unexpected changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements;
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economic weakness, including inflation, or political instability in particular foreign economies and markets;
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compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;
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foreign taxes, including withholding of payroll taxes;
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foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country;
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difficulties staffing and managing foreign operations;
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workforce uncertainty in countries where labor unrest is more common than in the United States;
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potential liability under the Foreign Corrupt Practices Act of 1977 or comparable foreign regulations;
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challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the United States;
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production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and
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business interruptions resulting from geo-political actions, including war and terrorism.
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the federal Anti-Kickback Statute, which prohibits, among other things, knowingly and willfully soliciting, receiving, offering or paying any remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce, or in return for, either the referral of an individual, or the purchase, lease, order or recommendation of any good, facility, item or service for which payment may be made, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs;
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federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment or approval from Medicare, Medicaid, or other third-party payors that are false or fraudulent or knowingly making a false statement to improperly avoid, decrease or conceal an obligation to pay money to the federal government;
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the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created new federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare
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HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and their respective implementing regulations, which impose requirements on certain covered healthcare providers, health plans, and healthcare clearinghouses as well as their respective business associates that perform services for them that involve the use, or disclosure of, individually identifiable health information, relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization;
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the federal Physician Payment Sunshine Act, created under the Affordable Care Act, and its implementing regulations, which requires certain manufacturers of drugs, devices, biologicals and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the United States Department of Health and Human Services, or HHS, information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, as well as require certain manufacturers and group purchasing organizations to report annually ownership and investment interests held by physicians and their immediate family members; and
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federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers.
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decreased demand for our product candidates;
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injury to our reputation;
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withdrawal of clinical trial participants;
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initiation of investigations by regulators;
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costs to defend the related litigation;
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a diversion of management’s time and our resources;
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substantial monetary awards to clinical trial participants or patients;
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product recalls, withdrawals or labeling, marketing or promotional restrictions;
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loss of revenue;
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exhaustion of any available insurance and our capital resources;
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the inability to commercialize any product candidate; and
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a decline in our share price.
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the availability of financial resources to commence and complete our planned clinical trials;
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reaching agreement on acceptable terms with prospective clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different clinical trial sites;
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recruiting suitable patients to participate in a clinical trial;
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having patients complete a clinical trial or return for post-treatment follow-up;
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clinical trial sites deviating from clinical trial protocol, failing to follow GCPs, or dropping out of a clinical trial;
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adding new clinical trial sites; or
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manufacturing sufficient quantities of qualified materials under cGMPs and applying them on a subject by subject basis for use in clinical trials.
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the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials;
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we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that our product candidates have the necessary safety, purity, and potency for any of their proposed indications;
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the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval;
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we may be unable to demonstrate that our product candidates’ clinical and other benefits outweigh their safety risks;
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we may encounter serious and unexpected adverse events during clinical trials that render our products unsafe for use in humans;
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the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials;
|
•
|
the data collected from clinical trials of our product candidates may not be sufficient to the satisfaction of the FDA or comparable foreign regulatory authorities to support the submission of a BLA or other comparable submission in foreign jurisdictions or to obtain regulatory approval in the United States or elsewhere;
|
•
|
the FDA or comparable foreign regulatory authorities may fail to approve our manufacturing processes and/or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and
|
•
|
the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.
|
•
|
restrictions on the marketing or manufacturing of our product candidates, withdrawal of the product from the market, or voluntary or mandatory product recalls;
|
•
|
fines, warning letters or holds on clinical trials;
|
•
|
refusal by the FDA to approve pending applications or supplements to approved applications filed by us or suspension or revocation of license approvals;
|
•
|
suspension or termination of manufacturing at one or more manufacturing facilities;
|
•
|
product seizure or detention, or refusal to permit the import or export of our product candidates; and
|
•
|
injunctions or the imposition of civil or criminal penalties.
|
•
|
the clinical indications for which our product candidates are approved;
|
•
|
physicians, hospitals, cancer treatment centers and patients considering our product candidates as a safe and effective treatment;
|
•
|
the potential and perceived advantages of our product candidates over alternative treatments;
|
•
|
the prevalence and severity of any side effects;
|
•
|
product labeling or product insert requirements of the FDA or other regulatory authorities;
|
•
|
limitations or warnings contained in the labeling approved by the FDA;
|
•
|
the timing of market introduction of our product candidates as well as competitive products;
|
•
|
the cost of treatment in relation to alternative treatments;
|
•
|
the availability of adequate coverage, reimbursement and pricing by third-party payors and government authorities;
|
•
|
the willingness of patients to pay out-of-pocket in the absence of coverage by third-party payors, including government authorities;
|
•
|
relative convenience and ease of administration, including as compared to alternative treatments and competitive therapies;
|
•
|
confusion or lack of understanding regarding the effects of rimiducid and the timing and size of dosing of rimiducid after immune cell therapy; and
|
•
|
the effectiveness of our sales and marketing efforts.
|
•
|
a covered benefit under its health plan;
|
•
|
safe, effective and medically necessary;
|
•
|
appropriate for the specific patient;
|
•
|
cost-effective; and
|
•
|
neither experimental nor investigational.
|
•
|
the demand for our product candidates, if we obtain regulatory approval;
|
•
|
our ability to set a price that we believe is fair for our products;
|
•
|
our ability to generate revenue and achieve or maintain profitability;
|
•
|
the level of taxes that we are required to pay; and
|
•
|
the availability of capital.
|
•
|
the scope of rights granted under the license agreement and other interpretation-related issues;
|
•
|
whether and the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;
|
•
|
our right to sublicense patent and other rights to third parties under collaborative development relationships;
|
•
|
our diligence obligations with respect to the use of the licensed technology in relation to our development and commercialization of our product candidates, and what activities satisfy those diligence obligations; and
|
•
|
the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners.
|
•
|
if and when patents will issue;
|
•
|
the degree and range of protection any issued patents will afford us against competitors including whether third parties will find ways to invalidate or otherwise circumvent our patents;
|
•
|
whether or not others will obtain patents claiming aspects similar to those covered by our patents and patent applications; or
|
•
|
whether we will need to initiate litigation or administrative proceedings which may be costly whether we win or lose.
|
•
|
the commencement, enrollment or results of the planned clinical trials of our product candidates or any future clinical trials we may conduct, or changes in the development status of our product candidates;
|
•
|
any delay in our regulatory filings for our product candidates and any adverse development or perceived adverse development with respect to the applicable regulatory authority’s review of such filings, including without limitation the FDA’s issuance of a “refusal to file” letter or a request for additional information;
|
•
|
adverse results or delays in clinical trials;
|
•
|
our decision to initiate a clinical trial, not to initiate a clinical trial or to terminate an existing clinical trial;
|
•
|
adverse regulatory decisions, including failure to receive regulatory approval of our product candidates;
|
•
|
changes in laws or regulations applicable to our products, including but not limited to clinical trial requirements for approvals;
|
•
|
adverse developments concerning our CID technology platform and our small molecule drug rimiducid;
|
•
|
adverse developments concerning our manufacturers;
|
•
|
our inability to obtain adequate product supply for any approved product or inability to do so at acceptable prices;
|
•
|
our inability to establish collaborations if needed;
|
•
|
our failure to commercialize our product candidates;
|
•
|
additions or departures of key scientific or management personnel;
|
•
|
unanticipated serious safety concerns related to the use of our product candidates;
|
•
|
introduction of new products or services offered by us or our competitors;
|
•
|
announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors;
|
•
|
our ability to effectively manage our growth;
|
•
|
the size and growth of our initial target markets;
|
•
|
our ability to successfully treat additional types of diseases and cancers or at different stages;
|
•
|
actual or anticipated variations in quarterly operating results;
|
•
|
our cash position;
|
•
|
our failure to meet the estimates and projections of the investment community or that we may otherwise provide to the public;
|
•
|
publication of research reports about us or our industry, or immunotherapy in particular, or positive or negative recommendations or withdrawal of research coverage by securities analysts;
|
•
|
changes in the market valuations of similar companies;
|
•
|
overall performance of the equity markets;
|
•
|
sales of our common stock by us or our stockholders in the future;
|
•
|
trading volume of our common stock;
|
•
|
changes in accounting practices;
|
•
|
ineffectiveness of our internal controls;
|
•
|
disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;
|
•
|
significant lawsuits, including patent or stockholder litigation;
|
•
|
general political and economic conditions; and
|
•
|
other events or factors, many of which are beyond our control.
|
•
|
a board of directors divided into three classes serving staggered three-year terms, such that not all members of the board will be elected at one time;
|
•
|
a prohibition on stockholder action through written consent, which requires that all stockholder actions be taken at a meeting of our stockholders;
|
•
|
a requirement that special meetings of stockholders be called only by the chairman of the board of directors, the chief executive officer, or by a majority of the total number of authorized directors;
|
•
|
advance notice requirements for stockholder proposals and nominations for election to our board of directors;
|
•
|
a requirement that no member of our board of directors may be removed from office by our stockholders except for cause and, in addition to any other vote required by law, upon the approval of not less than two-thirds of all outstanding shares of our voting stock then entitled to vote in the election of directors;
|
•
|
a requirement of approval of not less than two-thirds of all outstanding shares of our voting stock to amend any bylaws by stockholder action or to amend specific provisions of our certificate of incorporation; and
|
•
|
the authority of the board of directors to issue convertible preferred stock on terms determined by the board of directors without stockholder approval and which convertible preferred stock may include rights superior to the rights of the holders of common stock.
|
|
Price Range
|
|||||||
|
High
|
|
Low
|
|||||
Year Ended December 31, 2014
|
|
|
|
|
||||
Fourth Quarter (commencing December 18, 2014)
|
|
$
|
27.38
|
|
|
$
|
18.20
|
|
|
|
|
|
|
||||
Year Ended December 31, 2015
|
|
|
|
|
||||
First Quarter
|
|
$
|
33.63
|
|
|
$
|
19.73
|
|
Second Quarter
|
|
$
|
29.33
|
|
|
$
|
20.20
|
|
Third Quarter
|
|
$
|
21.71
|
|
|
$
|
13.66
|
|
Fourth Quarter
|
|
$
|
23.84
|
|
|
$
|
12.25
|
|
|
Cumulative Total Return date ended
|
||||||||||||||||||
|
12/18/2014
|
|
3/31/2015
|
|
6/30/2015
|
|
9/30/2015
|
|
12/31/2015
|
||||||||||
|
(Inception)
|
|
|
|
|
|
|
|
|
||||||||||
Bellicum
|
$
|
100.00
|
|
|
$
|
94.34
|
|
|
$
|
86.60
|
|
|
$
|
59.16
|
|
|
$
|
82.53
|
|
Nasdaq Composite
|
$
|
100.00
|
|
|
$
|
111.41
|
|
|
$
|
119.70
|
|
|
$
|
98.16
|
|
|
$
|
109.66
|
|
Nasdaq Biotechnology
|
$
|
100.00
|
|
|
$
|
104.00
|
|
|
$
|
105.82
|
|
|
$
|
98.04
|
|
|
$
|
106.26
|
|
|
Year Ended December 31,
|
||||||||||||||
|
2015
|
|
2014
|
|
2013
|
|
2012
|
||||||||
|
(in thousands, except share data)
|
||||||||||||||
Statement of Operations:
|
|
|
|
|
|
|
|
||||||||
Grant revenues
|
$
|
282
|
|
|
$
|
1,780
|
|
|
$
|
1,941
|
|
|
$
|
1,470
|
|
Operating expenses:
|
|
|
|
|
|
|
|
||||||||
Research and development
|
33,561
|
|
|
12,071
|
|
|
7,899
|
|
|
6,156
|
|
||||
License fees
|
3,184
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
ARIAD restructuring costs
|
—
|
|
|
43,212
|
|
|
—
|
|
|
—
|
|
||||
General and administrative
|
12,672
|
|
|
4,335
|
|
|
1,964
|
|
|
1,583
|
|
||||
Total operating expenses
|
49,417
|
|
|
59,618
|
|
|
9,863
|
|
|
7,739
|
|
||||
Loss from operations
|
(49,135
|
)
|
|
(57,838
|
)
|
|
(7,922
|
)
|
|
(6,269
|
)
|
||||
Interest income
|
641
|
|
|
35
|
|
|
4
|
|
|
7
|
|
||||
Interest expense
|
(12
|
)
|
|
(1,791
|
)
|
|
(51
|
)
|
|
(1
|
)
|
||||
Loss on disposal of assets
|
(42
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Change in fair value of warrant liability
|
—
|
|
|
(24,371
|
)
|
|
—
|
|
|
—
|
|
||||
Net loss
|
$
|
(48,548
|
)
|
|
$
|
(83,965
|
)
|
|
$
|
(7,969
|
)
|
|
$
|
(6,263
|
)
|
Preferred stock dividends
|
—
|
|
|
(1,432
|
)
|
|
(1,093
|
)
|
|
(757
|
)
|
||||
Net loss attributable to common stockholders
|
$
|
(48,548
|
)
|
|
$
|
(85,397
|
)
|
|
$
|
(9,062
|
)
|
|
$
|
(7,020
|
)
|
Basic and diluted net loss per share
|
$
|
(1.84
|
)
|
|
$
|
(34.04
|
)
|
|
$
|
(5.05
|
)
|
|
$
|
(4.26
|
)
|
Weighted average common shares outstanding— basic and diluted
|
26,346,603
|
|
|
2,508,960
|
|
|
1,795,992
|
|
|
1,648,198
|
|
|
As of December 31,
|
||||||||||||||
|
2015
|
|
2014
|
|
2013
|
|
2012
|
||||||||
|
(in thousands)
|
||||||||||||||
Balance Sheet Data:
|
|
|
|
|
|
|
|
||||||||
Cash, cash equivalents and investment securities
|
$
|
150,365
|
|
|
$
|
191,602
|
|
|
$
|
11,168
|
|
|
$
|
1,632
|
|
Working capital
|
89,445
|
|
|
189,586
|
|
|
9,963
|
|
|
256
|
|
||||
Total assets
|
160,406
|
|
|
195,794
|
|
|
14,942
|
|
|
5,186
|
|
||||
Convertible preferred stock
|
—
|
|
|
—
|
|
|
39,926
|
|
|
21,658
|
|
||||
Accumulated deficit
|
(161,492
|
)
|
|
(112,944
|
)
|
|
(28,979
|
)
|
|
(21,010
|
)
|
||||
Total stockholders’ equity (deficit)
|
152,017
|
|
|
191,636
|
|
|
(28,152
|
)
|
|
(19,473
|
)
|
•
|
CaspaCIDe is our safety switch, incorporated into our HSCT, and in certain of our CAR-T or TCR, product candidates, where it is inactive unless the patient experiences a serious side effect. In that event, rimiducid is administered to fully or partially eliminate the cells, with the goal of terminating or attenuating the therapy and resolving the serious side effect.
|
•
|
CIDeCAR consists of CAR-T cells modified to include the signaling domains of two proteins, MyD88 and CD40. Together, these form our proprietary dual co-stimulatory domain, or MC, which is designed to activate T cells. Incorporation of CaspaCIDe in a CIDeCAR product candidate is intended to allow the enhanced potency of MC co-stimulation to be deployed safely in patients.
|
•
|
GoCAR-T consists of CAR-T cells that are modified to include MC. In contrast to CIDeCAR, MC is structured in GoCAR-T as a rimiducid-driven molecular switch, separate from the chimeric antigen receptor. GoCAR-T is designed to allow control of the activation and proliferation of the CAR-T cells through the scheduled administration of a course of rimiducid infusions that may continue until the desired patient outcome is achieved. In the event of emergence of side effects, the level of activation of the GoCAR-T cells is designed to be attenuated by extending the interval between rimiducid doses and/or reducing the dosage per infusion.
|
•
|
BPX-501.
