TYME TECHNOLOGIES, INC. You should read the following discussion and analysis of our financial condition
and results of operations together with our financial statements and related
notes appearing in this Annual Report. Some of the information contained in this
discussion and analysis or set forth elsewhere in this Annual Report, including
information with respect to our plans and strategy for our business and related
financing, includes forward-looking statements that involve risks and
uncertainties. As a result of many factors, including those factors set forth in
the "Risk Factors" section of this Annual Report, our actual results could
differ materially from the results described in or implied by the
forward-looking statements contained in the following discussion and analysis.
As used in this report, unless the context suggests otherwise, "we," "us,"
"our," "the Company," "TYME" or "Tyme Technologies" refer to
Overview
TYME is an emerging biotechnology company developing CMBTs that are intended to be effective across a broad range of solid tumors and hematologic cancers, while also maintaining patients' quality of life through relatively low toxicity profiles. Unlike targeted therapies that attempt to regulate specific mutations within cancer, the Company's therapeutic approach is designed to take advantage of a cancer cell's innate metabolic requirements to cause cancer cell death through oxidative stress and exposure to the body's natural immune system.
The Company is currently focused on developing its novel compound, SM-88, as well as further evaluating its preclinical pipeline of novel CMBTTM programs, and TYME 19 as a potential therapeutic for SARS Co V-2 diseases. The Company is also exploring options to further diversify its product candidate pipeline. The Company believes that early clinical results demonstrated by SM-88 in multiple advanced cancers, including breast, sarcomas, pancreatic, and prostate, reinforce the potential of our emerging CMBT™ pipeline.
Exploration of Strategic Options and Diversification
On
The Company continues to believe there are additional opportunities that could
enhance value for TYME stockholders, notwithstanding its announcement, in
The Strategic Planning Committee of the Board, which is led by TYME Board Member
Strategic Review
In the first half of calendar year 2021, the Company undertook a comprehensive strategic review with the goal of aligning the Company's development plans with core strategic goals.
The strategic review was extensive and involved internal and external assessments by industry experts, KOLs and advisors with considerable experience in the various areas we sought to probe and explore.
The strategic review process resulted in several key takeaways including, but not limited to:
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• broad activity across 15 cancer types as seen in the First in Human study
and Compassionate Use program and confirmation of strong IP portfolio
provides us extra development opportunities, for which focus is critical;
• the second-line Precision Promise trial was the priority in pancreatic
cancer;
• breast cancer is a priority indication for development as part of
pipeline diversification beyond pancreatic cancer;
• there is a need to refine our understanding of the MOA and identify
biomarkers to enhance targeting of patient populations; and
• the rapidly changing COVID-19 landscape requires a reevaluation of the
market potential and development pathway for
TYME-19.
The Company's current strategy, including ongoing studies, the Preclinical
Pipeline Programs and diversification efforts, has been developed based on the
takeaways from the strategic review, as well as on subsequent developments. Key
elements of the Company's strategy include to (i) successfully advance the
development of SM-88 across a broad range of cancers, (ii) work towards
identifying actionable biomarkers for patient selection or treatment response to
SM-88, (iii) continue to invest in our technology platform and expand the
breadth and depth of our IP portfolio, and (iv) build a balanced portfolio of
proprietary and partnered programs. For more information about our strategy, see
Item 1. Business-- "
Ongoing Studies
OASIS (Metastatic HR+/HER2- Breast Cancer After CDK4/6 Inhibitors)
We are collaborating with
HoPES Phase II Trial in sarcoma
In early 2020, the open-label Phase 2 investigator sponsored trial of SM-88
therapy in sarcoma, HoPES, opened. This trial has two cohorts, each expecting to
enroll 12 patients. The first is SM-88 with MPS as salvage treatment in patients
with mixed rare sarcomas, the other is SM-88 with MPS as maintenance treatment
for patients with metastatic Ewing's sarcoma that had not progressed on prior
therapy. The primary objectives are to measure ORR and PFS. Secondary objectives
include DOR, OS, CBR using RECIST, and incidence of treatment-emergent AEs.
