POSEIDA THERAPEUTICS, INC. The following discussion and analysis of our financial condition and results of
operations should be read in conjunction with our unaudited condensed
consolidated financial statements and related notes appearing elsewhere in this
Quarterly Report on Form 10-Q and our audited consolidated financial statements
and the related notes thereto included in our Annual Report on Form 10-K for the
year ended
Overview
We are a clinical-stage biopharmaceutical company dedicated to utilizing our
proprietary genetic engineering platform technologies to create next-generation
cell and gene therapeutics with the capacity to cure. We were incorporated in
We have discovered and are developing a broad portfolio of product candidates in a variety of indications based on our core proprietary platforms, including our non-viral piggyBac DNA Delivery System, Cas-CLOVER Site-specific Gene Editing System and nanoparticle and AAV-based gene delivery technologies. Our core platform technologies have utility, either alone or in combination, across many cell and gene therapeutic modalities and enable us to engineer our portfolio of product candidates that are designed to overcome the primary limitations of current generation cell and gene therapeutics.
Within cell therapy, we believe our technologies allow us to create product candidates with engineered cells that engraft in the patient's body and drive lasting durable responses that may have the capacity to result in single treatment cures. Our CAR-T therapy portfolio consists of both autologous and allogeneic, or off-the-shelf, product candidates. We are advancing a broad pipeline and have multiple CAR-T product candidates in the clinical phase in both hematological and solid tumor oncology indications. Within gene therapy, we believe our technologies have the potential to create next-generation therapies that can deliver long-term, stable gene expression that does not diminish over time and that may have the capacity to result in single treatment cures.
Our most advanced investigational clinical programs are:
• P-PSMA-101, which is an autologous CAR-T product candidate targeting
prostate-specific membrane antigen, or PSMA, being developed to treat
patients with metastatic castrate-resistant prostate cancer, or mCRPC, and
salivary gland carcinoma. We are currently evaluating P-PSMA-101 in a
Phase 1 clinical trial. We presented encouraging preliminary results from
our Phase 1 clinical trial of P-PSMA-101 in our first solid tumor
indication on February 17, 2022 at ASCO-GU and may provide a further
clinical update likely in 2023. We also have a second-generation program,
P-PSMA-ALLO1, which is an allogeneic program, targeting PSMA utilizing a
VH binder, in preclinical development.
• P-BCMA-ALLO1, which is a fully allogeneic CAR-T product candidate
targeting BCMA, being developed to treat relapsed/refractory multiple
myeloma patients. We are currently evaluating P-BCMA-ALLO1 in a Phase 1
clinical trial and we expect initial clinical data from our Phase 1
clinical trial in the second half of 2022 subject to coordination with
Roche, as defined below. While P-BCMA-ALLO1 is currently manufactured at a
contract manufacturing organization, or CMO, we previously announced our
plan to transition manufacturing of P-BCMA-ALLO1 to our internal pilot
manufacturing plant and these transition efforts are ongoing. In July
2022 , we entered into a collaboration and license agreement, or the Roche
Collaboration Agreement, with F. Hoffmann-La Roche Ltd and Hoffmann-La
Roche Inc. , or, collectively Roche, pursuant to which P-BCMA-ALLO1 will be
exclusively licensed to Roche. Roche will be responsible for a majority of
future development costs for P-BCMA-ALLO1 and will assume future
development activities following the completion of the Phase 1 clinical
trial.
• P-MUC1C-ALLO1, which is a fully allogeneic CAR-T product candidate for
multiple solid tumor indications. We believe P-MUC1C-ALLO1 has the
potential to treat a wide range of solid tumors derived from epithelial
cells, such as breast, colorectal, lung, ovarian, pancreatic and renal
cancers, as well as other cancers expressing a cancer-specific form of the
Mucin 1 protein, or MUC1-C. We are currently evaluating P-MUC1C-ALLO1 in a
Phase 1 clinical trial and we
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expect initial clinical data from our Phase 1 clinical trial in the second
half of 2022. P-MUC1C-ALLO1 is the first program for which clinical
product will be sourced from our internal pilot manufacturing facility.
