UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
For the quarterly period ended
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TABLE OF CONTENTS
i
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
We make forward-looking statements under the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and in other sections of this Quarterly Report on Form 10-Q (this “Form 10-Q”). In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “should,” “would,” “could,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “potential” or “continue,” and the negative of these terms and other comparable terminology. These forward-looking statements, which are subject to known and unknown risks, uncertainties and assumptions about us, may include projections of our future financial performance based on our growth strategies and anticipated trends in our business. These statements are only predictions based on our current expectations and projections about future events. There are important factors that could cause our actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements.
While we believe we have identified material risks, these risks and uncertainties are not exhaustive. Other sections of this Form 10-Q may describe additional factors that could adversely impact our business and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risks and uncertainties emerge from time to time, and it is not possible to predict all risks and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.
Although we believe the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance or achievements. Moreover, neither we nor any other person assumes responsibility for the accuracy or completeness of any of these forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. We are under no duty to update any of these forward-looking statements after the date of this Form 10-Q to conform our prior statements to actual results or revised expectations, and we do not intend to do so.
We caution you not to place undue reliance on the forward-looking statements, which speak only as of the date of this Form 10-Q in the case of forward-looking statements contained in this Form 10-Q.
You should not rely upon forward-looking statements as predictions of future events. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. We qualify all of our forward-looking statements by these cautionary statements. Although we believe that the expectations reflected in the forward looking-statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Therefore, you should not rely on any of the forward-looking statements. In addition, with respect to all of our forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
EXPLANATORY NOTE
In this Quarterly Report on Form 10-Q, and unless the context otherwise requires, the “Company,” “we,” “us,” and “our” refer to Bluejay Diagnostics, Inc. and its wholly-owned subsidiary Bluejay SpinCo, LLC, taken as a whole.
ii
PART I - FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements.
Bluejay Diagnostics, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
June 30, | December 31, | |||||||
2022 | 2021 | |||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | $ | ||||||
Inventories | ||||||||
Prepaid expenses and other current assets | ||||||||
Total current assets | ||||||||
Property and equipment, net | ||||||||
Operating lease right-of-use assets | ||||||||
Other non-current assets | ||||||||
Total assets | $ | $ | ||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | $ | ||||||
Accrued expenses | ||||||||
Total current liabilities | ||||||||
Non-current liabilities: | ||||||||
Operating lease liability, non-current | ||||||||
Total liabilities | ||||||||
Commitments and Contingencies (See Note 9) | ||||||||
Stockholders’ equity | ||||||||
Common stock, $ | ||||||||
Additional paid-in capital | ||||||||
Accumulated deficit | ( | ) | ( | ) | ||||
Total stockholders’ equity | ||||||||
Total liabilities, redeemable and stockholders’ equity | $ | $ |
See notes to unaudited condensed consolidated financial statements.
Reflects a 1-for-3.15 stock dividend effective June 7, 2021.
1
Bluejay Diagnostics, Inc.
Condensed Consolidated Statements
of Operations
(Unaudited)
Three Months
Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Revenue | $ | $ | $ | $ | ||||||||||||
Cost of sales | ||||||||||||||||
Gross profit | ||||||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | ||||||||||||||||
General and administrative | ||||||||||||||||
Sales and marketing | ||||||||||||||||
Total operating expenses | ||||||||||||||||
Operating loss | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
Other income: | ||||||||||||||||
Interest income (expense), net of amortization of premium | ( | ) | ( | ) | ||||||||||||
Grant income | ||||||||||||||||
Other income, net | ||||||||||||||||
Total other income, net | ||||||||||||||||
Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
$ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||||
Weighted average common shares outstanding: | ||||||||||||||||
See notes to unaudited condensed consolidated financial statements.
Reflects a 1-for-3.15 stock dividend effective June 7, 2021.
2
Bluejay Diagnostics, Inc.