Preclinical Pipeline Programs
The Company has begun a comprehensive translational preclinical program. We have engaged Evotec, a leading global research and development company to aid in the execution of these activities, and we are also incorporating several complementary academic collaborations into this multi-faceted program. The overall goal of these activities is to potentially identify actionable biomarkers of sensitivity and activity to SM-88 in various cancers,
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complementary combination drugs strategies for SM-88, and other cancer metabolism targets that could benefit from treatment. Additionally, the Company intends to incorporate liquid and tumor biopsies to future clinical trials to contribute to the biomarker identification. We anticipate this engagement will have several stages, and that it is likely to last through this fiscal year and into future periods.
TYME-18 and TYME-19
TYME-18 is a CMBTTM compound under development that is delivered intratumorally. TYME-18 leverages a member of the bile acid family to create a potential treatment for inoperable tumors. Preliminary observations of the local administration of TYME-18, a combination of a proprietary surfactant system and natural sulfonic acid, suggested its potential as an important regulator of energy metabolism that may impede the ability of tumors to increase in size, which, in addition to its lytic functionality, could prove useful in difficult-to-treat cancers. The Company is assessing development priorities to determine if additional advancement of this program is warranted at this time.
TYME-19 is an oral synthetic member of the bile acid family. The Company also uses bile acids in its anti-cancer drug candidate, TYME-18. Because of its expertise in bile acids and their effects, the Company was able to identify TYME-19 as a well-characterized bile acid with potential antiviral properties. Bile acids have primarily been used for liver disease; however, like all steroids, they are messenger molecules that modulate a number of diverse critical cellular processes. Bile acids can modulate lipid and glucose metabolism and can remediate dysregulated protein folding, with potentially therapeutic effects on cardiovascular, neurologic, immune, and other metabolic systems. Some agents in this class have also previously shown antiviral properties. In in vitro preclinical testing, TYME-19 prevented COVID-19 viral replication at doses without meaningful cytotoxicity to the treated cells. Previous independent preclinical research has also shown select bile acids may have had broad antiviral activity.
The Company has retained virology experts at Evotec to assess the mechanisms of TYME-19. Evotec is a global drug development company that has the capability to access the multiple existing and emerging variants of the COVID-19 virus. TYME and Evotec are testing the ability of TYME-19 to interrupt the cellular pathways commonly used by viruses to produce viral proteins as well as cellular responses to viral infection that cause local inflammation. Prolonged inflammation from SARS-CoV-2 can lead to some of the severe outcomes experienced by infected patients. We expect the work by Evotec will provide us with information allowing us to assess the potential path forward for the program.
Tumor Targeting Technology
TYME has developed a technology ("Tumor Targeting Technology") by which the tyrosine isomer L metyrosine (L-?-methylparatyrosine) can be fused with a second therapeutic agent in a manner that creates a fusion compound that may allow targeted accumulation of the treatment by the cancer cells in a novel manner. The Company is assessing potential development paths for this technology.
Discontinuing Programs
Precision Promise Trial- SM-88 with MPS as 2nd line therapy in metastatic pancreatic cancer
In
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On
TYME-88-PANC (Part 2) (third-line Metastatic Pancreatic Cancer)
In fiscal year 2020, we launched our pivotal study for SM-88 in the third-line treatment of pancreatic cancer through an amendment to our ongoing TYME-88-Panc trial (Part 2), with the first patient dosed in the third quarter of the fiscal year. As described previously, the COVID-19 pandemic significantly impacted enrollment of this trial such that it appears it is likely to complete enrollment in a similar timeline to the second-line Precision Promise pancreatic cancer trial. There has also been a higher than expected dropout of patients randomized to the chemotherapy control arm, which could potentially impact the interpretative and regulatory utility of the data.
Following the strategic review discussed above, considering, in part, the timeline and regulatory utility for this trial compared to the parallel Precision Promise trial and concentration of investment in this specific cancer, management concluded that it would be best to focus on the second-line Precision Promise trial which offers treatment options to patients earlier in their disease and includes tumor biopsy and biomarker analyses that aligns with the Company's overall strategic focus on targeted identifying therapies.