We manufacture these product candidates using our non-viral piggyBac DNA Delivery System. Our fully allogeneic CAR-T product candidates are developed using well-characterized cells derived from a healthy donor as starting material with the goal of enabling treatment of potentially hundreds of patients from a single manufacturing run. Doses are cryopreserved and stored at treatment centers for future off-the-shelf use. In addition, our allogeneic product candidates use our proprietary Cas-CLOVER site-specific Gene Editing System to reduce or eliminate reactivity, as well as our booster molecule technology for manufacturing scalability.
Our most advanced preclinical cell therapy program is:
• P-CD19CD20-ALLO1, which is a fully allogeneic CAR-T product candidate for
B-cell hematological indications. This is our first Dual CAR program,
which contains two fully functional CAR molecules to target cells that
express at least one of the two intended targets. We believe that our
ability to include two fully functional CAR molecules into a T cell could
provide a competitive advantage compared to current therapies. We
anticipate an IND filing and initiation of a Phase 1 clinical trial in the
first half of 2023. P-CD19CD20-ALLO1 will also be exclusively licensed to
Roche pursuant to the Roche Collaboration Agreement and Roche will be
responsible for a majority of future development costs for
P-CD19CD20-ALLO1 and will assume future development activities following
the completion of the Phase 1 clinical trial.
Our gene therapy product candidates have been developed by utilizing our piggyBac technology together with AAV to overcome the major limitations of traditional AAV gene therapy. We believe that our approach can result in integration and long-term stable expression at potentially much lower doses than AAV technology alone, thus also conferring cost and tolerability benefits. Our eventual goal is to completely replace AAV with our non-viral nanoparticle technology, freeing future product development in gene therapy of AAV limitations.
Our most advanced gene therapy programs are:
• P-OTC-101, which is a liver-directed gene therapy combining piggyBac
technology with AAV and nanoparticles for the in vivo treatment of
Ornithine Transcarbamylase, or OTC, deficiency. OTC deficiency is an often
fatal or morbid urea cycle disease caused by congenital mutations in the
OTC gene with a high unmet medical need. We have made the decision to
develop the P-OTC-101 program utilizing a hybrid of non-viral nanoparticle
delivery system to deliver RNA and AAV to deliver DNA and are working on
an updated timeline for the program.
• P-FVIII-101, which is a liver-directed gene therapy combining piggyBac
technology with our nanoparticle delivery technology for the in
vivo treatment of Hemophilia A. Hemophilia A is a bleeding disorder caused
by a deficiency in Factor VIII production with a high unmet need.
P-FVIII-101 utilizes piggyBac gene modification delivered via lipid
nanoparticle that has demonstrated stable and sustained Factor VIII
expression in animal models. Our P-FVIII-101 program is included in the
collaboration and license agreement, or the Takeda Collaboration
Agreement, with Takeda Pharmaceuticals USA, Inc. , or Takeda, and Takeda
will be responsible for all future development costs.
We expect our expenses and losses to increase substantially for the foreseeable future as we continue our development of, and seek regulatory approvals for, our product candidates, including P-PSMA-101 and P-MUC1C-ALLO1, and begin to commercialize any approved products. While we anticipate an overall increase in development costs as we continue to expand the number of product candidates in our pipeline and pursue clinical development of those candidates, we expect a decrease in our development costs on a per program basis as we are transitioning to our allogeneic platform. In addition, all or some of the development costs related to partnered gene therapy programs and cell therapy programs will be reimbursed by Takeda and Roche, respectively. We also expect our general and administrative expenses will increase for the foreseeable future to support our increased research and development and other corporate activities. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials and our expenditures on other research and development activities.
