STEMLINE THERAPEUTICS, INC. Unless the context requires otherwise, references in this report to "Stemline,"
"Company," "we," "us" and "our" refer to
The following discussion and analysis contains forward-looking statements about our plans and expectations of what may happen in the future. Forward-looking statements are based on a number of assumptions and estimates that are inherently subject to significant risks and uncertainties, and our results could differ materially from the results anticipated by our forward-looking statements as a result of many known or unknown factors, including, but not limited to, those factors discussed in "Item 1A. Risk Factors." See also the "Special Cautionary Notice Regarding Forward-Looking Statements" set forth at the beginning of this report.
You should read the following discussion and analysis of our financial condition
and results of operations together with our financial statements and related
notes included in our audited financial statements and notes thereto for the
year ended
Overview
We are a commercial-stage biopharmaceutical company focused on discovering,
acquiring, developing and commercializing oncology therapeutics. ELZONRIS®
(tagraxofusp-erzs) was approved by the
We are also advancing a pipeline of additional novel therapeutic candidates, including felezonexor (SL-801), an oral small molecule XPO-1 inhibitor currently in an ongoing Phase 1 trial of patients with advanced solid tumors, SL-901, a kinase inhibitor currently in investigational medicinal product dossier, or IMPD, enabling studies, and SL-1001, an oral small molecule RET (rearranged during transfection) kinase inhibitor currently in investigational new drug, or IND, directed studies intended for patients with a variety of genetically-defined malignancies.
Merger Agreement
On
Pursuant to the terms and subject to the conditions of the Merger Agreement,
Purchaser will commence a tender offer (the "Offer") no later than
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Purchaser's obligation to purchase the Shares tendered in the Offer is conditioned, among other things, upon the valid tender of a majority of the total number of Shares outstanding at the time of the expiration of the Offer and the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.
The Offer will initially expire at one minute after
FDA-approved product ELZONRIS
ELZONRIS, a targeted therapy directed to CD123, was approved by the FDA for the
treatment of BPDCN in adult and pediatric patients two years and older, and is
commercially available in
BPDCN, formerly known as blastic NK-cell lymphoma, is an aggressive, orphan hematologic malignancy with historically poor outcomes. BPDCN may present with features similar to, and can be mistaken for, certain diseases including AML, non-Hodgkin's lymphoma, or NHL, acute lymphoid leukemia, or ALL, myelodysplastic syndrome, or MDS, and CMML, and other malignancies including those with skin manifestations as well as certain or nonmalignant cutaneous conditions. BPDCN typically presents in the bone marrow and/or skin, and may also involve lymph nodes and viscera. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56, as well as other markers including TCL-1.
In
In addition, Stemline has instituted a global Early Access Program, or EAP, whereby physicians may seek access to Stemline's investigational medicine outside of a clinical trial and/or before it is commercially available.
ELZONRIS - Market Expansion Efforts
ELZONRIS is designed to specifically target CD123. CD123 is highly expressed on BPDCN and is a key marker, as a part of a triad of markers, that enables proper diagnosis of BPDCN. Additionally, CD123 represents a potential target for therapeutic research in a variety of cancers beyond BPDCN, as well as certain autoimmune disorders. Expression of CD123 has also been associated with poor prognosis and clinical outcomes in additional diseases including AML and CMML.
As such, we are seeking to broaden the commercial potential of ELZONRIS through ongoing clinical trials in additional indications including CMML, myelofibrosis, or MF, multiple myeloma, or MM, and acute myeloid leukemia, or AML, and potentially others.
Chronic Myelomonocytic Leukemia (CMML)
At the 2019
In Stage 1, ELZONRIS at 12 mcg/kg/day for 3 days every 3-6 weeks was the highest tested dose for CMML, and a maximum tolerated dose, or MTD, was not reached. In Stage 2, patients are receiving ELZONRIS at 12 mcg/kg/day for three (3) days every 3-6 weeks.
Median age was 69 years (range: 42-80); 83% were male. 52% (12/23) of patients had baseline splenomegaly by physical examination (measured in centimeters that spleen was palpable below the left costal margin). The most common treatment-related adverse events, or TRAEs, were hypoalbuminemia (35%), thrombocytopenia (30%), vomiting and nausea (each 26%), and anemia (22%). There were 3 cases of capillary leak syndrome; all three cases were grade 2. The most common TRAEs, grade 3+, were thrombocytopenia (30%), anemia (17%), and nausea (4%).