We are developing a CaspaCIDe product candidate, BPX-501, as an adjunct T-cell therapy administered after allogeneic HSCT. BPX-501 is designed to improve transplant outcomes by enhancing the recovery of the immune system following an HSCT procedure. BPX-501 addresses the risk of infusing donor T cells by enabling the elimination of donor T cells through the activation of the CaspaCIDe safety switch if there is an emergence of uncontrolled GvHD.
|
•
|
BPX-701
is a CaspaCIDe-enabled natural high affinity T cell receptor, or TCR, product candidate designed to target malignant cells expressing the preferentially-expressed antigen in melanoma, or PRAME. Initial planned indications for BPX-701 development are Refractory or Relapsed Acute Myeloid Leukemia, or AML, and Myelodysplastic Syndromes, or MDS, with an additional study planned for metastatic uveal melanoma. Each of these is an orphan indication where PRAME is highly expressed and for which current treatment options are limited.
|
•
|
BPX-601
is a GoCAR-T product candidate containing our proprietary iMC, inducible MyD88/CD40, activation switch, designed to treat solid tumors expressing prostate stem cell antigen, or PSCA. Preclinical data shows enhanced T-cell proliferation, persistence and
in vivo
anti-tumor activity compared to traditional CAR T therapies. The initial planned indication for BPX-601 development is non-resectable pancreatic cancer.
|
•
|
BPX-401
is a CIDeCAR product candidate incorporating our proprietary MC co-stimulatory domain and the CaspaCIDe safety switch, designed to target blood cancers expressing CD19.
|
•
|
per patient clinical trial costs;
|
•
|
the number of patients that participate in the clinical trials;
|
•
|
the number of sites included in the clinical trials;
|
•
|
the process of collection, differentiation, selection and expansion of immune cells for our cellular immuno-therapies;
|
•
|
the countries in which the clinical trials are conducted;
|
•
|
the length of time required to enroll eligible patients;
|
•
|
the number of doses that patients receive;
|
•
|
the drop-out or discontinuation rates of patients;
|
•
|
potential additional safety monitoring or other studies requested by regulatory agencies;
|
•
|
the duration of patient follow-up; and
|
•
|
the efficacy and safety profile of the product candidates.
|
|
|
2015
|
|
2014
|
|
2013
|
|
2012
|
|
Total Inception To Date Through December 31, 2015
|
||||||||||
Program
|
|
(in thousands)
|
||||||||||||||||||
BPX-201
|
|
$
|
2,528
|
|
|
$
|
2,056
|
|
|
$
|
1,563
|
|
|
$
|
1,943
|
|
|
$
|
9,164
|
|
BPX-401
|
|
1,686
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,686
|
|
|||||
BPX-501
|
|
13,602
|
|
|
6,041
|
|
|
3,062
|
|
|
2,240
|
|
|
25,631
|
|
|||||
BPX-601
|
|
940
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
940
|
|
|||||
BPX-701
|
|
1,093
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,093
|
|
|||||
General
|
|
13,712
|
|
|
3,974
|
|
|
3,274
|
|
|
1,973
|
|
|
30,779
|
|
|||||
Total
|
|
$
|
33,561
|
|
|
$
|
12,071
|
|
|
$
|
7,899
|
|
|
$
|
6,156
|
|
|
$
|
69,293
|
|
|
Year ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
Change
|
||||||
|
(in thousands)
|
||||||||||
Grant revenues
|
$
|
282
|
|
|
$
|
1,780
|
|
|
$
|
(1,498
|
)
|
Operating expenses:
|
|
|
|
|
|
||||||
Research and development
|
33,561
|
|
|
12,071
|
|
|
21,490
|
|
|||
License fees
|
3,184
|
|
|
—
|
|
|
3,184
|
|
|||
ARIAD license restructuring
|
—
|
|
|
43,212
|
|
|
(43,212
|
)
|
|||
General and administrative
|
12,672
|
|
|
4,335
|
|
|
8,337
|
|
|||
Total operating expenses
|
49,417
|
|
|
59,618
|
|
|
(10,201
|
)
|
|||
Loss from operations
|
(49,135
|
)
|
|
(57,838
|
)
|
|
8,703
|
|
|||
Other income (expense):
|
|
|
|
|
|
||||||
Interest income
|
641
|
|
|
35
|
|
|
606
|
|
|||
Interest expense
|
(12
|
)
|
|
(1,791
|
)
|
|
1,779
|
|
|||
Change in fair value of warrant liability
|
—
|
|
|
(24,371
|
)
|
|
24,371
|
|
|||
Loss on disposition of fixed assets
|
(42
|
)
|
|
—
|
|
|
(42
|
)
|
|||
Total other income (expense)
|
587
|
|
|
(26,127
|
)
|
|
26,714
|
|
|||
Net loss
|
$
|
(48,548
|
)
|
|
$
|
(83,965
|
)
|
|
$
|
35,417
|
|
|
Year ended December 31,
|
||||||||||
|
2014
|
|
2013
|
|
Change
|
||||||
|
(in thousands)
|
||||||||||
Grant revenues
|
$
|
1,780
|
|
|
$
|
1,941
|
|
|
$
|
(161
|
)
|
Operating expenses:
|
|
|
|
|
|
||||||
Research and development
|
12,071
|
|
|
7,899
|
|
|
4,172
|
|
|||
ARIAD license restructuring
|
43,212
|
|
|
—
|
|
|
43,212
|
|
|||
General and administrative
|
4,335
|
|
|
1,964
|
|
|
2,371
|
|
|||
Total operating expenses
|
59,618
|
|
|
9,863
|
|
|
49,755
|
|
|||
Loss from operations
|
(57,838
|
)
|
|
(7,922
|
)
|
|
(49,916
|
)
|
|||
Other income (expense):
|
|
|
|
|
|
||||||
Interest income
|
35
|
|
|
4
|
|
|
31
|
|
|||
Interest expense
|
(1,791
|
)
|
|
(51
|
)
|
|
(1,740
|
)
|
|||
Change in fair value of warrant liability
|
(24,371
|
)
|
|
—
|
|
|
(24,371
|
)
|
|||
Total other expense
|
(26,127
|
)
|
|
(47
|
)
|
|
(26,080
|
)
|
|||
Net loss
|
$
|
(83,965
|
)
|
|
$
|
(7,969
|
)
|
|
$
|
(75,996
|
)
|
•
|
successful enrollment in, and completion of, clinical trials;
|
•
|
receipt of marketing approvals from applicable regulatory authorities;
|
•
|
making arrangements with third-party manufacturers;
|
•
|
obtaining and maintaining patent and trade secret protection and regulatory exclusivity; and
|
•
|
launching commercial sales of our products, if and when approved, whether alone or in collaboration with others.
|
•
|
initiate or continue clinical trials of BPX-501, BPX-701, BPX-601, BPX-401 and any other product candidates;
|
•
|
continue the research and development of our product candidates;
|
•
|
seek to discover additional product candidates;
|
•
|
seek regulatory approvals for our product candidates that successfully complete clinical trials;
|
•
|
establish a sales, marketing and distribution infrastructure and scale-up manufacturing capabilities and facilities to commercialize products which receive regulatory approval;
|
•
|
enhance operational, financial and information management systems and hire additional personnel, including personnel to support development of our product candidates and, if a product candidate is approved, our commercialization efforts; and
|
•
|
incur additional costs associated with being a public company.
|
|
Year ended December 31,
|
||||||||||
|
2015
|
2014
|
2013
|
||||||||
|
(in thousands)
|
||||||||||
Net cash used in operating activities
|
$
|
(35,726
|
)
|
|
$
|
(57,308
|
)
|
|
$
|
(7,612
|
)
|
Net cash used in investing activities
|
(86,453
|
)
|
|
(804
|
)
|
|
(366
|
)
|
|||
Net cash provided by financing activities
|
818
|
|
|
238,546
|
|
|
17,514
|
|
|||
Net cash inflow (outflow)
|
$
|
(121,361
|
)
|
|
$
|
180,434
|
|
|
$
|
9,536
|
|
|
(in thousands)
|
||||||||||||||||||
|
Total
|
|
1 Year
|
|
2 - 3 Years
|
|
4 - 5 Years
|
|
More Than
5 Years
|
||||||||||
License agreements (1)
|
$
|
141,010
|
|
|
$
|
932
|
|
|
$
|
5,310
|
|
|
$
|
22,345
|
|
|
$
|
112,423
|
|
Operating lease agreements (2)
|
8,415
|
|
|
1,857
|
|
|
3,853
|
|
|
2,705
|
|
|
—
|
|
|||||
Contract manufacturing arrangements (3)
|
4,006
|
|
|
3,808
|
|
|
174
|
|
|
24
|
|
|
—
|
|
|||||
Facility lease agreement (4)
|
1,368
|
|
|
1,368
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Toxicology study agreements (5)
|
518
|
|
|
518
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Sponsored research agreements (6)
|
228
|
|
|
119
|
|
|
109
|
|
|
—
|
|
|
—
|
|
|||||
Capital lease agreements (7)
|
235
|
|
|
42
|
|
|
84
|
|
|
84
|
|
|
25
|
|
|||||
Total contractual obligations
|
$
|
155,780
|
|
|
$
|
8,644
|
|
|
$
|
9,530
|
|
|
$
|
25,158
|
|
|
$
|
112,448
|
|
(1)
|
License agreements
- We have entered into several license agreements under which we obtained rights to certain intellectual property. Under the agreements, we could be obligated for payments upon successful completion of clinical and regulatory milestones regarding the products covered by this license. The obligations listed in the table above represent estimates of when the milestones will be achieved. We cannot assure that the timing of the milestones will be completed when estimated or at all. See Note 12 to the financial statements included herein.
|
(2)
|
Operating lease agreements
- The amounts above are comprised of two five-year lease agreements. The first lease will expire on January 31, 2020 and the second lease expires on August 31, 2020. See Note 12 to the financial statements included herein.
|
(3)
|
Contract manufacturing arrangements
- We have entered into several manufacturing service arrangements with various terms. The obligations listed in the table above represent estimates of when certain services will be performed.
|
(4)
|
Facility lease agreement
- In March 2013 we entered into a two-year manufacturing facility agreement for cell processing for a clinical trial. In February 2015, the agreement was extended for an additional two years. Subsequently, in December 2015, the contract was terminated but expected to last an additional three months while BPX-201 clinical trials wind down.
|
(5)
|
Toxicology study agreements
- In December 2015 we entered into an agreement for various toxicology studies which are estimated to be completed during 2016.
|
(6)
|
Sponsored research agreements
- During 2015, we entered into two separate sponsored research agreements to undertake research which is of mutual interest to all parties. One agreement includes a commitment over 14 months and the other includes a commitment over a three-year period.
|
(7)
|
Capital lease agreements
- During 2015, we entered into two office capital lease agreements covering a six year term. The commitment includes equipment, maintenance and supplies.
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2015
|
|
2014
|
|
2013
|
||||||
|
|
(in thousands)
|
||||||||||
General and administrative
|
|
$
|
4,832
|
|
|
$
|
386
|
|
|
$
|
19
|
|
Research and development
|
|
3,577
|
|
|
525
|
|
|
372
|
|
|||
Total
|
|
$
|
8,409
|
|
|
$
|
911
|
|
|
$
|
391
|
|
|
December 31, 2015
|
|
December 31, 2014
|
||||
ASSETS
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
70,241
|
|
|
$
|
191,602
|
|
Investment securities, available for sale - short-term
|
23,820
|
|
|
—
|
|
||
Accounts receivable – interest and other receivables
|
440
|
|
|
298
|
|
||
Prepaid expenses and other current assets
|
2,389
|
|
|
1,322
|
|
||
Total current assets
|
96,890
|
|
|
193,222
|
|
||
Investment securities, available for sale - long-term
|
56,304
|
|
|
—
|
|
||
Property and equipment, net
|
6,882
|
|
|
2,427
|
|
||
Other assets
|
330
|
|
|
145
|
|
||
TOTAL ASSETS
|
$
|
160,406
|
|
|
$
|
195,794
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
2,106
|
|
|
$
|
1,209
|
|
Accrued expenses and other current liabilities
|
5,080
|
|
|
2,163
|
|
||
Deferred revenue
|
—
|
|
|
13
|
|
||
Current portion of capital lease obligation
|
13
|
|
|
—
|
|
||
Current portion of deferred rent
|
246
|
|
|
97
|
|
||
Current portion of deferred manufacturing costs
|
—
|
|
|
154
|
|
||
Total current liabilities
|
7,445
|
|
|
3,636
|
|
||
Long-term liabilities:
|
|
|
|
||||
Capital lease obligation
|
118
|
|
|
—
|
|
||
Deferred rent
|
826
|
|
|
209
|
|
||
Deferred manufacturing costs
|
—
|
|
|
313
|
|
||
TOTAL LIABILITIES
|
8,389
|
|
|
4,158
|
|
||
Commitments and contingencies: (Note 12)
|
|
|
|
|
|
||
Stockholders’ Equity:
|
|
|
|
||||
Common stock: $0.01 par value; 200,000,000 shares authorized at December 31, 2015 and 2014; 27,609,344 shares issued and 26,931,881 shares outstanding at December 31, 2015; 27,050,055 shares issued and 26,372,592 shares outstanding at December 31, 2014
|
276
|
|
|
271
|
|
||
Treasury stock: 677,463 shares held at December 31, 2015 and 2014
|
(5,056
|
)
|
|
(5,056
|
)
|
||
Additional paid-in capital
|
318,591
|
|
|
309,365
|
|
||
Accumulated other comprehensive loss