We do not expect to generate any revenues from product sales unless and until we successfully complete development and obtain regulatory approval for P-PSMA-101 and P-MUC1C-ALLO1, or any other product candidates, which will not be for at least the next several years, if ever. If we obtain regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution activities. Accordingly, until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through equity offerings, debt financings or other capital sources, including potential grants, collaborations, licenses or other similar arrangements. However, we may not be able to secure additional financing or enter into such other arrangements in a timely manner or on favorable terms, if at all. There can be no assurances that we will be able to secure such additional sources of funds to support our operations, or, if such funds are available to us, that such additional financing will be sufficient to meet our needs. Our failure to raise capital or enter into such other arrangements when needed would have a negative impact on our financial condition and could force us to delay, reduce or
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terminate our research and development programs or other operations, or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
The manufacturing process for our allogeneic product candidates is nearly
identical to the process for our autologous product candidates, except for the
gene editing and related steps. We work with a number of third-party contract
manufacturing organizations for production of our product candidates. We also
work with a variety of suppliers to provide our manufacturing raw materials
including media, DNA and RNA components. We have completed construction of an
internal pilot GMP manufacturing facility in
Collaboration Agreements
Roche Collaboration Agreement
In
For each Tier 1 Program, we will perform development activities through a Phase 1 dose escalation clinical trial, and Roche is obligated to reimburse a specified percentage of certain costs incurred by us in our performance of such activities, up to a specified reimbursement cap for each Tier 1 Program. For each Tier 2 Program, we will perform research and development activities either through selection of a development candidate for IND-enabling studies or, subject to Roche's election and payment of an option maintenance fee, through completion of a Phase 1 dose escalation clinical trial. In addition, for each Tier 2 Program for which Roche exercises its option for an exclusive license, Roche is obligated to pay us an option exercise fee. For each Tier 1 Program and Tier 2 Program, we will perform manufacturing activities until the completion of a technology transfer to Roche.
The parties will conduct an initial two-year research program to explore and preclinically test a specified number of agreed-upon next generation therapeutic concepts relating to allogeneic CAR-T cell therapies. Subject to Roche's election and payment of a fee, the parties would subsequently conduct a second research program of 18 months under which the parties would explore and preclinically test a specified number of additional agreed-upon next generation therapeutic concepts relating to allogeneic CAR-T therapies. Roche may designate up to six heme malignancy-directed, allogeneic CAR-T programs from the two research programs, for each of which we will perform research and development activities through selection of a development candidate for IND-enabling activities, or each, a Collaboration Program. Upon its designation of each Collaboration Program, Roche is obligated to pay a designation fee. After we complete lead optimization activities for a Collaboration Program, Roche may elect to transition such program to Roche with a payment to us or terminate it. Alternatively, Roche may elect, for a limited number of Collaboration Programs, to have us conduct certain additional development and manufacturing activities through the completion of a Phase 1 dose escalation clinical trial, in which case Roche will pay certain milestones and reimburse a specified percentage of our costs incurred in connection with such development and manufacturing activities. For each Collaboration Program, we will perform manufacturing activities until the completion of a technology transfer to Roche.
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Under the Roche Collaboration Agreement, Roche is obligated to make an upfront
payment to us of
We are further entitled to receive, on a product-by-product basis, tiered royalty payments in the mid-single to low double digits on net sales of products from the Tier 1 Programs, optioned Tier 2 Programs and Collaboration Programs and in the low to mid-single digits for Licensed Products, in each case, subject to certain customary reductions and offsets. Royalties will be payable, on a product-by-product and country-by-country basis, until the latest of the expiration of the licensed patents covering such product in such country or ten years from first commercial sale of such product in such country.
The Roche Collaboration Agreement will become effective upon the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and continue on a product-by-product and country-to-country basis until there is no remaining royalty or other payment obligations. The Roche Collaboration Agreement includes standard termination provisions, including for material breach or insolvency and for Roche's convenience. Certain of these termination rights can be exercised with respect to a particular product or license, as well as with respect to the entire Roche Collaboration Agreement.