Condensed Consolidated Statements of Changes in Redeemable Preferred Stock and
Stockholders’ Equity (Deficit)
(Unaudited)
Stockholders Equity | ||||||||||||||||||||
Additional | Total | |||||||||||||||||||
Common Stock | Paid-In | Accumulated | Stockholders’ | |||||||||||||||||
Shares | Amount | Capital | Deficit | Equity | ||||||||||||||||
Balance at December 31, 2021 | $ | $ | $ | ( | ) | $ | ||||||||||||||
Impact of adoption of ASC 842 | - | ( | ) | ( | ) | |||||||||||||||
Stock-based compensation expense | - | - | ||||||||||||||||||
Exercise of common stock Series B Warrants | ( | ) | ||||||||||||||||||
Net loss | - | - | ( | ) | ( | ) | ||||||||||||||
Balance at March 31, 2022 | $ | $ | $ | ( | ) | $ | ||||||||||||||
Stock-based compensation expense | - | - | - | |||||||||||||||||
Exercise of common stock Series B Warrants | ||||||||||||||||||||
Net loss | - | - | - | ( | ) | ( | ) | |||||||||||||
Balance at June 30, 2022 | $ | $ | $ | ( | ) | $ |
Redeemable, Convertible Preferred Stock | Stockholders Deficit | |||||||||||||||||||||||||||||||||||||||||||
Additional | Total | |||||||||||||||||||||||||||||||||||||||||||
Series A | Series B | Series C | Common Stock | Paid-In | Accumulated | Stockholders’ | ||||||||||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | Capital | Deficit | Deficit | ||||||||||||||||||||||||||||||||||
Balance at December 31, 2020 | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||||||||||||||||
Accretion of redeemable, convertible preferred stock to redemption value | - | - | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||
Stock-based compensation benefit | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||
Fair value of warrants issued for service | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||
Net loss | - | - | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||
Balance at March 31, 2021 | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||||||||||||||||
Accretion of redeemable, convertible preferred stock to redemption value | - | - | - | - | - | ( | ) | - | ( | ) | ||||||||||||||||||||||||||||||||||
Stock-based compensation benefit | - | - | - | - | - | - | - | - | - | |||||||||||||||||||||||||||||||||||
Conversion of redeemable, convertible preferred stock into common stock | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | - | |||||||||||||||||||||||||||||||
Exercise of common stock warrants | - | - | - | |||||||||||||||||||||||||||||||||||||||||
Conversion of Amended 2017 Convertible Notes | - | - | - | |||||||||||||||||||||||||||||||||||||||||
Reclassification of Series B Warrants | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||
Net loss | - | - | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||
Balance at June 30, 2021 | - | $ | - | $ | - | $ | $ | $ | $ | ( | ) | $ | ( | ) |
See notes to unaudited condensed consolidated financial statements.
Reflects a 1-for-3.15 stock dividend effective June 7, 2021.
3
Bluejay Diagnostics, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
Six Months Ended June 30, | ||||||||
2022 | 2021 | |||||||
CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
Net Loss | $ | ( | ) | $ | ( | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation expense | ||||||||
Stock-based compensation expense | ||||||||
Amortization of right-of-use asset | ||||||||
Gain on forgiveness of note payable, Paycheck Protection Program | ( | ) | ||||||
Non-cash interest expense | ||||||||
Gain on revaluation of derivative warrant liability | ( | ) | ||||||
Changes in operating assets and liabilities: | ||||||||
Inventory | ( | ) | ||||||
Prepaid expenses and other current assets | ( | ) | ||||||
Other non-current assets | ( | ) | ||||||
Accounts payable | ( | ) | ( | ) | ||||
Due to related party | ( | ) | ( | ) | ||||
Accrued expenses and other current liabilities | ||||||||
Net cash used in operating activities | ( | ) | ( | ) | ||||
CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
Purchase of property and equipment | ( | ) | ( | ) | ||||
Net cash used in investing activities | ( | ) | ( | ) | ||||
CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
Payments of deferred offering costs | ( | ) | ||||||
Payments of principal on notes payable | ( | ) | ||||||
Payments of convertible debenture issuance costs | ( | ) | ||||||
Proceeds from issuance of convertible debentures | ||||||||
Payments on note payable, Paycheck Protection Program | ( | ) | ||||||
Net cash provided by financing activities | ||||||||
Decrease in cash and cash equivalents | ( | ) | ||||||
Cash and cash equivalents, beginning of period | ||||||||
Cash and cash equivalents, end of period | $ | $ | ||||||
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION AND NON-CASH FINANCING ACTIVITIES | ||||||||
Interest paid | $ | $ | ||||||
Accretion of Series A redeemable, convertible preferred stock dividend | $ | $ | ||||||
Accretion of Series A redeemable, convertible preferred stock issuance costs and fair value adjustment | $ | $ | ||||||
Accretion of Series B redeemable, convertible preferred stock dividend | $ | $ | ||||||
Accretion of Series B redeemable, convertible preferred stock issuance costs | $ | $ | ||||||
Accretion of Series C redeemable, convertible preferred stock dividend | $ | $ | ||||||
Accretion of Series C redeemable, convertible preferred stock issuance costs | $ | $ | ||||||
Exercise of warrants through debt principal conversion | $ | $ | ||||||
Conversion of preferred stock into common stock | $ | $ | ||||||
Conversion of amended 2017 convertible notes | $ | $ | ||||||
Reclassification of derivative warrant liability into additional paid-in capital | $ | $ | ||||||
Fair value of warrants for common stock issued for services | $ | $ |
See notes to unaudited condensed consolidated financial statements.