Therefore, the Company decided to stop enrollment and begin the process of
closing down the trial. Patients currently on therapy are allowed to continue
treatment until progression or unacceptable toxicity. The closing of this trial
may require several months to complete. During the year ended
COVID-19 Update
In
We have also taken important steps to protect the health and welfare of our employees, consultants and board members, by continuing to provide a fully "work-from-home" option. Although we have operated in the COVID-19 environment for approximately two years, there remains substantial uncertainty about the extent to which COVID-19 will impact our product candidates and business, including patients' willingness to participate and remain in clinical trials, the timing of meeting enrollment expectations, the ability of our third-party partners to remain operational and our access to capital markets and financing sources and depends on numerous evolving factors that are highly uncertain and cannot be accurately predicted, including those identified under "Risk Factors" in this report, many of which are beyond our control. Management continues to monitor the situation closely and intends to continue to adapt and implement process adjustments as needed.
Recent Developments
Nasdaq Notice
On
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that we are therefore not in compliance with the minimum bid price requirement
for continued inclusion on The Nasdaq Capital Market under Nasdaq Listing Rule
5550(a)(2). Nasdaq's notice has no immediate effect on the listing or trading of
our common stock. The Company can regain compliance with the
Critical Accounting Policies and Estimates and Recent Accounting Pronouncements
Critical accounting estimates are those made in accordance with generally
accepted accounting principles in
Research and Development Expenses
Research and development costs are expensed as incurred and are primarily comprised of, but not limited to, external research and development expenses incurred under arrangements with third parties, such as CROs, CMOs and consultants that conduct clinical and preclinical studies, costs associated with preclinical and development activities, costs associated with regulatory operations, depreciation expense for assets used in research and development activities and employee related expenses, including salaries and benefits for research and development personnel. Costs for certain development activities, such as clinical studies, are accrued, over the service period specified in the contract and recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations or information provided to us by our vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the patterns of costs incurred, and are reflected in the consolidated financial statements as prepaid or accrued expense.
Income Taxes
Our income tax expense, deferred tax assets and liabilities, and liabilities for
unrecognized tax benefits reflect management's best estimate of current and
future taxes to be paid. We are subject to federal income taxes in
Deferred income taxes arise from temporary differences between the tax basis of assets and liabilities and their reported amounts in the financial statements, which will result in taxable or deductible amounts in the future. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. The assumptions about future taxable income require the use of significant judgment and are consistent with the plans and estimates we are using to manage the underlying businesses. In evaluating the objective evidence that historical results provide, we consider three years of cumulative operating income (loss).
A valuation allowance is provided when, after consideration of available positive and negative evidence, that it is not more likely than not that the benefit from deferred tax assets will be realizable. In recognition of this risk, we have provided a full valuation allowance against the net deferred tax assets.
The calculation of our tax liabilities involves dealing with uncertainties in the application of complex tax laws and regulations in various jurisdictions. ASC 740 "Income Taxes" states that a tax benefit from an uncertain tax position
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may be recognized when it is more likely than not that the position will be sustained upon examination, including resolutions of any related appeals or litigation processes, on the basis of the technical merits.
As of
The Company files federal income tax returns in
Stock-Based Compensation
We follow the authoritative guidance for accounting for stock-based compensation in ASC 718, "Compensation-Stock Compensation." The guidance requires that stock-based payment transactions be recognized in the financial statements based on their fair value at the grant date and recognized as compensation expense over the vesting period as services are being provided.
The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model. The use of the Black-Scholes option pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the common stock consistent with the expected term of the option, using a blend of the Company's expected volatility and those of similar companies, risk-free interest rates, the value of the common stock and expected dividend yield of the common stock. For awards subject to time-based vesting conditions, we recognize stock-based compensation expense equal to the grant date fair value of stock options on a straight-line basis over the requisite service period, which is generally the vesting term. The Company accounts for forfeitures as they occur, rather than estimating forfeitures as of an award's grant date.
The Company adopted ASU 2018-07 and, as such, the fair value of options granted to non-employees is estimated at the date of grant only, and the expected term is determined using the simplified method for options granted to non-employees and consultants.