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ELZONRIS monotherapy demonstrated improvements in splenomegaly and bone marrow complete responses, or CRs, in patients with relapsed/refractory CMML. 100% (12/12) of evaluable patients with baseline splenomegaly, by physical examination, had a spleen response: 67% (8/12) of these patients had splenomegaly reductions by at least 50%, and 50% (4/8) of these patients with baseline splenomegaly of 5 cm or more below the left costal margin had splenomegaly reductions of at least 50%. In addition, three patients had bone marrow CRs including one patient who was bridged to stem cell transplant, or SCT.
Myelofibrosis (MF)
At the 2019
Median age was 69 years (range: 54-87); 52% were female. 79% (23/29) of patients had baseline splenomegaly by physical examination (measured by spleen that is palpable >5 cm below costal margin). In Stage 1, no dose limiting toxicities, or DLT, were identified and a MTD was not reached. The most common TRAEs were alanine aminotransferase levels increased, headache and hypoalbuminemia (each 17%).
The most common TRAEs, grade 3+, were anemia (14%), thrombocytopenia (7%) and fatigue (3%). There was also one case of CLS which was grade 3.
ELZONRIS monotherapy demonstrated improvements in splenomegaly in patients with relapsed/refractory MF. 53% (8/15) of evaluable patients with baseline spleen size >5 cm palpable by physical exam below the left costal margin experienced a reduction in splenomegaly: 20% (3/15) of patients had splenomegaly reduction by at least 35% measured by palpation during physical exam below left costal margin. 44% (7/16) of patients had splenomegaly reduction by at least 29% and 25% (4/16) had splenomegaly reductions by at least 45%. Additionally, 45% (9/20) of evaluable patients had symptom burden reduction, including 3 with symptom response per IWG-MRT 2013 MF response criteria.
We continue to enroll patients with relapsed/refractory MF, and have expanded the trial to increased enrollment and add additional sites, in order to further elucidate the safety and efficacy profile of ELZONRIS in this patient population, including in patient subsets with monocytosis, thrombocytopenia and CD123 expression. By the end of 2020, we expect to provide updates on this cohort, including potential registration pathways in MF.
Multiple Myeloma (MM)
ELZONRIS, in combination with pomalidomide and dexamethasone, was assessed in a Phase 1/2 clinical trial in relapsed/refractory multiple myeloma.
At the 2019 ASH annual conference in
Notably, five patients achieved partial responses, or PRs, along with decreases in plasmacytoid dendritic cell, or pDC, levels while on treatment. The presence of pDCs, which is the cell of origin of BPDCN, has been linked with myeloma growth and aggressiveness. These patients also experienced decreased levels of myeloma-related laboratory assessed values after 1 cycle of treatment with ELZONRIS combined with pomalidomide and dexamethasone.
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Given the promising early results, and the strong scientific rationale, potential avenues for further development in this indication are currently under consideration. These include new patient populations, combination with daratumumab, and/or novel agents such as XPO1 inhibitors.
Acute Myeloid Leukemia (AML)
An investigator-sponsored trial of ELZONRIS in combination with azacitidine and venetoclax is currently being evaluated in the dose escalation stage of a Phase 1/2 trial of patients with relapsed/refractory AML, first-line AML who are unfit for chemotherapy, or high-risk MDS. CD123 expression will be assessed. The trial is enrolling and data updates are expected later this year and on into next year.
Additional trials and potential indications for ELZONRIS
A Phase 1/2 trial for ELZONRIS as a maintenance therapy, post-stem cell transplantation, in patients with BPDCN is open for enrollment. We expect to provide further program updates later this year and on into next year.
Additional planned trials include ELZONRIS as monotherapy or in combination with other agents in a basket of CD123 + malignancies which may include ALL, hairy cell leukemia, Hodgkin's disease, and certain other lymphomas, as well as ELZONRIS trials in combination with other agents in patients with CMML and in trials in patients with CD123+ or BPDCN-like AML.