4
Bluejay Diagnostics, Inc.
Notes to the Condensed Consolidated Financial Statements
(Unaudited)
1. NATURE OF OPERATIONS AND BASIS OF PRESENTATION
Business
Bluejay Diagnostics, Inc. (the “Company”), which commenced its activities on March 20, 2015, is incorporated under the laws of the State of Delaware.
The Company is a medical diagnostic company focused on developing cost efficient, rapid, near patient tests for triage and monitoring of disease progression.
The Company is utilizing the Symphony technology platform and Symphony IL-6 test licensed from Toray Industries, Inc. of Japan (see Note 3). The Company is also developing biomarkers for detection of other diseases such as hsTNT/I for myocardial injury and NT-proBNP for cardiac heart failure.
On June 4, 2021, the Company formed Bluejay Spinco, LLC, (“SpinCo”) a wholly owned subsidiary of the Company, for purposes of further development of the Company’s ALLEREYE diagnostic test. ALLEREYE received clearance by the U.S. Food and Drug Administration (the “FDA”) in October 2017 as a point-of-care device offering healthcare providers a cost effective, reliable, easy to use solution for diagnosing Allergic Conjunctivitis.
Risks and Uncertainties
The Company is subject to a number of risks similar to other companies in its industry, including rapid technological change, competition from larger biotechnology companies and dependence on key personnel. The Company is also impacted by inflationary pressures and global supply chain disruptions currently impacting many companies.
Liquidity
Since its inception, the Company has
devoted substantially all of its efforts to business planning, research and development, and raising capital. Successful transition from
a pre-revenue company to attaining profitable operations is dependent upon achieving a level of revenues adequate to support the Company’s
cost structure. As of June 30, 2022, the Company had $
The Company believes it has sufficient
cash to fund its operations for at least the next 12 months from the date of these financial statements. However, the Company has experienced
net losses and negative cash flows from operating activities since its inception and has an accumulated deficit of $
5
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in conformity with generally accepted accounting principles in the United States (“US GAAP”) consistent with those applied in, and should be read in conjunction with, the Company’s audited financial statements and related footnotes for the year ended December 31, 2021 included in the Company’s Annual Report on Form 10-K. The unaudited condensed consolidated financial statements reflect all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of the Company’s financial position as of June 30, 2022, its results of operations and cash flows for the six months ended June 30, 2022 and 2021, in accordance with US GAAP. The unaudited condensed consolidated financial statements do not include all of the information and footnotes required by US GAAP for complete financial statements, as allowed by the relevant U.S. Securities and Exchange Commission (“SEC”) rules and regulations; however, the Company believes that its disclosures are adequate to ensure that the information presented is not misleading. The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All intercompany balances and transactions have been eliminated in consolidation.
The results for the six months ended June 30, 2022 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2022, or any other interim period within this fiscal year.
On June 7, 2021, the Company’s Board
of Directors declared a stock dividend of
2. SIGNIFICANT ACCOUNTING POLICIES
During the six months ended June 30, 2022, there were no changes to the significant accounting policies as described in the 2021 Audited Financial Statements with the exception of the addition of significant account policies related to revenue, inventory and leases.
Use of estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts and disclosures reported in these condensed consolidated financial statements and accompanying notes. Actual results could differ materially from those estimates. The Company believes judgment is involved in accounting for the fair value-based measurement of stock-based compensation, accruals, convertible notes and warrants. The Company evaluates its estimates and assumptions as facts and circumstances dictate. As future events and their effects cannot be determined with precision, actual results could differ from these estimates and assumptions, and those differences could be material to the condensed consolidated financial statements.
Revenue Recognition
The Company recognizes revenue under the core principles of depicting the transfer of control to the Company’s customers in an amount reflecting the consideration to which the Company expected to be entitled. In order to achieve that core principle, the Company applies the following five step approach: (1) identify the contract with a customer, (2) identify the performance obligations in that contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract, and (5) recognize revenue when a performance obligation is satisfied.
