2023 Q3 Form 10-Q Financial Statement

#000155837023014705 Filed on August 14, 2023

View on sec.gov

Income Statement

Concept 2023 Q3 2023 Q2 2022 Q2

Balance Sheet

Concept 2023 Q3 2023 Q2 2022 Q2
SHORT-TERM ASSETS
Cash & Short-Term Investments $35.97M $62.49M
YoY Change -42.44% -27.15%
Cash & Equivalents $36.00M $62.49M
Short-Term Investments
Other Short-Term Assets $629.1K $1.708M
YoY Change -63.16% 198.62%
Inventory
Prepaid Expenses
Receivables
Other Receivables
Total Short-Term Assets $39.29M $65.67M
YoY Change -40.16% -31.91%
LONG-TERM ASSETS
Property, Plant & Equipment $394.9K $774.5K
YoY Change -49.01% 51.98%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets
YoY Change
Total Long-Term Assets $1.182M $1.335M
YoY Change -11.51% -23.3%
TOTAL ASSETS
Total Short-Term Assets $39.29M $65.67M
Total Long-Term Assets $1.182M $1.335M
Total Assets $40.48M $67.01M
YoY Change -39.59% -31.76%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $2.479M $1.675M
YoY Change 48.03% -7.96%
Accrued Expenses $8.759M $7.853M
YoY Change 11.54% -1.87%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $11.46M $9.528M
YoY Change 20.24% -4.99%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00
YoY Change
Other Long-Term Liabilities $0.00 $237.4K
YoY Change -100.0% -49.31%
Total Long-Term Liabilities $0.00 $237.4K
YoY Change -100.0% -49.31%
TOTAL LIABILITIES
Total Short-Term Liabilities $11.46M $9.528M
Total Long-Term Liabilities $0.00 $237.4K
Total Liabilities $11.46M $9.765M
YoY Change 17.32% -6.97%
SHAREHOLDERS EQUITY
Retained Earnings -$295.4M
YoY Change
Common Stock $53.94K
YoY Change
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $29.02M $57.24M
YoY Change
Total Liabilities & Shareholders Equity $40.48M $67.01M
YoY Change -39.59% -31.76%