Takeda Collaboration Agreement
In
Under the Takeda Collaboration Agreement, Takeda made an upfront payment to us
of
In-License Agreements
Below is a summary of our key license agreements. For a more detailed description of these and our other license agreements, see the section titled "Business-In-License Agreements" and Note 11 to our annual consolidated financial statements included in our 2021 Annual Report.
• License Agreement with Janssen Biotech Inc. , or the Janssen Agreement,
pursuant to which we obtained exclusive worldwide rights to research,
develop, manufacture and commercialize pharmaceutical products comprising
autologous CAR-modified T-cells or any CAR-modified natural killer or
CAR-modified natural-killer-like cells expressing certain Centyrin
molecules CAR-modified for the treatment or prevention of any disease in
humans. This is the binding technology we use in our P-PSMA-101 product
candidate.
• 2017 Commercial License Agreement with TeneoBio, Inc. (a subsidiary of
Amgen Inc.), or the 2017 TeneoBio Agreement, pursuant to which we obtained
exclusive worldwide rights to use and develop pharmaceutical products
comprising allogeneic T-cells expressing a CAR molecule containing certain
heavy chain sequences provided by TeneoBio for the treatment of human
disease. We use this heavy-chain-only binder in our P-BCMA-ALLO1 product
candidate.
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• 2018 Commercial License Agreement with TeneoBio, or the 2018 TeneoBio
Agreement, for the development and use of TeneoBio's human
heavy-chain-only antibodies in CAR-T cell therapies. Under the terms of
the 2018 TeneoBio Agreement, we have the option to obtain exclusive rights
to research, develop and commercialize up to a certain number of targets,
including but not limited to the binders used in our P-CD19CD20-ALLO1 and
P-PSMA-ALLO1 product candidates.
• License Agreement with Xyone Therapeutics, Inc. (as successor-in-interest
to Genus Oncology, LLC ), or the Xyone Agreement, pursuant to which we
obtained an exclusive worldwide license under certain patents and a
non-exclusive worldwide license under certain know-how controlled by Xyone
to research, develop and commercialize pharmaceutical products
incorporating CAR cells expressing antibodies and derivatives thereof
targeting MUC1-C, or a Xyone licensed product, and a non-exclusive
worldwide license under certain patents and know-how controlled by Xyone
to research, develop and commercialize companion diagnostics for the
treatment, prevention and palliation of human diseases and conditions. We
use a Xyone antibody or derivative thereof targeting MUC1-C as a binder in
our P-MUC1C-ALLO1 product candidate.
CIRM Grant Funding
In 2017, we were granted an award in the amount of
Components of Our Results of Operations
Revenues
Collaboration Revenue
Collaboration revenue consists of revenue recognized from our collaboration and license agreement with Takeda and reflects the timing and pattern in which we deliver the contractual deliverables to Takeda.
Operating Expenses
Research and Development
Research and development expenses consist primarily of external and internal costs incurred for our research and development activities, including development of our platform technologies, our drug discovery efforts and the development of our product candidates.
External costs include:
• expenses incurred in connection with the preclinical and clinical
development of our product candidates and research programs, including
under agreements with third parties, such as consultants, contractors and
contract research organizations, or CROs;
• the cost of developing and scaling our manufacturing process and
manufacturing drug products for use in our preclinical studies and
clinical trials, including under agreements with third parties, such as
consultants, contractors and contract manufacturing organizations, or
CMOs;
• payments made under third-party licensing agreements;
• the cost of manufacturing clinical materials for use in our preclinical
studies and clinical trials; and
• laboratory supplies and research materials.