In addition to BPDCN, CMML, MF and AML, additional potential indications for ELZONRIS include other hematologic cancers, solid tumors, and certain autoimmune disorders which are under evaluation for further development.
Clinical pipeline product candidates
SL-801
Felezonexor (SL-801) is a structurally novel, oral, small molecule, reversible inhibitor of Exportin-1, or XPO1, a nuclear transport protein implicated in a variety of malignancies. XPO1 is a clinically validated target in oncology, and the FDA recently approved an XPO1 inhibitor in patients with relapsed/refractory multiple myeloma. Felezonexor has demonstrated preclinical in vitro and in vivo antitumor activity against a wide array of solid and hematologic cancers. Felezonexor's potential ability to reversibly bind XPO1 may offer the possibility to mitigate side effects and help optimize the therapeutic index. We are currently enrolling patients with advanced solid tumors in a Phase 1 dose escalation trial of single agent felezonexor. The dosing regimen for felezonexor was revised in an effort to improve tolerability while maintaining dose intensity, and dosing resumed at 70 mg/day with a new schedule (Schedule B).
In
A PR of duration 18+ weeks, was achieved with single agent felezonexor in a fourth line patient with KRAS-positive, microsatellite stable, or MSS, colorectal cancer. The PR (based on RECIST 1.1 criteria) was reported after two cycles of felezonexor (70mg then 65mg due to elevated creatinine), with the patient demonstrating serial reductions in the two target lesions (liver and spleen).
Response and treatment with felezonexor were ongoing at the time of presentation. Stable disease, or SD, was achieved in 12 patients, with 11/12 of these patients third line or greater. Five patients had SD for 4 and 11 months, including 1 patient with basal cell carcinoma with SD for ~11 months, and 20% disease shrinkage was noted in one patient with a heavily pre-treated neuroendocrine tumor.
We believe the ideal therapeutic dose and regimen have yet to be determined. Dose escalation is ongoing, and we intend to provide further updates as the Phase 1 clinical trial continues to enroll.
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SL-1001
SL-1001 is an oral, selective small molecule RET (rearranged during
transfection) kinase inhibitor. Genetic alterations in the RET kinase have been
found in a diverse range of cancers. We believe RET kinase represents a
clinically validated target in multiple oncology indications. In
SL-901
SL-901 is an oral, small molecule kinase inhibitor. In
SL-701
SL-701 is an immunotherapy designed to direct the immune system to attack
targets present on brain cancer and other malignancies. SL-701 is comprised of
several short synthetic peptides that correspond to epitopes of targets
including IL-13R?2, EphA2, and survivin; two of these synthetic peptides
(IL-13R?2 and survivin) are mutant and believed to enhance immune activity. We
completed a Phase 2 trial of SL-701 in adult patients with second-line
glioblastoma, or GBM. Phase 2 data preliminarily suggest SL-701 is generating
target specific CD8+ T-cell responses in patients, which may be translating into
improved clinical outcomes, including improved overall survival, or OS, in a
subset of patients, which could form the basis of studies. SL-701 was awarded
ODD from the FDA for the treatment of glioma in
SL-501
SL-501 is a novel CD123-targeted therapy in preclinical development that has demonstrated potency, in vitro and in vivo, against several hematologic tumor types, including AML, CMML, Hodgkin's lymphoma, and NHL.
Financings
We have devoted substantially all of our resources to the preclinical and
clinical development of our product and product candidates, the design and
implementation of our regulatory strategy for our Biologics License Application,
or BLA, and MAA filings, preparation for launch and commercialization of our
approved product, launching and commercializing our approved product,
manufacturing our product and product candidates, strengthening and building our
intellectual property portfolio, conducting investor relations, raising capital,
providing general and administrative support for these operations, and the
execution of our business plan. We have funded our operations primarily through
public sales of common stock to our investors. With the
From inception through
We have never been profitable and our net loss from operations for the three
months ended
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Litigation
From time to time, we are involved in legal proceedings in the ordinary course of our business. Refer to Footnote 17: Commitments and Contingencies for more information on legal proceedings.