|
(302
|
)
|
|
—
|
|
||
Accumulated deficit
|
(161,492
|
)
|
|
(112,944
|
)
|
||
Total stockholders’ equity
|
152,017
|
|
|
191,636
|
|
||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$
|
160,406
|
|
|
$
|
195,794
|
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
REVENUES
|
|
|
|
|
|
||||||
Grants
|
$
|
282
|
|
|
$
|
1,780
|
|
|
$
|
1,941
|
|
Total revenues
|
282
|
|
|
1,780
|
|
|
1,941
|
|
|||
OPERATING EXPENSES
|
|
|
|
|
|
||||||
Research and development
|
33,561
|
|
|
12,071
|
|
|
7,899
|
|
|||
License fees
|
3,184
|
|
|
—
|
|
|
—
|
|
|||
ARIAD restructuring costs
|
—
|
|
|
43,212
|
|
|
—
|
|
|||
General and administrative
|
12,672
|
|
|
4,335
|
|
|
1,964
|
|
|||
Total operating expenses
|
49,417
|
|
|
59,618
|
|
|
9,863
|
|
|||
LOSS FROM OPERATIONS
|
(49,135
|
)
|
|
(57,838
|
)
|
|
(7,922
|
)
|
|||
OTHER INCOME (EXPENSE)
|
|
|
|
|
|
||||||
Interest income
|
641
|
|
|
35
|
|
|
4
|
|
|||
Interest expense
|
(12
|
)
|
|
(1,791
|
)
|
|
(51
|
)
|
|||
Loss on disposal of assets
|
(42
|
)
|
|
—
|
|
|
—
|
|
|||
Change in fair value of warrant liability
|
—
|
|
|
(24,371
|
)
|
|
—
|
|
|||
Total other income (expense)
|
587
|
|
|
(26,127
|
)
|
|
(47
|
)
|
|||
NET LOSS
|
$
|
(48,548
|
)
|
|
$
|
(83,965
|
)
|
|
$
|
(7,969
|
)
|
Preferred stock dividends
|
—
|
|
|
(1,432
|
)
|
|
(1,093
|
)
|
|||
Net loss attributable to common stockholders
|
$
|
(48,548
|
)
|
|
$
|
(85,397
|
)
|
|
$
|
(9,062
|
)
|
Net loss per common share attributable to common shareholders, basic and diluted
|
$
|
(1.84
|
)
|
|
$
|
(34.04
|
)
|
|
$
|
(5.05
|
)
|
Weighted-average shares outstanding-basic and diluted
|
26,346,603
|
|
|
2,508,960
|
|
|
1,795,992
|
|
|||
|
|
|
|
|
|
||||||
Net Loss
|
$
|
(48,548
|
)
|
|
$
|
(83,965
|
)
|
|
$
|
(7,969
|
)
|
Other comprehensive loss:
|
|
|
|
|
|
||||||
Unrealized loss on securities, net
|
(302
|
)
|
|
—
|
|
|
—
|
|
|||
Comprehensive loss
|
$
|
(48,850
|
)
|
|
$
|
(83,965
|
)
|
|
$
|
(7,969
|
)
|
|
Series A
|
|
Series B
|
|
Series C
|
|
Common Stock
|
|
Treasury Stock
|
|
Additional Paid-In Capital
|
|
Accumulated Deficit
|
|
Other Comprehensive Loss
|
|
Total Stockholders' Equity (Deficit)
|
|||||||||||||||||||||||||||||||||
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||
Balance, January 1, 2013
|
2,544,539
|
|
|
$
|
7,634
|
|
|
2,849,929
|
|
|
$
|
14,024
|
|
|
—
|
|
|
$
|
—
|
|
|
1,725,992
|
|
|
$
|
17
|
|
|
—
|
|
|
$
|
—
|
|
|
$
|
1,519
|
|
|
$
|
(21,010
|
)
|
|
$
|
—
|
|
|
$
|
(19,474
|
)
|
Share-based compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
391
|
|
|
|
|
|
|
391
|
|
|||||||||||||||||||||
Conversion of debt and interest into Series B preferred stock
|
|
|
|
|
757,497
|
|
|
3,503
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
—
|
|
||||||||||||||||||||
Issue Series B preferred stock, net of issuance costs
|
|
|
|
|
2,955,857
|
|
|
13,671
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6
|
)
|
|
|
|
|
|
(6
|
)
|
|||||||||||||||||||
Accretion of Series B preferred stock to redemption value
|
|
|
|
|
|
|
1,094
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,094
|
)
|
|
|
|
|
|
(1,094
|
)
|
||||||||||||||||||||
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(7,969
|
)
|
|
|
|
(7,969
|
)
|
|||||||||||||||||||||
Balance, December 31, 2013
|
2,544,539
|
|
|
$
|
7,634
|
|
|
6,563,283
|
|
|
$
|
32,292
|
|
|
—
|
|
|
$
|
—
|
|
|
1,725,992
|
|
|
$
|
17
|
|
|
—
|
|
|
$
|
—
|
|
|
$
|
810
|
|
|
$
|
(28,979
|
)
|
|
$
|
—
|
|
|
$
|
(28,152
|
)
|
Share-based compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
911
|
|
|
|
|
|
|
911
|
|
|||||||||||||||||||||
Issuance of restricted stock grant
|
|
|
|
|
|
|
|
|
|
|
|
|
117,647
|
|
|
1
|
|
|
|
|
|
|
(1
|
)
|
|
|
|
|
|
—
|
|
|||||||||||||||||||
Exercise of stock options
|
|
|
|
|
|
|
|
|
|
|
|
|
12,615
|
|
|
|
|
|
|
|
|
11
|
|
|
|
|
|
|
11
|
|
||||||||||||||||||||
Issuance of common stock in an IPO, net of issuance costs
|
|
|
|
|
|
|
|
|
|
|
|
|
8,452,500
|
|
|
85
|
|
|
|
|
|
|
146,218
|
|
|
|
|
|
|
146,303
|
|
|||||||||||||||||||
Issue Series B preferred stock, net of issuance costs
|
|
|
|
|
1,582,706
|
|
|
7,320
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
—
|
|
||||||||||||||||||||
Issue Series C preferred stock, net of issuance costs
|
|
|
|
|
|
|
|
|
10,091,743
|
|
|
42,074
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
—
|
|
||||||||||||||||||||
Exercise of Series C warrants, net of issuance costs
|
|
|
|
|
|
|
|
|
6,524,195
|
|
|
72,187
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
—
|
|
||||||||||||||||||||
Exercise of common warrants
|
|
|
|
|
|
|
|
|
|
|
|
|
510,524
|
|
|
5
|
|
|
|
|
|
|
245
|
|
|
|
|
|
|
250
|
|
|||||||||||||||||||
Accretion of Series B dividend
|
|
|
|
|
|
|
1,432
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,432
|
)
|
|
|
|
|
|
(1,432
|
)
|
||||||||||||||||||||
Payment of Series B dividend
|
|
|
|
|
|
|
(173
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
—
|
|
|||||||||||||||||||||
Repurchase of common stock held by ARIAD
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(677,463
|
)
|
|
(5,056
|
)
|
|
|
|
|
|
|
|
(5,056
|
)
|
||||||||||||||||||||
Conversion of preferred stock
|
(2,544,539
|
)
|
|
(7,634
|
)
|
|
(8,145,989
|
)
|
|
(40,871
|
)
|
|
(16,615,938)
|
|
|
(114,261
|
)
|
|
16,230,777
|
|
|
163
|
|
|
|
|
|
|
162,603
|
|
|
|
|
|
|
162,766
|
|
|||||||||||||
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(83,965
|
)
|
|
|
|
(83,965
|
)
|
|||||||||||||||||||||
Balance, December 31, 2014
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
$
|
—
|
|
|
27,050,055
|
|
|
$
|
271
|
|
|
(677,463
|
)
|
|
$
|
(5,056
|
)
|
|
$
|
309,365
|
|
|
$
|
(112,944
|
)
|
|
$
|
—
|
|
|
$
|
191,636
|
|
Share-based compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,409
|
|
|
|
|
|
|
8,409
|
|
|||||||||||||||||||||
Exercise of stock options
|
|
|
|
|
|
|
|
|
|
|
|
|
182,238
|
|
1
|
|
|
|
|
|
|
481
|
|
|
|
|
|
|
482
|
|
||||||||||||||||||||
Issuance of common stock - Employee Stock Purchase Plan
|
|
|
|
|
|
|
|
|
|
|
|
|
21,690
|
|
|
|
|
|
|
|
347
|
|
|
|
|
|
|
347
|
|
|||||||||||||||||||||
Exercise of common warrants
|
|
|
|
|
|
|
|
|
|
|
|
|
355,361
|
|
4
|
|
|
|
|
|
|
(4
|
)
|
|
|
|
|
|
—
|
|
||||||||||||||||||||
Other
|
|
|
|
|
|
|
|
|
|
|
|
|
—
|
|
|
|
|
|
|
|
|
(7
|
)
|
|
|
|
|
|
(7
|
)
|
||||||||||||||||||||
Comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(48,548
|
)
|
|
(302
|
)
|
|
(48,850
|
)
|
||||||||||||||||||||
Balance, December 31, 2015
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
$
|
—
|
|
|
27,609,344
|
|
|
$
|
276
|
|
|
(677,463
|
)
|
|
$
|
(5,056
|
)
|
|
$
|
318,591
|
|
|
$
|
(161,492
|
)
|
|
$
|
(302
|
)
|
|
$
|
152,017
|
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
CASH FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
|
|
||||||
Net loss
|
$
|
(48,548
|
)
|
|
$
|
(83,965
|
)
|
|
$
|
(7,969
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
||||||
Depreciation expense
|
1,199
|
|
|
667
|
|
|
587
|
|
|||
Share-based compensation
|
8,409
|
|
|
911
|
|
|
391
|
|
|||
Loss on disposal of property and equipment
|
42
|
|
|
—
|
|
|
—
|
|
|||
Loss on disposition of investment securities
|
33
|
|
|
—
|
|
|
—
|
|
|||
Amortization of lease liability
|
(94
|
)
|
|
(89
|
)
|
|
(95
|
)
|
|||
Amortization of premium on investment securities, net
|
573
|
|
|
—
|
|
|
—
|
|
|||
Interest expense converted into preferred stock
|
—
|
|
|
—
|
|
|
3
|
|
|||
Change in fair value of warrant liability
|
—
|
|
|
24,371
|
|
|
—
|
|
|||
Changes in operating assets and liabilities:
|
|
|
|
|
|
||||||
Accounts receivable
|
(142
|
)
|
|
448
|
|
|
(745
|
)
|
|||
Prepaid expenses and other current assets
|
(1,067
|
)
|
|
(1,068
|
)
|
|
592
|
|
|||
Other assets
|
(185
|
)
|
|
339
|
|
|
(287
|
)
|
|||
Accounts payable
|
897
|
|
|
659
|
|
|
(1
|
)
|
|||
Accrued liabilities and other
|
2,778
|
|
|
225
|
|
|
698
|
|
|||
Deferred revenue – grants
|
(13
|
)
|
|
13
|
|
|
(1,039
|
)
|
|||
Deferred rent
|
859
|
|
|
5
|
|
|
14
|
|
|||
Deferred manufacturing costs
|
(467
|
)
|
|
176
|
|
|
239
|
|
|||
NET CASH USED IN OPERATING ACTIVITIES
|
(35,726
|
)
|
|
(57,308
|
)
|
|
(7,612
|
)
|
|||
CASH FLOWS FROM INVESTING ACTIVITIES:
|
|
|
|
|
|
||||||
Purchases of investment securities
|
(101,649
|
)
|
|
—
|
|
|
—
|
|
|||
Proceeds from sale of investment securities
|
20,617
|
|
|
—
|
|
|
—
|
|
|||
Purchases of property and equipment
|
(5,421
|
)
|
|
(804
|
)
|
|
(366
|
)
|
|||
CASH USED IN INVESTING ACTIVITIES
|
(86,453
|
)
|
|
(804
|
)
|
|
(366
|
)
|
|||
CASH FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|
|
|
||||||
Proceeds from issuance of common stock
|
347
|
|
|
160,609
|
|
|
—
|
|
|||
Proceeds from exercise of stock options
|
482
|
|
|
—
|
|
|
—
|
|
|||
Payment of issuance costs on common stock
|
(7
|
)
|
|
(14,242
|
)
|
|
—
|
|
|||
Proceeds from issuance of preferred stock
|
—
|
|
|
62,320
|
|
|
13,671
|
|
|||
Payment of issuance costs on preferred stock
|
—
|
|
|
(3,524
|
)
|
|
(7
|
)
|
|||
Proceeds from exercise of preferred warrants
|
—
|
|
|
39,145
|
|
|
—
|
|
|||
Proceeds from exercise of common warrants
|
—
|
|
|
250
|
|
|
—
|
|
|||
Payment for repurchase of common stock
|
—
|
|
|
(5,056
|
)
|
|
—
|
|
|||
Payment of preferred dividends
|
—
|
|
|
(155
|
)
|
|
—
|
|
|||
Payment on capital lease obligation
|
(4
|
)
|
|
—
|
|
|
—
|
|
|||
Proceeds from notes payable
|
—
|
|
|
—
|
|
|
3,500
|
|
|||
Proceeds from line of credit
|
—
|
|
|
386
|
|
|
550
|
|
|||
Payments on line of credit
|
—
|
|
|
(1,187
|
)
|
|
(200
|
)
|
|||
NET CASH PROVIDED BY FINANCING ACTIVITIES
|
818
|
|
|
238,546
|
|
|
17,514
|
|
|||
NET CHANGE IN CASH AND CASH EQUIVALENTS
|
(121,361
|
)
|
|
180,434
|
|
|
9,536
|
|
|||
CASH AND CASH EQUIVALENTS AT BEGINNING OF YEAR
|
191,602
|
|
|
11,168
|
|
|
1,632
|
|
|||
CASH AND CASH EQUIVALENTS AT END OF YEAR
|
$
|
70,241
|
|
|
$
|
191,602
|
|
|
$
|
11,168
|
|
SUPPLEMENTAL CASH FLOW INFORMATION:
|
|
|
|
|
|
||||||
Cash paid during the period for interest
|
$
|
—
|
|
|
$
|
1,767
|
|
|
$
|
47
|
|
NON-CASH INVESTING AND FINANCING ACTIVITIES
|
|
|
|
|
|
||||||
Dividends accreted on preferred stock
|
$
|
—
|
|
|
$
|
1,432
|
|
|
$
|
1,094
|
|
Conversion of notes payable into preferred stock
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
3,500
|
|
Preferred stock dividends paid in common stock
|
$
|
—
|
|
|
$
|
3,196
|
|
|
$
|
—
|
|
Capital lease obligation incurred for property and equipment
|
$
|
135
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Accrued liabilities for purchases of property and equipment
|
$
|
139
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Number of shares
|
|||||||
|
December 31, 2015
|
|
December 31, 2014
|
|
December 31, 2013
|
|||
Series A Convertible Preferred Stock - as converted to common stock
|
—
|
|
|
—
|
|
|
1,496,782
|
|
Series B Convertible Preferred Stock - as converted to common stock
|
—
|
|
|
—
|
|
|
3,860,754
|
|
Warrants to purchase common stock
|
—
|
|
|
—
|
|
|
866,570
|
|
Options to purchase common stock
|
3,628,973
|
|
|
2,733,793
|
|
|
1,574,398
|
|
Stock dividends to be issued as payment for Series B dividends
|
—
|
|
|
—
|
|
|
101,951
|
|
Unvested shares of restricted stock
|
88,236
|
|
|
117,647
|
|
|
—
|
|
Total common stock equivalents
|
3,717,209
|
|
|
2,851,440
|
|
|
7,900,455
|
|
|
|
|
|
Fair Value Measurements at Reporting Date Using
|
||||||||||||
|
|
Balance at
December 31, 2015 |
|
Quoted prices in active
markets for identical assets (Level 1) |
|
Significant other
observable inputs (Level 2) |
|
Significant unobservable
inputs (Level 3) |
||||||||
|
|
(in thousands)
|
||||||||||||||
Cash Equivalents:
|
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
|
$
|
52,714
|
|
|
$
|
52,714
|
|
|
$
|
—
|
|
|
$
|
—
|
|
U.S. government agency-backed securities
|
|
9,500
|
|
|
—
|
|
|
9,500
|
|
|
—
|
|
||||
Total Cash Equivalents
|
|
$
|
62,214
|
|
|
$
|
52,714
|
|
|
$
|
9,500