Cashflow Statement

Concept 2023 Q3 2023 Q2 2022 Q2

Facts In Submission

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<p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><b style="font-weight:bold;">(1) Nature of Business and Liquidity</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-weight:bold;visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">a. Nature of Business</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">Zynerba Pharmaceuticals, Inc., together with its subsidiary, Zynerba Pharmaceuticals Pty Ltd (collectively, “Zynerba,” the “Company,” or “we”), is a clinical stage specialty pharmaceutical company focused on the development of pharmaceutically-produced transdermal cannabinoid therapies for orphan neuropsychiatric disorders, including Fragile X syndrome (“FXS”) and chromosome 22q11.2 deletion syndrome (“22q”). We have been granted orphan drug designations from the United States Food and Drug Administration (“FDA”) and the European Commission for the use of cannabidiol for the treatment of FXS and 22q. In addition, we have received Fast Track designation from the FDA for treatment of behavioral symptoms associated with FXS. The Company has decided to prioritize its resources on FXS and 22q, both of which have no approved products. While we believe the data from the Company’s autism spectrum disorder (“ASD”) clinical development program to date are compelling, given the difficult financial market, the Company has decided to defer the start of the Phase 3 development program in ASD. </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"> <span style="visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">The Company is subject to those risks associated with any clinical stage pharmaceutical company that has substantial expenditures for research and development. There can be no assurance that the Company's research and development projects will be successful, that products developed will obtain necessary regulatory approval, or that any approved product will be commercially viable. In addition, the Company operates in an environment of rapid technological change and is largely dependent on the services of its employees and consultants.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">b. Liquidity</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;background:#ffffff;margin:0pt;">Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 205-40, Presentation of Financial Statements - Going Concern (“ASC 205-40”), requires management to assess the Company’s ability to continue as a going concern for one year after the date the financial statements are issued. This standard requires management to 1) identify and disclose if there are initial conditions indicating substantial doubt about the Company’s ability to continue as a going concern within one year of the issuance date of the financial statements, 2) disclose the principal conditions that gave rise to substantial doubt, 3) disclose management’s evaluation of the significance of those conditions in relation to the Company’s ability to meet its obligations and 4) disclose management’s plans that are intended to mitigate the adverse conditions. In accordance with the accounting standard, when considering management’s plans to mitigate the conditions giving rise to substantial doubt, management can only consider those plans which are probable to be successfully implemented.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;background:#ffffff;margin:0pt;"> </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;background:#ffffff;margin:0pt;">As of June 30, 2023, the Company had cash and cash equivalents of $36.0 million and an accumulated deficit of $295.4 million. For the six months ended June 30, 2023, the Company reported a net loss of $20.9 million and cash used in operating activities of $16.3 million. The Company expects that its existing cash and cash equivalents will be sufficient to enable the Company to fund its operating expenses and capital expenditure requirements to mid-year 2024, but not more than one year after the date of the filing of this Quarterly Report on Form 10-Q, and therefore management has concluded that substantial doubt exists about the Company’s ability to continue as a going concern. </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:27.75pt;background:#ffffff;margin:0pt;"><span style="visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;background:#ffffff;margin:0pt;">The Company’s ability to continue as a going concern is dependent upon its ability to raise additional funding. Management believes that the Company’s liquidity position as of the date of this filing provides sufficient runway to achieve important research and development milestones. Management intends to raise additional capital through equity offerings and/or debt financings, or from other potential sources of liquidity, which may include new collaborations, licensing or other commercial agreements for one or more of the Company’s research programs or patent portfolios or divestitures of the Company's assets. The Company’s ability to access the capital markets or otherwise raise such capital may be adversely impacted by geopolitical tensions and macroeconomic events and the recent disruptions to, and volatility in, financial markets in the United States and globally resulting from multiple factors such as COVID-19, inflationary pressures, banking instability, rising interest rates and the ongoing conflict in Ukraine. There is no assurance that such financing will be available when needed or on acceptable terms. If the Company is unable to raise capital when needed or on attractive terms, it would be forced to delay, reduce, or eliminate its research and development programs or other operations. If any of these events occur, the Company’s ability to achieve its operational goals would be adversely affected.</p><p style="font-family:'Times New Roman','Times','serif';font-size:12pt;text-indent:24.5pt;background:#ffffff;margin:0pt;"><span style="font-size:10pt;margin-bottom:5pt;margin-top:5pt;visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;background:#ffffff;margin:0pt;">The interim consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates continuity of operations, the realization of assets and the satisfaction of liabilities and commitments in the normal course of business.</p>
CY2023Q2 us-gaap Cash And Cash Equivalents At Carrying Value
CashAndCashEquivalentsAtCarryingValue
36000000.0
CY2023Q2 us-gaap Retained Earnings Accumulated Deficit
RetainedEarningsAccumulatedDeficit
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us-gaap Net Income Loss
NetIncomeLoss
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us-gaap Net Cash Provided By Used In Operating Activities
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us-gaap Use Of Estimates
UseOfEstimates
<p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">b. Use of Estimates</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial<b style="font-weight:bold;"> </b>statements and reported amounts of expenses during the reporting period. Actual results could differ from such estimates.</p>
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ResearchAndDevelopmentExpensesBeforeIncentive
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us-gaap Research And Development Expense
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us-gaap Research And Development Expense
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us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
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PropertyPlantAndEquipmentGross
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AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment
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CY2023Q2 us-gaap Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
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us-gaap Depreciation
Depreciation
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us-gaap Depreciation
Depreciation
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CY2023Q2 us-gaap Accrued Salaries Current
AccruedSalariesCurrent
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AccruedSalariesCurrent
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AccruedResearchAndDevelopmentExpensesCurrent
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CY2023Q2 us-gaap Other Accrued Liabilities Current
OtherAccruedLiabilitiesCurrent
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CY2022Q4 us-gaap Other Accrued Liabilities Current
OtherAccruedLiabilitiesCurrent
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CY2023Q2 us-gaap Accrued Liabilities Current
AccruedLiabilitiesCurrent
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CY2022Q4 us-gaap Accrued Liabilities Current
AccruedLiabilitiesCurrent
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CY2023Q2 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Number Of Shares Authorized
ShareBasedCompensationArrangementByShareBasedPaymentAwardNumberOfSharesAuthorized
6900000
CY2023Q2 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Number Of Shares Available For Grant
ShareBasedCompensationArrangementByShareBasedPaymentAwardNumberOfSharesAvailableForGrant
6182640
us-gaap Lease Practical Expedients Package
LeasePracticalExpedientsPackage
true
CY2023Q2 us-gaap Lease Practical Expedient Lessor Single Lease Component
LeasePracticalExpedientLessorSingleLeaseComponent
true
zyne Area Of Leasable Office Space
AreaOfLeasableOfficeSpace
10877
CY2021Q1 us-gaap Operating Lease Liability
OperatingLeaseLiability
755085
CY2021Q1 us-gaap Operating Lease Right Of Use Asset
OperatingLeaseRightOfUseAsset
752391
CY2021Q1 zyne Operating Lease Deferred Rent Liability Included Right Of Use Asset
OperatingLeaseDeferredRentLiabilityIncludedRightOfUseAsset
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CY2023Q2 us-gaap Operating Lease Right Of Use Asset
OperatingLeaseRightOfUseAsset
219037
CY2023Q2 us-gaap Operating Lease Weighted Average Remaining Lease Term1
OperatingLeaseWeightedAverageRemainingLeaseTerm1
P0Y10M24D
CY2023Q2 us-gaap Operating Lease Weighted Average Discount Rate Percent
OperatingLeaseWeightedAverageDiscountRatePercent
0.0276
CY2023Q2 us-gaap Lessee Operating Lease Liability Payments Remainder Of Fiscal Year
LesseeOperatingLeaseLiabilityPaymentsRemainderOfFiscalYear
120210
CY2023Q2 us-gaap Lessee Operating Lease Liability Payments Due Next Twelve Months
LesseeOperatingLeaseLiabilityPaymentsDueNextTwelveMonths
100175
CY2023Q2 us-gaap Lessee Operating Lease Liability Payments Due
LesseeOperatingLeaseLiabilityPaymentsDue
220385
CY2023Q2 us-gaap Lessee Operating Lease Liability Undiscounted Excess Amount
LesseeOperatingLeaseLiabilityUndiscountedExcessAmount
2506
CY2023Q2 us-gaap Operating Lease Liability
OperatingLeaseLiability
217879
us-gaap Operating Lease Cost
OperatingLeaseCost
120842
us-gaap Operating Lease Cost
OperatingLeaseCost
120842
us-gaap Variable Lease Cost
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us-gaap Variable Lease Cost
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us-gaap Lease Cost
LeaseCost
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us-gaap Lease Cost
LeaseCost
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us-gaap Operating Lease Payments
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us-gaap Operating Lease Payments
OperatingLeasePayments
160316
us-gaap Operating Lease Payments
OperatingLeasePayments
152487

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