Financial Operations Overview
Product Revenues
Total revenue consists of net sales of ELZONRIS, which was commercially launched
in
Cost of Goods Sold
Cost of goods sold consists of all inventory costs related to manufacturing ELZONRIS finished drug product for sale to our customer and royalty fees paid based on product shipments. These costs include expenses incurred by our contract manufacturing organizations, or CMOs, to manufacture drug substance and drug product. Cost of goods sold also includes expenses related to labeling and packaging of drug product, indirect manufacturing overhead and stability testing and provisions for inventory obsolescence. Royalty costs due to the licensor of ELZONRIS are also recorded in cost of goods sold as a period cost.
Research and Development Expenses
The following table shows our research and development expenses for the
three-month periods ended
Three Months Ended
March 31,
2020 2019
ELZONRIS $ 5,184,440 $ 9,116,428
Other product candidates 1,394,204 1,722,290
Personnel expenses 4,125,879 5,550,846
Other expenses 838,793 564,258
Total research and development expenses
Research and development expenses consist of costs associated with the development of our product candidates and our platform technology, which include:
· clinical trial costs;
· chemistry, manufacturing and controls, or CMC, related costs, particularly as
they relate to process characterization and validation expenses for ELZONRIS as required to support BLA submission requirements; · nonclinical costs;
· regulatory costs, including BLA related expenses;
· employee-related expenses, including salaries, benefits, travel and stock-based
compensation expense, and consultant costs;
· costs associated with work contracted and conducted by third-party contract
research organizations, or CROs, CMOs, academic institutions and consultants; and
· license fees and milestone payments related to in-licensed products and
technology.
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We expense research and development costs to operations as incurred. We account for nonrefundable advance payments for goods and services that will be used in future research and development activities expenses when the services have been performed or when the goods have been received, rather than when the payments are made.
We utilize our employee and infrastructure resources across multiple research and development projects. We do not allocate employee-related expenses or depreciation to any particular project. The components of our research and development costs are described in more detail in "Results of Operations."
We anticipate that our future research and development expense levels will trend higher in future periods as we continue the preclinical and clinical development of our other product candidates, including ELZONRIS in additional indications and territories.
The successful development of ELZONRIS in additional indications, including but not limited to CMML, and our other product candidates is highly uncertain. As of this time, other than as discussed above, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete development of our product candidates or the period, if any, in which material net cash inflows from our product candidates may commence. This is due to the numerous risks and uncertainties associated with developing drugs, including the uncertainty of:
· the scope, enrollment, rate of progress and costs of our planned, as well as
any additional, clinical trials and other research and development activities;
· timing and results of future clinical trials;
· the potential benefits of our product candidates over other therapies;
· the potential safety risks of our product candidates compared to other
therapies;
· the costs, timing and outcome of regulatory interactions, submissions, and
potential approvals;
· our ability to market and commercialize, either on our own or with strategic
partners, and achieve market acceptance and reimbursement for any of our product candidates that we are developing or may develop in the future;
· our ability to manufacture, at a reasonable expense, adequate supplies or our
product candidates for use in planned and future clinical trials and/or commercial distribution in the event of a successful regulatory approval; and
· the costs of preparing, filing, prosecuting, defending and enforcing patents
and other intellectual property.
A change in the outcome of any of these or similar variables with respect to the development of a product or product candidate could mean a significant change in the costs and timing associated with the development of that product or product candidate. For example, if the FDA or other regulatory authority were to require us to conduct clinical trials beyond those which we currently anticipate will be required for the completion of clinical development of a product candidate, we could be required to expend significant additional financial resources and time on the completion of clinical development. A similar result could occur if we experience significant delays in the progress of, including enrollment in, any clinical trials.
Selling, General and Administrative Expenses
Selling, general and administrative expenses consist primarily of selling and marketing expenses in support of the commercial launch and personnel cost, including stock-based compensation expense. In addition, our selling, general and administrative expenses are related to legal, finance, human resources, investor relations, and business development. Other general and administrative expenses include facility costs, insurance expense and professional fees for consulting and accounting services.