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
||||||||
Investment Securities:
|
|
|
|
|
|
|
|
|
||||||||
U.S. government agency-backed securities
|
|
$
|
22,388
|
|
|
$
|
—
|
|
|
$
|
22,388
|
|
|
$
|
—
|
|
Corporate debt securities
|
|
51,547
|
|
|
—
|
|
|
51,547
|
|
|
—
|
|
||||
Municipal bonds
|
|
6,189
|
|
|
—
|
|
|
6,189
|
|
|
—
|
|
||||
Total Investment Securities
|
|
$
|
80,124
|
|
|
$
|
—
|
|
|
$
|
80,124
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
|
|
|
Fair Value Measurements at Reporting Date Using
|
||||||||||||
|
|
Balance at
December 31, 2014 |
|
Quoted prices in active
markets for identical assets (Level 1) |
|
Significant other
observable inputs (Level 2) |
|
Significant unobservable
inputs (Level 3) |
||||||||
|
|
(in thousands)
|
||||||||||||||
Cash Equivalents:
|
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
|
$
|
43,587
|
|
|
$
|
43,587
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total Cash Equivalents
|
|
$
|
43,587
|
|
|
$
|
43,587
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Investment Securities:
|
Amortized Cost
|
|
Gross Unrealized Gains
|
|
Gross Unrealized Losses
|
|
Aggregate Estimated Fair Value
|
||||||||
|
(in thousands)
|
||||||||||||||
U.S. government agency-backed securities
|
$
|
22,417
|
|
|
$
|
1
|
|
|
$
|
(30
|
)
|
|
$
|
22,388
|
|
Corporate debt securities
|
51,807
|
|
|
1
|
|
|
(261
|
)
|
|
51,547
|
|
||||
Municipal bonds
|
6,200
|
|
|
—
|
|
|
(11
|
)
|
|
6,189
|
|
||||
Total Investment Securities
|
$
|
80,424
|
|
|
$
|
2
|
|
|
$
|
(302
|
)
|
|
$
|
80,124
|
|
|
|
|
|
|
|
|
December 31,
|
||||||
|
|
|
|
|
|
|
2015
|
|
2014
|
||||
|
|
Estimated Useful Lives
|
|
(in thousands)
|
|||||||||
Leasehold improvements
|
|
|
|
5
|
years
|
|
$
|
4,092
|
|
|
$
|
1,506
|
|
Lab equipment
|
|
|
|
5
|
years
|
|
3,741
|
|
|
1,717
|
|
||
Office furniture
|
|
|
|
5
|
years
|
|
931
|
|
|
335
|
|
||
Software
|
|
|
|
3
|
years
|
|
109
|
|
|
75
|
|
||
Computer equipment
|
|
3
|
to
|
5
|
years
|
|
401
|
|
|
205
|
|
||
Equipment held under capital leases
|
|
|
|
5
|
years
|
|
135
|
|
|
—
|
|
||
Total
|
|
|
|
|
|
|
9,409
|
|
|
3,838
|
|
||
Less: accumulated depreciation
|
|
|
|
|
|
|
(2,527
|
)
|
|
(1,411
|
)
|
||
Property and equipment, net
|
|
|
|
|
|
|
$
|
6,882
|
|
|
$
|
2,427
|
|
|
|
December 31,
|
||||||
|
|
2015
|
|
2014
|
||||
|
|
(in thousands)
|
||||||
Accrued payroll
|
|
$
|
1,332
|
|
|
$
|
731
|
|
Manufacturing costs
|
|
2,412
|
|
|
—
|
|
||
Patient treatment costs
|
|
333
|
|
|
128
|
|
||
Medical facility fees
|
|
282
|
|
|
201
|
|
||
Commission on exercise of warrants
|
|
—
|
|
|
731
|
|
||
Other
|
|
721
|
|
|
372
|
|
||
Total accrued expenses and other current liabilities
|
|
$
|
5,080
|
|
|
$
|
2,163
|
|
|
(in thousands, except shares)
|
|||||||||||||||||||||||||||||||
|
Series A
|
|
|
|
|
Series B
|
|
|
|
|
Series C
|
|
|
|
|
|||||||||||||||||
|
Shares
|
|
Initial
Value
|
|
Redemption
Value
|
|
Shares
|
Initial
Value
|
|
Redemption
Value
|
Shares
|
|
Initial
Value
|
|
Redemption
Value
|
|||||||||||||||||
Outstanding January 1, 2013
|
2,544,539
|
|
|
$
|
7,634
|
|
|
$
|
7,634
|
|
|
2,849,929
|
|
|
$
|
13,181
|
|
|
$
|
14,024
|
|
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Issuance of Series B preferred stock for cash, net
|
—
|
|
|
—
|
|
|
—
|
|
|
2,955,857
|
|
|
13,671
|
|
|
13,671
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Conversion of debt and interest into Series B preferred stock
|
|
|
|
|
|
|
757,497
|
|
|
3,503
|
|
|
3,503
|
|
|
|
|
|
|
|
||||||||||||
Accretion of Series B dividends
|
|
|
|
|
|
|
|
|
-
|
|
|
1,094
|
|
|
|
|
|
|
|
|||||||||||||
Outstanding December 31, 2013
|
2,544,539
|
|
|
$
|
7,634
|
|
|
$
|
7,634
|
|
|
6,563,283
|
|
|
$
|
30,355
|
|
|
$
|
32,292
|
|
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Issuance of Series B preferred stock for cash, net
|
—
|
|
|
—
|
|
|
—
|
|
|
1,582,706
|
|
|
7,320
|
|
|
7,320
|
|
|
|
|
|
|
|
|||||||||
Issuance of Series C preferred stock for cash, net
|
|
|
|
|
|
|
|
|
|
|
|
|
10,091,743
|
|
|
42,074
|
|
|
42,074
|
|
||||||||||||
Issuance of Series C preferred stock on exercise of warrants
|
|
|
|
|
|
|
|
|
|
|
|
|
6,524,195
|
|
|
72,187
|
|
|
72,187
|
|
||||||||||||
Accretion of Series B dividends
|
|
|
|
|
|
|
|
|
-
|
|
|
1,432
|
|
|
|
|
|
|
|
|||||||||||||
Payment of Series B dividends
|
|
|
|
|
|
|
|
|
|
|
(173
|
)
|
|
|
|
|
|
|
||||||||||||||
Conversion to common stock
|
(2,544,539)
|
|
|
(7,634
|
)
|
|
(7,634
|
)
|
|
(8,145,989
|
)
|
|
(37,675
|
)
|
|
(40,871
|
)
|
|
(16,615,938)
|
|
|
(114,261
|
)
|
|
(114,261
|
)
|
||||||
Outstanding December 31, 2014
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Outstanding December 31, 2015
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
Year Ended December 31,
|
|||||||
|
|
2015
|
|
2014
|
|
2013
|
|||
Risk-free interest rate
|
|
1.71
|
%
|
|
1.86
|
%
|
|
1.58
|
%
|
Volatility
|
|
74
|
%
|
|
95
|
%
|
|
90
|
%
|
Expected life (years)
|
|
6.08
|
|
|
6.09
|
|
|
6.25
|
|
Expected dividend yield
|
|
0
|
%
|
|
0
|
%
|
|
0
|
%
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2015
|
|
2014
|
|
2013
|
||||||
|
|
(in thousands)
|
||||||||||
General and administrative
|
|
$
|
4,832
|
|
|
$
|
386
|
|
|
$
|
19
|
|
Research and development
|
|
3,577
|
|
|
525
|
|
|
372
|
|
|||
Total
|
|
$
|
8,409
|
|
|
$
|
911
|
|
|
$
|
391
|
|
Options
|
|
Outstanding Stock Options
|
|
Weighted-Average
Exercise Price
|
|
Weighted-Average
Remaining
Contractual Term (in years)
|
|
(in thousands) Aggregate Intrinsic Value
|
||||
Balance at December 31, 2013
|
|
1,574,398
|
|
$
|
2.33
|
|
|
8.26
|
|
$
|
275
|
|
Granted
|
|
1,188,806
|
|
$
|
8.67
|
|
|
|
|
|
||
Exercised
|
|
(12,615)
|
|
$
|
2.55
|
|
|
|
|
|
||
Forfeited
|
|
(16,796)
|
|
$
|
2.55
|
|
|
|
|
|
||
Balance at December 31, 2014
|
|
2,733,793
|
|
$
|
5.09
|
|
|
8.39
|
|
$
|
49,076
|
|
Granted
|
|
1,089,767
|
|
$
|
22.23
|
|
|
|
|
|
||
Exercised
|
|
(182,238)
|
|
$
|
2.64
|
|
|
|
|
$
|
3,236
|
|
Forfeited
|
|
(12,349)
|
|
$
|
14.99
|
|
|
|
|
|
||
Balance at December 31, 2015
|
|
3,628,973
|
|
$
|
10.32
|
|
|
8.03
|
|
$
|
39,021
|
|
Exercisable as of December 31, 2015
|
|
1,677,355
|
|
$
|
3.84
|
|
|
6.82
|
|
$
|
27,612
|
|
Restricted Stock Shares
|
Outstanding Restricted
Shares
|
|
Weighted-Average
Fair Value at Date of Grant Per Share
|
|||
Balance at December 31, 2013
|
—
|
|
|
|
||
Granted
|
117,647
|
|
|
$
|
19.00
|
|
Vested
|
—
|
|
|
|
||
Forfeited
|
—
|
|
|
|
||
Balance at December 31, 2014
|
117,647
|
|
|
$
|
19.00
|
|
Granted
|
—
|
|
|
—
|
|
|
Vested
|
(29,411)
|
|
|
$
|
19.00
|
|
Forfeited
|
—
|
|
|
—
|
|
|
Balance at December 31, 2015
|
88,236
|
|
|
$
|
19.00
|
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
|
(in thousands, except per share)
|
||||||||||
Weighted-average grant date fair value of options granted
|
$
|
16.09
|
|
|
$
|
13.30
|
|
|
$
|
1.38
|
|
Weighted-average grant date fair value of restricted shares granted
|
$
|
—
|
|
|
$
|
19.00
|
|
|
$
|
—
|
|
Aggregate intrinsic value of options exercised
|
$
|
3,236
|
|
|
$
|
59
|
|
|
$
|
—
|
|
Total fair value of restricted shares vested
|
$
|
656
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Cash received by Company upon option exercises
|
$
|
482
|
|
|
$
|
11
|
|
|
$
|
—
|
|
Options Outstanding
|
|
Options Exercisable
|
|||||||||||||||
Exercise Price
|
|
Total Shares
|
|
Weighted- Average Remaining Contractual Term (in years)
|
|
Weighted-Average Exercise Price
|
|
Total Shares
|
|
Weighted- Average Remaining Contractual Term (in years)
|
|
Weighted-Average Exercise Price
|
|||||
$ .51 to $2.55
|
|
1,412,543
|
|
6.37
|
|
$
|
2.33
|
|
|
1,346,174
|
|
|
6.31
|
|
$
|
2.32
|
|
$ 7.47 to $19.00
|
|
1,282,663
|
|
8.97
|
|
$
|
9.60
|
|
|
303,380
|
|
|
8.87
|
|
$
|
8.90
|
|
$ 20.09 to $24.48
|
|
933,767
|
|
9.24
|
|
$
|
23.40
|
|
|
27,801
|
|
|
9.43
|
|
$
|
22.40
|
|
Total
|
|
3,628,973
|
|
8.03
|
|
Total
|
|
|
1,677,355
|
|
|
6.82
|
|
|
Year
|
|
Operating Leases
|
|
Capital Leases
|
||||
|
|
(in thousands)
|
||||||
2016
|
|
$
|
1,857
|
|
|
$
|
42
|
|
2017
|
|
1,903
|
|
|
42
|
|
||
2018
|
|
1,950
|
|
|
42
|
|
||
2019
|
|
2,001
|
|
|
42
|
|
||
2020
|
|
704
|
|
|
42
|
|
||
Thereafter
|
|
—
|
|
|
25
|
|
||
Total minimum rentals
|
|
$
|
8,415
|
|
|
$
|
235
|
|
|
December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
|
(in thousands)
|
||||||||||
U.S. tax benefit at statutory rate
|
$
|
(16,506
|
)
|
|
$
|
(28,548
|
)
|
|
$
|
(2,709
|
)
|
Meals and entertainment
|
24
|
|
|
10
|
|
|
4
|
|
|||
Incentive stock options
|
12
|
|
|
98
|
|
|
115
|
|
|||
Warrant expense
|
—
|
|
|
8,286
|
|
|
—
|
|
|||
Federal deferred tax true-up
|
(187
|
)
|
|
—
|
|
|
—
|
|
|||
Return to provision
|
(2
|
)
|
|
—
|
|
|
—
|
|
|||
Deferred tax valuation allowances
|
17,920
|
|
|
20,586
|
|
|
3,027
|
|
|||
Research and development credit
|
(1,261
|
)
|
|
(432
|
)
|
|
(437
|
)
|
|||
Income tax expense
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
|
(in thousands)
|
||||||
Deferred tax liabilities:
|
|
|
|
||||
Depreciation
|
$
|
(933
|
)
|
|
$
|
(127
|
)
|
Prepaid expenses
|
—
|
|
|
(189
|
)
|
||
Tenant improvement allowance
|
—
|
|
|
(83
|
)
|
||
Total deferred tax liabilities
|
(933
|
)
|
|
(399
|
)
|
||
Deferred tax assets:
|
|
|
|
||||
Net operating loss carry-forward
|
28,229
|
|
|
14,044
|
|
||
Nonqualified stock options
|
2,248
|
|
|
268
|
|
||
Restricted stock expense
|
20
|
|
|
16
|
|
||
Employee stock purchase plan
|
82
|
|
|
—
|
|
||
Tenant improvement liability
|
341
|
|
|
96
|
|
||
Deferred contract manufacturing costs
|
—
|
|
|
161
|
|
||
Intangible assets
|
15,716
|
|
|
—
|
|
||
Unrealized loss on investment securities
|
103
|
|
|
—
|
|
||
Research and development credit
|
2,519
|
|
|
1,258
|
|
||
ARIAD license restructuring
|
—
|
|
|
14,977
|
|
||
Other
|
23
|
|
|
7
|
|
||
Total deferred tax assets
|
49,281
|
|
|
30,827
|
|
||
Valuation allowance
|
(48,348
|
)
|
|
(30,428
|
)
|
||
Total deferred tax
|
$
|
—
|
|
|
$
|
—
|
|
Net current deferred tax liability
|
$
|
—
|
|
|
$
|
(175
|
)
|
Net non-current deferred tax asset
|
—
|
|
|
175
|
|
||
Total deferred tax
|
$
|
—
|
|
|
$
|
—
|
|
|
(in thousands except per share data)
(1)
|
||||||||||||||
2015
|
First Quarter
|
|
Second Quarter
|
|
Third Quarter
|
|
Fourth Quarter
(2)
|
||||||||
Total revenues
|
$
|
107
|
|
|
$
|
84
|
|
|
$
|
57
|
|
|
$
|
34
|
|
Loss from operations
|
$
|
(7,808
|
)
|
|
$
|
(10,705
|
)
|
|
$
|
(13,617
|
)
|
|
$
|
(17,005
|
)
|
Net loss
|
$
|
(7,758
|
)
|
|
$
|
(10,534
|
)
|
|
$
|
(13,408
|
)
|
|
$
|
(16,848
|
)
|
Net loss per share attributable to common shareholders - basic and diluted
|
$
|
(0.30
|
)
|
|
$
|
(0.40
|
)
|
|
$
|
(0.51
|
)
|
|
$
|
(0.63
|
)
|
|
|
|
|
|
|
|
|
||||||||
2014
|
First Quarter
|
|
Second Quarter
|
|
Third Quarter
|
|
Fourth Quarter
(3)
|
||||||||
Total revenues
|
$
|
552
|
|
|
$
|
553
|
|
|
$
|
660
|
|
|
$
|
15
|
|
Loss from operations
|
$
|
(2,277
|
)
|
|
$
|
(3,273
|
)
|
|
$
|
(2,898
|
)
|
|
$
|
(49,390
|
)
|
Net loss
|
$
|
(2,290
|
)
|
|
$
|
(3,281
|
)
|
|
$
|
(4,097
|
)
|
|
$
|
(74,298
|
)
|
Preferred dividends
|
$
|
(540
|
)
|
|
$
|
(564
|
)
|
|
$
|
(328
|
)
|
|
$
|
—
|
|
Net loss attributable to common shareholders
|
$
|
(2,830
|
)
|
|
$
|
(3,845
|
)
|
|
$
|
(4,425
|
)
|
|
$
|
(74,298
|
)
|
Net loss per share attributable to common shareholders - basic and diluted
|
$
|
(1.52
|
)
|
|
$
|
(1.81
|
)
|
|
$
|
(2.08
|
)
|
|
$
|
(18.99
|
)
|
(1)
|
The amounts were computed independently for each quarter, and the sum of the quarters may not total the annual amounts due to rounding.
|
(2)
|
The 2015 fourth quarter results include a non-refundable upfront fee to Agensys of
$3.0
million under the license agreement. See Note 12.
|
(3)
|
The 2014 fourth quarter results include ARIAD license restructuring of
$43.2 million
and the change in fair value of the warrant liability of
$23.2 million
. See Note 11.
|
|
|
|
|
Bellicum Pharmaceuticals, Inc.