Derivative Warrant Liability
Certain freestanding common stock warrants that are related to the issuance of common stock are classified as liabilities and recorded at fair value due to characteristics that require liability accounting, primarily the obligation to issue registered shares of common stock upon notification of exercise and certain price protection provisions. Warrants of this type are subject to re-measurement at each balance sheet date and any change in fair value is recognized as a component of other income (expense) in the consolidated statement of operations. As noted in Note 8, Stockholders' Equity, the Company classifies a warrant to purchase shares of its Common Stock as a liability on its consolidated balance sheet if the warrant is a free-standing financial instrument that contains certain price protection features that cause the warrants to be treated as derivatives or requires the issuance of registered common shares upon exercise. Each warrant of this type is initially recorded at fair value on date of grant using the Monte Carlo simulation model or the Black Scholes model and is subsequently re-measured to fair value at each subsequent balance sheet date. Changes in fair value of the warrant are recognized as a component of other income (expense) in the consolidated statement of operations. The Company will continue to adjust the liability for changes in fair value until the earlier of the exercise or expiration of the warrant. The Company utilizes Level 3 fair value criteria to measure the fair value of the warrants.
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Refer to Note 2 to our Consolidated Financial Statements for a discussion of Recent Accounting Pronouncements.
Results of Operations
Year ended
Net loss for the year ended
Cash used in operating activities for the year ended
Adjusted net loss, which excludes the change in fair value of warrant liability,
amortization of employees, directors and consultants stock options and gain on
warrant exchange, was
Revenue
During the years ended
Operating Expenses
For the year ended
• Research and development expenses were $13,445,000 for the year ended
March 31, 2022 , compared to $16,709,000 for the year ended March 31,
2021 , representing a decrease of $3,264,000 . The majority of research
and development expenditures have been incurred in respect of our
lead drug candidate SM-88 and its technology platform. Research and
development expenditures also included costs for pre-clinical studies
on SM-88 MOA, biomarker identification and TYME-19. Research and
development activities primarily consist of the following:
• Study and consulting expenses were $11,022,000 for the year
ended March 31, 2022 , compared to $12,637,000 for the year
ended March 31, 2021 representing a decrease of $1,615,000
between the comparable periods. The decrease is mainly
attributable to lower ongoing trial costs due to the
discontinued TYME-88-Panc Part 2 third-line Metastatic
Pancreatic Cancer and Precision Promise trials, partially
offset by costs incurred related to the OASIS clinical trial
as well as mechanism of action and biomarker preclinical
studies.
• Salary and salary related expenses for research and
development personnel were $1,846,000 for the year ended
March 31, 2022 , compared to $2,693,000 for the year ended
March 31, 2021 , representing a decrease of $847,000 between
comparable periods, primarily due to lower headcount for
roles currently outsourced to consultants.
• Included in research and development expense for the year
ended March 31, 2022 is $577,000 of stock based compensation
related to stock options granted to research and development
personnel compared to $1,379,000 for the year ended March 31,
2021 ,
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representing a decrease of $802,000 between the comparable
periods, primarily attributable to fully vested grants and
cancellation/forfeiture of options.
• General and administrative expenses were $9,632,000 for the year
ended March 31, 2022 , compared to $10,186,000 for the year ended
March 31, 2021 , representing a decrease of $554,000 . The general and
administrative expenses include:
• Stock based compensation related to stock options granted was
$1,875,000 for the year ended March 31, 2022 , compared to
$2,078,000 for the year ended March 31, 2021 , representing a
decrease of $203,000 , primarily attributable to fully vested
grants and cancellation/forfeiture of options.
• Legal, professional services, accounting and auditing
expenses for the year ended March 31, 2022 , were $2,668,000 ,
compared to $3,150,000 for the year ended March 31, 2021 ,
representing a decrease of $482,000 .
• Salary and salary related expenses for non-research and
development personnel were $3,301,000 for the year ended
March 31, 2022 , compared to $3,235,000 for the year ended
March 31, 2021 , representing an increase of $66,000 between
the comparable periods.
• Other general and administrative expenses for the year ended
March 31, 2022 were $1,788,000 , compared to $1,723,000 for
the year ended March 31, 2021 , an increase of $65,000 .
• Severance expense was $2,437,000 for the year ended March 31, 2022 ,
compared to $322,000 for the year ended March 31, 2021 , representing
an increase of $2,115,000 which primarily represents severance
expense attributable to the Release Agreement, dated March 24, 2022 ,
pursuant to which the Chief Science Officer resigned and received a
lump sum severance payment of $2.1 million that would have been
payable under his employment agreement. Severance expense for the
year ended March 31 2021 included amounts related to the Separation
and General Release Agreement entered into with its Chief Medical
Officer for separation of employment as of March 31, 2021 , classified
in salary and salary related expenses for research and development
personnel in prior year.