Internal costs include:
• personnel-related expenses, consisting of employee salaries, related
benefits and stock-based compensation expense for employees engaged in
research, development and manufacturing functions;
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• the cost to develop manufacturing capability at our San Diego facility for
manufacture of cell therapies for use in clinical trials; and
• facilities, depreciation and other expenses, consisting of direct and
allocated expenses for rent and maintenance of facilities and insurance.
We expense research and development costs as incurred. External expenses are recognized based on an evaluation of the progress to completion of specific tasks using information provided to us by our service providers or our estimate of the volume of service that has been performed at each reporting date. Upfront payments and milestone payments made for the licensing of technology are related to clinical stage programs and expensed as research and development in the period in which they are incurred. Advance payments that we make for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses or other long-term assets. These amounts are expensed as the related goods are delivered or the services are performed.
At any one time, we are working on multiple research programs. We track external costs by the stage of program, clinical or preclinical. Our internal resources, employees and infrastructure are not directly tied to any one program and are typically deployed across multiple programs. As such, we do not track internal costs on a specific program basis.
Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to CRO activity and manufacturing expenses. We expect that our research and development expenses will increase substantially in connection with our planned preclinical and clinical development activities in the near term and in the future, including in connection with our ongoing Phase 1 trial of P-PSMA-101 for the treatment of patients with mCRPC, Phase 1 trial of P-BCMA-ALLO1 for the treatment of patients with relapsed/refractory multiple myeloma and Phase 1 trial of P-MUC1C-ALLO1 for the treatment of patients with solid tumor cancers and additional clinical programs expected to commence as we expand our pipeline of drug candidates. We cannot accurately estimate or know the nature, timing and costs of the efforts that will be necessary to complete the preclinical and clinical development of any of our product candidates. Our development costs may vary significantly based on factors such as:
• the number and scope of preclinical and IND-enabling studies;
• per patient trial costs;
• the number of trials required for approval;
• the number of sites included in the trials;
• the countries in which the trials are conducted;
• the length of time required to enroll eligible patients;
• the number of patients that participate in the trials;
• the drop-out or discontinuation rates of patients;
• potential additional safety monitoring requested by regulatory agencies;
• the duration of patient participation in the trials and follow-up;
• the cost and timing of manufacturing our product candidates;
• the phase of development of our product candidates;
• the efficacy and safety profile of our product candidates;
• the extent to which we establish additional licensing agreements; and
• whether we choose to partner any of our product candidates and the terms
of such partnership.
A change in the outcome of any of these variables with respect to the development of any of our product candidates could significantly change the cost structure and timing associated with the development of respective product candidates. We may never succeed in obtaining regulatory approval for any of our product candidates. We may obtain unexpected results from our clinical trials and preclinical studies.
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General and Administrative
General and administrative expenses consist primarily of salaries and related costs, including stock-based compensation, for personnel in executive, finance and administrative functions. General and administrative expenses also include direct and allocated facility-related costs as well as professional fees for legal, patent, consulting, investor and public relations, and accounting and audit services. We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support our continued research activities and development of our product candidates, including P-PSMA-101, P-BCMA-ALLO1 and P-MUC1C-ALLO1, and begin to commercialize any approved products.
Other Income (Expense) Interest Expense
Interest expense consists of interest expense on outstanding borrowings under our loan agreement and amortization of debt discount and debt issuance costs.
Other Income (Expense), Net
Other income (expense), net consists of interest income and miscellaneous income and expense unrelated to our core operations. Interest income is comprised of interest earned on our available-for-sale securities.