The Company recognizes revenue when performance obligations under the terms of the contract with the customer are satisfied and are recognized at a point in time, which is also when control is transferred. When the Company performs shipping and handling activities after the transfer of control to the customer (e.g. when control transfers prior to delivery), they are considered fulfillment activities and, accordingly, the costs are accrued for when the related revenue is recognized. Sales tax and valued added taxes collected from the customers relating to product sales and remitted to governmental authorities are excluded from revenues.
6
Leases
Effective January 1, 2022, the Company adopted ASC 842, Leases (“ASC 842”). The Company has adopted ASC 842 using the optional transition method and, as a result, there have been no reclassification of prior comparable periods due to this adoption.
The Company has arrangements involving the lease of facilities. Under ASC 842, at inception of the arrangement, the Company determines whether the contract is or contains a lease and whether the lease should be classified as an operating or a financing lease. This determination, among other considerations, involves an assessment of whether the Company can control the underlying asset and have the right to obtain substantially all to the economic benefits or outputs from the asset.
The Company recognizes right-of-use (“ROU”) assets and lease liabilities as of the lease commencement date based on the net present value of the future minimum lease payments over the lease term. ASC 842 requires the leases to use the rate implicit in the lease unless it is not readily determinable and then it may use its incremental borrowing rate (“IBR”) to discount the future minimum lease payments. Most of the Company’s leases do not provide an implicit rate; therefore, the Company uses its IBR to discount the future minimum lease payments. The Company determines its IBR with its credit rating and other economic information available as of the commencement date, as well as the identified lease term. During the assessment of the lease term, the Company considers its renewal options and extensions within the arrangements and the Company includes these options when it’s reasonably certain to extend the term of the lease.
The Company leases include both lease and non-lease components. Consideration is allocated to the lease and non-lease components based on estimated standalone prices. The Company has elected to exclude non-lease components from the calculation of its ROU assets and lease liabilities.
The Company has lease arrangements that contain incentives for tenant improvements as well as fixed rent escalation clauses. For contracts with tenant improvement incentives that are determined to be leasehold improvements and the Company is reasonably certain to exercise, it records a reduction to the lease liability and amortizes the incentive over the identified term of the lease as a reduction to rent expense. The Company records rental expense on a straight-line basis over the identified lease term on contracts with rent escalation clauses.
Inventory
Inventories, which are mainly comprised of finished goods, are valued at the lower of cost or net realizable value, with the cost being determined on a weighted-average basis. The cost of finished goods consists mainly of purchase price, freight, and custom duties. Net realizable value is the estimated selling price in the ordinary course of business, less any applicable selling costs. As of June 30, 2022 there was no reserve for excess or obsolete inventory.
Stock-based compensation
Share-based compensation expense for all share-based payment awards made to employees, directors and non-employees is measured based on the grant-date fair value of the award. Share-based compensation expense for awards granted to non-employees is determined using the fair value of the consideration received or the fair value of the equity instruments issued, whichever is more reliably measured.
The Company uses the Black-Scholes option pricing model to determine the fair value of options granted. The Company recognizes the compensation cost of share-based awards on a straight-line basis over the requisite service period. For stock awards for which vesting is subject to performance-based milestones, the expense is recorded over the implied service period after the point when the achievement of the milestone is probable, or the performance condition has been achieved.
The Company recognizes forfeitures related to employee share-based payments when they occur. Forfeited options are recorded as a reduction to stock compensation expense.
7
Research and development expenses
Costs incurred in the research and development of new products are expensed as incurred. Research and development costs include, but are not limited to, salaries, benefits, stock-based compensation, laboratory supplies, fees for professional service providers and costs associated with product development efforts, including preclinical studies and clinical trials.
The Company estimates preclinical study and clinical trial expenses based on the services performed, pursuant to contracts with research institutions and clinical research organizations that conduct and manage preclinical studies and clinical trials on its behalf.
Segment Reporting
Management has determined that the Company has one operating segment, which is consistent with the Company structure and how it manages the business. As of June 30, 2022 and December 31, 2021, all of the Company’s assets were located in the United States.
Net Loss per Share
Basic net loss per share is computed by dividing the net loss by the weighted-average number of shares of common stock outstanding for the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss by the weighted average number of shares of common stock and dilutive common stock equivalents outstanding for the period determined using the treasury stock and if-converted methods. Dilutive common stock equivalents are comprised of convertible preferred stock, convertible notes, options outstanding under the Company’s stock option plan and warrants. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding as inclusion of the potentially dilutive securities would be antidilutive.