|
|
|
|
|
Date: March 14, 2016
|
By:
|
/s/ Thomas J. Farrell
|
|
|
Thomas J. Farrell
President and Chief Executive Officer
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/ Thomas J. Farrell
|
|
President, Chief Executive Officer and Member of the Board of Directors
(Principal Executive Officer)
|
|
March 14, 2016
|
Thomas J. Farrell
|
|
|
|
|
|
|
|
|
|
/s/ Alan A. Musso
|
|
Chief Financial Officer and Treasurer
(Principal Financial and Accounting Officer)
|
|
March 14, 2016
|
Alan A. Musso
|
|
|
|
|
|
|
|
|
|
/s/ Kevin M. Slawin, M.D.
|
|
Chief Technology Officer and Member of the Board of Directors
|
|
March 14, 2016
|
Kevin M. Slawin, M.D.
|
|
|
|
|
|
|
|
|
|
/s/ James Brown
|
|
Chairman of the Board of Directors
|
|
March 14, 2016
|
James Brown
|
|
|
|
|
|
|
|
|
|
/s/ Reid M. Huber, Ph.D.
|
|
Member of the Board of Directors
|
|
March 14, 2016
|
Reid M. Huber, Ph.D.
|
|
|
|
|
|
|
|
|
|
/s/ Frank B. McGuyer
|
|
Member of the Board of Directors
|
|
March 14, 2016
|
Frank B. McGuyer
|
|
|
|
|
|
|
|
|
|
/s/ Jon P. Stonehouse
|
|
Member of the Board of Directors
|
|
March 14, 2016
|
Jon P. Stonehouse
|
|
|
|
|
|
|
|
|
|
/s/ Stephen R. Davis
|
|
Member of the Board of Directors
|
|
March 14, 2016
|
Stephen R. Davis
|
|
|
|
|
Exhibit
Number |
|
Description
|
||
|
|
|||
3.1
|
|
Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on December 23, 2014).
|
||
|
|
|||
3.2
|
|
Amended and Restated Bylaws of the Registrant (incorporated by reference to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K, filed with the SEC on December 23, 2014).
|
||
|
|
|||
4.1
|
|
Reference is made to Exhibits 3.1 and 3.2.
|
||
|
|
|||
4.2
|
|
Form of Common Stock Certificate of the Registrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-200328), originally filed with the SEC on November 18, 2014).
|
||
|
|
|||
4.3
|
|
Second Amended and Restated Investor Rights Agreement by and among the Registrant and certain of its stockholders, dated August 22, 2014 (incorporated by reference to Exhibit 4.2 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-200328), originally filed with the SEC on November 18, 2014).
|
||
|
|
|||
4.4
|
|
Registration Rights Agreement by and among the Registrant and Baker Brothers Life Sciences, LP, and two of its affiliated funds, dated January 15, 2016.
|
||
|
|
|||
10.1+
|
|
Form of Indemnification Agreement by and between the Registrant and its directors and officers (incorporated by reference to Exhibit 10.1 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-200328), originally filed with the SEC on November 18, 2014).
|
||
|
|
|||
10.2+
|
|
Bellicum Pharmaceuticals, Inc. 2006 Stock Option Plan and Form of Nonqualified Stock Option Agreement (incorporated by reference to Exhibit 10.2 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-200328), originally filed with the SEC on November 18, 2014).
|
||
|
|
|||
10.3+
|
|
Bellicum Pharmaceuticals, Inc. 2011 Stock Option Plan and Forms of Incentive Stock Option Grant Agreement and Nonqualified Stock Option Agreement (incorporated by reference to Exhibit 10.3 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-200328), originally filed with the SEC on November 18, 2014).
|
||
|
|
|||
10.4+
|
|
Bellicum Pharmaceuticals, Inc. 2014 Equity Incentive Plan and Form of Stock Option Grant Notice, Stock Option Agreement and Notice of Exercise thereunder (incorporated by reference to Exhibit 10.4 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-200328), originally filed with the SEC on November 18, 2014).
|
||
|
|
|||
10.5+
|
|
Bellicum Pharmaceuticals, Inc. Non-Employee Director Compensation Policy.
|
||
|
|
|||
10.6+
|
|
Third Amended and Restated Employment Agreement by and between the Registrant and Thomas J. Farrell, dated November 17, 2014 (incorporated by reference to Exhibit 10.6 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-200328), originally filed with the SEC on November 18, 2014).
|
||
|
|
|||
10.7+
|
|
Amended and Restated Employment Agreement by and between the Registrant and David M. Spencer, Ph.D., dated November 17, 2014 (incorporated by reference to Exhibit 10.7 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-200328), originally filed with the SEC on November 18, 2014).
|
||
|
|
|||
10.8+
|
|
Employment Agreement by and between the Registrant and Joseph H. Senesac, dated November 16, 2014 (incorporated by reference to Exhibit 10.12 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-200328), originally filed with the SEC on November 18, 2014).
|
||
|
|
|||
10.9+
|
|
Employment Agreement by and between the Registrant and Peter L. Hoang, dated November 17, 2014 (incorporated by reference to Exhibit 10.13 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-200328), originally filed with the SEC on November 18, 2014).
|
||
|
|
|||
10.10
|
|
Notice of Expansion of Licensed Field to Obtain Additional Exclusive Rights (incorporated by reference to Exhibit 10.14 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-200328), originally filed with the SEC on November 18, 2014).
|
||
|
|
|||
10.11*
|
|
Amended and Restated License Agreement by and between the Registrant and ARIAD Pharmaceuticals, Inc., dated March 7, 2011 (incorporated by reference to Exhibit 10.15 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-200328), originally filed with the SEC on November 18, 2014).
|
||
|
|
Exhibit
Number |
|
Description
|
||
10.12*
|
|
Omnibus Amendment Agreement by and between Registrant and ARIAD Pharmaceuticals, Inc., dated October 3, 2014 (incorporated by reference to Exhibit 10.16 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-200328), originally filed with the SEC on November 18, 2014).
|
||
|
|
|||
10.13*
|
|
Exclusive License Agreement by and between the Registrant and Baylor College of Medicine, dated March 20, 2008 (incorporated by reference to Exhibit 10.17 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-200328), originally filed with the SEC on November 18, 2014).
|
||
|
|
|||
10.14*
|
|
Exclusive License Agreement by and between the Registrant and Baylor College of Medicine, dated June 27, 2010 (incorporated by reference to Exhibit 10.18 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-200328), originally filed with the SEC on November 18, 2014).
|
||
|
|
|||
10.15*
|
|
Cancer Research Grant Contract by and between the Registrant and the Cancer Prevention and Research Institute of Texas, dated July 27, 2011 (incorporated by reference to Exhibit 10.19 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-200328), originally filed with the SEC on November 18, 2014).
|
||
|
|
|||
10.16*
|
|
Exclusive License Agreement by and between the Registrant and Baylor College of Medicine, effective November 1, 2014 (incorporated by reference to Exhibit 10.20 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-200328), originally filed with the SEC on November 18, 2014).
|
||
|
|
|||
10.17
|
|
Lease Agreement by and between Registrant and Sheridan Hills Developments L.P., dated June 1, 2012 (incorporated by reference to Exhibit 10.21 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-200328), originally filed with the SEC on November 18, 2014).
|
||
|
|
|
||
10.18
|
|
First Amendment to Lease Agreement by and between Registrant and Sheridan Hills Developments L.P., dated September 13, 2013 (incorporated by reference to Exhibit 10.22 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-200328), originally filed with the SEC on November 18, 2014).
|
||
|
|
|||
10.19
|
|
Second Amendment to Lease Agreement by and between Registrant and Sheridan Hills Developments L.P., dated June 20, 2014 (incorporated by reference to Exhibit 10.23 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-200328), originally filed with the SEC on November 18, 2014).
|
||
|
|
|||
10.20
|
|
Third Amendment to Lease Agreement by and between Registrant and Sheridan Hills Developments L.P., dated July 21, 2014 (incorporated by reference to Exhibit 10.24 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-200328), originally filed with the SEC on November 18, 2014).
|
||
|
|
|||
10.21
|
|
Fourth Amendment to Lease Agreement by and between Registrant and Sheridan Hills Developments L.P., dated November 12, 2014 (incorporated by reference to Exhibit 10.25 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-200328), originally filed with the SEC on November 18, 2014).
|
||
|
|
|||
10.22
|
|
Loan and Security Agreement by and between the Registrant and Comerica Bank, dated December 13, 2012 (incorporated by reference to Exhibit 10.27 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-200328), originally filed with the SEC on November 18, 2014).
|
||
|
|
|||
10.23
|
|
First Amendment to Loan and Security Agreement by and between the Registrant and Comerica Bank, dated March 1, 2014 (incorporated by reference to Exhibit 10.28 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-200328), originally filed with the SEC on November 18, 2014).
|
||
|
|
|||
10.24
|
|
Second Amendment to Loan and Security Agreement by and between the Registrant and Comerica Bank, dated July 3, 2014 (incorporated by reference to Exhibit 10.29 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-200328), originally filed with the SEC on November 18, 2014).
|
||
|
|
|||
10.25+
|
|
Employment Agreement by and between the Registrant and Alan A. Musso, dated December 4, 2014 (incorporated by reference to Exhibit 10.30 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-200328), originally filed with the SEC on November 18, 2014).
|
||
|
|
|||
10.26+
|
|
Incentive Award Program (incorporated by reference to Exhibit 10.1 to the Registrant's report on Form 8-K filed with the SEC on February 27, 2015.
|
||
|
|
|
||
10.27+
|
|
Amended and Restated Employment Agreement between the Registrant and Annemarie Moseley, Ph.D., dated April 1, 2015(incorporated by reference to Exhibit 10.1 to the Registrant's report on Form 8-K filed with the SEC on April 7, 2015).
|
||
|
|
|
||
10.28+
|
|
Employment Agreement between the Registrant and Kevin M. Slawin, M.D., dated April 6, 2015 (incorporated by reference to Exhibit 10.2 to the Registrant's Registration report on Form 8-K filed with the SEC on April 7, 2015)
|
||
|
|
|
||
10.29+
|
|
Employment Agreement between the Registrant and Ken Mosley, dated April 1, 2015 (incorporated by reference to Exhibit 10.3 to the Registrant's report on Form 10-Q filed with the SEC on May 12, 2015)
|
||
|
|
|
Exhibit
Number |
|
Description
|
||
10.30*
|
|
License Agreement by and between the Registrant and Academish Ziekenhuis Leiden, also acting under the name Leiden University Medical Centre, effective as of April 20, 2015 (incorporated by reference to Exhibit 10.1 to the Registrant's report on Form 10-Q filed with the SEC on August 13, 2015).
|
||
|
|
|
||
10.31*
|
|
License Agreement by and between the Registrant and BioVec Pharma, Inc., dated as of June 4, 2015 (incorporated by reference to Exhibit 10.2 to the Registrant's report on Form 10-Q filed with the SEC on August 13, 2015).
|
||
|
|
|
||
10.32
|
|
Lease Agreement by and between the Registrant and Sheridan Hills Developments L.P., dated as of May 6, 2015.
|
||
|
|
|
||
10.33#
|
|
Exclusive License Agreement by and between the Registrant and Agensys, Inc., effective as of December 10, 2015.
|
||
|
|
|
||
23.1
|
|
Consent of Ernst & Young LLP, an Independent Registered Public Accounting Firm.
|
||
|
|
|||
24.1
|
|
Power of Attorney. Reference is made to the signature page hereto.
|
||
|
|
|||
31.1
|
|
Certification of the Principal Executive Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934.
|
||
|
|
|||
31.2
|
|
Certification of the Principal Financial Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934.
|
||
|
|
|||
32.1
|
|
Certification of the Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
||
|
|
|||
32.2
|
|
Certification of the Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
||
|
|
|
|
+
|
|
Indicates management contract or compensatory plan.
|
|
|
|
*
|
|
Confidential treatment has been granted with respect to certain portions of this exhibit. Omitted portions have been filed separately with the SEC.
|
|
|
|
#
|
|
Certain provisions of this exhibit have been omitted pursuant to a request for confidential treatment.
|
Bellicum Pharmaceuticals, Inc.
|
|
a Delaware Corporation
|
|
|
|
By:
|
/s/ Ken Moseley
|
Name:
|
Ken Moseley
|
Title:
|
SVP & GC
|
|
|
[Signature Page to Registration Rights Agreement]
|
[Signature Page to Registration Rights Agreement]
|
667, L.P.
By: BAKER BROS. ADVISORS LP, management company and investment adviser to 667, L.P., pursuant to authority granted to it by Baker Biotech Capital, L.P., general partner to 667, L.P., and not as the general partner
By:
/s/ Scott L. Lessing
Scott L. Lessing
President
BAKER BROTHERS LIFE SCIENCES, L.P.
By: BAKER BROS. ADVISORS LP, management company and investment adviser to BAKER BROTHERS LIFE SCIENCES, L.P., pursuant to authority granted to it by Baker Brothers Life Sciences Capital, L.P., general partner to BAKER BROTHERS LIFE SCIENCES, L.P., and not as the general partner
By:
/s/ Scott L. Lessing
Scott L. Lessing
President
14159, L.P.
By: BAKER BROS. ADVISORS LP, management company and investment adviser to 14159, L.P., pursuant to authority granted to it by 14159 Capital, L.P., general partner to 14159, L.P., and not as the general partner.
By:
/s/ Scott L. Lessing
Scott L. Lessing
President
|
[Signature Page to Registration Rights Agreement]
|
|
|
[Signature Page to Registration Rights Agreement]
|
|
1.
|
Annual Board Service Retainer
:
|
b.
|
Chairman of the Board Service Retainer (in addition to Eligible Director Service Retainer): $25,000
|
c.
|
Lead Independent Director Service Retainer (in addition to Eligible Director Service Retainer): $15,000
|
3.
|
Annual Committee Chair Service Retainer (in addition to Committee Member Service Retainer)
:
|
Months Following the
Commencement Date
|
Annual Base Rent Rate Per
Square Foot of Net Rentable Area
|
Annual Base Rent
|
Monthly
Payment
|
1-12
|
$30.75
|
$778,098.00
|
$64,841.50
|
13-24
|
$31.80
|
$804,667.20
|
$67,055.60
|
25-36
|
$32.95
|
$833,766.80
|
$69,480.57
|
37-48
|
$34.10
|
$862,866.40
|
$71,905.53
|
49-60
61-72
73-84
85-96
97-108
109-120
|
$35.30
$36.50
$37.80
$39.10
$40.50
$41.90
|
$893,231.20
$923,596.00
$956,491.20
$989,386.40
$1,024,812.00
$1,060,237.60
|
$74,435.93
$76,966.33
$79,707.60
$82,448.87
$85,401.00
$88,353.13
|
Months Following the
Commencement Date
|
Annual Base Rent Rate Per
Square Foot of Net Rentable Area
|
Annual Base Rent
|
Monthly
Payment
|
1-60
61-120
|
$7.00
$8.00
|
$5,656.00
$6,464.00
|
$471.33
$538.67
|
|
|
|
|
(1)
|
Wages and salaries of all employees engaged in the operation, security, cleaning and maintenance of the Complex, including customary taxes, insurance and benefits relating thereto, allocated based upon the time such employees are engaged directly in providing such services, but not above the level of property manager.
|
(2)
|
All supplies, tools, equipment and materials used in operation and maintenance of the Complex.
|
(3)
|
Cost of all utilities for the Complex, including but not limited to the costs of water, electricity, gas, heating, lighting, air conditioning and ventilation; provided, however, in the event that Landlord elects to meter or sub-meter any or all of the aforementioned utilities in accordance with Section 7.E hereof, Operating Expenses shall not include the cost of such metered or sub-metered utilities provided to the Leased Premises or the leased premises of the other tenants in the Complex.
|
(4)
|
Cost of all janitorial service, maintenance and service agreements for the Complex and the equipment therein, including alarm service, security service, window cleaning, janitorial service, trash removal and elevator maintenance.
|
(5)
|
Cost of all insurance relating to the Complex which Landlord may elect to obtain, including but not limited to casualty and liability insurance applicable to the Complex and Landlord’s personal property used in connection therewith; the amount of the commercially reasonable deductible paid by Landlord or deducted from any insurance proceeds paid to Landlord shall also constitute an Operating Expense.