Results of Operations
Comparison of the Three Months Ended
The following table summarizes our results of operations (in thousands):
Three Months Ended June 30,
2022 2021 Change
Revenues:
Collaboration revenue $ 2,700 $ - $ 2,700
Total revenue 2,700 - 2,700
Operating expenses:
Research and development 35,008 36,008 (1,000 )
General and administrative 9,237 8,871 366
Total operating expenses 44,245 44,879 (634 )
Loss from operations (41,545 ) (44,879 ) 3,334
Other income (expense):
Interest expense (1,543 ) (843 ) (700 )
Other income (expense), net 52 17 35
Net loss before income tax (43,036 ) (45,705 ) 2,669
Income tax expense - - -
Net loss $ (43,036 ) $ (45,705 ) $ 2,669
Collaboration Revenue
Collaboration revenue of
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Research and Development Expenses
The following table summarizes our research and development expenses (in
thousands):
Three Months Ended June 30,
2022 2021 Change
External costs:
Clinical stage programs(1) $ 8,628 $ 12,726 $ (4,098 ) Preclinical stage programs and other
unallocated expenses 7,759 9,442 (1,683 ) Internal costs: Personnel 14,844 10,876 3,968 Facilities and other 3,777 2,964 813
Total research and development expenses
(1) Clinical stage programs include costs related to P-BCMA-ALLO1, P-MUC1C-ALLO1,
and P-PSMA-101 programs for the three months ended June 30, 2022 and costs
related to P-BCMA-101 and P-PSMA-101 programs for the three months ended June
30, 2021 .
Research and development expenses were
General and Administrative Expenses
General and administrative expenses were
Interest Expense
Interest expense was
Other Income (Expense), Net
Other income, net was less than
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Comparison of the Six Months Ended
The following table summarizes our results of operations (in thousands):
Six Months Ended June 30,
2022 2021 Change
Revenues:
Collaboration revenue $ 4,135 $ - $ 4,135
Total revenue 4,135 - 4,135
Operating expenses:
Research and development 83,858 65,103 18,755
General and administrative 18,782 17,240 1,542
Total operating expenses 102,640 82,343 20,297
Loss from operations (98,505 ) (82,343 ) (16,162 )
Other income (expense):
Interest expense (2,620 ) (1,681 ) (939 )
Other income (expense), net 32 5 27
Net loss before income tax (101,093 ) (84,019 ) (17,074 )
Income tax expense - - -
Net loss $ (101,093 ) $ (84,019 ) $ (17,074 )
Collaboration Revenue
Collaboration revenue of
Research and Development Expenses
The following table summarizes our research and development expenses (in
thousands):
Six Months Ended June 30,
2022 2021 Change
External costs:
Clinical stage programs(1) $ 31,656 $ 22,947 $ 8,709 Preclinical stage programs and other
unallocated expenses 15,822 15,460 362 Internal costs: Personnel 29,409 20,993 8,416 Facilities and other 6,971 5,703 1,268
Total research and development expenses
(1) Clinical stage programs include costs related to P-BCMA-ALLO1, P-MUC1C-ALLO1,
and P-PSMA-101 programs for the six months ended June 30, 2022 and costs
related to P-BCMA-101 and P-PSMA-101 programs for the six months ended June
30, 2021 .
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Research and development expenses were
General and Administrative Expenses
General and administrative expenses were
Interest Expense
Interest expense was
Other Income (Expense), Net
Other income, net was less than
Liquidity and Capital Resources
We were incorporated in
Our operations have focused on organizing and staffing our company, business
planning, raising capital, in-licensing and acquiring intellectual property
rights and establishing and protecting our intellectual property portfolio,
developing our genetic engineering technologies, identifying potential product
candidates and undertaking research and development and manufacturing
activities, including preclinical studies and clinical trials of our product
candidates, and engaging in strategic transactions. Our primary use of cash is
to fund operating expenses, which consist primarily of research and development
expenditures, and to a lesser extent, general and administrative expenditures.