Potentially dilutive securities not included in the calculation of diluted net loss per share because to do so would be anti -dilutive are as follows (in common stock equivalent shares):
June 30, | ||||||||
2022 | 2021 | |||||||
Convertible debentures | ||||||||
Options to purchase common stock | ||||||||
Warrants for common stock | ||||||||
Class A warrants for common stock | ||||||||
Class B warrants for common stock |
Recently Adopted Accounting Standards
In February 2016, the Financial Accounting
Standards Board (“FASB”) issued ASU 2016-02, Leases. The new guidance requires the recognition of lease liabilities,
representing future minimum lease payments, on a discounted basis, and corresponding right-of-use assets on a balance sheet for most
leases, along with requirements for enhanced disclosures to give financial statement users the ability to assess the amount, timing,
and uncertainty of cash flows arising from leasing arrangements. The Company adopted the provisions of ASU 2016-02 on January 1, 2022
and elected to implement the transition package of practical expedients permitted within the new standard, which included (i) not reassessing
whether expired or existing contract contain leases, (ii) not reassessing lease classification, and (iii) not revaluing initial direct
costs for existing leases. Adoption of the new standard resulted in the recording of initial right-of-use assets and lease liabilities
of approximately $
8
3. LICENSE AND SUPPLY AGREEMENT WITH TORAY INDUSTRIES
On October 6, 2020, the Company entered
into a license and supply agreement (“Toray Agreement”) with Toray Industries, Inc. (“Toray”). Under the Toray
Agreement, the Company received the exclusive license to make and distribute protein detection cartridges that has a function of automatic
stepwise feeding of reagents (“Toray Cartridges”) outside of Japan. In exchange for the license, the Company committed to
make two payments of $
At June 30, 2022 and December 31, 2021, no amounts were accrued related to the Toray Agreement.
4. WARRANTS
The following table summarizes information with regard to warrants outstanding at June 30, 2022:
Shares | Exercisable for | Weighted Average Exercise Price | Weighted Average Remaining Life (in Years) | |||||||||||
Common Stock Warrants | $ | |||||||||||||
Class A Warrants | $ | |||||||||||||
Class B Warrants | $ |
No warrants were issued during the six months ended June 30, 2022.
9
Class A Warrants and Class B Warrants
In conjunction with the Company’s
IPO, the Company issued
Class A Warrants entitle the holder
to purchase
Class B Warrants entitle the holder
to purchase
5. STOCK COMPENSATION
Stock Incentive Plans
In 2018, the Company adopted the 2018
Stock Incentive Plan (the “2018 Plan”) for employees, consultants, and directors. The 2018 Plan, which is administered by
the Board of Directors, permits the Company to grant incentive and nonqualified stock options for the purchase of common stock, and restricted
stock awards. The maximum number of shares reserved for issuance under the 2018 Plan is
On July 6, 2021, the Company’s board
of directors and stockholders approved and adopted the Bluejay Diagnostics, Inc. 2021 Stock Plan (the “2021 Plan”). A total
of
Stock Award Activity
The following table summarizes the status of the Company’s non-vested restricted stock awards for the six months ended June 30, 2022:
Non-vested Restricted Stock Awards | ||||||||
Number of Shares | Weighted Average Grant Date Fair Value | |||||||
Outstanding at December 31, 2021 | $ | |||||||
Granted | ||||||||
Vested | ||||||||
Forfeited | ||||||||
Outstanding at June 30, 2022 | $ |
10
The following is a summary of stock option activity for the six months ended June 30, 2022:
Number of Stock Options | Weighted Average Exercise Price Per Share | Weighted Average Remaining Contractual Life in Years | Aggregate Intrinsic Value | |||||||||||||
Outstanding at December 31, 2021 | $ | $ | ||||||||||||||
Granted | ||||||||||||||||
Exercised | ||||||||||||||||
Cancelled and forfeited | ( | ) | ||||||||||||||
Outstanding at June 30, 2022 | $ | $ | ||||||||||||||
Exercisable at June 30, 2022 | $ | $ |
The weighted average grant date fair
value of options granted during the six months ended June 30, 2022 was $
The Company calculated the grant-date fair value of stock option awards granted during the six months ended June 30, 2022 and 2021 using the Black-Scholes model with the following assumptions:
Six Months Ended June 30, | ||||||||
2022 | 2021 | |||||||
Risk-free interest rate | ||||||||
Expected dividend yield | ||||||||
Volatility factor | ||||||||
Expected life of option (in years) |
Stock-Based Compensation Expense
For the three and six months ended June 30, 2022 and 2021, the Company recorded stock-based compensation expense as follows:
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Research and development | $ | $ | $ | $ | ||||||||||||
General and administrative | ||||||||||||||||
Sales and marketing | ||||||||||||||||
Total stock-based compensation | $ | $ | $ | $ |
At June 30, 2022, there was approximately
$
11
6. RELATED PARTY TRANSACTIONS
NanoHybrids, LLC
In December 2021, the Company entered
into an agreement with NanoHybrids, LLC (“NanoHybrids”) to utilize the Company’s research and development staff and
laboratory facility when available to perform work for NanoHybrids. Any hours worked by Company employees for NanoHybrids is billed to
NanoHybrids at a bill rate of the respective employee’s fully burdened personnel cost plus
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Income from NanoHybrids included in Other Income | $ | $ | $ | $ | ||||||||||||
Cash receipts from NanoHybrids | $ | $ | $ | $ |
As of | ||||||||
June 30, 2022 | December 31, 2021 | |||||||
Amounts receivable from NanoHybrids included in Prepaids and Other Current Assets | $ | $ |
Toray Industries, Inc.