|
(6)
|
Accounting costs and audit fees attributable to Landlord's ownership of the Complex, including without limitation in connection with tax returns. All taxes and assessments and other governmental charges (whether federal, state, county or municipal and whether they be by taxing districts or authorities presently taxing the Leased Premises or by others subsequently created or otherwise) and any other taxes and improvement assessments attributable to the Complex, or its operation or the revenues or rents received therefrom (whether directly or indirectly through the use of a franchise, margin or other similar tax and whether or not such taxes allow for the deduction of expenses in calculating the base amount on which the tax is levied) but excluding, however, federal and state taxes on income (collectively, "
Taxes
”); provided, however, that if at any time during the Term, new taxes, assessments, levies, impositions or charges are imposed on the rents received from the Complex or the rents reserved herein or any part thereof (whether directly or indirectly through the use of a franchise, margin or other similar tax), or the present method of taxation or assessment shall be so changed that the whole or any part of the taxes, assessments, levies, impositions or charges now levied, assessed or imposed on real estate and the improvements thereof shall be discontinued and as a substitute therefor, or in lieu of an increase to the tax rate thereof, taxes, assessments, levies, impositions or charges shall be levied, assessed and/or imposed wholly or partially as a capital levy or otherwise on the rents received from the Complex or the rents reserved herein or any part thereof (whether directly or indirectly through the use of a franchise, margin or similar tax and whether or not such taxes allow for the deduction of expenses in calculating the base amount on which the tax is levied), then such substitute or additional taxes, assessments, levies, impositions or charges, to the extent so levied, assessed or imposed, shall be deemed to be included within Taxes to the extent that such substitute or additional tax would be payable if the Complex were the only property of the Landlord subject to such tax. It is agreed that Tenant will also be responsible for ad valorem taxes on its personal property and on the value of leasehold improvements to the extent that the same exceed standard building allowance, provided, however, that such amount(s) is(are) expressly set out in the tax statements from the taxing authorities, or are reasonably determinable from tax statements that pertain specifically to the Leased Premises,
|
(7)
|
Amortization of the cost of installation of capital investment items that have been (whether before or during the Term) or are hereafter installed for the purpose of reducing Operating Expenses or which may be required by any laws, ordinances, orders, rules, regulations and requirements which are amended, become effective or are interpreted differently after the Commencement Date which impose any duty with respect to or otherwise relate to the use, condition, occupancy, maintenance or alteration of the Complex. All such costs which relate to the installation of such capital investment items shall be amortized over the reasonable life of the capital investment item, with the reasonable life and amortization schedule being determined in accordance with generally accepted accounting principles as reasonably determined by Landlord.
|
(8)
|
The property management fees incurred by Landlord, in no event to exceed four percent (4%) of the gross revenues (but expressly excluding parking revenues) received by Landlord on the Complex.
|
(9)
|
Cost of repairs and general maintenance (excluding repairs and general maintenance paid by proceeds of insurance or by Tenant or other third parties) for the Complex.
|
(10)
|
The reasonable rental value of the Building management office (which shall not exceed 3,000 square feet of Net Rentable Area).
|
(11)
|
All costs incurred by Landlord for the purpose of reducing Operating Expenses, including, without limitation, the cost of all tax protests (subject to the provisions set forth in Section 6.B(7) above.
|
(1)
|
Except as set forth in Section 6.B(7) above, expenditures classified as capital expenditures, including without limitation, capital improvements, capital repairs, capital equipment and capital tools, under generally accepted accounting principles consistently applied, including rental payments with respect to capital items, or any non-cash charges such as depreciation or amortization. All costs incurred for the acquisition and renovation, construction and improving of the Complex and Garage, and readying same for occupancy and use, including without limitation tap fees or other one-time utility charges and initial installation of landscaping improvements, light fixtures and other items, even if the replacement thereof is permitted to be included in Operating Expenses shall be excluded from Operating Expenses.
|
(2)
|
Advertising, promotional expenses, leasing commissions, attorneys fees, costs and disbursements and other expenses incurred in connection with the leasing of the Complex or negotiations or disputes relating to leasing and lease interpretations with tenants or prospective tenants or other occupants of the Complex. Personnel costs of persons on-site and off-site to the extent same are engaged in leasing activities shall be excluded from Operating Expenses. Gifts, meals and entertainment expenses incurred with tenants, tenant prospects and brokers shall be excluded from Operating Expenses.
|
(3)
|
The cost of repairs or other work occasioned by any casualty which is covered by insurance or coverable by standard all risk property insurance available in Texas, or by the exercise of the right of eminent domain or otherwise reimbursed to Landlord from another source, net of deductibles carried by Landlord, and reasonable out-of-pocket cost of adjustment.
|
(4)
|
Landlord's cost of HVAC, electricity, water, janitorial and other services or benefits sold or provided to tenants in the Complex and for which Landlord is entitled to be reimbursed by such tenants as a separate additional charge or rental over and above the base rent or additional rent payments payable under the lease agreement with such tenant. The cost of providing HVAC services to other tenants at times or in quantities in excess of that made available to Tenant without special charge under this Lease Agreement, and the cost of providing electricity, water, janitorial or other services to other tenants in quantities or at specifications in excess of that made available to Tenant without special charge under this Lease Agreement, shall be excluded from Operating Expenses regardless of whether Landlord offers such services to other tenants without special charge under the terms of such other tenants' leases.
|
(5)
|
All costs (including permit, license and inspection fees), however paid, in demolishing, removing, completing, fixturing, furnishing, renovating, decorating or otherwise altering or improving space for tenants or other occupants of the Complex or for vacant space, or for any management office, including space planning, interior design and engineering work.
|
(6)
|
Except as set forth in Section 6.B(7) above, all costs incurred by Landlord in connection with the design or construction of the Complex or any equipment therein and related facilities, the correction of defects in design, construction or in the discharge of Landlord's obligations under
Exhibit G
attached to this Lease Agreement.
|
(7)
|
Except as set forth in Section 6.B(7) above, all costs of removing, remediating, encapsulating and/or monitoring any hazardous waste, substance or material, including, without limitation, asbestos containing materials, but excluding automotive fuels discharged in driving and parking areas of the Complex. Notwithstanding Section 6.B(7) above, all operating and capital costs required by or incurred in connection with (i) the installation of any capital improvement required by any law, ordinance or regulation enacted before the Effective Date, including, without limitation, the Americans with Disabilities Act, the Texas Architectural Barriers Act, the Houston Life Safety Ordinance, but excluding any changes in interpretations, enforcement or ruling thereon after the Effective Date, (ii) the existence of
|
(8)
|
All costs, including without limitation fines, penalties and legal fees, incurred or imposed in connection with any legal violation by Landlord or the property manager or any breach or default by Landlord under any loan or mortgage instrument or any lease or license agreement. All costs, including without limitation interest, late charges, penalties and legal fees, incurred in connection with any late payment by Landlord.
|
(9)
|
Except as otherwise provided in Section 6.B(6) above, federal and state taxes on income and inheritance, estate and gift taxes of Landlord, the property manager and their respective affiliates, and all taxes imposed on or calculated on the basis of any mortgage encumbering the Complex or Garage or in connection with any transfer of ownership of the Complex or Garage or beneficial interests therein.
|
(10)
|
Ad valorem taxes attributable to the leasehold improvements of Tenant and the other tenants of the Complex in excess of Complex standard but only to the extent (a) Landlord is reimbursed directly by such other tenants for any ad valorem taxes attributable to the above Building standard leasehold improvements of such other tenants or (b) a separate allocation is made by the applicable taxing authority.
|
(11)
|
All payments to any affiliate of Landlord for services in excess of the costs of arms-length, third-party providers for services of comparable quality and scope.
|
(12)
|
Compensation paid to clerks, attendants or other persons in commercial concessions operated by Landlord or the property manager.
|
(13)
|
All costs incurred in connection with the operation, maintenance or repair of any antennae or satellite facilities, unless such services are being provided to all tenants of the Complex, including Tenant.
|
(14)
|
Except as otherwise provided in Section 6.B(6) above, other costs (including consulting fees and related disbursements) incurred in connection with Landlord's ownership of the Complex to the extent not directly related to the operation, maintenance and repair thereof, including without limitation, costs of any disputes between Landlord and its employees or the property manager and costs of selling, syndicating, financing, mortgaging or hypothecating any of the Landlord's interest in the Complex and/or common areas, costs of defending Landlord's title or interest in and to said property.
|
(15)
|
All contributions to charitable organizations.
|
(16)
|
All contributions to reserves for Operating Expenses.
|
(17)
|
Except as otherwise provided in Section 6.B(6) above, any special assessments of taxes from any city, county, state or federal governmental agency, including, but not limited to, such items as parking income taxes.
|
(18)
|
Costs of repair or replacement for any item to the extent that Landlord is reimbursed for same pursuant to a warranty.
|
(19)
|
Costs which Landlord is reimbursed by its insurance carrier or by any tenant's insurance carrier or by any other entity.
|
(20)
|
Any fines, costs, penalties or interest resulting from the negligence or willful misconduct of the Landlord or its agents, contractors or employees.
|
(21)
|
Any bad debt loss, rent loss or reserves for bad debt or rent loss.
|
(22)
|
All payments of principal, interest or other charges of any kind incurred in connection with any indebtedness secured by the Complex, and any payments under any ground lease or other underlying lease; provided that if Landlord makes payment of ad valorem taxes to its lender, rather than to taxing authorities, then payment to the lender shall not be included in Operating Expenses, but payments by the lender to taxing authorities shall be considered payments by Landlord, to be included in Operating Expenses to the extent otherwise provided for herein.
|
(23)
|
The cost of any additional casualty insurance premium for the Complex in excess of the standard rate payable by Landlord, which additional cost is attributable to: (a) the tenancy of a particular tenant or tenants in the Complex other than Tenant or (b) the use of any part of the Complex by Landlord other than for purposes of providing general services to the Complex.
|
(24)
|
Accounting costs and audit fees attributable to Landlord's ownership (as opposed to the operation) of the Complex, including in connection with Landlord’s income tax returns.
|
(1)
|
Domestic water at those points of supply provided for general use of the tenants of the Building;
|
(2)
|
Chilled water piping to the main Building back bone located in the center of the Building mechanical rooms on the fifth (5
th
) floor of the Building for central heat, ventilation and air conditioning in season, twenty-four (24) hours per day, seven (7) days per week, all as more particularly described on
Exhibit H
attached hereto and made a part hereof for all purposes;
|
(3)
|
Electric lighting service for all public areas and special service areas of the Building in the manner and to the extent deemed by Landlord to be in keeping with the standards of other comparable medical office buildings in and in the vicinity of the Texas Medical Center area of Houston, Texas;
|
(4)
|
Janitor service on a five (5) day week basis, in the manner and to the extent deemed standard by Landlord during the periods and hours as such services are normally furnished to tenants in the Building and such window-washing as may from time to time in Landlord’s judgment reasonably be required, all in keeping with the standards of other comparable medical office buildings in and in the vicinity of the Texas Medical Center area of Houston, Texas;
|
(5)
|
On-site security personnel and equipment for the Building; provided, however, that Tenant agrees that Landlord shall not be responsible for the adequacy or effectiveness of such security provided that (i) Landlord has exercised reasonable care in the selection of the security contractor and equipment, and (ii) the scope and extent of the security services contracted for by Landlord are in keeping with the standards of other comparable medical office buildings in and in the vicinity of the Texas Medical Center area of Houston, Texas;
|
(6)
|
Electrical facilities to furnish 24 hours a day, seven days a week (i) power to operate typewriters, personal computers, calculating machines, photocopying machines and other equipment that operates on 120/208 volts (collectively, the “
Low Power Equipment
”); provided, however, total rated connected load by the Low Power Equipment shall not exceed an annual average of four (4) watts per square foot of Net Rentable Area of the Manufacturing Space and Interior Mechanical Space and (ii) power to operate Tenant’s lighting and Tenant’s equipment that operates on 277/480 volts (collectively, the “
High Power Equipment
”); provided, however, total rated connected load by the High Power Equipment shall not exceed an annual average of two (2) watts per square foot of Net Rentable Area of the Manufacturing Space and Interior Mechanical Space. In the event that the Tenant's connected loads for low electrical consumption (120/208 volts) and high electrical consumption (277/480 volts) are in excess of those loads stated above, as determined by an independent utility consultant, and Landlord agrees to provide such additional load capacities to Tenant (such determination to be made by Landlord in its sole discretion), then Landlord may install and maintain, at Tenant’s expense, electrical submeters, wiring, risers, transformers, and electrical panels, and other items required by Landlord, in Landlord’s discretion, to accommodate Tenant’s design loads and capacities that exceed those loads stated above, including, without limitation, the installation and maintenance thereof.
|
(7)
|
All Building standard fluorescent bulb replacement and all incandescent bulb replacement in the Common Areas of the Complex; and
|
(8)
|
Non-exclusive passenger elevator service to the Manufacturing Space twenty-four (24) hours per day and non-exclusive freight elevator service during normal business hours of the Building.
|
(1)
|
in the event such assignee or sublessee fails to meet the conditions set forth in subparagraph (3) below, to refuse to permit Tenant to assign this Lease Agreement or sublet such space, and in such case this Lease Agreement shall continue in full force and effect in accordance with the terms and conditions hereof; or
|
(2)
|
to terminate this Lease Agreement as to the space so affected as of the date so specified by Tenant in which event Tenant shall be relieved of all obligations hereunder as to such space arising from and after such date; provided, however, that if Landlord elects to terminate this Lease Agreement pursuant to this Section 12.A(2), Tenant shall have ten (10) days after receipt of written notice of Landlord’s election during which Tenant may, if it so desires, withdraw its request for Landlord’s consent to such assignment or sublease, in which event this Lease Agreement shall remain in full force and effect as if such request for Landlord’s consent had not been made; or
|
(3)
|
to permit Tenant to assign this Lease Agreement or sublet such space for the duration specified in such notice, such approval not to be unreasonably withheld, conditioned or delayed, if (a) the nature and character of the proposed assignee or sublessee and the principals thereof, their business and activities and intended use of the Leased Premises are in Landlord’s reasonable judgment consistent with the current standards of the Building and the floor or floors on which the Leased Premises are located, (b) neither the proposed assignee or sublessee (nor any party which, directly or indirectly, controls or is controlled by or is under common control with the proposed assignee or sublessee) is a department, representative or agency of any governmental body or then an occupant of any part of the Building or a party with whom Landlord is then negotiating to lease space in the Building or in any adjacent Building owned by Landlord or an affiliate of Landlord in and in the vicinity of the Texas Medical Center area of Houston, Texas, (c) the form and substance of the proposed sublease or instrument of assignment are acceptable to Landlord (which
|
(1)
|
Landlord leases other space in the Building prior to re-letting the Leased Premises;
|
(2)
|
Landlord refuses to relet the Leased Premises to any Affiliate of Tenant, or any principal of Tenant, or any Affiliate of such principal;
|
(3)
|
Landlord refuses to relet the Leased Premises to any person or entity whose creditworthiness Landlord in good faith deems unacceptable;
|
(4)
|
Landlord refuses to relet the Leased Premises to any person or entity because the use proposed to be made of the Leased Premises by such prospective tenant is not of a type and nature consistent with that of the other tenants in the Building or the floor where the Leased Premises are situated as of the date Tenant defaults under this Lease Agreement, or because such use would, in the good faith opinion of Landlord, impose unreasonable or excessive demands upon the Building;
|
(5)
|
Landlord refuses to relet the Leased Premises to any person or entity, or any affiliate of such person or entity, who has been engaged in litigation with, or who has threatened litigation against, Landlord or any of its affiliates, or whom Landlord in good faith deems to be unreasonably or excessively litigious;
|
(6)
|
Landlord refuses to relet the Leased Premises because the tenant or the terms and provisions of the proposed lease are not approved by the holders of any liens or security interests in the Building or any part thereof, or would cause Landlord to breach or be in default of, or to be unable to perform any of its covenants under, any agreements between Landlord and any third party;
|
(7)
|
Landlord refuses to relet the Leased Premises because the proposed tenant is unwilling to execute and deliver Landlord’s standard lease form without substantial tenant-oriented modifications or such tenant requires improvements to the Leased Premises to be paid at Landlord’s cost and expense; or
|
(8)
|
Landlord refuses to relet the Leased Premises to a person or entity whose character or reputation, or the nature of whose business, Landlord in good faith deems unacceptable;
|
With a copy to:
|
Jones Lang LaSalle
|
With a copy to:
|
Property Management Office
|
To the Tenant:
|
At the address noted for Tenant on the signature page hereof until the Commencement Date, at which time it shall become the Address of the Leased Premises.