Other Income/Expenses
For the year ended
For the year ended
For the year ended
Investment and interest income for the year ended
Income Tax
Our effective income tax rate for the years ended
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Adjusted net loss and adjusted net loss per share as presented in this report
are non-GAAP measures. The adjustments relate to the change in fair value of
warrant liability, amortization of employees, directors and consultants stock
options and gain on warrant exchange. These financial measures are presented on
a basis other than in accordance with
Reconciliation of Net Loss to Adjusted Net Loss
For the Year Ended March 31,
2022 2021
Net loss (GAAP) $ (23,626,000 ) $ (28,979,000 ) Adjustments:
Change in fair value of warrant liability (1,807,000 ) 3,915,000 Gain on warrant exchange - (2,229,000 )
Amortization of employees, directors and consultants stock options
2,452,000 3,457,000
Adjusted net loss (non-GAAP) $ (22,981,000 ) $ (23,836,000 )
Reconciliation of Net Loss Per Share to Adjusted
Basic and Diluted Net Loss Per Share
For the Year Ended March 31,
2022 2021
Net loss per share (GAAP) $ (0.14 ) $ (0.22 ) Adjustments:
Change in fair value of warrant liability (0.01 ) 0.03 Gain on warrant exchange - (0.02 )
Amortization of employees, directors and consultants stock options
0.02 0.03
Adjusted basic and diluted net loss per share
(non-GAAP) $ (0.13 ) $ (0.18 ) The Non-GAAP Measures for the year ended
a) The warrants issued as part of an equity offering on April 2, 2019 were
measured at fair value using a Monte Carlo model which takes into account,
as of the valuation date, factors including the current exercise price,
the remaining contractual term of the warrant, the current price of the
underlying stock, its expected volatility, the risk-free interest rate for
the term of the warrant and the estimates of the probability of
fundamental transactions occurring.
The
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The warrant liability is revalued at each reporting period or upon exercise.
Changes in fair value are recognized in the consolidated statements of
operations and are excluded from adjusted net loss and adjusted net loss per
share.
b) The Company uses the Black-Scholes option pricing model to determine fair
value of stock options granted. For employees and non-employees, the
compensation expense is amortized over the requisite service period which
approximates the vesting period. The expense is excluded from adjusted net
loss and adjusted net loss per share.
c) Gain on warrant exchange resulted from the difference in fair value of the
warrants issued as part of the equity offering on April 2, 2019 before
their exchange (as described under the subheading "Historical Financings"
below) and the fair value of the common stock exchange shares and the May
2020 Warrant granted pursuant to the Share Exchange Agreements and the
Warrant Exchange Agreement, respectively.
Adjusted basic net loss per share is computed by dividing adjusted net loss by the weighted average number of shares of Company common stock outstanding for the period, and adjusted diluted loss per share is computed by also including common stock equivalents outstanding for the period. During the periods presented, the calculation excludes any potential dilutive common shares and any equivalents as they would have been anti-dilutive as the Company incurred losses for the periods then ended.
Liquidity and Capital Resources
Liquidity and Capital Requirements Outlook
On
The Company intends to continue to use the net proceeds of this offering for the development of our clinical and preclinical assets and for general corporate purposes, capital expenditures, working capital and general and administrative expenses. We may also use a portion of the net proceeds to acquire or invest in businesses, products and technologies that are complementary to our own to further diversify our product pipeline and are exploring various strategic options as described above. In addition, we may also use the proceeds, and may require additional capital, to engage in potential partnerships or collaborations. The Company's most significant funding needs are in connection with (i) participating in the investigator-initiated HoPES clinical trial of SM-88 in sarcoma, (ii) participating in OASIS, our investigator-initiated prospective open-label Phase II trial, evaluating the efficacy and safety of SM-88 with MPS for the treatment of metastatic HR+, HER2- breast cancer after treatment, (iii) conducting preclinical studies of an injectable form of SM-88, (iv) conducting preclinical studies in connection with our other preclinical pipeline products, TYME-19, TYME-18 and Tumor Targeting Technology, and (v) conducting additional or related studies of other potential drug candidates. If we determine to move beyond the preclinical stage for any of our preclinical product candidates or if we pursue studies in other cancer types, our liquidity requirements will be increased. Additionally, if the Company completes a material transaction resulting from its strategic evaluation process, the Company will, among other potential payment obligations, be obligated to pay each of its executive officers a retention bonus within 20 days of such transaction.