In June 2022, the Company sold five Symphony analyzers to our business
partner, Toray, for $
7. PROPERTY AND EQUIPMENT
Property and equipment consisted of the following at June 30, 2022 and December 31, 2021:
Depreciable lives | June 30, 2022 | December 31, 2021 | ||||||||
Construction-in-process | $ | $ | ||||||||
Furniture, fixtures, and equipment | ||||||||||
Website | ||||||||||
Lab equipment | ||||||||||
Leasehold improvements | ||||||||||
Less: accumulated depreciation | ( | ) | ( | ) | ||||||
Property and equipment, net | $ | $ |
8. LEASES
The Company primarily enters into lease arrangements for office and laboratory space. A summary of supplemental lease information is as follows:
Six Months Ended June 30, 2022 | ||||
Weighted average remaining lease term | ||||
Weighted average discount rate | % | |||
Operating cash flows from operating leases | $ |
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A summary of the Company’s lease assets and liabilities are as follows:
June 30, 2022 | ||||
Operating lease right-of-use asset | $ | |||
Total lease assets | ||||
Current portion of lease liability included in accrued expenses | ||||
Noncurrent lease liabilities | ||||
Total lease liabilities | $ |
A summary of the Company’s estimated lease payments are as follows:
Year | ||||
2022 (1) | $ | |||
2023 | ||||
2024 | ||||
2025 | ||||
2026 | ||||
Thereafter | ||||
Total future lease payments | ||||
Less: Imputed interest | ||||
Present value of lease liability | $ |
(1) | Excludes the six months ended June 30, 2022. |
9. COMMITMENTS AND CONTINGENCIES
Purchase Commitments
As of June 30, 2022, the Company has
entered into non-cancelable purchase commitments primarily for inventory and key advisory and product development services. The purchase
commitments covered by these agreements are for less than one year and aggregate to approximately $
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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and analysis of our financial condition and results of operations in conjunction with the unaudited condensed consolidated financial statements and the related notes appearing elsewhere in this Form 10-Q. This discussion contains forward-looking statements reflecting our current expectations that involve risks and uncertainties. Actual results and the timing of events could differ materially from those discussed in our forward-looking statements as a result of many factors, including those set forth under “Risk Factors” and elsewhere in this Form 10-Q.
Overview
We are a medical diagnostics company focused on improving patient outcomes through cost efficient, rapid, near-patient products for triage and monitoring of disease progression. We believe there is a market need for an on-site and rapid diagnostic system that can be employed for testing and monitoring. Our diagnostic system, which we refer to as “Symphony,” is an exclusively licensed, patented, low-cost, system that consists of a small footprint instrument and single-use indication specific test cartridges.. We believe, if cleared, authorized, or approved by the U.S. Food and Drug Administration (“FDA”), the Symphony System can provide a solution to this market need with rapid, laboratory quality results in the Intensive Care Unit (“ICU”), Emergency Room (“ER”), and other hospital and clinical settings . Currently, testing is generally performed in a laboratory, and the transportation and logistics of transporting the samples to the lab and obtaining the results takes 8-48 hours. Our platform is a sample-to-result system that has been shown in a clinical study to provide results in approximately 20 minutes. Our business model is to generate revenue from the sale of the portable Symphony System, and from the sale of single-use indication specific cartridges used for the diagnostic test. Once the test material, a small volume whole blood sample, is transferred to a Symphony Cartridge, no additional sample preparation or pre-processing is required.