|
With a copy to:
|
DuBois, Bryant & Campbell, LLP
|
1.
|
Tenant shall pay as rental for the Parking Spaces the rates charged from time to time by the operator of the Garage, plus all taxes applicable thereto. During the first twelve (12) months following the Commencement Date, the initial monthly rate for each of the Parking Spaces for reserved parking shall be $240.00 plus taxes and for unreserved parking shall be $165.00 plus taxes. Said rentals shall be due and payable to Landlord or its parking manager, as designated in writing by Landlord at the address of the Landlord’s property manager specified in Section 31 of this Lease Agreement (or such other address as may be designated by Landlord in writing from time to time), as additional rent on the first day of each calendar month during the Term.
|
2.
|
In the event Tenant so desires, and upon ten (10) days’ prior written notice to Landlord, Tenant may convert up to ten percent (10%) of its Parking Spaces for unreserved parking to Parking Spaces for reserved parking. In the event Tenant elects to convert such unreserved Parking Spaces to reserved Parking Spaces in accordance with this Paragraph 2, Landlord shall provide said Parking Spaces for reserved parking to Tenant during the balance of the Term at the rates charged from time to time for reserved Parking Spaces in the Garage plus all taxes applicable thereto. From and after the date Tenant commences leasing such parking spaces for reserved parking, the term “Parking Spaces” shall be deemed to include such reserved Parking Spaces.
|
3.
|
Notwithstanding
anything contained in this
Exhibit C
to the contrary, Landlord shall have the right to recapture any Parking Space not utilized by Tenant for six (6) consecutive months beginning after the first twelve (12) calendar months of the Term, and in the event Landlord exercises such right, Landlord shall have no further obligations to Tenant with respect to such Parking Spaces and the number of reserved or unreserved Parking Spaces, as the case may be, referred to above in this
Exhibit C
shall be correspondingly reduced.
|
4.
|
Landlord will issue to Tenant parking tags, stickers or access cards for the Parking Spaces, or will provide a reasonable alternative means of identifying and controlling vehicles authorized to park in the contract Garage. Tenant shall surrender each such tag, sticker or other identifying device to Landlord upon termination of the Parking Space related thereto.
|
5.
|
Landlord, at its discretion, shall have the right from time to time, upon written notice to Tenant, to designate the area(s) within which vehicles may be parked. Tenant agrees that although Landlord shall mark with signage Tenant’s reserved Parking Spaces, Landlord shall have no obligation to enforce such reservation by ticketing, towing or affixing a notice to cars parked in Tenant’s reserved Parking Spaces by those who are not Tenant’s customers, guests, invitees and employees; provided, however, Landlord will use commercially reasonable efforts to direct tenants at the Complex to abide by the parking rules.
|
6.
|
If for any reason beyond Landlord’s reasonable control Landlord fails or is unable to provide any of the Parking Spaces to Tenant at any time during the Term or any renewals or extensions hereof, and such failure continues for two (2) business days after Tenant gives Landlord written notice thereof, Tenant’s obligation to pay rental for any Parking Space which is not provided by Landlord shall be abated for so long as Tenant does not have the use thereof and Landlord shall use its diligent good faith efforts to provide alternative parking arrangements in the Garage or within a one-half (1/2) mile radius of the Building for the number of vehicles equal to the number of Parking Spaces not provided by Landlord. Tenant shall pay for any alternative parking provided by Landlord so long as Tenant is not paying rent for the Parking Spaces. This abatement and good faith effort
|
7.
|
If the Term commences on other than the first day of a calendar month or terminates on other than the last day of a calendar month, then rentals for the Parking Spaces shall be prorated on a daily basis.
|
8.
|
Tenant shall indemnify, defend (with counsel reasonably acceptable to Landlord) and hold harmless the Landlord Parties from and against all liabilities, obligations, losses, damages, penalties, claims, actions, suits, costs, expenses and disbursements (including court costs and reasonable attorneys’ fees) resulting directly or indirectly from the use of the Parking Spaces, unless caused by the gross negligence or willful misconduct of Landlord or the Landlord Parties.
|
9.
|
Landlord may provide parking in the Garage or in surface lots for visitors to the Building in an area designated by Landlord and in a capacity determined by Landlord to be appropriate for the Building. Landlord reserves the right to charge and collect a fee for parking in the visitor Garage or in the surface lots in an amount determined by Landlord or the operator of the Garage to be appropriate. Provided that no Event of Default has occurred, Landlord agrees to allow Tenant to validate the parking ticket of Tenant’s visitors with a stamp or other means approved in advance by Landlord, and to bill Tenant for the parking charges so validated by Tenant on a monthly basis. Said visitor parking charges shall be due and payable to Landlord as additional rent within ten (10) days after Tenant’s receipt of such statement. Alternatively, Landlord may establish a parking validation program whereby tenants may, at their option, purchase prepaid parking validation stickers or other means of identification for specific increments of visitor parking charges, which the tenants may then distribute to their visitors and invitees to be submitted to the Garage attendant as payment for the applicable increment of visitor parking charge.
|
10.
|
Upon the occurrence of an Event of Default, Landlord shall have the right (in addition to all other rights, remedies and recourse hereunder and at law) to terminate Tenant’s use of the Parking Spaces without prior notice or warning to Tenant.
|
11.
|
Landlord shall have the right to relocate the Garage to any future parking facilities Landlord may construct on the Land, provided Tenant has use of 35 parking spaces.
|
1.
|
Cars must be parked entirely within the stall lines painted on the floor.
|
2.
|
All directional signs and arrows and signs designating wheelchair accessible parking spaces must be observed.
|
3.
|
The speed limit shall be five (5) miles per hour.
|
4.
|
Parking prohibited:
|
(a)
|
in areas not striped for parking
|
(b)
|
in aisles
|
(c)
|
where “no parking” signs are posted
|
(d)
|
on ramps where indicated
|
(e)
|
in cross-hatched areas
|
(f)
|
in spaces reserved for exclusive use by designated lessees
|
(g)
|
in such other areas as may be designated by Landlord or Landlord’s agent(s).
|
5.
|
Parking stickers or any other device or form of identification supplied by Landlord shall remain the property of Landlord and shall not be transferable. There will be a replacement charge payable by Tenant equal to the amount posted from time to time by Landlord for loss of any parking card or parking sticker.
|
6.
|
Garage managers and attendants are not authorized to make or allow any exceptions to these Rules and Regulations.
|
7.
|
Every parker is required to park and lock his own car. All responsibility for loss or damage to cars and contents, property or persons is assumed by the parker.
|
8.
|
Tenant is required to give Landlord, on a quarterly basis, a list of employees parking in the Garage which shall include year, make and model of car and license number.
|
9.
|
In order to protect Landlord’s property, Landlord shall have the right, but not the obligation, to install cameras in the Garage.
|
10.
|
Landlord is entitled to limit the size of the parked vehicles by weight, height or width without constituting a breach of its obligation to provide parking hereunder.
|
1.
|
All tenants will refer all contractors’ representatives and installation technicians who are to perform any work within the Building to Landlord for Landlord’s supervision, approval (which approval shall not be unreasonably withheld, conditioned or delayed) and control before the performance of any such work. This provision shall apply to all work performed in the Building including, but not limited to, installations of telephones, computer equipment, electrical devices and attachments, and any and all installations of every nature affecting floors, walls, woodwork, trim, windows, ceilings, equipment and any other physical portion of the Building. Tenant shall not mark, paint, drill into, or in any way deface any part of the Building or the Leased Premises, except with the prior written consent of the Landlord, and as the Landlord may direct; provided, however, Tenant may hang pictures, bulletin boards, white boards and the like within the Leased Premises without prior consent of or notice to Landlord.
|
2.
|
The work of the janitorial or cleaning personnel shall not be hindered by Tenant after 5:30 p.m., and such work may be done at any time when the offices are vacant. The windows, doors and fixtures may be cleaned at any time. Tenant shall provide adequate waste and rubbish receptacles, cabinets, book cases, map cases, etc., necessary to prevent unreasonable hardship to Landlord in discharging its obligations regarding cleaning service.
|
3.
|
Prior to the commencement of any construction in the Leased Premises, Tenant shall deliver evidence of its contractor’s and subcontractor’s insurance, such insurance being with such companies, for such periods and in such amounts as Landlord may reasonably require, naming the Landlord Parties as additional insureds.
|
4.
|
No sign, advertisement or notice shall be displayed, painted or affixed by Tenant, its agents, servants or employees, in or on any part of the outside or inside of the Building or Leased Premises without prior written consent of Landlord, and then only of such color, size, character, style and material and in such places as shall be approved and designated by Landlord. Signs on doors and entrances to the Leased Premises shall be placed thereon by Landlord.
|
5.
|
Except as otherwise provided in this Lease Agreement and for such items as are installed as part of the Leasehold Improvements, Tenant shall not place, install or operate on the Leased Premises or in any part of the Building any engine, refrigerating, heating or air conditioning apparatus, stove or machinery, or conduct mechanical operations, or place or use in or about the Leased Premises any inflammable, explosive, hazardous or odorous solvents or materials without the prior written consent of Landlord. No portion of the Leased Premises shall at any time be used for cooking, sleeping or lodging quarters. Tenant may use coffee pots, refrigerators and microwaves in Leased Premises.
|
6.
|
Tenant shall not make or permit any loud or improper noises in the Building or otherwise interfere in any way with other tenants.
|
7.
|
Landlord will not be responsible for any lost or stolen personal property or equipment from the Leased Premises or public areas, regardless of whether such loss occurs when the area is locked against entry or not.
|
8.
|
Tenant, or the employees, agents, servants, visitors or licensees of Tenant, shall not, at any time or place, leave or discard rubbish, paper, articles, plants or objects of any kind whatsoever outside the doors of the Leased Premises or in the corridors or passageways of the Building or attached Parking Areas. No animals (other
|
9.
|
No additional lock or locks shall be placed by Tenant on any door in the Building unless written consent of Landlord shall have first been obtained. Two (2) keys will be furnished by Landlord for the Leased Premises, and any additional key required must be obtained from Landlord. A charge will be made for each additional key furnished. All keys shall be surrendered to Landlord upon termination of tenancy.
|
10.
|
None of the entries, passages, doors, hallways or stairways in the Building shall be blocked or obstructed.
|
11.
|
Landlord shall have the right to determine and prescribe the weight and proper position of any unusually heavy equipment, including computers, safes, large files, etc., that are to be placed in the Building, and only those which in the exclusive judgment of the Landlord will not do damage to the floors, structure and/or elevators may be moved into the Building. Any damage caused by installing, moving or removing such aforementioned articles in the Building shall be paid for by Tenant.
|
12.
|
All holiday and other decorations must be constructed of flame retardant materials. Live Christmas trees are not permitted in the Leased Premises.
|
13.
|
Tenant shall provide Landlord with a list of all personnel authorized to enter the Building after hours (6:00 p.m. to 7:00 a.m. Monday through Friday, and 24 hours a day on Saturdays, Sundays and Holidays).
|
14.
|
The following dates shall constitute “
Holidays
” as said term is used in this Lease Agreement: New Year’s Day, Memorial Day, Independence Day, Labor Day, Thanksgiving, the Friday following Thanksgiving Day and Christmas and any other holiday recognized and taken by tenants cumulatively occupying at least one-half (1/2) of the Net Rentable Area of office space of the Building. The Holidays set forth herein may not be changed by Landlord during the Term.
|
15.
|
The following hours shall constitute the normal business hours of the Building: between 7:00 a.m. and 6:00 p.m. from Monday through Friday and between 8:00 a.m. and 12:00 noon on Saturdays, all exclusive of Holidays. The aforementioned hours of operation may not be changed by Landlord during the Term.
|
16.
|
Movement of furniture or office equipment in or out of the Building, or dispatch or receipt by Tenant of any heavy equipment, bulky material or merchandise which requires use of elevators or stairways, or movement through the Building’s service dock or lobby entrance shall be restricted to such hours as Landlord shall designate. All such movement shall be in a manner to be agreed upon between Tenant and Landlord in advance. Such prior arrangements shall be initiated by Tenant. The time, method and routing of movement and limitations for safety or other concern which may prohibit any article, equipment or other item from being brought into the Building shall be subject to Landlord’s reasonable discretion and control. Any hand trucks, carryalls or similar appliances used for the delivery or receipt of merchandise or equipment shall be equipped with rubber tires, side guards and such other safeguards as the Building shall require. Although Landlord or its personnel may participate in or assist in the supervision of such movement, Tenant assumes full responsibility for all risks as to damage to articles moved and injury to persons or property engaged in such movement, including equipment, property and personnel of Landlord if damaged or injured as a result of acts in connection with carrying out this service for Tenant, from the time of entering the property to completion of work. Landlord shall not be liable for the acts of any person engaged in, or any damage or loss to any of said property or persons resulting from any act in connection with such service performed for Tenant.
|
17.
|
Landlord shall designate one elevator to be the freight elevator to be used to handle packages and shipments of all kinds. The freight elevator shall be available to handle such deliveries from 9:00 a.m. to 11:00 a.m. and 2:00 p.m. to 3:30 p.m. weekdays. Parcel Post, express, freight or merchants’ deliveries can be made anytime
|
18.
|
Any additional services as are routinely provided to tenants, not required by the Lease Agreement to be performed by Landlord, which Tenant requests Landlord to perform, and which are performed by Landlord, shall be billed to Tenant at Landlord’s cost plus five percent (5%).
|
19.
|
All doors leading from public corridors to the Leased Premises are to be kept closed when not in use.
|
20.
|
Canvassing, soliciting or peddling in the Building is prohibited and Tenant shall cooperate to prevent same.
|
21.
|
Tenant shall give immediate notice to the Building Manager in case of accidents in the Leased Premises or in the Building or of defects therein or in any fixtures or equipment, or of any known emergency in the Building.
|
22.
|
Tenant shall not use the Leased Premises or permit the Leased Premises to be used for photographic, multilith or multigraph reproductions, except in connection with its own business.
|
23.
|
The requirements of Tenant will be attended to only upon application to the Building Manager. Employees of Landlord shall not perform any work or do anything outside of their regular duties, unless under special instructions from the Building Manager.
|
24.
|
Tenant shall place or have placed solid pads under all rolling chairs such as may be used at desks or tables. Any damages caused to carpet by not having same shall be repaired or replaced at the expense of Tenant.
|
25.
|
Tenant, or the employees, agents, servants, visitors or licensees of Tenant shall abide by the rules and regulations for the Parking Areas included in the Parking Agreement attached hereto as
Exhibit C
.
|
26.
|
Except as otherwise noted, Landlord reserves the right to rescind any of these Rules and Regulations of the Building, and to make such other and further rules and regulations as in its reasonable judgment shall from time to time be needful for the safety, protection, care and cleanliness of the Building, the Leased Premises and the Parking Areas, the operation thereof, the preservation of good order therein and the protection and comfort of the other tenants in the Building and their agents, employees and invitees, which rules and regulations, when made and written notice thereof is given to Tenant, shall be binding upon Tenant in like manner as if originally herein prescribed, provided such changes do not unreasonably interfere with Tenant’s use or occupancy of or access to the Leased Premises.