We anticipate that our selling, general and administrative expenses will be
higher in future periods due to continued spend to support the commercialization
of ELZONRIS in
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Interest Income
Interest income consists of interest earned on our cash, cash equivalents, and
short-term investments. Our primary investment is in 100%
Critical Accounting Policies and Estimates
To understand our consolidated financial statements, it is important to understand our critical accounting policies and estimates. We prepare our consolidated financial statements in accordance with generally accepted accounting principles, or GAAP. The preparation of financial statements also requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, costs and expenses and related disclosures. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances. Actual results could differ significantly from the estimates made by our management. To the extent that there are differences between our estimates and actual results, our future financial statement presentation, financial condition, results of operations and cash flows will be affected. We believe that the accounting policies discussed below are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management's judgments and estimates.
For a discussion of our critical accounting estimates, see the section entitled
"Management's Discussion and Analysis of Financial Condition and Results of
Operations" in our Annual Report on Form 10-K for the year ended
Revenue Recognition
Effective
Product Revenue, Net
We have obtained marketing approval from FDA to sell ELZONRIS in
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Government Contracts
We entered into contracts (i) to participate in the Medicaid Drug Rebate Program
and the Medicare Part D program, and (ii) to sell to the
We estimate the rebates that will be provided to Government Payors for these programs. These rebate estimates are based upon (i) the government-mandated discounts applicable to government-funded programs, (ii) information obtained from its customer and (iii) information obtained from other third parties regarding the payor mix for ELZONRIS. The liability for these rebates consists of estimates of claims for the current year and estimated future claims that will be made for product shipments that have been recognized as revenue but remain in the distribution channel inventories at the end of each reporting period.
Product Returns
Consistent with industry practice, we offer a limited right of return for product that has been purchased. To estimate sales with a right of return, we will assess, on a quarterly basis, the number of vials that are held in inventory throughout the distribution channel. Amounts for estimated product returns are established in the same period that the related gross revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included as a component of accrued expenses and other current liabilities.
We offer co-pay assistance programs which are intended to provide financial assistance to qualified commercially-insured patients with prescription drug copayments required by payers. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with product that has been recognized as revenue but remains in the distribution channel at the end of each reporting period. The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included as a component of accrued expenses and other current liabilities.
Distribution Fees
Distribution fees include fees paid to our distributors for the distribution of our product based on contractual rates. In addition, we compensate for data and other administrative activities. Therefore, estimates for these costs are recorded as a reduction of revenue, based on contractual terms.
Accounts Receivable, Net
Accounts receivable, net primarily relates to amounts due from our customer, net
of applicable revenue reserves. We analyze accounts that are past due for
collectability and provides an allowance for receivables when collection becomes
doubtful. Given the nature and limited history of collectability of our accounts
receivable, an allowance for doubtful accounts is not deemed necessary at
Inventories, Net
We capitalize inventory costs associated with the manufacturing of ELZONRIS
after regulatory approval or when, based on management's judgment, future
commercialization is considered probable and the future economic benefit is
expected to be realized. Otherwise, such costs are expensed as research and
development. The majority of manufacturing costs for ELZONRIS units recognized
as revenue during the three months ended
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We value our inventories at the lower of cost or estimated net realizable value. We determine the cost of our inventories, which includes amounts related to materials and manufacturing overhead, on a first-in, first-out basis. We perform an assessment of the recoverability of capitalized inventory during each reporting period, and we write down any excess and obsolete inventories to their estimated realizable value in the period in which the impairment is first identified. Such impairment charges, should they occur, are recorded within cost of product revenues. The determination of whether inventory costs will be realizable requires estimates by management. If actual market conditions are less favorable than projected by management, additional write-downs of inventory may be required which would be recorded as a cost of product sales in the statement of operations and comprehensive loss.
Foreign Currency
The functional currency of our international subsidiaries is generally the Euro.
We translate the financial statements of our international subsidiaries to
Recent Accounting Pronouncements
See Note 2, "Summary of Significant Accounting Policies" for our discussion about adopted and pending recent accounting standards.