Since inception, we have incurred net losses from operations each year and we expect to continue to incur losses for the foreseeable future, at least until we are cleared, authorized or approved by the FDA. We incurred net losses of approximately $4.0 million and $834,000 for the six months ended June 30, 2022 and 2021, respectively. We had $15.3 million in cash and cash equivalents and a $11.7 million accumulated deficit at June 30, 2022, with net cash used in operating activities of approximately $3.6 million for the six months ended June 30, 2022.
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Results of Operations
Comparison of the Three Months and Six Months Ended June 30, 2022 and 2021
The following table sets forth our results of operations for the three and six months ended June 30, 2022 and 2021:
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Revenue | $ | 249,040 | $ | - | $ | 249,040 | $ | - | ||||||||
Cost of sales | 200,129 | - | 200,129 | - | ||||||||||||
Gross Profit | 48,911 | - | 48,911 | - | ||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | 756,283 | 225,992 | 1,451,040 | 250,175 | ||||||||||||
General and administrative | 1,196,996 | 389,830 | 2,516.815 | 529,741 | ||||||||||||
Sales and marketing | 81,357 | 50,250 | 135,042 | 119,354 | ||||||||||||
Total operating expenses | 4,102,897 | 666,072 | 4,102,897 | 899,270 | ||||||||||||
Operating loss | (1,985,725 | ) | (666,072 | ) | (4,053,986 | ) | (899,270 | ) | ||||||||
Other income | ||||||||||||||||
Interest income, net of amortization of premium | - | (59,167 | ) | - | (32,116 | |||||||||||
Grant income | - | 75,000 | - | 75,000 | ||||||||||||
Other income | 48,323 | 10,006 | 103,181 | 21,965 | ||||||||||||
Total other income, net | 48,323 | 25,839 | 103,181 | 64,849 | ||||||||||||
Net loss | $ | (1,937,402 | ) | $ | (640,233 | ) | $ | (3,950,805 | ) | (834,421 | ) |
Revenue and Gross Profit
Revenue and gross profit increased approximately $249,000 and $49,000 respectively, for the three and six month periods ended June 30, 2022, as compared to the same periods in 2021. The increase was due to a minor sale of five Symphony analyzers to our business partner, Toray. Future sales to Toray are not currently anticipated.
Research and Development
Research and development expenses for the three and six months ended June 30, 2022 were approximately $756,000 and $1.5 million, respectively, as compared to approximately $226,000 and $250,000, respectively, for the comparable periods in 2021. The increase in research and development expenses is due to the advancement of our clinical studies and to support the scale-up manufacturing of the Symphony IL-6 Test.
General and Administrative
General and administrative expenses for the three and six months ended June 30, 2022 were approximately $1.2 million and $2.5 million, respectively, as compared to approximately $390,000 and $530,000, respectively, for the comparable periods in 2021. The increase in general and administrative reflects the Company’s investment in scalable infrastructure, as well as expenses to support public company operations due to the completion of our initial public offering in November 2021.
Sales and Marketing
Sales and marketing expenses for the three and six months ended June 30, 2022 were approximately $81,000 and $135,000, respectively, as compared to approximately $50,000 and $119,000, respectively, for the comparable periods in 2021. While these expenses have been limited to date, we expect to increase these efforts when appropriate to support our commercial growth.
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Liquidity and Capital Commitments
Liquidity
We have funded our operations primarily through the net proceeds from our IPO on November 10, 2021. As of June 30, 2022, the Company had approximately $15.3 million in unrestricted cash and cash equivalents. We expect that our cash position will be sufficient to fund operations for at least twelve months, inclusive of executing our plan for regulatory approval and initial commercialization of our Symphony IL-6 Test.
Summary Statement of Cash Flows
The following table sets forth the primary sources and uses of cash and cash equivalents for each of the periods presented.
Six Months Ended June 30, | ||||||||
2022 | 2021 | |||||||
Cash proceeds (used in) provided by: | ||||||||
Operating activities | $ | (3,536,317 | ) | $ | (728,801 | ) | ||
Investing activities | (169,599 | ) | (1,934 | ) | ||||
Financing activities | - | 2,218,831 | ||||||
Net decrease in cash and cash equivalents | $ | (3,705,916 | ) | $ | 1,488,096 |
Net cash used in operating activities
During the six months ended June 30, 2022, we used approximately $3.5 million in operating activities, an increase of $2.8 million as compared to approximately $733,000 for the comparable period in 2021. The increase in net cash used in operating activities was primarily due to increases in inventory, personnel costs and expenses incurred for public company operations.