|
27.
|
Landlord will provide 35 cardkeys or other access devices during the Term to Tenant and Tenant agrees to return all of these cardkeys and other access devices to Landlord upon expiration or termination of this Lease Agreement. All others will be furnished to Tenant at a cost of Fifty and 00/100 Dollars ($50.00) per card or a mutually agreed upon price for each other access device. Any future increase in the cost of cardkeys and other access devices will be passed on to Tenant for any additional cardkeys and other access devices required.
|
28.
|
Tenant, or its employees, agents, servants, visitors, invitees or licensees of Tenant, shall not smoke or permit to be smoked cigarettes, cigars or pipes within the Leased Premises or Building. Smoking shall be confined to area(s) designated by Landlord but shall in no event be closer than twenty-five feet (25’) to any entrance to the Building. Landlord shall have no obligation to Tenant for failure of another tenant, its employees, agents, servants, visitors, invitees or licensees to comply with this paragraph.
|
29.
|
Tenant shall not attempt to adjust wall-mounted thermostats in the Building. If there is any damage to wall-mounted thermostats due to attempts by Tenant to adjust thermostats, Landlord may repair such damage at the sole cost and expense of the Tenant.
|
1.
|
The Manufacturing Space
consists of
square feet of Net Rentable Area. The Interior Mechanical Space
consists of
square feet of Net Rentable Area and the Exterior Mechanical Space consists of _________ square feet of Net Rentable Area.
|
2.
|
Except for those items shown on the attached “punch list”, if any, which Landlord will remedy within 30 days hereof, Landlord has fully completed the construction work required under the terms of the Lease Agreement.
|
3.
|
The Leased Premises are tenantable, the Landlord has no further obligation for construction (except as specified above), and Tenant acknowledges that both the Building and the Leased Premises are satisfactory in all respects.
|
4.
|
The Commencement Date of the Lease Agreement is hereby agreed to be the _____ day of _________, 2015.
|
5.
|
The Expiration Date of the Lease Agreement is hereby agreed to be the _____ day of _________, 2020.
|
1.
|
A true and correct copy of the Lease Agreement, including any and all amendments and modifications thereto, is attached hereto as
Exhibit A
;
|
2.
|
The original Lease Agreement is dated
, 201__, and has been assigned, modified, supplemented or amended only in the following respects:
|
3.
|
Tenant is in actual occupancy of the Leased Premises under the Lease Agreement; the Leased Premises are known as Suite
, of the Project; and the Leased Premises contain approximately
square feet;
|
4.
|
The initial term of the Lease Agreement commenced on
, 201__, and ends at 11:59 p.m. on
, 201__, at a monthly base rent of $
, and no rentals or other payments in advance of the current calendar month have been paid by Tenant, except as follows:
|
5.
|
Base Rent with respect to the Lease Agreement has been paid by Tenant through
, 201__; all additional rents and other charges have been paid for the current periods;
|
6.
|
There are no unpaid concessions, bonuses, free months’ rent, rebates or other matters affecting the rent for Tenant, except as follows:
|
7.
|
No security or other deposit has been paid by Tenant with respect to the Lease Agreement, except as follows:
|
8.
|
The Lease Agreement is in full force and effect and, to Tenant’s current actual knowledge, there are no events or conditions existing which, with notice or the lapse of time or both, could constitute a monetary or other default of the Landlord under the Lease Agreement, or entitle Tenant to any offset or defense against the prompt current payment of rent or constitute a default by Tenant under the Lease Agreement, except as follows:
|
9.
|
All improvements required to be made by Landlord under the terms of the Lease Agreement have been satisfactorily completed and accepted by Tenant as being in conformity with the Lease Agreement, except as follows:
|
10.
|
Tenant has no option to expand or rent additional space within the Project or any right of first refusal with regard to any additional space within the Project, other than the Leased Premises, except as follows:
|
11.
|
Tenant has no right or option to renew the Lease Agreement for any period of time after the expiration of the initial term of the Lease Agreement, except as follows:
|
12.
|
To Tenant’s current actual knowledge, any and all broker’s leasing and other commissions relating to and/or resulting from Tenant’s execution of the Lease Agreement and occupancy of the Leased Premises have been paid in full and no broker’s leasing or other commissions will be or become due or payable in connection with or as a result of either Tenant’s execution of a new Lease Agreement covering all or any portion of the Leased Premises or any other space within the Project or Tenant’s renewal of the Lease Agreement, except as follows:
|
13.
|
To Tenant’s current actual knowledge, the use, maintenance or operation of the Leased Premises complies with, and will at all times comply with, all applicable federal, state, county or local statutes, laws, rules and regulations of any governmental authorities relating to environmental, health or safety matters (being hereinafter collectively referred to as the “Environmental Laws”);
|
14.
|
[intentionally deleted];
|
15.
|
Tenant has not received any notices, written or oral, of violation of any Environmental Law or of any allegation which, if true, would contradict anything contained herein and there are not writs, injunctions, decrees, orders or judgments outstanding, no lawsuits, claims, proceedings or investigations pending or threatened, relating to the use, maintenance or operation of the Leased Premises, nor is Tenant aware of a basis for any such proceeding;
|
16.
|
There are no actions, whether voluntary or otherwise, pending against Tenant under the bankruptcy or insolvency laws of the United States or of any state.
|
17.
|
Tenant has no right of refusal or option to purchase the Leased Premises or the Project.
|
18.
|
Tenant understands that the Lease Agreement may be assigned to Addressee and Tenant agrees to attorn to Addressee in all respects in accordance with the Lease Agreement.
|
1.
|
Tenant’s Insurance.
|
2.
|
Landlord’s Insurance.
|
3.
|
Waiver of Subrogation.
|
1.
|
A full service health club and fitness facility offering such fitness programs, recreational facilities, personal training and other related services as Tenant may determine which may include, without limitation, the following primary permitted uses: a jogging track, weight and aerobic training, racquetball and other racquet sports, gymnasiums, basketball, swimming pool, jacuzzi, sauna and whirlpool facilities, steam rooms, aerobics and/or floor exercise, strength training, cardio fitness training, free weights, exercise machinery and equipment, martial arts, spinning, boxing, yoga, circuit training and personal training.
|
2.
|
A long term acute care hospital.
|
3.
|
A first class delicatessen style sandwich shop.
|
4.
|
A medical facility having in the Building a linear accelerator, CT scan imaging equipment, PET scan imaging equipment and/or MRI equipment, all for oncological diagnosis and treatment purposes.
|
1.
|
Tenant hereby subordinates all of its right, title and interest under the Lease to the lien, operation and effect of the Mortgage s (as the same may be modified and/or extended from time to time) now or hereafter in force against the Property, and to any and all existing and future advances made under such Mortgage.
|
2.
|
In the event that Lender becomes the owner of the Property by foreclosure, deed in lieu of foreclosure, or otherwise, Tenant agrees to unconditionally attorn to Lender and to recognize it as the owner of the Property and the Landlord under the Lease. The Lender agrees not to terminate the Lease or disturb or interfere with Tenant’s possession of the Leased Premises during the term of the Lease, or any extension or renewal thereof, so long as Tenant is not in default under the Lease beyond applicable notice, grace and cure periods, if any.
|
3.
|
Tenant agrees to commence paying all rents, revenues and other payments due under the Lease directly to Lender after Lender notifies Tenant that Lender is the owner and holder of the Loan and is invoking Lender’s rights under the Loan documents to directly receive from Tenant all rents, revenues and other payments due under the Lease. By making such payments to Lender, Tenant shall be deemed to have satisfied all such payment obligations to Landlord under the Lease.
|
4.
|
This Agreement shall inure to the benefit of and be binding upon Lender’s affiliates, agents, co-lenders and participants, and each of their respective successors and assigns (each a “
Lender Party
” and collectively, the “
Lender Parties
”).
|
5.
|
For the convenience of the parties any number of counterparts hereof may be executed, and each such executed counterpart shall be deemed an original, and all such counterparts together shall constitute one and the same instrument. Facsimile or .PDF transmission of an executed counterpart of this Agreement shall be deemed to constitute due and sufficient delivery of such counterpart, and such facsimile or .PDF signatures shall be deemed original signatures for purposes of enforcement and construction of this Agreement.
|
Defined Term
|
Section in which Defined
|
Term
|
10.1
|
Third Party Claim
|
7.1
|
Third Party Claim of INF
|
5.4(a)
|
Third Party IP License
|
4.3(d)
|
iv-1) […***…]
|
US$[…***…]
|
iv-2) […***…]
|
US$[…***…]
|
v-1) […***…]
|
US$[…***…]
|
v-2) […***…]
|
US$[…***…]
|
If to BELLICUM,
addressed to:
|
BELLICUM PHARMACEUTICALS, INC.
2130 W. Holcombe Boulevard, Suite 800
Houston, Texas 77030
Attention: President and Chief Executive Officer
Telephone: +1 (832) 384-1111
Facsimile: +1 (832) 384-1150
|
With a copy to (which does not constitute notice):
|
BELLICUM PHARMACEUTICALS, INC.
2130 W. Holcombe Boulevard, Suite 800
Houston, Texas 77030
Attention: Chief Financial Officer
Telephone: +1 (832) 384-1116
Facsimile: +1 (832) 384-1150
|
With a copy to (which does not constitute notice):
|
BELLICUM PHARMACEUTICALS, INC.
2130 W. Holcombe Boulevard, Suite 800
Houston, Texas 77030
Attention: General Counsel
Telephone: +1 (832) 384-1107
Facsimile: +1 (281) 768-7695
|
If to AGENSYS,
addressed to:
|
AGENSYS, INC.
1800 Stewart Street
Santa Monica, CA 90404
Attention: Shane M. Popp
Telephone: +1-424-280-5205
Facsimile: +1-424-280-5052
|
With a copy to (which does not constitute notice):
|
AGENSYS, INC.
1800 Stewart Street
Santa Monica, CA 90404
Attention: Head of Research
|
With a copy to (which does not constitute notice):
|
ASTELLAS PHARMA INC.
2-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan
Attention: Vice President, Legal & Compliance
Telephone: +81-3-3244-3231
Facsimile:+81-3-3244-5811
|
Exhibit A:
|
|
AGENSYS Patent Rights
|
Exhibit B:
|
|
AGENSYS Licensed Patent Rights
|
Exhibit C:
|
|
AGENSYS’S Affiliates
|
Exhibit D:
|
|
[…***…] |
Company name
|
|
Country
|
Astellas US Holding, Inc.
|
USA
|
Astellas US LLC
|
USA
|
Astellas Pharma US, Inc.
|
USA
|
OSI Pharmaceuticals, LLC
|
USA
|
(OSl) Pinelawn LLC
|
USA
|
OSl Ardsley LLC
|
USA
|
Ocogene Science Inc.
|
USA
|
Astellas Pharma Canada Inc.
|
Canada
|
Astellas Farma Brasil Importacao e Distribucao de Medicamentos Ltda.
|
Brazil
|
Astellas Pharma Global Development, Inc.
|
USA
|
Astellas Scientific and Medical Affairs, Inc.
|
USA
|
Astellas Research Institute of America LLC
|
USA
|
Agensys, Inc.
|
USA
|
Astellas US Technologies, Inc.
|
USA
|
Astellas Pharma Technologies, Inc.
|
USA
|
Astellas Venture Capital LLC
|
USA
|
Astellas Venture Management LLC
|
USA
|
Astellas Bio Inc.
|
USA
|
Perseid Therapeutics LLC
|
USA
|
Fujisawa Investments for Entrepreneurship, L.P.
|
USA
|
Astellas Venture Fund I LP
|
USA
|
Fujisawa Investments for Entrepreneurship II, L.P.
|
USA
|
|
|
Astellas B.V.
|
Netherlands
|
Astellas Pharma Ges.mbH
|
Austria
|
Astellas Pharma EOOD
|
Bulgaria
|
Astellas d.o.o. za promet lijekovima
|
Croatia
|
Astellas Pharma s.r.o.
|
Czech
|
Astellas Pharma A/S
|
Denmark
|
Astellas Pharma JLT
|
Dubai
|
Astellas Pharma S.A.S
|
France
|
Astellas Pharma GmbH
|
Germany
|
Astellas Deutschland GmbH
|
Germany
|
Klinge Pharma GmbH
|
Germany
|
Astellas Pharmaceuticals AEBE
|
Greece
|
Astellas Pharma Kft
|
Hungary
|
Astellas Pharma Co. Ltd.
|
Ireland
|
Astellas Pharma S.p.A.
|
Italy
|
Astellas Pharma Europe BV
|
Netherlands
|
Astellas Pharma International BV
|
Netherlands
|
Astellas Pharma BV
|
Netherlands
|
Astellas Pharma Sp.z.O.O.
|
Poland
|
Astellas Farma Limitada
|
Portugal
|
Yabrofarma, LDA
|
Portugal
|
Astellas Pharma S.R.L.
|
Rumania
|
ZAO Astellas Pharma
|
Russia
|
Astellas Pharma Production LLC
|
Russia
|
Astellas Pharma Pty.
|
South Africa
|
Astellas Pharma S.A.
|
Spain
|
Yamanouchi Spain, S.L.
|
Spain
|
Astellas Pharma AB
|
Sweden
|
Astellas Pharma A.G.
|
Switzerland
|
Astellas Pharma llaç Ticaret ve Sanayi A.Ş.
|
Turkey
|
Astellas Pharma, trzenje in distribucija farmacevtskih izdelkov d.o.o.
|
Slovenia
|
Limited Liability Company “Astellas Pharma”
|
Ukraine
|
Astellas Pharma Europe Limited
|
UK
|
Astellas Pharma Limited
|
UK
|
Bripharm Ltd.
|
UK
|
Paines & Byrne, Limited
|
UK
|
Astellas Ireland Co., Ltd.
|
Ireland
|
Prosidion Limited
|
UK
|
Oxford Real Estate Owner Ld.
|
UK
|
Oxford Real Estate Owner 2 Ltd.
|
UK
|
|
|
|
|
Astellas Pharma Korea, Inc.
|
Korea
|
Astellas Pharma Taiwan, Inc.
|
Taiwan
|
Astellas Pharma China, Inc.
|
China
|
Astellas Pharma Hong Kong Co., Ltd.
|
Hong Kong
|
Astellas Pharma (Thailand) Co., Ltd.
|
Thailand
|
Astellas Pharma Philippines, Inc.
|
Philippine
|
P. T. Astellas Pharma Indonesia
|
Indonesia
|
Astellas Pharma India PVT, Ltd.
|
India
|
Astellas Pharma Singapore Pte. Ltd
|
Singapore
|
|
|
|
|
Astellas Pharma Australia Pty Ltd.
|
Australia
|
Rainbowseeker Insurance, Inc.
|
Micronesia
|
|
|
Date: March 14, 2016
|
/s/Thomas J. Farrell
|
|
Thomas J. Farrell
|
|
President and Chief Executive Officer
|
|
(Principal Executive Officer)
|
Date: March 14, 2016
|
/s/ Alan A. Musso
|
|
Alan A. Musso
|
|
Chief Financial Officer and Treasurer
|
|
(Principal Financial Officer)
|
(1)
|
this Annual Report on Form 10-K of the Registrant, to which this certification is attached as an exhibit (the “Report”), fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 (15 U.S.C. 78m); and
|
(2)
|
the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Registrant.
|
Date: March 14, 2016
|
/s/ Thomas J. Farrell
|
|
Thomas J. Farrell
|
|
President and Chief Executive Officer
|
(1)
|
this Annual Report on Form 10-K of the Registrant, to which this certification is attached as an exhibit (the “Report”), fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 (15 U.S.C. 78m); and
|
(2)
|
the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Registrant.
|
Date: March 14, 2016
|
/s/ Alan A. Musso
|
|
Alan A. Musso
|
|
Chief Financial Officer and Treasurer
|