Primarily as a result of its active clinical trials, including timing of
enrollment, as well as other business developments, and based on its current
operating plan, but not taking into consideration to the execution or completion
of any transaction that may result from the evaluation of strategic options and
diversification initiatives as described above, the Company currently
anticipates that its quarterly cash operating expense will approximate
As of
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Management has concluded that substantial doubt does not exist regarding the Company's ability to satisfy its obligations as they come due during the twelve-month period following the issuance of these financial statements. This conclusion is based on the Company's assessment of qualitative and quantitative conditions and events, considered in aggregate as of the date of issuance of these financial statements that are known and reasonably knowable. Among other relevant conditions and events, including the ongoing COVID-19 pandemic and related government and economic responses, the Company has considered its operational plans, liquidity sources, obligations due or expected, funds necessary to maintain the Company's operations, and potential adverse conditions or events as of the issuance date of these financial statements.
The Company has historically funded its operations primarily through equity offerings of its common stock. As a clinical-stage entity, without product revenues and ongoing needs to fund our clinical development activities and general operations, we regularly evaluate opportunities to raise capital and obtain necessary, as well as opportunistic financing. To meet our liquidity needs, we currently expect to use existing cash balances and marketable securities in the short term, and a variety of other means as longer term funding sources, including potential issuances of debt or equity securities in public or private financings, option exercises, and partnerships and/or collaborations. The demand for the equity and debt of biopharmaceutical and biotechnology companies like ours is dependent upon many factors, including the general state of the financial markets. During times of extreme market volatility, capital may not be available on favorable terms, if at all. Our inability to obtain such additional capital could materially and adversely affect our business operations.
While we will continue to seek capital through a number of means, there can be no assurance that additional financing will be available on acceptable terms, if at all, and our negotiating position in capital generating efforts may worsen as existing resources are used. Moreover, as discussed above, should the Company be unable to maintain compliance with Nasdaq listing requirements, our ability to raise funds and, therefore, our liquidity, could be negatively impacted. See Item 1A - Risk Factors for additional information.
Additional equity financing, which we expect to raise, may be dilutive to our stockholders; debt financing, if available, may involve significant cash payment obligations and covenants that restrict our ability to operate as a business; and our stock price may not reach levels necessary to induce option exercises. If we are unable to raise the funds necessary to meet our long-term liquidity needs, we may have to delay or discontinue the development of certain or all of our drug candidates or raise funds on terms that we currently consider unfavorable.
From time to time, we may also restructure our outstanding securities or seek to repurchase or redeem them if we believe doing so would provide us with additional flexibility to raise capital or is otherwise in the best interests of the Company.
Historical Financings
As further described above under the heading "Liquidity and Capital Requirements
Outlook", on
On
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On
Exchange Agreements
In
The Company also entered into an exchange agreement (the "Warrant Exchange
Agreement") with another Holder of
After such exchanges, the
Cash Flows
Net cash used in or provided by operating, investing and financing activities from continuing operations were as follows:
2022 2021
Net cash used in operating activities
-
Net cash provided by financing activities
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Our cash used in operating activities in the year ended
Our cash used in operating activities in the year ended
Investing Activities
During the year ended
Financing Activities
During the year ended
During the year ended
Seasonality
The Company does not believe that its operations are seasonal in nature.
Contractual Obligations and Commitments
In the course of the Company's normal business operations, it enters into
agreements and arrangements with contract service providers to assist in the
performance of its research and development and clinical research activities. At
Contract Service Providers
On
Purchase Commitments
The Company has entered into contracts with manufacturers to supply certain components used in SM-88 in order to achieve favorable pricing on supplied products. These contracts have non-cancellable elements related to the scheduled deliveries of these products in future periods. Payments are made by us to the manufacturer when the products are delivered and of acceptable quality. The outstanding future contract obligations structured to match
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clinical supply needs for the Company's ongoing trials and registration activity
are approximately
Leases
The Company leases office space in
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