Cash used to fund operating expenses is impacted by the timing of when we pay
these expenses, as reflected in the change in our outstanding accounts payable
and accrued expenses. We have not yet commercialized any of our product
candidates and we do not expect to generate revenue from sales of any product
candidates for several years, if at all. We have funded our operations primarily
through the sale of equity, debt financings and collaborations. Since our
inception, we have raised
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We expect that our cash, cash equivalents and short-term investments as of
Loan Agreement
In 2017, we entered into a loan and security agreement with Oxford, as
subsequently amended, or Amended Loan Agreement, pursuant to which we drew a
Term A loan in the amount of
In
In connection with the repayment of the balance outstanding under the Amended
Loan Agreement, we incurred amendment and final payment fees of
On
Cash Flows
The following table sets forth the primary sources and uses of cash and cash equivalents (in thousands):
Six Months Ended June 30,
2022 2021
Cash used in operating activities $ (91,053 ) $ (70,144 )
Cash provided by (used in) investing activities (81,572 ) 185,444
Cash provided by financing activities 29,263 427
Net increase (decrease) in cash and cash equivalents
Cash Used in Operating Activities
During the six months ended
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assets and liabilities for the six months ended
During the six months ended
Cash Provided by (Used in) Investing Activities
During the six months ended
During the six months ended
The timing of purchases and sales of our short-term investments is driven by available cash balance and maturity of existing investments. The purchase of property and equipment for all periods related to equipment purchases as we expanded our research and development and manufacturing activities, in addition to corporate office space.
Cash Provided by Financing Activities
During the six months ended
During the six months ended
Contractual Obligations and Commitments
We enter into contracts in the normal course of business with contract research organizations, CMOs and other third parties for preclinical research studies, clinical trials and testing and manufacturing services. These contracts do not contain minimum purchase commitments and are cancelable by us upon prior written notice. Payments due upon cancellation consist of payments for services provided or expenses incurred, including noncancelable obligations of our service providers, up to one year after the date of cancellation. The amount and timing of such payments are not known.
We have also entered into several license agreements under which we are obligated to make aggregate milestone payments upon the achievement of specified preclinical, clinical and regulatory milestones as well as royalty payments. The payment obligations under these license agreements are contingent upon future events, such as our achievement of specified milestones or generating product sales. We record these milestone payments when they are estimable and probable to be achieved. Estimating the timing or likelihood of achieving these milestones or generating future product sales requires significant judgment and is subject to uncertainty.
During the six months ended
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Critical Accounting Policies and Significant Judgments and Estimates
Management's discussion and analysis of our financial condition and results of
operations are based upon our financial statements, which are prepared in
accordance with accounting principles that are generally accepted in
There were no significant changes during the six months ended
JOBS Act
We are an emerging growth company, as defined in Section 2(a) of the Securities Act of 1933, as amended, or the Securities Act, as modified by the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. The JOBS Act permits an "emerging growth company" such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies. We have elected to use this the extended transition period under the JOBS Act until the earlier of the date we (i) are no longer an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, our consolidated financial statements may not be comparable to companies that comply with new or revised accounting pronouncements as of public company effective dates. The JOBS Act also allows up to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies, including relief from the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended, less extensive disclosure obligations regarding executive compensation in our registration statements, periodic reports and proxy statements, exemptions from the requirements to hold a nonbinding advisory vote on executive compensation, and exemptions from stockholder approval of any golden parachute payments not previously approved. We may also elect to take advantage of other reduced reporting requirements in future filings. As a result, our stockholders may not have access to certain information that they may deem important and the information that we provide to our stockholders may be different than, and not comparable to, information presented by other public reporting companies.
We will remain an emerging growth company until the earliest to occur of:
(1) the last day of the fiscal year in which we have more than
We are also a smaller reporting company, as defined in the Securities Exchange
Act of 1934. We may continue to be a smaller reporting company even after we are
no longer an emerging growth company. We may take advantage of certain of the
scaled disclosures available to smaller reporting companies and will be able to
take advantage of these scaled disclosures for so long as (i) our voting and
non-voting common stock held by non-affiliates is less than
Recent Accounting Pronouncements
A description of recently issued accounting pronouncements that may potentially impact our financial position, results of operations or cash flows is disclosed in Note 2 to our condensed consolidated financial statements.
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