Results of Operations
Comparison of Three Months Ended
Product revenue, net. We began commercial sales of ELZONRIS within the
Costs of goods sold. Cost of goods sold for the first quarter of 2020 was
Research and development expense. Research and development expense was
Selling, general and administrative expense. Selling, general and administrative
expense was
Interest income. Interest income was
Liquidity and Capital Resources
Sources of Liquidity
As of
We have financed our operations to date primarily through proceeds from public
sales of common stock via our 2013 initial public offering, or IPO, and
subsequent follow-on public offerings. Since inception through
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Cash Flows
The following table sets forth the primary sources and uses of cash for each of
the periods set forth below:
Three Months Ended
March 31,
2020 2019
Net cash used in operating activities $ (13,773,474 ) $ (22,137,027 ) Net cash provided by (used in) investing activities 29,252,837 (49,629,151 ) Net cash provided by financing activities
215,378 86,337,021
Exchange rate changes (25,500 ) -
Net increase in cash and cash equivalents $ 15,669,241 $ 14,570,843 Operating activities. The use of cash in all periods resulted primarily from our
net losses adjusted for stock-based compensation expense, non-cash depreciation
expense and changes in the components of working capital. The net cash used in
operating activities during the three months ended
Investing activities. The net cash provided by and used in financing activities
for the three months ended
Financing activities. The net cash provided by financing activities for the
three months ended
Funding Requirements
Our product and product candidates are in clinical or preclinical development, including ELZONRIS for CMML, MF, AML, and potentially other indications, as well as SL-801, SL-1001, SL-901, and SL-701 at various stages of development. We expect to continue to incur significant expenses for the foreseeable future. We anticipate that our expenses will increase if and as we:
· continue the ongoing clinical trials, and initiate additional clinical trials,
of our product candidates;
· devise and implement our regulatory strategy, including for our regulatory
filings in theU.S. and abroad;
· manufacture alternative formulations of ELZONRIS drug product;
· continue the research and development of ELZONRIS in additional indications and
our other product candidates;
· seek to identify additional product candidates;
· acquire or in-license other products and technologies;
· seek marketing approvals for ELZONRIS in additional indications and our other
product candidates should they successfully complete pre-market clinical trials;
· establish, either on our own or with strategic partners, a manufacturing,
sales, marketing and distribution infrastructure to commercialize any products
for which we may obtain marketing approval;
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· continue to incur legal expenses relating to our ongoing litigation;
· maintain, leverage and expand our intellectual property portfolio; and
· add operational, financial and management information systems and related
personnel, including personnel to support our product development and future
global commercialization efforts.
We believe that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements for at least the next two years. We have based this estimate on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with the commercialization of our approved product, development and potential commercialization of our approved product in additional indications and/or our other product candidates, and the extent to which we may enter into collaborations with third-parties for development and commercialization of our product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenses associated with commercialization and development of our product and product candidates. Our future capital requirements will depend on many factors, including:
· the progress and results of the ongoing and future clinical trials of our
product candidates;
· the costs of future commercialization activities, including product sales
promotion, marketing, manufacturing and distribution, for our approved product or future additional regulatory approvals;
· the scope, progress, results and costs of research and development, preclinical
development, laboratory testing and clinical trials for our product candidates now or in the future;
· the extent to which we acquire or in-license other products and technologies;
· the costs, timing of regulatory preparation and outcome of regulatory review,
in theU.S. or abroad, of our product or product candidates;
· income, if any, received from commercial sales of our product or product
candidates, should our approved product be approved in additional indications or territories or any of our candidates, beyond our currently approved product, receive marketing approval;
· the cost of litigation with third parties, if any;
· the costs of preparing, filing and prosecuting patent applications, maintaining
and enforcing our intellectual property rights and defending intellectual property-related claims; and
· our ability to establish any future collaboration arrangements on favorable
terms, if at all.
Until such time, if ever, that we can generate substantial product revenue and related income, we expect to finance our cash needs through a combination of efforts which may include equity offerings, debt financings, collaborations, strategic alliances and licensing arrangements. We do not have any committed external sources of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of a common stockholder. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funding through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future income streams, research programs or product candidates or grant licenses on terms that may not be favorable to us.
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If we are unable to raise additional funding through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Off-Balance Sheet Arrangements
We did not have any off-balance sheet arrangements during the periods presented, and we do not currently have any relationships with any organizations or financial partnerships, such as structured finance or special purpose entities, that would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes.
Income Taxes
Coronavirus Aid, Relief and Economic Security Act ("CARES Act")
In response to the COVID-19 pandemic, the Coronavirus Aid, Relief and Economic
Security Act ("CARES Act") was signed into law on
Tax Loss Carryforwards
As of
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