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Net cash provided by investing activities
During the six months ended June 30, 2022, we used approximately $170,000 in investing activities, an increase of 100% as compared to the comparable period in 2021. The increase in net cash used in investing activities was primarily due to capital purchases of laboratory equipment.
Net cash used in financing activities
During the six months ended June 30, 2022, we did not engage in any financing activities. During the six months ended June 30, 2021, approximately $2.2 million was provided by financing activities, primarily due to proceeds from our issuance of convertible debentures.
Recently Adopted Accounting Standards
See Note 2 to our condensed consolidated financial statements (under the caption “Recently Adopted Accounting Standards”).
Emerging Growth Company and Smaller Reporting Company Status
We are an emerging growth company, as defined in the Jumpstart Our Business Startups Act (the “JOBS Act”). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. We elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that 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, these condensed consolidated financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates. We are using the extended transition period for any other new or revised accounting standards during the period in which we remain an emerging growth company.
We will remain an emerging growth company until the earliest of (i) the last day of our first fiscal year (a) following the fifth anniversary of the completion of this offering, (b) in which we have total annual gross revenues of at least $1.07 billion or (c) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by non-affiliates exceeds $700 million as of the prior June 30th and (ii) the date on which we have issued more than $1 billion in non-convertible debt securities during the prior three-year period.
We are also a “smaller reporting company,” meaning that the market value of our stock held by non-affiliates is less than $700 million and our annual revenue is less than $100 million during the most recently completed fiscal year. We may continue to be a smaller reporting company if either (i) the market value of our stock held by non-affiliates is less than $250 million or (ii) our annual revenue is less than $100 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700 million. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Reports on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.
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JOBS Act Accounting Election
The JOBS Act provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act of 1933, as amended, for complying with new or revised accounting standards. In other words, an “emerging growth company” can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have irrevocably elected not to avail ourselves of this extended transition period and, as a result, we will adopt new or revised accounting standards on the relevant dates on which adoption of such standards is required for other public companies.
We have implemented all new accounting pronouncements that are in effect and may impact our financial statements and we do not believe that there are any other new accounting pronouncements that have been issued that might have a material impact on our financial position or results of operations.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.
Item 4. Controls and Procedures
(a) Evaluation of Disclosure Controls and Procedures and Changes in Internal Control over Financial Reporting
We conducted an evaluation under the supervision and with the participation of our management, including the Chief Executive Officer and Chief Financial Officer (our principal executive officer and principal financial officer, respectively), regarding the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) as of the end of the period covered by this report. Based on this evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures were effective as of June 30, 2022. We continue to review our disclosure controls and procedures and may from time to time make changes aimed at enhancing their effectiveness and to ensure that our systems evolve with our Company’s business. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met.
(b) Changes in Internal Control Over Financial Reporting
There was no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the quarter ended June 30, 2022 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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PART II - OTHER INFORMATION
Item 1. Legal Proceedings
From time to time in the ordinary course of our business, we may be involved in legal proceedings, the outcomes of which may not be determinable. The results of litigation are inherently unpredictable. Any claims against us, whether meritorious or not, could be time consuming, result in costly litigation, require significant amounts of management time and result in diversion of significant resources. We are not able to estimate an aggregate amount or range of reasonably possible losses for those legal matters for which losses are not probable and estimable. We have insurance policies covering potential losses where such coverage is cost effective.
We are not at this time involved in any legal proceedings.
Item 1A. Risk Factors
For a discussion of potential risks or uncertainties, see “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, on file with the SEC. There have been no material changes to the risk factors disclosed in such registration statement.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
None.
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Item 6. Exhibits
INDEX TO EXHIBITS
* | Filed herewith. |
(1) | The certifications on Exhibit 32 hereto are deemed not “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that Section. Such certifications will not be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Bluejay Diagnostics, Inc.
SIGNATURE | TITLE | DATE | ||
/s/ Neil Dey |
Chief Executive Officer and Director | August 10, 2022 | ||
Neil Dey | (on behalf of the registrant) | |||
/s/ Kenneth Fisher |
Chief Financial Officer | August 10, 2022 | ||
Kenneth Fisher | (principal financial and accounting officer) |
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